Medical knowledge | Medicine » Access to Medicine Index 2016

Source: http://www.doksinet Access to Medicine Index 2016 Source: http://www.doksinet ACCESS TO M E D I CI N E FO U N DATI O N The Access to Medicine Foundation is a non-profit organisation. It aims to advance access to medicine in low- and middle-income countries by stimulating and guiding the pharmaceutical industry to play a greater role in improving access to medicine. For ten years, the Foundation has been building consensus on the role for the pharmaceutical industry in improving access to medicine and vaccines. It published its first benchmark of industry activity in this area in 2008, in the first Access to Medicine Index, now in its fifth iteration. In 2017, the Foundation will publish the first Access to Vaccines Index, funded by the Dutch National Postcode Lottery. AD D R ESS Scheepmakersdijk 5a NL-2011 AS Haarlem The Netherlands CO NTAC T On behalf of the Access to Medicine Foundation, please contact Jayasree K. Iyer, Executive Director E jiyer@atmindex.org and

info@atmindexorg T +31 (0)23 53 39 187 W www.accesstomedicineindexorg FU N D E RS This report was made possible with financial support from the UK government, the Bill & Melinda Gates Foundation and the Dutch Ministry of Foreign Affairs. Source: http://www.doksinet Access to Medicine Index 2016 ACCESS TO MEDICINE FOUNDATION November 2016 Source: http://www.doksinet Access to Medicine Index 2016 ACKNOWLE DG E M E NTS The 2016 Access to Medicine Index has been made possible through collaboration with experts and specialists from across the access-to-medicine space.1 The Foundation is grateful for their time and expertise, and would like to thank them for providing valuable insights throughout the development of the 2016 Index. Funders Reviewers Bill & Melinda Gates Foundation Esteban Burrone The UK government Jennifer Dent The Dutch Ministry of Foreign Affairs Suzanne Hill Hans Hogerzeil Expert Review Committee Jillian Kohler Hans Hogerzeil (Chair) Niranjan

Konduri Sanne Frost Helt Suzanne Hill Regina Kamoga Other Contributors Richard Laing Sunday Kisoma Aurelia Nguyen Renée van Binsbergen Eduardo Pisani Dennis Ross-Degnan Research team Dilip Shah Danny Edwards Helena Viñes Fiestas Tara Prasad Clarke Cole Technical subcommittees Luca Genovese Peter Beyer Catherine Gray Esteban Burrone Suvi Karuranga Jennifer Dent Maike Nellestijn Jaime Espín Michele Forzley Editorial team Nick Chapman Jayasree K. Iyer Warren Kaplan Danny Edwards Jillian Kohler Anna Massey Niranjan Konduri Emma Ross Prashant Yadav 1 This acknowledgement does not infer that the individuals and institutions mentioned above endorse the Access to Medicine Index analyses or results. Decisions regarding the inclusion of feedback were made by the Access to Medicine Foundation. 4 Source: http://www.doksinet Access to Medicine Index 2016 A book of solutions People are living longer, healthier lives than ever The ranking provides the big

picture – which com- before. We continue to make progress toward pany is best, overall, at mobilising to reach the major public health goals: polio is close to being poor. Importantly, the Index is also a book of eradicated, as is guinea worm; more than 45% of potential solutions. We have identified good prac- people living with HIV/AIDS have access to ARVs; tices in almost all areas we measure. Which means important vaccines for malaria and dengue fever there is plenty companies can achieve without are being implemented. But at the same time, our going back to the drawing board – by expanding models for providing healthcare are leaving people good company practices to more products, coun- behind. Globally, two billion people cannot access tries, diseases and populations. The challenge is the medicine they need, most of whom live hand to ensure this knowledge benefits those with the to mouth. greatest need for change. Pharmaceutical companies, as the innovators

There is a social contract between pharmaceutical and producers of life-saving medicine, act early companies and the people who need their prod- in the value chain. When they take positive steps, ucts. Our research suggests that many people in the impact on access can be huge – with signifi- the industry are committed to fulfilling this con- cant savings for healthcare budgets, and of course, tract. But progress is slower than many of us in terms of improving human life and wellbeing. would like. It opens the door to questions about Without action by these companies, alongside gov- the benefits brought by new pharmaceutical prod- ernments, NGOs and others, it will be impossible ucts, the need to focus access activities vs diversi- to bring modern medicine to everyone. fying, and how best to include the poor in sustainable business models. At the Access to Medicine Foundation, we have been tracking the world’s largest research-based pharmaceutical companies for ten

years now, looking at how they bring medicine within reach of people in low- and middle-income countries. Since the first Access to Medicine Index in 2008, we have observed progress in many areas, from R&D to better IP-management and greater local activity in low-income countries. Leading companies have Jayasree K. Iyer held their top spots over the years by asking the Executive Director right questions, reviewing their paths and challeng- Access to Medicine Foundation ing themselves to keep improving, against a changing backdrop of stakeholder expectations and competing priorities. 5 Source: http://www.doksinet Access to Medicine Index 2016 Table of contents 2016 ACCESS TO M E D ICI N E I N D EX 79 CO M PANY RE PO RT CARDS – OVE R ALL R AN KI NG 80 GSK 9 How the industry performs 84 Johnson & Johnson 10 Leaders access strategies support the business 88 Novartis 11 Risers positioned for progress 92 Merck KGaA 11 Fallers overtaken by peers 96

Merck & Co., Inc 100 Sanofi 8 12 KE Y FI N D I NGS 104 AstraZeneca 12 Collaborative research models appear effective in engaging the 108 Gilead industry in developing urgently needed products with low com- 112 AbbVie mercial potential. 116 Novo Nordisk Good practice in making products affordable and available is 120 Eisai limited 124 Bayer Companies increasingly view access to medicine as a way to 128 Bristol-Myers Squibb develop their business in emerging markets. 132 Pfizer Six companies systematically match activities to local priorities 136 Takeda when strengthening health systems. 140 Boehringer Ingelheim 144 Eli Lilly 14 15 16 19 I N DUSTRY ANALYSES 148 Daiichi Sankyo 20 Research & Development 152 Roche 30 Product Deployment 156 Astellas 46 Governance & Compliance 54 Capacity Building 63 CO M PANY R AN KI NGS PE R TECH N ICAL ARE A 64 General Access to Medicine Management B EST & I N NOVATIVE PR ACTI CES

66 Market Influence & Compliance General Access to Medicine Management 68 Research & Development See pages 47, 48, 49, 50, 52, 90, 94, 102, 106, 118, 70 Pricing, Manufacturing & Distribution 122, 134, 142, 146, 72 Patents & Licensing 74 Capacity Building Market Influence & Compliance 76 Product Donations See pages 51, 52, 82, 98, 102, 110 161 APPE N D I CES Research & Development 162 Methodology scopes See pages 26, 27, 82, 86, 90, 94, 98, 102, 106, 122, 165 Stakeholder engagement 2015 134, 154 166 Ranking, scoring and review process 168 Identifying best practices & innovations Pricing, Manufacturing & Distribution 169 Indicators and Scoring Guidelines See pages 32, 34, 36, 37, 83, 87, 91, 107, 111, 119 185 List of figures 186 Definitions Patents & Licensing 187 Report card analysis: further explanation See pages 38, 40, 41, 83, 95, 107, 111, 131 188 Priority countries 190 Acronyms Capacity Building See

pages 16, 57, 58, 59, 60, 83, 91, 95, 99, 103, 107, 127, 135, 147 Product Donations See pages 41, 111, 131 6 Source: http://www.doksinet Access to Medicine Index 2016 About this report The Access to Medicine Index analyses 20 of the FR AM EWO RK O F ANALYSIS worlds largest research-based pharmaceutical The 2016 Index used a framework of 83 metrics to measure company companies on how they make medicines, vaccines performances relating to 51 high-burden diseases in 107 countries. For and diagnostics more accessible in low- and mid- the 2016 Index, the weight of the performance pillar was increased to dle-income countries. It highlights best and inno- 50%. The framework is reviewed every two years, with reference to the vative practices, and areas where progress has Expert Review Committee of independent experts, from, among others, been made and where action is still required. It the WHO, governments, patient organisations, the industry, academia has been published

every two years since 2008. and investors. This process ensures that Index metrics express what Methodology Framework stakeholders expect from pharmaceutical companies. What the Index analyses 15% 25% 50% 10% Commitments Transparency Performance Innovation 10% General Access to Medicine Management 10% Market Influence & Compliance 20% Research & Development The Index analyses data gathered via a detailed survey of pharmaceutical company behaviour regarding access to medicine. The period of analysis for this Index is 1 June 2014 to 31 May 2016. Once data is submitted by the companies in scope, it is verified, cross-checked and supplemented by the Foundation’s research team using public databases, sources and supporting documentation. The research team scores each company’s performance per indicator, before analysing industry progress in key areas. Pricing, Manufacturing & Distribution 25% New in 2016: sharper analysis of needs The 2016 Index has a

sharper focus on whether companies target their actions toward the people with the greatest need for better access to Patents & Licensing 15% medicine. For example, in pricing, the Index examines whether com10% Capacity Building 10% Product Donations panies price products fairly in the countries with the greatest need for those specific products. In R&D, it looks at whether companies are developing products that are urgently needed, yet offer little commercial incentive. S EC TI O N S I N TH I S R E PO RT The Index findings are presented at various levels in the following order: 1) Overall Ranking and Key 2) Four industry-level analyses 3) Seven company subrankings 4) Company Report Cards Findings The four analyses cover: Research Each subranking compares The 20 report cards each provides This section includes the 2016 & Development for people in how companies perform in one the most detailed overview of each Overall Ranking of pharmaceutical low- and

middle-income coun- Technical Area, across four dimen- company’s performance in the companies, and summarises how tries; Product Deployment, using sions: Commitments, Transparency, 2016 Index. They include best and the industry has performed across pricing, licensing and donations; Performance and Innovation. innovative practices and a detailed all areas measured. It sets out the Governance & Compliance, and analysis of the company’s portfo- drivers behind changes in ranking; how closer integration of these lio and pipeline for high-burden the reasons why companies place policy areas can benefit access to diseases. high or low in the Index; and the medicine; and whether companies Key Findings identified in 2016. match Capacity Building activities to local priorities. 2,93 4 5 4 Novartis AG 6 Merck KGaA Sanofi 15 AstraZeneca plc. 2,53 8 5 Gilead Sciences Inc. 2,45 9 9 AbbVie Inc. 2,39 2 Novo Nordisk A/S 2,35 11 Eisai Co., Ltd 2,34

10 Bayer AG 2,03 11 13 13 Bristol-Myers Squibb Co. 1,97 16 Pfizer Inc. 1,87 15 20 Takeda Pharmaceutical Co., Ltd 16 14 Boehringer Ingelheim GmbH 17 17 Eli Lilly & Co. 18 19 Daiichi Sankyo Co., Ltd 19 12 Roche Holding AG 20 18 Astellas Pharma Inc. tial (or tiered) pricing, discounts, flat prices, price caps, floor prices, nonprofit models, responding to tenders, dual/local branding, managed entry Pharmaceutical companies report 850 1,67 3 4 analysis will continue to shape price adjustments for respiratory and cardiovascular disease products in these now have equitable pricing strategies. gies, despite their being seen as particu- markets. AstraZeneca has also cre- Many products have multiple strategies, larly important for increasing affordabil- ated an internal Affordability Centre of ity where there is high socio-economic to maximise patient access and affordability. One of its key roles is to integrate the case in many large MICs.

ability-to-pay analysis into everyday busi- ing strategy and how to integrate it into their processes. AstraZeneca’s International Region busiability-to-pay analysis in certain coun- ness division has conducted an in-depth Lower ranked companies have each Roche* and Astellas. Roche is less their use of intra-country equitable improved in at least one measure, transparent than its peers, yet it pricing (where affordability is consid- the 2016 Index used tougher meas- new access initiatives and strong ures than in 2014. Change by these processes for ensuring compliance. While Astellas shows some A third (280 out of 850) of products Looking across all 280 products with Companies are targeting middle-income improvements, such as a new on the market for high-burden diseases equitable pricing strategies (including countries (MICs) more frequently than pledge not to enforce IP rights have at least one equitable pricing strat- those that target no priority countries),

low-income countries (LICs): companies even where commercial incentives (albeit those considered key for and rose from 20th place, and in certain poor countries, these egy. However, only 187 (67%) of these companies target only 20% of the prior- took 25% of the opportunities to target are lacking. Their access strategies access). AstraZeneca joins the top Bayer, which lost ground as others were not sufficient to avoid being products are equitably priced in one or ity countries they could potentially have a priority MIC, vs 18% of the opportu- improved. overtaken. support commercial objectives, with clear business rationales. ten, with an expanded access strategy and notable pricing practices. *Merck & Co., Inc is known as MSD outside the US and Canada Merck KGaA’s healthcare division is known as EMD Serono in the US and Canada. 8 *Roche declined to provide data to the 2016 Access to Medicine Index. It referred to the fact that oncology, which is not in the

Index scope, is its main focus for improving access to medicine. Roche has been included in the Index as it can also improve access in areas in scope where it has products and expertise. Publically available data, along with information from past submissions, were used to assess its performance sidering socio-economic factors in its six laggards. Companies on higher pricing strategies: it consistently con- rankings tend to engage in more struc- leader in absolute terms, with 10 prod- siders an average of three. It considers the following factors most frequently: more priority countries. On average, the reached (621 out of 3,036). Priority nities to target a priority LIC. It is par- strategies for each of these 187 prod- countries are those with people with a ticularly concerning that LICs are being ucts target just three priority countries. high need for the product in question Depending on the disease, each strat- (See box on page 32). overlooked, as people living in

these countries generally have a low ability egy has an average of ten priority coun- to pay out of pocket, and public sector tries that it could target. financing is limited. 34 tured donation programmes, of a broader scale and scope. They take on a greater level of responsibility with of donation programmes. come countries), Only 44 (5%) products out of 850 have a strategy that 2016 2014 280 700 95 61 570 .including with price differentiation within countries .including in at least one priority country* Eisai Co., Ltd 5 Novartis AG 4 10 8 = 8 11 16 12 7 ble diseases are focusing more on spe- 17 cific target groups and on adapting to a 44 single country context. The Index now provision of financial assistance to local .and with at least one socio-economic factor taken into account. Johnson & Johnson 9 7 tions since 2014. Companies continue includes philanthropic activities (the Products priced equitably. 6 14 6 to donate medicines for

Neglected extended. Programmes for communica34 850 470 5 1 programmes being expanded and 185 5 = 13 Tropical Diseases (NTDs), with NTD 230 4 9 Overall, there have been only minor shifts in industry activity in product dona- Figure 4. True needs-based pricing ismany limited particularly important where inequality is high (e.g, in large middle-in- 3 10 meet the key criteria looked at by the Index and applies in even one priority country*. organisations) under Capacity Building. 3.5 3.5 2 4. 0 Donations 0 reaches a comparatively high number Leader 1 2 3 4 Eli Lilly & Co. 2.4 Roche Holding AG 2.3 2.3 Bristol-Myers Squibb Co. 1.9 AstraZeneca plc 1.8 18 Takeda Pharmaceutical Co., Ltd 15 Boehringer Ingelheim GmbH 20 Daiichi Sankyo Co., Ltd 1.7 1.6 1.1 1.1 Astellas Pharma Inc. 2014 0 Commitments 1 Transparency 2 3 Performance 4 5 Innovation ing and capacity building. However, GSK falls back in compliance: eg, it was found to have

breached criminal law in China R&D for low- and middle-income countries, bases R&D part- for bribery. GSK has taken steps to prevent such breaches in nerships on access-oriented terms, and has the most R&D the future, including eliminating individual sales targets. CHANGE SINCE 2014 • Has new policy for mitigating risks of conflicts expanded its lymphatic filariasis (LF) These three companies, together with Eisai, Novartis, Pfizer and Merck KGaA, programme, which also has a rigorous monitoring and auditing system. Pfizer comprise the leading group. All seven has increased the scale and scope of donate medicines both ad hoc for emer- its structured donation programmes, for onchocerciasis. Merck & Co, Inc’s gency relief and through structured and has put standardised procedures commitment to eliminating NTDs donation programmes. Importantly, all in place for engaging with international Products without equitable pricing 570 850 Products with 93

equitable pricing, but not in a priority country Opportunities taken Opportunities missed where equitable pricing strategies exist (all products, diseases, and strategies) seven work with international organi- the London Declaration: it has a struc- sations in their donation programmes, tured donation programme that works tracking the reception of donated prod- 35 organisations and NGOs. Middle group lacks stringent monitor- toward the global eradication of rabies. ucts and requiring regular reports from ing and auditing requirements Johnson & Johnson runs the largest of interest following recruitment from the public sector. commitments, and toward one to improve clin- partners on results and outcomes of the number of donation programmes: it has • Commits to disclosing the status of its patents in the future. ical trial data transparency. related to corruption and unethical marketing multiple times, including a breach of criminal • Signed the Declaration by

the Pharmaceutical, Biotechnology and Diagnostics Industries on or enforcing patents in Least Developed Countries and low income countries (LICs). Combating Antimicrobial Resistance. law in China for bribery. 2012* 2013* Europe 2014 USA 2015 Other 9 obstructive pulmonary disorder and HIV/AIDS. countries in scope: with 113 medicines and vac- Its diverse pipeline targets all four disease cat- cines, and 57 R&D projects. It has a wide range egories in scope. Since 2014, ten of GSK’s R&D of off-patent products that are still relevant for 52 113 45 projects progressed along the pipeline: including vaccines for paediatric respiratory syncyt- for soil-transmitted helminthiasis, amitriptyline Communicable development. Many of its R&D projects target Non-communicable Neglected tropical Multiple categories Maternal and neonatal high-priority product gaps with low commercial GSK’s portfolio includes products for multiple incentive, including its

preventive vaccine can- ischaemic heart disease. 4 1 ial virus and malaria, which moved into clinical for unipolar depressive disorders and migraine prophylaxis, amoxicillin (Amoxyl®) for infec- didates for HIV/AIDS, malaria, TB, typhoid fever infectious diseases, HIV/AIDS, neglected tropical and shigellosis. diseases (NTDs) and mental health conditions. Pipeline projects innovative approach to building R&D capacity in Africa that targets local skills gaps. First-line treatments and essential medicines 42% 0 23% 10 20 30 40 In partnership, with access provisions (ap) status of all of its products, providing informa- Continue to target known needs through inno- 35% 50 60 59 70 80 In partnership, w/o ap 90 100 Not in partnership GSK has multiple R&D partnerships based on terms for ensuring access to 14 0 20 40 10 60 80 First-line & on WHO Essential Medicines List 28 100 First-line only 120 140 On WHO-EML only Other A high

proportion of GSK’s relevant products are listed on the WHO EML systems. GSK has introduced innovative initia- tion on where each product has been filed for vative and adaptive R&D. GSK should leverage successful products. Together these cover all disease categories, with part- and/or as first-line treatments: e.g, abacavir (Ziagen®), lamivudine (Zeffix®) tives and policies to strengthen its compliance registration and where it has been approved, as its strength at engaging in R&D that addresses ners including Fiocruz, Johnson & Johnson and Monash University. and fluticasone (Flixotide®). Pipeline by stage of development Adaptive medicines and vaccines with laws and regulation. It has an opportunity well as the dates of registration, per country. global health priorities. The company can con- Operationalise new commitment to engaging target defined, high-priority product gaps. to further foster innovation in this area, and to share its findings with

the industry. tinue to develop diverse product types that in voluntary licensing. GSK can actively identify Provide pricing guidelines to third-party sales CD 2 5 2 2 Ensure access to products on the WHO EML. NTD agents. GSK can provide pricing guidelines as non-exclusive voluntary licensing of products GSK has one of the largest numbers of prod- MNH a standard practice to third-party sales agents for high-burden diseases outside of HIV/AIDS. ucts on the WHO Model Essential Medicines (distributors, wholesalers, etc.) in low- and mid- generic medicine manufacturing partners for the Possible products could include fluticasone furo- List (EML). GSK can evaluate access barri- There are seven companies in the dle-income countries, depending on the local ate (Flixotide®) and salbutamol (Ventolin®), ers to these products in all low- and middle-in- programmes. middle pack: Sanofi, Bayer, AbbVie, market, supply chain, and legal and regulatory both first-line

treatments for respiratory dis- come countries. It can ensure their availabil- Eisai and Pfizer are two of the biggest Roche. All seven, like the leaders, risers in this Technical Area. Eisai has commit to ensuring donation activities Novo Nordisk, Eli Lilly, Gilead and Among its most recently registered products are first-line treatments for asthma, chronic income countries (LMICs). • Increases capacity building efforts, with an OPPORTUNITIES Continue innovating to strengthen compliance 2011 Rest of world Products per disease category GSK has one of the largest portfolios of relevant products, and a similarly large pipeline of (via WIPO Re:Search). strategies than in 2014. period of analysis. 76 14,166 MN Corporate and other unallocated turnover *Revenue from divestments. PORTFOLIO AND PIPELINE tious diseases and clopidogrel (Gridokline®) for • Commits to licensing products in lower-middle • Has multiple new R&D IP-sharing agreements • Has more

products with equitable pricing oncology portfolio to Novartis in return. As part of the deal, the two companies created a new 26,000 24,000 22,000 20,000 1 8,000 1 6,000 1 4,000 1 2,000 1 0,000 8,000 6,000 4,000 2,000 0 consumer healthcare business, with GSK retaining majority control. ture with Pfizer and Shionogi focused on the diseases in scope: e.g, albendazole (Zentel®) • Publishes a new policy on not filing for • Was found to have breached laws and codes areas. Two were launched during the six programmes covering three disease Opportunities missed as there is no equitable pricing strategy (all products and diseases) of HIV/AIDS medicines. In 2014, the company acquired Novartis’ vaccine business (excluding its influenza vaccines), and divested its marketed ogy, immuno-inflammation, respiratory and rare diseases. Sales in emerging markets account projects that address the needs of people in • Has made progress toward four specific R&D pricing practices.

of beneficiaries and countries through extends beyond the diseases listed in research, development, and commercialization maceuticals, vaccines and consumer healthcare. Its core areas of research in pharmaceuticals are: HIV/AIDS and infectious diseases, oncol- cine strategy that aligns with its corporate strategy, and company-wide ownership and accountability for access. Its leadership is reflected in many areas: it has clearly committed to • Improves its accountability for its sales agents’ the Mectizan® donation programme 5,700 8,736 SALES AND OPERATIONS GSK operates through three divisions: phar- for approximately 25% of total sales. GSK holds Opportunities to target priority countries with equitable 2,415 0 a 77.4% stake in ViiV Healthcare, a joint ven- more than 8,000 opportunities to target a priority country with an afforda- 621 Commitments Transparency Performance Innovation equitable pricing strategies, and is a leader in voluntary licens- bility scheme.

pricing strategies average PERFORMANCE projects that target independently identified, high-priority For each disease in scope, the Index has identified priority countries with a Products with equitable pricing in 187 at least one priority country 5 Not in scope average product gaps. It leads in product donations and in applying particular need for greater access to related products). Combined, these 280 Products with equitable pricing strategies in priority countries 1 leader Turnover by geographic region GSK is in 1st place for the fifth time. It is the most access-ori- programme has the largest scope and scale, although Merck & Co., Inc products on the market for diseases in scope, this accounts for only 7% of GBP 23,923 MN Consumer Healthcare In scope, has sales In scope, has no sales ented company in the Index, with a clear access-to-medi- Gilead Sciences Inc. 17 3. 4 3. 7 Vaccines 3 3.0 2.7 2.6 GSK, Merck & Co., Inc and Johnson try. Only 20% of

these opportunities were taken (621) Looking at all 850 72 MN 6,028 MN 3,657 MN Pharmaceuticals Leader Leader 3.5 Novo Nordisk A/S 17 19 = 19 Patents Capacity 3.5 AbbVie Inc. 11 18 3. 6 3. 2 3.2 Bayer AG 12 16 R&D Pricing & Johnson take the top three ranks. equitable pricing strategies had 3,036 opportunities to target a priority coun- Turnover by segment (2015) 4 Sanofi 15 2016 2. 2 Merck KGaA 14 13 4. 2 Compliance 3.8 Pfizer Inc. Leaders commit to tackling NTDs *Priority countries are disease-specific: for each disease in its scope, the 2016 Index has identified countries with (a) high burdens of the disease and high inequality; and (b) low-income levels. gies, including 187 with a strategy that applies in at least one priority country. companies has been incremental. Exceptions are Takeda, which launched a new access strategy companies (those with fewer than 50 marketed products), AstraZeneca is the Out of all products for diseases in

scope, 280 have equitable pricing strate- this group. Novo Nordisk falls to 10th place. Its solid access framework applies to few products 3.8 Figure 18. Most opportunities to match pricing actions to need are overlooked tries. This has shaped the division’s new pricing policy, which now takes account H IG H - N E E D PO PU L ATIO NS ARE OVE RLOO KE D BY PRICI NG STR ATEG I ES identified priorities in the access agenda. For example, they invest in R&D for urgently needed products, 4.0 Merck & Co., Inc ucts that meet this criteria. Access to Medicine Index 2016 Sales in countries in scope Ranking by strategic pillar GSK’s lymphatic filariasis donation advances in other measures, with ment in access to medicine. There have been two significant shifts in GlaxoSmithKline plc 2 diseases in question. It has seven mar- up a portal to train staff on its new pric- AstraZeneca analyses populations’ ability to pay do not have equitable pricing strategies.

Companies have also not expanded ing companies in the top ten each 3 2 = keted products with equitable pricing ness practice. The company has also set I N N OVAT I O N ing still hovers around one third. Most products for high-burden diseases still show strength in at least one area, companies show needs-orientation, matching actions to externally 1 these still respresent a third of all 850 products on the market, and their use Excellence, which has a regional team inequality, limited public financing and a lack of universal health coverage. This is heart disease, lower respiratory infections and HIV/AIDS. However, the pro- GSK leads for the fifth time ahead and withstood closer scrutiny: within a country). As in 2014, approximately a third of products with equi- portion of products with equitable pric- The scores are spread widely, with three groups: seven leaders, followed by a middle group of seven and then of price differentiation within countries remains static.

Such strategies are Management Company ranking Product Donations fied during methodology development. regard to the monitoring and auditing table pricing have intra-country strate- Figure 38. GSK is the leader when it comes to con- Figure 17. True needs-based pricing is limited There are more products with equitable pricing strategies than in 2014. Yet, countries. The diseases with the most Capacity Building Product Donations target 31% of the priority countries for the diseases in question. Of the smaller 10 of affordability in these markets. The products on the market for high-burden of Johnson & Johnson, Novartis yet have room to deepen engage- 5 equitably priced products are: ischaemic Research & Development Pricing, Manufacturing & Distribution LOWEST R AN KI N GS Lagging furthest behind are evant portfolio. Together, the strategies Together, strategies for these products reach 77% of priority countries for the strategies that target priority

countries. 0 General Access to Medicine Management 5 I N CR E M E NTAL I M PROV E M E NTS and Merck KGaA. Critically, these Epilepsy Contraceptive methods Market Influence & Compliance Patents & Licensing 1,32 2 I N TH E TO P TE N Following the first four, the remain- take these eight factors into account, alongside a further nine factors identi- ple disease indications. ered for multiple population segments diseases. More products than in 2014 for example, for different regions and 1,70 1,61 1,36 1 LE AD E RS S E E B US I N ESS R ATI O NALE I N ACCESS in question. In turn, Novartis has 35 products, accounting for 49% of its rel- GlaxoSmithKline plc 5 HOW TH E CO M PAN I ES PE RFO RM Gilead has the highest proportion of products (50%) with equitable pricing 3.43 Stock Exchange: XLON • Ticker: GSK • HQ: Brentford, UK • Employees: 101,255 PRODUCT DONATIONS This figure shows the number of products per disease with equitable pricing. Products may

have multi- agreements and patient assistance 1,77 0 Asthma programmes. More products have equitable pricing consider when setting prices. In 2016, the Index analysed which companies strategies that target priority countries. Cirrhosis of the liver ing approaches in low- and middle-in- 2,65 2,58 14 Hypertensive heart disease Chronic obstructive pulmonary disease (COPD) come countries: including differen- 2,83 Merck & Co., Inc* 8 7 Diabetes Companies use a wide range of pric- 2,87 7 6 10 12 HIV/AIDS lio. Together, the strategies target 35% of the priority countries for the diseases SCO RE 1= Ranking by technical area socio-economic factors that companies Leaders in targeting high-burden, high-inequality, low-income countries RA N K 1 (2014) Product Donations MN GBP 3,43 Johnson & Johnson accounts for 39% of its relevant portfo- Ischaemic heart disease Lower respiratory infections Access to Medicine Index 2016 Access to Medicine Index 2016

TECH N ICAL ARE A ANALYSIS 1 .0 GlaxoSmithKline plc. 3 to assess people’s ability to pay. This depends on multiple socio-economic factors. The 2014 Index identified eight for a disease in scope. 1 socio-economic factors To ensure affordability, companies need in absolute and relative terms. GSK has 41 products with equitable pricing strategies that target priority countries. This in scope. Astellas is the only company 2 Most companies pay little attention to with more than 50 marketed products), GSK and Novartis are the leaders, both ing), companies take only 7% of the opportunities to target a priority coun- that does not yet use equitable pricing 1 Among the largest companies (those market for high-burden diseases (including those without equitable pric- try with an equitable pricing strategy. Takeda is the most recent company to 3 strategies In 2016, ischaemic heart disease has risen to replace HIV/AIDS as the disease with the most products engage: it now has

inter-country equitaACCESS TO M E D I CI N E I N D EX 2016 – OVE R ALL R AN KI NG Figure 16. Top 10 diseases with the most products with equitable pricing with equitable pricing. ble pricing strategies for five products Figure 1 Access to Medicine Index 2016 Looking at all 850 products on the of companies using equitable pricing strategies has increased steadily: from 16 in 2012, to 18 in 2014, to 19 in 2016. 3.4 Access to Medicine Index 2016 Increase in use of equitable pricing Over the past four years, the number 4.0 Access to Medicine Index 2016 Access to Medicine Index 2016 Overall Ranking 3.8 7 Technical Areas 4 Strategic Pillars 5 10 Innovative medicines and vaccines 4 NTD MNH NCD NCD Multiple 0 Discovery 2 9 CD 2 2 Multiple 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market

Approval systems. eases listed on the WHO Model Essential Medicines List (EML). In support of this commit- the availability of alternative products in specific GSK’s innovative pipeline includes several maternal and neonatal health pro- GSK is adapting a range of products, including paediatric formulations, fixed- Publish information about products’ registra- ment, GSK can also fulfil its commitment to dis- countries. jects: retosiban for spontaneous pre-term labour, a maternal vaccine for res- dose combinations and products with new routes of administration. It is tion status. GSK can publish the registration close patent statuses. piratory syncytial virus and a Group B Streptococcus vaccine. adapting a component of its candidate malaria vaccine for thermostability. 80 ity and affordability, aligning with demand and 81 7 Source: http://www.doksinet Access to Medicine Index 2016 Access to Medicine Index 2016 Overall Ranking Figure 1 ACCESS TO M E D ICI N E I N

D EX 2016 – OVE R ALL R AN KI NG 1 1 GlaxoSmithKline plc. 3,43 2 3 Johnson & Johnson 2,93 3 4 Novartis AG 2,87 4 6 Merck KGaA 2,83 5 7 Merck & Co., Inc* 2,65 6 8 Sanofi 2,58 7 15 AstraZeneca plc. 2,53 8 5 Gilead Sciences Inc. 2,45 9 9 AbbVie Inc. 2,39 10 2 Novo Nordisk A/S 2,35 11 11 Eisai Co., Ltd 2,34 12 10 Bayer AG 2,03 13 13 Bristol-Myers Squibb Co. 1,97 14 16 Pfizer Inc. 1,87 15 20 Takeda Pharmaceutical Co., Ltd 1,77 16 14 Boehringer Ingelheim GmbH 1,70 17 17 Eli Lilly & Co. 1,67 18 19 Daiichi Sankyo Co., Ltd 1,61 19 12 Roche Holding AG 1,36 20 18 Astellas Pharma Inc. 1,32 0 1 2 3 4 General Access to Medicine Management Market Influence & Compliance Research & Development Pricing, Manufacturing & Distribution Patents & Licensing Capacity Building Product Donations 5 LE AD E RS S E E B US I N ESS I N TH E TO P TE N I N CR E M E NTAL LOWEST R AN KI N GS R ATI O

NALE I N ACCESS Following the first four, the remain- I M PROVE M E NT S Lagging furthest behind are GSK leads for the fifth time ahead ing companies in the top ten each Lower ranked companies have each Roche* and Astellas. Roche is less of Johnson & Johnson, Novartis show strength in at least one area, improved in at least one measure, transparent than its peers, yet it and Merck KGaA. Critically, these yet have room to deepen engage- and withstood closer scrutiny: advances in other measures, with companies show needs-orienta- ment in access to medicine. There the 2016 Index used tougher meas- new access initiatives and strong tion, matching actions to externally have been two significant shifts in ures than in 2014. Change by these processes for ensuring compli- identified priorities in the access this group. Novo Nordisk falls to companies has been incremen- ance. While Astellas shows some agenda. For example, they invest in 10th place. Its solid

access frame- tal. Exceptions are Takeda, which improvements, such as a new R&D for urgently needed products, work applies to few products launched a new access strategy pledge not to enforce IP rights even where commercial incentives (albeit those considered key for and rose from 20th place, and in certain poor countries, these are lacking. Their access strategies access). AstraZeneca joins the top Bayer, which lost ground as others were not sufficient to avoid being support commercial objectives, ten, with an expanded access strat- improved. overtaken. with clear business rationales. egy and notable pricing practices. *Merck & Co., Inc is known as MSD outside the US and Canada Merck KGaA’s healthcare division is known as EMD Serono in the US and Canada. 8 *Roche declined to provide data to the 2016 Access to Medicine Index. It referred to the fact that oncology, which is not in the Index scope, is its main focus for improving access to medicine. Roche

has been included in the Index as it can also improve access in areas in scope where it has products and expertise. Publically available data, along with information from past submissions, were used to assess its performance Source: http://www.doksinet Access to Medicine Index 2016 H OW TH E I N DUSTRY PE RFORMS Overall, moderate progress is visible in diseases in scope can be made more national challenges, with eight com- the pharmaceutical industry’s efforts accessible to the poor. panies signing on to a new Industry to improve access to medicine, espe- Roadmap for Progress on Combating cially when it comes to refining the way Matching action to needs Antimicrobial Resistance. Collaborative access activities are organised, devel- Access-to-medicine strategies with research models, including with the opment of relevant products, waiving of the greatest potential impact are those public sector, appear to be effective patent rights in the poorest countries, aimed

at addressing high-priority needs. in engaging the industry in developing and granting manufacturers licences to The 2016 Index has assessed the extent urgently needed products when there make generic versions of their products. to which a company’s access operations is low commercial incentive for a single Across the areas the Index measures, are needs-oriented, and where actions company to address the need alone. there have been new or expanded initia- match specific priorities identified by, tives and commitments. for instance, countries, the global health From pipeline to patient community or the Index. Companies vary in what areas they However, some areas are static. For focus their efforts on when it comes to example, there has been no progress in In R&D, this means developing products moving products from the pipeline to a key measure of affordability – the pro- to meet the needs of people in low- the patient. A few are seeking registra- portion

of products covered by pricing and middle-income countries, whether tion of their new products in countries schemes that take into account the abil- or not there is a market. When prod- where they are particularly needed, rap- ity to pay. In addition, more can be done ucts gain marketing approval, it means idly and transparently, but this good when it comes to developing access ensuring products are registered where practice is limited across the industry. plans in the R&D stage to ensure prod- they are needed, and then considering All companies apart from one have now ucts can be more quickly and widely affordability for different people in dif- engaged in equitable pricing. While this deployed once they emerge from the ferent countries when setting prices. It consideration of affordability is a pos- pipeline, and in registering new prod- also means targeting locally identified itive sign, its application is limited; the ucts in the countries where they are

priorities when strengthening health proportion of products covered by such most needed. systems in low- and middle-income pricing strategies is static at one-third. countries. Across these areas, the analyIn many companies, the way access-to- sis reveals uneven performance. medicine activities are managed is More companies now waive patent rights to certain products in specific maturing. More companies (17) have High-priority R&D regions. New voluntary licences have strategies for increasing access to med- More than 100 products for high-bur- been agreed for seven additional com- icine, and many (12) also view access as den diseases have entered company pounds since 2014. Most of these are a way of developing business in emerg- pipelines since 2014. R&D is one area for HIV/AIDS but, for the first time, ing markets. A few companies (5) are where there is evidence that the indus- such licences have been extended to a piloting new business models that aim

try is responding to externally iden- second disease (hepatitis C). They also to reach low-income populations. tified needs. The G-FINDER tool has cover more countries than in 2014, but identified 84 product gaps – where their full potential remains untapped, The pharmaceutical industry is very there is urgent need but low commer- especially in middle-income countries. diverse and this is reflected in the way cial incentive to engage in R&D – that companies approach access to med- relate to diseases covered by the Index. Most companies are building a range icine, which access challenges they Companies are addressing 31 of these of health system capacities in low- and choose to address and how, and which gaps, through developing 151 products. middle-income countries. Only six are products they focus on. The direction of However, six companies account for demonstrating a consistent response to the Index is to assume that every prod- the bulk of this

activity. Meanwhile, the specific needs by matching those activi- uct for the high-burden and neglected industry continues to respond to inter- ties to locally identified priorities. 9 Source: http://www.doksinet Access to Medicine Index 2016 LE AD E RS ACCESS STR ATEG I ES SU PPO RT TH E BUSI N ESS LE AD E RS PE R FO R MAN CES PE R TECH N I C AL AR E A The top four companies in the Index 2 N D PL ACE : J O H N SO N & J O H N SO N have well-organised access pro- Johnson & Johnson, in 2nd place, has grammes driven by strong leadership established a new Global Public Health developed over years of building exper- organisation, to address global health tise. Their access strategies have a busi- problems in specific disease areas. The ness rationale and support their market company demonstrates deepened com- development goals with models that mitment through the establishment of view low- and middle-income popula- its global public health strategy, which

tion segments as target markets, which links product development, manufac- increases their sustainability. Leading ture, distribution and capacity building. companies conceive of innovative busi- It has the largest relevant pipeline of all ness models and commit to future companies (tied with GSK) and it shows activities, and then follow through, consideration of need, for example in implementing plans and scaling up ini- how it applies socio-economic factors tiatives. An important distinguishing when setting prices. characteristic is that they are showing they address need – albeit inconsist- 3rd place: Novartis ently. They invest in R&D that is respon- Novartis, ranked 3rd, has a strategic and sive to low- and middle-income coun- systematic approach to access that is try needs. This responsiveness to need embedded in its corporate strategy. Its is, to some extent, reflected in how and access-to-medicine strategy is tailored where they deploy their

products once to address all socio-economic seg- they gain regulatory approval. ments of the population and it has one of the strongest relevant pipelines. For 1st place: GSK example, its recently launched Novartis GSK remains in 1st place for the fifth Access business model shows a pre- time. It is clear that GSK views access paredness to take calculated risks in to medicine as a way of developing and reaching more people, while its access driving business in emerging markets. management approach is more closely It has also consistently shown, over the aligned with stakeholder expecta- previous five Indices, that it addresses tions than that of any other company. urgent public health needs through Novartis is the overall leader in capacity access policies and practices. building, showing the most consistent consideration of local needs in these It follows commitment by action: its activities. well-publicised strategic focus on GSK: scores 3.43 overall

Management 4. 2 Compliance 2. 2 R&D 3. 6 Pricing 3. 2 Patents 3. 4 Capacity 3. 7 Leader Leader lead 4. 0 Donations 0 Leader 1 2 3 4 avera Johnson & Johnson: scores 2.93 overall Management 3. 9 Compliance 2. 3 R&D 3. 3 Pricing 2. 6 Patents 2. 1 Capacity 3. 1 lead 3. 8 Donations 0 1 2 3 4 5 avera Novartis: scores 2.87 overall Management 4. 9 Compliance 1 .6 R&D 3. 2 Pricing 2. 5 Patents 1 .4 Capacity 4. 0 Leader Leader increasing access to medicine is trans- 4th place: Merck KGaA lated into numerous initiatives and pro- Merck KGaA, in 4th place, has risen up grammes across all areas measured by the ranking for the fourth consecu- the Index. GSK is developing the most tive Index. It has shown best practice, R&D projects that target high-prior- for example, in aligning its access-re- ity product gaps with low commer- lated targets with the Sustainable cial incentive. It tops the Index for con-

Development Goals, demonstrating sidering affordability when setting its responsiveness to external priori- prices, and comes a close second in ties. More than half its pipeline targets the access-enabling management of non-commercial product gaps, making IP. It is a leading performer in address- it one of the companies with the high- ing needs when it builds capacity, espe- est proportion of such projects. Its con- cially in pharmacovigilance and R&D. It sideration of need is evident in its com- was found to have breached corruption paratively good practice in register- laws in China during the period of anal- ing new products in some high-burden ysis. It followed this with new policies countries, and in the extent to which it and practices designed to improve com- adapts brochures and packaging to suit The overall score is calculated using a weighted pliance with laws and standards. local needs. combination of scores per technical area. 10 5 lead 3. 5

Donations 0 1 2 3 4 5 avera Merck KGaA: scores 2.83 overall Management 3. 6 Compliance 2. 2 R&D 3. 4 Pricing 2. 3 Patents 2. 5 Capacity 2. 8 Donations 3. 5 0 lead 1 2 3 4 5 avera Source: http://www.doksinet Access to Medicine Index 2016 RISE RS POSITI O N E D FO R PROG RESS Two companies have made a signifi- ing affordability-based pricing to more It launched a new access-to-medicine cant leap in performance: AstraZeneca products than in 2014. It has also exten- strategy that supports its overall busi- and Takeda. They have extensively sively updated and expanded its access ness strategy. Takeda has specific R&D expanded and updated their access strategy, which it operationalises in part targets related to access to medicine, strategies, identifying those areas through its Healthy Heart Africa pro- and shares IP with researchers for leish- where they are best placed to provide gramme. AstraZeneca takes a transpar- maniasis and

Chagas disease. It has also support, and are now well-positioned ent approach to IP management, dis- recently implemented pricing strate- for future progress. closing how and where it will enforce gies that differentiate between coun- patents or issue licences, and disclosing tries based on income levels and newly patent statuses. commits not to file for or enforce pat- Rises eight: AstraZeneca AstraZeneca is one of the biggest risers, ents in sub-Saharan Africa. It has also climbing eight positions into the top Rises five: Takeda progressed in its capacity building 10. It has improved in multiple areas, Takeda is one of the biggest risers, activities. including introducing a new affordabil- moving five places to 15th, with signif- ity-based pricing strategy and expand- icant improvement in multiple areas. FALLE RS OVE RTAKE N BY PE E RS Novo Nordisk, Roche and Gilead have as it can also improve access to the experienced the most significant drops other

important products in its portfo- in ranking. There are different reasons lio. Information from public sources and for their position changes, including past submissions were used to assess The Access to Medicine Index exam- being overtaken by peers with deeper its performance. Roche has strong ines how companies perform in performances and greater transparency. enforcement processes for ensur- seven areas: ing compliance, yet its approach to • General Access to Medicine LO O KI N G D E E PE R Falls three: Gilead IP-management remains static. It does Gilead has fallen three places, from 5th not commit to R&D for low- and mid- • Market Influence & Compliance to 8th position, despite being a leader in dle-income countries. Its equitable pric- • Research & Development key areas, such as mitigating the impact ing strategies apply to a limited subset • Pricing, Manufacturing & of patents on affordability and supply. of its products.

Management Distribution • Patents & Licensing It has pioneered the use of non-exclusive voluntary licensing beyond HIV/ Falls eight: Novo Nordisk • Capacity Building AIDS, and has solid ethics compliance Novo Nordisk has fallen eight places, • Product Donations processes. However, in R&D, its per- from 2nd, but remains in the top ten. formance remains comparatively low: Its solid framework for access manage- For a comparative analysis of com- its relevant pipeline is smaller than the ment applies to only a small part of its pany performances in each area, see industry average and it lags in ensuring portfolio, namely human insulin prod- pages 63-77. ethical clinical trial conduct and on clin- ucts. Novo Nordisk is the only company ical data transparency. Despite strong in the Index with an exclusive focus on commitment to and transparency in diabetes. In turn, diabetes is one of the registration, its performance in filing for only diseases in

scope where older, registration in countries in need is weak. off-patent products are considered Gilead implements few capacity building treatments of choice. Looking across activities, with limited targeting of local its entire portfolio, Novo Nordisk has priorities. equitable pricing strategies for a small proportion of its portfolio and has not Falls seven: Roche engaged in licensing. It now publishes Roche has fallen seven places, from the statuses of its patents. It has a small 12th to 19th. Roche declined to provide pipeline of products for people in low- data to the 2016 Index: citing the fact and middle-income countries. The com- that oncology, which is not in scope, is pany has maintained its performance in its main focus for access to medicine. capacity building, but has been outper- Roche has been included in the Index formed by peers. 11 Source: http://www.doksinet Access to Medicine Index 2016 KE Y FI N D I NG : RESE ARCH & D EVE LO PM E NT

Collaborative research models appear effective in engaging the industry in developing urgently needed products with low commercial potential Large pharmaceutical companies are core group of six account for nearly are less involved in addressing the gaps developing 420 products for the 51 three-quarters of the 151 high-prior- for other product types. Other stake- most burdensome diseases and condi- ity, low-incentive products in develop- holders are paying attention to these, tions in low- and middle-income coun- ment. GSK is developing the most, with for example to develop diagnostics and tries. This includes more than 100 prod- 32 projects in the pipeline, followed by vector control products. ucts that have entered the pipeline AbbVie, with 19 projects, and Johnson since the previous Index and 151 with & Johnson with 17. Meanwhile, four of Some diseases that urgently need prod- low commercial potential but which are these companies devote more than 50% ucts,

such as soil-transmitted helminthi- urgently needed, mainly by the poor. of their relevant pipelines to high-prior- asis, have very few R&D projects target- ity, low-incentive product gaps. ing them, while others, such as Buruli The Index examines 22 diseases and ulcer, trachoma, cysticercosis and syphi- conditions for which the G-FINDER tool PRO D U C T GAPS U NAD D R ESS E D lis, have none. Some diarrhoeal diseases from Policy Cures has identified a need G-FINDER has identified 84 high-prior- are being addressed, but not cholera, for new products with limited commer- ity product gaps for the 22 diseases in giardiasis or particular intestinal E. coli cial incentive. Companies are addressing the scope of the Index. Companies are infections even though they have all 18 of these diseases, with most activ- directly addressing 31 of these gaps. been identified as needing attention. ity focusing on malaria, HIV/AIDS and The industry is addressing most gaps

tuberculosis, followed by viral hepatitis. for medicines, as well as some of the R& D I N PARTN E RS H I P gaps in vaccines, including for HIV/AIDS, The majority (67%) of the R&D pro- Activity in this area is concentrated hepatitis C, shigellosis and typhoid and jects for high-priority, low-incentive among a handful of companies. A paratyphoid fever. However, companies products are being conducted in partnership, signalling that collaborative models are effective at engaging companies in R&D aimed at addressing pri- Figure 2. Six companies account for majority of projects targeting high-priority, ority product gaps. This proportion is low-incentive gaps significantly higher than for other R&D There are 151 high-priority, low-incentive R&D projects in company pipelines. Nearly three quarters are in scope, where 14% of projects involve being developed by just six companies. For four of these companies, this accounts for more than 50% of partners.

Three quarters of partner- their pipelines for high-burden diseases: GSK, AbbVie, Sanofi and Merck KGaA. ships for high-priority, low-incentive products involve companies partnering with public, non-governmental and/or GSK non-profit organisations. Another 14% AbbVie of them involve collaboration between companies, and these partnerships Johnson & Johnson focus mainly on products for HIV/AIDS Sanofi and hepatitis C. The remaining ones Novartis involve wider partnership that entails Merck KGaA 0 5 10 15 20 25 Number of high-priority/low-incentive R&D projects 12 KF R&D, based on S R&D5a 30 35 collaboration among several companies and public-sector actors. Source: http://www.doksinet Access to Medicine Index 2016 ACCESS PL AN S I N PL ACE FO R M OST between clinical phases II and III. The H I G H - PR I O R IT Y PI PE LI N E PRO D U C TS majority (72%) of late-stage projects Overall, 56% of 151 high-priority, low-in- have access plans in

place. centive products in R&D have access plans in place. As expected, there are more products with access plans toward the end of the pipeline; there is a marked increase as projects move into Figure 3. Pharma companies are addressing over one third (37%) of product gaps with low commercial incentive Chagas disease 15 1 Projects that target multiple diseases, or are being developed by multiple ATMI Disease Specific disease target Medicines companies, are counted more than once. Microbicides Vaccines (Therapeutic) Buruli ulcer (35 projects), followed by HIV/AIDS (23), TB (21) and then viral hepatitis (13). Diagnostics Vaccines (Preventive) product gaps with low commercial incentive. Most of these target malaria Vector Control Products Companies are developing products for 31 out of 84 (37%) high-priority Devices (for reproductive health only) clinical development, and then again Contraceptive methods Reproductive health products* 2

Dengue and chikungunya Dengue 9 Diarrhoeal diseases Cholera* Cryptosporidiosis* 1 Enterotoxigenic E. coli infection 1 Giardiasis [lambliasis] Rotaviral enteritis* 1 Shigellosis* 2 Typhoid and paratyphoid fevers 2 Other intestinal E. coli infections HIV/AIDS* 17 3 3 Human African trypanosomiasis 4 Leishmaniasis 11 Leprosy 1 5 High-priority, low-incentive 5 product gap, unaddressed by com- 30 3 2 panies in scope 2 High-priority, low-incentive Due to N. meningitidis* product gap, addressed by compa- Due to S. pneumoniae* 5 nies in scope. Includes number of 9 R&D projects. Lower respiratory infections Due to S. pneumoniae* Lymphatic filariasis Malaria Maternal haemorrhage Meningitis

Postpartum haemorrhage* Onchocerciasis 5 Blank cell: no high-priority, low-in- Ascariasis 2 centive product gap identified by Hookworm diseases 2 G-FINDER19 Schistosomiasis Soil transmitted helminthiasis Strongyloidiasis 1 Syphilis* Taeniasis/cysticercosis Trachoma Tuberculosis 19 2 12 1 Viral hepatitis Hepatitis C genotypes 4, 5, 6* *Specific product gap identified, e.g, for a new administration route to be developed, or serotypes to be targeted 13 Source: http://www.doksinet Access to Medicine Index 2016 KE Y FI N D I NG : PRODUCT D E PLOYM E NT Good practice in making products affordable and available is limited The Index analyses how pharmaceuti- their newest products where they are LI CE N S I N G E XPAN DS B UT E XCLU D ES cal companies deploy medicines, diag- needed*; Gilead commits to filing for KE Y M I D D LE- I N CO M E CO U NTR I ES

nostics and vaccines once they have registration of new products in low- Since 2014, seven companies have pub- emerged from the pipeline. It finds that and lower-middle-income countries lished new or expanded pledges to companies generally do not systemati- (LICs; LMICs) within 12 months of gain- waive or abandon patent rights in cer- cally target populations with the highest ing regulatory approval, and also pub- tain countries or regions. A total of 16 needs in their registration, pricing and lishes when and where products are now have such pledges. These vary in licensing actions. registered. breadth and scope, with some covering PRO D U C TS B E I N G R EG I STE R E D I N O N E LI M ITE D N E E DS - BA S E D PR I CI N G panies now voluntarily publish details Q UARTE R O F H I G H - N E E D CO U NTR I ES Companies are considering affordability of their patent portfolios, which sup- A product can only be sold in a country for more products than they did in

2014, ports the supply of generic medicines. once it has been registered. For every but the proportion of the industry port- This compares with none doing so in disease it covers, the Index has devel- folio covered by such equitable pricing 2014. More HIV/AIDS products are cov- oped a priority country list and exam- schemes remains the same. ered by voluntary licences, and, for the more countries and regions. Three com- ines to what extent companies try to first time, such licences are being used, register their newest products in them. Only 5% of products are covered by by Bristol-Myers Squibb and Gilead, to It found that companies have tried to pricing strategies that meet the key expand access to products for a second register their newest products in only a criteria set by the Index – i.e, achiev- disease: hepatitis C. quarter of these countries. ing affordability for different population groups within countries; with reference These steps are promising.

However, However, some companies are showing to multiple socio-economic factors – large middle-income countries (MICs) good practice in the area of needs-re- and apply in at least one country with a such as Mexico, Ukraine and Thailand sponsive product registration. For particular need for access*. Three com- are often excluded from licences. MICs example, Novartis and Novo Nordisk panies – GSK, AstraZeneca and Sanofi – are home to the majority of the world’s have filed to register most of are responsible for most of this activity. poor. Figure 4. True needs-based pricing is limited Figure 5. Voluntary licensing contin- Only 44 (5%) products out of 850 have a strategy that meet the key criteria looked for by the Index and ues to expand that applies in even one priority country*. Since 2014, more compounds have been covered Figure 1. True needs-based pricing is limited by voluntary licence agreements. For the first time, this includes products for a

disease other 280 than HIV/AIDS: hepatitis C. 185 34 850 95 61 570 Number of patented compounds voluntarily licensed for hepatitis C 17 44 9 Products priced equitably. .including with price differentiation within countries 14KF PD, based on S PD 4 .including in at least one priority country* .and with at least one socio-economic factor taken into account. 2014 4 12 2016 Number of patented compounds voluntarily licensed for HIV/AIDS *Priority countries are disease-specific: for each disease in its scope, the 2016 Index has identified countries with (a) high burdens of the disease and high inequality; and (b) low-income levels. Source: http://www.doksinet Access to Medicine Index 2016 KE Y FI N D I NG : GOVE RNANCE & CO M PLIANCE Companies increasingly view access to medicine as a way to develop their business in emerging markets Companies are refining the ways they to meeting access targets. Stakeholder However, the Index has found evi- organise efforts to

increase access to engagement to increase access to med- dence that breaches of laws or codes medicine. Most (17) now have a detailed icine is now commonplace and generally relating to corruption, unethical mar- access-to-medicine strategy. AbbVie, well organised. keting and anti-competitive behav- Astellas and Daiichi Sankyo are the iour continue to arise. Misconduct fol- exceptions. While they have approaches M I SCO N D U C T PUTS ACCESS PL AN S AT lowing weak enforcement of compli- for increasing access to medicine, they RISK ance systems can limit access to med- have not set out an overarching access Compliance with standards of con- icine and put companies’ reputations strategy. duct has an impact on access to medi- and investments in access to medi- cine. For the first time, the 2016 Index cine at risk. In many low- and middle-in- Many (12) companies also view access analysed companies’ compliance per- come countries, regulatory systems are as a

way to develop their business in formances alongside their systems and weaker. Nevertheless, companies are emerging markets. These companies strategies for improving access to med- expected to conduct all their business in identify where access strategies sup- icine. The aim is to highlight where a responsible, ethical manner. port the bottom line: for example, by closer integration of these areas of supporting entrance into new markets, policy and management would benefit by expanding their consumer base, or access to medicine. by anticipating long-term financial gains. Where access strategies have a clear Companies have comprehensive com- business rationale, companies have pliance systems aimed at ensuring a greater incentive to deliver on and employees meet agreed standards of expand them, increasing their potential behaviour. Two companies are adopt- sustainability. ing innovative compliance-management policies and practices: GSK has recently Some companies

(5) are piloting or introduced an employment policy to expanding inclusive business models, mitigate risks related to conflicts of where independently identified public interest that could arise when it hires health needs are prioritised and where staff from the public sector, and Gilead target markets also include low-in- provides specific compliance training to come population segments. Novartis, third parties, such as sales agents and for example, has a global strategy for distributors. reaching all socio-economic population segments, using scalable and replicable access models. Figure 6. The industry scores well in access management, but lags in compliance Where the Index measures management and compliance, companies perform best when it comes to Half of the companies in the Index have setting access-to-medicine strategies. Low scores in compliance take account of unethical Figure detailed 1. The industry scores well in management, but lags in compliance set clear

access-related goals linked behaviour. Such misconduct can limit access medicine, putting companies’ investments in access to Companies perform best when it comes to to setting detailed access-to-medicine strategies. Low scores to international health targets, such in compliance medicine at risk.take account of unethical behaviour Such misconduct can limit access to medicine, putting companies’ investments in access to medicine at risk. as those included in the Sustainable Development Goals (SDGs). To achieve their goals, all companies use performance management systems where bonuses and other incentives are linked Management 3.4 Compliance 2.1 0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 15 Source: http://www.doksinet Access to Medicine Index 2016 KE Y FI N D I NG : CAPACIT Y BU I LD I NG Six companies systematically match activities to local priorities when strengthening health systems Gaps in local healthcare infrastructure 3. Explicitly define roles,

responsibili- is an established industry partner for are hampering the delivery of medi- ties and accountability mechanisms resolving manufacturing issues. Rather cines and vaccines to millions of people, for all partners, and establish trans- than training individual manufacturers, mainly in poorer countries. Most phar- parent systems to manage conflicts AstraZeneca works with the University’s maceutical companies in the Index are of interest Chemical Engineering School to help building a range of health system capacities in low- and middle-income countries. The 2016 Index has identified six 4. Agree to clear commitments over appropriate timeframes 5. Ensure continuous improvement pharmaceutical companies that are con- through regular, transparent moni- sistently addressing independently pri- toring and evaluation oritized gaps through their capac- address identified skills and knowledge gaps, training students as well as site staff. China is also a focus area

for building R&D capacity, alongside Brazil, with ity building programmes: AstraZeneca, B E ST PR AC TI CES some companies also building R&D GSK, Johnson & Johnson, Merck & Co., The six companies are using a range capacity in Kenya and South Africa. GSK Inc.*, Merck KGaA and Novartis. of best practice approaches to build has supported a comprehensive inves- capacity. In manufacturing, for example, tigation into local R&D skills gaps and These companies are building local Merck KGaA has a system for continu- capacity building needs in sub-Saha- capacities across the pharmaceutical ally improving quality standards, includ- ran Africa. It worked with the Liverpool value chain: for R&D, manufacturing, ing at 53 third-party manufacturing School of Tropical Medicine’s Capacity supply chain management and phar- sites on four continents. The company Research Unit to assess the capacity macovigilance (systems for ensuring conducts audits,

monitors quality con- of key institutions in Africa to under- drug safety). They work with govern- trol and carries out technology trans- take research on non-communicable ments and NGOs, among others, often fers. It also provides additional training, diseases. in formal partnerships, to understand tailored to each third-party site’s needs. where action is most needed. They also Critically, it immediately shares lessons Sub-Saharan Africa receives more frequently evaluate the impact of those from local inspections across its manu- attention than other areas when it activities. facturing network. Most companies (18) comes to improving supply chain man- in the Index are improving local exper- agement. For example, Novartis’ SMS FIVE AC TI O N S TO ACH I E VE B EST tise in medicine production, mainly in for Life programme is a public-private PR AC TI CE large manufacturing countries such as partnership that aims to keep phar- The 2016 Index has identified

five China, India and Brazil. macy shelves in sub-Saharan Africa well common actions companies take to stocked. It enables healthcare workers ensure initiatives are filling local capac- AstraZeneca has developed a best prac- at public health facilities to use mobile ity gaps: tice approach to improving manufac- phones to track stock levels and help 1. Work with local partners to under- turing standards across the Chinese prevent stock-outs. The data collected stand and align with country-specific industry. In 2006, the company identi- belongs to the relevant national minis- needs fied widespread issues in pharmaceu- try of health. 2. Define specific and measurable goals with partners 16 tical manufacturing in China, particularly with meeting safety standards. Merck & Co., Inc is working with part- Tianjin University in northern China ners to improve delivery of a range of Source: http://www.doksinet Access to Medicine Index 2016 contraceptives to local

health centres scaled up nationally between 2013 and in Senegal through an Informed Push 2016. Management of the programme is Model. This involves logistics profes- being handed over to Senegal’s National sionals from regional supply pharma- Supply Pharmacy. cies making deliveries to local health centres, where they collect stock data to help prepare for the next delivery *Merck & Co., Inc is known as MSD outside the US and Canada. Merck KGaA’s healthcare division is known as EMD Serono in the US and Canada. cycle. The model was piloted in two districts in 2012, in partnership with local and international stakeholders (including the Senegalese government), and Figure 7. To build capacity within the pharmaceutical value chain, six leaders systematically address local needs The Index examines companies’ activities to build capacity in four areas Novartis) systematically identify and address local skills and infrastructure across the pharmaceutical value chain that

impact access to medicine: R&D, gaps, which will help ensure activities make a greater contribution to health manufacturing, supply chain management and pharmacovigilance. This figure systems as a whole. shows how companies respond to local capacity needs in each area. Six leaders (AstraZeneca, GSK, Johnson & Johnson, Merck & Co, Inc, Merck KGaA, R&D ACTIVITY MANUFACTURING SUPPLY CHAIN MANAGEMENT PHARMACOVIGILANCE Companies are more active Most companies build Many best practice initia- Majority of companies than in 2014, with a simi- capacity in-house and with tives but large scope for update their safety labels lar proportion of long-term others. Three commit to better information-sharing, globally, but sharing safety initiatives. Four companies assessing third-party train- e.g, to report suspected data is less common. directly target local skills ing needs. falsified medicines. GSK, Merck & Co., Inc, AstraZeneca, Daiichi Sankyo, GSK,

Johnson & Johnson, AbbVie, Bayer, GSK, Merck KGaA, Novartis Johnson & Johnson, Merck & Co., Inc, Novartis, Johnson & Johnson, Merck KGaA Sanofi Novartis gaps. LEADERS ACTIVE NUMBER GEOGRAPHIC FOCUS 15 China, Brazil, Kenya and 18 China, India and Brazil 14 Sub-Saharan Africa 16 Latin America South Africa 17 Source: http://www.doksinet Access to Medicine Index 2016 18 Source: http://www.doksinet Access to Medicine Index 2016 Analyses of industry activity This section includes four analyses of industry performance, exploring how the 20 companies are addressing key access-to-medicine challenges in low- and middle-income countries. They are based on the Index analysis of data submitted by the companies, contextualised against real-world constraints and stakeholder expectations where possible and appropriate. Research & Development: Leaders in R&D address needs and ensure access for people living in lowand middle-income countries. Product

Deployment: Companies use a mix of tools to address availability and affordability, yet good practices extend to only a few products and diseases. Companies do not consistently include poor populations in registration, pricing and licensing actions. Governance & Compliance: Pharmaceutical companies continue to refine their approaches for increasing access to medicine. Yet poor compliance risks undermining these investments Capacity Building: Leaders consistently target local needs through best practice approaches to capacity building 19 Source: http://www.doksinet Access to Medicine Index 2016 I N DUSTRY ANALYSIS: RESE ARCH & D EVE LO PM E NT Leaders in R&D address needs and ensure access for people living in low- and middle-income countries CO NTEX T MAI N FI N D I NGS Many new health products are urgently More projects in the pipeline – 420 in total needed – particularly for people in Companies have 420 R&D projects that address specific needs of people

in low- low- and middle-income countries. The and middle-income countries: 93 more than in 2014, with 102 new ones. The pipe- Access to Medicine Index assesses com- line focuses heavily on five diseases: lower respiratory infections, diabetes, malaria, panies’ efforts to engage in R&D for 51 viral hepatitis and HIV/AIDS – diseases that place relatively large burdens on low- diseases and conditions that have the and middle-income countries and either have large commercial markets, or tend to greatest burdens in low- and middle- be highly prioritised by stakeholders. income countries and the greatest need in terms of access to medicine. Within Over one third of R&D projects target a high-priority, low-incentive product gap this scope, it also looks at whether com- G-FINDER identifies high-priority, low-incentive product gaps for 22 of the 51 dis- panies are developing products that are eases and conditions in scope: 84 gaps in total. For 18 of these diseases,

companies urgently needed, but offer little commer- are taking action, addressing 31 product gaps with 151 projects. These mainly target cial incentive to innovate. For this sec- malaria (35 projects), HIV/AIDS (23) and TB (21). The industry is addressing most ondary analysis, it refers to the prod- gaps for medicines, as well as some gaps in vaccines (including for HIV/AIDS, hepa- uct gaps identified by Policy Cures (G-FINDER).1-4 Every company in the titis C and shigellosis). Companies are less involved in addressing the gaps for other Index, regardless of its size or therapeu- and syphilis. In some cases, products exist for these diseases but are not optimal, or tic focus, for example, can play an impor- are unsuitable for use in resource-low settings. product types, and have no projects targeting Buruli ulcer, trachoma, cysticercosis tant role in addressing the need for new pharmaceuticals. Six companies with distinctive pipelines lead in developing products for the

poor In product development, six companies lead: GSK is in front, followed by Johnson & Johnson, Novartis, Sanofi, Merck KGaA and then AbbVie. Collectively, they account for over half (55%) the total industry pipeline, and almost three quarters (72%) of products targeting high-priority, low-incentive product gaps. Each has a distinctive pipeline and unique strengths, and all are among the leaders in multiple measures. Companies do not systematically plan ahead to ensure successful R&D projects are rapidly accessible Companies rarely have policies for systematically ensuring products developed in partnership (whether partners are public or private) are rapidly made accessible. However, in practice, R&D projects conducted in partnership include access plans more often than for in-house projects. Companies can learn from their experiences of R&D partnerships to ensure all relevant projects have access plans in place as early as possible. 20 Source: http://www.doksinet

Access to Medicine Index 2016 I NTRO DUCTI O N Despite the huge achievements of clear and transparent strategies to modern medicine, many new health for non-communicable diseases).5 In recognition of this, alternative incen- products are urgently needed – particu- tive models have been developed: ples of provisions that are critical for larly for people in low- and middle-in- “push” mechanisms that help reduce ensuring access. come countries. The level of urgency R&D expenditure, such as research differs per disease and is influenced subsidies and public-private partner- Given the complex landscape of press- by many different factors: for example, ships; as well as “pull” incentives that ing global health priorities, companies prevalence of disease, whether effective aim to reward R&D outcomes, such as need to make predictable and sustained treatments exist, and whether these advanced market commitments, price investments, and follow clear

plans treatments answer the needs of people arrangements and specific regula- in order to develop key products that in low- and middle-income countries. tory measures. To explore how compa- target unmet needs in low- and mid- nies are engaging in R&D for products dle-income countries. These steps are To meet these needs, companies must where the market is limited or absent, also essential for maintaining profitabil- carefully consider which product attrib- the 2016 Index uses a gap analysis con- ity and a competitive edge in the phar- utes are needed. This means consid- ducted by Policy Cures (G-FINDER) to maceutical market. ering whether new or more effective match R&D projects to high-priority, products are necessary; whether to low-incentive product gaps.1-4 adapt products for different environ- ensure access, providing the best exam- To lead when it comes to R&D that supports access to medicine, a company mental and demographic conditions; Once

a product is approved, it must be needs to be effective, ethical and trans- or whether to create and adapt other made rapidly accessible. This requires parent about its R&D activities. It also product types, such as diagnostics, for advance planning. Companies can put needs to ensure projects represent real use in resource-limited settings. measures (or “access provisions”) in breakthroughs on global health chal- place to accelerate the speed at which lenges. Every company, regardless of its Incentives for commercial investment in the product becomes available in suffi- size or therapeutic focus, can play an pharmaceutical R&D are largely tied to cient quantities at an affordable price important role in addressing the need the potential profitability of successful to those who need it. This should be for new pharmaceuticals. This is borne innovations. Where populations cannot done as early in the product develop- out by the 2016 Index analysis of the

pay for pharmaceuticals, their needs go ment process as possible. Access pro- R&D pipelines of the world’s largest largely unaddressed by R&D. To com- visions can take many forms, includ- research-based pharmaceutical com- pound this, there are other factors that ing patent waivers, voluntary licensing, panies: it finds that the leaders in prod- dis-incentivise companies from engag- supply commitments, registration tar- uct development have diverse pipelines, ing in “non-commercial” R&D, including gets, or equitable pricing strategies. while matching high-priority product a lack of clearly-defined R&D priorities Products developed through public-pri- gaps and planning ahead for access. linked to public health need (including vate R&D partnerships tend to involve R&D RE MAI NS CO NCE NTR ATE D O N FIVE D ISE ASES , WITH MO RE THAN A TH I RD O F PROJ ECTS TARG ETI NG H I G H - PRIORIT Y, LOW- I NCE NTIVE PRO DUCT GAPS Overall, the number

of R&D projects est burdens in low-income and low- countries. These gaps, identified by that meet Index criteria has increased er-middle income countries, and/or are G-FINDER, are for diseases and condi- since 2014. The 20 companies in the one of the WHO-defined Neglected tions that: a) disproportionately impact Index are conducting 420 R&D projects Tropical Diseases (NTDs). Per project, low- and middle-income countries; b) that address the needs of people living the Index applies further inclusion crite- have no existing product, or products in low- and middle-income countries. ria, depending on: the disease in ques- that are not suitable for use in low- and This is 93 projects more than in 2014, tion, whether the project is innova- middle-income countries; AND c) do not and includes at least 102 new projects. tive or adaptive, which phase of devel- offer a commercial incentive to engage At least 83 projects have been discon- opment it is in and

whether plans for in R&D. Using this scope, G-FINDER has tinued since 2014.* access are in place. identified 84 product gaps for 22 of the In this chapter, the 2016 Index exam- The 2016 Index gives extra credit of the Index. In this analysis, these gaps ines R&D that targets diseases within to R&D projects that target spe- are referred to as high-priority, low-in- the scope of the Index: 51 diseases and cific high-priority, low-incentive prod- centive product gaps. conditions that either have the great- uct gaps in low- and middle-income 51 diseases and conditions in the scope *The increase in R&D projects is not fully explained by the number of new and discontinued projects: it is also impacted by changes to the disease scope and R&D inclusion criteria since the 2014 Index. 21 Source: http://www.doksinet Access to Medicine Index 2016 eases in scope. The most attention is on Figure 8. Companies have 420 relevant R&D projects malaria (35

projects), followed by HIV/ Companies are developing 420 products that meet the needs of people in low- and middle-income AIDS (23), TB (21) and then viral hepa- countries. Of these, 36% target a high-priority product gap (they are urgently needed and yet have little titis (13). commercial potential). 30% have plans in place to ensure successful products are made accessible – the The industry is addressing most gaps majority of which target a high-priority product gap. for medicines, as well as some of the gaps in vaccines, including for HIV/AIDS, Other R&D projects 64% Projects with access plans in place 420 30% hepatitis C, shigellosis and typhoid and paratyphoid fever. However, companies are less involved in addressing the gaps for other product types. Other stakeholders are paying attention to these, 36% for example to develop diagnostics and R&D projects that target vector control products. high-priority, low-incentive product gaps Of these 151

projects, 22 (15%) have The G-FINDER tool from Policy Cures identifies high-priority product gaps where there is both a need for new products and insufficient commercial market incentives to drive R&D. moved along the pipeline since 2014 and approximately one quarter (35, or 23%) are new. These 35 new projects Five out of 51 diseases get the most tis. Thus, R&D is concentrated in dis- account for approximately one third attention eases with relatively large burdens in (34%) of the new projects captured by R&D for all 51 diseases and conditions low- and middle-income countries and the 2016 Index. in scope is concentrated on the same that either have large commercial mar- five as in 2014, albeit in a different kets, or tend to be highly prioritised by High-priority, low-incentive prod- order: lower respiratory infections gets stakeholders. Some, but not all, of these uct gaps for five diseases remain the most attention, with 52 projects projects target

high-priority, low-incen- unaddressed (including the highest number of new tive gaps. Conversely, a quarter of the diseases projects); diabetes now follows with 41 in the scope of the Index are not being projects; then malaria and viral hepati- R&D with low commercial incentive addressed by the R&D activities of the tis with 35 each; and HIV/AIDS with 32. The G-FINDER tool from Policy Cures companies measured. In some cases, Together, projects for these diseases identifies high-priority product gaps there is no need for new products to account for 191 (46%) out of 415 med- where there is both a need for new be developed, but rather existing prod- icines, vaccines and diagnostics that products and insufficient commercial ucts need to be made more accessi- companies are developing. The remain- incentive to drive R&D.6 It looks at 22 ble. Companies have no projects target- ing five products (out of 420) are plat- diseases in the scope of the Index,

iden- ing high-priority, low-incentive product form technologies. Out of 420 projects, tifying 84 high-priority, low-incentive gaps for Buruli ulcer, trachoma, cysticer- 37 target more than one of the diseases product gaps. Companies are taking cosis and syphilis. In some cases, prod- in scope. Looking only at new projects, action for 18 of these diseases, target- ucts either exist for these diseases but the focus on lower respiratory infec- ing 31 gaps. In total, this accounts for 151 are not optimal, or are unsuitable for tions is followed by kidney diseases, out of 420 (36%) of the R&D projects use in resource-low settings. malaria, diabetes, TB and viral hepati- that companies are developing for dis- SIX CO M PAN I ES WITH D ISTI NCTIVE PI PE LI N ES LE AD I N R&D FO R TH E POO R Six companies with distinctive pipe- nue). Their relevant pipelines are among different breadths of diseases (from lines lead in R&D for the poor the ten largest, yet

still range in size AbbVie targeting 10 diseases, to Sanofi The same six companies lead as in 2014 substantially (from 20 projects from targeting 20 and Novartis 22). when it comes to developing products Merck KGaA, to 57 from both GSK and for the poor: GSK, Johnson & Johnson, Johnson & Johnson). All six companies Each company’s pipeline has unique Novartis, Sanofi, Merck KGaA and are targeting communicable diseases, characteristics: for example, while AbbVie. They approach R&D in distinct non-communicable diseases and NTDs. Novartis’ relevant pipeline focuses ways, with diverse pipelines that target GSK and Novartis also reported pro- heavily on developing innovative medi- a range of therapeutic areas. jects for maternal and neonatal health. cines, more than half of Sanofi’s pipeline The companies vary in size (by reve- Looking closer, the leaders also target focuses on adapting medicines and vac- 22 Source: http://www.doksinet Access to

Medicine Index 2016 Figure 9. Efforts to meet product R&D needs are uneven Companies have 420 R&D projects for diseases in scope, including 37 that target multiple diseases. For 22 diseases in scope, high-priority product gaps with low commercial incentive have been identified by G-FINDER. These gaps are targeted by 151 R&D projects. Lower respiratory infections Diarrhoeal diseases HIV/AIDS Malaria Tuberculosis Meningitis Measles Syphilis Pertussis Tetanus Viral hepatitis 121,068,536 Schistosomiasis Soil transmitted helminthiasis Leishmaniasis Lymphatic filariasis Rabies Food-borne trematodiases Human African trypanosomiasis Dengue and chikungunya Onchocerciasis Taeniasis/cysticercosis Trachoma Leprosy Echinococcosis Chagas disease Buruli ulcer Dracunculiasis Yaws 3,700,597 Neglected tropical diseases Maternal and neonatal health Preterm birth complications Birth asphyxia and birth trauma Neonatal sepsis and infections Other neonatal conditions Maternal haemorrhage

Hypertensive disorders of pregnancy Abortion Obstructed labour Maternal sepsis Contraceptive methods Non-communicable diseases Ischaemic heart disease Stroke COPD Unipolar depressive disorders Diabetes mellitus Cirrhosis of the liver Kidney diseases Asthma Epilepsy Anxiety disorders Migraine Hypertensive heart disease Bipolar affective disorder Schizophrenia G-FINDER gap* DALY burden* Communicable diseases Pipeline products (medicines, vaccines and diagnostics) 52 89,536,536 68,614,932 52,991,412 36,403,940 26,674,319 Many products in development 11,194,628 6,403,176 target lower respiratory infections, 5,657,488 yet few target the specific product 5,384,352 gap identified by G-FINDER (for 4,576,806 preventive vaccines for pneumonia and meningitis caused by 3,360,656 S. pneumoniae) GSK and Pfizer have 3,196,523 been developing multi-dose 2,810,555 packaging for their Synflorix® and 2,083,208 1,875,000 Prevenar13® vaccines respectively. 1,248,941 1,238,610

593,762 503,000 214,395 199,424 144,000 44,408 No company in scope is addressing syphilis No data No data through R&D, despite the disproportionately high No data burden of this disease on low- and middle-income countries. There is a specific need for new oral, 91,782,664 63,824,424 single-dose products suitable for use in these 36,107,007 settings. 10,896,418 3,289,000 2,797,000 2,138,000 1,792,000 1,309,000 Maternal and neonatal health conditions place a large No data burden on low- and middle-income countries. Yet only four 70,459,863 companies – GSK, Merck & Co., Inc, Novartis and Pfizer – 56,454,095 are developing products for these conditions. 52,471,475 35,521,719 26,915,498 22,422,505 18,128,559 16,223,415 14,347,659 13,175,172 10,150,681 10,113,460 5,920,895 5,133,445 50 0 10 20 30 40 60 *See 2015 Methodology for the 2016 Access to Medicine Index. *The G-FINDER tool from Policy Cures identifies high-priority product gaps where there is both

a need for new products and insufficient commercial incentive to drive R&D. 23 Source: http://www.doksinet Access to Medicine Index 2016 Figure 3. Pharma companies are addressing over one third (37%) of product gaps with low commercial incentive Companies are developing products for 31 out of 84 (37%) high-priority product gaps with low commercial incentive. Most of these target malaria (35 projects), followed by HIV/AIDS (23), TB (21) and then viral hepatitis (13). Projects that target multiple diseases, or are being developed by multiple Devices (for reproductive health only) 15 1 Microbicides Chagas disease Specific disease target Diagnostics Vaccines (Therapeutic) Buruli ulcer ATMI Disease Medicines Vaccines (Preventive) Vector Control Products companies, are counted more than once. Contraceptive methods Reproductive health products* 2 Dengue and chikungunya Dengue 9 Diarrhoeal diseases Cholera*

Cryptosporidiosis* 1 Enterotoxigenic E. coli infection 1 Giardiasis [lambliasis] Rotaviral enteritis* 1 Shigellosis* 2 Typhoid and paratyphoid fevers 2 Other intestinal E. coli infections 17 3 3 Human African trypanosomiasis 4 Leishmaniasis 11 Leprosy 1 5 HIV/AIDS* Lower respiratory infections Due to S. pneumoniae* Lymphatic filariasis Malaria 5 30 3 2 Maternal haemorrhage Postpartum haemorrhage* 2 Meningitis Due to N. meningitidis* Due to S. pneumoniae* 5 Onchocerciasis 9 Schistosomiasis 5 High-priority, low-incentive Ascariasis 2 product gap, unaddressed by com- Hookworm diseases 2 panies in scope Strongyloidiasis 1 High-priority, low-incentive Syphilis*

product gap, addressed by compa- Taeniasis/cysticercosis nies in scope. Includes number of Trachoma R&D projects. 19 2 12 1 Soil transmitted helminthiasis Tuberculosis Viral hepatitis Hepatitis C genotypes 4, 5, 6* *Specific product gap identified, e.g, for a new administration route to be developed, or serotypes to be targeted 24 Blank cell: no high-priority, low-incentive product gap identified by G-FINDER19 Source: http://www.doksinet Access to Medicine Index 2016 cines to meet specific needs of people Development, in addition to local factory. As in 2014, the majority of in low- and middle-income countries. assessments of product needs. Slightly R&D for high-burden diseases is inno- more than half the companies in the vative in nature (73%, or 308 out of Leaders share six characteristics Index have provided evidence of making 420). However, companies are also Despite this variation, the way these this

connection. All 20 have taken the relied upon to adapt existing products, six companies conduct R&D has broad first step of making a general commit- improve their characteristics, and meet similarities. Leaders in product devel- ment to conducting R&D for high-bur- the specific needs of poor and vulnera- opment generally share the following den diseases and/or for low- and mid- ble populations. A small group of com- characteristics: dle-income countries. panies excels in this area: over half of 1. Clear R&D strategies tied to public health needs; the relevant pipelines of Bayer, Daiichi To fulfil their commitments, companies Sankyo and Sanofi consist of prod- must invest. Yet R&D investments are ucts being adapted for use in countries poorly aligned with global public health in scope. 35% of the industry’s adap- needs. Transparency in this regard tive projects are for fixed-dose combi- diverse product types and innovative helps to guide

collaboration and pre- nations, 17% are new formulations or and adaptive products; vent duplication. It also helps identify delivery methods to ease administration 2. R&D projects that target identified product gaps; 3. An R&D pipeline that includes 4. Products that move along the (e.g improved taste, inhaled delivery) remaining product R&D gaps, and to pipeline; define priorities for new investments. Novartis and Sanofi are the only compa- and 16% target paediatric populations. clinical trial policies and practices; nies to publish details about their rele- cations to new diseases and diseases and vant R&D investments. They are among strains, temperature-stable formula- 13 companies that disclose data about tions and simplified regimens (e.g once- clinical data and intellectual property their relevant R&D investments to the daily pill, shorter vaccine schedule). with other researchers. Index. The remaining seven compa- 5 5. Research

supported by responsible 6. Policies and practices for sharing The remainder include expanded indi- nies did not provide such information Five companies moved the largest pro- Companies steer R&D according to (Bristol-Myers Squibb, Eli Lilly, Gilead, portions of their relevant pipelines into public health need Merck & Co., Inc*, Pfizer and Roche). new stages of development: Astellas, Eli All R&D starts with planning. Companies Lilly, Johnson & Johnson, Novo Nordisk can have many different reasons for While innovation dominates, a core and Pfizer. In the past two years, com- pushing their R&D activities in differ- group excels in adaptations panies received 25 market approvals for ent directions. To develop products Translating commitments and invest- innovative and adapted medicines and that people in low- and middle-income ments into new products requires vaccines. Over half targeted diabetes, countries need, the answer is to tie

considerable, continuous effort. viral hepatitis and HIV/AIDS. The com- R&D commitments to externally agreed Pharmaceutical companies are relied panies with the most approvals were public health needs, such as defined upon to innovate products where treat- AbbVie, Gilead, Johnson & Johnson and in the 2030 Agenda for Sustainable ments are not available or unsatis- Sanofi. Figure 10. Product development: six leaders consistently lead across several key measures The leaders in product development account for over 50% of the relevant lines varying in size and scope, and targeting a range of therapeutic areas. industry pipeline. They approach R&D in distinct ways, with diverse pipe- Nevertheless, the way they conduct R&D has broad similarities. Product development rank Company Strategies for Position by number engagement based of projects address- Diverse prod- Position by number on public health ing high-priority uct types in of innovative Position

by number needs product gaps development projects of adaptive projects 1 GSK Yes Top 5 Yes Top 5 Top 5 2 Johnson & Johnson Yes Top 5 Yes Top 5 Top 5 2 Novartis Yes Top 5 Medicines only Top 5 Top 10 3 Sanofi Yes Top 5 Yes Top 10 Top 5 4 Merck KGaA Yes Top 10 Yes Bottom 10 Top 5 5 AbbVie Yes Top 5 Medicines only Top 10 Top 10 *Merck & Co., Inc is known as MSD outside the US and Canada Merck KGaA’s healthcare division is known as EMD Serono in the US and Canada 25 Source: http://www.doksinet Access to Medicine Index 2016 Figure 11. Seven companies have the strongest focus on high-priority product gaps with low commercial incentive A core group of companies directs more than half of their R&D projects toward urgently needed new products that offer little commercial potential. The 20 companies in scope are developing 151 such products in total. These seven companies account for 99 of them R&D for high-priority, low-incentive

product gaps R&D for product gaps not identified as having low commercial incentive GSK GSK AbbVie AbbVie Sanofi Sanofi Merck KGaA Merck KGaA Eisai Eisai Gilead Gilead Bayer Bayer 0 5 10 Number of R&D projects 15 20 25 30 35 30 25 20 15 10 5 0 Number of R&D projects Senegal and Uganda, where the com- cebo controls, and scientific require- Pfizer moves projects along the pany has identified unmet need and ments and research protocols). Almost pipeline demand for injectable contraceptives.8 all companies provide evidence of moni- B ES T PR AC T I CE Although Pfizer has a small relevant toring, auditing and applying disciplinary pipeline compared to its peers, it has Clinical trial conduct and data-sharing action to ensure compliance with their moved a high proportion of its pro- Over half (224 out of 410 or 55%) of codes of practice. Astellas and Gilead jects to the next development stage. the investigational medicines and

vac- are the exceptions. In October 2014, it received US FDA cines captured by the Index were in clin- approval for its meningococcal sero- ical development during the period Since 2014, no company was found to group B vaccine (Trumenba®), the first of analysis, including in countries in have been judged in breach of interna- of its kind to be approved in the USA.7 scope. All companies have policies to tional clinical trial guidelines. Weak reg- Pfizer also received UK approval for an ensure clinical trials are conducted eth- ulatory systems in lower income coun- update to the label for medroxypro- ically. However, only seven companies tries make it likely that breaches are not gesterone acetate (Sayana Press®) in go beyond International Conference being detected and prosecuted. 2015, allowing women to administer the on Harmonisation Guideline for Good long-acting contraceptive by self-injec- Clinical Practice (ICH-GCP), by incorpo- Companies are also

expected to share tion. Pfizer aims to introduce this label rating key principles of the Declaration clinical trial data to demonstrate the update outside the EU, initially focus- of Helsinki into their codes of conduct safety and efficacy of investigational ing on countries such as Burkina Faso, (e.g, post-trial provisions, use of pla- products and newly launched products. Figure 12. More than half of companies are developing products other than medicines Most products in development are medicines, although ten companies have relevant vaccines in development (57 in total), and five are developing diagnostics and platform technologies GSK Sanofi Johnson & Johnson Pfizer (5 of each). The diagnostics are for HIV/AIDS and malaria, and Takeda the majority of the platform technologies are to support vac- Merck KGaA cine development. Daiichi Sankyo Astellas AstraZeneca Eisai Merck & Co Roche 0 Vaccines 26 5 Diagnostics 10 Platform technologies 15 Microbicides 20

25 Vector control products Source: http://www.doksinet Access to Medicine Index 2016 In general, companies publish detailed Eisai now have systems for handling commitments and policies in this area. requests for data that involve independ- However, most companies struggle to ent panels. Only Gilead lacks such a address all criteria stakeholders expect mechanism. of them: namely, clearly committing to registering and publishing results for all Sharing intellectual property (IP) can trials, specifying that results will be pub- also facilitate R&D with access objec- lished within twelve months, and pub- tives: 14 companies provided evidence lishing results regardless of outcome. of 32 projects in which they share IP Despite generally strong performance in with research institutions or drug dis- this area, in practice, clinical trial results covery initiatives. IP-sharing is also are not always reported and transpar- involved in 27 of the industry’s 139

R&D ency levels vary widely between com- partnerships. These IP-sharing pro- panies.9 The question remains: to what jects almost all target HIV/AIDS, lower extent do companies translate their respiratory infections, malaria, TB commitments into action? and NTDs. Eisai, Merck KGaA, AbbVie, Takeda and GSK lead in this area, in this Data generated throughout prod- order. uct R&D should be shared openly to accelerate innovation. Companies are expected to share clinical trial data with qualified third parties, such as scientific researchers, to support research activities. Astellas, Daiichi Sankyo and I N N OVAT I O N R&D for antimicrobials – companies make progressive moves Where traditional market incentives are key external stakeholders, including On September 20, 2016, eight of insufficient, companies must seek inno- national governments. One such exam- the nine signatories to the Davos vative new mechanisms for driving R&D ple is seen in DRIVE-AB,

a multi-sec- Declaration signed onto a new Industry that allow for development costs to be toral initiative funded by the Innovative recouped. The market for antimicrobi- Medicines Initiative, which aims to iden- Roadmap for Progress on Combating Antimicrobial Resistance.13 This als is one example. Despite the emerg- tify how new economic models can be roadmap describes four key commit- ing global threat of antimicrobial resist- ments the companies will deliver on, ance (AMR), several factors mean R&D used to stimulate the development of novel antibiotics.11 This year, nine com- for new and repurposed antimicrobi- panies – AstraZeneca, GSK, Johnson existing antibiotics, diagnostics and als is poorly incentivised. The exist- & Johnson, Merck & Co., Inc, Merck vaccines, and collaborating with public ence of currently effective, low-cost KGaA, Novartis, Pfizer, Roche and partners to overcome innovation chal- generic antibiotics and the need to con-

Sanofi – joined 89 others by signing lenges in product R&D. serve new antibiotics for last-line treat- the Declaration by the Pharmaceutical, ments mean new antimicrobials will be Biotechnology and Diagnostics Other companies with relevant exper- restricted for use and are unlikely to be tise and resources are encouraged to profitable until close to the end of their Industries on Combating Antimicrobial Resistance (Davos Declaration).12 This patent life.10 entails a commitment to investing in including improving access to new and join these efforts. Those with promis- R&D that responds to public health ing antimicrobials in their pipelines14 are called on to continue to devote A novel system for driving R&D for needs with new, innovative diagnostics resources to efficiently bring these antimicrobials is needed, for exam- and treatments. This Declaration is an products to market. This includes GSK, ple, to incentivise collaboration across important

example of industry mem- which is developing gepotidacin, Merck the industry and ensure new prod- bers coming together to constructively & Co., Inc, which is developing imipe- ucts are profitable despite low ini- address R&D challenges in an area nem/cilastatin/relebactam, and Pfizer, tial volume of sales. Establishing such where high product need, unique R&D which is taking over the development a system requires collaboration within risks and unique market dynamics exist. of ceftaroline/avibactam, among other the pharmaceutical industry and with antimicrobials, from AstraZeneca.15 27 Source: http://www.doksinet Access to Medicine Index 2016 CO M PAN I ES CAN D EVE LO P ACCESS PL ANS FO R ALL PRO DUCTS I N D EVE LO PM E NT Over the past two decades, R&D part- in the terms and conditions of those However, as in 2014, most compa- nerships, particularly product develop- partnerships. nies (19) do not have internal policies in place to ensure access

provisions are ment partnerships (PDPs), have demonstrated that collaborating across sec- For both collaborative and in-house systematically included in their R&D tors reduces duplication, enables risk- R&D, there are more projects with partnerships.18 Merck & Co, Inc leads and expertise-sharing, and leads to successful innovations.16 These pro- access provisions in later stages of as the only company in the industry that development. This is when target prod- publishes such a policy: the company jects tend to target diseases with little uct profiles are better defined and can applies the principles laid out in its com- or no commercial market, and typi- be linked more clearly to access strate- mitment to WIPO Re:Search to all rel- cally include measures for ensuring suc- gies. However, companies should start evant partnerships. The next step is to cessful products are accessible. These to lay access plans as early in product outline how products

developed in part- measures or “access provisions” are development as possible. For example, nership for a broader range of diseases put in place during the R&D phase. GSK’s dengue vaccine project with the and countries will be made accessible. Companies must learn from these expe- Walter Reed Army Institute of Research riences to develop access plans for all and Bio-Manguinhos/Fiocruz (which is Companies are still not transparent product development, earlier in the in pre-clinical development) includes about the terms and conditions of their development process. tiered pricing plans for public and pri- R&D partnerships, unless required to be vate markets. by a partner. As a result, there is little In 2016, one third of relevant pipeline insight into which candidates developed projects are being conducted in part- In early stages of development, 39% of in partnership will be supported by pro- nership: 64% of these involve public and R&D

partnerships have access provi- visions for access, if approved in low- non-profit partners, 27% involve private sions in place, compared to just 9% for and middle-income countries. partners, and 9% include a mix of public in-house projects. It is clearly possible and private partners. As in 2014, there to plan early for access. are relatively few partnerships targeting non-communicable diseases, and these Via WIPO Re:Search, nine companies exclusively involve private partners. agree to share intellectual property for R&D targeting malaria, TB and NTDs Over half the industry has incorporated (Eisai, GSK, Johnson & Johnson, Merck access plans in at least one in-house & Co., Inc, Merck KGaA, Novartis, Pfizer, R&D project, with Daiichi Sankyo, Sanofi and Takeda). These companies Gilead, GSK and Sanofi leading in this have agreed to include terms that pro- area. Of the projects conducted in part- mote access to resulting products in nership, 51%

include access provisions, Least Developed Countries in research up from 39% since 2014. Eisai and GSK partnerships that arise out of WIPO lead at conducting relevant R&D in part- Re:Search.17 nerships and including access provisions Figure 13. Access provisions are set R&D in partnership: % of projects with access provisions, earlier when projects conducted in broken down by provision type partnership Compared to in-house R&D, a higher proportion Early-stage of R&D projects conducted in partnership include Late-stage access provisions – plans for ensuring a success- stages, 39% of projects carried out in partnerships have access provisions in place, compared to just 9% for in-house projects. 100% 0% 20% 40% 80% 100% Early-stage 100% Late-stage 100% 0% 20% Affordable pricing 40% Donation programmes Responsible IP-management 28 60% In-house R&D: % of projects with access provisions, broken down by provision type ful candidate is

made accessible. This relationship is seen at all stages of development In early 100% 60% 80% Local clinical trial sites Sufficient supply 100% Registration targets WHO prequalification No evidence of current access Source: http://www.doksinet Access to Medicine Index 2016 CONCLUSI O N The leaders in R&D develop products that target high-burden diseases, address high-priority, low-incentive product gaps, and include plans to ensure successful innovations are rapidly and widely deployed. Collectively, companies are developing 420 projects that meet the needs of populations in low- and middle-income countries, including 151 products that are urgently needed, despite there being little commercial incentive to develop them. R&D conducted in partnership includes access plans more often and earlier than in-house R&D, signalling that collaborative models are an effective mechanism for engaging the pharmaceutical sector in R&D oriented to the needs of populations in

low- and middle-income countries. RE FE RE NCES 1 Policy Cures. “Neglected Disease R&D Matrix: G-FINDER diseases, products and technologies.” 2015 Accessed 10 October 2016 at http://www.policycuresresearch org/downloads/Y8%20GFINDER%20 ND%20matrix.pdf 2 Policy Cures. “Neglected Disease R&D Scope Document”. 2015 Accessed 10 October 2016 at http://www.policycuresresearchorg/downloads/Y8%20 GFINDER%20ND%20scope%20doc.pdf 3 Policy Cures. “Reproductive Health R&D Matrix: Reproductive health areas, products and technologies.” 2014 Accessed 10 October 2016 at http://www.policycuresresearchorg/downloads/GFINDER%20 RH%20matrix%202014.pdf 4 Policy Cures. “Reproductive health R&D scope document.” 2014 Accessed 10 October 2016 at http://www.policycuresresearchorg/downloads/GFINDER%20 RH%20scope%20doc%202014.pdf 5 Kieny MP, Viergever RF, Adam T, Boerma T, Røttingen J. “Global platform to inform investments for health R&D”. The Lancet. 2016; 387: 1156-1157 6

Policy Cures. “Neglected Disease Research and Development: The Ebola Effect.” 2015 Accessed 18 September 2016 at http://www.policycuresorg/ downloads/Y8%20GFINDER%20full%20 report%20web.pdf 7 FDA News Release: First vaccine approved by FDA to prevent serogroup B Meningococcal disease. 29 October 2014. http://wwwfdagov/NewsEvents/ Newsroom/PressAnnouncements/ ucm420998.htm [Accessed 18 September 2016] 8 Pfizer. “Pfizer’s Sayana® Press Becomes First Injectable Contraceptive In The United Kingdom Available For Administration By Self-Injection.” 24 September 2015. Accessed 18 September 2016 at http://www.pfizercom/news/ press-release/press-release-detail/pfizer s sayana press becomes first injectable contraceptive in the united kingdom available for administration by self injection 9 Miller JE, Korn D, Ross JS. “Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012.” BMJ

Open 2015; 5:e009758 doi:10.1136/ bmjopen-2015-009758 10 DRIVE-AB: Re-investment in R&D and Responsible Antibiotic Use. “What is DRIVE-AB?” Accessed 14 October 2016 at http://drive-ab.eu/about/ 11 Review on Antimicrobial Resistance. “Securing New Drugs for Future Generations: The Pipeline of Antibiotics.”May 2015 Accessed 18 September 2016 at https://amr-review. org/sites/default/files/SECURING%20 NEW%20DRUGS%20FOR%20 FUTURE%20GENERATIONS%20 FINAL%20WEB 0.pdf 12 Review on Antimicrobial Resistance. “Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance.” 2016. Accessed 18 September at http:// amr-review.org/industry-declaration 13 International Federation of Pharmaceutical Manufacturers & Associations. “Industry Roadmap for Progress on Combating Antimicrobial Resistance. 20 September 2016 Accessed 10 October 2016 at http://www.ifpma

org/resource-centre/industry-roadmap-for-progress-on-combating-antimicrobial-resistance/ 14 The Pew Charitable Trusts. “Antibiotics Currently in Clinical Development.” 17 February 2014. Accessed 18 September 2016 at http://www.pewtrustsorg/en/ multimedia/data-visualizations/2014/antibiotics-currently-in-clinical-development Pfizer.” 24 August 2016 [Press release] Accessed 18 September 2016 at https:// www.astrazenecacom/media-centre/ press-releases/2016/AstraZeneca-to-sellsmall-molecule-antibiotics-business-toPfizer-24082016.html 16 Cole CB, Iyer JK. “Ensuring sustained incentives for pharmaceutical companies to develop medicine for the poor.” 22 June 2016. Access to Medicine Foundation. Accessed 18 September 2016 at http://www.accesstomedicineindexorg/sites/2015atmindexorg/files/ publication/ensuring sustained incentives for pharmaceutical companies to develop medicine for the poor 0.pdf 17 World Intellectual Property Organization. “WIPO Re:Search: Guiding Principles.”

8 June 2011 Accessed 18 September 2016 at http://www.wipoint/ export/sites/www/research/docs/guiding principles.pdf 18 Merck. “Public Policy Statement: Social Licensing Approach for Research Development Partnerships for Neglected Tropical Diseases (NTDs).” January 2014 Accessed 18 September 2016 at https:// www.merckcom/about/views-and-positions/Public-Policy-Statement-SocialLicensing-Approach-for%20ResearchDeveloppdf 15 AstraZeneca. “AstraZeneca to sell small molecule antibiotics business to 29 Source: http://www.doksinet Access to Medicine Index 2016 I N DUSTRY ANALYSIS: PRO DUCT D E PLOYM E NT Companies use a mix of tools to address availability and affordability, yet good practices extend to only a few products and diseases. Companies do not consistently include poor populations in registration, pricing and licensing actions. CO NTEX T MAI N FI N D I NGS This chapter analyses pharmaceutical Registration is limited, particularly where the need for better access is

greatest product deployment: how pharmaceu- Most companies (18) have filed to register some of their newest products in some tical companies ensure their products low- and middle-income countries (LICs; MICs). Across the industry, however, most reach the people who need them. As a (125, or 78%) of the companies’ 160 newest products are registered in less than half first step, companies must register their of the corresponding priority countries*. Looking only at the newest products, com- products in countries where they are panies file for registration in only 25% of the priority countries they could poten- needed. They can then use three main tially have reached. product-deployment tools: equitable pricing, responsible IP management and Little evidence of needs-based pricing product donations. These three tools are Almost all companies (19) use equitable pricing for products in scope (Astellas considered by stakeholders to have the is the exception). GSK leads,

with equitable pricing for more than 60 products biggest potential impact on supply and However, the extent of equitable pricing hovers around one third of the 850 prod- affordability. The Index evaluates how ucts on the market for high-burden diseases. Further, only 5% of products (44) are pharmaceutical companies approach covered by needs-based pricing: strategies that set different prices for different registration and use these three tools. population segments within a country (intra-country equitable pricing); take multi- It assesses how companies are tailor- ple socio-economic factors into account when assessing affordability; and apply in ing them to reach the people in great- at least one priority country. est need for improved access to specific products. For this analysis, the Index has Voluntary licensing expands into hepatitis C identified priority countries* for each dis- While companies remain cautious in their use of voluntary licensing, there is move-

ease in scope: countries with a particular ment. Since 2014, companies have licensed products for a diseases other than HIV/ need for access to products for the dis- AIDS for the first time: hepatitis C. However, middle-income countries (MICs) with ease in question. large populations in need are often excluded from licence scopes. 13 companies now publicly disclose patent filing/enforcement policies. Three companies have independently published information about their patents, the first to do so. Donation programmes are being tailored to local needs Companies continue to engage in product donations, with most programmes addressing neglected tropical diseases (NTDs) and communicable diseases. Programmes for communicable diseases are becoming increasingly tailored toward local needs, while programmes for NTDs have the most specific public-health-related targets, such as control, elimination or eradication. There is little data on the impact of structured donation programmes outside

of the NTD space. 30 Source: http://www.doksinet Access to Medicine Index 2016 I NTRO DUCTI O N Pharmaceutical companies are increas- Companies must consider many fac- the opportunity to contribute to supply ingly entering low- and middle-in- tors: such as the state of the healthcare and affordability. Donations are viewed come country markets – home to system, the profiles of target popula- as a useful tool for reaching the poorest the majority of the world’s poorest tions and the characteristics of the dis- and most vulnerable populations in cer- people.1 Whether products reach the ease and products in question. tain circumstances: such as to eradicate people who need them in these mar- or eliminate a disease, or to bridge the kets depends on the choices companies In this analysis, “product deployment” treatment gap where governments are make when deploying their medicines, refers to how pharmaceutical compa- unable to pay. vaccines and diagnostics

to these target nies ensure their products reach the populations. people who need them. They have a The Index has analysed how pharma- range of tools available. Stakeholders ceutical companies are using these four There is no “one-size-fits-all-products” broadly agree* on the most effec- ways to ensure product deployment. approach to product deployment. The tive ones: rapid and widespread prod- The purpose is to assess how compa- potential impact of an approach on uct registration; equitable pricing to nies are tailoring and combi and tai- access to medicine depends on whether make products affordable for differ- loring them to ensure the people who it addresses the challenges that each ent payers; and responsible IP manage- need their products can access them. disease, product and population brings. ment that gives other manufacturers ACCESS TO M E D ICI N E B EG I NS WITH REG ISTR ATI O N A product can only be marketed in a to greater public

accountability, coordi- publish where products are registered, country once it has been registered nation and collaboration between those and when, and their criteria for decid- there. So to ensure a product can be working to make products available. ing where to register them. Although made available as rapidly as possible, 18 companies register some products the company must start the registra- No company excels in all three areas in low- and middle-income countries tion process as a product leaves the of registration (LICs; MICs), registration is a low-scor- R&D pipeline. This is especially critical The Index evaluates three areas of reg- ing area. Four companies perform well where there is an urgent public health istration behaviour: (1) whether com- in one or two areas measured, but none need for the product. Rapid registration panies set disease-specific, time-bound meet the highest expectations looked is also key for securing market access

registration targets; (2) whether they for by the Index in all three criteria (see and growing a strong market share. file to register new products where they figure 1). Transparency around registration leads are most needed; and (3) whether they Figure 14. Pro-access registration is patchy, even among the leaders Four companies perform well in one or two areas of registration measured, but none meet the Index’s highest expectations in all three. Novartis is the leader Other companies deliver a mixed performance, with most filing to register at least some of their newest products in the countries that need them the most. Publishes registration Sets registration targets Files to register information Criteria used Ranking Within 12 For diseases Product reg- to make reg- months of Newest In priority istration istration Company in scope For LICs For LMICs approval products countries* status decisions 1 Novartis Some Some No No Majority Majority No No

2 Novo Nordisk Some No Some No Majority Majority No No Some Some No No Majority Some Some Some Majority Majority Majority Yes Some Some Yes Some 3 4 Merck & Co., Inc. Gilead *Priority countries are disease-specific sets of countries with a particular need for access to the products in question. *The methodology for each Access to Medicine Index is developed through careful review, with input from experts working across the access-to-medicine field. These reviews align the methodology with evolving global health priorities, while reinforcing and refining the Index metrics in key areas. 31 Source: http://www.doksinet Access to Medicine Index 2016 Novartis and Novo Nordisk have filed AstraZeneca, Boehringer Ingelheim, The remaining 17 companies do not to register their ten newest products Bristol-Myers Squibb, Eisai, Eli Lilly, publish any of this information. Some in the majority of the relevant priority Johnson & Johnson, Pfizer, Roche and

state that they make it available on countries (54% and 67%, respectively). Takeda). request or only to specific health authorities. The lack of pro-access reg- Yet neither company has moved rapidly to register their three newest products Gilead and Merck & Co., Inc* lead when istration represents missed opportu- (those launched since 2015 by Novartis; it comes to publishing where prod- nities: not only for people who would those launched since 2013 by Novo ucts are registered and how they benefit from access to these medi- Nordisk). These have so far been reg- decide where to register them. Gilead’s cines, but also for companies, who miss istered in only a few priority countries. best-practice approach is described opportunities to build confidence in Across the industry, most (78%) of the below. Merck & Co, Inc publishes the new products. companies’ 160 newest products are registration status of some medicines registered in less than half of the

corre- online (including all its ARVs), but does sponding priority countries. Together, not always include where and when companies target only one quarter of products were registered. Johnson & the priority countries they could poten- Johnson publishes an online directory tially have reached with registration of what products are sold in a given filing. country. Gilead commits to filing new prod- B ES T PR AC T I CE ucts for registration in as many LICs Gilead publishes key registration and MICs as possible within 12 months information of approval by the US Food and Drug Gilead publishes where it has filed for Administration (FDA) and/or European specific products to be registered, Medicines Agency (EMA). Nine other including whether and when filings were companies have at least set limited successful. This information is availa- registration targets, albeit without a ble for most of Gilead’s products for dis- clear timeframe. Half of all companies

eases in scope, including all its HIV/AIDS still do not have any registration tar- and hepatitis C products. gets for high-burden diseases (Astellas, *Merck & Co., Inc is known as MSD outside the US and Canada. Merck KGaA’s healthcare division is known as EMD Serono in the US and Canada. NEW METRIC A N A LYSIS Using ‘priority countries’ to indicate how companies match affordability and Leaders take steps to ensure prod- registration actions to need ucts can be used appropriately To make a product available in a coun- quality) and (2) at least five low-in- Companies can adapt brochures and try, it must first be registered for sale. come countries. For certain diseases, packaging to help patients and health- The next step is to ensure the prod- ten countries meet both criteria. For care workers understand how to use uct is affordable by implementing equi- others, the list extends beyond ten a product appropriately. Novartis is table pricing strategies. In

these two countries to ensure both criteria are the leader with a best practice in this areas, the 2016 Index has evaluated met. area, followed by GSK and Johnson the extent to which companies con- & Johnson. These companies adapt sider the needs of people living in “pri- These lists do not include all countries materials to address several types of ority countries”. The designation is dis- with people who have a high need for needs of local populations, at various ease-specific: for each disease in its access to relevant products. Rather, levels of the health system, including scope, the 2016 Index has identified companies’ registration and equitable patients, nurses and physicians. Not priority countries with (a) high-burdens pricing practices in priority countries surprisingly, across all companies, the of the disease and high inequality and indicate how the company takes need most common adaptations address (b) low-income levels. into account

across countries with high language: 13 companies adapt mate- access needs. rials into local languages. Novartis Each set of priority countries includes See pages 188-189 for more and AstraZeneca are the only com- (1) the ten countries with the highest information. panies to take account of cultural burdens of disease (adjusted for ine- 32 considerations. Source: http://www.doksinet Access to Medicine Index 2016 AFFO RDAB I LIT Y: H IG H - N E E D POPU L ATIONS OVE RLOO KE D BY PRICI NG STR ATEG I ES Affordability is the cornerstone of Pricing strategies must address peo- The Index examines two types of equi- access to medicine. Governments need ples ability to pay table pricing strategy: inter-country to prioritise health and ensure ade- Companies must think in terms of strategies, which set prices according quate coverage of healthcare for their affordability for different population to a country’s ability to pay (i.e, GDP/ people. Companies can take two

main segments. Affordability matters for GNI per capita); and intra-country strat- approaches to improving affordability: patients and for health systems, includ- egies, which set different prices for dif- directly, through equitable pricing ini- ing public sector budgets. In the end, ferent population segments within a tiatives; and indirectly, by managing IP affordability depends on who is paying country. responsibly, which can lead to lower and the constraints they face. prices. Both approaches make business sense. They give companies access to Figure 15. Most companies act on their commitments to equitable pricing large and growing markets where they Gilead and GSK are the leaders in this area. They have committed to using both inter- and intra-coun- can also build reputation and relation- try pricing segmentation for the majority of diseases they are active in – and they have taken steps ships. This section examines how companies engage in equitable pricing:

targeted pricing strategies that aim to toward fulfilling these commitments. Most companies’ commitments are matched by actions: they have applied equitable pricing to at least some products for each disease where they have committed to equitable pricing. make products affordable for all population segments, including the poor, whether or not products are paid for by Commitment Implementation to equitable of equita- pricing ble pricing patients or healthcare systems. strategies* among other factors. Yet, pharmaceutical companies have an additional social responsibility: to consider affordability for all, for the public sector as well as in the private sector. Companies’ actions match their commitments to affordability Almost all pharmaceutical companies (19) have made some commitment to making products affordable – three more than in 2014. Seven have expanded existing commitments to more disease areas or product types. Such commitments are the first step toward greater

public accountability for product pricing. GSK and Gilead make the strongest commitments, covering most diseases in scope where they have products on the market. For many companies, there is still a way to go to cover all of their products for diseases and countries in scope. Astellas and Takeda have made commitments to affordability in certain countries, but not in relation to products in scope (although Astellas is currently considering this). Company Intra-country levels, demand and willingness to pay, Inter-country different markets, depending on income Intra-country ufacturers to charge different prices in Inter-country In most industries, it is normal for man- Gilead GSK AstraZeneca Bristol-Myers Squibb Novartis AbbVie Bayer Eli Lilly Covers the majority of diseases Merck KGaA in scope for which the company Novo Nordisk* Covers some diseases in scope Daiichi Sankyo

for which the company has Eisai Only a general commitment to Merck & Co., Inc Roche Sanofi Pfizer Boehringer Ingelheim Johnson & Johnson Takeda Astellas has products products equitable pricing *For at least one relevant product for each disease with a commitment *Only active in one relevant disease area, proportion of products measured instead of proportion of diseases 33 Source: http://www.doksinet Access to Medicine Index 2016 Increase in use of equitable pricing Over the past four years, the number Figure 16. Top 10 diseases with the most products with equitable pricing of companies using equitable pricing strategies strategies has increased steadily: from In 2016, ischaemic heart disease has risen to replace HIV/AIDS as the disease with the most products 16 in 2012, to 18 in 2014, to 19 in 2016. with equitable pricing. Takeda is the most recent company to engage: it now has

inter-country equitable pricing strategies for five products Ischaemic heart disease Lower respiratory infections HIV/AIDS in scope. Astellas is the only company that does not yet use equitable pricing for a disease in scope. Diabetes Hypertensive heart disease Cirrhosis of the liver Asthma Companies use a wide range of pric- Epilepsy ing approaches in low- and middle-in- Chronic obstructive pulmonary disease (COPD) come countries: including differen- tial (or tiered) pricing, discounts, flat Contraceptive methods prices, price caps, floor prices, non- 0 5 10 profit models, responding to tenders, This figure shows the number of products per disease with equitable pricing. Products may have multi- dual/local branding, managed entry ple disease indications. agreements and patient assistance programmes. More products have equitable pricing ered for multiple population segments of affordability in these markets. The Pharmaceutical companies report 850 within a

country). As in 2014, approx- analysis will continue to shape price products on the market for high-burden imately a third of products with equi- adjustments for respiratory and car- diseases. More products than in 2014 table pricing have intra-country strate- diovascular disease products in these now have equitable pricing strategies. gies, despite their being seen as particu- markets. AstraZeneca has also cre- Many products have multiple strategies, larly important for increasing affordabil- ated an internal Affordability Centre of for example, for different regions and ity where there is high socio-economic Excellence, which has a regional team countries. The diseases with the most inequality, limited public financing and a to maximise patient access and afforda- equitably priced products are: ischaemic lack of universal health coverage. This is bility. One of its key roles is to integrate heart disease, lower respiratory infec- the case in many large MICs.

ability-to-pay analysis into everyday business practice. The company has also set tions and HIV/AIDS. However, the proportion of products with equitable pric- I N N OVAT I O N up a portal to train staff on its new pric- ing still hovers around one third. Most AstraZeneca analyses populations’ ing strategy and how to integrate it into products for high-burden diseases still ability to pay their processes. do not have equitable pricing strategies. AstraZeneca’s International Region business division has conducted an in-depth Companies have also not expanded ability-to-pay analysis in certain coun- their use of intra-country equitable tries. This has shaped the division’s new pricing (where affordability is consid- pricing policy, which now takes account H I G H - N E E D PO PU L ATIO NS ARE OVE RLOO KE D BY PRI CI NG STR ATEG I ES A third (280 out of 850) of products Looking across all 280 products with Companies are targeting middle-income on the market for

high-burden diseases equitable pricing strategies (including countries (MICs) more frequently than have at least one equitable pricing strat- those that target no priority countries), low-income countries (LICs): companies egy. However, only 187 (67%) of these companies target only 20% of the prior- took 25% of the opportunities to target products are equitably priced in one or ity countries they could potentially have a priority MIC, vs 18% of the opportu- more priority countries. On average, the reached (621 out of 3,036). Priority nities to target a priority LIC. It is par- strategies for each of these 187 prod- countries are those with people with a ticularly concerning that LICs are being ucts target just three priority countries. high need for the product in question overlooked, as people living in these Depending on the disease, each strat- (See box on page 32). countries generally have a low ability egy has an average of ten priority coun- to pay out of

pocket, and public sector tries that it could target. financing is limited. 34 Source: http://www.doksinet Access to Medicine Index 2016 Looking at all 850 products on the Among the largest companies (those Most companies pay little attention to market for high-burden diseases with more than 50 marketed products), socio-economic factors (including those without equitable pric- GSK and Novartis are the leaders, both To ensure affordability, companies need ing), companies take only 7% of the in absolute and relative terms. GSK has to assess people’s ability to pay. This opportunities to target a priority coun- 41 products with equitable pricing strat- depends on multiple socio-economic try with an equitable pricing strategy. egies that target priority countries. This factors. The 2014 Index identified eight accounts for 39% of its relevant portfo- socio-economic factors that companies Leaders in targeting high-burden, lio. Together, the strategies target 35%

consider when setting prices. In 2016, high-inequality, low-income countries of the priority countries for the diseases the Index analysed which companies Gilead has the highest proportion of in question. In turn, Novartis has 35 take these eight factors into account, products (50%) with equitable pricing products, accounting for 49% of its rel- alongside a further nine factors identi- strategies that target priority countries. evant portfolio. Together, the strategies fied during methodology development. Together, strategies for these products target 31% of the priority countries for reach 77% of priority countries for the the diseases in question. Of the smaller GSK is the leader when it comes to con- diseases in question. It has seven mar- companies (those with fewer than 50 sidering socio-economic factors in its keted products with equitable pricing marketed products), AstraZeneca is the pricing strategies: it consistently con- strategies that target

priority countries. leader in absolute terms, with 10 prod- siders an average of three. It considers ucts that meet this criteria. the following factors most frequently: Figure 17. True needs-based pricing is limited There are more products with equitable pricing strategies than in 2014. Yet, come countries), Only 44 (5%) products out of 850 have a strategy that these still represent a third of all 850 products on the market, and their use meet the key criteria looked at by the Index and applies in even one prior- of price differentiation within countries remains static. Such strategies are ity country*. Figure 4. True needs-based pricing ismany limited particularly important where inequality is high (e.g, in large middle-in2014 2016 280 230 700 185 34 850 470 95 61 570 Products priced equitably. .including with price differentiation within countries .including in at least one priority country* 17 44 .and with at least one socio-economic factor taken into

account. *Priority countries are disease-specific: for each disease in its scope, the 2016 Index has identified countries with (a) high burdens of the disease and high inequality; and (b) low-income levels. Figure 18. Most opportunities to match pricing actions to need are overlooked Out of all products for diseases in scope, 280 have equitable pricing strate- try. Only 20% of these opportunities were taken (621) Looking at all 850 gies, including 187 with a strategy that applies in at least one priority country. products on the market for diseases in scope, this accounts for only 7% of For each disease in scope, the Index has identified priority countries with a more than 8,000 opportunities to target a priority country with an afforda- particular need for greater access to related products). Combined, these 280 bility scheme. equitable pricing strategies had 3,036 opportunities to target a priority counProducts with equitable pricing strategies in priority countries

Products without equitable pricing 570 Products with equitable pricing in 187 at least one priority country 850 Products with 93 equitable pricing, but not in a priority country Opportunities to target priority countries with equitable pricing strategies 621 2,415 5,700 Total opportunities = 8,736 Opportunities taken Opportunities missed where equitable pricing strategies exist (all products, diseases, and strategies) Opportunities missed as there is no equitable pricing strategy (all products and diseases) 35 Source: http://www.doksinet Access to Medicine Index 2016 presence and maturity of healthcare system infrastructure, availability of A N A LYSIS A N A LYSIS healthcare system financing and demo- More companies can set pricing More companies set guidelines to graphics within a country. In contrast, guidelines for sales agents facilitate drug recalls than in 2014 inter-country strategies take an average The Index measures two steps compa- The Index also

measures whether of just two factors into account; most nies can take to ensure medicines are companies have stringent drug-re- intra-country strategies consider an affordable for patients: whether they call guidelines and whether they track average of just one factor. provide pricing guidelines to in-house products to ensure recalls can be com- and third-party sales agents, which pleted efficiently. Compared to 2014, Progress toward true needs-based can help limit mark-ups; and whether four more companies (AbbVie, Bristol- pricing is limited they monitor prices and mark-ups in Myers Squibb, Merck KGaA and Pfizer) Only 44 out of 850 (5%) products are different markets. have product-recall guidelines in place covered by strategies that (a) set differ- In 2016, accountability for sales’ in all of the countries in scope where ent prices for different population seg- agents pricing practices remains their products are available. In total, ments within a country

(intra-coun- low-scoring. Yet there have been 18 companies now have these guide- try equitable pricing); (b) take multi- improvements. Six companies lines. However, Novo Nordisk is the ple socio-economic factors into account (Astellas, Bayer, Daiichi Sankyo, only company that publishes details of when setting prices; and (c) target at Eisai, Johnson & Johnson and Novo its drug recalls. least one priority country. Nordisk) provide pricing guidelines across the rest of the companies, most to all sales agents, including in-house B ES T PR AC T I CE and third-party operatives. They also GSK considers eight socio-economic either monitor mark-ups or prices, or factors when setting prices for a first- audit sales agents’ pricing practices. line broad spectrum antibiotic Across different countries, GSK’s equitable pricing strategy for amoxicillin/clavulanate potassium (Augmentin®) consid- Figure 19. Leaders have a higher proportion of marketed products with

equita6strategies Leaders have higher priority proportion of marketed products with equitable pricing bleFigure pricing thata target countries ers (1) the burden of infectious diseases, For most products on the market, companies do not have equitable pricing strategies in place. Of For most products on the market, companies do not have equitable pricing strategies in place. Of those that do, those that do, only some products have strategies that target the relevant priority countries. Gilead some products haveofstrategies target relevant priority countries. Gilead the highest proportion of hasonly the highest proportion products that (50%) with the equitable pricing strategies that targethas prior- (2) healthcare system funding (and resulting out-of-pocket spending), (3) demographics and population distribution, (4) level of economic development, (5) level of inequality, (6) supply chain factors, (7) raising patient awareness and, (8) ensuring appropriate use, both by patients and

physicians. The strategy targets 88% of priority countries and uses different equitable pricing mechanisms in different countries. B ES T PR AC T I CE AstraZeneca considers five socio-economic factors when setting prices for a first-line heart disease medicine AstraZeneca’s intra-country equitable pricing strategy for ticagrelor (Brilinta®) considers five socio-economic factors: (1) disease burden, (2) the availability of public financing, (3) levels of inequality, (4) supply chain conditions and (5) patient awareness. The strategy targets 27% of priority countries. In India, China and Brazil, it targets multiple population segments. This strategy is particularly important as ticagrelor is used first36 strategies that target priority countries. products (50%) with pricing strategies thatmore targetthan priority countries.products), Among the largest ity countries. Among theequitable largest companies (those with 50 marketed GSK and companies (thoseare with thanboth 50 marketed

products), GSKterms. and Novartis are the leaders, both in absolute and relative Novartis themore leaders, in absolute and relative terms. Gilead 50% 50% Novartis 49% 30% Merck & Co 39% 61% GSK 38% 43% AstraZeneca 31% 38% Daichi 29% 57% NovoNordisk 27% 73% BMS 27% 60% Eli Lilly 25% 75% Sanofi 22% 64% Pfizer 20% 62% AbbVie 20% 60% Merck KGaA 11% 87% J&J 9% 91% Eisai 8% 75% Bayer 8% 80% BI 6% 85% Roche 5% 92% Takeda 2% 90% Astellas 100% % of products with equitable 0,0 pricing strategies 0,2 that target at least 0,4one priority country 0,6 % of products with equitable pricing strategies that target other Index countries % of products with no equitable pricing strategies 0,8 Source: http://www.doksinet The Index looked at how often companies consider 17 different socio-economic factors when addressing affordability. The figure shows which factors are most frequently taken into account (by the 187 equitable pricing

Medicine Index 2016 strategies that consider more than one factor). Companies look most often at Access diseaseto burden, followed by healthcare system financing and healthcare system infrastructure. This suggests that, when setting prices, companies are more focused on number of patients, who will pay for the product, and whether a product can be distributed and administered. 0% setting prices, com-effectively Figure 20. When % of equitable pricing strategies* that consider socio-economic factors, per factor. 21% about disease panies think most 0% burden, healthcare financing and 19% healthcare infrastructure The Index looked31% at how often companies con- Disease burden/prevalence/endemic countries Healthcare system financing/funding Healthcare system infrastructure/maturity Demographics sider 17 different 14% socio-economic factors when 0% addressing affordability. The figure shows which 13% factors are most frequently taken into account when companies 0% assess affordability.

Companies Level of economic development Cost (of R&D/production/supply) Commitment from government Demand 14% look most often at disease burden, followed 18% financing and healthcare by healthcare system Level of inequality 20% This suggests that comsystem infrastructure. Ensuring patient education and disease awareness 2% panies are more focused on number of patients, 0%product, and whether who will pay for the a product can be 17% effectively distributed and administered. Availability of alternative treatments Countrys economic situation/vulnerability Unmet need/public health need Ensuring appropriate use 12% Level of human development 9% 3% Supply chain 8% Regulatory system *Of 187 equitable pricing strategies that consider at least one socio-economic factor. 0% line in the prevention of atherothrom- uation of the country/region (3) cost, botic events. It is also on patent, and and (4) availability of public financing. AstraZeneca is the only manufacturer.

This equitable pricing strategy applies in examining price and sales-volume data. (Bayer, GSK, 0 Four companies 10 20 30 Johnson 40 & Johnson and Merck KGaA) disclose all priority countries for HIV/AIDS. The complete price and volume-of-sales 800mg daily dose of Prezista® is used information at a highly granular level, Johnson & Johnson uses four in second-line regimens. It is offered at per country and for both the public and socio-economic factors to set prices USD 36 per unit (USD 1.20 per patient private sectors. This shows that they for essential HIV/AIDS product in all per day, ex-factory) in sub-Saharan Africa implement their equitable pricing strat- priority countries and in Least Developed Countries (for egies. The rest of the companies either For darunavir (Prezista®), which is both public and private markets). don’t provide granular data for all rele- B ES T PR AC T I CE on-patent and on the WHO Model vant products, provide granular

details Essential Medicines List (EML), Johnson Limited evidence of strategy only either for price or for volume infor- & Johnson considers four socio-eco- implementation mation, or disclose no information at all. nomic factors: (1) status of the pan- The Index assesses whether companies demic, (2) economic and healthcare sit- implement their pricing strategies by LE AD E RS TAKE AN ACCESS- O RI E NTE D APPROACH TO I NTE LLECTUAL PRO PE RT Y MANAG E M E NT Affordability, competition and supply are transparent about the patents have published new or expanded pol- are related to how companies manage they hold; and whether they engage in icies for patent filing, enforcement or their intellectual property (IP). This has non-exclusive voluntary licensing. abandonment. role of Indian generic manufacturers in Greater clarity on where companies Progress on patent transparency increasing the affordability and supply will exercise IP rights Patent transparency

complements com- of HIV/AIDS medicines.2 Companies Companies can publicly commit them- panies’ licensing activities as well as have an obligation to manage their IP selves to abandoning, not filing and their promises not to file for or enforce rights responsibly, to ensure they do not not enforcing patent rights in specific patent rights.4 Over successive indices, limit access to medicine for poor and countries, e.g, on a public website or this has consistently been one of the vulnerable populations. in a strategy paper. These patent poli- industry’s lowest-performing areas. been amply demonstrated through the cies give added clarity to generic mediThe Index measures three central ways cine manufacturers and to international Three companies have made the first in which companies can manage IP drug procurers when making decisions independent moves, increasing the responsibly: whether they have respon- about supplying products to these mar- transparency of

their patents. Merck sible patenting policies; whether they kets. Since 2014, seven companies KGaA led in late 2014. AstraZeneca and 37 50 Source: http://www.doksinet Access to Medicine Index 2016 A N A LYSIS A N A LYSIS Limited support for TRIPS flexibilities Evidence of anti-competitive behaviour Companies are expected to support ship, either to lobbying for the applica- the flexibilities built into the interna- tion of IP protection that exceeds the Closely related to responsible IP man- tional intellectual property (IP) system. provisions set out in the original TRIPS agement, companies have a legal These were confirmed by the Doha agreement, or to influencing legisla- duty to operate within frameworks Declaration on the TRIPS agreement tion intended to enable countries to of competition law, and to refrain and public health.3 They enable WTO take advantage of TRIPS flexibilities. from behaving in an anti-competitive member states to, among other things,

However, it is possible for companies manner. This can include, for example, set aside patent rights to protect public to take contrasting positions to those engaging in pay-for-delay activities, health. As in 2014, companies acknowl- taken by the associations of which price collusion, or any other mecha- edge these flexibilities to a limited they are members: GSK describes a nism prohibited by law that obstructs extent. AstraZeneca goes further than procedure for disagreeing with posi- fair competition. most, acknowledging that countries tions taken by trade associations and are free to determine what constitutes to ensure those positions do not form Three companies (Eli Lilly, Merck a “public health emergency”. Only one part of its regular public engagement KGaA and Novo Nordisk) were the company, Merck KGaA, acknowledges activities. object of negative judgements, fines that it is the right of countries to deter- or settlements for anti-competitive

mine grounds for compulsory licences. behaviour identified during the period of analysis. For Eli Lilly and Merck In contrast to even this limited level KGaA, these related to activities in of support, all 20 companies were countries in the scope of the Index linked, via trade association member- (Mexico, Brazil, respectively.) Novo Nordisk have followed. These ture, and all either disclose or commit to graphic scope: to sub-Saharan Africa. three companies disclose a varying level disclosing the statuses of their patents. Since 2014, seven patented compounds of detail about their patents. There is are newly subject to non-exclusive vol- an opportunity for an open discussion Use of voluntary licensing expands untary licensing: four for hepatitis C and about the level of transparency that Licensing can stimulate competition, three for HIV/AIDS. best serves public health, and to agree reduce prices and bolster supply. To Since the first company (Gilead) joined the

appropriate ownership, form, func- have a significant impact on access, in 2012, the MPP has been the cen- tion and mandate for a global database licences should be non-exclusive, trans- tral independent driver of access-ori- on pharmaceutical patent statuses. parent and include access-friendly ented licensing in the pharma indus- terms. Licensing newly registered prod- try. Companies with the most pro-ac- GSK has committed to disclosing its ucts – or even products that are still in cess criteria in their agreed licences* patent library in the future. As reported development – accelerates the speed have all negotiated agreements through in 2014, companies who engage with at which products can be made accessi- the MPP (AbbVie, Bristol-Myers Squibb, the Medicines Patent Pool (MPP) also ble and affordable in volume in low- and Gilead, GSK and Merck & Co., Inc) disclose information about the patents middle-income countries (LICs; MICs). on ARVs, which the

MPP makes public. Companies should register products There is further room for licensing HIV/ where licensees are based, to enable AIDS products: notably, for adult formu- manufacture to begin rapidly. Since lations of Merck & Co., Inc’s raltegra- Clarity in approach to IP management 2014, one more company (AbbVie) vir (Isentress®), licensed to two man- AstraZeneca, GSK and Merck KGaA have has started issuing non-exclusive vol- ufacturers; and Johnson & Johnson’s published frameworks that show how untary licences: for its paediatric and etravirine (Intelence®), licensed to they plan to manage intellectual prop- adult formulations of ritonavir/lopina- only one manufacturer, with a com- erty. They all include policies on not filing vir (Aluvia®), via the Medicines Patent paratively narrow geographic scope. for and/or not enforcing patent rights Pool (MPP). Aluvia is recommended However, these are currently both third- and clearly state where these

policies as a first-line treatment for children line regimens, with comparatively lim- apply. All three companies have stated under three years of age, and as a sec- ited markets. how and where they would consider ond-line treatment for adults. The adult issuing licences that facilitate manufac- licence is comparatively limited in geo- B ES T PR AC T I CE 38 * Long patent life remaining/pre-registration, optional technology transfer, no restriction on API supply, no restriction on supply to countries who issue compulsory licences, ability to supply where patents are not in force, broad geographic scope. Source: http://www.doksinet Access to Medicine Index 2016 Figure 21. Company’s patenting policies vary widely in Policies can limit possibility for depth and potential impact manufacture If policies exclude countries with signif- A total of 13 companies now have public patent policies, although they vary icant manufacturing capacity (such as widely in breadth and

scope: some cover more products; some cover more India), they may support supply via inter- countries and regions. Whether these policies are impactful depends on national drug procurers, but are unlikely which countries they cover, the products’ patent statuses and clinical value, to have a significant impact on the likeli- and whether there is a realistic possibility of generic medicine manufacture. hood of generic medicine manufacture. Many companies’ IP policies focus on least developed countries (LDCs) and low-income countries (LICs). These typ- Patent status transparency yes yes ◗ ◗ ◗ ◗ Johnson & Johnson‡ yes yes ◗ ◗ Merck & Co., Inc yes yes AbbVie yes ◗ a public willingness to license products for supply. For example, GSK explicitly ent products for generic manufacture for the next 10 years. This includes per- ers that wish to supply patented products to LDCs. ◗ ◗ Policies for specific

products Policies can be linked to specific on-patent products, preferably those with sig- Novartis yes panies can support their policies with yes Roche† To achieve their intended impact, com- agrees to issue licences to manufactur- yes yes pendently choose to take measures not mission to supply to all LMICs. Novartis yes Novo Nordisk GSK Merck KGaA meaning that these countries can inde- agrees to consider licensing all on-pat- Eli Lilly rights on pharmaceuticals until 2033, to enforce patents. ◗ yes LDCs from needing to recognise patent All MICs Publicly disclosed policies Eisai Some UMICs yes Some LMICs Bristol-Myers Squibb† LICs yes LDCs* Boehringer Ingelheim* yes Africa yes addition, the WTO further extended Sub-Saharan AstraZeneca since 2014 Astellas* ically have less manufacturing capacity (exceptions include Bangladesh). In New/expanded Disclosure of ARV statuses (via MPP) Self-disclosure Company Patent filing and

enforcement policies nificant clinical relevance. Johnson & Johnson’s and Boehringer Ingelheim’s darunavir (Prezista®) and nevirapine policies focus on only one product each: (Viramune®), respectively. Both products are on the WHO Model Essential Policies not publicly disclosed Bayer Medicines List (EML), and Prezista® is an alternative second-line treatment for adults. However, they are both largely Daiichi Sankyo off-patent, which arguably reduces Gilead yes the value of these commitments. Pfizer yes covers the on-patent, extended-release Boehringer Ingelheim’s declaration also Sanofi yes Takeda§ yes version of nevirapine (Viramune XL®). Scopes of policies vary widely 16 companies have filing and enforcement poli- Legend Patent filing and enforcement policies: Non-filing and non-enforcement cies with defined geographic scopes: 13 are publicly Non enforcement available. Four companies do not have such policies Non-filing

(AbbVie, Gilead, Pfizer and Daiichi Sankyo). ◗ For sub-set of products *Not all LDCs are covered: For Merck KGaA, Djibouti is excluded. For AstraZeneca, Angola, Gambia and Ethiopia are excluded. *Astellas’ public policy applies to select LDCs and LICs. *Nevirapine XR (Viramune XR®), in 135 countries. †Bristol Myers Squibbs and Roches sub-Saharan African policies apply only to ARVs. ‡ Darunavir (Prezista®), in 128 countries. §Takedas commitment in sub-Saharan Africa excludes South Africa. 39 Source: http://www.doksinet Access to Medicine Index 2016 eases in scope (HIV/AIDS and hepatitis come country markets (see figure 9). Gilead’s systematic approach to C). Typically, it has done so prior to reg- Gilead also implemented anti-diversion- pro-access licensing istering its products, enabling the swifter ary clauses viewed as having negative Amidst heavy criticism for the prices of entry of generics into markets within potential effects. its new hepatitis C

treatments in devel- licensing territories. Critically, Gilead oped and some middle-income coun- also licenses directly to generic medi- Which countries benefit from try markets, Gilead uses non-exclusive cine manufacturers, achieving compara- licences? voluntary licensing widely to support tively pro-access terms, clarity and geo- The most impactful licences will include access in low- and middle-income coun- graphic reach. The newer hepatitis C a broad range of countries in need, par- tries. Gilead licenses its entire on-pat- licences have not been criticism-free, ticularly MICs, which are home to sig- ent portfolio of products that target dis- however: they exclude certain middle-in- nificant populations of poor people. B ES T PR AC T I CE Figure 22. Licensing coverage of middle-income countries outside of Africa varies Hepatitis C Looking at the ten non-African MICs that are home to the most people living with hepatitis C*, licence This figure shows all

countries in the scope of the Index that have been coverage breaks down as follows: included in at least one non-exclusive voluntary licence for either an HIV/ AIDS or hepatitis C product. Non-exclusive voluntary licences focused first • Gilead includes five of these countries in all of its hepatitis C products: Egypt, Pakistan, India, on sub-Saharan Africa, including middle-income countries (MICs). In 2016, licences typically cover all sub-Saharan African countries, including MICs, as Uzbekistan, Indonesia. • Bristol-Myers Squibb includes four of these well as all low-income countries (LICs) and least developed countries (LDCs) countries in its daclatasvir (Daklinza®) licences: outside of Africa. However, coverage of MICs outside of Africa varies Pakistan, India, Uzbekistan, Indonesia. Covered by licences for at least one HIV/AIDS product AND at least one hepatitis C product Covered by at least one licence for an HIV/AIDS product but not for a hepatitis C product Not

covered by licences for either HIV/AIDS or hepatitis C products Not in scope Important MICs remain excluded from licensing HIV/AIDS agreements. Looking at the ten non-African MICs that are home to the most people While companies succeed in including some MICs with high living with HIV/AIDS*, licence coverage breaks down as follows: inequity in the scopes of their licences, they leave other such MICs out. Adult formulations • Gilead includes five of these countries in its tenofovir alafenamide For HIV/AIDS products: Brazil, China and Mexico are not covered by any licensing agreement. These countries are home to more than 1.8 million people living with HIV/AIDS licences: India, Indonesia, Thailand, Vietnam and Pakistan. • Johnson & Johnson includes five of these countries in its rilpivirine (Edurant®) licences: India, Indonesia, Thailand, Vietnam and Pakistan. • Bristol-Myers Squibb includes two of these countries in its atazanavir For hepatitis C products: Armenia,

Brazil, China, Colombia, (Reyataz®) licence: India and Pakistan. Mexico, Moldova, Kosovo, Peru, Tajikistan, Thailand and Ukraine are not covered by licences. These countries are Paediatric formulations home to 22.4 million people living with hepatitis C • GSK (ViiV Healthcare) includes seven of these countries in its dolutegravir (Tivicay®) licences: India, Indonesia, Thailand, Vietnam, Ukraine, Colombia and Pakistan. * India, Brazil, China, Indonesia, Thailand, Vietnam, Ukraine, Mexico, Colombia and Pakistan, in descending order (UNAIDS, 2013) * China, Egypt, Pakistan, India, Brazil, Uzbekistan, Thailand, Indonesia, Ukraine, and Mexico, in descending order (Gower, 2014; Lavanchy 2010) 40 • Merck & Co., Inc includes five of these countries in its licence for raltegravir (Isentress®) licences: India, Indonesia, Vietnam, Ukraine and Pakistan • AbbVie includes four of these countries in its lopinavir/ritonavir (Aluvia®) licences: Indonesia, Thailand, Vietnam and

Pakistan. Source: http://www.doksinet Access to Medicine Index 2016 Companies’ licences all cover the over- include MICs in their licensing agree- now view licensing as an important tool whelming majority of Least Developed ments or non-assert declarations, or for efficiently deploying products for Countries (LDCs), LICs and sub-Saharan apply intra-country equitable pricing. many diseases, particularly in high-vol- African countries. However, they vary How companies balance licensing and ume markets. GSK has signalled that when it comes to permitting supply to affordability strategies for MICs gives it is open to licensing its entire pat- countries outside of the patent’s scope; a good indication of whether they sys- ented portfolio, including future oncol- and to the degree to which they include tematically consider the ability of the ogy products. AstraZeneca has also sig- lower-middle and upper-middle income poorest populations to access their nalled a

readiness to license its prod- countries (LMICs; UMICs) outside of products. However, large middle-in- ucts, but has excluded products for Africa in the licensed territory. come countries such as Mexico, Ukraine non-communicable diseases, which and Thailand are often excluded from account for most of its patented licences. The companies with licences portfolio. B ES T PR AC T I CE Permitting supply where patents are covering the most MICs home to the not in force highest numbers of people living with In its licence for dolutegravir (Tivicay®), HIV or hepatitis C (outside of Africa) are Licensing for hepatitis C products by negotiated via the MPP, GSK permits Gilead and GSK (see figure 9). Gilead, Bristol-Myers Squibb I N N OVAT I O N Bristol-Myers Squibb and Gilead have supply outside of the agreed territory to wherever patents are not in force, includ- Licensing enters new disease space licensed products in a new disease area. ing countries of

manufacture. This ena- In a change from 2014, licensing is now Gilead licenses three products for supply bles manufacturers based in India, a key being applied to products for hepati- to 101 countries via 11 manufacturers: manufacturing country, to boost access tis C, as well as for HIV/AIDS. Five com- sofosbuvir (Sovaldi®), sofosbuvir/ledi- to dolutegravir (Tivicay®) to more than panies in scope are marketing new-gen- pasvir (Harvoni®), sofosbuvir/velpatasvir 30 additional countries not mentioned in eration hepatitis C products: AbbVie, (Epclusa®). Epclusa® is pan-genotypic the licence. Bristol-Myers Squibb, Gilead, Johnson & Pan-genotypic products are particu- Johnson and Merck & Co., Inc Bristol- larly important in low-income settings Leaders address need in key MICs Myers Squibb has agreed to license where genotyping capacity may be weak. Middle-income countries (MICs) are daclatasvir (Daklinza®) and Gilead has Bristol-Myers Squibb has agreed

licens- home to the majority of the world’s agreed to license sofosbuvir (Sovaldi®), ing terms with the Medicines Patent poor, and shoulder the greatest share of the global disease burden.5,6 Compared sofosbuvir/ledipasvir (Harvoni®) and Pool (MPP). It has licensed daclatasvir sofosbuvir/ledipasvir/velpatasvir (Daklinza®) for supply to 112 countries, to low-income countries (LICs), they (Epclusa®) respectively. These prod- and to countries beyond the agreed are also more likely to present commer- ucts (except for Epclusa®) are on the geographic scope where patent rights cial opportunities for pharmaceutical WHO Model EML. are not infringed. When this prod- companies. To increase access to prod- uct is combined with Gilead’s sofos- ucts for poorer segments of the pop- Licensing need not be limited to HIV/ buvir (Sovaldi®), it has pan-genotypic ulation in MICs, companies can either AIDS and hepatitis C. Companies should potential. CO M PAN I ES CO NTI

N U E TO RU N STRUCTU RE D, LO NG -TE RM DO NATI O N PROG R AM M ES TO RE ACH TH E POO REST Product donations by private compa- main focus of structured donation pro- new long-term donation programmes nies are an important tool for reaching grammes. The 2012 London Declaration have been rolled out for communicable the poorest in specific circumstances: on Neglected Tropical Diseases has diseases. Another new programme, tar- for the control, elimination or eradica- united global health partners in erad- geting respiratory distress in newborns, tion of diseases; to enable governments icating, eliminating or controlling ten was launched by AbbVie, the only com- to obtain necessary products; and to NTDs by 2020.6 This includes eleven pany active in donating medicines for provide bridging supplies until longer- companies in scope, who are donat- maternal & neonatal health. term solutions are established. In 2016, ing essential medicines via structured 13 companies

are engaging in struc- donation programmes. Collectively, they tured donation programmes. These target all nine NTDs for which a thera- Donating new medicines for hepati- companies are joined by six more in peutic intervention is available. tis C I N N OVAT I O N For communicable diseases, most pro- making ad hoc donations in humanitarian emergencies. Only Astellas does not Companies are now increasingly active grammes (five out of seven) address engage in product donations. Neglected in donations for diseases beyond the HIV/AIDS. Companies are also taking Tropical Diseases (NTDs) remain the NTDs. Since the previous Index, three innovative approaches. Bristol-Myers 41 Source: http://www.doksinet Access to Medicine Index 2016 Figure 23. Pharmaceutical companies continue to be active in donations for high-burden diseases Pharmaceutical companies have been donating products for many years. eases. Programmes for NTDs are carried out in cooperation with WHO, For

example, Merck & Co., Inc has been donating ivermectin (Mectizan®) which publishes information on outcomes and impact. Other programmes since 1987. The table shows the 34 donation programmes that are currently are generally conducted in partnership with governments and relief organisa- running, and their scale and scope. Where programmes target Neglected tions, with companies taking greater responsibility for monitoring outcomes Tropical Diseases (NTDs), the number of beneficiaries is generally high, and impact. reflecting the international push to eliminate, eradicate or control these dis- non-endemic countries Human African Trypanosomiasis Scale All endemic and Nifurtimox (Lampit®) date Chagas disease Planned end Disease or condition Bayer donation Company Date of first scope Geographic N EG LEC TE D TRO PI C AL D I S E A S ES 2004 2020 12,673* All endemic countries 2009 2020 61,174 All endemic countries 2002 2020 Not provided 23 countries

2013 2020 265,000,000 5 countries 2012 2020 Not provided 66 countries 1999 Until elimi- (type gambiense) Nifurtimox (Lampit®) Human African Trypanosomiasis (type rhodesiense) Suramin (Germanin®) Eisai Lymphatic filariasis Diethylcarbamazine citrate (DEC) Gilead Visceral leishmaniasis Amphotericin B (AmBisome®) GSK Lymphatic filariasis Albendazole (Zentel®) >820,000,000 nation goals 61 countries 2011 Albendazole (Zentel®) Until elimi- donated 5.3 billion treatments for lymphatic filariasis (LF), reaching at least 820 achieved Soil-transmitted helminthiasis Since 2000, GSK has million people*. Many 690,800,000 have been treated multiple times. nation goals achieved Johnson & Soil-transmitted helminthiasis Johnson Mebendazole (Vermox®) Merck & Co., Lymphatic filariasis Inc. Ivermectin (Mectizan®) 37 countries 2007 2020 All endemic countries 1987 Until elimi- Not provided 1,200,000,000 nation goals Merck & Co., Inc achieved

Merck KGaA Onchocerciasis All co-endemic LF Ivermectin (Mectizan®) and onchocerciasis nation goals countries achieved Rabies India, Kenya, Tanzania, Nobivac Rabies® Other parts of Africa Schistosomiasis 10 countries 1987 Until elimi- 2006 2030 2008 Until elimi- Praziquantel (Cesol®) 1,500,000,000 Fascioliasis, paragonimiasis scale donation programme in terms of 449,528 74,000,000 nation goals the number of treatments donated. These treatments reach more than 250 million people each year. achieved Novartis runs the largest 8 countries 2006 Not provided 1,150,000 Global 2000 2020 5,000,000 33 countries 1998 2020 128,000,000 36 countries 2001 2020 200,000 Triclabendazole (Egaten®) Leprosy Multidrug therapy combination (lamprene/rimactane/dapsone) Pfizer Trachoma Azithromycin (Zithromax®) Sanofi Human African Trypanosomiasis Eflornithine (Ornidyl®), melarsoprol (Arsobal®), pentamidine (Pentacarinat®) People treated Treatments donated

Dogs treated *Since 2009. Data prior to 2009 is not provided *Global programme to eliminate lymphatic filariasis: progress report, 2015 (WHO). 42 Source: http://www.doksinet Access to Medicine Index 2016 Scale Until elimi- 5,000 date 2015 Planned end Georgia donation Hepatitis C Date of first Disease or condition Gilead scope Company Geographic CO M M U N I C AB LE D I S E A S ES Ledipasvir/sofosbuvir (Harvoni®), nation goals sofosbuvir (Sovaldi®) achieved HIV/AIDS Myanmar 2013 Efavirenz/emtricitabin/tenofovir HIV/AIDS Johnson Rilpivirine (Edurant®) 2,000 there is a disoproxil fumarate (Atripla®) Johnson & "As long as need" China 2015 Not provided HIV/AIDS (paediatric) Kenya, South Africa, 2014 2039 Darunavir (Prezista®), etravirine Swaziland and Zambia Georgia 2015 Not provided Botswana 2000 Provided 300 Not provided (Intelence®) TB 200 Bedaquiline (Sirturo®) Merck & Co., HIV/AIDS Inc. Efavirenz

(Stocrin®), raltegravir has committed to 245,340 HIV/AIDS-related fungal infections free to people with 63 countries 2000 Fluconazole (Diflucan®) "As long as Not provided there is a need" Eli Lilly Epilepsy, bipolar affective disor- ant TB in more than dle-income countries. Countries can request Cambodia 2013 "As long as der, migraine requested by Divalproex sodium (Depakote®) partners" Diabetes (paediatric) multi-drug-resist100 low- and mid- N O N - CO M M U N I C AB LE D I S E A S ES AbbVie providing bedaquiline (Sirturo®) for confidentially (Isentress®) Pfizer Johnson & Johnson Not provided bedaquiline donations through the Stop TB Partnership. 23 countries 2009 2018 13,500 Kenya 2000 Not provided 1,475 Kenya 2005 2021 2,122 7 countries 2012 Not provided Not provided 15 countries 2006 2020 Not provided 9 countries 2009 2020 14,058 9 countries 2009 2020 14,058 2015 Committed Insulin lispro

(Humalog®) Diabetes (paediatric) Insulin lispro (Humalog®) Mental health conditions Olanzapine (Zyprexa®), fluoxetine hydrochloride (Prozac®) Johnson & Diabetes (paediatric) Johnson OneTouch® diagnostics Schizophrenia Holoperidol (Haldol®), pimozide (Orap®), pipamperone (Dipiperon®), risperidone (Risperdal®) Novo Diabetes (paediatric) Nordisk Human insulins (Actrapid®, Roche Diabetes (paediatric) Insulatard®, Mixtard®) blood glucose meter (Accu-Chek®) MATE R NAL & N EO NATAL H E ALTH CO N D ITI O N S AbbVie Respiratory distress in newborns Honduras, India, Beractant (Survanta®) Jamaica, Paraguay 100 for "the long AbbVies long-term term" Respiratory distress in newborns Kosovo 2013 Beractant (Survanta®) Committed 2,100 for "the long sual. Long-term commitments to donat- M U LTI PLE D I S E A S ES Bipolar affective disorder, tions for neonatal conditions is unu- term" AbbVie commitment to dona- ing products are

most Kosovo 2013 "As long as epilepsy, infectious diseases, requested by migraine partners" Not provided frequently made for NTDs and communicable diseases. Clarithromycin (Biaxin®), divalproex sodium (Depakote®) 43 Source: http://www.doksinet Access to Medicine Index 2016 Squibb has launched a donation pro- to more horizontal approaches. For tion of these programmes. This also gramme for its on-patent product for example, Merck & Co., Inc is address- applies to the structured programmes hepatitis C (daclatasvir (Daklinza®)), ing people co-infected with TB and HIV/ targeting non-communicable diseases which is intended to bridge the gap AIDS in Botswana, and Bristol-Meyers set up by Eli Lilly, Johnson & Johnson before generics enter the market. Squibb is addressing patients co-in- and Novo Nordisk, which target mental Gilead has launched a programme for fected with HIV/AIDS and the hepati- health conditions and/or diabetes. donating

both sofosbuvir (Sovaldi®) tis C virus. These programmes tend to and sofosbuvir/ledipasvir (Harvoni®), include capacity building activities to Low transparency on impact also for hepatitis C. This is a coun- improve the outcomes and impact: for monitoring try-wide programme to eradicate the example, Gilead facilitates local and WHO is responsible for monitoring hepatitis C virus in Georgia which has a regional health system strengthen- donation programmes targeting NTDs. high prevalence of this disease. ing through its donation programmes, Five companies regularly audit donation by contributing to the development programmes for diseases other than Programmes are being tailored to of screening, training and awareness NTDs, but monitoring is the responsi- local needs activities. bility of partner organisations (AbbVie, Donation programmes are increas- Boehringer Ingelheim, Bristol-Meyers ingly being tailored toward local needs. Compared to NTD donation pro-

Squibb, Eisai and Johnson & Johnson). Almost all donation programmes for a grammes, programmes addressing com- There is little data on the impact of communicable disease launched in the municable diseases do not target clearly donation programmes outside of the last five years are focused on a single defined health outcomes, such as erad- NTD space. Companies are encouraged country, and are being carried out in ication. For this reason, it is crucial that to expand evaluation of the impact of close cooperation with governments companies consider the long-term sus- their donation programmes. This would and local organisations. Moreover, these tainability of improvements in access to enable companies to assess the long- programmes are embedded in national medicines – particularly where life-long term outcomes and health impact of health programmes, indicating a shift treatment is needed – beyond the dura- their contribution. CONCLUSI O N There is evidence

of slow movement in companies’ approaches to product deployment. They are using equitable pricing for more products than in 2014 and some companies are more transparent about product registration status than they were in 2014. Some companies are becoming more progressive and transparent in their IP management. Companies have responded to international calls to donate products to control and eliminate NTDs Overall, however, the industry gives a mixed performance when it comes to consistently deploying medicines, vaccines and diagnostics to low-resource settings. RE FE RE NCES 1 Ascher J, Bogdan B, Dreszer J, Zho G. “Pharma’s next challenge.” July 2015 Accessed 1 November at http://www.mckinseycom/industries/ pharmaceuticals-and-medical-products/ our-insights/pharmas-next-challenge 2 Waning B, Diedrichsen E, Moon S. “A lifeline to treatment: the role of Indian Generic Manufacturers in supplying 44 antiretroviral medicines in developing countries.” Journal of the

International AIDS Society. 2010 3 World Trade Organization. “Declaration on the TRIPS Agreement and Public Health” 20 November 2001. Accessed 14 October at https://www.wtoorg/english/thewto e/minist e/min01 e/mindecl trips epdf 4 Beall R, Attaran A. “Which patent and where? Why international patent transparency by companies is needed for medicines.” Nature Biotechnology 2016; 34 (9) 5 Edwards P, Sumner A. “The Future of Global Poverty in a Multi-Speed World. New Estimates of Scale and Location 2010-2030”. Centre for Global Development. 2013 6 Glassman A. “New Data, Same Story: Disease Still Concentrated in MiddleIncome Countries” Centre for Global Development. 2013 Source: http://www.doksinet Access to Medicine Index 2016 45 Source: http://www.doksinet Access to Medicine Index 2016 I N DUSTRY ANALYSIS: GOVE RNANCE & CO M PLIANCE Pharmaceutical companies continue to refine their approaches for increasing access to medicine. Yet poor compliance risks

undermining these investments. CO NTEX T MAI N FI N D I NGS Governance and compliance are two pil- Almost all companies (17) now have a detailed access-to-medicine strategy. lars of corporate management. They Leaders are aligning them with their corporate strategies enable companies to achieve strategic Pharmaceutical companies are expanding into markets in low- and middle-in- goals in an efficient, ethical and trans- come countries. The Index finds that leaders increasingly view access to medicine parent manner. Failure of these systems, as a way of developing their businesses in these markets. Possibly as a result, their however, can lead to corruption. Its con- access-to-medicine strategies now frequently support corporate objectives (e.g, to sequences can include the diversion of enter specific markets, or to reach low-income populations). This is demonstrated public funds away from essential health- by the use of inclusive business models in low- and

middle-income countries: care, or the over- or wrongful prescrip- models that view low- and middle-income populations segments as target markets. tion and use of medicines. Companies are refining the ways they organise and coordinate efforts to increase Integrating governance and compliance access to medicine systems can minimise the risk of failure. Companies are setting clear access-related goals linked to international health tar- For the first time, the 2016 Access to gets, such as those included in the Sustainable Development Goals (SDGs). To Medicine Index reports jointly on General achieve these goals, more companies are using performance management systems Access to Medicine Management (gov- with access-linked targets and performance-linked incentives. Stakeholder engage- ernance) and Market Influence & ment to increase access to medicine is now commonplace and generally well organ- Compliance (compliance). The aim is ised, with some companies using

secondment and volunteering programmes to to highlight where access to medicine help foster innovation. can benefit from a closer integration of these areas of policy and management. Companies have comprehensive compliance systems, yet misconduct continues Companies have comprehensive compliance systems for ensuring employees meet In this analysis, governance refers to: agreed standards of behaviour. Some companies are adopting innovative compli- ensuring oversight, enabling accounta- ance-management policies and practices, such as revolving-door policies to miti- bility and engaging with stakeholders – gate risks related to conflicts of interest. Yet, most companies continue to breach specifically in relation to access-to-med- laws or codes relating to corruption and unethical marketing. Companies may be at icine activities. Compliance refers to: greater risk of non-compliance in low- and middle-income countries, where regula- ensuring processes, operations and prac-

tory systems are likely to be weaker. This underscores the need for strong enforce- tices meet standards, codes, regulations ment of compliance systems for companies operating in these jurisdictions. and laws – particularly where they relate to access to medicine. 46 Source: http://www.doksinet Access to Medicine Index 2016 I NTRO DUCTI O N Governance and compliance are two cal behaviour, such as corruption and marketing). In all these different inter- pillars of corporate management.1 conflicts of interest. In the pharmaceu- actions, cases of misconduct have the When they are managed together,2 tical industry, this can cause the diver- potential to undermine a company’s they create responsible and account- best efforts to improve access. able processes for working toward sion of public funds away from essential healthcare,3,4 or the over- or mis-pre- set goals. For the first time, the 2016 scription of medicines, for example. Pro-access business models are

more Access to Medicine Index reports Poor compliance is a particular cause common, but misconduct puts pro- jointly on General Access to Medicine for concern where regulatory frame- gress at risk Management (governance) and Market works and prosecutorial systems are In 2016, companies have increasingly Influence & Compliance (compliance). weak.⁵ Compliance is increasingly being refined the ways they plan for and The aim is to highlight where access incorporated into corporate strategies manage their efforts to increase access to medicine can benefit from a closer to help ensure financial soundness, fair to medicine. The industry scores most integration of these areas of policy and treatment of customers and market highly when it comes to setting access management. Integrating governance integrity.⁶ To manage and minimise risks strategies, often referring to inclu- and compliance systems can improve an – including reputational ones – phar- sive

economics concepts (such as the organisation’s ability to achieve strate- maceutical companies can integrate shared value approach,⁸ or the base gic objectives. compliance within their access-manage- of the pyramid⁹) to provide the ration- ment structures, particularly in low- and ale for new, access-oriented busi- middle-income countries. ness models. Yet the industry’s per- Good governance and compliance improve access formance in compliance is not keeping Having an access-to-medicine strat- Managing external relations pace. There is evidence that most com- egy increases a company’s chances of Companies interact with different panies have continued to breach laws or making targeted, measurable and sus- stakeholders for different purposes: codes relating to marketing, which may tainable improvements to access to either to gather input from outside be undermining the success of their medicine. This includes setting specific groups (via stakeholder

engagement), access-to-medicine strategies in low- objectives relating to access to medi- to promote the company’s positions and middle-income countries. This is cine. To translate the strategy into pos- and interests (via lobbying) or to secure despite companies implementing more itive outcomes, companies need good market presence and penetration (via comprehensive compliance systems. governance. This includes strong performance management processes, board-level responsibility for access to Figure 6. The industry scores well in access management, but lags in compliance medicine, and a strategic approach to Where the Index measures management and compliance, companies perform best when it comes to stakeholder engagement. Access strat- setting detailed access-to-medicine strategies. Low scores in compliance take account of unethical Figure 1. The industry scores well in management, but lags in compliance behaviour. Such misconduct can limit access to medicine, putting

companies’ investments in access to Companies perform best when it comes to setting detailed access-to-medicine strategies. Low scores medicine at risk. in compliance take account of unethical behaviour. Such misconduct can limit access to medicine, egies that support corporate aims and have a business rationale are more likely to receive internal support among management and executives. However, companies’ investments in access can be undermined, or even curtailed, by misconduct. Failure of governance and putting companies’ investments in access to medicine at risk. Management 3.4 Compliance 2.1 0 compliance systems can lead to unethi- 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 ACCESS STR ATEG I ES I NCRE ASI NG LY HAVE BUSI N ESS CASES Most companies (17) have a detailed alone approaches for improving access its access-to-medicine strategy. strategy for increasing access to med- to their medicines. The Novartis Access to Medicines Framework, implemented in

2015, is icine. These include a set of programmes with time-bound quantita- B ES T PR AC T I CE based on the income pyramid. It ena- tive and qualitative targets that contrib- Access strategy based on the income bles the company to target middle-, ute to company-wide access goals. The pyramid lower-middle and low-income popu- three companies that still lack an over- Novartis has developed a best prac- lation segments, drawing on a portfo- all access strategy (AbbVie, Astellas, tice for reaching all socio-eco- lio of access models that Novartis has Daiichi Sankyo) do use a range of stand- nomic population segments through determined are scalable and replica47 Source: http://www.doksinet Access to Medicine Index 2016 ble. In the framework, affordability deci- Novartis and Sanofi). These include B ES T PR AC T I CE sions are made according to income Incubator for social business ideas level. Income levels are also used to indi- In 2016, Boehringer Ingelheim

has been the Sustainable Development Goals (SDGs),⁹ the 2012 London Declaration cate where other barriers to access are credited by the Index for two new busi- on Neglected Tropical Diseases10 and likely to exist. Each business division has ness models developed through its the WHO 25-By-25 global monitor- access-to-healthcare initiatives and an Making More Health partnership with ing framework for preventing and con- access-to-healthcare implementation NGO Ashoka, in Kenya. An incubator for trolling non-communicable diseases.11 plan (not publicly available). This frame- new social business ideas, it brings social Using external benchmarking frame- work includes the approaches shown in innovators and partner organisations works enables companies to collaborate figure 2. together in workshops. The incubator on achieving agreed global health goals. develops, supports and scales up innoAccess to medicine as a driver for vative business models that meet local

business growth needs. B ES T PR AC T I CE Benchmarking access targets against the SDGs Companies are increasingly setting access-related objectives that align Companies are working toward Merck KGaA is in the process of rea- with corporate goals. Alignment in agreed priorities ligning its access-related targets to the this sense refers to access-to-medi- Once companies have set their strate- SDGs and has started to report pro- cine strategies that support or contrib- gies, they must monitor their implemen- gress against them. It pays special atten- ute to companies’ corporate strategies. tation, by working to a clear timeline of tion to SDG 2 (Zero Hunger); SDG 3 Twelve companies have an access strat- qualitative and quantitative targets. Half (Good Health and Well-Being); SDG egy that aligns with their overall corpo- of the companies measured use exter- 4 (Quality Education); SDG 5 (Gender rate goals and is underpinned by a busi- nal benchmarking

frameworks (AbbVie, Equality); SDG 6 (Water and Sanitation); ness rationale. Business rationales iden- AstraZeneca, Bayer, Eisai, GSK, Johnson SDG 13 (Climate Action); and SDG 17 tify where the access strategy supports & Johnson, Merck KGaA, Novo Nordisk, (Partnerships for the Goals). As an exam- the bottom line: for example, entering new markets, expanding the consumer base, or anticipating long-term finan- Figure 24. How strategies can target all income segments cial gains. Where access strategies have Access strategies can follow the base-of-the-pyramid approach. This approach uses different tools a clear business rationale, companies to reach different income segments. While the long-term success of this approach is not yet proven, have a greater incentive to deliver on it does have advantages. It enables initiatives to be tailored to different levels of income, and income and expand them, increasing their long- levels can be used to indentify where other

access barriers exist. The figure shows which tools are most term sustainability. commonly used for reaching population segments with different incomes. I N N OVAT I O N Seven new business models in 2016 promising innovative models, all focused on access for low- and middle-income populations: Boehringer Ingelheim’s PreCare and Coupon Scheme; Eli Lilly’s Expanding Access for People (LEAP) initiative; Novartis’ Access Programme and ComHIP; Pfizer’s Global Established Products; Merck KGaA’s Su-Swastha project (already identified as an innovative business model in 2014, and now in the scale-up phase). Information about these models can be found in the company report cards (see pp78-156), and on the Population segments by income* Patient assistance programmes tems. The Index has identified seven Tenders which often have weaker health sys- Differential pricing cially in emerging and frontier markets, High income (> USD 50.00 per day) Upper middle income (USD

20.01 – 5000 per day) Middle income (USD 10.01 – 2000 per day) Low income (USD 2.01 – 1000 per day) Poor (≤ USD 2.00 per day) 2016 Access to Medicine Index website. *Pew Research, 2011. Figures expressed in 2011 purchasing power parities in 2011 prices 48 Structured donation programmes Equitable pricing ness models to support access, espe- Non-exclusive voluntary licensing There is a need for innovative busi- Source: http://www.doksinet Access to Medicine Index 2016 ple, related to SDG 2, in 2015, Merck For example, some companies offer KGaA’s Su-Swastha programme pro- employees opportunities to volunteer Pfizer’s Global Health Fellowships vided vitamin and food supplements to in countries in scope. These are usu- Pfizer’s non-financial incentive and vol- 15,432 people and held 44 health camps ally run in partnership with stakehold- unteering programme focuses on provid- in India. Novo Nordisk will systematically

ers and include an element of capac- ing high-quality, efficient health services review its contributions toward each of ity building and knowledge-transfer (i.e, to under-served communities. Fellows the 17 SDGs, focusing on those related from the company to the stakeholder). complete short-term assignments with to global health. Five companies (AbbVie, Boehringer NGOs and other organisations. For Ingelheim, Eisai, Merck & Co., Inc and example, in 2015, two fellows were sec- Seven companies have board mem- Pfizer) explicitly emphasise the value onded to PharmAccess, a Dutch foun- bers responsible for access of these programmes for gathering dation, to enhance the quality and finan- Assigning board-level responsibility for insights into local contexts that can cial health of local pharmacies in Ghana. access helps to ensure companies will potentially foster innovation. During their assignments, fellows feed B ES T PR AC T I CE set and achieve their access

objectives. their experiences back to a range of col- Seven companies (AbbVie, AstraZeneca, leagues. Their insights are used when GSK, Merck KGaA, Novartis, Pfizer and setting corporate access strategy. Roche) have taken this step, with the remaining companies assigning executive-level responsibility. As a conse- Figure 25. Companies view employee’s hands-on involvement as a source of quence, all companies regularly dis- insight cuss their access performances in board In total, 10 companies have an initiative that involves employees working directly with partner organisa- meetings. The use of bonuses and tions. Five companies (AbbVie, Boehringer Ingelheim, Eisai, Merck & Co, Inc and Pfizer) view them as a incentives to reward access-related per- channel for gathering insights into local contexts that can potentially foster innovation. formance at the highest levels can help gress toward access-related targets, which they set at both a company-wide and employee

level. This compares with one third of companies in 2014. A few companies (AbbVie, Astellas Secondment / volunteering management systems to track pro- Company Stakeholder engagement initiative AbbVie FutureFit Bayer Volunteering Program Boehringer Ingelheim Making More Health* Eisai SECI Model* GSK Partnership Associates Program Johnson & Johnson Trust Secondment Strategy Program Merck & Co Fellowship For Global Health Merck KGaA AR-MADA Programme Novartis Corporate Volunteering Program Pfizer Global Health Fellows* Focus on innovation All companies now use performance Learning / knowledge management Non-financial incentive ensure access targets are achieved. and Boehringer Ingelheim) have yet to reward good access-related performances, with either financial or non-financial incentives. Stakeholder engagement through secondments A strategic approach to stakeholder engagement can improve the acceptability,

relevance and effectiveness of companies’ access approaches. Companies employ a variety of methods for engaging with stakeholders: such as partnerships; collaborations; dialogues; and conferences, panels and other platforms. These are commonly organised around specific disease areas, access issues or products. Notably, 10 companies (see figure 3) have a pro- gramme that enables employees to work directly with stakeholders: eight are volunteering or secondment programmes; six are framed as non-financial incentives linked to access targets. *Best practice innovation incubator *Best practice stakeholder engagement *Best practice secondment programme 49 Source: http://www.doksinet Access to Medicine Index 2016 B ES T PR AC T I CE Eisai’s knowledge-creation model Eisai’s Socialization, Externalization, Combination and Internalization (SECI) model generates insights by considering employees are encouraged to use 1% of their business hours to interact with patients. During

Externalization, employees’ insights are translated into project MSD Bayer “tacit“ and “explicit” knowledge alongside each other.12 During Socialisation, Bayers Volunteering Program offers a non-finan- One of Merck & Co., Incs Global Health Fellows, cial performance incentive to employees. Nardi Odijk, works with a hospital in rural Nepal to help develop a supply chain strategy. concepts for increasing access. During Pfizer Combination, the concepts are firmed up into an action plan. Finally, during Boehringer Ingelheim Internalization, the action plan enters the pilot phase. For example, this model has been used to implement a tiered pricing strategy in India. Boehringer Ingelheims Making More Health part- secondments as a form of stakeholder nership acts as an incubator for new social busi- engagement. ness ideas in Kenya and elsewhere. Merck KGaA Pfizers Global Health Fellows scheme uses Through its volunteering programme, Merck KGaA supports

AR-MADA, an NGO, in providing medical assistance in rural Madagascar. LE AD E RS I N ACCESS GOVE RNANCE L AG I N CO M PLIANCE Companies’ investments in access can There is a real risk that such incentives transparency toward compliance do not be undermined, or even curtailed, by are misaligned with public health goals. correspond with good performance. misconduct and unethical behaviour. This is the case, for example, with off-la- Moreover, companies that lead in access This damages patient trust and diverts bel marketing, where companies recom- governance often lag when it comes to resources away from healthcare, lim- mend medicines for conditions they are cases of misconduct. iting access to quality-assured medi- not approved to treat. In resource-lim- cines, particularly for the most vulner- ited contexts, the issue is complicated Larger companies with broad geo- able groups. The frequency of corrup- further by the lack of functioning reg- graphic spread may

be at greater risk tion may be linked to improper depend- ulatory systems, which can enable mis- of misconduct, but this is not necessar- encies and a misalignment of incentives conduct to take root. ily a causal relationship. Companies can within the pharmaceutical system.14,15 For example, legislators and regulators Companies are expected to always fact, the 2014 Index found no clear link may depend on financial contributions follow the highest standards of ethi- between company size and misconduct. from the pharma sector for their cam- cal behaviour. Where unethical behav- This underscores the need for strin- paigns. Doctors may rely on companies iour and non-compliance do occur, man- gent compliance systems where com- for knowledge about medicines, and agement is expected to show zero tol- panies expand into low- and middle-in- financially, in the form of gifts and other erance. However, as in 2014, the Index come country markets. In these territo-

payments. finds that strong commitments and ries, regulatory frameworks and prose- 50 act to mitigate this risk. As a matter of Source: http://www.doksinet Access to Medicine Index 2016 cutorial systems may be unable to react of national civil or criminal laws. Four unethical behaviour in low- and mid- appropriately to cases of misconduct. occurred in a country in scope. The dle-income countries. 5 overall number of breaches has dropped since 2014: from 73 to 51. Independent research16 suggests that this does not Despite misconduct, most compa- Gilead and Novo Nordisk) were not found by a court or regulator, during necessarily indicate an improvement in systems the period of analysis, to have breached conduct and may also be due to judicial Despite continued cases of misconduct, criminal or civil laws or codes of con- and regulatory systems. all 20 companies have compliance sys- Only four companies (AbbVie, Eisai, duct related to corruption or unethi- nies

have comprehensive compliance tems in place. Some have been imple- cal marketing. A total of 51 settlements Corruption in low- and middle-income mented, expanded or improved follow- were identified by the Index: the major- countries often goes undetected. This ing misconduct or agreements with ity (31) were breaches of codes of con- is why the Index uses global incidences governments and regulators. duct; the remaining 20 were breaches of breaches as a proxy for companies’ Figure 26. The compliance chain: most companies have good, replicable compliance practices in place Compliance systems comprise complementary tools and policies. They pro- only company not applying them consistently to all third parties, but it is con- vide guidance or set limits for employees to follow in their day-to-day work, sidering to start doing so. The figure below shows examples of steps compa- or when interacting with public officials, healthcare practitioners and other nies are taking

to support standard compliance management, such as train- stakeholders. Companies have good, replicable practices for ensuring com- ing and disciplinary action. pliance. All 20 companies have enforcement processes: Daiichi Sankyo is the HIRING ONBOARDING WORKING Selection process Interactions with politicians Employee performance Ethical screening Conflicts of interest policy Disciplinary actions Revolving door policy Ban on political contributions Non-sales related incentives for sales agents Interactions with public officials Dedicated training and guidelines Interactions with third parties Dedicated training and guidelines Enforcement of company codes on third parties Interactions with healthcare Auditing professionals Risk-based Transparency of marketing Applied to third parties practices Use of internal and external resources Good ethics as a criterion for Non-sales-related incentives Innovation: GSK’s revolving Innovation: Gilead’s Pocket hiring

for sales agents door policy Guide to Regional Business Takeda is piloting an ethi- AstraZeneca, Bayer, Eisai, Eli To mitigate against potential Partner Compliance cal screening process that it Lilly, GSK, Merck KGaA and conflicts of interest, GSK is the This detailed tool was intro- applies to prospective employ- Novartis are implementing only company in the Index to duced in 2014 and focuses ees during recruitment. It con- incentives for their sales agents have introduced a “cooling off” on a wide variety of interac- sists of questionnaire designed that are not related to sales period for staff hired from the tions and activities with phy- to identify potential areas of targets. Instead, they reward public sector. These staff are sicians and government offi- concerns, and scenarios for other qualities, such as tech- not permitted to work on any cials. This approach is particu- testing applicants’ ethical deci- nical knowledge and level of

project from their previous role larly relevant to Gilead, due to sion-making processes. service. for six months. This includes a the fact that its business model ban on engaging with former largely relies on third party dis- colleagues still working on tributors. Gilead offers in-per- those projects. son compliance courses, featuring case-based scenarios to business partners in multiple regions. 51 Source: http://www.doksinet Access to Medicine Index 2016 Transparency around lobbying and flict of interest policy. GSK and Merck requirements are often absent. Only marketing KGaA are the only companies to pub- one company (Merck & Co., Inc) pub- Companies engage in a range of mar- lish their policies on political contribu- lishes information about its marketing ket-influencing activities in order to tions: GSK does not make any political activities in countries in scope. build acceptance and use of their prod- contributions, including a ban on con- ucts.

These can unduly influence public tributions to candidates for State office officials and/or healthcare profession- in the US; Merck KGaA does not make Transparency around marketing in als to purchase and prescribe products any political contribution to holders of some countries in scope unnecessarily, putting patient safety and access to medicine at risk.14, 15 To allow or candidates for political offices, polit- Merck & Co., Inc is the only company ical parties or related organisations. It that is transparent about marketing stakeholders to determine whether should be noted that GSK’s US oper- activities in some countries in scope. these interactions are appropriate ating company has set up a Political It began voluntarily disclosing finan- and ensure companies are accounta- Action Committee (PAC) to enable cial support provided to patient organ- ble, transparency is essential. The Index employees to make lawful voluntary izations in Europe, the Middle

East and looks for companies’ transparency contributions. The majority of compa- Africa in 2008. In 2009, it began to dis- regarding memberships of associations nies (12) do, however, state that they close grants to other third-party organ- and financial support provided, plus do not make political contributions in isations (such as medical societies and board seats held; transparency of policy countries in scope. scientific organisations) in the same positions; transparency of political con- B ES T PR AC T I CE regions. It publishes the recipients, tributions; transparency of conflicts of International standards for transparency amounts received, dates of payment and interest policy; transparency of market- around marketing activities are set out projects supported. Disclosures cover ing activities. in the US Physicians Payments Sunshine Act.17 This governs the payments and all donations, grants and membership Transparency remains low in all areas

transfers of value that can be made and other medical or scientific organisa- While the leaders excel in some areas to US-based healthcare profession- tions. Its rationale is to earn and retain of marketing and lobbying transpar- als. Since 2016, pharmaceutical compa- the trust and confidence of custom- ency, overall, companies perform poorly nies are also required to report about ers, employees, shareholders and other here. Only six companies (Gilead, GSK, payments made to EU-based health- stakeholders. Johnson & Johnson, Merck KGaA, care professionals and organisations. In emerging and frontier markets, such 18 Novartis and Roche) disclose their con- Figure 27. Even among the leaders, no company excels in all areas of marketing and lobbying transparency Transparency remains low in all areas measured by the Index that relate to ethical behaviour. While the leaders excel in some areas, none meet all transparency criteria measured in 2016. Board seats held

Marketing code Memberships (with financial support) Political contributions (disclosure of or policy forbidding them) Conflict of Interest policy Marketing activities 2 Gilead 3 Merck & Co., Inc, 4 Merck KGaA 5 Daiichi Sankyo Ranking in Compliance 1 Johnson & Johnson Company Transparent: the information is publicly available. Partially transparent: only some information is publicly available. Not transparent: the information is not publicly available. 52 fees paid over to professional societies Source: http://www.doksinet Access to Medicine Index 2016 CONCLUSI O N Misconduct can limit access to medicine. As such, weak enforcement of compliance systems puts companies’ investments in access to medicine at risk One solution is to integrate governance and compliance systems, and put processes in place to ensure they support access-to-medicine objectives. Where companies have a strategy of expanding

into low- and middle-income countries, they can explore ways such integration can fit within their access strategies. This would facilitate the development and deployment of inclusive business models in these country markets. RE FE RE NCES 1 Tarantino A., “Governance, Risk, and Compliance Handbook: Technology, Finance, Environmental, and International Guidance and Best Practices”, John Wiley & Sons, 2008, page 31 2 Sadiq S. and Governatori G, “Managing Regulatory Compliance in Business Processes” in Handbook on Business Process Management 2, Springer Berlin Heidelberg, 2015, accessed 9 September 2016 https://ts.data61csiroau/publications/nictaabstracts/7038pdf, pages 5-14 Transparency International, 2006 5 Ensor T. and Weinzierl S “Regulating health care in low- and middle-income countries: Broadening the policy response in resource constrained environments”, 2007, Social Science & Medicine 65 6 Deloitte. “The changing role of compliance” 2015 Accessed 9

September 2016 at https://www2.deloittecom/content/dam/Deloitte/gr/Documents/financial-services/gr fs the changing role of compliance en noexp.pdf 3 Azfar O., “Corruption and the delivery of health and education services”, Chapter 12 in Bertram Spector B. ed “Fighting corruption in developing countries”, 2005, Bloomfield, CT, Kumarian Press 7 Porter M. E and Kramer M R, “Creating shared value: redefining capitalism and the role of the corporation in society”, 1, 2011, Harvard Business Review 4 “Handbook for curbing corruption in public procurement - experiences from Indonesia, Malaysia and Pakistan”, 8 Prahalad, C.K and Hart SL “The Fortune at the Bottom of the Pyramid”, Strategy + Business, 26 9 http://www.undporg/content/undp/ en/home/sdgoverview/post-2015-development-agenda.html, accessed 9 September 2016 10 http://unitingtocombatntds.org/ resource/london-declaration, accessed 9 September 2016 11 http://www.whoint/nmh/ global monitoring framework/en/ 12

Kirah A., “Co-creation: a new way of doing business in an age of uncertainty”, accessed 9 September 2016, http://timreview.ca/article/304 13 Sah S. and Fugh-Berman A, “Physicians under the Influence: Social Psychology and Industry Marketing Strategies,” Journal of Law, Medicine & Ethics 41, no. 3 (2013): 665-672 14 Jorgensen P.D, “Pharmaceuticals, Political Money, and Public Policy: A Theoretical and Empirical Agenda,” Journal of Law, Medicine & Ethics 14, no. 3 (2013): 561-570. 15 Public Citizen, “Twenty-Five Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2015”, http:// www.citizenorg/documents/2311pdf, accessed 9 September 2016 16 https://www.congressgov/ bill/111th-congress/senate-bill/301/text, accessed 9 September 2016 17 http://transparency.efpiaeu/the-efpiacode-2, accessed 9 September 2016 53 Source: http://www.doksinet Access to Medicine Index 2016 INDUSTRY ANALYSIS: CAPACIT Y BUILDING Leaders consistently target local

needs through best practice approaches to capacity building CO NTEX T MAI N FI N D I NGS The pharmaceutical industry has an Six leaders addressing local capacity needs important role and an interest in sup- Six leaders systematically address local needs when engaging in capacity build- porting low- and middle-income coun- ing: AstraZeneca, GSK, Johnson & Johnson, Merck & Co., Inc*, Merck KGaA, and tries to strengthen local health sys- Novartis. The leaders proactively engage with stakeholders to understand and tems. To maximise the impact on access respond to local capacity gaps, and measure the impact of their initiatives. to medicine and to prevent conflicts of interest, companies’ activities must How to achieve best practice in capacity building respond to local needs. This is more To ensure local needs are addressed, capacity building initiatives should address than good practice: it is a minimum five criteria: 1) involve local partners; 2) have specific

and measurable goals; 3) requirement. have clearly defined roles, responsibilities and accountability mechanisms; 4) have clear commitments and timeframes; and 5) have regular monitoring and In 2016, the Index examines more closely evaluation and public sharing of approaches, progress and learnings. how companies assess local skills and infrastructure gaps, and then design initi- Many companies are actively building capacity across the value chain and atives to target them. Overall, companies beyond are engaged in a similar level of capacity Pharmaceutical companies are building local capacity across the pharmaceutical building activities to 2014. Some com- value chain. Their philanthropic efforts often target identified needs outside the panies focus on one or two key areas value chain, strengthening health systems more broadly. of expertise, while others undertake a range of diverse activities. Manufacturing capacity gets the most attention More companies are active

in manufacturing than in other areas. To build R&D and manufacturing capacity, companies are most active where infrastructure is stronger (e.g, China, Brazil, India and South Africa) Sub-Saharan Africa is the main focus for R&D partnerships and supply-chain strengthening. Efforts to build pharmacovigilance capacities are concentrated in Latin America. *Merck & Co., Inc is known as MSD outside the US and Canada. Merck KGaA’s healthcare division is known as EMD Serono in the US and Canada. 54 Source: http://www.doksinet Access to Medicine Index 2016 I NTRO DUCTI O N manner to embed long-term, sustain- manufacturing, supply chain man- Health system strengthening is crit- able solutions to countries’ own, inde- agement and pharmacovigilance. ical for achieving the Sustainable pendently identified capacity building Pharmaceutical companies are build- Development Goals and achieving uni- needs and priorities. They should work ing local capacities in low- and

mid- versal health coverage.1 The World with partners – whether government, dle-income countries across all areas Health Organization identifies six health non-government or private sector – measured and at a similar level over- system building blocks: services; work- who understand local contexts, and who all to 2014. While companies focus on force; information systems; medical can engage effectively with the industry different areas, six leaders systemati- products; financing; and governance.2 The pharmaceutical value chain inter- to drive shared goals, without conflicts cally assess local capacity needs, design of interest. The 2016 Index has meas- targeted initiatives, and measure their sects these areas. Pharmaceutical com- ured companies’ consideration of local impact: AstraZeneca, GSK, Johnson & panies have an important role to play needs more comprehensively and strin- Johnson, Merck & Co., Inc, Merck KGaA, and an interest in building low-

and mid- gently than before. and Novartis. develop, produce, distribute and moni- The six leaders They identify and address local skills tor the use of medicines. The Index examines companies’ activ- and infrastructure gaps, which will help dle-income countries’ capacities to ities to build capacity in four areas ensure activities make a greater contri- Wherever companies build capac- across the pharmaceutical value chain bution to health systems as a whole. ity, they should work in a structured that impact access to medicine: R&D, BU I LD I NG R&D AN D MAN U FACTU RI NG CAPACITI ES: CO M PAN I ES FOCUS O N CH I NA AN D OTH E R COU NTRI ES WITH STRO NG E R I N FR ASTRUCTU RE Local R&D capacity can help drive the needs.4 Once approved for sale, these medicine in major emerging markets emergence of a pharmaceutical and ser- products need to be manufactured at a with higher levels of infrastructure, par- vices sector,3 and companies and coun- scale

and quality that ensures safe and ticularly China, Brazil and India. China is tries can both benefit when medicines, reliable access. Predictably, the Index the most common focus of initiatives vaccines and diagnostics are developed shows that companies generally sup- to build either R&D or manufacturing to specifically meet emerging market port the local R&D and production of capacities. Overall, sub-Saharan Africa Figure 7. To build capacity within the pharmaceutical value chain, six leaders systematically address local needs The Index examines companies’ activities to build capacity in four areas ers (AstraZeneca, GSK, Johnson & Johnson, Merck & Co., Inc, Merck KGaA, across the pharmaceutical value chain that impact access to medicine: R&D, Novartis) systematically identify and address local skills and infrastructure manufacturing, supply chain management and pharmacovigilance. This figure gaps, which will help ensure activities make a greater

contribution to health shows how companies respond to local capacity needs in each area. Six lead- systems as a whole. R&D ACTIVITY MANUFACTURING SUPPLY CHAIN MANAGEMENT PHARMACOVIGILANCE Companies are more active Most companies build Many best practice initia- Majority of companies than in 2014, with a simi- capacity in-house and with tives but large scope for update their safety labels lar proportion of long-term others. Three commit to better information-sharing, globally, but sharing safety initiatives. Four companies assessing third-party train- e.g, to report suspected data is less common. directly target local skills ing needs. falsified medicines. GSK, Merck & Co., Inc, AstraZeneca, Daiichi Sankyo, GSK, Johnson & Johnson, AbbVie, Bayer, GSK, Merck KGaA, Novartis Johnson & Johnson, Merck & Co., Inc, Novartis, Johnson & Johnson, Merck KGaA Sanofi Novartis gaps. LEADERS ACTIVE NUMBER GEOGRAPHIC FOCUS 15 China, Brazil,

Kenya and 18 China, India and Brazil 14 Sub-Saharan Africa 16 Latin America South Africa 55 Source: http://www.doksinet Access to Medicine Index 2016 Figure 28. Companies build R&D and manufacturing capacity in countries with stronger infrastructure, while strengthening supply chains and pharmacovigilance systems more widely When building R&D and manufacturing capacity, the industry is most active where infrastructure is stronger (e.g, Brazil, China, India, Kenya and South Africa) At the regional level, sub-Saharan Africa is a focus area for R&D partnerships and supply chain strengthening, but manufacturing capacity building is limited here. In Latin America, efforts to build pharmacovigilance capacity are concentrated but supply chain strengthening is not a focus. Middle East & North Africa Europe & Central Asia (8 countries in scope): The indus- (9 countries in scope): Limited try focuses here on pharmacov- capacity building activities overall.

igilance and manufacturing, with limited activities in R&D and supply chain management. Most activity is in Egypt and Iran. East Asia & Pacific (18 countries in scope): The industry focuses on Latin America & Caribbean manufacturing, while (18 countries in scope): The industry focuses on pharmacovigilance, with limited activities in supply chain management. South Asia (8 countries being relatively active in scope): The industry in all capacity building focuses on manufactur- areas. Most activity is in ing, with limited activi- China and Indonesia. ties in R&D and pharma- Most activity is in Brazil and Sub-Saharan Africa Mexico. (46 countries in scope): The industry focuses on R&D and supply chain management, with covigilance. Most activity is in India and Pakistan. limited activities in manufacturing and pharmacovigilance. Most activity is in Kenya and South Africa. AC T I O NS FO R CO M PA N I ES How do pharmaceutical companies ensure capacity

building initiatives address local needs? As capacity building initiatives can also have a commer- itly commits to preventing conflicts of interest, takes a cial benefit, it is essential that they address local needs for strong approach to doing so, and commits to Comic Relief specific capacities. The Index has identified five actions for allocating grants independently. ensuring that company initiatives effectively meet real needs and skills gaps.5 The list below includes initiatives from the Agree to clear commitments (financial and otherwise) over six leading companies in this area of the Index that demon- appropriate timeframes, including (where relevant) a strong strate how each action can be implemented. transition strategy that ensures the initiative’s long-term sustainability and local ownership. As part of its Into the Light Work with local partners to understand and align with project, Johnson & Johnson worked with local partners in country-specific needs

and resources. AstraZeneca partners the Philippines, including the University of the Philippines – with Tianjin University to address manufacturing skills gaps National Institutes of Health. The partnership developed a at the industry level in China. This is an example of best prac- national mental health information system, and planned for tice (read more: p56). the system to be managed by the university from the outset. Following a successful scale-up, Merck & Co., Inc is currently Define specific and measurable goals with partners. Merck transitioning leadership of its Informed Push Model partner- KGaA provides additional support to all its third-party man- ship for strengthening supply chains to the Senegalese gov- ufacturers, with performance indicators tailored to different ernment (read more: p56). manufacturers (read more: p56). Ensure continuous improvement through regular monitorExplicitly define roles, responsibilities and accountabil- ing and

evaluation; and publically share approaches, pro- ity mechanisms for all partners, and establish transpar- gress and learnings. For example, Novartis has evaluated ent systems to manage conflicts of interest. In 2015, GSK the impact of its SMS for Life project on reducing medicine stock-outs, and published the findings6,7 (read more: p56). announced a five-year partnership with Comic Relief to improve health system capacity to address malaria. It explic- 56 Source: http://www.doksinet Access to Medicine Index 2016 is the most common region for R&D institutes. This latter approach in par- Majority of companies building manu- partnerships. Companies have a much ticular can have far-reaching impact, facturing capacity lower focus on building local manufac- when companies actively address local 18 companies undertook manufac- turing capacities here. When it comes gaps in research expertise and build turing capacity building activities that to R&D, companies

work both in com- institutional know-how to reduce “brain met Index criteria: including training, paratively affluent countries, includ- drain”.11,12 secondments, workshops and technol- ing Kenya and South Africa (which have existing R&D hubs), as well as in low-in- ogy transfers. As in 2014, more of these were directed at third-party manufac- B ES T PR AC T I CE come countries such as Tanzania and Partnering to target local R&D skills turers (50%) than in-house manufactur- Uganda. When building local manufac- gaps ers (41%). Nearly 10% were directed at turing capacities, however, they run a Novartis and GSK take a comprehensive unaffiliated organisations (e.g, universi- relatively small number of initiatives (in approach to partnering with in-coun- ties, governments and other manufac- Kenya, Nigeria, Senegal, South Africa). try research organisations to identify turers), indicating a response to capac- The reason for this imbalance is unclear.

local skills gaps and design partnerships ity building activities which is driven by to target identified needs. For exam- more than commercial concerns. Building upon existing R&D capacity is ple, Novartis’ long-term collaboration potentially promising for developing with Addis Ababa University (Ethiopia) Companies should ensure that capacity medicines that target the specific needs focuses on post-graduate students, to building activities are mutually agreed of people living in the wider region. address local skills gaps in conducting and sustainable, particularly where Building local production capacity will Phase 1 trials. there is no direct commercial relation- also not necessarily improve access ship. Four companies undertook such to medicine without ensuring reliable quality and economies of scale.8,9 The activities (AstraZeneca, Bristol-Myers Pharmaceutical Manufacturing Plan for Interestingly, more companies are build- Africa confirms the need for

pragma- ing local manufacturing capacities than tism here.10 actually commit to doing so. 12 com- Squibb, Daiichi Sankyo, Merck KGaA). panies specifically commit to assessing GSK Looking across the geographic scope of the Index, companies are building R&D skills gaps and supporting in-house and/ or third-party plants to meet high man- capacities within their own facilities, This lab in Ghana supported the trial of GSKs ufacturing standards. Of these, three with third-party companies and with malaria vaccine candidate. commit to building third-party capaci- local universities and public research ties in response to local needs. B ES T PR AC T I CE Innovative assessment of R&D needs Figure 29. Leaders target local skills GSK’s Africa 2020 strategy includes Figure 30. Companies build manufac- gaps in R&D capacity building extensive collaborations with academic turing capacity with a diverse range of 15 companies reported a total of 60 partnerships

institutions across Africa, through the partners to build R&D capacity across 22 countries. Of Investment in Academia project and 18 companies undertook manufacturing capac- these, four (GSK, Merck & Co., Inc, Merck KGaA Africa NCD Open Lab. Notably, the Open ity building activities that met Index criteria. As in and Novartis) identified specific R&D skills gaps Lab is working in partnership with the 2014, more of these were directed at third-party and targeted these gaps through capacity buildFigure 3: Leaders target local skills Liverpool School of Tropical Medicine’s manufacturers than in-house manufacturers. Figure 4. Companies build manufactu- ing activities." gaps in R&D partnerships Companies with R&D partnerships: local Companies with no needs assessed and R&D partnerships targeted 5 Capacity Research Unit to independently assess NCD research capacity in African institutions, and identify capacity building gaps and

opportunities. ring capacity with a diverse range of partners Unaffiliated manufacturers 9% 4 In-house manufacturers 41% GSK 20 11 Third-party manufacturers 50% Companies with R&D partnerships: local needs GSKs Investment in Academia project trains sci- not targeted entists from Kenya, Nigeria, Ethiopia and Ghana in analytical techniques. 15 companies reported a total of 60 partnerships to build R&D capacity across 22 countries. Of these, four (GSK, Merck & Co., Merck KGaA and Novartis) identified specific R&D skills gaps and targeted these gaps through capacity building activities. 57 Source: http://www.doksinet Access to Medicine Index 2016 B ES T PR AC T I CE ship, the company shares its expertise Supporting high manufacturing on biologic manufacturing with over 40 standards vaccine manufacturers (including com- Merck KGaA applies a single quality panies based in Bangladesh, Egypt and standard to all its manufacturers (includ- Vietnam) to

support the global produc- ing in-house plants in Brazil, China, India, tion of high quality vaccines. AstraZeneca Mexico and Pakistan, as well as 53 conAstraZeneca has a long-term partner- scope). This is facilitated by a global ship with Tianjin University that aims to information-sharing system and Virtual improve manufacturing safety stand- Plant Team. The Team (also recognised ards at the industry level in China. Rather A researcher carries out crystallisation studies as best practice in the 2014 Index) pro- than training individual manufacturers, in automated multi-reactor equipment at Tianjin vides an additional layer of support, AstraZeneca provides funding, train- University and AstraZenecas shared lab facility. expertise and training to third-party ing and other support to the universi- plant managers. ty’s Process Safety Laboratory to fill local IntraHealth International tracted third-parties in countries in skills gaps. The company’s expertise is

Merck KGaA also has a training part- shared more widely via the university’s nership with the Developing Countries connections with manufacturers, to build Vaccine Manufacturers Network, a vol- industry-wide capacity. untary public-health driven alliance, to support the continuing education of Network members. Through the partner- Informed Push Model: a healthworker in Senegal checks stock and removes expired contraception. WI D EST G EOG R APH IC SCO PE I N SU PPLY CHAI N AN D PHARMACOVI G I L ANCE SYSTE M STRE NGTH E N I NG Whether medicines are developed and Supply chain strengthening has a countries (including Liberia, Niger and manufactured locally, functional supply sub-Saharan African focus Togo). chains and pharmacovigilance systems Fourteen companies are strengthen- are essential for safe access to medi- ing supply chains, particularly in sub-Sa- Merck & Co., Inc continues to work with cine in all countries. Yet these are often haran Africa, and

mostly through partners to support the Informed Push particularly weak in low- and middle-income countries.13,14 The Index analy- short-term initiatives. Three com- Model, adapting commercial distribu- panies demonstrate best practices tion principles to improve last-mile con- sis shows that companies take a wider (Sanofi, Merck & Co., Inc, Novartis) The traceptive distribution and stock man- geographic scope in the areas of supply common elements of these initiatives agement in Senegal (best practice in the strengthening and pharmacovigilance, include: a phased approach with regu- 2014 Index). The company partnered than when building R&D or manufactur- lar progress checks; partnerships with with local and international stakeholders ing capacities. local stakeholders, aiming for local own- to pilot and scale up the program from ership; and continuous improvement in 2012, which involves dedicated logis- response to local needs: tics professionals

bringing products from Sub-Saharan Africa is the most common region for supply-chain strengthening, whereas no such activities were identi- regional supply pharmacies to health B ES T PR AC T I CE centres, and collecting stock data to con- fied in Latin America. This could possi- Improving logistics and stock tinuously inform the next delivery cycle. bly reflect less need for capacity build- management Merck & Co., Inc is currently supporting ing, for example, due to the level of sup- Since 2010, Sanofi developed and the sustainable and long-term transition port provided in this region through piloted a training program on pharma- of its management to the Senegalese the Pan American Health Organization ceutical supply chain management for government’s National Supply Pharmacy (PAHO) Strategic Fund, which assists national purchasing centres, in response (an autonomous medicine purchasing governments in strengthening supply chain management systems.15 In

Latin to specific logistics issues faced in agency). America, companies focus more on up and adapted the training program in Novartis’ SMS for Life public-private building pharmacovigilance capacities. partnership with the African Association partnership uses mobile phones and Again, this could be driven by PAHO’s of Essential Drugs National Purchasing other technology to track stock levels at support for pharmacovigilance harmoni- Centres (ACAME), to address the needs public health facilities and improve stock sation in the region. of ACAME member countries. The pro- management of malaria treatments and gram has now been rolled out in several other essential medicines. 16 58 sub-Saharan Africa. The company scaled Source: http://www.doksinet Access to Medicine Index 2016 Protecting patients from falsified medicines Company transparency can help improve the planning, regulation and ple, newly measured in 2016, is how Merck KGaA Sherri Schwaninger security

of supply chains. A key examcompanies report suspected cases of falsified and/or substandard medicines to relevant authorities. The WHO encourages rapid reporting of sus- Drug inspectors in Nigeria are trained in the use Medical Stores Limited in Lusaka, Zambia, is part pected (i.e, unconfirmed) cases, to of the mobile Minilab from Merck KGaA, which of Novartiss SMS for Life project using mobile allow a fast response to emergencies.17 This is required in the European Union18 identifies medicines with insufficient levels of the technology to track stock levels. active ingredient. and other strong regulatory environHaving successfully implemented the ments, and countries with weak regu- Latin America is focus for strengthen- program in over 10,000 health facili- lation and/or enforcement can benefit ing pharmacovigilance ties since its launch in 2009, the com- from proactive transparency by compa- Since 2014, 14 companies worked with pany is now working with

governments nies. Company policies vary: two com- local partners to strengthen pharma- in Gabon, Nigeria and Zambia to scale panies, AbbVie and Daiichi Sankyo, covigilance systems, mainly in Latin up the use of the latest, tablet-based commit to reporting cases of falsified America (including Brazil, Mexico and platform. medicines to relevant authorities in less Peru). Activities were generally short- than a week. Daiichi Sankyo commits to term and targeted directly at regula- reporting suspected cases in this time- tory authorities, although some compa- GSK’s mVacciNation program uses frame, while AbbVie confirms cases nies also worked with distributors and mobile technologies before reporting. universities. Eight companies demon- I N N OVAT I O N Through its innovative mVacciNation strate product stewardship by updating program in Mozambique, GSK is contin- their products’ safety labels in relevant B ES T PR AC T I CE uing to test whether mobile

technolo- Portable labs build flexible capacity countries in a systematic and timely gies can help increase childhood immu- In order to support the rapid detec- way, regardless of whether the product nisation, in partnership with the Ministry tion of falsified medicines that contain is patented. Two companies voluntar- of Health. The program uses mobile incorrect levels of active pharmaceuti- ily share post-marketing safety surveil- technology to support health workers, cal ingredients, Merck KGaA’s Minilabs lance data with regulatory authorities. improve record keeping, and improve initiative has provided over 700 porta- Six additional companies – the lead- vaccine stock management. The pilot ble laboratories and related training to ers in this area – do both: AbbVie, Bayer, is being independently evaluated by healthcare professionals in more than 90 GSK, Johnson & Johnson, Novartis and the University of Cape Town and the countries via the Global

Health Pharma Takeda. Mozambique National Institute of Health. Fund. Minilabs can currently be used to help authenticate 80 active ingredients, including medicines for TB, malaria, HIV/ AIDS and antimicrobials. Figure 31. Mixed performance in safety information sharing GSK Since 2014, 14 companies worked with local partners to strengthen pharmacovigilance systems. Eight companies demonstrate product stewardship by updating their products’ safety labels in relevant countries in a systematic and timely way, regardless of whether the product is patented. Two companies vol- In Nampula, Mozambique, a healthworker uses untarily share post-marketing safety surveillance data with regulatory authorities. Six companies do GSKs mVacciNation mobile technology to both: AbbVie, Bayer, GSK, Johnson & Johnson, Novartis and Takeda. improve patient-record keeping. 6 0 5 Good practice: Product stewardship 8 10 Product stewardship only 2 15 4 20 Voluntary data sharing only Neither

& voluntary data sharing 59 Source: http://www.doksinet Access to Medicine Index 2016 I N N OVAT I O N I N N OVAT I O N Multi-pronged approaches focus on In 2015, Bayer co-founded a Special specific diseases Interest Group within the International AstraZeneca’s Healthy Heart Africa pro- Society of Pharmacovigilance, bring- gramme, targeting hypertension in ing together regulatory authorities from Kenya, includes a broad scope of capac- Southeast Asia and international experts ity building activities. It aims to improve to develop and share innovative risk min- awareness among health care profes- imisation methods and tools. The group sionals (with processes to mitigate con- As part of AstraZenecas Healthy Heart Africa has developed an innovative customis- flict of interest) and within the commu- programme, a healthworker screens a man for able open-source tool to facilitate the nity regarding hypertension risk factors hypertension. The programme has

raised screen- development of locally-appropriate risk and treatment, in partnership with the ing levels among men from 35% to 50% in some management guidelines. Ministry of Health. AstraZeneca is also areas. AstraZeneca Open-source risk-management tool supporting targeted supply chain manPhilanthropy focuses on capacity agement skills, local research capacity building outside the value chain and data infrastructure related to NCD Companies also work outside the tra- risk factors. Nana Kofi Acquah/Novartis Foundation ditional pharmaceutical value chain to strengthen health system infrastructure Eli Lilly is undertaking a range of technol- and human resources. These activities ogy-based projects in India to build local are generally philanthropic. However, capacity to effectively diagnose, treat activities to build wider capacities can and follow up TB patients. Examples also be strategic and conflicts of inter- include a mobile application to sup- est may

arise. Mitigating this risk, high port healthcare workers in rural areas performing companies ensure that their to identify, refer and track patients with activities here (philanthropic or oth- pulmonary TB, and a web-based tool Novartis is testing new programmes for improv- erwise) aim for sustainable capacity to improve case notification to India’s ing leprosy diagnosis. Here, a doctor tests the skin improvements aligned with local priori- National TB Program and treatment sensitivity of a boy who has been treated for the ties and interests. adherence of patients treated by private disease in Ifakara, Tanzania. sector health services. 8 companies analysed have strong philanthropic approaches, in which they Novartis continues its innovative, commit to: targeting local health needs; research-based capacity building strat- aiming for long-term improvements; egy in two disease-specific areas: lep- identifying clear objectives; and measur- rosy and malaria. In

partnership with ing outcomes. Leaders in this area also local stakeholders, the company is test- build capacities outside the value chain ing new programs to improve leprosy through initiatives that meet high stand- diagnosis, contact tracing and treatment, ards, and can give clear explanations for mainly in south-east Asia. This includes a how they address local needs and con- mobile platform connecting rural health flicts of interest. care providers with specialists in the Philippines. Novartis is supporting the training of healthcare workers to promote rational use of malaria treatment in Tanzania, and strengthening malaria surveillance and vector control in Namibia through a targeted parasite elimination programme. 60 Source: http://www.doksinet Access to Medicine Index 2016 CONCLUSI O N Overall, companies are engaged in a similar level of capacity building activities to 2014. Some companies focus on one or two key areas of expertise, while others undertake a range

of diverse activities. Six leaders systematically address local needs when engaging in capacity building: AstraZeneca, GSK, Johnson & Johnson, Merck & Co., Inc, Merck KGaA, and Novartis The leaders proactively engage with stakeholders to understand and respond to local capacity gaps, and measure the impact of their initiatives. Pharmaceutical companies are building local capacity across the pharmaceutical value chain. Their philanthropic efforts often target identified needs outside the value chain, strengthening health systems more broadly. More companies are active in manufacturing than in other areas. To build R&D and manufacturing capacity, companies are most active where infrastructure is stronger (e.g, China, Brazil, India and South Africa). Sub-Saharan Africa is the main focus for R&D partnerships and supply-chain strengthening. Efforts to build pharmacovigilance capacities are concentrated in Latin America RE FE RE NCES 1 IFPMA. “Adoption of the sustainable

development goals (SDGs)” 2015 Accessed 2 August 2016 at http://www. ifpma.org/resource-centre/ifpma-statement-on-the-adoption-of-the-sustainabledevelopment-goals-sdgs/ 2 WHO. “Everybody’s Business: Strengthening health systems to improve health outcomes – WHO’s Framework for Action.” 2007 Accessed 2 August 2015 at http://www.whoint/healthsystems/strategy/everybodys businesspdf 3 Organisation for Economic Co-operation and Development (OECD). “Innovation for Development: A Discussion of the Issues and an Overview of Work of the OECD Directorate for Science, Technology and Industry.” 2012 Accessed 2 August 2016 at http://www.oecdorg/ innovation/inno/50586251.pdf 4 Edwards M. “R&D in emerging markets: A new approach for a new era” 2010 Accessed 2 August 2016 at http://www. mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/rand-38d-in-emerging-markets-a-new-approach-for-a-new-era Buse K and Tanaka S. “Global Public5 Private Health

Partnerships: lessons learned from ten years of experience and evaluation.” International Dental Journal 2011; 61 (Suppl. 2): 2-10 6 Githinji S, Kigen S, Memusi D, Nyandigisi A, Mbithi A, Wamari A, Muturi A, Jagoe G, Barrington J, Snow R, Zurovac D. “Reducing Stock-Outs of Life Saving Malaria Commodities Using Mobile Phone Text-Messaging: SMS for Life Study in Kenya.” PLoS ONE 2013; 8(1): e54066 7 Barrington J, Wereko-Brobby O, Ward P, Mwafongo W, Kungulwe S. “SMS for Life: a pilot project to improve anti-malarial drug supply management in rural Tanzania using standard technology.” Malaria Journal. 2010; 9 (298) 8 Kaplan W and Laing R. “Local Production of Pharmaceuticals: Industrial Policy and Access to Medicines” 2005. Accessed 27 July 2016 at http://www. who.int/medicines/technical briefing/ tbs/aplanLocalProductionFinal5b15d.pdf 9 WHO. “Local Production for Access to Medical Products: Developing a Framework to Improve Public Health.” 2011. Accessed 2 August 2016

at http:// www.whoint/phi/publications/Local Production Policy Framework.pdf 10 African Union. “Pharmaceutical Manufacturing Plan for Africa: Business Plan.” 2012 Accessed 2 August 2016 at http://apps.whoint/medicinedocs/documents/s20186en/s20186enpdf 11 Chataway J, Smith J, Wield D. “Partnerships for Building Science and Technology Capacity in Africa: Canadian and UK Experience.” 2005 Accessed 2 August 2016 at https://www.idrcca/sites/ default/files/sp/Documents%20EN/partnerships-ST-africa-canadian-uk-experience.pdf 12 Becker R. “International Higher Education Collaboration in the South: Worldwide Developments.” 2012 Netherlands Organisation for International Cooperation in Higher Education. Accessed 4 August 2016 at https://www. epnuffic.nl/en/publications/find-a-publication/international-higher-education-collaboration-in-the-south-worldwide-developmentspdf 13 Matower L. “Improving Pharmaceutical Supply Chain Management Systems in ResourceLimited Countries: Time to

Change Approaches to Capacity Building.” Research and Reviews: Journal of Pharmacy and Pharmaceutical Sciences. 2015; 4(2): 56-59. who.int/medicinedocs/documents/ s18625en/s18625en.pdf 17 WHO. “Substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products.” 2016 Accessed 5 August 2016 at http://www.whoint/ mediacentre/factsheets/fs275/en/ 18 Official Journal of the European Union. “Directive 2011/62/EU of the European Parliament and of the Council.” 2011. Accessed 2 August 2016 at http:// ec.europaeu/health/files/eudralex/vol-1/ dir 2011 62/dir 2011 62 en.pdf 14 WHO & The Global Fund. “Joint Stakeholder Meeting on Quality Assurance of Essential Medicines: Meeting Report.” 2011. Accessed 2 August at https:// www.quamedorg/media/16668/who globalfund qa essentialmedicines aug2011 report.pdf 15 Pan American Health Organization. “PAHO Strategic Fund.” 2016 Accessed 29 July 2016 at http://www.pahoorg/hq/ index.php?option=com

content&view=article&id=12163%3Apaho-strategic-fund&catid=8775%3Aabout&Itemid=42005&lang=en 16 PAHO. “Good Pharmacovigilance Practices for the Americas (PANDRH Technical Document No. 5)” 2011 Accessed 8 August 2016 at http://apps. 61 Source: http://www.doksinet Access to Medicine Index 2016 62 Source: http://www.doksinet Access to Medicine Index 2016 Company rankings per Technical Area The Index evaluates the world’s largest pharmaceutical companies across seven areas of activity. Called Technical Areas, these are considered key to enhancing access to medicine in low- and middle-income countries. Within each area, the Index also analyses company behaviour in four Strategic Pillars: Commitments, Transparency, Performance and Innovation. The following section comprises seven analyses of company behaviour, one for each Technical Area. Each analysis includes a ranking of how the companies performed in the area in question. The seven Technical Areas are:

• General Access to Medicine Management • Market Influence & Compliance • Research & Development • Pricing, Manufacturing & Distribution • Patents & Licensing • Capacity Building • Product Donations 1 = 1 2 3 3 6 4 n/a 5 = 2016 Index position 2014 Index position 5 6 17 7 12 8 4 9 2 10 7 11 8 12 18 13 14 14 16 15 13 16 9 17 11 18 20 19 Company Ranking per Technical Area Four strategic pillars: Commitments Transparency Performance Innovation 10 20 19 2016 2014 0 Commitments 1 Transparency 2 3 Performance 4 5 Innovation A score of 0 means the lowest and 5 ­signifies the highest possible score among the company set. 63 Source: http://www.doksinet Access to Medicine Index 2016 TECH N I CAL ARE A ANALYSIS General Access to Medicine Management GENERAL ACCESS TO MEDICINE MANAGEMENT HOW TH E CO M PAN I ES PE RFO RM Figure 32. Company ranking General Access to Medicine Management This is a relatively

high-scoring area. 1 2 Novartis AG 4.9 The top five companies are close to 2 3 Novo Nordisk A/S 4.3 3 1 GlaxoSmithKline plc 4.2 4 5 Merck & Co., Inc 4.1 5 14 AstraZeneca plc 4.0 gradually toward the lower end of the 6 4 Johnson & Johnson 3.9 ranking: the higher-ranked companies 7 = 7 Sanofi 3.9 take increasingly refined approaches 8 = 8 Eisai Co., Ltd 3.8 9 12 Eli Lilly & Co. 3.7 10 6 Merck KGaA 3.6 matching stakeholders’ expectations: five companies now score more than four points, with the clear leader close to achieving the full five. Scores fall to improving access to medicine. Companies continue to improve in General Access to Medicine 11 = 11 Bayer AG 3.6 Management. Most companies have 12 Gilead Sciences Inc. 3.4 taken some steps to improve the ways 13 = 13 Pfizer Inc. 3.4 14 16 Boehringer Ingelheim GmbH 3.1 15 17 Bristol-Myers Squibb Co. 3.0 strategies. Companies are developing 16 19 Takeda

Pharmaceutical Co., Ltd 3.0 innovative ideas for improving access: 17 15 AbbVie Inc. 2.9 in their business models, approaches to 18 = 18 Astellas Pharma Inc. 2.1 19 Roche Holding AG 1.8 Daiichi Sankyo Co., Ltd 1.6 the organise and coordinate efforts to improve access to medicine. Most companies have detailed access to medicine governance, stakeholder engagement and performance management systems. Leaders are innovators The leading five companies are led by Novartis, which scores close to the full 9 10 20 = 20 2016 2014 0 Commitments 1 Transparency 2 3 Performance 4 5 Innovation five points, then Novo Nordisk, GSK, Merck & Co., Inc and AstraZeneca, which all score more than four. These egy, indicating that access-to-medicine Novo Nordisk once again performs well five companies are top performers in all is seen as a business driver. Novartis is in this area. It has strengths in all areas areas. One of the main differentiators is implementing two

promising new busi- of measurement, only dipping when in innovations. Novartis, Novo Nordisk ness models and has developed an inno- it comes to the innovativeness of its and AstraZeneca all report promising vative tool for measuring the environ- new business models and the trans- business models or approaches to gov- mental, social and economic impact parency of its stakeholder engagement ernance. AstraZeneca is the biggest of its business in financial terms. In processes. GSK loses first position, but riser in this area. It has climbed nine key areas, it meets the highest criteria remains in the top three. Compared to positions, from 14th to 5th, due to large looked for by the Index: it has a strong 2014, it did not score in innovation. improvements in its strategy, perfor- performance management system, with mance management tools and stake- clear targets and both financial and Followers do not keep pace holder engagement processes. non-financial incentives,

and it takes The top five are followed by an a strategic approach to stakeholder upper-middle group of six: Johnson & Novartis meets almost all criteria looked engagement, considering the perspec- Johnson, Sanofi, Eisai, Eli Lilly, Merck for by the Index. Its access-to-medicine tives of local stakeholders, and is trans- KGaA and Bayer. The rankings of these strategy supports its corporate strat parent about the outcomes. companies have largely not changed, 64 Source: http://www.doksinet Access to Medicine Index 2016 with the exception of Merck KGaA. It AbbVie is one of the few companies has fallen from 6th to 10th: its perfor- that still does not have a comprehen- mance has remained static while peers sive strategy for increasing access to have improved. medicine. It does use a series of strategic approaches to make its medi- Companies in this group score rela- cines accessible, yet these approaches tively well. For example, Eisai has a solid are not

joined up into an overarching system in place to manage its access-re- strategy. lated performance, but falls behind in innovation. Bayer has above-average Laggards left behind performance across all areas but does There are three companies that clearly not engage with local stakeholders in a lag behind: Astellas, Roche and Daiichi structured way. Sankyo. Neither Astellas nor Daiichi Sankyo have a clear access strategy, There are some areas where these they perform poorly in stakeholder companies do not keep pace with engagement, and in management pro- the leaders: namely, in the incentives cesses for increasing access to medi- structures they have in place linked to cine. They also provide less evidence of access-related targets, and the level innovation. Roche’s ranking is affected at which they assign responsibility for by an overall lack of transparency access activities (at executive level, across several areas of measurement. rather than board-level).

Mixed performances at lower ranks The lower-middle group also includes six companies: Gilead, Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, Takeda and AbbVie. These companies deliver a mixed performance overall, and their rankings in this area have largely not changed. A common area of weakness is the transparency of their stakeholder engagement activities and approaches. Some companies also have limited or no incentive structures to reward the achievement of access-related targets, and are less innovative. Boehringer Ingelheim stands out for working consistently on innovative business models: it has a unique, best-practice incubator model for developing and rolling-out pilots. Takeda improves its performance in this area, with a new access-to-medicine strategy. Its stakeholder engagement performance is still relatively low 65 Source: http://www.doksinet Access to Medicine Index 2016 TECH N I CAL ARE A ANALYSIS Market Influence & Compliance MARKET INFLUENCE &

COMPLIANCE HOW TH E CO M PAN I ES PE RFO RM Figure 33. Company ranking Market Influence & Compliance Scores remain generally low, but there 1 = 1 Gilead Sciences Inc. 3.8 has been considerable movement 2 = 2 Novo Nordisk A/S 2.9 3 6 Eisai Co., Ltd 2.7 4 12 Roche Holding AG 2.6 5 18 Sanofi 2.5 are comprehensive and supported by 6 17 Johnson & Johnson 2.3 detailed enforcement processes. Only 7 16 Merck & Co., Inc 2.3 four companies were not found during 8 4 AbbVie Inc. 2.2 9 5 GlaxoSmithKline plc 2.2 10 7 AstraZeneca plc 2.2 tlements found by the Index in a coun- 11 14 Merck KGaA 2.2 try in scope took place in China. 12 19 Eli Lilly & Co. 1.9 13 15 Takeda Pharmaceutical Co., Ltd 1.8 14 8 Bayer AG 1.7 15 20 Daiichi Sankyo Co., Ltd 1.6 between companies. Companies’ systems for ensuring compliance with codes of conduct, laws and regulations continue to fail, even when they the period of analysis to have

been the subject of settlements related to corruption or unethical marketing. All set- Fourteen companies have risen or fallen by four or more positions since 2014. The largest driver in ranking changes 15 11 Novartis AG 1.6 pany is judged, during the period of 16 3 Bristol-Myers Squibb Co. 1.5 analysis, to have breached a law, regula- 17 9 Astellas Pharma Inc. 1.5 tion or code of conduct relating to cor- 18 10 Boehringer Ingelheim GmbH 1.3 19 13 Pfizer Inc. 0.8 2016 2014 comes from breaches: where a com- ruption or marketing. Company transparency regarding lobbying and marketing is generally low There is continuing cause for concern regarding companies’ apparently weak enforcement of com- 0 Commitments 1 Transparency 2 3 Performance 4 5 Innovation pliance with laws and codes of conduct. This concern is particularly relevant where companies are expanding into keting anywhere in the world. For Gilead access, in particular those related to the

countries with weak regulatory frame- and Novo Nordisk, this is the second responsible use of intellectual property, works and prosecutorial systems. time they have met this expectation. and trade issues. However, like most other companies, it is not transparent Four leaders with strong compliance Gilead once again ranks 1st, extend- about its marketing activities in coun- systems ing its lead. It provided evidence of tries in scope. The leading group comprises four com- having a high-quality system for ensur- panies: Gilead, Novo Nordisk, Eisai and ing employees comply with laws, reg- Gilead is followed once again by Novo Roche. These companies have all strong ulations and codes of conduct. This Nordisk, which is among the leaders enforcement processes that also apply system includes compliance training across all areas of measurement, with to their third parties. None of the top for third-party contractors. Gilead has the exception of innovation. Eisai has

three companies were found, during also taken the innovative step of devel- climbed to 3rd place, due to its strong the period of analysis, to have been the oping a dedicated compliance pocket performance in compliance and the subject of settlements for breaches guide for business partners. It also per- poorer performance of peers. Roche of criminal or civil laws or regulations forms strongly in other areas: notably it climbs eight positions to join the leading relating to corruption or unethical mar- publishes its policy positions related to group in 2016. Although it was found 66 Source: http://www.doksinet Access to Medicine Index 2016 to have breached one code of conduct minimal legal requirements when asked (for a case of unethical marketing), it to disclose payments made to political has a comparatively strong compliance parties or to healthcare professionals. system, which includes a clear approach to managing conflicts of interest. More breaches, less

transparency This pack is followed by another tightly Movement in the middle ranks ranked group, of six companies: Eli Lilly, The leaders are followed by a large Takeda, Bayer, Daiichi Sankyo, Novartis group of seven companies (ranked 5th and Bristol-Myers Squibb, in that order. to 11th), all tightly clustered: Sanofi, Most were the subject of civil or crim- Johnson & Johnson, Merck & Co., Inc, inal settlements for cases of corrup- AbbVie, GSK, AstraZeneca and Merck tion or unethical marketing during KGaA, in that order. Sanofi, ranked the period of analysis. The exceptions 5th, has risen the furthest (13 posi- here are Eli Lilly and Bayer, who were tions). This is mainly due to signifi- found to have breached codes of con- cant improvements in its compliance duct. They are not transparent about system: it conducts annual audits in its their lobbying or marketing activities. priority markets and rotational audits Novartis was found to have breached in

other countries sensitive to risk. civil laws for corruption or unethical GSK was found to have breached civil marketing three times, once in China, laws for corruption or unethical mar- and to have breached codes of con- keting twice, once in China, and to duct four times (for cases of unethical have breached codes of conduct else- marketing). where, in cases of unethical marketing. Johnson & Johnson was also found to Bristol-Myers Squibb is the biggest have breached both civil laws and codes faller in this Technical Area: falling of conduct during the period of analysis. from 3rd to 17th place. It was found to have breached civil law in China for Merck & Co., Inc is another big riser, corruption. It also demonstrates no from 16th to 7th. Although it was found transparency across several areas of to have breached civil laws and codes measurement. of conduct, it leads for the transparency of its marketing activities in countries Serious misconduct and

lack of in scope: it is the only company that transparency publishes the financial support given The three laggards, Astellas, Boehringer to patients’ organisations and medical Ingelheim and Pfizer, have all been sub- societies in countries in scope. AbbVie ject to civil or criminal settlements follows in 8th place. Although it was during the period of analysis for corrup- not found to have acted unethically, this tion or unethical marketing. They are is counter-balanced by below-average not transparent about their ethical mar- transparency regarding lobbying and keting or lobbying practices, nor do they marketing activities. disclose details of their compliance systems. Pfizer occupies 20th place It was Generally, these seven companies have found to have breached laws or codes been found to have acted unethically for corruption and unethical market- one or two times. In lobbying and mar- ing more times than other companies, keting, they generally do not go

beyond including in China. 67 Source: http://www.doksinet Access to Medicine Index 2016 TECH N I CAL ARE A ANALYSIS Research & Development RESEARCH & DEVELOPMENT HOW TH E CO M PAN I ES PE RFO RM Figure 34. Company ranking Research & Development The pack is evenly divided into four 1 = 1 GlaxoSmithKline plc 3.6 groups of five companies, with clear 2 3 Merck KGaA 3.4 3 2 Johnson & Johnson 3.3 4 9 Sanofi 3.2 5 = 5 Novartis AG 3.2 not specifically address the R&D needs 6 4 AbbVie Inc. 3.0 of people in poor countries. The gap 7 6 Takeda Pharmaceutical Co., Ltd 2.8 between the top ten and the bottom 8 10 Eisai Co., Ltd 2.6 9 12 Daiichi Sankyo Co., Ltd 2.6 10 7 AstraZeneca plc 2.6 more products that address the needs 11 8 Merck & Co., Inc 2.2 of people in low- and middle-income 12 14 Bayer AG 2.2 gaps between each group and the next. Leaders generally engage in R&D to fill high-priority gaps.

Conversely, laggards have smaller pipelines and do ten has widened in 2016. The 20 companies are developing countries than in 2014. The 2016 Index 13 18 Boehringer Ingelheim GmbH 2.0 14 17 Pfizer Inc. 1.8 15 11 Novo Nordisk A/S 1.8 age scores are approximately the same 16 15 Gilead Sciences Inc. 1.6 overall, as is the range of scores across 17 20 Astellas Pharma Inc. 1.6 the 20 companies. Within the pack, 18 16 Eli Lilly & Co. 1.5 Roche Holding AG 1.4 Bristol-Myers Squibb Co. 1.3 measures companies against higher expectations of behaviour in R&D, with companies largely keeping pace: aver- however, the top ten has pulled ahead, splitting the industry into two clear groups. 19 = 19 20 13 2016 2014 Companies’ performances in R&D are 0 Commitments diverse, reflecting their varying abili- 1 Transparency 2 3 Performance 4 5 Innovation ties to work ethically and transparently toward scientific breakthroughs that meet the needs

of people in low- and a public health rationale, for example, Beyond this, these five companies excel middle-income countries. Companies by linking R&D priorities to the 2030 in different areas. GSK, Merck KGaA do plan ahead to ensure products are Agenda for Sustainable Development. and Sanofi target high-priority prod- accessible following approval, espe- They all lead in product develop- uct gaps with over half of their pipe- cially when working in partnerships. As ment, with relatively large pipelines line projects (the gaps, as identified by a next step, they can ensure such plans that demonstrably address the needs G-FINDER, show where there is a clear are developed for all relevant projects, of people in low- and middle-income product need, yet no commercial incen- and in as much detail and as early in the countries (i.e, by targeting high-bur- tive). GSK, Johnson & Johnson, Merck R&D process as possible. den diseases and taking specific steps

KGaA and Sanofi are adapting rela- to make products suitable for people tively large numbers of products (e.g, Leaders target priority R&D gaps in a country in scope). They all signed paediatric formulations or improved Four companies have retained their top the Declaration by the Pharmaceutical, treatment regimens) and/or technol- 5 positions: GSK, Merck KGaA, Johnson Biotechnology and Diagnostics ogies for use in countries in scope. & Johnson and Novartis. Sanofi edges Industries on Combating Antimicrobial Johnson & Johnson continues to lead past Novartis into 4th position. These Resistance. at moving products along the pipeline. five companies all commit to R&D with 68 Johnson & Johnson, Merck KGaA and Source: http://www.doksinet Access to Medicine Index 2016 Novartis have the most robust policies approximately half the number of rel- for ensuring ethical clinical trial conduct evant projects as in 2014. For all three, (although GSK and

Sanofi also perform less than 20% of their relevant pipelines well in this regard). Sanofi and Novartis target high-priority product gaps. are the only companies to publish some details of their R&D investments for dis- Two big risers: improve in product eases in scope. development and trial ethics The biggest risers are Sanofi and Daiichi GSK and Merck KGaA lead when it Sankyo. These companies have larger comes to working in partnership: both pipelines of relevant products than in companies include access provisions in 2014, together accounting for 22 new the terms and conditions of a large pro- projects targeting 14 diseases. Sanofi portion of their R&D partnerships; both rises five positions into the top five, share intellectual property with a rela- having improved its overall transpar- tively large number of research institu- ency and its performance in product tions and neglected-disease drug-dis- development and clinical trial practice. covery

initiatives. Daiichi Sankyo rose three places, having moved more products through the pipe- The top ten set themselves apart line, and providing stronger evidence The leaders are followed by a pack of responsible clinical trial policies and of five: AbbVie, Takeda, Eisai, Daiichi practices. Sankyo and AstraZeneca (in that order). These five maintain similar ranks to Laggards do not address unmet needs 2014, while improving their perfor- The bottom five ranks are occupied mances. Contrastingly, companies in the by Gilead, Astellas, Eli Lilly, Roche and lower-middle group, ranked 11th to 15th, Bristol-Myers Squibb (in that order). give more mixed performances. Two All except Roche have small relevant are among the biggest fallers in R&D pipelines. All except Eli Lilly have rel- (Merck & Co., Inc and Novo Nordisk) atively poor policies and practices to Three (Bayer, Boehringer Ingelheim and ensure clinical trials are conducted eth- Pfizer) have maintained

similar levels ically: for example, they have not incor- of performances to 2014, but have porated important principles from the been pushed up in the ranking due to Declaration of Helsinki into their clin- changes in performances from peers. In ical trial codes of conduct. Neither do 2016, there is a clearer divide between they live up to expectations of open- the top and bottom ten companies in ness regarding clinical trial data. When R&D. it comes to collaborative R&D, these five companies are either not engag- Biggest fallers perform poorly in ing in R&D partnerships for diseases in product development scope or perform poorly at basing R&D Two of these companies, Merck & Co., partnerships on terms that provide for Inc. and Novo Nordisk, are among the access. Looking at the pipelines cap- biggest fallers in R&D in 2016, along- tured by the Index, Bristol-Myers Squibb side Bristol-Myers Squibb. All three and Eli Lilly are not working

in partner- have small relevant pipelines, com- ship (neither are Boehringer Ingelheim pared to their peers. Further, Bristol- in 13th place, or Novo Nordisk, in 15th). Myers Squibb and Novo Nordisk report 69 Source: http://www.doksinet Access to Medicine Index 2016 TECH N I CAL ARE A ANALYSIS Pricing, Manufacturing & Distribution PRICING, MANUFACTURING & DISTRIBUTION HOW TH E CO M PAN I ES PE RFO RM Figure 35. Company ranking Pricing, Manufacturing & Distribution The scores in this area are getting 1 7 GlaxoSmithKline plc 3.2 closer, with one company leading by a 2 5 Johnson & Johnson 2.6 3 13 Novartis AG 2.5 4 8 Sanofi 2.4 5 3 Novo Nordisk A/S 2.4 and brochure and packaging adapta- 6 9 Merck KGaA 2.3 tions. More companies are engaging in 7 1 Gilead Sciences Inc. 2.3 equitable pricing, and for more prod- 8 19 AstraZeneca plc 2.2 9 6 Merck & Co., Inc 2.2 10 2 AbbVie Inc. 2.2 11 4 Bayer AG 2.1 Bristol-Myers

Squibb Co. 1.9 clear margin. Nevertheless, there are approximately four densely clustered groups, separated by performances in equitable pricing, filing for registration ucts, than in 2014. Although the scores are closer, the average score in this area has dropped since 2014. Closer scrutiny in equitable pricing and filing for registration 12 = 12 13 17 Daiichi Sankyo Co., Ltd 1.8 14 10 Eisai Co., Ltd 1.7 15 16 Pfizer Inc. 1.6 – a smaller leading group than in 2014, 16 20 Takeda Pharmaceutical Co., Ltd 1.3 when six companies were out in front. 17 18 Eli Lilly & Co. 1.2 The top 11 companies remain largely 18 14 Boehringer Ingelheim GmbH 1.1 19 15 Astellas Pharma Inc. 0.8 20 11 Roche Holding AG 0.7 2016 2014 has revealed some weaknesses in company practice. The three leaders are GSK, Johnson & Johnson and Novartis unchanged, although three companies within this group have fallen more than five positions. Two companies have joined the

top ten, each rising ten positions or more 0 Commitments 1 Transparency 2 3 Performance 4 5 Innovation (AstraZeneca and Novartis). The five lowest-ranking companies are split into two clusters: the three companies patients’ needs and constraints in any it comes to filing to register products ranked 16th to 18th employ some equi- of these areas. Regarding accountabil- in countries with a particular need for table pricing strategies. These are sep- ity for sales agents’ pricing practices greater access. arated by a large gap from the com- and the issuing of drug recalls, compa- panies ranked 19th and 20th: Astellas nies are closely clustered: they mainly GSK has jumped from 7th place in 2014 is the only company that has not yet meet basic standards, with few compa- to 1st in 2016. It leads in equitable pric- implemented equitable pricing strat- nies standing out. ing: all of its products with equitable egies, and Roche did not disclose key information.

pricing are priced with consideration Leaders prioritise need for socio-economic factors in at least All three leaders are frontrunners when some countries in scope; it uses equita- The groups are separated by perfor- it comes to adapting brochures and ble pricing for more products than any mances in three areas: equitable pricing packaging materials to address the other company in scope; and has the strategies, filing for registration and the needs of patients and administrators in most marketed products with equitable consideration of rational use (brochure countries in scope. GSK and Johnson pricing strategies that target countries and packaging adaptation). The indus- & Johnson are also leaders in equitable with a particular need for access to the try does not take sufficient account of pricing, and Novartis is a leader when products in question.* 70 Source: http://www.doksinet Access to Medicine Index 2016 GSK is also a leader when it comes to Large

middle group Laggards slip in all areas facilitating the rational use of its prod- In the upper middle group (4th to 11th Ranks 16 to 18 are occupied by Takeda, ucts: it has adapted packaging and bro- place) are Sanofi, Novo Nordisk, Merck Eli Lilly and Boehringer Ingelheim. chures to take account of local lan- KGaA, Gilead, AstraZeneca, Merck & These three fall behind in most areas, guage, literacy, demographic and envi- Co., Inc, AbbVie and Bayer This group but deliver average performances ronmental needs. delivers mixed performances across the when it comes to facilitating their prod- different areas measured: all excel in ucts’ rational use and drug recalls pol- Johnson & Johnson moves from 5th some areas but lag in others. Most com- icies. The lowest two ranks are taken to 2nd place. It is a leader in its consid- panies in this group were in the top ten by Astellas and Roche. Astellas has eration of socio-economic factors for in 2014. Five of

these companies have not yet implemented equitable pric- inter-country equitable pricing, and in fallen since 2014, including the three ing for any products in scope, and does providing price- and volume-of-sales companies that occupied the top three not adapt its brochures or packag- information for countries targeted by positions in 2014 (Gilead, AbbVie and ing to facilitate products’ rational use. its equitable pricing strategies. Two- NovoNordisk). AstraZeneca is the only It has also not filed to register any of thirds of its products with inter-country company in this group that was not in its ten newest products in any priority equitable pricing consider socio-eco- the top ten in 2014. countries.* Roche is the biggest faller, nomic factors, including economic dropping nine places since 2014. This development, public health need, dis- AstraZeneca has risen 11 places from is mainly because it has provided the ease burden, health care situation of 19th in

2014 to 8th in 2016. Compared Index with no information in several key the country/region, cost analysis, and to 2014, AstraZeneca has significantly areas, including price and volume-of- the level of out-of-pocket payments. increased the number of products with sales data, registration targets and how Johnson & Johnson has adapted pack- equitable pricing strategies. It has con- it attempts to facilitate the rational use aging and brochures to take account of ducted an in-depth analysis of the abil- of its products. It has equitable pricing local language, literacy, demographic ities of different population segments strategies for a limited proportion of its and environmental needs of patients in a subset of countries to pay for its portfolio. and at the point of dispensation. products. The results have been used to shape its new pricing policy, and Novartis joins the leaders in 2016. It has will continue to inform pricing adjust- risen 10 places into 3rd,

making it one ments. The policy has already been of the biggest risers. It has extended implemented for certain products and equitable pricing to more than twice countries in scope. AstraZeneca has as many products as in 2014, partly also created an Affordability Centre of through the Novartis Access pro- Excellence to train staff on this new gramme. It leads in product registra- policy. tion, having filed to register all of its ten newest products in countries with a The lower middle group includes particular need for access to the prod- Bristol-Myers Squibb, Daiichi Sankyo, uct in question.* Novartis is also the Eisai and Pfizer. These companies have leader in facilitating the rational use of low scores across most areas but do not its products with a best practice: it has completely lag in any given area (except adapted packaging and brochures to in their level of accountability for sales take account of all five of the relevant agents’ pricing practices).

Only Bristol- needs identified by the Index (language, Myers Squibb was in this group in 2014. literacy, cultural, demographic and envi- Daiichi Sankyo and Pfizer have risen ronmental considerations) at various while Eisai has dropped. levels of the health system, including physicians, pharmacists and patients. * Priority countries are disease-specific sets of countries with a particular need for access to the products in question. See pages 188-189 for more information 71 Source: http://www.doksinet Access to Medicine Index 2016 TECH N I CAL ARE A ANALYSIS Patents & Licensing PATENTS & LICENSING HOW TH E CO M PAN I ES PE RFO RM Figure 36. Company ranking Patents & Licensing The companies divide into four groups. 1 = 1 Gilead Sciences Inc. 3.4 There are three clear leaders, with very 2 = 2 GlaxoSmithKline plc 3.4 3 = 3 Bristol-Myers Squibb Co. 3.1 Merck & Co., Inc 2.5 Merck KGaA 2.5 close scores for the leading pair. These are followed

by six above-average per- 4 18 5 4 nies’ diverse approaches to responsi- 6 16 AstraZeneca plc 2.5 ble IP-management, as well as the var- 7 13 Boehringer Ingelheim GmbH 2.1 ying quality and transparency of these 7 15 Johnson & Johnson 2.1 8 17 AbbVie Inc. 2.1 9 5 Eisai Co., Ltd 1.6 atively low-performing area on aver- 10 6 Novartis AG 1.4 age, yet with improvement in three 11 7 Roche Holding AG 1.3 key dimensions. Firstly, more compa- 12 = 12 formers. Across all 20 companies, the wide spread of scores reflects compa- approaches. Patents & Licensing remains a compar- Novo Nordisk A/S 1.2 13 19 Astellas Pharma Inc. 1.2 14 11 Pfizer Inc. 1.0 panies in total, with at least two more 15 14 Eli Lilly & Co. 0.9 to follow). Across all 20 companies, 16 10 Sanofi 0.8 17 20 Takeda Pharmaceutical Co., Ltd 0.6 18 8 Bayer AG 0.5 9 Daiichi Sankyo Co., Ltd 0.3 nies commit publicly to not filing for or enforcing

patents in subsets of low- or middle-income countries (now 13 com- there is greater willingness to engage in non-exclusive voluntary licensing. Looking at those companies that do engage, the use of licensing has deepened, with some evidence of innovation. 19 2016 2014 Some companies, however, remain con- 0 Commitments servative. Thirdly, three companies have 1 Transparency 2 3 Performance 4 5 Innovation addressed patent transparency for the first time. In other areas, industry performance remains static Companies sons. Gilead’s approach to voluntary GSK is a strong performer in licens- generally remain conservative in their licensing represents best practice. It ing, which it uses for HIV/AIDS prod- positions on the Doha Declaration on has licensed all its on-patent prod- ucts. Its licensing approach for dolute- the TRIPS agreement and public health ucts for diseases in scope, often before gravir (Tivicay®) has a wide geographic (exceptions are

AstraZeneca, GSK and market approval, making them available reach. It permits the supply of Tivicay® Merck KGaA). There is evidence of con- for manufacture by third parties. This to countries outside the licensed ter- tinued lobbying for tougher IP protec- includes multiple hepatitis C products, ritory, including in countries of manu- tion in countries in scope. definitively demonstrating that licens- facture or supply, whether or not the ing is suitable for non-HIV/AIDS prod- relevant patent is in force there. GSK Leaders deliver breadth, depth, clarity ucts. Gilead is the only company to have clearly states where it will not file for and innovation reached voluntary licensing terms out- or enforce patents, and commits to dis- The same three companies lead as in side the Medicines Patent Pool that closing patent statuses in the future. It 2014. All three have pulled ahead from are comparable (e.g, in terms of their pledges to consider voluntary licensing the

pack, with Gilead and GSK extend- transparency and geographic breadth) for its entire portfolio in all lower-mid- ing their lead over Bristol-Myers Squibb. with the pro-access terms negotiated dle-income countries (LMICs). Gilead and GSK lead for different rea- via the Pool. 72 Source: http://www.doksinet Access to Medicine Index 2016 Bristol-Myers Squibb is third, with a patents on ARV darunavir (Prezista®) The laggards: some static, with others strong, consistent performance in to 128 countries. Boehringer Ingelheim set to rise licensing. It was the first company (8th), has the widest geographic scope Among the final six companies, most to license a product for hepatitis C of any non-assert declaration made: it lag because they have not improved, (daclatasvir (Daklinza®)). Tivicay® and promises not to enforce its patent on while Eli Lilly and Pfizer fall back due Daklinza® are available for licensing the extended-release formulation of to settlements

or judgements concern- to multiple manufacturers through the nevirapine (Viramune XR®) in any low- ing anti-competitive behaviour. Daiichi Medicines Patent Pool. or middle-income country (LICs, MICs), Sankyo, Bayer, Pfizer, Sanofi and Takeda totalling 135 countries. AbbVie (9th) has all lack transparency, with no public Diverse approaches to newly licensed both paediatric and adult statement about how they plan to file IP-management formulations of the ARVs ritonavir and for or enforce patents, no public com- The next six companies are clus- lopinavir (Aluvia®) to multiple manu- mitment to licensing and no transpar- tered, yet they take different pro-ac- facturers. It falls back for the compara- ency around patent statuses. Bayer, cess approaches to IP-management. tively low transparency of its approach Sanofi and Takeda, however, have Merck & Co., Inc (4th) uses non-exclu- to filing for and enforcing patents. stated (to the Index) that they will not

sive voluntary licensing, albeit on nar- file for and/or enforce patents in spe- rower terms than the leaders. It has Ranks 10 to 14 are occupied by compa- cific groups of countries: Bayer will newly licensed paediatric formulations nies that have either not yet licensed not file in LDCs, Takeda will not file or of the anti-retroviral (ARV) raltegra- or have comparatively limited licens- enforce in sub-Saharan Africa, except vir (Isentress®) through the Medicines ing activity, but have stated where they South Africa; Sanofi will not file or Patent Pool. AstraZeneca (5th) and plan to file for or exercise IP rights enforce in LDCs and LICs. Takeda has Merck KGaA (6th) do not yet engage in (Eisai, Novartis, Roche, Novo Nordisk also indicated to the Index that it is will- licensing, but AstraZeneca pledges not and Astellas, in that order). Eisai’s com- ing to consider licensing. Eli Lilly is the to file for new patents, and Merck KGaA mitment is the broadest: it

has a com- only lagging company to make a public pledges not to file for new patents or to mitment to not enforcing patents in commitment to not filing for or enforc- enforce existing patents. Both pledges least developed countries (LDCs), LICs ing patents (specifically, in LDCs). Pfizer apply to a comparatively broad range and low human development coun- is the only lagging company to engage of countries. Both publish the status tries (LHDCs). Astellas, Novo Nordisk in licensing (via joint venture ViiV of patents held in countries in scope. and Roche all commit to not filing for Healthcare). Both acknowledge aspects of countries’ or enforcing patents in LDCs and LICs, right to determine the grounds for com- with Roche also applying this commit- pulsory licences. They are both open ment to its ARVs in sub-Saharan Africa. to engaging in licensing in the future, Novartis commits to not enforcing pat- with AstraZeneca specifying precisely ents in LDCs, and

agrees to offer licens- where and for which product catego- ing for supply to those countries. For ries it would consider voluntary licens- Astellas, Eisai and Novo Nordisk these ing terms. Merck KGaA is held back by all represent new public commitments. a negative judgement during the period Astellas, Novartis and Roche are will- of analysis relating to anti-competitive ing to consider licensing. Novo Nordisk behaviour in Brazil. has now published the status of its patents worldwide, but is held back by a Johnson & Johnson follows in 7th. negative judgement during the period Although it has not engaged in licens- of analysis relating to anti-competitive ing to the same degree as the leaders, behaviour. this is counter-balanced by the breadth of its non-assert declaration: it has expanded its promise not to enforce its 73 Source: http://www.doksinet Access to Medicine Index 2016 TECH N I CAL ARE A ANALYSIS Capacity Building CAPACITY BUILDING HOW TH E CO M PAN

I ES PE RFO RM Figure 37. Company ranking Capacity Building The scores are spread widely, with 1 3 Novartis AG 4.0 the pack divided into four groups: six 2 5 GlaxoSmithKline plc 3.7 3 6 Johnson & Johnson 3.1 4 8 AstraZeneca plc 3.0 5 7 Merck & Co., Inc 2.9 gards. This reflects the diversity of 6 10 Merck KGaA 2.8 company performances: both in the 7 1 Novo Nordisk A/S 2.5 breadth of activities per company and 8 2 Sanofi 2.4 9 11 Pfizer Inc. 1.8 10 19 Astellas Pharma Inc. 1.8 similar level of capacity building activ- 10 17 Takeda Pharmaceutical Co., Ltd 1.8 ity as in 2014. Manufacturing in particu- 11 20 Daiichi Sankyo Co., Ltd 1.7 lar continues to be a focus area. Many 12 = 12 AbbVie Inc. 1.7 Bayer AG 1.7 leaders (including two distinct frontrunners), closely followed by a pair of good performers, a closely-ranked middle group of eight and four lag- how they target local needs. As a pack, companies demonstrate a

companies exhibit best practice in one 13 9 14 16 Eisai Co., Ltd 1.5 2016 Index places more emphasis on 15 = 15 Eli Lilly & Co. 1.5 how companies ensure their activities 16 Bristol-Myers Squibb Co. 1.3 or more areas. Average scores are lower than in 2014. This is partly because the address local needs and skills gaps. This change has also led to some changes in the leading group. Leaders target local needs across all areas In the leading group, Novartis and GSK 18 17 4 Boehringer Ingelheim GmbH 1.2 18 14 Gilead Sciences Inc. 0.9 19 13 Roche Holding AG 0.3 2016 2014 0 Commitments 1 Transparency 2 3 Performance 4 5 Innovation are clear frontrunners, standing out for their strength across all five areas, and for consistently targeting country-spe- erally demonstrate most, if not all, of 2014 leaders are overtaken, despite cific requirements. Novartis is par- the following behaviours: clear com- maintaining performance ticularly strong in

R&D capacity build- mitments and processes to assess The middle pack is led by Novo Nordisk ing in countries in scope, while GSK’s and address local needs through their and Sanofi – ranked 1st and 2nd in 2014. strengthening of local pharmacovigi- capacity building activities; formalised While both maintained their perfor- lance systems is notable. Both compa- and often long-term partnerships with mances since 2014, they have been out- nies improved their performance in key local stakeholders such as governments performed by the current leaders, par- areas from 2014, and were among the and non-government organisations; a ticularly in areas relating to company few to increase their scores in 2016. As proactive approach to sharing informa- transparency and information shar- a result, they have risen to the top two tion with relevant stakeholders; and a ing. Nevertheless, both companies per- spots. willingness to pilot new capacity build- form well overall

and there is a clear gap ing approaches, and to measure and between them and the densely-packed The six leading companies have activ- share the outcomes of these. This is a middle group. Capacity building outside ities in all five areas, and showed fre- relatively stable group: all six leaders in the pharmaceutical value chain is a key quent and systematic consideration 2016 have made comparatively small strength for both. of local needs. These companies gen- changes in ranking since 2014. 74 Source: http://www.doksinet Access to Medicine Index 2016 Japanese companies rise into middle ity building activities. However, it capacity in Index countries was average, group does demonstrate a relatively strong but the company submitted no relevant The middle pack comprises eight approach to strengthening pharmacov- R&D partnerships. companies, newly including all four igilance systems in countries in scope. Japanese companies measured in the Bayer is one of

the furthest fallers in The remaining company in the lag- Index. Three were the biggest risers 2016 (four places). ging group, Bristol-Myers Squibb, does overall: Astellas (nine places), Daiichi not clearly target skills gaps within the Sankyo (nine places) and Takeda (seven Laggards show limited consideration pharmaceutical value chain. It has a low places). This reflects increased engage- of local needs level of capacity building activities in ment and capacity building activities There are four laggards: Bristol-Myers R&D and manufacturing, and no rele- among this group, who were ranked Squibb, Boehringer Ingelheim, Gilead, vant activities in supply chain manage- toward the bottom in 2014. Astellas and Roche. They demonstrate a rela- ment and pharmacovigilance. However, has improved its performance in multi- tively narrow range of relevant activ- the company does have a very strong ple areas, especially capacity building in ities, and did not show

particular philanthropic approach and builds supply chain management and outside strength in any area. In the activities capacities outside the value chain in the pharmaceutical value chain. Daiichi they do undertake, their considera- response to local needs. Sankyo also improved its performance tion of local needs to strengthen health in several areas, making the strong- system capacity is generally limited. est commitment to reporting falsified Most companies in the bottom group medicines (newly measured in 2016). had larger-than-average score drops, Takeda’s improved ranking reflects its reflecting poorer performance in real performance in pharmacovigilance and terms (notwithstanding methodologi- R&D capacity building. The remaining cal changes). Japanese company, Eisai, rose two positions from 2014. Three laggards were also among the biggest fallers: Boehringer Ingelheim (13 Overall, the middle pack has mixed places), Roche (six places), and Gilead

strengths and weaknesses, and their (four places). Boehringer Ingelheim’s consideration of local needs is incon- performance in R&D capacity building sistent. Some companies do not in Index countries was average, but it is demonstrate any activities in certain less active in key areas such as manu- areas, but have specific strengths. For facturing. It was also outperformed by example, Pfizer performed relatively other companies in areas such as phar- well in supply chain management capac- macovigilance and in building capaci- ity building, but demonstrated no rel- ties not linked to the pharmaceutical evant activities to strengthen phar- value chain. Roche publicly acknowl- macovigilance systems. AbbVie, on edges the importance of capacity build- the other hand, performed very well ing for improving access to medicine in pharmacovigilance, but gave no evi- and health outcomes, and continues to dence of relevant capacity building in undertake such

activities in countries in manufacturing. scope. However, it did not share sufficient details of these activities publicly Other companies are actively build- or directly to the Index. It is therefore ing capacities in all areas, yet are not difficult to determine the companys performing uniformly across them: performance and progress in this area, for example, compared to 2014, Bayer as reflected in its lower score. Gileads demonstrated fewer relevant capac- performance in building manufacturing 75 Source: http://www.doksinet Access to Medicine Index 2016 TECH N I CAL ARE A ANALYSIS Product Donations PRODUCT DONATIONS HOW TH E CO M PAN I ES PE RFO RM Figure 38. Company ranking Product Donations The scores are spread widely, with 1 3 GlaxoSmithKline plc 4.0 three groups: seven leaders, followed 2 = 2 Merck & Co., Inc 3.8 3 6 Johnson & Johnson 3.8 4 9 Eisai Co., Ltd 3.5 5 = 5 Novartis AG 3.5 Pfizer Inc. 3.5 Merck KGaA 3.5 Sanofi 3.2

Bayer AG 3.0 AbbVie Inc. 2.7 Novo Nordisk A/S 2.6 Eli Lilly & Co. 2.4 by a middle group of seven and then six laggards. Companies on higher rankings tend to engage in more structured donation programmes, of a broader scale and scope. They take on 5 14 a greater level of responsibility with 6 4 regard to the monitoring and auditing 7 10 of donation programmes. 8 = 8 9 13 shifts in industry activity in product dona- 10 1 tions since 2014. Companies continue 11 16 to donate medicines for Neglected 12 7 Roche Holding AG 2.3 13 12 Gilead Sciences Inc. 2.3 14 17 Bristol-Myers Squibb Co. 1.9 ble diseases are focusing more on spe- 15 11 AstraZeneca plc 1.8 cific target groups and on adapting to a 16 18 Takeda Pharmaceutical Co., Ltd 1.7 17 15 Boehringer Ingelheim GmbH 1.6 18 20 Daiichi Sankyo Co., Ltd 1.1 Astellas Pharma Inc. 1.1 Overall, there have been only minor Tropical Diseases (NTDs), with NTD programmes being expanded and

extended. Programmes for communica- single country context. The Index now includes philanthropic activities (the provision of financial assistance to local organisations) under Capacity Building. 19 = 19 2016 2014 Leaders commit to tackling NTDs 0 Commitments GSK, Merck & Co., Inc and Johnson 1 Transparency 2 3 Performance 4 5 Innovation & Johnson take the top three ranks. GSK’s lymphatic filariasis donation programme has the largest scope expanded its lymphatic filariasis (LF) and scale, although Merck & Co., Inc These three companies, together with programme, which also has a rigorous reaches a comparatively high number Eisai, Novartis, Pfizer and Merck KGaA, monitoring and auditing system. Pfizer of beneficiaries and countries through comprise the leading group. All seven has increased the scale and scope of the Mectizan® donation programme donate medicines both ad hoc for emer- its structured donation programmes, for onchocerciasis.

Merck & Co, Inc’s gency relief and through structured and has put standardised procedures commitment to eliminating NTDs donation programmes. Importantly, all in place for engaging with international extends beyond the diseases listed in seven work with international organi- organisations and NGOs. the London Declaration: it has a struc- sations in their donation programmes, tured donation programme that works tracking the reception of donated prod- Middle group lacks stringent monitor- toward the global eradication of rabies. ucts and requiring regular reports from ing and auditing requirements Johnson & Johnson runs the largest partners on results and outcomes of the There are seven companies in the number of donation programmes: it has programmes. middle pack: Sanofi, Bayer, AbbVie, six programmes covering three disease Novo Nordisk, Eli Lilly, Gilead and areas. Two were launched during the Eisai and Pfizer are two of the biggest Roche. All

seven, like the leaders, period of analysis. risers in this Technical Area. Eisai has commit to ensuring donation activities 76 Source: http://www.doksinet Access to Medicine Index 2016 meet international guidelines for med- Laggards not involved in structured icine donations, such as those set out donation programmes by WHO and PQMD. However, when it The six lowest-ranked companies are comes to ensuring these quality stand- not involved in structured donation pro- ards are met, these six companies gen- grammes: Bristol-Myers Squibb, Astra erally do not require donation partners Zeneca, Boehringer-Ingelheim, Takeda, to report regularly on outcomes and Daiichi Sankyo and Astellas. Four of impact, and do not systematically audit them, however, are active in ad hoc their partners. donations for emergency relief: BristolMyers Squibb, AstraZeneca, Boehringer Among these companies, Sanofi, Novo Ingelheim and Takeda. The spread in Nordisk, and Roche are involved in

one scores in this group is the result of structured donation programme, while their different monitoring and audit- the other four engage in several. AbbVie ing requirements, and the transparency remains the only company to engage of the type, volume and destinations of in donations for maternal and neona- their ad hoc donations. tal health, and has expanded the scope of this activity during the period of anal- Bristol-Myers Squibb is the only com- ysis. Three of these companies have pany in this group that commits to long-term donation programmes tar- engaging in long-term structured dona- geting NTDs with a comparatively wide tion programmes. It is currently devel- geographic scope: Bayer, Sanofi and oping an innovative programme aimed Gilead. at curing hepatitis C in patients co-infected with the hepatitis C virus and Gilead has initiated an innovative pro- HIV, donating its recently launched gramme in collaboration with the and patented product daclatasvir

government of Georgia and the U.S (Daklinza®). The programme will run Centers for Disease Control and in cooperation with AmeriCares, the Prevention (CDC) to develop a national Clinton Health Access Initiative (CHAI) hepatitis C action plan. The company is and Duke University. donating recently launched, patented medicines: sofosbuvir (Sovaldi®) and Daiichi Sankyo and Astellas received sofosbuvir/ledipasvir (Harvoni®). the lowest scores. Daiichi Sankyo was engaged in only one ad hoc donation, to Nine of the companies in the top ten in Palestine, and Astellas did not provide this area of the Index, plus Gilead, have evidence of any structured or ad hoc signed the 2012 London Declaration donations during the period of analysis. on Neglected Tropical Diseases: Bayer, Eisai, GSK, Johnson & Johnson, Merck KGaA, Merck & Co., Inc, Novartis, Pfizer and Sanofi. Collectively, they target all nine NTDs listed in the London declaration for which a therapeutic

intervention is available. 77 Source: http://www.doksinet Access to Medicine Index 2016 78 Source: http://www.doksinet Access to Medicine Index 2016 Company Report Cards The 2016 Access to Medicine Index includes a set Sales and Operations of 20 company report cards, which each provide a General description of the company’s operations, contextualised analysis of one company’s perfor- revenue per region and geographical reach. mance in the 2016 Index. This includes a summary of its strengths and weaknesses, any best and Portfolio and Pipeline innovative practices, as well as the drivers behind Analysis of the company’s portfolio of marketed changes in its ranking. Each report card includes products and pipeline of R&D products that fall overviews of the company’s portfolio and pipe- within the scope of the Index, in line with specific line, and identifies tailored opportunities for it to inclusion and exclusion criteria. This section looks increase

access to medicine. at the size and focus of the company’s portfolio The report cards are divided into six sections: and pipeline, whether the company has products that are considered first-line or are on the WHO Performance Essential Medicines List; whether it is developing Explanation of the company’s position in the 2016 innovative products or adapting existing products Index and summary of its access-to-medicine per- to suit the needs of people in low- andmiddle-in- formance, including the drivers behind the compa- come countries, and whether it develops products ny’s changes in ranking and the main areas where it through partnerships. scores well or poorly compared to peers. Performance by Technical Area Changes since 2014 Overview of the company’s performance in each Update on where the company’s access-to-med- area measured by the Index, including descriptions icine performance has notably changed since the of: 2014 Index (positive and negative

changes), and • The company’s position in the Technical Area where its performance has remained static. It includes new or expanded commitments, strategies, activities and programmes. subrankings; • Main areas where the company performs well or poorly; • Significant changes and developments since Opportunities Tailored opportunities for the company to improve 2014; and • Innovations and best practices. access to medicine, taking account of its R&D pipeline, product portfolio, current equitable pricing strategies and approach to IP management, among other factors. 79 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 1 3.43 = GlaxoSmithKline plc 1 (2014) Stock Exchange: XLON • Ticker: GSK • HQ: Brentford, UK • Employees: 101,255 Ranking by technical area Ranking by strategic pillar 5 R&D 3. 6 Pricing 3. 2 Patents 3. 4 Capacity 3. 7 Donations 4. 0 0 4 Leader 3 Leader 2 1 leader Leader 1 2 3 4 5 average

average 1 .0 2. 2 3.8 Compliance 3.4 4. 2 4.0 Management Commitments Transparency Performance Innovation 0 PERFORMANCE GSK is in 1st place for the fifth time. It is the most access-ori- projects that target independently identified, high-priority ented company in the Index, with a clear access-to-medi- product gaps. It leads in product donations and in applying cine strategy that aligns with its corporate strategy, and com- equitable pricing strategies, and is a leader in voluntary licens- pany-wide ownership and accountability for access. Its lead- ing and capacity building. However, GSK falls back in compli- ership is reflected in many areas: it has clearly committed to ance: e.g, it was found to have breached criminal law in China R&D for low- and middle-income countries, bases R&D part- for bribery. GSK has taken steps to prevent such breaches in nerships on access-oriented terms, and has the most R&D the future, including eliminating individual

sales targets. CHANGE SINCE 2014 • Has new policy for mitigating risks of conflicts • Has made progress toward four specific R&D of interest following recruitment from the commitments, and toward one to improve clin- public sector. ical trial data transparency. • Commits to disclosing the status of its patents in the future. • Publishes a new policy on not filing for • Was found to have breached laws and codes • Signed the Declaration by the Pharmaceutical, related to corruption and unethical marketing Biotechnology and Diagnostics Industries on multiple times, including a breach of criminal Combating Antimicrobial Resistance. law in China for bribery. Countries and low income countries (LICs). • Commits to licensing products in lower-middle • Has multiple new R&D IP-sharing agreements • Has more products with equitable pricing or enforcing patents in Least Developed income countries (LMICs). (via WIPO Re:Search). strategies than in 2014.

• Increases capacity building efforts, with an • Improves its accountability for its sales agents’ pricing practices. innovative approach to building R&D capacity in Africa that targets local skills gaps. OPPORTUNITIES Continue innovating to strengthen compliance status of all of its products, providing informa- Continue to target known needs through inno- systems. GSK has introduced innovative initia- tion on where each product has been filed for vative and adaptive R&D. GSK should leverage tives and policies to strengthen its compliance registration and where it has been approved, as its strength at engaging in R&D that addresses with laws and regulation. It has an opportunity well as the dates of registration, per country. global health priorities. The company can con- to further foster innovation in this area, and to share its findings with the industry. tinue to develop diverse product types that Operationalise new commitment to engaging target

defined, high-priority product gaps. in voluntary licensing. GSK can actively identify Provide pricing guidelines to third-party sales generic medicine manufacturing partners for the Ensure access to products on the WHO EML. agents. GSK can provide pricing guidelines as non-exclusive voluntary licensing of products GSK has one of the largest numbers of prod- a standard practice to third-party sales agents for high-burden diseases outside of HIV/AIDS. ucts on the WHO Model Essential Medicines (distributors, wholesalers, etc.) in low- and mid- Possible products could include fluticasone furo- List (EML). GSK can evaluate access barri- dle-income countries, depending on the local ate (Flixotide®) and salbutamol (Ventolin®), ers to these products in all low- and middle-in- market, supply chain, and legal and regulatory both first-line treatments for respiratory dis- come countries. It can ensure their availabil- systems. eases listed on the WHO Model Essential ity

and affordability, aligning with demand and Medicines List (EML). In support of this commit- the availability of alternative products in specific Publish information about products’ registra- ment, GSK can also fulfil its commitment to dis- countries. tion status. GSK can publish the registration close patent statuses. 80 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Turnover by segment (2015) 72 MN 6,028 MN GBP 23,923 MN 14,166 MN 3,657 MN Pharmaceuticals Corporate and other unallocated turnover Vaccines Consumer Healthcare In scope, has sales Turnover by geographic region In scope, has no sales MN GBP Not in scope SALES AND OPERATIONS GSK operates through three divisions: phar- research, development, and commercialization maceuticals, vaccines and consumer health- of HIV/AIDS medicines. In 2014, the company care. Its core areas of research in pharmaceuti- acquired Novartis’ vaccine business (excluding cals are:

HIV/AIDS and infectious diseases, oncol- its influenza vaccines), and divested its marketed ogy, immuno-inflammation, respiratory and rare oncology portfolio to Novartis in return. As part diseases. Sales in emerging markets account of the deal, the two companies created a new for approximately 25% of total sales. GSK holds consumer healthcare business, with GSK retain- a 77.4% stake in ViiV Healthcare, a joint ven- ing majority control. 26,000 24,000 22,000 20,000 1 8,000 1 6,000 1 4,000 1 2,000 1 0,000 8,000 6,000 4,000 2,000 0 2011 2012* Rest of world 2013* Europe 2014 USA 2015 Other *Revenue from divestments. ture with Pfizer and Shionogi focused on the PORTFOLIO AND PIPELINE Products per disease category 9 GSK has one of the largest portfolios of rele- Among its most recently registered products vant products, and a similarly large pipeline of are first-line treatments for asthma, chronic projects that address the needs of people in obstructive

pulmonary disorder and HIV/AIDS. countries in scope: with 111 medicines and vac- Its diverse pipeline targets all four disease cat- cines, and 57 R&D projects. It has a wide range egories in scope. Since 2014, ten of GSK’s R&D of off-patent products that are still relevant for projects progressed along the pipeline: includ- diseases in scope: e.g, albendazole (Zentel®) ing vaccines for paediatric respiratory syncyt- for soil-transmitted helminthiasis, amitriptyline ial virus and malaria, which moved into clinical for unipolar depressive disorders and migraine development. Many of its R&D projects target prophylaxis, amoxicillin (Amoxyl®) for infec- high-priority product gaps with low commercial tious diseases and clopidogrel (Gridokline®) for incentive, including its preventive vaccine can- GSK’s portfolio includes products for multiple ischaemic heart disease. didates for HIV/AIDS, malaria, TB, typhoid fever infectious diseases, HIV/AIDS,

neglected tropical and shigellosis. diseases (NTDs) and mental health conditions. Pipeline projects 23% 10 20 45 4 1 Communicable Non-communicable Neglected tropical Multiple categories Maternal and neonatal First-line treatments and essential medicines 42% 0 52 111 30 40 35% 50 In partnership, with access provisions (ap) 60 60 70 80 In partnership, w/o ap 90 100 Not in partnership 11 0 20 40 10 60 80 First-line & on WHO Essential Medicines List 30 100 First-line only 120 140 On WHO-EML only Other GSK has multiple R&D partnerships based on terms for ensuring access to A high proportion of GSK’s relevant products are listed on the WHO EML successful products. Together these cover all disease categories, with part- and/or as first-line treatments: e.g, abacavir (Ziagen®), lamivudine (Zeffix®) ners including Fiocruz, Johnson & Johnson and Monash University. and fluticasone (Flixotide®). Pipeline by stage of development

Adaptive medicines and vaccines CD 2 5 NTD 2 2 5 10 Innovative medicines and vaccines 4 2 9 CD NTD MNH MNH NCD NCD Discovery 2 Multiple Multiple 0 2 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval GSK’s innovative pipeline includes several maternal and neonatal health pro- GSK is adapting a range of products, including paediatric formulations, fixed- jects: retosiban for spontaneous pre-term labour, a maternal vaccine for res- dose combinations and products with new routes of administration. It is piratory syncytial virus and a Group B Streptococcus vaccine. adapting a component of its candidate malaria vaccine for thermostability. 81 Source: http://www.doksinet Access to Medicine Index 2016 GlaxoSmithKline plc PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE

Elimination of individual sales targets. GSK has and out-sourced clinical trials are conducted MANAGEMENT implemented a system for compensating sales ethically. RANK 3 professionals that eliminates individual sales tar- SCORE 4.2 gets. Sales staff performance measurements High transparency around clinical trials data. Loses leadership but remains on podium. GSK now include level of technical knowledge, quality The company has high standards of clinical trial drops two positions to 3rd, as peers gain the of services delivered and overall performance of data transparency, including providing scientific edge in access management. It maintains an GSK’s business. Nevertheless, GSK does not dis- researchers access to patient-level data upon overall good performance here, with strengths in close the payments it makes to healthcare pro- request, via clinicalstudydatarequest.com all areas of measurement except innovation. fessionals working in countries in scope.

Access strategy aligns with corporate strategy. Lobbying activities are transparent and appear crobial resistance. GSK signed the Declaration GSK’s access strategy aligns with its corporate responsible. GSK is transparent about its policy by the Pharmaceutical, Biotechnology strategy and focuses on pricing, innovative per- positions on access. It has a policy of not making and Diagnostics Industries on Combating formance incentives and marketing. It includes political contributions, including in the USA. Its Antimicrobial Resistance in January 2016, an Africa 2020 strategy with access objectives. US branch has a Political Action Committee for thereby committing to investing in R&D that Access is a driver for the company’s vaccines and employees to make contributions. aims to meet public health needs. Innovation: signing on to combat antimi- ViiV Healthcare businesses. Has breached criminal law in China for bribery. Shares intellectual property with several

part- Company-wide ownership of access. GSK’s GSK has been found in breach of criminal law in ners. GSK shares intellectual property for Corporate Executive Team is accountable for China for bribery of non-government person- research into HIV/AIDS, malaria, TB and NTDs. ensuring access objectives and progress toward nel to obtain commercial gains. It received a fine The company has reached several new agree- each target are achieved. Each layer of targets of GBP 297 mn. It has also been found in breach ments via WIPO Re:Search, as of 2015, includ- and actions has accountable owners. Progress of codes of conduct for ethical marketing three ing providing a researcher at the University of against these commitments is reported to the times, and of civil law in the US during the period British Columbia with a set of proprietary com- board-level Corporate Responsibility Committee. of analysis. pounds with different anti-malarial properties. Top performer in

stakeholder engagement. Innovation: revolving-door policy to prevent GSK has a clear strategy for stakeholder engage- conflicts of interest. GSK introduced a “cool- PRICING, MANUFACTURING & ment, which includes processes for engagement ing-off” period for new employees from the DISTRIBUTION by its local offices. Local stakeholder perspec- public sector: for six months, they cannot work RANK 1 tives are collected during all phases of the com- on projects they were involved with in their pre- pany’s activities. GSK publishes its stakeholder vious role. This includes a ban on direct engage- Rises six places to become the leader. GSK engagement information. ment with former colleagues still working on jumps from 7th to 1st in 2016, taking the lead those projects during the cooling-off period. in equitable pricing, notably for its considera- Uses financial and non-financial incentives to SCORE 3.2 tion of socio-economic factors in equitable pric- reward

performance. GSK uses both finan- ing strategies across its portfolio. All its prod- cial and non-financial incentives to reward good RESEARCH & DEVELOPMENT ucts with equitable pricing consider socio-eco- performance and motivate employees to per- RANK 1 nomic factors. SCORE 3.6 form on access-related issues. Its Partnership Associates Programme allows employees to R&D commitments tied to clear targets. GSK Equitable pricing strategies for more products. complete internal secondments and work on has a long-standing commitment to develop- GSK has more products with equitable pricing Positive Action, the company’s HIV/AIDS com- ing products and technologies for the benefit of strategies than in 2014, covering a broad range munity partnership programme that has been global health. Its R&D commitments are regu- of diseases, including HIV/AIDS, lower respira- implemented in more than 30 countries. larly reviewed and updated in response to stake- tory

infections, asthma, pertussis and hyperten- holder feedback. Progress is published yearly in sive heart disease. Some (38%) of GSK’s prod- its Responsible Business Supplement. ucts have equitable pricing strategies that target MARKET INFLUENCE & COMPLIANCE priority countries (disease-specific sub-sets of Commitment to R&D partnerships, but no countries with a particular need for access to policy. GSK has a broad commitment to con- the product in question). These reach 35% of Compliance failure, including in China, leads to ducting R&D and engaging in partnerships that corresponding priority countries. In absolute drop of four positions. GSK dropped four posi- support access. However, the company has no terms, GSK has the most products with equita- tions, out of the top five, due to poor compliance clear policy to ensure access-oriented terms are ble pricing strategies that target priority coun- and multiple settlements relating to unethical included in

its research partnerships. tries. It considers more socio-economic factors RANK 9 SCORE 2.2 behaviour. GSK is now implementing new systems and policies for improving compliance that determine affordability than any company Takes measures to ensure clinical trials are conducted ethically. GSK has policies in place and takes measures to ensure its in-house 82 per strategy, on average. Source: http://www.doksinet Access to Medicine Index 2016 Tracking products to the pharmacy to facilitate include access-oriented terms, and cover a com- Best practice: approach to R&D capacity recalls. GSK has product tracking systems in paratively high number of middle income coun- building. GSK has many local R&D partnerships, countries in scope that can trace products to the tries with high HIV/AIDS prevalence, through, for particularly in sub-Saharan Africa and Latin wholesaler and distributor level, with onward example, a tiered royalty structure for dolutegra- America.

Most specifically address local needs, traceability via local systems to the pharmacy vir (Tivicay®), a treatment for HIV/AIDS. and some are long-term, such as the GSK’s level. The company uses this system to monitor engagement with Fiocruz in Brazil to develop stock returns from agreed outlets (e.g, whole- Broad acknowledgement of countries’ rights, new medicines for NTDs, initially Chagas disease salers, pharmacies, etc.) and report on stock as codified in the Doha Declaration. GSK makes and leishmaniasis. recoveries in the case of a recall. a comparatively broad acknowledgement of the rights agreed for national governments in the Innovation: strengthening research and Pricing guidelines for in-house employees. Doha Declaration on the TRIPS agreement and supply chain management capacity in Africa. GSK has pricing guidelines and monitoring and public health, and outlines its process for dis- GSK has two innovative capacity building initi- auditing mechanisms

that govern in-house tancing itself from trade association positions atives: through its Africa 2020 strategy, it aims employees. (e.g, on access) that it disagrees with to fill local R&D skills gaps; and its mVacciNa- Weak disclosure of registration information. Best practice: clarity in approach to intellec- chain management in Mozambique (scaled up GSK does not publish its decision-making cri- tual property management. GSK clearly indi- since 2014). teria or product registration status. GSK’s reg- cates where it is prepared to forego filing for istration commitment is confidential. The com- or enforcing patents (in LICs and LDCs), where pany performs relatively poorly. It has filed to it is prepared to license, for which products PRODUCT DONATIONS register the majority of its 10 newest products in and it gives an indication of the terms it would RANK 1 some (32%) priority countries (disease-specific consider. tion partnership aims to improve vaccine

supply SCORE 4.0 Leader in product donations. GSK moves from sub-sets of countries with a particular need for Best practice: permitting supply where pat- 3rd to 1st position. It donates the largest volume ents are not enforced. GSK achieves a broad of products, through its lymphatic filariasis (LF) Leader in adapting brochures and packag- geographic scope in its licence for dolutegravir and soil-transmitted helminthiasis donation pro- ing materials for rational use. GSK adapts bro- (Tivicay®) by agreeing to permit supply outside gramme, to which it is committed long-term. chures and packaging in a variety of ways in of the agreed territory where patents are not in order to facilitate rational use at different levels force, regardless of whether a patent is in place Pledged to donate albendazole (Zentel®) to of the health system. For example, it addresses in the country of manufacture. WHO until elimination. GSK has pledged to access to the product in question).

donate albendazole (Zentel®) to WHO until language needs using tri-lingual export packs for LF is eliminated. It has committed to donating vaccines, addresses literacy needs by using pictorial comic books for patients and images for CAPACITY BUILDING Zentel® to control soil-transmitted helminthia- administrators. RANK 2 sis among school-age children. It has donated 17 SCORE 3.7 billion tablets since 2014: it is the largest dona Best practice: equitable pricing for first-line Consistently strong in meeting local capac- broad spectrum antibiotic. GSK’s equitable pric- ity building needs. GSK improves on its strong ing strategy for amoxicillin/clavulanate potas- performance in 2014 with a comprehensive Has structured international donation poli- sium (Augmentin®) takes multiple socio-eco- and innovative approach to building capacity in cies. GSK publishes its global pharmaceutical nomic factors into account: (1) disease burden; response to local needs in a range

of countries. policy for its donations approach. In July 2015, (2) healthcare system funding; (3) demograph- The company is particularly strong in building it updated its standard operating procedure ics and population distribution; (4) level of eco- capacity outside the pharmaceutical value chain (SOP) with a new approval process and report- nomic development; (5) inequality levels; (6) and in pharmacovigilance. ing requirement for ad hoc donations. Its policy supply chain factors; (7) patient awareness; and tion programme of any company in scope. complies with WHO and PQMD guidelines. (8) appropriate use by patients and physicians. It Leader in strengthening pharmacovigilance targets high-need countries, with different pric- systems. GSK voluntarily shares safety data with Involved in numerous emergency relief efforts. ing mechanisms in different countries. authorities and updates safety labels for prod- GSK donated antibiotics and other essential ucts in

countries in scope. It has an above-aver- medicines for humanitarian aid in 93 countries, age number of activities to build local pharma- through its partners AmeriCares, Direct Relief, covigilance capacity, focusing on Latin America. IMA World Health, MAP International and Project PATENTS & LICENSING RANK 2 HOPE. The company is transparent about the SCORE 3.4 Leader in building capacity outside the value value of its product donations, reporting figures Among the leaders once again in IP manage- chain. GSK’s approach to philanthropic activi- per partner on its website. ment. This is due to its consistent approach to ties is very strong: it aims to sustainably address supporting affordability and supply by licensing local health needs and requires impact assess- Strict monitoring and auditing requirements. its HIV/AIDS products and through the transpar- ment. The company discloses a number of initia- GSK requires annual shipping reports from part- ency of

its intellectual property strategy. tives to build capacities outside the pharmaceu- ner organisations. GSKs partners and third-party tical value chain, including through its Save the consultants conduct field visits to evaluate and Children partnership. assess in-country partners. In addition, part- Committed to patent transparency. Though GSK has not yet made any disclosure of its ners are required to send impact reports demon- patent statuses in countries within scope, it has Above average in building manufacturing and strating use and reach. For longer-term health- committed to doing so. supply chain management capacity. GSK has care programmes, they must also send narrative a relatively high number of activities to build reports and case studies. Consistent engagement in voluntary licens- manufacturing capacity in-house and with third ing. GSK continues to pursue a broad licensing parties (for example, in India and Brazil) and approach for ARVs via ViiV

healthcare and the strengthen local supply chains (e.g, in Pakistan Medicines Patent Pool. Its licensing agreements and Vietnam). 83 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 2 2.93 Johnson & Johnson 3 (2014) Stock Exchange: XNYS • Ticker: JNJ • HQ: New Brunswick, NJ, US • Employees: 127,100 Ranking by technical area Ranking by strategic pillar 5 2. 3 R&D 3. 3 Pricing 2. 6 Patents 2. 1 Capacity 3. 1 4 3 2 1 leader 0 1 2 3 4 5 3.3 3. 8 Donations average average 0.2 Compliance 3.3 3. 9 3.2 Management Commitments Transparency Performance Innovation 0 PERFORMANCE Johnson & Johnson rises one place to 2nd, with leading multiple socio-economic factors when setting prices between approaches in several areas. Its strong performance is driven countries, as well as in demonstrating that pricing strategies by a broad access strategy, with a clear direction for its long- have been implemented. It

has expanded its commitment not term access programme in Africa. It has a large relevant pipe- to assert patent rights. It is the most active in product dona- line, and has moved a greater proportion of projects along the tions, with six programmes across three disease areas. It is pipeline than in the previous Index. Its use of equitable pric- strong in building capacity, particularly in supply chain man- ing remains constant. It is among the leaders in considering agement and pharmacovigilance. CHANGE SINCE 2014 • Has a new Global Public Health organisation, • Has moved more projects along the pipe- plants in India, providing tailored support for established to address global health problems line than during the previous analysis period achieving high standards (e.g, by assigning a in specific disease areas. (2012-2014). person-in-plant). • Increases the transparency of its marketing and lobbying activities. • Has a 50% larger pipeline for diseases in scope

• Has equitable pricing strategies for the same number of products as in 2014. • Newly commits to long-term product donation programmes for TB and HIV/AIDS. • Has expanded the geographic scope of its than in 2014, with new projects for a wide pledge not to assert IP rights over darunavir range of diseases. (Prezista®) • Is piloting a comprehensive process for assessing capacity gaps in third-party manufacturing OPPORTUNITIES Expand Global Public Health access approach Set registration targets for key diseases. For erage these strengths to become an industry to more disease areas. Johnson & Johnson is pipeline products, Johnson & Johnson can set frontrunner at bringing products to market for active in a wide variety of disease areas. The disease-level targets for registering products high-need diseases. company can expand the remit of its new Global in countries in scope. This helps ensure early Public Health organisation to cover access to access to

products in countries that need them Extend pledge not to enforce patent rights, medicine for more disease areas. most. The company can register existing prod- and its engagement in voluntary licensing. ucts, e.g, bedaquiline (Sirturo®), in more coun- Johnson & Johnson can extend its pledge not Expand use of equitable pricing strategies, tries with high disease burdens. Bedaquiline is to enforce IP rights to more high-need products. with addition of intra-country segmentation. on-patent, is used to treat multi-drug-resist- Likewise, Johnson & Johnson can expand its use Johnson & Johnson can expand its inter-country ant TB (MDR-TB) and is on the WHO Model of non-exclusive voluntary licensing to ensure equitable pricing strategies to more products. Essential Medicines List (EML). access to and supply of its on-patent high-need The company can also implement intra-coun- medicines. try equitable pricing strategies in markets with Implement time-bound

R&D targets for devel- high-levels of inequality and/or high out-of- oping high-need products. Johnson & Johnson pocket payments. clearly ties its R&D commitments to global health priorities, and is efficient at moving projects along its pipeline. The company can lev- 84 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Sales by segment (2015) 1 3,507 MN 25,1 37 MN USD 70,074 MN 31 ,430 MN Consumer Pharmaceutical Medical devices In scope, has sales Sales by segments In scope, has no sales MN USD Not in scope SALES AND OPERATIONS 70,000 60,000 50,000 40,000 Johnson & Johnson operates in three segments: 30,000 Consumer Healthcare, Pharmaceuticals and 20,000 Medical Devices. Its Pharmaceuticals segment is focused on: cardiovascular and metabolism; 1 0,000 immunology; infectious diseases and vaccines; 0 neuroscience; and oncology. Johnson & Johnson 2011 2012 Rest of world is present in 69 countries in

scope, and its sales 2013 2014 Asia-Pacific/Africa 2015 Europe USA in emerging and frontier markets account for approximately 20% of total sales. PORTFOLIO AND PIPELINE Products per disease category 4 Johnson & Johnson has a mid-sized portfolio date medicines for four communicable diseases of products for diseases in scope: 49 medicines, and four neglected tropical diseases (NTDs), as 3 preventive vaccines, and 4 diagnostics. This well as several vaccines. Together with Cue Inc, includes products for liver diseases, heart dis- Johnson & Johnson is developing a point-of- eases, mental health conditions and diabetes. care viral load test for HIV/AIDS. Johnson & Johnson has one of the largest pipe- A number of projects have moved along the lines of projects that address the needs of pipeline since 2014. In 2015, the FDA approved people in countries in scope: 57 R&D projects three-month paliperidone palmitate (Invega in total, approximately a third

of which target Trinza®) for schizophrenia, which is being regis- high-priority product gaps with low commer- tered in multiple countries in scope. 18 56 26 3 5 Communicable Non-communicable Neglected tropical Multiple categories Maternal and neonatal Its portfolio covers all disease categories in scope. cial incentive. Its pipeline has a strong focus on The majority of its projects for communicable dis- mental health conditions, and includes candi- eases target HIV/AIDS and viral hepatitis. Pipeline projects 1 8% 0 First-line treatments and essential medicines 21 % 10 20 10 61 % 30 40 50 In partnership, with access provisions (ap) 60 70 80 In partnership, w/o ap 90 100 Not in partnership 7 0 14 21 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other Several research partnerships, such as with GSK and the TB Alliance, include Approximately 60% of Johnson & Johnson’s

medicine and vaccine portfo- provisions for broader access to the product following market approval. lio is listed on the WHO EML and/or as first-line treatments: e.g, simeprevir (Olysio®), risperidone (Risperdal®) and darunavir (Prezista®). Pipeline by stage of development CD 11 NTD 3 3 Innovative medicines and vaccines 5 5 CD 4 NTD MNH MNH NCD Adaptive medicines and vaccines 11 3 NCD Multiple Multiple 0 Discovery 2 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval Johnson & Johnson is developing a range of innovative products. It is target- Johnson & Johnson is adapting a range of products for people in high-need ing respiratory syncytial virus through several projects, including preventive countries, including several fixed-dose combinations for HIV/AIDS and paedi-

vaccines for infants and the elderly, which have moved to phase I since 2014. atric formulations targeting TB and soil-transmitted helminthiasis. 85 Source: http://www.doksinet Access to Medicine Index 2016 Johnson & Johnson PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE accountable to its policies. It regularly con- considers access in emerging economies and MANAGEMENT ducts due diligence and background checks on resource-limited settings. RANK 6 third-parties to check compliance with its pol- SCORE 3.9 icies. It also requires third-parties are trained, Commitment to R&D partnerships, but no Drops 2 positions, as peers improve faster. and for contracts to include specific contractual policy. Johnson & Johnson commits to includ- Johnson & Johnson moves from 4th to 6th, with commitments to abide by all applicable anti-cor- ing access-oriented terms in its R&D contracts. a good overall performance and strengths across ruption laws.

However, the company does not have a policy most areas of measurement. that ensures or specifies inclusion of these Some transparency of lobbying activities. measures in its partnerships. Broad access strategy and new Global Public Johnson & Johnson states that it publishes Health organisation. Johnson & Johnson’s the political contributions it makes in countries Comprehensive policy to ensure clinical trials access strategy includes pricing, in-country reg- where this is required by law. The company pro- are conducted ethically. Johnson & Johnson has istration, supply-chain development and drug- vides a list of trade associations of which it is a policies and takes measures to ensure its clin- safety monitoring. The company has established member, but does not disclose how much finan- ical trials are conducted ethically. Its policies a new Global Public Health organisation with the cial support it has provided to them. Johnson & are strong: they

include measures on scientific objective of addressing global health issues in Johnson publishes its policy for managing con- requirements, research protocols and provisions maternal, newborn and child health, HIV/AIDS flict of interest. for post-trial access to investigational medicines. and TB. Found to have engaged in unethical behaviour. High transparency around clinical trials. The Top performer in stakeholder engagement. The Johnson & Johnson was found to have breached company upholds high standards of clinical trial company has a clear strategy for stakeholder civil law and codes of conduct multiple times data transparency, including providing scientific engagement, which is needs-based and includes related to unethical marketing activities and fail- researchers access to patient-level data upon directions for its subsidiaries. The company’s ure-to-warn cases. request via an independent review panel (under Global Public Health strategy is based on the

the Yale Open Data Access Project). inputs and insights of numerous actors around Comprehensive audit system in place. The com- the world and across sectors. The company is pany’s Corporate Internal Audit division con- Innovation: signing on to combat anti- transparent about its stakeholder engagement ducts independent audits of its businesses, microbial resistance. Johnson & Johnson activities and processes. addressing compliance, corruption and privacy. signed the Declaration by the Pharmaceutical, Its operating companies are generally audited Biotechnology and Diagnostics Industries on Uses secondment as non-financial perfor- every three or five years, depending on the risk Combating Antimicrobial Resistance in January mance incentive. Its Trust Secondment Strategy profile. 2016, thereby committing to investing in R&D that aims to meet public health needs. Programme allows employees to share their skills and knowledge with NGOs during second- Limited

performance in ethical market- ments of three to six months. The programme ing. Johnson & Johnson has a marketing code ensures NGOs gain access to skill-sets they lack, of conduct that also applies to third parties. PRICING, MANUFACTURING & while employees learn about needs in the field. Nevertheless, it has no incentives for sales DISTRIBUTION agents other than sales targets. The company RANK 2 Market Access Counters to track performance. also fails to disclose information about its mar- Among other tools, Johnson & Johnson has a keting activities in countries in scope. SCORE 2.6 Rises 3 places to join the leaders. Johnson & Johnson rises into the top three. It is a leader tracking system for measuring the prevalence of when it comes to considering socio-economic diseases in particular countries. Using public and private reimbursement data, it generates a real- RESEARCH & DEVELOPMENT factors in its inter-country equitable pricing time patient

counter based on sales and treat- RANK 3 strategies. It is also a leader in demonstrating SCORE 3.3 that its strategies are being implemented (evi- ment assumptions. Continued strong performance with a large dence is provided in the form of price and vol- pipeline of high-need products. Johnson & ume-of-sales information). It is also a leader in MARKET INFLUENCE & COMPLIANCE Johnson continues to perform strongly in R&D. how it facilitates the rational use of its products RANK 6 Its pipeline is 50% larger than in 2014, and the for populations in need. SCORE 2.3 company has moved a significant portion of its Rises 11 places due to improved enforcement projects along its pipeline since 2014. processes. Johnson & Johnson climbs from 17th Same number of equitably priced products. Johnson & Johnson has equitable pricing strate- into the top ten in this area. This is due to the R&D commitments linked to public health gies for the same limited

number of products as good quality of its enforcement processes for rationale. Johnson & Johnson commits to devel- in 2014. Its pricing strategies mainly cover HIV/ third parties and its increased transparency. oping products in order to achieve the maxi- AIDS products, as well as products for TB, viral mum public health impact globally. Its commit- hepatitis and meningitis. Only a few (9%) of its Enforcement processes for third parties. ments are tied to stakeholders’ priorities and to products have pricing strategies that target pri- Johnson & Johnson holds key third-parties major global disease burdens. It systematically ority countries (disease-specific sub-sets of 86 Source: http://www.doksinet Access to Medicine Index 2016 countries with a particular need for access to PATENTS & LICENSING building local pharmacovigilance capacity, includ- relevant products). Yet, together, these strate- RANK 7 ing a long-term partnership in China. SCORE 2.1

gies target the majority (59%) of corresponding priority countries. For two-thirds of its products Improved performance in multiple areas. Building manufacturing capacity in a range of with inter-country equitable pricing strategies, Johnson & Johnson has climbed into the top countries. Johnson & Johnson demonstrates a the company has taken socio-economic factors ten in this area, in part by engaging with the comprehensive commitment to assessing and into account: including economic development, Medicines Patent Pool and with the Paediatric building capacity for in-house and third-party public health need, disease burden, state of the HIV Treatment Initiative. It has expanded the manufacturers. The company undertakes a healthcare system, costs and the level of out-of- scope of its pledge not to assert patent rights to number of capacity building activities, in Egypt, pocket payments. darunavir (Prezista®). India, Morocco, South Africa and Vietnam. Pricing

guidelines for sales agents. Johnson & Broad geographic scope for Prezista® non-as- Building R&D capacity in China. It has several Johnson’s contracts with sales agents (includ- sert pledge. Johnson & Johnson has expanded partnerships with local research organisations to ing third-party) include price restrictions. Sales its policy of not enforcing its patent rights over build R&D capacity in diverse countries, includ- agents’ prices are monitored and audited for Prezista®, an ARV. This non-enforcement pledge ing their long-term Tsinghua-Janssen Joint some products, in line with local compliance law. now covers 128 countries, including a mix of Research Center on Infectious Diseases in China. lower- and upper-middle-income countries. Strong approach to philanthropy. It has a very Partial transparency about where products are registered. Johnson & Johnson does not pro- Limited transparency around non-exclusive strong philanthropic approach,

including target- vide evidence of disease-specific registration voluntary licences. Johnson & Johnson has ing local needs. However, it does not demon- targets. It publishes some information about agreed non-exclusive voluntary licensing terms strate how it identifies, prevents or mitigates products’ registration status (not including when with five or more manufacturers for rilpivir- conflicts of interest when building capacities submissions were filed or approved) for Janssen ine (Edurant®), an ARV. However, it is not fully outside the pharmaceutical value chain. products. Johnson & Johnson has filed to reg- transparent about the terms and conditions. ister more than half (60%) of its newest products in some priority countries (disease-spe- Increased engagement with the Medicines PRODUCT DONATIONS cific sub-sets of countries with a particular need Patent Pool. Johnson & Johnson has built its RANK 3 for access to relevant products). Most of these

engagement with the Medicines Patent Pool products were launched between 2011 and 2013. through the Paediatric HIV Treatment Initiative. Rises three positions. It has the most structured One of PHTI’s priorities is to develop an opti- donation programmes: six programmes covering Consistent recall guidelines. Johnson & mised, generic fixed-dose combination of darun- three disease areas, with two new programmes Johnson has globally consistent guidelines for avir and ritonavir for children living with HIV. launched in the period of analysis. where its products are available. It does not pub- Limited support for the Doha Declaration. Launched new HIV/AIDS and TB donation pro- lish information on drug recalls. Johnson & Johnson publicly supports the Doha grammes. In 2015, Johnson & Johnson launched Declaration on the TRIPS agreement and public two new donation programmes. In its new HIV/ Leader in facilitating the rational use of its health. Its support

for compulsory licensing is AIDS donation programme, it supports China’s products. Johnson & Johnson provides evidence limited to when the alternatives are exhausted. efforts to treat HIV/AIDS in intravenous drug SCORE 3.8 issuing drug recalls in all countries in scope users. It will donate rilpivirine (Edurant®) to of adapting brochures and packaging for its HIV/ AIDS products, including using local languages Low patent transparency. Johnson & Johnson treat up to 500 HIV/AIDS patients in selected in Anglophone, Francophone and Lusophone makes no direct public disclosure of patent methadone clinics. In collaboration with USAID, Africa, as well as diagrams to take account of status, but publishes the contact details of the Johnson & Johnson will provide 30,000 treat- varying literacy levels. For use at the point of dis- specific person at the company who provides ment courses of bedaquiline (Sirturo®) for TB. pensation, Johnson & Johnson provides

dosing them, and invites requests for information. Commits to supporting controlling soil-trans- guidelines for its donated paediatric HIV/AIDS mitted helminthiasis. Johnson & Johnson medicines. To address environmental considerations, it uses blister packs in some settings CAPACITY BUILDING has committed to providing up to 200 million RANK 3 doses annually of mebendazole (Vermox®) for SCORE 3.1 Best practice in inter-country equitable de-worming treatments until 2020. pricing. For darunavir (Prezista®), which is Strong overall performance in capacity build- on patent and on the WHO EML, Johnson & ing, targets local needs. Johnson & Johnson Commits to quality medical donations. Johnson Johnson considers four socio-economic fac- maintains its solid performance: it is active in all & Johnson’s commitment to quality medi- tors when setting prices. Its pricing strategy for areas with key strengths in building supply chain cal donations is

reinforced by its Guidelines for darunavir applies in all priority countries for HIV/ management and pharmacovigilance capacity. Product Donations (GPD), which complies with AIDS (countries with a particular need for access Many of its activities target specific local needs. WHO and PQMD guidelines. a not-for-profit price for all sub-Saharan Africa Leader in improving supply chain management. Involved in donations for emergency relief. and all Least Developed Countries. The 800mg It is very active in building supply chain manage- Johnson & Johnson provided ad hoc donations, daily dose of Prezista® is used in second-line ment capacity through partnerships and infor- including diagnostics, pharmaceutical and con- regimens. It is offered at USD 36 per unit (USD mation sharing. Its focus is on sub-Saharan sumer products, and disaster relief donations. 1.20 per patient per day ex-factory) in sub-Saha- Africa (e.g, in Sierra Leone and Zambia) to relevant products).

Johnson & Johnson sets Strict monitoring and auditing requirements. ran Africa and in Least Developed Countries (for both public and private markets). Leader in strengthening pharmacovigilance Johnson & Johnson requires donation partners systems. Johnson & Johnson voluntarily shares to submit annual reports. It coordinates a two- safety data with authorities and updates safety year auditing process to ensure compliance with labels for its products in countries in scope. The agreed conditions for product donation. company has a number of diverse activities for 87 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 3 2.87 Novartis AG 4 (2014) Stock Exchange: XSWX • Ticker: NOVN • HQ: Basel, Switzerland • Employees: 122,966 Ranking by technical area Ranking by strategic pillar 5 R&D 3. 2 Pricing 2. 5 Patents 1 .4 Capacity 4. 0 Donations 3. 5 0 4 3 2 Leader 1 2 3 1 leader 4 5 average average 1 .1 1 .6

3.0 Compliance Leader 2.8 4. 9 3.6 Management Commitments Transparency Performance Innovation 0 PERFORMANCE Novartis rises one place to 3rd. It has an access strategy tropical diseases (food-borne trematodiases and leprosy). embedded in its broader corporate strategy, and which Novartis takes a comprehensive and innovative approach addresses all segments of the socio-economic pyramid. It is a to capacity building, consistently addressing local needs. leader in filing products for registration, and has applied equi- However, its strengths are not reflected in its compliance table pricing to significantly more products than in 2014. It system or in the transparency of its marketing and lobbying is also a leader in donations: two programmes stand out for activities. Novartis also does not publish patent statuses and their reach and broad coverage, which both target neglected has not engaged in licensing. CHANGE SINCE 2014 • Established the Novartis Access

programme • Is developing an approach that will value the • Has signed the Declaration by the in 2015, which offers a portfolio of 15 on- environmental, social and economic impact of Pharmaceutical, Biotechnology and and off-patent products for non-communica- some of its initiatives. Diagnostics Industries on Combating ble diseases (NCDs) at USD 1 per month, per treatment. Antimicrobial Resistance. • Falls back in compliance, with a settlement following a case of corruption in a country in • Has more than doubled the number of its products with equitable pricing. • Partnered with national regulatory authorities • Established a Global Health Group for improv- • No improvement in its accountability for its sales agents’ pricing practices. • Has not published the status of its patents. scope (China). ing R&D by building a better understanding of in Egypt and Mexico in 2015 to improve awareness of the importance of pharmacovigilance. unmet medical

needs in low-income countries and responding to them. OPPORTUNITIES Plan for the long-term sustainability of its Increase sensitivity of affordability assess- Strengthen and innovate compliance system. Novartis Access programme. Novartis can take ments in low- and middle-income coun- Novartis has general guidelines for interacting steps to ensure the longevity of its new Novartis tries. Novartis can expand its consideration with public officials and supporting political and Access programme. If the programme proves of socio-economic factors in its inter-coun- policy advocacy. It can strengthen its compliance not to be economically sustainable, Novartis can try equitable pricing strategies, to ensure prod- system by building on these with new, specific agree with local stakeholders to ensure patients ucts are affordable, for example, for omalizumab guidelines governing all interactions with differ- covered by this programme retain access to (Xolair®), which is the

only registered recombi- ent actors along the medicines supply chain. medicines following the pilot phase. nant monoclonal antibody to treat moderate to severe allergic asthma. Continue to target known needs through inno- Ensure access to products on the WHO EML. Novartis has one of the largest numbers of prod- vative and adaptive R&D. Novartis can leverage Operationalise commitment to voluntary ucts on the WHO Model Essential Medicines List its strength at engaging in R&D for global health licensing. Novartis can operationalise and (EML). It can evaluate access barriers to these priorities. The company can continue to develop broaden its commitment to engaging in vol- products in all low- and middle-income coun- innovative medicines that target defined, untary licensing in Least Developed Countries tries. It can ensure their availability and afforda- high-priority product gaps, and continue its stra- (LDCs) to increase access to its patented prod- bility,

aligning with demand and the availability of tegic expansion of adaptive R&D for high-bur- ucts. Further, Novartis can broaden this commit- alternative products in specific countries. den diseases. ment to enable supply to other countries. 88 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Net sales by segment (2015) 9,1 57 MN USD 49,414 MN 9,81 2 MN 30,445 MN Pharmaceuticals Alcon Sandoz In scope, has sales Net sales by geographic region In scope, has no sales MN USD Not in scope SALES AND OPERATIONS 55,000 50,000 45,000 40,000 35,000 30,000 Novartis is organised in three divisions: company divested its vaccine business (exclud- Innovative Medicines, Alcon (eye care products) ing influenza vaccines) to GSK in an assets swap and Sandoz (generic medicines). Its pharmaceu- that included the acquisition of GSK’s marketed 1 5,000 tical division focuses on: cardiovascular disease, oncology portfolio. As part of the

deal, the two 1 0,000 respiratory diseases, neuroscience, immunology, companies created a new consumer healthcare dermatology and oncology. The company aims business, with majority control being retained to expand its portfolio with products for infec- by GSK. Novartis has sales in 77 countries within tious diseases, regenerative medicine and aging. the scope of the Index. 25,000 20,000 5,000 0 2011 2012 2013 Asia/Africa/Australasia 2014 Europe 2015 Americas Novartis’s focus has recently shifted: in 2015, the PORTFOLIO AND PIPELINE Products per disease category Novartis has one of the largest portfolios for rel- keting authorisation for three medicines for rele- evant diseases of all companies in the Index, vant diseases in the next two years, including for and one of the largest pipelines of projects that cardiovascular disease and asthma. 7 12 3 74 address the needs of people in countries in scope: with 74 products and 45 R&D projects. 2

Novartis is developing medicines for ten NCDs, six communicable diseases, four neglected trop- In Novartis’s portfolio, 50 medicines target ical diseases (NTDs) and three maternal and one or more NCDs, including hypertensive and neonatal health conditions. Its candidates for ischaemic heart disease and unipolar depres- malaria, TB and NTDs target high-priority prod- sive disorders. In Q4 2015, the company gained uct gaps with low commercial incentive. Several EU approval for sacubitril/valsartan (Entresto®), of its product candidates have progressed along Novartis has 74 medicines for relevant diseases, which has a new mechanism of action for treat- the pipeline since 2014. mainly for infectious diseases, heart diseases, 50 First-line treatments and essential medicines 32 87% 10 20 Multiple categories mental health conditions and respiratory diseases. Pipeline projects 1 3% Non-communicable Neglected tropical Maternal and neonatal ing heart failure.

Novartis expects to file for mar- 0 Communicable 30 40 50 In partnership, with access provisions (ap) 60 70 80 In partnership, w/o ap 90 100 Not in partnership 10 0 20 17 40 15 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other Novartis is collaborating to develop medicines for malaria and dengue, A high proportion of Novartis’ products for diseases in scope are on the among others. WHO EML and/or that are first-line treatments: e.g, omalizumab (Xolair®), budesonide (Miflonide®) and lamprene/rimactane/dapsone. Pipeline by stage of development CD 4 NTD 7 Innovative medicines and vaccines 2 CD NTD MNH MNH NCD Adaptive medicines and vaccines 19 4 2 NCD Multiple Multiple 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55

Received Market Approval Novartis is developing innovative medicines for all four disease categories. Novartis is adapting products for malaria, TB, maternal haemorrhage, hyper- The majority are in early stages of development. tensive heart disease, lower respiratory infections, diarrhoeal diseases, meningitis and kidney diseases. 89 Source: http://www.doksinet Access to Medicine Index 2016 Novartis AG PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE MARKET INFLUENCE & COMPLIANCE ing in R&D to meet the needs of people living MANAGEMENT RANK 15 in LICs. The company has a newly established RANK 1 SCORE 1.6 Global Health group that aims to improve R&D SCORE 4.9 Below average compliance results in a drop of by increasing the understanding of unmet med- New leader in this area. Novartis ranks 1st here, four places. Novartis moves from 11th to 15th ical needs in LICs. Novartis has published its rel- rising one position since 2014. The company is

position. This is due in part to the settlement evant R&D targets and has a system for annually a leader in all areas, with a best-practice access of a case of corruption in a country in scope reviewing its progress against them. strategy, as well as by innovations in business (China). Commitment to R&D partnerships, but no models and performance management systems. Transparent in some dimensions, but not about policy. Novartis includes access-oriented terms Centralised performance management system, memberships. Novartis is transparent about its in its R&D partnerships for communicable dis- tracks costs of access initiatives. The company lobbying activities and public policy positions, eases and NTDs. However, it does not have a has a centralised performance management including anti-counterfeiting and non-enforce- systematic framework to ensure all partnerships system that uses quantitative and qualitative ment of patents in LDCs. It states that it does

are based on access-oriented terms. measures to collect data and appraise perfor- not make any political contributions in coun- mance across its global operations. It also tracks tries in scope. Nevertheless, it is not transparent Comprehensive policy to ensure clinical trials the actual costs of each major access initiative about its memberships of relevant organisations are conducted ethically. Novartis has poli- and reports on these as part of its annual corpo- (such as patient groups). The company has pub- cies and takes measures to ensure its clini- rate responsibility strategy update. lished its conflict of interest policy. cal trials are conducted ethically. Its policies Top performer in stakeholder engagement. Found to have breached corruption law in a requirements, research protocols and post-trial Novartis has a clear, detailed stakeholder country within scope. Novartis agreed to pay provisions. engagement strategy that includes directions USD 25 mln to

settle charges that violated the for the company’s subsidiaries. Furthermore, the Foreign Corrupt Practices Act by making illegal High transparency around clinical trials. The company is transparent about its stakeholder payments to health care providers in China. company upholds high standards of clinical trial are strong: they include measures on scientific engagement activities. data transparency, including providing scientific Comprehensive auditing system in place. The researchers access to patient-level data upon Innovaton: two access-oriented business company’s internal audit department checks for request, via clinicalstudydatarequest.com models. Novartis Access offers 15 on- and compliance with internal anti-bribery, anti-cor- off-patent medicines for NCDs in lower-middle ruption and ethical marketing codes. The scope Innovation: signing on to combat antimicro- income (LMICs) and low-income countries (LICs) of these activities covers the whole company

bial resistance. Novartis signed the Declaration at the cost of USD 1 per month per treatment. (territories, divisions and functions). It applies to by the Pharmaceutical, Biotechnology This has significantly increased the number of all company staff, but only to some third parties. and Diagnostics Industries on Combating Antimicrobial Resistance in January 2016, Novartis products with equitable pricing strategies. In 2015, it set up ComHIP, a three-year pro- Mixed performance in ethical marketing and thereby committing to investing in R&D that gramme designed to evaluate the impact of an anti-corruption. Novartis has a marketing code aims to meet public health needs. innovative healthcare model on hypertension of conduct. Its incentives for sales personnel are control and self-management in Ghana. not related only to sales targets. Nevertheless, the company does not provide information PRICING, MANUFACTURING & Innovation: performance management sys- about

its marketing activities or the payments DISTRIBUTION tems. Novartis is exploring an approach to it makes to individuals or organisations in coun- RANK 3 enable it to quantify, measure and value the tries in scope. The company has whistle-blower environmental, social and economic impact of facilities but anonymity is not fully ensured. Rises ten places into the top three. Novartis jumps from 13th in 2014 to 3rd place. It improves its social activities and related initiatives, among its performance in equitable pricing and is a other activities. This information could also inform the company’s decision-making process. SCORE 2.5 RESEARCH & DEVELOPMENT leader in filing to register products in high-bur- RANK 5 den countries. SCORE 3.2 Best Practice: Novartis Access Strategy Framework. The company’s Access to Medicines Holds strong position with one of the largest Significant expansion of equitable pricing strat- Framework guides the development of its equi-

pipelines in scope. Novartis confirms its strong egies. Compared to 2014, Novartis has more table and affordable solutions targeted toward position in R&D, with clear R&D commitments than doubled the number of its products with all segments of the socio-economic pyramid. and a large pipeline spanning all four disease cat- equitable pricing strategies. This is in part due Access initiatives are embedded in Novartis’s egories. The company performs well once again to its Novartis Access programme and to ten- business divisions. Each one has an implementa- in clinical trial conduct and transparency. ders for products that previously had no equi- tion plan that aligns with its business. 90 table pricing strategies. The company’s pricing R&D commitments tied to clear targets. strategies cover a wide range of diseases, includ- Novartis has a clear commitment to engag- ing hypertensive heart disease, ischaemic heart Source: http://www.doksinet Access to

Medicine Index 2016 disease, lower respiratory infections and diabe- Open to non-exclusive voluntary licens- PRODUCT DONATIONS tes. In total, 49% of its products for diseases in ing. Novartis supports its commitment not to RANK 5 scope have pricing strategies that target priority enforce patent rights with a public agreement to countries, reaching 31% of corresponding prior- grant licences to third parties for supply to the Novartis remains in 5th place. Novartis remains ity countries (disease-specific sub-sets of coun- UN-defined LDCs. 5th with two on-going structured donation programmes. The company is involved in two WHO tries with a particular need for access to relevant products). SCORE 3.5 No transparency around its position on trade donation programmes for NTDs: targeting food- policy. Novartis has not published its position on borne trematodiases and leprosy. Leader in registering products where they are the Doha Declaration on the TRIPS agreement needed.

Novartis commits to registering prod- and public health. However, it did support the Continues to eliminate leprosy. Since 2000, ucts for a sub-set of diseases in some low- and time-based extension to LDCs. Novartis has been providing high-quality multi-drug therapy (MDT) free of charge through middle-income countries but provides no time- WHO. The aim is to make the therapy availa- frame. Nevertheless, in practice, it has filed to register all of its ten newest products in the CAPACITY BUILDING ble to all leprosy patients. In 2015, Novartis has majority of corresponding priority countries RANK 1 renewed its pledge with WHO to work to end SCORE 4.0 leprosy, extending its donation of MDT medi- (disease-specific sub-sets of countries with a particular need for access to relevant products). Leader in capacity building, consistently Some of these products were first marketed in addresses local needs. Novartis improves on its 2015 or 2016. already strong performance in

2014 by demon- Complies with external standards. Novartis dis- strating a comprehensive approach to capac- closes its donations policy, which covers ad hoc Consistent recall guidelines. Novartis has glob- ity building across all areas measured. It con- and structured donations, and is based on WHO ally consistent guidelines for issuing drug recalls sistently addresses local needs, with a focus on guidelines. in all countries relevant to the Index where its sub-Saharan Africa, performing particularly well products are available. It does not publish its in capacity building outside the pharmaceutical Transparent on outcome measures. Monitoring drug recalls. value chain and R&D. on the ground is mainly done by Novartis’ dona- Monitors prices where possible. For countries in Leader in building capacity outside the value from its partner organisations. Its donation tar- scope and where legally possible, Novartis mon- chain. Novartis takes a very strong approach

gets are captured in its Access to Healthcare itors the prices charged by its distributors and to philanthropy, primarily through its Novartis Table, which is publicly available on the Novartis works actively with them in an effort to ensure Foundation: it targets local health needs, aims corporate website. This is annually updated and compliance with agreed upon price ceilings, in for sustainability, and includes impact measure- published with the Novartis Annual Report and order to enhance patient affordability. ments. The company builds capacities outside CR Report. cines for leprosy to 2020. tion partners. Novartis receives regular reports the pharmaceutical value chain, with many initia Best practice: working to ensure products tives in sub-Saharan Africa. can be used appropriately. Novartis adapts its Involved in humanitarian aid programmes. Novartis provided antibiotics for humanitar- brochures and packaging materials to address Strong in strengthening

pharmacovigilance sys- ian aid programmes. Most of its emergency-re- all five of the local needs looked for by the tems. Novartis voluntarily shares safety data lief donations are granted by its generic division, Index (language, literacy, cultural, demographic with authorities and updates safety labels in Sandoz. and environmental considerations). It does so countries in scope. The company has a number to facilitate the product’s rational use at vari- of diverse activities to build local pharmacovigi- ous levels of the health system. This includes lance capacity, in Egypt, Mexico and Thailand. an anti-microbial resistance campaign for physicians, pharmacists and patients in Brazil, Mexico, Best practice: approach to R&D capacity Ecuador and Colombia. building. Novartis has a large number of local partnerships that specifically address local needs, including a long-term engagement with PATENTS & LICENSING the University of Cape Town in South Africa RANK

10 focused on drug discovery for malaria and TB. SCORE 1.4 Mid-ranking performance, held back by low Best practice: SMS for Life. Novartis’s SMS transparency. Novartis ranks in the middle of for Life public-private partnership uses mobile the pack. It has a clear policy of patent-non-en- phones and other technology to improve the forcement in LDCs, and has stated that it is pre- stock management of medicines in sub-Saha- pared to license products for manufacture for ran Africa. Having piloted the programme in over supply to those countries. However, it falls back 10,000 health facilities, the company is now due to low transparency: it has not published the working with several governments to scale up status of its patents, nor has it clearly stated its the latest tablet-based platform. position on trade policy. Innovation: building capacity to treat lep- No transparency regarding patent status. rosy and malaria. Novartis takes an innovative, Novartis has not

published the status of its research-based capacity building strategy in patents. two disease-specific areas. In partnership with local stakeholders, the company is testing new Public commitment not to enforce patents. programmes to improve leprosy diagnosis and Novartis has publicly committed not to enforce treatment, mainly in south-east Asia, and malaria its patent rights in LDCs. treatment in sub-Saharan Africa. 91 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 4 2.83 Merck KGaA 6 (2014) Stock Exchange: XFRA • Ticker: MRK • HQ: Darmstadt, Germany • Employees: 49,613 Ranking by technical area Ranking by strategic pillar 5 R&D 3. 4 Pricing 2. 3 Patents 2. 5 Capacity 2. 8 Donations 3. 5 0 4 3 2 1 leader 1 2 3 4 5 average average 0.8 2. 2 2.8 Compliance 3.2 3. 6 3.9 Management Commitments Transparency Performance Innovation 0 PERFORMANCE Merck KGaA once again rises two places, having improved in

adapts its brochures and packaging to suit local needs in mul- most areas. It has access-related targets that align with the tiple ways. However, it still applies equitable pricing to only Sustainable Development Goals, and clearly holds third par- a small portion of its products. It has one of the most trans- ties to the same ethical standards as its own employees. It parent approaches to IP management, but has been fined engages in R&D partnerships and shares IP and clinical trial for anti-competitive behaviour. It is now a leader in capacity data for research purposes. It has filed to register a high pro- building, with a range of initiatives, including a long-term pro- portion of its newest products in high-burden countries and it ject for identifying falsified medicines. CHANGE SINCE 2014 • Newly aligns access targets with the Sustainable Development Goals. • Clearly indicates where it is prepared to waive collaboration with the University of Namibia, is

prepared to license. in support of national malaria control pro- • Does not publish progress made against access-to-medicine targets. • Has launched a three-year malaria research patent rights, and where and what products it grammes in Namibia, Botswana and Zambia. • Publishes information about the patents its holds in countries in scope. • Has improved its accountability for its sales agents’ pricing practices. • Has signed the Declaration by the Pharmaceutical, Biotechnology and • Has equitable pricing strategies for the same number of products as in 2014. Diagnostics Industries on Combating Antimicrobial Resistance. OPPORTUNITIES Target local capacity building needs in Africa. Align access commitments and R&D early. (EML), in all low- and middle-income countries Merck KGaA intends to strategically expand its Merck KGaA can build on its new “Access to that need them. It can align with demand and presence in Africa between 2015 and 2020. The Health

in Developing Countries” charters, which with the availability of alternative products in company can ensure its capacity building activ- focus on intellectual property rights and pric- specific countries. ities (including in manufacturing and areas out- ing, to ensure it makes access plans for its prod- side the pharmaceutical value chain) continu- uct candidates before they gain marketing ally respond to local needs, and draw on ongoing approval. The company can put access provi- input from local stakeholders. The company can sions in place for its in-house (non-collaborative) also evaluate impact and publish its findings. R&D projects. Expand equitable pricing strategy to more Ensure access to mental health products on products. Merck KGaA can apply its equitable the WHO EML. Merck KGaA is the only company pricing strategy to more products, including all targeting all mental health conditions in scope. of its first line medicines for diabetes. It can take

It can assess access barriers for these condi- account of more socio-economic factors in its tions and ensure the availability and affordability inter-country equitable pricing strategies. of its mental health products, especially those listed on the WHO Model Essential Medicine List 92 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Net sales by business sector (2015) 2,555.6 MN EUR 12,844.7 MN 6,933.8 MN 3,355.3 MN Healthcare Life Science Performance Materials In scope, has sales Net sales by region In scope, has no sales MN EUR Not in scope 1 2,000 11 ,000 1 0,000 9,000 SALES AND OPERATIONS 8,000 7,000 Merck KGaA reorganised its business in October nership with Pfizer to jointly develop and com- 2014 and now operates through three busi- mercialize immuno-oncology products. About ness sectors: Healthcare (comprising the one third of Merck KGaA’s sales are generated in 3,000 Biopharma, Consumer Health, Allergopharma,

emerging markets and the company has oper- 2,000 and Biosimilars businesses), Life Science and ation in 77 countries within the scope of the Performance Materials. The Healthcare business Index. 6,000 5,000 4,000 1 ,000 0 2011* 2012* 2013* Middle East/Africa focuses on: oncology, immunology, neurology, Europe endocrinology and cardiovascular diseases. In November 2014, the company announced a part- 2014 Latin America 2015 Asia-Pacific North America *Due to a change in company reporting practices, numbers from 2011, 2012, 2013 and 2014 are incomparable. PORTFOLIO AND PIPELINE Products per disease category 5 10 Merck KGaA has a mid-sized portfolio of 58 Its R&D focuses on malaria and schistosomia- products for diseases relevant to the Index. It sis, as well as diabetes. Merck KGaA is develop- has a mid-sized pipeline of 20 R&D projects ing diagnostics for HIV/AIDS and malaria that that address the needs of people in countries in target needs in

countries in scope. It is also scope. working with Instituto de Biologia Experimental 2 58 e Tecnológic to develop a screening platform for 41 To date, the company’s focus for low- and mid- the discovery of new anti-malarials. Over half of dle-income countries has been on medicines and the company’s projects target high-priority prod- diagnostics. Merck KGaA’s relevant portfolio has uct gaps with low commercial incentive. Since a strong focus on non-communicable diseases 2014, Merck KGaA’s collaborative project to (NCDs), covering: all mental health conditions in develop a paediatric formulation of praziquan- Merck KGaA’s medicines portfolio has a strong scope; hypertensive and ischaemic heart disease; tel moved from pre-clinical to phase II of clinical focus on NCDs. Its four diagnostics address and diabetes. development. HIV/AIDS, malaria, and TB. Pipeline projects 20% 0 20 Non-communicable Neglected tropical Multiple categories First-line

treatments and essential medicines 24 5% 75% 10 Communicable 30 40 50 In partnership, with access provisions (ap) 60 70 80 In partnership, w/o ap 90 100 Not in partnership 7 0 14 20 12 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other Merck KGaA collaborates with Astellas in the Pediatric Praziquantel Merck KGaA has 45 medicines listed on the WHO EML and/or as first- Consortium, which plans to promote access to a new formulation of prazi- line treatments: e.g, bisoprolol/amlodipine, metformin (Glucophage®) and quantel, for example, via procurement by established organisations. praziquantel. Pipeline by stage of development Adaptive medicines and vaccines Innovative medicines and vaccines CD CD NTD NTD MNH MNH NCD NCD Multiple 4 0 Discovery 2 2 Multiple 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5

10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval Merck KGaA’s innovative pipeline includes four new investigational medi- Merck KGaA is adapting several products, including: a fixed-dose com- cines, all in early stages of development, for malaria and Neglected Tropical bination; pre-diabetes expansion; and smaller tablet of metformin Diseases (NTDs). (Glucophage®) to target countries in scope. 93 Source: http://www.doksinet Access to Medicine Index 2016 Merck KGaA PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE MARKET INFLUENCE & COMPLIANCE global health priorities. Merck KGaA has prom- MANAGEMENT RANK 11 ised to continue allocating 20% of its revenue RANK 10 SCORE 2.2 to R&D. SCORE 3.6 Improvements in ethical marketing result in Overtaken by peers, drops four places. Merck rise of three places. Merck KGaA moves from Commitment to R&D partnerships, but no KGaA falls from 6th to

10th position in this area. 14th to 11th position in this area. This is due to policy. Merck KGaA commits to sharing intellec- It has maintained its performance in absolute improved practices regarding ethical marketing tual property with institutions carrying out R&D terms, but has been overtaken by peers who and to having a thorough auditing system, which for diseases in scope. However, the company has improved their performance. also applies to third parties. no clear policy for ensuring these features or Access unit embedded in all company busi- Specific guidance on marketing conduct. In nesses. Merck KGaA has an Access to Health addition to its code of conduct, Merck KGaA has (A2H) unit embedded within all core functions 34 global policies that provide detailed guidance Comprehensive policy to ensure clinical trials and operating across all businesses. Its access to its employees on topics related to marketing, are conducted ethically. Merck KGaA has pol-

strategy is supported by its “Four As of Access such as sponsorship of events, engagement with icies and takes measures to ensure its clini- to Medicine” approach. This aims to leverage healthcare professionals, etc. However, Merck cal trials are conducted ethically. Its policies the company’s core competencies and expertise KGaA does not provide information about its are strong: they include measures on scientific across the health value chain. For Merck KGaA, marketing activities or the payments it makes to requirements, research protocols and post-trial the four As refer to the availability, affordability, patient and physician organisations (or similar) provisions. accessibility and awareness of medicine. in countries within scope. Some transparency on access-related out- Achieving a degree of transparency in lobby- company upholds high standards of clinical trial comes. Merck KGaA is not transparent with ing activities. Merck KGaA states publicly that it

data transparency. Access to patient-level data is regards to all access-related information. The does not make financial contributions to hold- provided to scientific researchers upon request company publishes on its website its commit- ers of or candidates for political office, political via the company’s own portal. Requests are pro- ments and objectives, but does not disclose parties or related organisations. It discloses its cessed by an internal committee and denied complete information and updates on overall memberships of industry associations, but does applications are sent for review by a panel performance. not provide information about the financial con- including independent members. other access-oriented terms are systematically included in its R&D partnerships. High transparency around clinical trials. The tributions it makes to those associations. It has a Mid-ranking performance on stakeholder conflict of interest policy. Innovation: signing

on to combat anti- microbial resistance. Merck KGaA signed engagement. The company takes a strategic approach to stakeholder engagement and is Multiple breaches of codes of conduct. Merck the Declaration by the Pharmaceutical, generally transparent with the related informa- KGaA has been found in breach of codes of con- Biotechnology and Diagnostics Industries on tion. Nevertheless, it does not provide informa- duct four times during the period of analysis. All Combating Antimicrobial Resistance in January tion on how its subsidiaries manage their local cases related to unethical marketing practices in 2016, thereby committing to investing in R&D stakeholder engagement activities. Among other countries out of the Index scope. that aims to meet public health needs. Dialogue Series, a platform for sharing inno- Audit system applies to third parties. Merck Shares intellectual property with several part- vation and best practices around barriers to KGaA conducts

audits as part of its general ners. Merck KGaA shares intellectual prop- access. review process. It checks the company’s facilities erty for malaria, TB and NTD research with sev- to ensure they comply. The audit programme eral partners, including the Drug for Neglected Innovation: scale up of pilot initiative. The also covers anti-corruption. It contractually Diseases Initiative, Medicines for Malaria Su-Swastha programme, identified by the Index requires third parties and their subcontrac- Venture, University of Yaoundé and University of as innovative in 2014, has been scaled up in the tors to follow compliance obligations, including Cape Town. past two years. The project aims to increase anti-bribery, labour standards and environmen- access to quality healthcare products at an tal regulations. activities, Merck KGaA hosts the Merck Access PRICING, MANUFACTURING & affordable price in rural India, and to address the DISTRIBUTION lack of healthcare

infrastructure in rural areas. RESEARCH & DEVELOPMENT Best practice: benchmarking access tar- RANK 2 RANK 6 SCORE 2.3 SCORE 3.4 Rises three places due to consistent perfor- gets. Merck KGaA is realigning all of its targets for its access initiatives to the Sustainable R&D commitments linked to public health mance. Merck KGaA rises three places from 9th Development Goals. rationale. Merck KGaA commits to innovat- It is one of the leaders in providing data on price ing internally and through external engagement points and volumes of sales (to demonstrate and collaboration. For infectious diseases, the implementation of pricing strategies) and per- company commits to addressing unmet needs forms well in filing to register products where in developing countries, according to defined they are needed. 94 Source: http://www.doksinet Access to Medicine Index 2016 Limited consideration of socio-economic fac- Evidence of anti-competitive behaviour. Merck

biologic manufacturing with network members tors. Merck KGaA has equitable pricing strate- KGaA has been fined by CADE, the Brazilian (including vaccine manufacturers in Bangladesh, gies for the same products as in 2014. The strat- competition regulator, for engaging in anti- Egypt and Vietnam). egies mainly cover hypertensive heart disease, competitive behaviour (preventing distributors ischaemic heart disease and diabetes. 11% of its from working with generic manufacturers). At Best practice: building capacity to help marketed products for high-burden diseases the time of analysis there was no record of an detect suspected falsified medicines. Through have pricing strategies that target priority coun- appeal being made. the Global Health Pharma Fund, Merck KGaA’s Minilabs initiative has provided over 700 low- tries, reaching 12% of the corresponding priority countries (disease-specific sub-sets of coun- Discloses patent statuses. Merck KGaA dis- cost, portable

laboratories (including donated tries with a particular need for access to relevant closes information about the statuses of the laboratories), and related training to healthcare products). The company considers the availabil- patents (including patent type and INN) it holds professionals in more than 90 countries around ity of public financing systems in its intra-coun- in countries in scope (for diseases in scope). the world to help control falsified medicines. try equitable pricing strategies, and only considers affordability for its inter-country equitable Best practice: Clarity in approach to pricing strategies. Intellectual Property. Merck KGaA indicates PRODUCT DONATIONS where it holds patents, where it will not file for RANK 6 SCORE 3.5 Mixed registration performance. Merck KGaA or enforce patents, it’s preparedness to license, has registration targets for products for a sub- in which disease area, and an indication of the Drops two positions. Merck

KGaA has dropped set of relevant diseases in a sub-set of low-in- terms. This clear approach gives confidence to from 4th to 6th position. It has one of the larg- come countries. It does not publish its crite- third parties. est structured donation programmes: the Merck Praziquantel Donation Programme. It has not ria for deciding where to register products, or started new programmes or made ad hoc dona- the actual registration status of its products. However, it has filed to register more than half CAPACITY BUILDING (80%) of its newest products in at least a few RANK 6 tions during the period of analysis. SCORE 2.8 Continues efforts to control schistosomia- priority countries (disease-specific sub-sets of countries with a particular need for access to Strong performance in meeting local capacity sis. Since 2007, Merck KGaA has supported relevant products). Many of these products were building needs. Merck KGaA has improved since the WHO in its efforts to control

schistosomia- first registered in 2008 or 2009. 2014. It is active in all areas measured by the sis in Africa. In 2012, the company renewed its Index and demonstrates key strengths in build- commitment, pledging to increase the number Consistent recall guidelines. Merck KGaA has ing R&D and manufacturing capacity. The com- of annually donated tablets of praziquantel globally consistent guidelines for issuing drug pany has several best practices, and targets local (Cesol®) to 250 million tablets. recalls in all countries relevant to the Index needs through many of its activities. Complies with WHO donations guidelines. where its products are available. Merck KGaA Strong in building R&D capacity. Merck KGaA Merck KGaA has policies and regulations in place has a relatively large number of partnerships that list the requirements and the process gov- Language, environmental and demographic with local research organisations to build R&D erning its donations.

It complies with WHO needs considered in brochures and packag- capacity in sub-Saharan Africa. Some partner- guidelines. ing. Merck KGaA adapts brochures and leaflets ships specifically address local needs, e.g, its to local languages so that local populations can malaria research programme with the University Monitoring is mainly the responsibility of part- understand important information. To address of Namibia to support governmental malaria ners. For its structured donation programme, hot and humid conditions, Merck KGaA uses blis- control programmes in southern Africa. the Merck Praziquantel Donation program, does not publish its drug recalls. Merck KGaA is not involved in distribution, mon- ter packs and is developing anti-tamper packaging, for example, to reduce the risk of children Active in building capacity outside the value itoring or reporting activities. WHO is respon- accidentally opening its products. chain. Merck KGaA’s philanthropic approach

sible for these activities, and performs impact aims for sustainable and measurable results, but assessments. does not clearly target local needs. In practice, PATENTS & LICENSING the company aims to fill local skills gaps out- Does not engage in emergency relief or human- RANK 5 side the pharmaceutical value chain, through itarian aid. Merck KGaA did not provide any rele- partnerships with the Indonesian and Philippine vant emergency relief or humanitarian aid dona- governments. tions during the period of analysis. It donated SCORE 2.5 Continuing strong performance. In 2014 Merck KGaA set a new bar for the transparency and seven Minilabs in African countries in 2015. clarity of its approach to IP management. This Best practice: approach to building capac- continues to earn Merck KGaA a place among ity in manufacturing. Merck KGaA applies a the higher ranking performers. single quality standard to all its manufacturers (in-house and third-party), facilitated

through Broad policy of not filing for or enforcing pat- an extensive global information-sharing system. ents. Merck KGaA has published lists of coun- The company provides an additional layer of tries where it promises not to file for or enforce support, expertise and regular training to local patents. This comprises 90% of countries within third-party plant managers through its Virtual the Index scope. Plant Team. Open to requests for non-exclusive licences. Best practice: supporting developing country While Merck KGaA does not yet engage in vaccine manufacturers. Merck KGaA has a part- non-exclusive voluntary licensing, it publicly nership with the Developing Countries Vaccine notes that it would welcome requests from qual- Manufacturers Network to support the net- ity manufacturers, focused on non-communica- work’s continuing education activities. The com- ble diseases. pany shares expertise on safety and quality in 95 Source: http://www.doksinet Access

to Medicine Index 2016 RA N K SCO R E 5 2.65 Merck & Co., Inc 7 (2014) Merck & Co., Inc is known as MSD outside the United States and Canada. Stock Exchange: XNYS • Ticker: MRK • HQ: Kenilworth, NJ, US • Employees: 68,000 Ranking by technical area Ranking by strategic pillar 5 R&D 2. 2 Pricing 2. 2 Patents 2. 5 Capacity 2. 9 Donations 3. 8 0 4 3 2 leader 1 2 3 4 5 average 0.5 2. 3 2.9 Compliance 2.8 4. 1 3.2 Management Commitments Transparency Performance Innovation 1 average 0 PERFORMANCE Merck & Co., Inc rises into the top 5 It has a strong approach relevant pipeline than the industry average, only a small pro- to access management and is among the most transpar- portion of which targets high-priority product gaps. Its equi- ent regarding marketing. It expands its engagement in licens- table pricing strategies take limited account of socio-eco- ing, including on access-oriented terms. In Capacity Building, nomic

factors, and it performs relatively poorly in terms of its its strengths are in supply chain management and in areas accountability for its sales agents’ pricing practices. Merck & beyond the pharmaceutical value chain, with many activities Co., Inc is in the top three in product donations, continuing its targeting local needs. However, it drops in R&D, with a smaller efforts to eliminate lymphatic filariasis and onchocerciasis. CHANGE SINCE 2014 • Has a leading strategy for stakeholder engagement, with defined processes for collecting Diagnostics Industries on Combating Antimicrobial Resistance. • Continues to build local capacity in multiple ways, with a notable improvement in R&D. views through local offices. • Still has relatively poor accountability for its • Has increased the transparency of its market- sales agents’ pricing practices. ing activities. • Reaches a comparatively wide target population with its ivermectin (Mectizan®) donation

programme. • Has not expanded its use of equitable pricing • Found twice since 2014 to have breached laws strategies. or codes relating to unethical behaviour. • Has agreed licences for paediatric formula• Has signed the Declaration by the Pharmaceutical, Biotechnology and tions of raltegravir (Isentress®), through the Medicines Patent Pool. OPPORTUNITIES Mitigate mark-ups in low- and middle-in- Expand strong approach to building R&D capac- Expand equitable pricing to more products. come countries. Merck & Co, Inc can improve ity. Merck & Co, Inc can expand its relatively Merck & Co., Inc can apply equitable pricing to its accountability for its sales agents’ pricing small-scale yet strong approach to addressing more products in low- and middle-income coun- practices. local R&D skills gaps through partnerships. It can tries, e.g, by implementing equitable pricing for undertake more partnerships in more locations the etonogestrel/ethinyl

estradiol vaginal ring where capacity building needs are identified. (NuvaRing®). Further expand approach to voluntary licensing. Merck & Co, Inc can expand its use of voluntary licensing as a mechanism for boosting Consider accessibility of products for non-com- the affordability and supply of key medicines in municable diseases during clinical stages of countries in scope. This could include expand- development. Merck & Co, Inc can put plans in ing licensing to adult formulations of raltegra- place (access provisions) to ensure new prod- vir (Isentress®). It can also assess the need for ucts for non-communicable diseases will be elbasvir/grazoprevir (Zepatier®) in countries accessible. It can set these plans while the prod- with high prevalence of hepatitis C virus (HCV) ucts are in late-stages of development. The genotype 1 or 4, with a view towards licensing. company can consider such access provisions both for collaborative as well as in-house R&D

projects. 96 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Sales by segment (2015) 1 ,389 MN 3 MN 3,324 MN USD 39,498 MN 34,782 MN Pharmaceutical Other revenues Animal Health Consumer Care In scope, has sales Sales by geographic area In scope, has no sales MN USD Not in scope SALES AND OPERATIONS 40,000 35,000 30,000 25,000 Merck & Co., Inc has three business segments: increased its focus on emerging markets and 20,000 Pharmaceuticals, Vaccines and Animal Health. has sales in 81 countries within the scope of the 1 5,000 The company’s core areas of focus are endocri- Index. 1 0,000 nology, oncology, infectious diseases and vac- 5,000 cines. In January 2015, the company acquired 0 Cubist Pharmaceuticals, a company specialised 2011* 2012* Rest of world in R&D for antibiotics for USD 9.5 bn In October Japan 2014, Merck & Co., Inc sold its Consumer Care business to Bayer for USD 14.2 bn It has 2013

Latin America 2014 2015 Asia-Pacific Europe/Middle East/Africa USA *Due to a change in company reporting practices, the numbers from 2011 and 2012 are incomparable with following reporting years. PORTFOLIO AND PIPELINE Products per disease category 3 Merck & Co., Inc has a mid-sized portfolio of vaccine (Vaxelis), and a combination of elbas- 50 products for diseases in scope, and a small vir and grazoprevir (Zepatier®) for chronic hep- pipeline of six R&D projects that address the atitis C. 7 17 3 needs of people in countries in scope. Its portfo- 50 lio includes six preventive vaccines and two vec- Merck & Co., Inc is developing medicines for dia- tor-control product. In non-communicable dis- betes, diarrhoeal diseases and HIV/AIDS, as well eases, Merck & Co., Inc focuses on diabetes and as a beta-lactamase inhibitor that combines rel- hypertensive and ischaemic heart disease. In ebactam with imipenem/cilastatin to treat com- communicable

diseases, it has a strong focus on plicated Gram-negative bacterial infections, and liver diseases, including HIV/AIDS and viral hep- a next-generation vaginal contraceptive ring, atitis. It has gained marketing authorisation for MK-8342B. A small portion of its pipeline targets Merck & Co., Inc’s portfolio targets all disease cat- several medicines since 2014, including a contra- high-priority product gaps with low commercial egories and includes six contraceptives. ceptive ring, a paediatric hexavalent combination incentive. Pipeline projects 1 7% 0 20 Communicable Non-communicable Neglected tropical Multiple categories Maternal and neonatal First-line treatments and essential medicines 1 7% 10 20 66% 30 40 13 50 In partnership, with access provisions (ap) 60 70 80 In partnership, w/o ap 90 100 Not in partnership 8 0 9 18 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other

Merck & Co., Inc is working with Samsung Bioepsis to develop insulin Over half of its medicine and vaccine portfolio is listed on the WHO EML glargine (Lantus®) for diabetes. The agreement includes sufficient supply and/or are first-line treatments: e.g, peginterferon alfa-2b (PegIntron®), commitments. ribavirin (Rebetrol®), efavirenz (Stocrin®) and boceprevir (Victrelis®). Pipeline by stage of development Innovative medicines and vaccines 2 CD Adaptive medicines and vaccines CD NTD NTD MNH MNH NCD NCD Multiple Multiple 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval There are several medicines in late-stage clinical development, including Merck & Co., Inc has two combinations in development: its next-generation bezlotoxumab for Clostridium difficile

infection (currently under review by vaginal contraceptive ring and a beta-lactamase inhibitor combined with imi- the FDA and EMA), and doravirine for the treatment of HIV-1 infections. penem/cilastatin for bacterial infections. 97 Source: http://www.doksinet Access to Medicine Index 2016 Merck & Co., Inc PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE former when it comes to the transparency of company commits to evaluating and responding MANAGEMENT its marketing activities. It was, however, found to the R&D needs of emerging markets. RANK 4 during the period of analysis to have breached Comprehensive policy to ensure clinical trials laws and codes relating to unethical behaviour. are conducted ethically. Merck & Co, Inc has SCORE 4.1 Rises one position. Merck & Co, Inc moves from policies and takes measures to ensure its clini- 5th to 4th place in this area. Once again, its over- Mixed performance on transparency of lob- cal trials are

conducted ethically. Its policies are all performance is good, with strengths across all bying activities. Merck & Co, Inc discloses its strong: they include measures governing the use areas of measurements, except innovation. policy positions related to access, in particu- of placebo controls, scientific requirements and lar, those related to the registration and com- research protocols. Access strategy aligned with corporate strat- mercialisation of its medicines. It does not make egy. Merck & Co, Inc’s access strategy covers political contributions in countries in scope. It High transparency around clinical trials. The five priority areas: (1) R&D, (2) manufacturing discloses its memberships of patient and other company upholds high standards of clinical trial and supply, (3) registration, (4) commercialisa- organisations, but provides no details regarding data transparency. Researchers can request tion and (5) community investment. Its access

financial support. The company does not pro- access to patient-level data via the company’s strategy is aligned with the company’s busi- vide any information about its conflict of inter- own portal. When the validity of a request is ness strategy: the ability to compete in all mar- est policy. uncertain, it is reviewed by an External Scientific kets is seen as key for the company’s long-term sustainability. Review Board. Subject of two settlements relating to unethical behaviour (not in countries of scope). Merck Innovation: signing on to combat antimi- Integrated, company-wide performance man- & Co., Inc was found during the period of analy- crobial resistance. Merck & Co, Inc signed agement system. Merck & Co, Inc has an inte- sis to have breached one civil law and one code the Declaration by the Pharmaceutical, grated performance management system that of conduct, both in the USA. These settlements Biotechnology and Diagnostics Industries on

measures progress toward its annual goals. The are related to unethical marketing activities and Combating Antimicrobial Resistance in January system tracks each employees’ progress toward one case of corruption. 2016, thereby committing to investing in R&D that aims to meet public health needs. their individual performance objectives. Merck & Co., Inc’s access strategy includes clear pri- Enforcement processes and disciplinary meas- orities, which have been translated into specific ures in place. The company has enforcement Clear policy on R&D collaborations. Merck & objectives, measures and targets. processes and disciplinary measures in place. It Co., Inc has a policy to ensure pro-access terms does not disclose whether disciplinary actions are included in a sub-set of its research con- Leader in stakeholder engagement. Merck & have been taken for non-compliance with corpo- tracts, focusing on product R&D for neglected Co., Inc has a

clear strategy for stakeholder rate policies. tropical diseases in Least Developed Countries. engagement that includes defined processes for collecting input from local stakeholders through Best Practice: transparency of marketing its local offices. The company is also trans- activities. Merck & Co, Inc is the only company PRICING, MANUFACTURING & parent with the public about its stakeholder to voluntarily publish the financial support it pro- DISTRIBUTION engagement. vides to patients’ organisations, medical socie- RANK 9 SCORE 2.2 ties and scientific organisations in some counEngages with local stakeholders via a volun- tries within scope. The information disclosed Drops three places as its peers overtake. Merck teering programme. One of the company’s sev- on its website includes the organisations, the & Co., Inc falls from 6th, as it takes limited eral stakeholder engagement initiatives, Merck & amounts, the dates of payment and the

projects account of socio-economic factors when setting Co., Inc’s Fellowship for Global Health is a three- for which the money was used. prices, and targets high-burden countries with equitable pricing to only a limited extent. It per- month, field-based volunteering programme forms relatively poorly when it comes to pro- designed to make use of the skills and talents of Merck & Co., Inc’s employees Employees RESEARCH & DEVELOPMENT viding pricing guidelines to sales agents. It does are assigned to non-profit organisations to help RANK 11 take some account of local needs to facilitate SCORE 2.2 rational use. improve health service delivery. In turn, employees gain insights from the field that can be used Decreased performance in R&D, with a smaller to improve the company’s ability to deliver inno- pipeline. Merck & Co, Inc drops three places in Mixed equitable pricing. Compared with in 2014, vative health solutions. R&D. Compared to peers,

it has a small pipeline, Merck & Co., Inc has not increased the number a low proportion of which targets high-priority of its products with equitable pricing strate- product gaps. Its change in rank is partly due to gies. Some of its products for high-burden dis- improved performances from peers. eases have pricing strategies that target some MARKET INFLUENCE & COMPLIANCE RANK 7 priority countries (diseases-specific sub-sets SCORE 2.3 R&D commitments linked to public health of countries with a particular need for access Rises 9 places, with a top performance in mar- rationale. Merck & Co, Inc has committed to to the product in question). Its pricing strate- keting transparency. Merck & Co, Inc rises from engaging in R&D for diseases that dispropor- gies cover a wide range of diseases, including 16th to 7th position. The company is a top per- tionately affect the poor. Where appropriate, the HIV/AIDS, hepatitis C and contraceptives, among 98

Source: http://www.doksinet Access to Medicine Index 2016 others. Many of its products with inter-coun- Limited support for the Doha Declaration. PRODUCT DONATIONS try equitable pricing strategies take socio-eco- Merck & Co., Inc publicly acknowledges and RANK 2 nomic factors into account, which may include endorses the Doha Declaration on the TRIPS disease burden or prevalence, unmet need, level agreement and public health, including the use Remains in 2nd place. Merck & Co, Inc holds of economic development or the state of the of compulsory licensing, though only in “extraor- second place. It has three ongoing structured local healthcare system. Its intra-country equi- dinary and limited” circumstances. donation programmes. Through its large-scale ivermectin (Mectizan®) programme for oncho- table pricing strategies consider factors such cerciasis and lymphatic filariasis (LF) it donated as affordability per group and the availability of public

financing. SCORE 3.8 CAPACITY BUILDING RANK 5 1.3 billion tablets during the period of analysis SCORE 2.9 Continues efforts to eliminate LF and control Tracks products during recalls. Merck & Co, Inc tracks the process of its recalls, including match- Strong capacity building performance over- onchocerciasis. Since 1987, Merck & Co, Inc ing the quantities of delivered, recovered and all, focusing on local needs. Merck & Co, Inc has been supporting WHO in the fight against destroyed product. is active in all areas of capacity building meas- onchocerciasis and LF. Its Merck Mectizan ured by the Index, demonstrating good perfor- Donation Programme contributes to the WHO Relatively poor performance in accountability mance in strengthening supply chains (includ- target of eliminating LF and controlling oncho- for sales agents’ pricing practices. Merck & Co, ing an innovative initiative) and capacity build- cerciasis in most countries, by 2020 and

2025, Inc.’s pricing guideline information is confidential ing outside the pharmaceutical value chain. The respectively. To achieve these goals, Merck & The company performs relatively poorly. company targets local needs through many of Co., Inc has committed to donating Mectizan® its activities. to all who need it for as long as necessary. action. Merck & Co, Inc commits to register- Leader in building capacity outside the value Helps prevent NTDs, going beyond the London ing products for a sub-set of diseases in some chain. Merck & Co, Inc has a very strong Declaration. With the Merck Afya Program, low-income countries, though it does not pro- approach to philanthropy: it targets local needs, Merck & Co., Inc contributes to the goal of erad- vide a timeframe. It publishes its criteria for aims for sustainable health system improve- icating rabies globally. Rabies is not included in deciding where to register its products, and ments and

includes monitoring and evaluation. The London Declaration on Neglected Tropical some data on where its products are regis- The company builds capacities outside the phar- Diseases. tered. It has filed to register more than half of its maceutical value chain, including in maternal and newest products (70%) in some priority coun- child health. Leader in registration, from commitment to Complies with external standards. Merck & Co, Inc. has published its approach to donations Its tries (disease-specific sub-sets of countries with a particular need for access to relevant Targets local R&D capacity building needs. policy on charitable product donations complies products). Several of these products were first Merck & Co., Inc has a number of short-term with WHO and PQMD guidelines. launched approximately 10 years ago. partnerships with local research organisations to build R&D capacity, focusing on sub-Saha- Undertakes regular audits. For ad hoc dona-

Adapts brochures and packaging materials to ran Africa (Tanzania and Cameroon). Notably, all tions, Merck & Co., Inc conducts on-site assess- a limited extent. Merck & Co, Inc provides evi- partnerships specifically address local needs. ments to ensure donated products are being handled appropriately at the first step of the dence that it adapts brochures and packaging materials to address language and literacy Less active in building manufacturing capac- donation supply chain. With its structured dona- needs, but not cultural, demographic or environ- ity. Merck & Co, Inc makes a general commit- tion programmes, Merck & Co., Inc requires mental needs. ment to building manufacturing capacity in shipping receipts, while monitoring and auditing countries in scope. It undertakes a number of are mainly the responsibility of its partners. The capacity building activities, including in-house company requires annual reports from partner PATENTS &

LICENSING (in Indonesia and China) and with third parties, organisations. RANK 4 in Brazil. SCORE 2.5 Involved in numerous emergency relief efforts. Rises from the lowest five to the top five. Best practice: Informed Push Model. Merck & Merck & Co., Inc made a wide range of ad hoc Merck & Co., Inc rises to 4th place, from 18th Co., Inc continues to work with partners to sup- donations, including of medicines for non-com- Its improved performance is connected to port the Informed Push Model, adapting com- municable diseases, and reaching more than 50 its expanded engagement in licensing with mercial distribution principles to improve last- countries. Its ad hoc donations are distributed the Medicines Patent Pool, and associated mile contraceptive distribution and stock man- through its partners AmeriCares, Direct Relief, improvements in licensing transparency and agement in Senegal. The company is partnering MAP International and Project HOPE.

access-orientation. with the Senegalese government to support the programme, which involves dedicated logistics Non-filing policy in low-income countries. professionals bringing products from regional Merck & Co., Inc has a public policy of not filing supply pharmacies to health centres, and collect- for patents in all Low Income Countries. To the ing stock data to continuously inform the next Index, it has also shared that this policy extends delivery cycle. to the Least Developed Countries. Innovation: strengthening supply chains in No disclosure of patent status. Merck & Co, Inc Nepal. In Nepal, Merck & Co, Inc has an inno- does not publish the status of its patents. vative partnership with locally-based NGO Possible focused on supply chain strengthen- Expanded engagement in licensing. Through ing. It is developing and implementing a digital the Medicines Patent Pool, Merck & Co., Inc has pharmaceutical supply chain management model agreed

licences for its paediatric formulations that aims to integrate with Nepal’s Electronic of raltegravir (Isentress®). These licences are Medical Record system to ensure replicability transparent, and include access-friendly terms. and sustainability. 99 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 6 2.58 Sanofi 8 (2014) Stock Exchange: XPAR • Ticker: SAN • HQ: Paris, France • Employees: 115,631 Ranking by technical area Ranking by strategic pillar 5 R&D 3. 2 Pricing 2. 4 Patents 0. 8 Capacity 2. 4 Donations 3. 2 0 4 3 2 1 leader 1 2 3 4 5 average average 0.8 2. 5 2.7 Compliance 2.9 3. 9 2.7 Management Commitments Transparency Performance Innovation 0 PERFORMANCE Sanofi rises two positions, following improvements in sev- ing, with more products with equitable pricing strategies. It eral areas. It takes a clear approach to access management, has recently agreed not to file for or enforce patent

rights in which includes exploring the link between climate change Least Developed Countries and low-income countries, and and health. It performs well in compliance, certifying its sales is actively working (via donations) toward the elimination of agents and auditing its operations according to risk. It has Human African Trypanosomiasis (HAT). In Capacity Building, expanded its relevant pipeline and is comparatively open with Sanofi has been outperformed by peers, despite maintaining regards to its clinical trial data. It improves in equitable pric- its performance overall. CHANGE SINCE 2014 • Innovates in the area of health and climate change, investigating and addressing health- • Has expanded equitable pricing to significantly more products. and access-related issues linked to climate change. • Has recently revised its donation policy to take account of additional stages of the donation process (last-mile delivery, safety and quality, • Has newly committed

to not filing for or etc.) enforcing patents in Least Developed • Is developing more relevant products, includ- Countries or low-income countries. ing several new fixed-dose combinations for treating TB and a paediatric formulation of primaquine for malaria. • Has launched a programme with the South African National Department of Health to improve the early detection and management • Has moved a greater proportion of its R&D of patients with concomitant diabetes and TB. projects from one stage of development to another than in the previous reporting period. OPPORTUNITIES Expand strong capacity building approach. by climate change: malaria, dengue, cholera, Continue to target known needs through inno- Sanofi can further improve its strong perfor- leishmaniasis and animal health. vative and adaptive R&D. Sanofi can continue to mance in capacity building in low- and middle-in- target defined, high-priority product R&D needs come countries: to target local

needs more stra- Consider equitable pricing and licensing more for low- and middle-income countries, including tegically, including in its ongoing programmes. broadly. Sanofi can consider using non-exclu- a range of product types and, in particular, lever- It can also share more information with relevant sive voluntary licensing to improve access to its aging its strengths in product adaptations. stakeholders (e.g, regulatory authorities and dis- products, including those still in development. tributors) to strengthen supply chains further. Likewise, it can extend equitable pricing to more Prioritise access to products on the WHO disease areas (e.g, diarrhoeal diseases, lower EML. Sanofi has the most products on the WHO Continue to develop work on climate change respiratory infections, ischaemic heart disease, Model Essential Medicines List (EML). It can and health. Sanofi is encouraged to continue stroke and hypertensive heart disease). Sanofi assess access

barriers to these products in all investigating the link between climate change is currently piloting equitable pricing in some of low- and middle-income countries that need and health. It can incorporate health needs these areas: it can commit to always consider- them. It can ensure their availability and afforda- linked to climate change in its R&D priorities, ing equitable pricing for products in these dis- bility, aligning with demand and the availability of and develop an appropriate implementation ease areas. alternative products in specific countries. strategy. It has already identified disease areas targeted by its products likely to be influenced 100 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Net sales by segment (2015) 4,743 MN EUR 34,542 MN 29,799 MN Pharmaceuticals Vaccines In scope, has sales Net sales by geographic region In scope, has no sales MN EUR Not in scope 30,000 25,000 SALES AND OPERATIONS

Ingelheim’s consumer healthcare business. 20,000 Sanofi consists of five business units: Vaccines Sanofi has sales in 96 countries in scope. (Sanofi Pasteur); Diabetes and Cardiovascular; Approximately one third of its sales are gener- General Medicines and Emerging Markets; ated in emerging markets. 1 5,000 1 0,000 Specialty Care; and Animal Health. The Specialty 5,000 Care unit is focused on: rare diseases, mul- 0 tiple sclerosis, oncology and immunology. 2011 2012 Rest of world In June 2016, Sanofi announced an assets 2013 Europe 2014 2015 North America swap with Boehringer Ingelheim, concerning Sanofi’s Animal Health division and Boehringer PORTFOLIO AND PIPELINE Products per disease category 19 Sanofi has the largest portfolio of relevant prod- Its pipeline focuses on medicines and vaccines ucts in the Index, with 157 products. It has a large for communicable diseases (nine diseases). It is pipeline of 28 R&D projects that address the

developing products for several NTDs and dia- needs of people in countries in scope. betes. Sanofi has a new project with the Bill and 53 157 Melinda Gates Foundation to explore the use of Sanofi’s portfolio includes medicines and preven- Micropellet technology to develop thermostable, tive vaccines, medical devices for diabetes, and cost-effective, novel combination vaccines. Over vector control products for communicable and half of Sanofi’s R&D projects target high-pri- neglected tropical diseases (NTDs). Its portfo- ority product gaps with low commercial incen- lio has a strong focus on diabetes and cardiovas- tive. Several of its products have been approved cular diseases. since 2014: e.g, Dengvaxia® gained regulatory Sanofi has the most medicines in its portfolio in approval in several countries in scope in 2015 the Index. It is most active in infectious diseases, (including in Brazil, Mexico and the Philippines). ischaemic heart disease and diabetes.

Pipeline projects 29% 0 20 1 9 Communicable Non-communicable Neglected tropical Multiple categories Maternal and neonatal First-line treatments and essential medicines 1 8% 10 75 30 64 53% 40 50 In partnership, with access provisions (ap) 60 70 80 In partnership, w/o ap 90 100 Not in partnership 10 0 20 40 60 31 80 First-line & on WHO Essential Medicines List 39 100 First-line only 120 140 On WHO-EML only Other Over half of Sanofi’s R&D partnerships include provisions to ensure access. A comparatively high proportion of Sanofi’s relevant products are listed on Fexinidazole, in phase III trials for HAT, will be part of its donation pro- the WHO EML and/or as first-line treatments: e.g, Shan5®, Menactra®, gramme with WHO. meglumine antimoniate (Glucantime®), and melarsoprol (Arsobal®). Pipeline by stage of development CD 2 NTD 2 Innovative medicines and vaccines 2 Adaptive medicines and vaccines 4 CD MNH MNH NCD NCD

Discovery 2 Multiple Multiple 0 2 5 NTD 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval Sanofi has several innovative vaccines in clinical development, including a tri- Sanofi’s pipeline focuses on product adaptations, including four projects to valent pneumococcal protein vaccine, an HIV/AIDS vaccine, an adjuvanted develop fixed-dose combinations for TB, and 2nd-generation vaccines for subunit TB vaccine and a Clostridium difficile vaccine. rabies and meningitis (to extend its use in infants up to 6 months old). 101 Source: http://www.doksinet Access to Medicine Index 2016 Sanofi PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE MARKET INFLUENCE & COMPLIANCE RESEARCH & DEVELOPMENT MANAGEMENT RANK 5 RANK 4 RANK 7 SCORE 2.5 SCORE 3.2 SCORE 3.9 Biggest riser in

the area, with advances in Rises five places into the top five. Sanofi rises Retains top ten position, staying firm in 7th transparency and compliance. Sanofi is the big- five places in this area. It has a larger relevant place. Sanofi retains its position, with a clear gest riser in this area, climbing 13 places into the pipeline than in 2014, and its policies for clinical approach to access management and an inves- top five. This is due to its above-average trans- trial conduct have improved, as has its openness tigation into the link between climate change parency and comprehensive compliance system. with clinical trial data. and health. Certification system for managing ethical mar- R&D commitments linked to public health Integrated approach to access spanning all keting practices. Sanofi’s marketing code is con- rationale. Sanofi commits to R&D targeting dis- stages of healthcare. Sanofi’s access approach sistent with industry standards. It has

developed eases in scope and has a clear R&D presence in aims to optimise patient outcomes, covering a certification system for regularly testing and relevant countries. The company’s R&D priorities prevention, detection, early diagnosis, treatment, updating the skills of its sales agents. The com- focus on unmet health needs, informed by the care and disease management. This approach pany discloses general information about its company’s teams in relevant countries. is designed to focus on innovation, affordability, marketing activities in some countries in scope, quality care and patient support and is fully inte- but provides no information about payments No policy for ensuring R&D partnerships pro- grated into the company business strategy. made to healthcare professionals. mote access. Sanofi does not commit to ensur- Transparent regarding access-related objec- Transparency of lobbying practices is limited. gets, affordable pricing strategies)

are systemat- tives and performance. The company publishes Sanofi discloses its policy positions on several ically included in its research partnerships. its access-related commitments, objectives and access-related topics, including counterfeit med- quantitative and qualitative targets, as well as icines and the Sustainable Development Goals. It High transparency in clinical trials. Sanofi its performance in access activities. It publishes states that political contributions are prohibited, upholds high standards of transparency regard- a dashboard tracking its progress against key unless expressly approved by the CEO, without ing its clinical trial data: including providing sci- access objectives. specifying whether or not they have occurred. entific researchers with access to patient-level The company provides a list of associations of data upon request, via clinicalstudydatarequest. Clear stakeholder engagement approach. which it is a member and discloses

financial con- com. Sanofi’s approach focuses on providing relia- tributions made. Its conflict of interest policy is ble information, building formalised dialogue not publicly available. ing access-oriented terms (e.g, registration tar- Innovation: signing on to combat antimicro- bial resistance. Sanofi signed the Declaration and consultation processes, and on forging partnerships for patient support and humanitarian Annual audits of high-risk third parties. The by the Pharmaceutical, Biotechnology aid programmes. Sanofi is transparent about its company conducts annual audits in its prior- and Diagnostics Industries on Combating stakeholder engagement activities, but does not ity markets and rotational audits in other coun- Antimicrobial Resistance in January 2016, publish its stakeholder selection process. tries sensitive to risk. External experts may be thereby committing to investing in R&D that used on specific tasks. For high-risk third parties, aims

to meet public health needs. Dedicated access award for employees. To Sanofi conducts an annual targeted evaluation of incentivise its staff, Sanofi organises biennial their CSR performance. Shares intellectual property with several partners. Sanofi shares intellectual property with CSR Awards to recognise high-impact accessto-healthcare programmes. Several criteria are Evidence of misconduct in marketing. Sanofi several partners in order to accelerate research used to identify the best programmes, such as: was found to have been the subject of settle- in TB, malaria and NTDs. Its partners include the level of innovation; added value for the stake- ments related to three breaches of codes of Drugs for Neglected Diseases initiative, WIPO holder; added value for Sanofi; sustainability and conduct during the period of analysis, for cases Re:Search, PreDiCT-TB, the Global Alliance for replicability. related to unethical marketing practices. TB Drug Development and

Cornell University. Innovation: exploration of link between Innovation: invoice management system to health and climate change. Sanofi’s starting track expenses. EASYDAY/EASYFOOD is a col- PRICING, MANUFACTURING & point is that climate change will have an impact laborative web-based project being piloted in DISTRIBUTION on health, especially in the most vulnerable China that aims to anticipate the risk of unethi- RANK 4 countries with weak infrastructure and weak cal behaviour in relation to events and dining resilience. The company has established an advi- expenses. The project includes a payment Rises four places due to improved equitable sory board, composed of international experts, and invoice management system to track the pricing. Sanofi moves from 8th into the top five, that regularly meets to discuss the topic and expenses of invitees attending promotional due to its improved performance in equitable inform company strategy. events. pricing,

and disclosure of volume-of-sales and SCORE 2.4 price-point information. 102 Source: http://www.doksinet Access to Medicine Index 2016 Equitable pricing for significantly more prod- ents in Least Developed Countries and low-in- No evidence of engagement in R&D capac- ucts. Sanofi has implemented equitable pricing come countries. ity building. Sanofi did not disclose any rele- for significantly more products than in 2014. Its vant partnerships with local universities or other equitable pricing strategies cover a wide range No transparency on patent status. Sanofi does public research organisations in countries in of diseases, including diabetes, malaria, schiz- not publish the status of its patents. scope to build R&D capacity. ophrenia and dengue, among others. Some (22%) of its products have pricing strategies Does not engage in licensing. Sanofi does not Best practice: training to strengthen supply that target priority countries (disease-specific

engage in non-exclusive voluntary licensing, and chains. Sanofi developed and piloted a supply sub-sets of countries with a particular need for has not stated whether it would consider doing chain management training programme for access to relevant products). Together, these so in the future. national medicine purchasing centres, scaled up in partnership with the African Association strategies reach just some (25%) corresponding priority countries. The company only considers Absence of competition-related breaches. of Essential Drugs National Purchasing Centres affordability in its inter-country equitable pric- Sanofi was not found to have been the sub- (ACAME). The programme has been rolled out ing strategies, overlooking other socio-economic ject of breaches, fines or judgements relating to in several countries, including Ghana and Sierra factors. However, it does consider the needs competition law during the period of analysis. Leone. of rural populations in its

intra-country equitaLimited transparency regarding its view of ble pricing. Doha Declaration. Sanofi makes no clear public PRODUCT DONATIONS Comprehensive product tracking for recalls. reference to the Doha Declaration on the TRIPS RANK 7 Sanofi has traceability systems in place for its agreement and public health, but acknowl- products at each step of the supply chain, which edges that, in a public health crisis or emer- Rises three positions. Sanofi moves from 10th allows products to be tracked. In the case of a gency, IP rights should not be a barrier to access to 7th position. Sanofi is involved in one WHO recall, its quality management department uses to medicine. donation programme for NTDs: targeting Human SCORE 3.2 African Trypanosomiasis (HAT). this system to follow up on the quantities of products that should be returned. Monitors prices but does not set pricing guide- CAPACITY BUILDING Continues to eliminate Human African RANK 8 Trypanosomiasis.

Sanofi has been support- SCORE 2.4 lines. Sanofi does not set pricing guidelines for ing WHO in its efforts to eliminate HAT. During its sales agents: its affiliates are responsible for Previously in the leading group, now outper- this Index period, Sanofi donated a combined defining the sales practices of regional agents formed in capacity building. Sanofi fell six total of 92,000 units of melarsoprol (Arsobal®), and distributors, and for monitoring them on a places, from 2nd. It is strong in building capac- pentamidine (Pentacarinat®), and eflornithine monthly basis. Sanofi monitors the prices set by ities outside the pharmaceutical value chain, (Ornidyl®). its own agents. where it focuses on local needs, and supply chain Mixed performance in registration. Sanofi com- management. Nevertheless, the company has Complies with WHO guidelines for dona- been outperformed by peers in 2016. tions. Sanofi disclosed its guidelines for donations, which are based on WHO

Guidelines for mits to registering products for a sub-set of relevant diseases in some low-income countries Leader in building capacity outside the value but provides no time-frame. In practice, it has chain. Sanofi’s approach to philanthropy, through filed to register all (100%) of its newest products the Sanofi Espoir Foundation, is strong: it works Monitoring is mainly the responsibility of part- in at least some priority countries (disease-spe- toward long-term change based on local needs, ners. Sanofi works with international organisa- cific sub-sets of countries with a particular need and includes impact measurement. The com- tions to make ad hoc donations. These organisa- for access to relevant products). These prod- pany builds capacities outside the pharmaceuti- tions conduct regular audits and send the results ucts were first launched between 1999 to 2016. cal value chain, focusing on NCDs (e.g, its Alerte to Sanofi. The organisations are responsible for

Sanofi has already registered products launched Santé partnership in Cameroon). monitoring, reporting and auditing. Sanofi does Medicine Donations. not directly conduct audits on its donation pro- in 2014 and 2016 in some priority countries. Strong in building manufacturing capacity. grams. For structured donation programmes Adapts brochures and packaging to limited Sanofi commits to assessing and building capac- Sanofi monitors and tracks the reception of extent. Sanofi adapts brochures and packaging ity in countries in scope for in-house manufac- donated products. materials to address language and environmen- turers. In practice, the company undertakes a rel- tal needs, but does not consider cultural, literacy atively large number of capacity building activ- Involved in numerous emergency relief efforts. or demographic needs. ities, including with third parties, in a range of Sanofi donated over 3 million boxes of med- countries in scope (e.g, Brazil, China and

India) icines and doses of vaccines in 11 countries during the period of analysis. The main desti- PATENTS & LICENSING Focus on Africa when strengthening pharma- nations of humanitarian aid included Nepal and RANK 16 covigilance systems. Sanofi has a relatively high India. In addition, Sanofi has provided humanitar- number of activities for building local pharma- ian aid to refugees in multiple countries. SCORE 0.8 Low ranking, but with a clearer stance. Sanofi covigilance capacity, focusing on Africa. For holds a low position in Patents & Licensing, with example, the company supports health workers no indication that it considers engaging in licens- from sub-Saharan African countries with weak ing, and low overall transparency. However, it pharmacovigilance systems to undertake fellow- has now disclosed a clearer stance on where it ships at WHO Collaborating Centres for pharma- promises not to file for or enforce its patents. covigilance in Morocco and

Ghana. Clarity over patents: will not file for or enforce patents in LDCs and LICs. Sanofi has not published its patenting strategy It has disclosed to the Index that it will not file for nor enforce pat- 103 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 7 2.53 AstraZeneca plc 15 (2014) Stock Exchange: XLON • Ticker: AZN • HQ: London, UK • Employees: 61,500 Ranking by technical area Ranking by strategic pillar 5 R&D 2. 6 Pricing 2. 2 Patents 2. 5 Capacity 3. 0 Donations 1 .8 0 4 3 2 1 leader 1 2 3 4 average 5 average 1 .6 2. 2 2.4 Compliance 2.8 4. 0 3.3 Management Commitments Transparency Performance Innovation 0 PERFORMANCE AstraZeneca is one of the biggest risers in 2016, climbing enforce patents or issue licences, and disclosing patent sta- eight positions into the top 10. It improves in multiple areas, tuses. It has several best and innovative practices: in pricing, including pricing, where it has

a new affordability-based patents and capacity building. In R&D, its relevant pipeline has pricing strategy. It has extensively expanded and updated grown, but with comparatively little movement and less col- its access strategy, which it operationalises, e.g, through laborative R&D based on pro-access terms. It has breached its Healthy Heart Africa programme. It takes a transparent civil laws and codes of conduct multiple times. It does not approach to IP management, disclosing how and where it will have a structured donation programme. CHANGE SINCE 2014 • Launched its Healthy Heart Africa programme, which aims to reach 10 million hypertensive • Provides volume-of-sales data for the first time. patients across Africa by 2025. countries. ucts in low- and middle-income countries. strategies than in 2014. • Improves in building manufacturing capacity, • Is developing more products: including medi- • Improves its accountability for its sales agents’

range of low-income countries, lower-middle income countries and upper-middle income • Still has no targets for registering new prod• Has more products with equitable pricing • Publicly commits to not file for patents in a where it undertakes a relatively large number cines for lower respiratory infections, asthma, of capacity building activities (mainly in India pricing practices, by providing pricing guide- chronic obstructive pulmonary disease and and China). lines for all local sales agents. diabetes. • Publishes the status of patents it holds in countries in scope. OPPORTUNITIES Monitor impact of Healthy Heart Africa pro- company to license a product targeting an NCD. management of asthma and chronic obstruc- gramme and expand to other regions. A first step would be to explicitly include NCD tive pulmonary disease (COPD). These belong AstraZeneca can evaluate the impact of its products in its commitment to licensing. to a therapeutic class listed on the

WHO Model hypertension-focused Healthy Heart Africa pro- Essential Medicines List (EML). The company gramme in Kenya and consider expanding it Further expand partnerships with academia for can also extend its policy to more priority coun- to other non-communicable diseases (NCDs) R&D capacity building. AstraZeneca can build tries (disease-specific sub-sets of countries with and countries/regions. It can use the lessons on its growing focus on academic partnerships in a particular need for access to relevant prod- learned from this programme to update its over- the UK to include public research organisations ucts): e.g, its equitable pricing strategy for all access strategy. in low- and middle-income countries. Such part- budesonide (Pulmicort®) can be expanded to nerships can be important for addressing local India, Bangladesh, Nigeria, and China. Broaden IP access strategy to include NCDs. research capacity gaps. Plan for access during R&D. AstraZeneca

can AstraZeneca can expand the reach of programmes such as Healthy Heart Africa by licens- Expand new equitable pricing strategy to consider appropriate access provisions for all ing products for NCDs. For Healthy Heart Africa, more products and countries. AstraZeneca of its relevant products while they are still in this could include ticagrelor (Brilinta®), a first- can apply its new affordability-based pricing the pipeline. This is important for key late-stage line option for preventing atherothrombotic policy to more key products: such as its selec- products, whether developed in-house or via events. This could make AstraZeneca the first tive beta-2-adrenoreceptor agonists, used in the research partnerships. 104 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Product sales by segment (2015) USD 23,641 MN Biopharmaceuticals In scope, has sales Product sales by geographic market In scope, has no sales MN USD Not in

scope SALES AND OPERATIONS 30,000 25,000 20,000 AstraZeneca has one business segment, biop- 1 5,000 harmaceuticals, with activities in five main areas: 1 0,000 respiratory disease; inflammation and autoimmunity; infection and neuroscience; oncology; 5,000 cardiovascular and metabolic diseases. At the 0 end of 2015, the company bought Takeda’s res- 2011 2012 2013 Asia/Africa/Australasia piratory business for USD 575 mn. AstraZeneca 2014 Europe 2015 Americas has sales in 67 countries in scope. PORTFOLIO AND PIPELINE Products per disease category 1 AstraZeneca has a mid-sized portfolio of rele- (Qtern®) for type 2 diabetes, the MEDI-550 vac- vant products, with 41 medicines and one pre- cine for preventing pandemic influenza, and cef- ventive vaccine, and a mid-sized pipeline of 16 tazidime/avibactam (Zavicefta®) for compli- R&D projects that address the needs of people cated Gram-negative bacterial infections. 5 42 in countries in scope. The

focus of its clinical pipeline reflects its The majority of medicines in AstraZeneca’s port- on-market portfolio: targeting lower respiratory folio target NCDs, with 18 medicines for hyper- infections, asthma, COPD and diabetes. It also tensive and ischaemic heart disease. It also has has discovery-stage projects targeting Chagas several medicines for diabetes, asthma and disease, leishmaniasis, dengue, lymphatic filaria- COPD. It has gained marketing authorization sis and onchocerciasis, which target high-priority AstraZeneca’s portfolio is heavily focused on from the European Medicines Agency for several product gaps with low commercial incentive. NCDs, which account for 86% of its total portfolio. 36 Communicable Non-communicable Multiple categories products since 2014: saxagliptin/dapagliflozin Pipeline projects First-line treatments and essential medicines 6% 25% 0 9 69% 10 20 30 40 50 In partnership, with access provisions (ap) 60 70 80 In

partnership, w/o ap 90 100 Not in partnership 5 12 0 16 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other AstraZeneca conducts R&D for neglected tropical diseases with partners 26 of AstraZeneca’s 42 products are on the WHO EML and/or are first- including the Liverpool School of Tropical Medicine and University College line treatments. Three for asthma and COPD are on the EML: budesonide London. The company is also part of the new NTD Drug Discovery Booster (Pulmicort®), terbutaline (Bricanyl®), formeterol (Oxis Turbuhaler®). Pipeline by stage of development Adaptive medicines and vaccines Innovative medicines and vaccines 3 CD NTD CD 3 NTD MNH MNH NCD 7 NCD Multiple Multiple 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40

45 50 55 Received Market Approval AstraZeneca focuses on developing innovative medicines. It is developing AstraZeneca has received EU-approval for ceftazidime-avibactam medicines targeting lower respiratory infections caused by Staphylococcus (Zavicefta®), a new combination antibiotic for Gram-negative bacterial aureus and respiratory syncytial virus, among others. infections. Phase III trial sites were conducted in high-burden countries 105 Source: http://www.doksinet Access to Medicine Index 2016 AstraZeneca plc PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE Not transparent about marketing practices in Commits to R&D that meets concrete public MANAGEMENT countries in scope. AstraZeneca’s ethical mar- health needs. AstraZeneca works with external RANK 5 keting code also applies to third parties, and the stakeholders to ensure the medicines it is devel- incentives it offers to sales staff are not linked to oping will fulfil unmet needs. The

company has Improvements across all areas make sales targets. Nevertheless, the company’s dis- also made specific commitments to conduct- AstraZeneca the biggest riser. AstraZeneca closure around its marketing programmes and ing R&D in China and Africa, in order to respond is the biggest riser in this area, climbing from related payments only meets minimum legal to the unique needs of people living in those 14th into the top five. It has improved in all areas requirements. regions. engagement integrated into its Healthy Heart Publishes policy positions but lacks transpar- Commitment to R&D partnerships, but no Africa programme. ency on lobbying. AstraZeneca has published its policy. AstraZeneca makes a clear commitment policy positions relating to compulsory licens- to making its intellectual property, compounds Access strategy aligned with corporate strat- ing, intellectual property, product counterfeit- and expertise available for free in a sub-set of

egy. AstraZeneca’s access strategy focuses on ing and pricing in emerging markets. It is also countries in scope. This includes for projects tar- product deployment, affordability and on remov- transparent regarding its memberships of indus- geting NTDs, TB and malaria. However, the com- ing healthcare barriers in low and middle-income try associations and about the board seats it pany has no clear policy for ensuring these fea- countries. This strategy is aligned with the com- holds. However, it does not disclose financial tures or other access-oriented terms are sys- pany’s core business strategy: access to health- contributions. tematically included in its R&D collaborations. sustainability framework, which is in turn inte- Enforcement processes in place, but little Takes measures to ensure clinical trials are grated within the corporate strategy. insight into disciplinary measures taken. The conducted ethically. AstraZeneca has policies company has

clearly-defined enforcement pro- in place and takes measures to ensure all its Healthy Heart Africa (HHA) programme newly cesses and disciplinary measures in place. in-house and outsourced clinical trials are con- launched. Initially launched in Kenya, Healthy Although it states that it has taken disciplinary ducted ethically. Heart Africa aims to reach 10 million hyperten- action following violations of its codes of con- sive patients across Africa by 2025: by estab- duct governing lobbying, corruption and market- Innovation: signing on to combat antimicro- lishing new partnerships; ensuring access to ing, it provides no further details. bial resistance. In January 2016, AstraZeneca SCORE 4.0 and has an innovative approach to stakeholder care is one of the five pillars of the company’s signed the Declaration by the Pharmaceutical, affordable anti-hypertensive medicines and serSolid risk-based audit system. AstraZeneca Biotechnology and Diagnostics Industries on

has an auditing system that uses a mixture Combating Antimicrobial Resistance, thereby Mature access management structures in place. of internal and external measures, such as committing to investing in R&D that aims to AstraZeneca is transparent about its targets and the Transparency International Corruption meet public health needs. about the progress it is making toward them. Perception Index. The scope of each audit is The company also has a dedicated incentive based on a market-specific risk assessment. In Sharing IP via the NTD Drug Discovery Booster. structure for encouraging senior management some cases, AstraZeneca audits its third parties. AstraZeneca shares intellectual property to sup- vices; and by developing local ownership. port the development of treatments for leish- to achieve access-related targets. Found in breach of civil laws and codes of con- maniasis and Chagas disease via the NTD Drug Innovation: approach to incorporating stake- duct

three times. AstraZeneca was found to Discovery Booster. In this project, funded by holder insights. As part of its HHA programme, have breached civil laws and codes of conduct the Global Health Innovative Technology Fund AstraZeneca has established a Global Advisory three times during the period of analysis. Among (GHIT) and established in 2015, six companies Board and Steering Committee that include others, it agreed to pay USD 46.5 mn in US, plus provide plates of compounds on a monthly basis both local and global stakeholders. These bodies interest, to resolve allegations that it underpaid to help the Drugs for Neglected Diseases initia- fulfil an advisory role, identifying and discussing rebates owed under the Medicaid Drug Rebate tive develop new leads. insights gathered, with the aim of improving the Program. programme. PRICING, MANUFACTURING & MARKET INFLUENCE & COMPLIANCE RANK 10 RESEARCH & DEVELOPMENT DISTRIBUTION RANK 10 RANK 8 SCORE 2.6

SCORE 2.2 SCORE 2.2 Falls three places. AstraZeneca is generally less Biggest riser in Pricing, Manufacturing & Drops three places due to breaches of corrup- active than in 2014: its relevant pipeline has Distribution. AstraZeneca rose 11 places from tion laws. AstraZeneca drops from 7th to 10th grown, but with comparatively little movement 19th in 2014 to 8th in 2016. This is mainly due to position. This is due to comparatively stronger and less collaborative R&D based on pro-access its innovative approach to equitable pricing and performances from peers. AstraZeneca was terms. Its rank also reflects changes in perfor- the implementation of this approach to products found in breach of civil laws and codes of con- mance among its peers. and countries in the scope of the Index. duct three times in the period of analysis. 106 Source: http://www.doksinet Access to Medicine Index 2016 Significant increase in products with equita- transparency, licensing

commitment and trade improvements, while monitoring and evaluat- ble pricing. Compared to 2014, AstraZeneca has policy. ing pre-defined objectives. The company’s focus significantly increased the number of its prod- areas include public health initiatives, increasing ucts with equitable pricing strategies, taking New public commitment not to file patents. disease awareness, health-related research, and affordability into account for products focused AstraZeneca publicly commits not to file for pat- addressing unmet health needs in under-served on hypertensive heart disease, ischaemic heart ents in a range of low-income countries, low- populations. disease and diabetes. However, only a third er-middle income countries and upper-middle (31%) of its products have pricing strategies that income countries that together cover 70% of Best practice: manufacturing capacity build- target some priority countries (disease-specific countries within the scope of the Index.

ing partnership in China. Rather than training individual manufacturers, AstraZeneca provides sub-sets of countries with a particular need for New commitment to licensing, with clear funding, training and other support to Tianjin exceptions. Although AstraZeneca has not yet University to fill local manufacturing skills gaps. Registration behaviour lags behind advances in licensed a product, it has now set out the situa- Via the university, the company’s expertise can pricing. AstraZeneca does not provide evidence tions where it would consider doing so. Its policy be shared more widely, to help improve manu- of disease-specific registration targets. It does excludes licences for products for non-commu- facturing safety standards at the industry level not publish where its products are registered or nicable diseases in lower-middle income coun- in China. the criteria it uses to decide when and where to tries, includes products on the WHO EML, and register its

products. The company has filed to permits supply to Least Developed Countries, Innovation: building capacity through Healthy register some (40%) of its newest products in low-income countries and lower-middle income Heart Africa. In 2014, AstraZeneca launched just a few (6%) priority countries (disease-spe- countries. its Healthy Heart Africa programme, targeting access to relevant products). hypertension in Kenya. The programme’s broad cific sub-sets of countries with a particular need for access to relevant products). While some Flexible acknowledgement of Doha. scope of capacity building activities is innovative, of these products were first launched more AstraZeneca publicly acknowledges and including working with the Ministry of Health to recently (between 2012 and 2014), most were endorses the Doha Declaration on the TRIPS develop national treatment guidelines, mobile- launched between 2000 and 2010. agreement and public health. It acknowledges based

training for health-workers, and targeted that countries have the right to determine what supply chain management support. Limited brochure & packaging adaptation to constitutes a public health emergency. Innovation: scale-up of Young Health facilitate products’ rational use. For its Healthy Heart Africa programme, in East African mar- Patent status disclosure. AstraZeneca pub- Programme. AstraZeneca has scaled up its kets, AstraZeneca has developed new artwork lishes the status of all patents it holds for high- Young Health Programme. The programme for felodipine (Plendil®), lisinopril (Zestril®) and need products in the high-burden countries focuses on preventing non-communicable dis- lisinopril/hydrochlorothiazide (Zestoretic®), measured by the Index, including publishing the ease among adolescents. Since 2014, it has been packs, to distinguish the HHA products from patent type. scaled up in India and expanded to Kenya. commercial products, which are

also for sale in Best practice: Clarity in approach to IP man- Kenya. agement. AstraZeneca clearly states the coun- PRODUCT DONATIONS Best practice: intra-country equitable pricing tries where it holds patents, where it will not file RANK 15 for ticagrelor. AstraZeneca’s intra-country equi- for patents, where it is prepared to license, and table pricing strategy for ticagrelor (Brilinta®) for which products, and gives an indication of Drops four places. AstraZeneca has dropped takes account of multiple socio-economic fac- the terms. four positions, from 11th to 15th. The company SCORE 1.8 is not active in any structured donation pro- tors (such as disease burden, public financing, grammes, but is active in ad hoc donations. inequality, supply chain mark-ups and patient awareness) to target specific population seg- CAPACITY BUILDING ments of three priority countries: India, China RANK 4 SCORE 3.0 Complies with external guidelines. All AstraZeneca donations

are covered within the and Brazil. This strategy is particularly important as ticagrelor is a first-line therapy in the preven- Active in all areas of capacity building, targets AstraZeneca Global Guidance Procedure and tion of atherothrombotic events, is on patent, local needs. AstraZeneca has improved its per- Guidance Community Investment. The com- and AstraZeneca is the only manufacturer. formance in capacity building. It is active in all pany’s guideline aligns with WHO and PQMD areas but demonstrates key strengths in building guidelines. Innovation: analysis of populations’ abilities manufacturing capacity and capacities beyond to pay. AstraZeneca has conducted an in-depth the pharmaceutical value chain. It takes an inno- Engages in monitoring and auditing. analysis of the abilities of different population vative approach, and targets local needs through AstraZeneca regularly audits its NGO partners, segments in a sub-set of countries to pay for many

activities. such as Americares, to ensure that they are com- its products. This has shaped its new pricing pliant with its regulations to ensure products are policy and will continue to do so in the future. Focus on Kenya for strengthening supply chains donated appropriately and as represented. The AstraZeneca has also created an Affordability and pharmacovigilance systems. AstraZeneca company also requires quarterly reports from Centre of Excellence and trains international focuses on Kenya, through its Healthy Heart partner organisations. staff on its new affordability approach. Africa programme, to build local supply chain management and pharmacovigilance capac- Involved in humanitarian aid programmes. ity. The company targets the capacity-build- AstraZeneca provided ad hoc donations for PATENTS & LICENSING ing needs of its NGO implementing partners humanitarian aid via its partner Americares, and RANK 6 through training and information sharing. in

response to natural crises such as typhoons in SCORE 2.5 the Philippines. Rises furthest due to clear new policies. Strong approach to philanthropy that meets AstraZeneca is the largest riser, climbing ten local needs. AstraZeneca’s approach to phil- places, due to a suite of new commitments and anthropic activities is very strong: it targets a clear public position on patent filing, patent local health needs, and is aimed at long-term 107 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 8 2.45 Gilead Sciences Inc. 5 (2014) Stock Exchange: XNAS • Ticker: GILD • HQ: Foster City, CA, US • Employees: approx. 8,000 Ranking by technical area Ranking by strategic pillar 5 R&D 1 .6 Pricing 2. 3 Patents 3. 4 Capacity 0. 9 Donations 2. 3 0 4 Leader 3 2 Leader 1 leader 1 2 3 4 5 average average 1 .3 3. 8 2.8 Compliance 2.2 3. 4 2.6 Management Commitments Transparency Performance Innovation 0 PERFORMANCE

Gilead drops to 8th place, despite being a leader in key areas, line is smaller than the industry average, and it lags in ensur- including in Patents & Licensing. It has pioneered the use of ing ethical clinical trial conduct and on clinical data transpar- non-exclusive voluntary licensing beyond HIV/AIDS, and its ency. It falls in pricing, despite leading in certain metrics It solid compliance processes protect it from breaching laws does not, for example, clearly make sales agents accounta- and regulations on unethical behaviour. Its new donation pro- ble or facilitate products’ rational use. Gilead has few capacity gramme aims to eliminate hepatitis C virus (HCV) in Georgia. building activities, focusing on manufacturing, and limited tar- Yet, in R&D, its performance remains low: its relevant pipe- geting of local gaps. CHANGE SINCE 2014 • Maintains a low level of transparency regarding its stakeholder engagement activities. • Has more products with

equitable pricing strategies than in 2014. • Has launched a new donation programme aimed at the elimination of hepatitis C in Georgia. • Maintains high standards of ethical behaviour: once again, it has not been found to • No longer provides volume-of-sales information. have breached laws or regulations relating to unethical behaviour. • Confirms its leadership in Patents & Licensing, having voluntarily agreed non-ex- • Maintains comparatively poor approaches for ensuring clinical trials are conducted ethically clusive licences for all on-patent products for high-burden communicable diseases. and for sharing clinical trial data. OPPORTUNITIES Expand into access strategies for non-com- Share results and lessons learned from dona- Expand training approach. Gilead can draw from municable diseases. Gilead can apply its access tion programme. Gilead’s donation programme its experience in compliance training to build approach for HIV/AIDS and hepatitis C prod-

for hepatitis C is the first to aim to eliminate capacities of third parties in more areas, taking ucts to its portfolio for non-communicable dis- this virus. As such, insight into its progress and local needs and capacity gaps into account. eases (NCDs) (e.g, ranolazine (Ranexa®), a sec- impact is particularly important to share. Gilead ond-line treatment for stable angina). This could can rigorously monitor and evaluate the drug Improve clinical trial transparency. Gilead lags help address the increasing burden of these con- donation programme it has initiated in Georgia, behind the industry in this area. It can ensure ditions in low- and middle-income countries. and then publish its results and lessons learned. its policy for clinical trial data transparency sets Expand licensing approach to more middle Ensure affordability of products world- col for publishing all results, regardless of out- income countries. Gilead can consider ways of wide. Gilead can expand

its consideration of come. The company can also introduce a mech- including more high-prevalence middle income socio-economic factors in its inter-country equi- anism for sharing anonymised patient-level data countries in the terms of its hepatitis C licens- table pricing strategies, to help ensure products with third parties. ing arrangements, through, for example, tiered are globally affordable for different populations. licensing policies. The company can mitigate the risk of mark-ups out a timeline for publishing results and a proto- on HIV/AIDS products by providing pricing guidelines to sales agents. 108 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Revenues by segment (2015) USD 32,639 MN Biopharmaceuticals In scope, has sales Revenues by geographic region In scope, has no sales MN USD Not in scope SALES AND OPERATIONS 30,000 25,000 20,000 Gilead is a biopharmaceutical company that Gilead markets products in 93

countries within operates through one segment: Human the scope of the Index. The company’s sales have Therapeutics. It focuses on HIV/AIDS, liver dis- grown steadily since 2014. 1 5,000 1 0,000 eases, haematology and oncology, inflamma- 5,000 tory and respiratory diseases and cardiovascu- 0 lar conditions. In 2015, the company announced 2011 2012 Rest of world the acquisition of EpiTherapeutics, a leader in 2013 Europe 2014 2015 USA epigenetics. PORTFOLIO AND PIPELINE Products per disease category 1 Gilead’s has a relatively small portfolio, with 17 everal of Gilead’s products have gained mar- medicines for diseases in scope. It has a rela- keting authorisation from the FDA since 2014, tively small pipeline, with 13 R&D projects, that including: elvitegravir/cobicistat/emtricitabine/ addresses the needs of people in countries in tenofovir alafenamide (Genvoya®) for HIV-1 scope. in 2015, and sofosbuvir/ledipasvir (Harvoni®) 2 17 for chronic

hepatitis C genotype 1, 4, 5 or 6 Its portfolio and pipeline are heavily focused on 14 infection. HIV/AIDS and viral hepatitis, which are the tar- Communicable gets of 14 of Gilead’s medicines. A relatively Multiple categories Non-communicable large proportion of Gilead’s pipeline targets high-priority product gaps with low commercial Gilead’s portfolio is heavily focused on HIV/AIDS incentive, for example fixed-dose combinations and viral hepatitis. Out of the 17 products in its (FDCs) for hepatitis C genotypes 4, 5 and 6. relevant portfolio, 14 target these diseases. Pipeline projects 8% 8% 0 First-line treatments and essential medicines 6 84% 10 20 30 40 50 In partnership, with access provisions (ap) 60 70 80 In partnership, w/o ap 90 100 Not in partnership 9 0 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other With Johnson & Johnson, Gilead is developing two

fixed-dose combinations Approximately half its products are on the WHO EML and/or are first-line: for HIV/AIDS. Whether they can be produced under Gilead’s licensing agree- e.g, sofosbuvir (Sovaldi®), tenofovir disoproxil fumarate (Viread®), and efa- ments will depend on the patent status of the regimens’ other compounds. virenz/emtricitabine/tenofovir disproxil fumarate (Atripla®). Pipeline by stage of development Adaptive medicines and vaccines Innovative medicines and vaccines 3 CD 5 CD NTD NTD MNH MNH NCD NCD Multiple Multiple 0 Discovery 4 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 40 Phase III 45 50 55 Received Market Approval Gilead has several innovative medicines in clinical development, targeting Gilead’s pipeline includes fixed-dose combinations for HIV/AIDS and hepa- hepatitis B virus (HBV),

HIV/AIDS and chronic obstructive pulmonary disease titis C. In January 2016, it applied to the FDA for the approval of tenofovir (COPD). Presatovir, targeting respiratory syncytial virus, is in phase II trials alafenamide as a once-daily treatment for chronic HBV. 109 Source: http://www.doksinet Access to Medicine Index 2016 Gilead Sciences Inc. PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE related to the responsible use of intellectual Lags behind in clinical trial data transparency. MANAGEMENT property, and trade issues. The company also Gilead has no policy on publishing clinical trial RANK 12 states that it makes no political contributions results within a given timeframe, nor of publish- in countries in scope. In the company’s Code of ing trial results regardless of outcome. It is the Drops out of top 10, as peers overtake. Gilead Ethics, Gilead discloses the details of its policy only company in the industry that does not have falls three

places, despite having a range of for managing conflicts of interest. a systematic mechanism for providing scientific SCORE 3.4 access initiatives and a solid performance man- researchers with access to anonymised patient- agement system. It does not publish information No breaches of laws or codes of conduct gov- related to its stakeholder engagement activities. erning ethical behaviour. As in 2014, Gilead has level data on request. not been the subject of any settlements for Does not share intellectual property. The com- Multiple access approaches. Gilead uses a series criminal, civil or regulatory infractions relating to pany did not provide evidence of sharing intel- of approaches to improve access to medicine, unethical marketing or corruption anywhere in lectual property with research institutions or such as pricing, generic licensing, health systems the world during the period of analysis. neglected-disease drug-discovery initiatives. strengthening,

registration and partnerships with NGOs and in R&D. Business Conduct team dedicated to managing ethical behaviour and access. Gilead’s PRICING, MANUFACTURING & Above average measuring and reporting on access-to-medicine group has its own dedicated DISTRIBUTION access outcomes. Gilead is transparent about its Business Conduct team that covers interactions RANK 7 access-related commitments, targets and per- in Latin America, Africa, Asia and the Pacific. All formance measurements. It has a centralised employees must undergo training in this respect Gilead drops six places, but remains among the performance management system with quar- and understand all the various elements of the leaders. Gilead falls from to 7th Although it per- terly reviews. The company has a broad strat- company’s business conduct manual. forms well in key areas, it does not perform con- SCORE 2.3 sistently across all dimensions, including equi- egy to incentivise employees to work

toward Innovation: compliance guidance and train- table pricing, setting pricing guidelines for sales ing for third parties. Gilead adopted a Regional agents or in facilitating products’ rational use. Low transparency on stakeholder engagement Business Partner Compliance Pocket Guide, It is less transparent than in 2014 about its vol- strategy and activities. Gilead has a clear stake- which addresses a range of interactions with umes of sales, which means there is little evi- holder engagement strategy, but does not pro- physicians and government officials. Gilead dence for the implementation of its pricing vide information regarding the stakeholder offers compliance training, featuring case-based strategies. Its inter-country equitable pricing engagement activities of its branch organisa- scenarios, to business partners across multi- strategies only consider a few socio-economic tions. Furthermore, the company does not pub- ple regions. In addition, Gilead has

developed an factors. lish information about its global stakeholder auditing programme for its partners. access-related goals, all financial in nature. Commits to registering products within a set engagement activities. timeframe. Gilead is the only company that MARKET INFLUENCE & COMPLIANCE RANK 1 RESEARCH & DEVELOPMENT commits to registering products for most of the RANK 16 diseases in scope (where it is active) in most SCORE 1.6 low-income and lower-middle income coun- SCORE 3.8 Continues to perform below par, particularly tries and within 12 months after gaining the first Leader in market influence and compliance. regarding trial data transparency and trial con- market approval. The company has filed to reg- Gilead once again ranks 1st in this area. It has a duct. Gilead’s relevant pipeline is smaller than ister half (50%) of its newest products in a few strong compliance system, including guidance the industry average, and it falls below indus-

priority countries (disease-specific sub-sets and contractual obligations to contractors. In an try standards for clinical trial conduct and clinical of countries with a particular need for access innovative move, the company has developed a data transparency. to relevant products). However, most of these compliance guide for third parties. products gained marketing authorisation quite Lack of clear strategies for operationalising recently: some only in 2015 and 2016. Mixed performance in ethical marketing and R&D commitments. The company has commit- anti-corruption. Gilead has an ethical marketing ted to conducting R&D for resource-limited set- Monitors prices and provides pricing guidelines code that also applies to third parties, but it has tings. However, it does not provide evidence for some products. Gilead monitors the selling no performance incentives other than sales tar- that it has measurable time-bound strategies for price and mark-ups of its

HIV/AIDS medicines in gets. Furthermore, Gilead does not disclose its ensuring its commitments are achieved. all applicable countries. For its hepatitis C prod- marketing activities and payments in countries ucts, the company sets pricing guidance for its within scope. The company is not a signatory to Poor measures to ensure clinical trials are con- the UN Global Compact. ducted ethically. Despite having policies in place sales agents via transfer prices. to ensure ethical clinical trial conduct, Gilead Consistent recall guidelines. Gilead has glob- Publicly discloses policy positions and con- does not provide evidence that it monitors clin- ally consistent guidelines for issuing drug recalls flict of interest policy. Gilead publishes its policy ical trial conduct or takes disciplinary action in all countries relevant to the Index where its positions related to access, in particular those when ethical violations occur. products are available. Gilead has not

recalled 110 Source: http://www.doksinet Access to Medicine Index 2016 a product for a relevant disease in a country in all of its hepatitis C portfolio. Notably, it did so Monitoring mainly the responsibility of part- scope during the period of analysis. It states that prior to registering the products. ners. Gilead contractually requires that donation it does make recall information publicly available. recipients have monitoring systems in place. The company receives regular reports on donated Does not adapt brochures or packaging to facil- CAPACITY BUILDING itate rational use. Gilead does not provide evi- RANK 18 products. SCORE 0.9 Donates generic HIV/AIDS medicines annu- dence that it adapts its brochures or packaging materials to address the needs of local popula- Limited focus on capacity building overall. ally. Gilead donates generic emtricitabine/teno- tions, e.g, in terms of language, literacy levels, Gilead’s performance drops in 2016. The com-

fovir disoproxil fumarate and efavirenz/emtric- environmental conditions, demographic or cul- pany builds manufacturing capacity in coun- itabine/tenofovir disoproxil fumarate each year tural needs. tries in scope, but with few activities in the other to Uganda Cares and HardtHaven (a Ghanaian areas measured by the Index (including R&D and orphanage for children who are HIV-positive). Targets countries with a high need for access. supply chain management). Its targeting of local Gilead purchases these products from Mylan. Most of Gilead’s products target most of the needs and capacity gaps is limited. Innovation: launched a hepatitis C donation countries with the highest need for access: it has the highest proportion of products (50%) Above average in building manufacturing programme. In April 2015, Gilead launched an with equitable pricing strategies that target the capacity. Gilead makes a general commitment innovative donation programme with the goal of

majority of priority countries (disease-specific to building manufacturing capacity in relevant eliminating hepatitis C virus in Georgia. The pro- sub-sets of countries with high need for access countries. In the period of analysis, the com- gramme includes universal screening and treat- to relevant products). Together, these strategies pany undertook a number of technology trans- ment, prevention and surveillance. The com- reach 77% of corresponding priority countries. fers with licensees for its HIV/AIDS and hepati- pany provided 5,000 free courses of sofosbu- They cover products for HIV/AIDS and hepatitis tis C medicines. vir (Sovaldi®) to the government of Georgia, and will provide 20,000 free courses of sofosbuvir/ C. Gilead now has more products with equitable pricing strategies than in 2014. Limited focus on strengthening pharmacovig- ledipasvir (Harvoni®) per year. ilance systems. Gilead routinely updates safety Best practice: high transparency of

products’ labels for its products in countries in scope. registration status. Gilead is the only company However, the company did not disclose vol- to publish the registration status of the major- untary safety data sharing with authorities, or ity of its products for high-burden diseases in external capacity building activities (such as full detail, including when and where the prod- training partnerships) to strengthen pharmacov- uct was filed for registration, and whether it has igilance systems in countries in scope. been approved. Below average in building capacity outside the value chain. Gilead’s philanthropic strategy is relPATENTS & LICENSING atively weak: it targets local needs but does not RANK 1 aim for measurable, sustainable objectives. The SCORE 3.4 company discloses one relevant initiative – HiVMaintains top rank in Patents & Licensing. This Link – to build HIV/AIDS treatment capacities in is due to its consistent approach to

supporting rural areas of Ethiopia and Uganda. affordability and supply of its patented portfolio through licensing, and to its innovative applica- Weak performance in building R&D and supply tion of licensing outside of the HIV/AIDS space. chain management capacity. Gilead did not disclose any relevant activities to build R&D capac- Continuing engagement in voluntary licens- ity or strengthen supply chains in countries in ing. Gilead continues to pursue a broad licens- scope during the period of analysis. ing approach for its patented in-scope products. Its licensing agreements include access-oriented terms, and cover a comparatively high number PRODUCT DONATIONS of middle income countries with high HIV/AIDS RANK 13 SCORE 2.3 or HCV prevalence. Gilead remains a mid-ranking company. It main Best practice: licensing all on-patent prod- tains its long-term donation programmes for vis- ucts in scope for high-burden diseases. Gilead ceral leishmaniasis and

HIV/AIDS, and in a new licenses all of its patented products for high-bur- programme to eliminate hepatitis C in Georgia. den communicable diseases, including agreements made bilaterally and via the Medicines Commits to supporting WHO’s leishmaniasis Patent Pool. It licenses products pre-registra- control program. Gilead committed to donating tion, publicly discloses the agreements, includes 380,000 vials of amphotericin B liposome for access-oriented terms, and includes a compara- injection (AmBisome®) over the next five years tively high number of middle-income countries for a WHO control programme for visceral leish- with high prevalences of the disease in question maniasis. Gilead’s donations to the programme (either HIV/AIDS or hepatitis C). started in 2011. Innovation: licensing beyond HIV/AIDS. Gilead Does not disclose its donation policy. Gilead has made the significant step of licensing prod- states that all its donations adhere to WHO ucts outside

of the HIV/AIDS space, to include Inter-Agency Guidelines. However, it did not dis- hepatitis C products. It has applied licensing to close its donation policies. 111 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 9 2.39 = AbbVie Inc. 9 (2014) Stock Exchange: XNYS • Ticker: ABBV • HQ: North Chicago, IL, US • Employees: approx. 28,000 Ranking by technical area Ranking by strategic pillar 5 R&D 3. 0 Pricing 2. 2 Patents 2. 1 Capacity 1 .7 Donations 2. 7 0 4 3 2 1 leader 1 2 3 4 5 average average 0.0 2. 2 2.9 Compliance 2.4 2. 9 2.4 Management Commitments Transparency Performance Innovation 0 PERFORMANCE AbbVie remains 9th. It has made positive moves: notably it ing and lobbying remains conservative. The company has has newly licensed HIV/AIDS products and increased its dona- been outperformed in other areas. It applies equitable pricing tions activities. Once again, it was not found to have breached

to more products than in 2014, only half target high-burden laws or regulations. Its performance in R&D remains strong, countries. AbbVie takes limited account of socio-economic including in IP-sharing and engagement in R&D partnerships. factors when setting prices for different groups within coun- Its performance is static in certain areas, such as in access tries. It is building pharmacovigilance capacity, mainly in Latin management, and its approach to transparency in market- America. CHANGE SINCE 2014 • Has implemented a new performance manage- • Has more products with equitable pricing ment system for governing its access-to-medi- strategies than in 2014, but still for limited cine activities. proportion of products. • Expands donation activity for respiratory distress in newborns to four countries. • Provides pharmacovigilance training to regu- • Has once again received no negative judgements concerning unethical behaviour. • Newly ties R&D

targets to the Sustainable Development Goals. • Improves its accountability for its sales agents’ pricing practices. lators and universities, with a focus on Latin America. • Licenses ritonavir/lopinavir (Kaletra®) for generic manufacture by multiple companies (via the Medicines Patent Pool). OPPORTUNITIES Introduce a structured approach to product Establish an overarching access strategy. Target local needs when building capacity. registration. A structured approach would AbbVie can further develop its access AbbVie can strengthen its identification and tar- entail setting clear registration targets within a approaches into a strategy and clearly align it geting of local skills gaps in low- and middle-in- fixed timeframe, tied to decision-making crite- with its corporate strategy. It can prioritise the come countries when engaging in capacity build- ria. This can help AbbVie ensure new products wider availability of high-need products for pop- ing (for

example, to increase local R&D capac- are brought to markets in low- and middle-in- ulations in need. This would require systemati- ity). The company can also demonstrate that it come countries as soon as possible upon leav- cally using more equitable pricing and reponsible has a clear process in place for mitigating con- ing the pipeline. It can also help ensure key, high- IP-management strategies. flicts of interest when building capacity outside need markets are not overlooked. The follow- the pharmaceutical value chain. ing products, for example, can be registered in Extend licensing activities. AbbVie can expand more high-need countries such as China and the geographic scope of licences agreed for for- Indonesia: combination ombitasvir/paritaprevir/ mulations of ritonavir (Kaletra®) in its licens- ritonavir (Technivie®) and dasabuvir/ombitas- ing activities. AbbVie can also use licensing to vir/paritaprevir+ritonavir (Viekira Pak®). increase access to

dasabuvir/ombitasvir/paritaprevir+ritonavir (Viekira Pak®). 112 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Net revenues by segment (2015) USD 22,859 MN Pharmaceutical Products In scope, has sales Net revenues by geographic area In scope, has no sales MN USD Not in scope 22,000 20,000 1 8,000 1 6,000 SALES AND OPERATIONS 1 4,000 1 2,000 AbbVie was established in 2013. It has one seg- In 2015, AbbVie completed the acquisition of ment, pharmaceutical products, with products Pharmacyclics, a haematological oncology com- for immunology, kidney disease, liver disease, pany, for approx. USD 208 bn 1 0,000 8,000 6,000 4,000 neuroscience, oncology and women’s health. 2,000 The company has sales in 81 countries in scope. 0 Approximately 20% of its sales are generated in 2011* Rest of world emerging and frontier markets. 2012* 2013 Japan Europe 2014 2015 North America *AbbVie Inc became an independent company on 1

January 2013. PORTFOLIO AND PIPELINE Products per disease category 2 AbbVie has a small portfolio of 10 products for The company is developing medicines that diseases in scope, and a mid-sized pipeline target five communicable diseases, four of 26 R&D projects that address the needs of Neglected Tropical Diseases (NTDs) and dia- people in countries in scope. betes. A large proportion of its pipeline targets 10 high-priority product gaps with low commerThe majority of AbbVie’s portfolio consists of cial incentive, including for malaria, viral hep- medicines for viral hepatitis, HIV/AIDS and epi- atitis and certain NTDs. Since 2014, several of lepsy. The company has gained five market AbbVie’s R&D projects have progressed along approvals since 2014: including, in Q4 2014, the pipeline. 6 2 Multiple categories Communicable Non-communicable FDA marketing authorization for dasabuvir (Exviera®) and ombitasvir/paritaprevir/ritona- AbbVie’s portfolio

focuses on communicable and vir (Technivie®), both for the treatment of hep- non-communicable diseases: the majority targets atitis C. HIV/AIDS, viral hepatitis and epilepsy. Pipeline projects First-line treatments and essential medicines 27% 0 27% 10 20 30 46% 40 50 In partnership, with access provisions (ap) 60 3 4 70 80 In partnership, w/o ap 90 100 Not in partnership 0 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other AbbVie is active in R&D collaborations. AbbVie has access-oriented terms 60% of the medicines in AbbVie’s portfolio are listed on the WHO EML and/ and conditions for a group of its R&D collaborations that target malaria and or as first-line treatments: e.g, clarithromycin (Biaxin®) and ombitasvir/pari- NTDs. taprevir/ritonavir (Technivie®). Pipeline by stage of development CD 2 2 NTD 5 3 Innovative medicines and vaccines 3 Adaptive medicines and

vaccines 2 4 CD NTD MNH MNH NCD NCD Multiple Multiple 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 40 Phase III 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval AbbVie’s relevant pipeline is focused on innovative medicines, with most pro- AbbVie’s paediatric oral powder formulation of ritonavir (Norvir®) for HIV/ jects in early stages of research. It has five viral hepatitis medicines in clinical AIDS was granted EU approval in 2015. It has several features intended to development, plus atrasentan for diabetic nephropathy. improve suitability for children, such as the elimination of alcohol. 113 Source: http://www.doksinet Access to Medicine Index 2016 AbbVie Inc. PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE Global Compact. AbbVie discloses only general ing by sharing expertise and compounds to sup- MANAGEMENT

information about its marketing programmes in port product R&D. RANK 17 low- and middle-income countries, and does not SCORE 2.9 specify payments made. Drops two places due to a lack of improvement Commitment to R&D partnerships, but no policy. AbbVie’s NTD Initiative has qualitative in access management. AbbVie moves from Lack of transparency regarding lobbying activ- R&D targets for NTDs that include providing 15th to 17th place. Its performance is average in ities. AbbVie discloses a list of trade associa- compounds for screening and technical exper- all areas of measurement. It is not transparent tions from around the world in which one of its tise to outside partners. However, it does not regarding its access targets, the performance of employees is a board member. Nevertheless, it report an official policy of ensuring access-ori- its access activities and its stakeholder engage- does not publish its policy positions on topics ented measures are

systematically included in its ment selection process. relevant to access to medicine, nor its policy to research partnerships. manage conflicts of interest. Takes strategic approaches to access but these Takes measures to ensure ethical clinical trial do not align with business strategy. Strategic Compliance with laws and codes. For the conduct. AbbVie has policies in place and takes approaches focus on, e.g, product registra- second consecutive Index, AbbVie has not been measures to ensure its in-house and outsourced tion, pricing, stakeholder engagement, patient the subject of any settlements for criminal, civil clinical trials are conducted ethically. assistance programmes, donations and R&D for or regulatory infractions relating to unethical NTDs. However, AbbVie has not specified how marketing or corruption anywhere in the world High transparency around clinical trials. AbbVie these components are connected, nor how they during the period of analysis.

maintains high clinical trial data transparency, including providing scientific researchers align with its business strategy. Strong disciplinary and enforcement systems. with access to patient-level data upon request. Has a centralised performance management AbbVie has strong procedures for holding all AbbVie manages requests for data in-house. system in place. AbbVie has assigned board- employees and business partners accountable Rejections based on scientific merit are for- level responsibility for access issues and has for their behaviour. If the company determines warded to an independent panel for review. implemented a centralised performance man- an employee has violated its code, laws, regu- agement system that measures the outputs, out- lations, policies or procedures, the employee is comes and impacts of its access-related activi- subject to remedial and/or disciplinary action, up PRICING, MANUFACTURING & ties. It does not disclose specific

access-related to and including termination of employment. DISTRIBUTION targets or whether they are being met. RANK 10 SCORE 2.2 Auditing system in place. The company has an Has stakeholder engagement strategy, but auditing system, but does not provide details Drops 8 places due to relatively poor pric- is not transparent. AbbVie has a stakeholder about its processes and whether these include ing and registration performance. AbbVie has engagement strategy and demonstrates how auditing third parties. equitable pricing strategies for more products than in 2014. However, it does not consider it incorporates input from local stakeholders. socio-economic factors when setting prices It also implements a stakeholder engagement programme, FutureFit, to ensure its employ- RESEARCH & DEVELOPMENT for different populations within a given coun- ees understand the needs and interests of their RANK 6 try. It also does not perform as well as the lead- SCORE 3.0 ers when it

comes to rapidly registering new company’s stakeholders. However, AbbVie does not publish details of the stakeholder groups it Drops two places but maintains strong perfor- products in high-burden countries, or to adapt- engages with, nor its process for selecting who mance. AbbVie’s drop in rank is explained by the ing its brochures and packaging to facilitate the to engage with. improved performance of its peers. It maintains rational use of its products. its strong level of engagement in collaborative R&D, and upholds high standards of clinical trial Modest increase in equitable pricing activ- MARKET INFLUENCE & COMPLIANCE conduct and data transparency. The company ity. Compared to 2014, AbbVie has more prod- RANK 8 has a mid-sized pipeline of projects intended to ucts with equitable pricing strategies: it now meet the needs of people in countries in scope. takes affordability into account when pric- Drops four places as a result of limited trans- A

large proportion of these target independently ing some hepatitis C products (in addition to parency. Overall, the company has a strong com- identified high-priority product gaps. products for HIV/AIDS, as in 2014). However, SCORE 2.2 pliance system, but its transparency around its only 20% of its products have equitable pricR&D commitments tied to clear targets. ing strategies that target priority countries (dis- AbbVie’s explicitly ties its R&D commitments to ease-specific sub-sets of countries with a par- Low transparency regarding ethical marketing external public health priorities, for example to ticular need for access to relevant products). and anti-corruption measures. AbbVie has a lim- Sustainable Development Goal 3. The company Together, they cover 50% of all corresponding ited marketing code and its sales staff are incen- has processes for goal-setting and monitoring priority countries. For its inter-country equitable tivised using sales targets

only, which may not and for evaluating progress toward its relevant pricing strategies, AbbVie considers either dis- be sufficient to curb unethical behaviour. The R&D commitments. It contributes to meeting ease burden or prevalence, as well as the state company is not a signatory of the United Nations the London Declaration targets by 2020, includ- of public financing systems. For its intra-coun- marketing and lobbying activities is limited. 114 Source: http://www.doksinet Access to Medicine Index 2016 try equitable pricing strategies, AbbVie only con- ritonavir containing Norvir® and Kaletra® in PRODUCT DONATIONS siders affordability for different population seg- an access-oriented manner (via the Medicines RANK 9 ments or payers. Patent Pool). This makes it the newest pharma- Limited insight into registration approach. SCORE 2.7 ceutical company to engage in non-exclusive vol- Rises four places. AbbVie moves from 13th to untary licensing. 9th

position. With four donation programmes, Abbvie has the second largest number of struc- AbbVie does not have disease-specific registration targets and does not publish products’ reg- Does not publish its policy positions on trade istration statuses or the decision-making crite- agreements. AbbVie does not disclose its policy ria it uses to file for registration. As a result, it is positions regarding the Doha Declaration on the Expands product donation activity. In 2015, uncertain to what extent the company registers TRIPS agreement and public health. AbbVie launched a new donation programme, tured donation programmes. in cooperation with Direct Relief, for beract- its products based on the need for access. ant (Survanta®), for respiratory distress in Newest products only registered in a few CAPACITY BUILDING newborns. It already donates this medicine in high-burden countries. AbbVie has filed to regis- RANK 12 Kosovo, in a programme with AmeriCares. Its SCORE

1.7 new programme aims to improve the survival ter a few of its recently launched products in all corresponding priority countries (disease-spe- No change in rank. AbbVie performs above rates of premature babies in Honduras, India, cific sub-sets of countries with a particular need average when it comes to strengthening phar- Jamaica, and Paraguay. for access to relevant products). However, most macovigilance systems and disclosed one of of these products were first marketed 15–20 the strongest commitments to reporting sus- Clear commitment to product donations. years ago. AbbVie has filed to register the two pected falsified medicines. Its performance in AbbVie has made a public commitment to sup- products launched since 2014 in only a few pri- other areas, however, is comparatively weak. It porting targeted product donations that build ority countries. does not have a clear focus on local needs when health system capacity, increase access to med- engaging in

capacity building. icine and strengthen health infrastructure. Consistent recall guidelines. AbbVie has glob- AbbVie also commits to adhering to a strict ally consistent guidelines for issuing drug recalls Among the leaders in strengthening pharma- Global Product Donations Policy, which aligns in all countries relevant to the Index where its covigilance systems. AbbVie voluntarily shares with WHO and PQMD guidelines. products are marketed. AbbVie has not recalled safety data with authorities upon request and a product for a relevant disease in a country in updates safety labels in countries in scope. The Improved monitoring of donations. AbbVie’s scope during the period of analysis but states company has a number of initiatives to build Global Product Donations Policy requires dona- that product recalls would be made public via its local pharmacovigilance capacity, focusing on tion partners to regularly report on whether company website. Latin America. donated

products reach target countries. AbbVie Widespread pricing monitoring and track- Strong information sharing to improve supply implemented and abide by appropriate policies ing. For its HIV/AIDS and hepatitis C products, chains. AbbVie commits to confirming sus- and procedure (set by WHO, the FDA, PDMA and AbbVie has systems for monitoring and tracking pected falsified medicines and reporting con- DEA). AbbVie regularly participates in third party prices in all countries. In certain markets, it also firmed cases in a timely manner, and shares audits of its donation partners. provides pricing guidance to distributors. other information to build supply chain manage- screens potential partners to ensure they have ment capacity in countries in scope. While the Makes ad hoc donations for disaster relief and Limited adaptations of its brochures and pack- company shares information, it does not under- in emergencies. Since 2014, AbbVie has donated aging. AbbVie does adapt

the brochures and take other supply chain strengthening activities products for disaster relief in response to the packaging for some of its HIV/AIDS and hepati- with local partners, such as training partnerships. 2015 Nepal earthquake and the 2014-2015 Ebola epidemic. tis C products, but only to address the language needs of patients in low- and middle-income Building R&D capacities in Brazil and countries. It does not provide any evidence that Bangladesh. AbbVie partners relatively rarely it takes literacy, environmental, demographic or with local research organisations. The company cultural needs into account. has partnerships to build R&D capacity in Brazil, focused on NTDs, and in Bangladesh, including for drug discovery and epidemiology. It does not PATENTS & LICENSING clearly commit to long-term partnerships or tar- RANK 8 geting local skills gaps. SCORE 2.1 Rises 9 places due to improved engagement in Limited evidence of mitigating conflict of

inter- licensing. AbbVie moves up from 17th position est in capacity building outside the value chain. to 8th due to its new engagement in pro-access AbbVie undertakes capacity building activities licensing (via the Medicines Patent Pool). It is outside the pharmaceutical value chain, focus- held back from rising further by its comparative ing on preterm newborn care, support and advo- lack of transparency regarding its approach to IP. cacy for patients living with hepatitis C and HIV/ AIDS, and health workforce training, but does Patent filing or enforcement policy unspecified. not clearly mitigate conflicts of interest. AbbVie does not specify its patenting policy in low income countries (i.e, where it commits not Weak approach to building manufacturing to file for or enforce patent rights). Neither does capacity. AbbVie does not have a clear strategy it publish the status of its patents. or process for building manufacturing capacity in response to local skills

gaps in countries Newly engages in non-exclusive licensing. in scope. It did not report any efforts to build AbbVie has agreed access-oriented licences local manufacturing capacity during the period for both paediatric and adult formulations of of analysis. 115 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 10 2.35 Novo Nordisk A/S 2 (2014) Stock Exchange: XCSE • Ticker: NOVOB • HQ: Bagsværd, Denmark • Employees: 41,122 Ranking by technical area Ranking by strategic pillar 5 R&D 1 .8 Pricing 2. 4 Patents 1 .2 Capacity 2. 5 Donations 2. 6 0 4 3 2 leader 1 2 3 4 5 average 0.5 2. 9 2.6 Compliance 2.3 4. 3 2.9 Management Commitments Transparency Performance Innovation 1 average 0 PERFORMANCE Novo Nordisk has fallen in this Index, yet remains in the top programme, which is limited in geographic and population ten. It maintains solid access management structures and scope. It now publishes the statuses

of its patents, but has yet compliance systems, but drops across other areas of meas- to agree a non-exclusive voluntary licence for one of its pat- urement. It has a small relevant pipeline, and engages little in ented products. In Capacity Building, the company no longer collaborative R&D. Its equitable pricing strategies only cover leads but remains strong overall. human insulin products, representing 27% of its portfolio for diseases in scope. Novo Nordisk has one structured donation CHANGE SINCE 2014 • Has leading access management structures in place, supported by two systems for tracking • Has improved its accountability for its sales agents’ pricing practices. and assessing access-related performance. 2 diabetes in urban areas. worldwide. ulations related to marketing and corruption since 2014. partnership programme designed to identify and address the root causes of the rise of type • Publishes information about all patents held • Has not been found

in breach of laws or reg- • Launched Cities Changing Diabetes in 2014, a • Expands Changing Diabetes in Children dona• Launched the No Empty Shelves partnership with PATH in 2014 to identify capacity gaps in • Has equitable pricing strategies for the same supply chain management for diabetes medi- human insulin products as in 2014 but has cines and technologies in low- and middle-in- updated its commitment to providing low- come countries. tion programme, enrolling five additional countries in 2016. priced human insulin, to include more countries and humanitarian organisations. OPPORTUNITIES Work with partners to address access con- Ensure sustainable access to insulin. In addi- second-line treatment for diabetes) to permit cerns for non-communicable diseases more tion to its pricing strategy for human insulin, generic medicine manufacturers to produce bio- broadly. Novo Nordisk can leverage its exper- Novo Nordisk can implement new measures to similars. This

can help address issues of afforda- tise in diabetes to support public and/or pri- support sustainable and affordable access to bility and supply. Considering the complexity of vate partners in strengthening care for different new diabetes treatments (including insulin ana- biosimilar production, the company can consider non-communicable diseases. logues) that are suitable for people in low- and additional technology transfer and support. middle-income countries. It can assess local Expand strong capacity building approach. needs per population segment when customis- Use stakeholder engagement to inform its Novo Nordisk can expand its capacity build- ing pricing. It can implement registration com- R&D priorities. Novo Nordisk can apply its exist- ing activities and target local needs and skills mitments to prioritise those markets where the ing model of engaging with health care profes- gaps more strategically (e.g, in its R&D partner- product is urgently

needed. sionals to ensure R&D priorities are based on ships in China and Iran). The company can also the needs of patients in low- and middle-income share information with local stakeholders to help Consider a company-wide approach to volun- countries. This includes ensuring specific access strengthen supply chains and pharmacovigilance tary licensing. Novo Nordisk can consider terms plans are in place for candidates currently in the systems. for voluntary licences of its patented innova- pipeline (e.g, for its candidate oral formulation tive diabetes products (e.g, long-acting ana- of insulin). logues such as insulin degludec (Tresiba®), a 116 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Net sales by segment (2015) 22,337 MN DKK 107,927 MN 85,590 MN Diabetes and obesity care Biopharmaceuticals In scope, has sales Net sales by geographic area In scope, has no sales MN DKK Not in scope 1 00,000 90,000 80,000 SALES

AND OPERATIONS 70,000 Novo Nordisk operates in two divisions: Diabetes 50,000 60,000 & Obesity Care, and Biopharmaceuticals. The 40,000 30,000 company is active in five product areas: diabe- 20,000 tes care, haemophilia, growth hormone therapy, 1 0,000 obesity and hormone replacement therapy. Novo 0 Nordisk has sales in 79 countries in scope, and 2011 2012 Rest of world over 20% of its sales come from emerging and 2013 China 2014 Japan/Korea 2015 Europe North America frontier markets. PORTFOLIO AND PIPELINE Products per disease category Novo Nordisk has the smallest relevant portfo- from the meglatidine therapeutic class. lio in the Index, with 11 medicines. It has a small The company is developing four medicines, all in pipeline of four R&D projects that address the phase I clinical trials. These include a long-acting needs of people in countries in scope. Its rele- basal insulin analogue for once-weekly dosing, vant portfolio and pipeline

focus exclusively on an appetite-regulating hormone peptide tyrosine diabetes. and a liver-preferential prandial insulin analogue. 11 The latter has progressed from discovery stage Nine of its 11 medicines are insulins, including to phase I trials since 2014. Non-communicable human insulin and insulin analogues. In 2015, its insulin degludec (Tresiba®) was approved for The company’s focus is on diabetes. It is not tar- use by the FDA. Its remaining two products are geting high-priority product gaps with low com- Novo Nordisk’s medicines all target diabetes: nine liraglutide (Victoza®), a glucagon-like peptide-1 mercial incentive, for diseases that disproportio- out of 11 are insulins and insulin analogues. receptor agonist, and repaglinide (Novonorm®), nately affect low- and middle-income countries. Pipeline projects First-line treatments and essential medicines 9 1 00% 0 10 20 30 40 50 In partnership, with access provisions (ap) 60 70 80 In

partnership, w/o ap 90 100 Not in partnership 0 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other Novo Nordisk’s relevant R&D projects are not being developed in Human insulin is Novo Nordisk’s only product on the WHO EML and/or listed partnership. as a first-line treatment. The company has two human insulins in its portfolio Pipeline by stage of development Innovative medicines and vaccines Adaptive medicines and vaccines CD CD NTD NTD MNH MNH NCD 4 NCD Multiple Multiple 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval Novo Nordisk’s pipeline focuses on innovative medicines. It is developing a Novo Nordisk is not currently adapting any products to meet the needs of daily oral insulin

tablet that will not require refrigeration, potentially improv- people living in low- or middle-income countries. ing access to insulin in settings without stable cold chains. 117 Source: http://www.doksinet Access to Medicine Index 2016 Novo Nordisk A/S PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE breaches of laws and regulations during the als to understand the hurdles to diabetes treat- MANAGEMENT period of analysis. Its transparency regarding ment. It does not provide evidence that it uses RANK 2 lobbying and marketing is above average. the insights gathered in order to base R&D strat- SCORE 4.3 egies on public-health and product needs. A leader, due to a strong strategy and sys- Goes beyond sales-linked incentives; has broad tems. Novo Nordisk once again performs well in marketing code. Novo Nordisk has a marketing Significant investment in R&D for diabetes. A this area, rising one place to 2nd. It has a strong code that also applies to

third parties. It rewards relatively high proportion of Novo Nordisk’s R&D access strategy, good performance management its sales agents for more than just sales, using investments are relevant to the Index. It pub- systems and an innovative initiative in govern- product availability and stock maintenance as lishes its investments into diabetes and obesity ance and stakeholder engagement. alternative performance metrics. Nevertheless, care (DKK 19,793 mn annually), approximately it does not disclose information about its mar- 90% of which is relevant to the Index. Access is integrated into corporate strategy, keting activities in countries in scope. at global and local levels. Globally, the com- No commitment to access-oriented R&D part- pany aims to reach 40mn people with diabetes Relatively high transparency regarding lobby- nerships. The company does not commit to by 2020. This target is included in the company’s ing. Novo Nordisk is transparent

about its lobby- ensuring access-oriented terms are system- annual strategic planning process. At the local ing activities and public policy positions. It states atically included in its research partnerships. level, Novo Nordisk assesses which of its activ- it does not make any political contribution in Neither does it publish the relevant terms and ities can be scaled up or adapted to increase countries in scope. It has a policy for mitigating conditions of its research collaborations. The their impact. conflicts of interest that is not publicly available. company has no relevant R&D partnerships nor Double performance management system. Auditing system in place. Novo Nordisk plans its Novo Nordisk uses two performance manage- audits based on an independent risk assessment, Takes measures to ensure clinical trials are ment systems to monitor and measure progress to ensure certain units are visited every year and conducted ethically. Novo Nordisk has poli-

towards access targets. The first is its Balanced that all units are visited every third year. Two to cies in place and takes measures to ensure its Scorecard, used for tracking the company’s three external audits of selected high-risk third in-house and outsourced clinical trials are con- goals, and the second is its People Performance parties are performed annually. ducted ethically. intellectual property sharing arrangements. Process system, for tracking employee targets. Compliance with laws and codes. As in 2014, High transparency around clinical trials. The Well-defined strategic stakeholder engage- Novo Nordisk has not been the subject of any company upholds high standards of clinical trial ment. Novo Nordisk has a strategic approach settlements for criminal, civil or regulatory data transparency, including providing scien- to stakeholder engagement. The process is infractions relating to unethical marketing or tific researchers access to patient-level data

well defined, making it easier for subsidiaries to corruption anywhere in the world during the upon request. Novo Nordisk has established an follow. The details are not publicly available period of analysis. independent, expert-review governing body to Innovation: governance and stakeholder Enforcement process applies to third parties. engagement approach. Cities Changing Novo Nordisk has an enforcement process in Diabetes is a cross-disciplinary and cross-sector place, including disciplinary measures. Sanctions PRICING, MANUFACTURING & partnership programme designed to identify and include re-training, counselling, oral warnings DISTRIBUTION address the root causes of the rise of type 2 dia- and dismissal. Termination clauses are in place in RANK 5 betes in urban areas including in Johannesburg, contracts with third parties. review such requests. Drops two places due to a static performance. Mexico City, Tianjin and Shanghai. It aims to sup- Novo Nordisk

falls from 3rd place as its static port the implementation of sustainable solutions in urban areas. SCORE 2.4 RESEARCH & DEVELOPMENT performance in equitable pricing is outper- RANK 15 formed by peers making improvements. SCORE 1.8 Best practice: benchmarking targets. Novo Nordisk is committed to systematically review- Drops in R&D, with a smaller pipeline for the Same products with equitable pricing. Novo ing its contribution to each of the 17 Sustainable poor. Novo Nordisk’s performance fell, largely Nordisk has equitable pricing strategies for the Development Goals, focusing on health and due to a decrease in the size of its adaptive pipe- same human insulin products as in 2014. It has improving the well-being and lives of patients. line that targets unmet medical or public health expanded its commitment to providing low- needs in countries in scope. The company was priced insulin: in 2017, it will guarantee a ceiling also overtaken by several peers

whose perfor- price of USD 4 per vial of human insulin in Least mance improved. Developed Countries. Some (27%) of its prod- MARKET INFLUENCE & COMPLIANCE RANK 2 ucts have pricing strategies that target prior- SCORE 2.9 Strong commitment to R&D for diabetes. One ity countries (disease-specific sub-sets of coun- Top performer in market influence and com- of Novo Nordisk’s strategic aims is to build and tries with a particular need for access to relevant pliance. Novo Nordisk is 2nd once again, with maintain a leading position in emerging mar- products). These strategies reach the majority a strong compliance system, and no confirmed kets. The company engages with profession- (70%) of corresponding priority countries. The 118 Source: http://www.doksinet Access to Medicine Index 2016 company currently only considers affordability Evidence of anti-competitive behaviour. During vant countries. It undertakes a number of capac- in its intra-country equitable

pricing strategies, the period of analysis Novo Nordisk reached a ity building activities, including permanently overlooking other socio-economic factors. settlement with the Michigan Federal court to attaching an in-house expert to a third-party settle an anti-trust action concerning repaglinide plant in India. Innovation: distribution project. In 2015, (Prandin®). At the time of analysis, there was no Novo Nordisk Business Area Africa (BAAF) ini- record of an appeal identified. PRODUCT DONATIONS tiated the BAAF Distribution Optimisation project to reduce the price to patients of its full dia- No public acknowledgement of the Doha betes portfolio and to work with distributors to Declaration. Novo Nordisk does not publicly optimise the supply chain. This is an important acknowledge the Doha Declaration, though it One of the biggest fallers. Novo Nordisk drops step as, even with Novo Nordisk’s ceiling price states that public health emergencies require to 10th

position. Novo Nordisk has one on-go- for Least Developed Countries, there are other exceptions to intellectual property rights in ing structured donation programme, with com- barriers along the distribution chain that can extraordinary circumstances. paratively limited geographic and population RANK 10 SCORE 2.6 coverage. increase the cost of insulin. Pricing guidelines for all local sales agents. CAPACITY BUILDING Continues to donate insulin for children. In Novo Nordisk provides guidelines on mar- RANK 7 2009, Novo Nordisk initiated its Changing SCORE 2.5 Diabetes in Children (CDiC) programme. It is gins and distributor fees. Additionally, it conducts a formal bi-annual internal audit on pric- Previous leader, now outperformed. Novo currently funded until the end of 2020, is imple- ing and pricing structures in all mid-sized and Nordisk fell six places, losing its leading position. mented in nine countries and provides insulin to large markets. Although Novo

Nordisk performed well, particu- 13,516 children. Five more countries were slated larly in capacity building outside the pharmaceu- to be enrolled in 2016. Leader in the area of registration. Novo tical value chain. It has been outperformed by Nordisk only commits to registering products peers. This is particularly the case with regard Complies with WHO guidelines for donations. for a sub-set of diseases in some lower-middle to sharing information with stakeholders to Novo Nordisk has internal guidelines for making income countries, but provides no timeframe. strengthen local supply chains and pharmacovig- emergency drug donations. These require adher- However, in practice, the company has filed to ilance systems. ence to WHO’s Guidelines for Drug Donations. majority of priority countries (disease-specific Leader in building capacity outside the value Tailored monitoring structure. Within its CDiC sub-sets of countries with a particular need for chain. Novo

Nordisk has a very strong approach programme, Novo Nordisk works with partners access to relevant products). The majority of to philanthropy, including targeting local needs, to ensure donated products are monitored and these products were launched over 10 years ago. through the World Diabetes Foundation. The that they reach intended users. As part of the company discloses a number of relevant initia- programme, each country has a system in place Consistent recall guidelines and public dis- tives for building locally-needed capacities out- for monitoring whether the donated insulin is closure of recalls. Novo Nordisk has consist- side the pharmaceutical value chain, focusing on administered to the intended users. Each system ent guidelines for issuing drug recalls in all coun- diabetes care. is tailored to the local setting. available. The company publicly discloses aggre- Building R&D capacity in China and Iran. Novo Makes ad hoc donations for emergency

relief. gate information on relevant recalls in its annual Nordisk has local partnerships for building dia- Since 2014, Novo Nordisk has donated insulin for report and is the only company to make any betes research capacity in Iran (with Tehran emergency relief. The company donated prod- public disclosure in this area. University of Medical Sciences), and China (with ucts during the 2014-2015 Ebola epidemic and the Chinese Academy of Sciences). Both part- the 2015 refugee crisis in Syria. register all (100%) of its newest products in the tries relevant to the Index where its products are Limited brochure & packaging adaptation for nerships are long-term, but it is not clear how rational use. Novo Nordisk provides evidence they target local skills gaps. of adapting brochure and packaging to address only language needs with the aim of facilitating Strengthening supply chains in sub-Saharan rational use by patients. Africa. Working in partnerships, Novo Nordisk is

actively strengthening local supply chains in countries in scope, particularly in sub-Saharan PATENTS & LICENSING Africa. However, the company did not demon- RANK 12 strate that it shares information with relevant SCORE 1.2 stakeholders to improve supply chain managePatent disclosure. Novo Nordisk publishes ment skills. information about the patent rights it holds. It indicates where the patent has been granted, Average performance in strengthening phar- whether extension has been applied for, and the macovigilance systems. Novo Nordisk has a patent number. number of activities for building local pharmacovigilance skills: including a partner- Public commitment not to file or enforce. Novo ship with the Bangladesh Ministry of Health to Nordisk has published a commitment not to improve capacity of the National Drug Control file for or enforce patents in Least Developed Laboratory. The company did not provide evi- Countries and low-income countries. dence that it

voluntarily shares safety data with relevant authorities. Lack of engagement in licensing. Novo Nordisk does not engage in non-exclusive voluntary Manufacturing capacity building receives least licensing of its patented products, and has made attention. Novo Nordisk makes a general com- no public offer to consider this. mitment to build manufacturing capacity in rele- 119 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 11 = 2.34 Eisai Co., Ltd 11 (2014) Stock Exchange: XTKS • Ticker: 4523 • HQ: Tokyo, Japan • Employees: 9,877 (consolidated) Ranking by technical area Ranking by strategic pillar 5 R&D 2. 6 Pricing 1 .7 Patents 1 .6 Capacity 1 .5 Donations 3. 5 0 4 3 2 1 leader 1 2 3 4 5 average average 0.0 2. 7 2.6 Compliance 2.4 3. 8 2.7 Management Commitments Transparency Performance Innovation 0 PERFORMANCE Eisai remains 11th. It improves modestly across all areas, but no disease-specific commitment

to registering new products is outperformed by peers. It is among the leaders in Market in countries in scope, nor does it use intra-country equitable Influence & Compliance, with no settlements relating to pricing for products in scope. Eisai has not licensed relevant unethical behaviour. It also improves in R&D, conducting a products, nor published patent statuses. Eisai’s donations for higher portion of relevant R&D through partnerships than lymphatic filariasis (LF) reach a significant number of benefi- any other. Many of these partnerships are based on terms for ciaries. It continues to build capacity in all areas of the value ensuring access. Eisai drops in pricing, however, as it makes chain, albeit through a relatively low number of activities. CHANGE SINCE 2014 • Maintains a comprehensive access-to-medicine strategy. • Has published its policy on clinical trial data • Continues to work toward the elimination transparency, and now provides

researchers of lymphatic filariasis through its donation with access to anonymised patient-level data. programme. • Takes a strong approach to stakeholder engagement, with a best-practice model • Has applied inter-country equitable pricing for creating insight through stakeholder strategies to more products than in 2014. interaction. • Commits to not enforcing its patents in Least • Has received no negative judgements concerning unethical behaviour. Developed Countries, low-income countries, or Low Human Development countries. OPPORTUNITIES Partner to build capacity in response to local Expand and strengthen R&D in partnership. in countries with high inequality and/or high out- needs. Eisai can build on its experience with Eisai can expand its collaborative R&D activities of-pocket spending (e.g, Afghanistan, Cambodia, partnerships in other areas (e.g, its best-prac- to more disease areas, building upon the strong Mexico, India). tice approach to

R&D collaborations) to expand public health rationale already informing its R&D and enhance its capacity building activities activities for neglected tropical diseases (NTDs), Expand pro-access approach to filing for and within the pharmaceutical value chain, by work- and recognising additional priorities set by global enforcing patents. Eisai can expand its pro-ac- ing with partners to understand and target local health stakeholders. The company can also cess approach to filing for and enforcing patents needs. ensure access-oriented terms are systematically in Least Developed Countries, low-income coun- included in its R&D partnership agreements. tries, or Low Human Development countries. Set registration targets for key diseases. Eisai Eisai can do this by publishing its approach to can set disease-level registration targets for Expand access approach to mental health prod- voluntary licensing and its use as a mechanism low- and middle-income

countries. This will ucts. Eisai can expand its approach for improv- to support affordability and supply. To comple- help ensure people in those countries gain early ing access to mental health products that are ment this approach, Eisai can publicly disclose access to high-need products. The company can needed in low and middle income countries the status of its patents, clearly showing where also register existing products in more countries (e.g, escitalopram (EsOK®), and amoxap- products are on and off patent, and when pat- with high burdens of disease. ine (Defanyl®)). The company can also imple- ents are due to expire. ment intra-country equitable pricing strategies 120 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Revenues by segment (2015) 1 6,1 62 MN JPY 547,923 MN 531 ,761 MN Pharmaceutical business Other business In scope, has sales Revenues by segments In scope, has no sales MN JPY Not in scope 500,000

450,000 400,000 SALES AND OPERATIONS 350,000 300,000 Eisai operates through two segments, with its Eisai currently has sales in 26 countries in the pharmaceuticals business offering prescrip- Index scope. However, sales are limited in coun- 200,000 tion pharmaceuticals, consumer healthcare and tries outside Japan and the US. 1 50,000 250,000 1 00,000 generic medicines. Eisai divested its diagnos- 50,000 tics business in November 2015. The compa- 0 ny’s focus areas are oncology and neuroscience, 2011* 2012* Rest of world including neurodegenerative and neurological 2013* China 2014 Japan 2015 Europe Americas disorders. *Due to a change in company reporting practices, numbers from 2011, 2012, 2013 and 2014 are incomparable. PORTFOLIO AND PIPELINE Products per disease category 1 Eisai has a small portfolio of relevant products, Compared with 2014, the company has a number of 12 medicines in total, and a mid-sized pipeline of new medicines in

development, targeting a of projects that address the needs of people in wide range of diseases: epilepsy; malaria; lym- countries in scope, with 14 R&D projects in total. phatic filariasis; onchocerciasis; Chagas disease; 1 12 and leishmaniasis. It also has projects targetThe majority of Eisai’s relevant medicines target ing influenza. Its projects for malaria and NTDs non-communicable diseases (NCDs). These are target high-priority product gaps with low com- mainly mental health conditions and neurological mercial incentive. 10 Communicable disorders: anxiety disorder; bipolar affective dis- Non-communicable Neglected tropical order; epilepsy; migraine; and unipolar depresEisai’s medicines target non-communicable dis- sive disorders. eases, mainly mental health conditions and neurological disorders, specifically epilepsy. 12 Pipeline projects First-line treatments and essential medicines 57% 0 29% 10 20 30 40 50 In partnership, with access

provisions (ap) 60 8 1 4% 70 80 In partnership, w/o ap 90 100 Not in partnership 0 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other Eisai has R&D partnerships in all its disease areas, except epilepsy. Many Three medicines, all off-patent, are listed on the WHO EML and/or as first- involve the Global Health Innovative Technology Fund (GHIT), which requires line treatments: valproate (Val.OK®), escitalopram (ESOK®) and diethyl- reasonable prices in low-income countries or royalty-free licences. carbamazine citrate (DEC). Pipeline by stage of development Adaptive medicines and vaccines Innovative medicines and vaccines CD 6 CD NTD 4 NTD MNH MNH NCD NCD Multiple Multiple 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45

50 55 Received Market Approval Eisai’s R&D focus is on innovative medicines. One of its medicines in clinical Eisai is collaborating to develop a fixed-dose combination (FDC) of benzni- development is the oral anti-malarial candidate compound SJ733, a non-ar- dazole and E1224 for Chagas disease. This project involves multiple access temisinin-based therapy with the potential to cure in a single dose. plans, including a no-profit, no-loss policy. 121 Source: http://www.doksinet Access to Medicine Index 2016 Eisai Co., Ltd PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE Mixed performance in ethical marketing and new in 2015. The company also shares intel- MANAGEMENT anti-corruption. Eisai has a marketing code of lectual property with partners such as the RANK 8 conduct with performance incentives linked to Wellcome Trust, Medicines for Malaria Venture, the number of patients reached and treated. Its Macrofilaricide Drug Accelerator and WIPO Remains

8th, with a best-practice stakeholder code also applies to third parties. Nevertheless, Re:Search. engagement model. It improves in all areas, and it does not disclose marketing activities in rele- has a best-practice stakeholder engagement vant countries, nor is it a signatory of the United No overarching policy for including access pro- programme. However, it does not rise in this Nations Global Compact. visions. Despite a strong performance in collab- SCORE 3.8 area because its peers have kept pace. orative R&D, Eisai does not commit to ensurSome transparency in lobbying activities. ing access-oriented terms are systematically Access strategy as a partnership model. Eisai’s Eisai has a section on its website dedicated to included in its research partnerships. access strategy is a partnership-based model publishing its policy positions, which include directed at improving the affordability, avail- Universal Health Coverage and anti-counterfeit- Best

Practice: collaborative R&D. Eisai’s ability and adoption of medicines. Along with ing. It is transparent about which organisations it World Health Initiative, established in 2012, pre- human healthcare and innovation, providing is a member of, but does not disclose the finan- sents a clear approach to engaging in prod- access is one of the company’s three corporate cial contributions it makes to these organisa- uct development partnerships. Compared to its guiding principles. The company sees its access tions. The company does not provide informa- peers, the company is conducting the highest approach as an opportunity to enter emerging tion on its conflict of interest policy. proportion of its R&D projects through partnerships, and a high proportion of these partner- markets. No negative judgements. Eisai has not been ships are based on terms for increasing access. Transparent on performance toward access the subject of any settlements for criminal,

targets. Eisai publishes information related to its civil or regulatory infractions relating to unethi- PRICING, MANUFACTURING & access-linked commitments, targets and perfor- cal marketing or corruption anywhere in the DISTRIBUTION mance on its website. Data is collected and ana- world during the period of analysis. The com- RANK 14 lysed through a centralised performance man- pany enforces an anti-bribery and anti-corrup- agement system. tion policy worldwide, but it is not clear whether Drops four places with limited registration or it also applies to third parties. pricing in high-need countries. Eisai falls four Incentives for access in place. Eisai provides SCORE 1.7 places from 10th, as its registration and pricing efforts are limited in countries with high burdens its employees with both financial and non-financial incentives to support performance rele- RESEARCH & DEVELOPMENT of disease. It does not implement intra-country vant to access. For

example, the Eisai Innovation RANK 8 equitable pricing in countries in scope. SCORE 2.6 Paper is a non-financial incentive: employees are offered the opportunity to write a paper pro- R&D commitments linked to public health. Eisai Modest increase in equitable pricing, but from moting access to medicine and to improve gen- is committed to treating diseases that impact low base. Compared to 2014, Eisai has increased eral awareness of access. low-income countries, through in-house projects the number of products with inter-country equi- and through product development partnerships. table pricing strategies. These are in the areas Best Practice: stakeholder engagement Eisai’s commitment to R&D for NTDs is informed of acute hepatitis B virus and epilepsy. Yet only model. Eisai implements a global “Socialisation, by a strong public health rationale, including con- a few (8%) of its products have pricing strate- Externalisation, Combination and

Internalisation sideration of resistance to and efficacy of cur- gies that target priority countries (disease-spe- (SECI)” model for creating new knowledge rent treatments, and priorities set by global cific sub-sets of countries with a particular need through interactive exchange between patients health stakeholders. for access to relevant products). Together, these and Eisai employees. It encourages all employees strategies reach just a few (4%) priority coun- around the world to use 1% of their total busi- Takes measures to ensure clinical trials are tries. Depending on the strategy, Eisai considers ness hours to interact with patients. The knowl- conducted ethically. Eisai has policies in place different socio-economic factors when setting edge acquired through this process is trans- and takes measures to ensure that its in-house prices, such as disease burden, public financing lated into pilots that are then implemented in and outsourced clinical trials are

conducted ethi- and healthcare systems and demand, supply and the business. cally. cost analyses. High transparency around clinical trials. The Pricing guidelines in place for most sales MARKET INFLUENCE & COMPLIANCE company upholds high standards of clinical trial agents. In most countries in scope where Eisai RANK 3 data transparency, including newly providing sci- conducts business, Eisai provides pricing guide- entific researchers access to patient-level data lines to local sales agents, including local affili- upon request, via clinicalstudydatarequest.com ates and third-party agents. The company moni- SCORE 2.7 Among the leaders in compliance. Eisai climbs three positions to 3rd. It performs strongly in tors prices in China, through an IT system. compliance, in part because it was not found, NTD Drug Discovery Booster. Eisai shares intel- during the period of analysis, to have been the lectual property for leishmaniasis and Chagas Consistent recall

guidelines. Eisai’s guidelines subject of settlements for unethical behaviour. disease via the NTD Drug Discovery Booster, for issuing drug recalls are consistent glob- 122 Source: http://www.doksinet Access to Medicine Index 2016 ally, and apply in all countries in scope where ily share safety data with authorities. The com- Regular audits. Eisai is one of the few com- its products are available. Eisai has not recalled pany has a small number of activities in Asia to panies undertaking regular audits and requir- a product for a disease in scope in a country in build local pharmacovigilance capacity. ing regular reporting on the distribution, stor- scope during the period of analysis. It does not have a policy to disclose recalls on its website. age, and administration of its structured donaNeglected tropical disease R&D capacity build- tion programme. ing. Eisai has a relatively small amount of partNo registration targets, no transparency nerships with local

research organisations to Eisai does not provide evidence of setting dis- build R&D capacity, focused on NTDs: with ease-specific registration targets. It does not Fiocruz in Brazil and the University of Khartoum publish where its products are registered or the in Sudan. It is not clear how the company targets criteria it uses to decide when and where to reg- local skills gaps through these partnerships. ister its products. The company has filed to register less than half (43%) of its newest products Focus on in-house manufacturing capacity in just a few priority countries (disease-specific building. Eisai’s commitment to assessing needs sub-sets of countries with a particular need for and building capacity in countries in scope is for access to relevant products). in-house manufacturers. The company undertakes a number of capacity building activities Language, literacy and environmental needs across Asia, including with third parties, but considered. Eisai

adapts the brochure and pack- focuses on strengthening in-house skills. aging of its DEC (diethylcarbamazine citrate) tablets to include information in local languages Weak performance in building capacity outside in Thailand, Myanmar, Indonesia and India. For the value chain. Eisai undertakes philanthropic the same product, it uses illustrations to ensure activities but does not disclose a clear philan- information can be understood by populations thropic strategy or relevant initiatives to build of varying literacy levels and addresses environ- capacities outside the pharmaceutical value mental needs by using blister packs. chain in response to local skills and infrastructure gaps in countries in scope of the Index. PATENTS & LICENSING RANK 9 SCORE 1.6 PRODUCT DONATIONS RANK 4 SCORE 3.5 Publicly commits to not enforcing patents. Eisai commits to not enforcing patents in Least One of the biggest risers. Eisai has risen from Developed Countries, low-income

countries, and 9th position to 4th. The company has increased Low Human Development Countries. its contribution to the lymphatic filariasis (LF) donation programme and is actively involved in No consideration of voluntary licensing. Eisai monitoring and auditing its programmes. does not engage in the non-exclusive voluntary licensing of its patented products, and has no Has one of the largest NTD donation pro- public stance detailing where and how it would grammes. Eisai is one of the companies reach- engage in licensing. ing the largest number of beneficiaries, with its donation programme for LF, carried out in coop- Clear positioning on IP policy. Eisai acknowl- eration with WHO. In this donation programme edges and endorses the Doha Declaration on the Eisai donates diethylcarbamazine citrate (DEC) TRIPS agreement and public health, and makes a and, as of last year, is involved in the delivery of public statement against the use of ever-green- LF test strips. ing

tactics to unfairly extend patent life. Complies with external standards. Eisai shares No disclosure of patent status. Eisai does not its donations approach publicly; it also states publish the status of its patents. that “All Product Provisions are carried out in accordance with the WHO Guidelines for Drug Donation”. CAPACITY BUILDING RANK 14 SCORE 1.5 Deploys diethylcarbamazine citrate (DEC) project managers. DEC project managers plan and Building capacity across the value chain, execute LF elimination activities in LF endemic through relatively few initiatives. Eisai builds countries throughout Asia, discussing with gov- capacity in all areas of the pharmaceutical value ernment officials as well as other relevant stake- chain, but has a relatively small number of activ- holders the ways in which to contribute to the ities and does not clearly focus on local needs. early realization of elimination from a local The company disclosed no relevant initiatives to

perspective. build capacity outside the value chain. Engages in ad hoc donation programmes in natStronger in strengthening pharmacovigilance ural disasters. Eisai provided emergency sup- systems, with a focus on Asia. Eisai demon- plies after natural disasters, including the 2014 strates that it updates safety labels for its prod- earthquake in China and cyclone Hudhud in India. ucts in countries in scope but does not voluntar- 123 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 12 2.03 Bayer AG 10 (2014) Stock Exchange: XFRA • Ticker: BAYN • HQ: Leverkusen, Germany • Employees: 116,800 Ranking by technical area Ranking by strategic pillar 5 Management 3. 6 Compliance 1 .7 R&D 2. 2 Pricing 2. 1 4 3 2 0. 5 3. 0 0 1 2 3 4 5 average average 0.5 Donations 1 leader 2.0 1 .7 2.5 Capacity 2.4 Patents Commitments Transparency Performance Innovation 0 PERFORMANCE Bayer falls two places, out of the top ten. Its

modest improve- ple, it is comparatively less transparent than in 2014 about its ments are frequently overshadowed by peers. It has made market influencing activities and compliance efforts. Its equi- some improvements in how it measures progress toward table pricing and product registration performance has not access-related goals, and has time-bound targets tied to its kept pace with peers. Bayer provides limited evidence that R&D commitment to addressing neglected tropical diseases. it takes a pro-access approach to IP management. Bayer is Bayer is comparatively active in strengthening pharmacovigi- engaged in large-scale structured donation programmes for lance systems. Elsewhere, however, it has dropped: for exam- Chagas disease and Human African Trypanosomiasis (HAT). CHANGE SINCE 2014 • Improves its measurements for tracking per- • Still does not publish its patenting approach. formance toward access targets, but it still lacks clear processes for

incorporating local • Is less active in building capacity beyond stakeholders’ perspectives in its access the pharmaceutical value chain and in local initiatives. manufacturing. • Has equitable pricing strategies for the same number of products as in 2014. • Continues to engage in donation programmes targeting Chagas disease and Human African Trypanosomiasis that cover all endemic • Has improved its accountability for its sales countries. agents’ pricing practices, by providing pricing guidelines for all local sales agents. OPPORTUNITIES Broaden access strategy beyond NTDs. engagement is crucial for understanding local would assert patent rights for current and future Bayer can broaden its access strategy beyond needs and for responding with suitable, sustain- products. To complement this approach, Bayer neglected tropical diseases (NTDs) to include able access strategies. can publicly disclose the status of its patents, ischaemic heart disease,

diabetes, lower respira- clearly showing where products are on and off tory infections and zoonotic diseases. In addi- Expand application of equitable pricing. Bayer tion, Bayer can review its pipeline to assess the can apply the intra-country equitable pricing relevance of its R&D projects for people in low- model that it uses for contraceptives to other Join efforts to combat antimicrobial resistance. and middle-income countries. For relevant pro- products (e.g, vector-control products, and for Bayer has three antibiotics on the WHO Model jects, it can put access plans in place before NTDs) and to a range of countries in scope. Essential Medicines List (EML) that are used in products gain approval. patent, and when patents are due to expire. clinical practice and are important for low-reGive a public position on filing for and enforcing source settings. The company can increase Develop an approach to local stakeholder patents. Bayer can develop and disclose a

public access to these medicines, while ensuring their engagement. Bayer can develop processes for position on the filing for and enforcement of responsible use. Bayer can join global efforts to selecting and engaging with local stakehold- patents. Thirteen other companies in the Index address antimicrobial resistance, for example by ers to help ensure local needs are addressed have already taken this step. This would help signing the Declaration by the Pharmaceutical, through its R&D, capacity building and access give drug procurement agencies and generic Biotechnology and Diagnostics Industries on management approaches. Local stakeholder manufacturers confidence about where Bayer Combating Antimicrobial Resistance. 124 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Sales by segment (2015) 1 ,1 01 MN 1 1 ,982 MN 1 5,308 MN EUR 46,324 MN 1 ,490 MN 6,076 MN 1 0,367 MN In scope, has sales Pharmaceuticals Animal

Health Consumer Health Covestro Crop Science Other Segments Sales by region In scope, has no sales MN EUR Not in scope SALES AND OPERATIONS 45,000 40,000 35,000 30,000 25,000 Bayer reorganised its corporate structure in portfolio of seeds and chemical and biological 2015. With the spin-off of Bayer MaterialScience pest management solutions, including products (Covestro), its new corporate structure com- for controlling and preventing vector-borne dis- prises three divisions (Pharmaceuticals, eases. In 2014, the company acquired Merck & Consumer Health and Crop Science) and its Co’s Consumer Care business for USD 14.2 bn Animal Health business unit. Its pharmaceuti- In 2016, Bayer signed a merger agreement with cals portfolio is focused on: cardiology, wom- Monsanto for USD 66 bn. Bayer has a broad geo- en’s healthcare, oncology, haematology, ophthal- graphic presence, covering 102 of the countries mology and radiology. CropScience has a broad in the

scope of the Index. 20,000 1 5,000 1 0,000 5,000 0 2011 2012 2013 2014 Latin America/Africa/Middle East Europe PORTFOLIO AND PIPELINE 2015 Asia/Pacific North America Products per disease category 5 5 Bayer has a mid-sized portfolio of 34 relevant Regarding its R&D pipeline, Bayer has a new products and a small pipeline of three R&D pro- R&D project to adapt emodepside for oncho- jects that address the needs of people in coun- cerciasis, and is working on two adaptations of tries in scope. nifurtimox (Lampit®) for Chagas disease. The 6 5 34 adaptations of nifurtimox have been in cliniIts portfolio consists of 27 medicines and con- cal development since at least 2014 (the previ- traceptives, and seven vector-control products ous Index), and clinical development of emodep- (all pesticides). Its vector-control products are side for use in humans began in December 2014. all registered for the prevention of malaria and/ Bayer’s R&D projects

target independently iden- or dengue. Bayer’s relevant medicine portfolio tified high-priority product gaps. 13 Communicable Non-communicable Neglected tropical Multiple categories Maternal and neonatal has a strong focus on contraceptive methods. Approximately one third of Bayer’s portfolio tar- The company is also active in infectious diseases, gets women’s health, mainly via contraceptives. hypertensive and ischaemic heart disease. Pipeline projects First-line treatments and essential medicines 33% 0 8 67% 10 20 30 40 50 In partnership, with access provisions (ap) 60 70 80 In partnership, w/o ap 90 100 Not in partnership 15 0 4 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other In December 2014, Bayer entered a product development partnership with A comparatively high proportion of Bayer’s relevant products are listed on the Drugs for Neglected Diseases initiative to

develop emodepside for use in the WHO EML and/or considered first-line treatments. These include the humans. Bayer has committed to providing this product at cost price contraceptives moxifloxacin (Avelox®) and nifurtimox (Lampit®). Pipeline by stage of development Adaptive medicines and vaccines Innovative medicines and vaccines CD CD NTD NTD MNH MNH NCD NCD Multiple Multiple 0 Discovery 2 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval Bayer is not developing any innovative products for diseases in scope for use Bayer is adapting its veterinary medicine emodepside to treat onchocerciasis in low- and middle-income countries. in humans. It is also adapting Lampit® for Chagas disease, developing a paediatric formulation and a shorter treatment regimen (to 60 and 30 days) 125

Source: http://www.doksinet Access to Medicine Index 2016 Bayer AG PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE access to medicine, in relation to access to Diseases initiative to develop emodepside for MANAGEMENT high-quality medicines and products and the use in humans, Bayer has committed to pro- RANK 11 development of sustainable health care systems. viding the product at cost price. However, it In addition, Bayer’s position supports the protec- does not commit to ensuring access-oriented Maintains position despite limited improve- tion of both the international patent system and terms are systematically included in its research ment. Bayer maintains its position, improving the its own intellectual property worldwide. It also partnerships. way it measures progress toward access-related discloses information about its liaison offices targets. However, at the local level, its stake- and their budgets in several cities worldwide. Takes measures to

ensure clinical trials are holder engagement activities are executed only Bayer does not publish its policy for preventing conducted ethically. Bayer has policies in place on an ad-hoc basis. conflicts of interest. and takes measures to ensure its in-house and Access activities are embedded in business Not transparent about breaches of laws and strategy. Bayer’s activities for improving access codes. Bayer did not provide any information Has system for sharing patient-level data, yet include sustainable and commercially-viable regarding its breaches of codes, regulations and disclosure is incomplete. Bayer’s has a policy of strategies, such as equitable pricing, patient-ac- laws and any consequent settlements. However, making clinical trial results available, but only for cess and assistance programmes, as well as sus- since 2014, the company was found to have approved drugs. This falls short of stakehold- tainable philanthropy and donation programmes.

breached codes of conduct five times for cases ers’ expectations that the results of all trials will The company states that providing access is an related to unethical marketing. be disclosed. Nevertheless, the company does SCORE 3.6 outsourced clinical trials are conducted ethically. essential part of its long-term licence to operate. provide scientific researchers with access to Makes no political contributions. Bayer states patient-level data upon request via clinicalstudy- Centralised performance management system that it does not make any donations or contribu- datarequest.com in place. Bayer uses a centralised system to col- tions of any kind to political parties, politicians or lect quantitative and qualitative data for tracking candidates for political office. It provides details Does not disclose terms of R&D partnerships. progress regarding access activities. This infor- of financial contributions made to industry asso- Bayer has a general position

to not disclose the mation is only partially disclosed. ciations during the period of analysis. terms and conditions of its R&D partnerships. Ad-hoc engagement with local stakeholders. Has enforcement processes and actively tracks laboration (for onchocerciasis) have been pub- Bayer has a clear and structured approach to compliance. The company has enforcement pro- lished by its partner, the Drugs for Neglected engaging with stakeholders at a regional and cesses and disciplinary measures in place. It does Diseases initiative: this makes the future acces- international level. However, it does not have a not report whether disciplinary measures have sibility of this product for populations in need specific approach for engaging with local stake- been taken during the period of analysis. Bayer more predictable. holders: these engagements are managed on a provides detailed information about its process case-by-case basis. for auditing compliance with its codes of

con- However, access plans for its emodepside col- duct: auditing activities take place following an PRICING, MANUFACTURING & annual audit plan, in addition to unannounced DISTRIBUTION MARKET INFLUENCE & COMPLIANCE ad-hoc audits. In 2015, the company performed RANK 11 RANK 14 198 audits. SCORE 1.7 SCORE 2.1 Drops seven places due to relatively poor perDrops six positions due to lower transparency. formance in equitable pricing and registration. Bayer’s transparency has fallen on several issues, RESEARCH & DEVELOPMENT Bayer falls out of the top five, into the bottom 10 relative to peers. However, it is one of the com- RANK 12 companies in 2016. This is due to a fall in its per- SCORE 2.2 panies that pledges not to make any political formance in equitable pricing and registration. contributions to political parties, politicians or Maintains mid-ranking position, with no signifi- Disappointingly, Bayer shows no evidence that candidates for

political office. cant improvements. Looking at Bayer’s relevant it has implemented the new differential pricing pipeline, it is the same size as in 2014, and the framework that it was piloting in 2014. Low performance in ethical marketing. While company maintained a mid-ranking performance Bayer’s marketing code of conduct is con- in R&D partnerships and IP-sharing. Limited consideration of socio-economic factors when setting prices. Bayer has the same sistent with industry standards, it does not enforce compliance of third-party sales agents. Committed to R&D for NTDs, with clear targets equitable pricing strategies as in 2014: all for Furthermore, Bayer only uses sales targets to set. Bayer commits to developing new products contraceptives. Some (8%) of its products have incentivise sales agents, rather than access- for NTDs. This includes applying for WHO pre- pricing strategies that target almost half of linked incentives. Bayer does not publish

infor- qualification for its adaptation of emodepside to the relevant priority countries (disease-spe- mation about marketing activities in countries treat onchocerciasis in humans by 2023. cific sub-sets of countries with a particular need within scope. for access to relevant products). However, its Measures in place to ensure R&D partnerships inter-country equitable pricing strategies only Some transparency on lobbying activities. promote access, but no clear policy. Within take affordability and no other socio-economic Bayer discloses its policy positions related to its collaboration with Drugs for Neglected factors into account. 126 Source: http://www.doksinet Access to Medicine Index 2016 Pricing guidelines for all sales agents. Bayer CAPACITY BUILDING (Germanin®) for Rhodesian-type HAT. These has provided pricing guidelines to all of its local RANK 13 programmes cover all endemic countries. They SCORE 1.7 sales agents (third party wholesalers and

dis- provided treatments for over ten thousand tributors) and has internal controlling systems in Strength in building pharmacovigilance capac- place to monitor the implementation of its pric- ity outweighed by poor performance else- ing policies. where. Bayer demonstrates a relatively strong Committed to supporting WHO for HAT and approach to strengthening pharmacovigilance Chagas disease. Since 2004, Bayer has com- Very low transparency regarding product reg- systems but is comparatively weak in other mitted to supporting WHO in its battle against istrations. Bayer has registration targets for areas, particularly in building capacities beyond Human African Trypanosomiasis (HAT) and a sub-set of relevant diseases in a sub-set of the pharmaceutical value chain and in manu- Chagas disease. Under its current supply agree- low-income countries. But it has not committed facturing. It does not consistently target local ment, Bayer provides a million Lampit® tablets

to registering new products within a set time- needs. annually. where it has filed to register its newest products Strongest area is in pharmacovigilance capac- Close collaboration with WHO for monitoring. for sale. In addition, it does not publish its cri- ity building. Bayer voluntarily shares safety Bayer donates products via WHO pre-selected teria for deciding where or when to register its data with authorities upon request and updates partners, who then report to Bayer. Reporting products. safety labels in relevant countries. It has a intervals are agreed before a donation is carried number of diverse activities for strengthening out. The company conducts external interviews Consistent recall guidelines. Bayer has glob- local pharmacovigilance systems, including an and discussions with partners. ally consistent guidelines for issuing drug recalls innovative initiative in this area (see below). people during the period of analysis. frame. In practice, Bayer

provides no details on Makes ad hoc donations for disaster relief and in all countries relevant to the Index where its products are available. Bayer does not publish Builds local manufacturing capacity, but only in emergencies. Since 2014, Bayer made 69 sep- whether it has issued recalls. in-house. Bayer makes a general commitment arate ad hoc donations for disaster relief and to build manufacturing capacity in countries in public health emergencies, including following Adaptations of brochures and packaging to scope. The company undertakes a small number the 2016 Nepal earthquake and 2014-2015 Ebola address range of needs. Bayer facilitates the of capacity building activities in a range of rel- epidemic. rational use of its products by providing instruc- evant countries (including Brazil, China, India tions in locally prevalent languages, by using pic- and Indonesia), but these are only directed at tograms for populations with low literacy levels in-house staff.

These activities focus on the and by using blister packs to improve product industry standards for Good Manufacturing stability in hot and humid conditions. Practices (GMP). Weak performance in building health-related PATENTS & LICENSING capacity outside the pharmaceutical value RANK 18 chain. Bayer’s approach to health-related phil- SCORE 0.5 anthropic projects is relatively weak: it includes Laggard in Patents & Licensing. Bayer drops 10 impact measurement but does not target local positions in this area, to 18th place. There is lim- needs, sustainability, or specific objectives. ited public evidence that it takes an access-ori- Bayer supports capacity building initiatives not ented approach to managing its intellectual directly related to the production and distribu- property. tion of medicines in Kenya and Uganda but does not demonstrate how it mitigates conflicts of Very low transparency regarding patenting interest. strategy. Bayer does not have a

public policy for patent filing and enforcement. It does not Innovation: open-source pharmacovigi- publish the status of its patents in countries in lance tool. In 2015, Bayer co-founded a Special scope. It has an internal policy not to file for pat- Interest Group within the International Society ents in Least Developed Countries. of Pharmacovigilance. The group brings together Southeast Asian regulatory authorities Does not engage in licensing and makes no and international experts to develop and share public commitment to doing so in future. Bayer innovative risk-minimisation methods and tools, does not engage in licensing, nor does it publicly including an open-source tool for developing acknowledge the potential usefulness of licens- customised risk-management guidelines. ing as a strategy for access-oriented product deployment. PRODUCT DONATIONS No clear position regarding the Doha RANK 8 SCORE 3.0 Declaration. Bayer does not publish its position on the Doha

Declaration on the TRIPS agree- Bayer remains in 8th place. Bayer has one of the ment and public health. highest numbers of donation programmes for NTDs, all carried out in cooperation with WHO. Absence of competition-related breaches. Bayer was not found to have been the subject of Wide-scale NTD donation programmes. Bayer breaches, fines or judgements relating to com- is engaged in long-term donation programmes petition law during the period of analysis. for NTDs: involving nifurtimox (Lampit®) for Chagas disease and Gambian-type Human African Trypanosomiasis (HAT), and suramin 127 Source: http://www.doksinet Access to Medicine Index 2016 RA N K 13 = SCO R E Bristol-Myers Squibb Co. 1.97 13 (2014) Stock Exchange: XNYS • Ticker: BMY • HQ: New York, NY, US • Employees: approx. 25,000 Ranking by technical area Ranking by strategic pillar 5 R&D 1 .3 Pricing 1 .9 Patents 3. 1 Capacity 1 .3 Donations 1 .9 0 4 3 2 1 leader 1 2 3 4 5 average

average 1 .0 1 .5 2.1 Compliance 1 .6 3. 0 2.6 Management Commitments Transparency Performance Innovation 0 PERFORMANCE Bristol-Myers Squibb remains 13th. Although it is a leader does have an access-to-medicine strategy, but it is not clearly in Patents & Licensing and has improved moderately in aligned with corporate strategy. The company consistently other areas, this is outweighed by significant falls in Market engages in licensing, now also for hepatitis C products. It has Influence & Compliance and in R&D. The company was found equitable pricing strategies for the same number of products to have engaged in corrupt practice in China. In R&D, it has as in 2014. Despite a strong approach to philanthropy, it lags a small pipeline of relevant products and a conservative in capacity building, particularly in the areas of pharmacovigi- approach to sharing clinical trial data. Bristol-Myers Squibb lance and supply chain strengthening. CHANGE SINCE

2014 • Has a better-defined access-to-medicine strategy than in 2014. • Improves its accountability for its sales agents’ pricing practices by monitoring prices. • Contributes to a new donation programme aimed at treating patients co-infected with HIV and chronic hepatitis C virus (HCV). • Maintains low transparency about its stakeholder engagement and marketing activities. • Has breached civil law relating to corruption in China. • Has a significantly smaller pipeline of products for people in low- and middle-income coun- • Has equitable pricing strategies for the same number of products as in 2014. • Has agreed pro-access licensing terms for daclatasvir (Daklinza®) for hepatitis C. • Is less active in building pharmacovigilance capacity than in 2014. tries (LMICs), less than half the size. OPPORTUNITIES Expand access approaches beyond HIV/AIDS Expand packaging adaptations to support within the pharmaceutical value chain: e.g, to and hepatitis C.

Bristol-Myers Squibb can con- rational use. Bristol-Myers Squibb can expand strengthen supply chain management and phar- sider expanding its access-oriented product the range of factors (beyond environmental macovigilance systems. deployment approach (e.g, its equitable pric- adaptations) that it takes into account when ing strategy for atazanavir (Reyataz®)) beyond adapting the brochures and packaging of its products for HIV/AIDS and hepatitis C. It can products. For example, it can systematically take explore similar approaches for its ischaemic account of local languages, literacy levels, cul- heart disease and stroke products. tural factors and demographic considerations for children and elderly populations. Link R&D strategy to need in low- and middle-income countries. Bristol-Myers Squibb can Expand strategic capacity building activities clearly link its R&D strategy to high-burden dis- to support local access to medicine. Bristol- eases and access

needs in low- and middle-in- Myers Squibb has a strong approach to philan- come countries. The company can also develop thropic capacity building in health-related areas, plans to ensure new products are accessible in beyond the production and supply of medi- these markets soon after they leave the pipeline. cines. It can use its experience here to broaden and strengthen its capacity building activities 128 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Revenues by segment (2015) USD 16,560 MN BioPharmaceuticals In scope, has sales Revenues by region In scope, has no sales MN USD Not in scope SALES AND OPERATIONS 20,000 1 8,000 1 6,000 1 4,000 1 2,000 Bristol-Myers Squibb produces biopharmaceu- of the Index. Revenues outside of the US and ticals for oncology, immuno-oncology, immu- Europe account for approximately one third of 8,000 noscience, cardiovascular, fibrotic diseases, total sales. 6,000 1 0,000 4,000 and

genetically defined diseases. In July 2016, 2,000 the company announced the acquisition of 0 Cormorant Pharmaceuticals, a company focused 2011 2012 Rest of world on the development of therapies for cancer and rare diseases, for USD 520 mn. Bristol-Myers 2013 Europe 2014 USA 2015 Other Squibb has sales in 37 countries within the scope Other revenues include: royalties and alliance-related revenues for products not sold by regional commercial organisations. PORTFOLIO AND PIPELINE Products per disease category Bristol-Myers Squibb has a small portfolio of 16 hepatitis C virus genotype 3. relevant products, and a small pipeline of five R&D projects that address the needs of people The company’s R&D projects for high-burden in countries in scope. diseases are all in early stages of development: it has medicines in phase I testing for HIV/AIDS, The majority of Bristol-Myers Squibb’s portfolio diarrhoeal diseases and ischaemic heart disease, is divided

between communicable and non-com- and a discovery-stage project for dengue. municable diseases, with nine and seven medi- 9 16 7 Communicable cines respectively. In communicable diseases, the This latter project for dengue is its only project company is mainly active in HIV/AIDS and viral that clearly targets a high-priority product gap hepatitis. In 2015, Bristol-Meyers Squibb gained with low commercial incentive. None of its rele- Its portfolio targets communicable and non-com- market approval from the FDA for daclatasvir vant projects have been shown to have moved to municable diseases, namely liver, cardiovascular (Daklinza®) for the treatment of chronic HCV a new stage of development since 2014. diseases and mental health conditions. Pipeline projects 7 10 20 Multiple categories First-line treatments and essential medicines 1 00% 0 Non-communicable 30 40 50 In partnership, with access provisions (ap) 60 70 80 In partnership, w/o ap 90 100 Not

in partnership 34 0 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other None of Bristol-Myers Squibb’s relevant pipeline projects are being con- Of the 16 medicines in Bristol-Myers Squibb’s portfolio, 12 are listed on the ducted through R&D partnerships with third-parties. WHO EML and/or are first-line treatments: e.g, daclatasvir (Daklinza®), entecavir (Baraclude®), and efavirenz (Sustiva®). Pipeline by stage of development Innovative medicines and vaccines 2 CD CD NTD NTD MNH MNH NCD Adaptive medicines and vaccines 2 NCD Multiple Multiple 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval Bristol-Myers Squibb’s pipeline for high-burden diseases focuses entirely on Bristol-Myers Squibb

supports paediatric R&D via its investigator-sponsored innovative medicines, including a PD-L1 inhibitor for HIV/AIDS, a TYK2 inhibi- research programme. It is adapting products for diseases in scope, but did tor for diarrhoeal diseases and two medicines for ischaemic heart disease. not provide evidence of how they meet needs of people in LMICs. 129 Source: http://www.doksinet Access to Medicine Index 2016 Bristol-Myers Squibb Co. PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE and marketing practices in China. This breach that its in-house and outsourced clinical trials MANAGEMENT led to a fine of approximately USD 14.7 mn in are conducted ethically. RANK 15 disgorgement, penalties and interest. SCORE 3.0 Poor system for sharing clinical trial results. Rises two positions with a clearer access Below average in governance of ethical mar- Bristol-Myers Squibb does not clearly commit strategy. Bristol-Myers Squibb moves up two keting. Bristol-Myers

Squibb contractually to sharing its clinical trial results within a speci- places from 17th. It has provided a clearer defi- enforces the application of its marketing code to fied timeframe. The company has a mechanism nition of its access strategy and improved in third parties. Nevertheless, it only uses sales tar- for third parties to request patient-level data: an the way it measures performance. However, the gets to drive employee performance. It does not internal committee approves requests before transparency of its stakeholder engagement publish information about marketing activities in they are sent to an independent review commit- activities is low. countries within scope. tee at Duke University. Comprehensive access strategy. Bristol-Myers Policy positions available online. Bristol-Myers Collaborates through intellectual property Squibb’s access-to-medicine strategy focuses Squibb discloses its policy positions related sharing. While the company has no

collabora- on nine areas: (1) Commitment to Patients; (2) to access to medicine on its website, includ- tions in its relevant pipeline, it has provided the Access Management; (3) R&D; (4) Partnering ing a statement that it does not make any politi- Drugs for Neglected Diseases Initiative, Institut with Patients and Physicians; (5) Clinical Trials; cal contributions outside of the USA. It only dis- Pasteur Korea and the University of Dundee (6) Improving Health Care Infrastructure and closes some of the financial contributions it with access to its compound libraries. Its aim is Practices; (7) Patents, Licensing and Technology makes to the trade associations it has joined. to advance the development of medicines for Transfer; (8) Product Quality and Safety; and (9) Drug Donations and Philanthropic Efforts. Chagas disease and leishmaniasis. This informaAudit system in place, with evidence of opera- tion is publicly disclosed. tionalisation. Audits are conducted

once every Has access initiatives, but no explicit align- two to three years. Where a Qualified Opinion ment with corporate strategy. Bristol-Myers report has been issued, audits are conducted PRICING, MANUFACTURING & Squibb has developed specific programmes annually until the issue is resolved. Audits may DISTRIBUTION and partnerships to help facilitate and manage include local third parties. In total, the audit team RANK 12 access-to-medicine activities. Nevertheless, conducts approximately 50 audits per year. No change in ranking. Bristol-Myers Squibb the company does not make clear how its remains in 12th position. It has the same number access-to-medicine strategy aligns with its corporate strategy. SCORE 1.9 RESEARCH & DEVELOPMENT of products with equitable pricing strategies as RANK 20 in 2014 (although not the same products). Its SCORE 1.3 Accountable through high transparency on strategies are equally distributed between prod- access

measurements. The company is trans- Falls to bottom of industry with big drop in parent with regards to its commitments, targets pipeline projects. Bristol-Myers Squibb’s perfor- and performance information related to access. mance has fallen since 2014. It has a significantly Equitable pricing that targets majority of It also has a centralised performance manage- smaller pipeline of relevant innovative products high-burden countries for some products. 27% ment system where progress is regularly tracked and is not adapting products or technologies for of Bristol-Myers Squibb’s products have equi- and monitored. people in low- and middle-income countries. It is table pricing strategies that, on average, target not engaged in any relevant R&D partnerships. more than half of the corresponding priority Low transparency on stakeholder engage- ucts for HIV/AIDS and for hepatitis C. countries (disease-specific sub-sets of coun- ment. Bristol-Myers Squibb has a

clear approach R&D commitments not clearly linked to low- tries with a particular need for access to rele- to stakeholder engagement, but does not pub- and middle-income country needs. In its vant products). This is a relatively high level of lish details of this process or the outcomes of its Sustainability 2020 goals, Bristol-Myers Squibb needs-targeting. Across its inter-country equi- activities. In addition, the company provides no commits to focusing its R&D on medicines and table pricing strategies, the socio-economic fac- evidence of how subsidiaries engage with stake- on areas of high unmet medical need. However, tors Bristol-Myers Squibb most commonly con- holders at the local level. the company’s commitments are not clearly siders are disease burden and level of economic linked to the needs of people in low- and mid- development. In its intra-country equitable pric- dle-income countries. ing strategies, it only considers disease burden/ MARKET

INFLUENCE & COMPLIANCE RANK 16 SCORE 1.5 prevalence and the government’s commitment No policy for basing R&D partnerships on to treating patients. access-oriented terms. The company has no Biggest faller in part due to corruption in policy to ensure access-oriented terms are sys- Monitors pricing, but has no pricing guide- China. Bristol-Myers Squibb dropped from 3rd tematically included in research partnerships. lines. Bristol-Myers Squibb does not have pric- to 16th position, due in part to a settlement ing guidelines for sales agents but it does moni- related to corruption in China. Bristol-Myers Takes measures to ensure clinical trials are Squibb was found to have breached the US conducted ethically. Bristol-Myers Squibb has Foreign Corrupt Practices Act, through its sales policies in place and takes measures to ensure 130 tor prices in all countries. Source: http://www.doksinet Access to Medicine Index 2016 No specific registration targets; limited

regis- CAPACITY BUILDING PRODUCT DONATIONS tration in practice. Bristol-Myers Squibb does RANK 16 RANK 14 SCORE 1.3 SCORE 1.9 not have disease-specific registration targets. It does not publish where its products are regis- Capacity building activities still limited overall. Rises three places. Bristol-Myers Squibb moved tered, or its criteria for deciding when and where Bristol-Myers Squibb demonstrates a relatively from 17th to 14th position. It is launching its first to file for registration. The company has filed to strong approach to capacity building outside the structured donation programme for a disease in register 70% of its newest products in just a few pharmaceutical value chain, including address- scope: for patients co-infected with the hepatitis priority countries (disease-specific sub-sets of ing local needs in countries in scope. However, C virus (HCV) and HIV. countries with a particular need for access to the company undertakes limited

activities for relevant products). On average, these products all areas within the value chain measured by the Complies with WHO guidelines for donations. were launched 10 years ago. Index and does not clearly target skills gaps. Bristol-Myers Squibb has standard operating Consistent guidelines for issuing recalls. Strong philanthropic approach. Through the national product donations. It complies with Bristol-Myers Squibb has globally consistent Bristol-Myers Squibb Foundation, the compa- WHO and PQMD guidelines. guidelines for issuing drug recalls in all coun- ny’s approach to philanthropic activities is very tries relevant to the Index where its products are strong: it targets local health needs, is aimed at Monitoring mainly the responsibility of part- available. Bristol-Myers Squibb has not recalled promoting health equity for vulnerable popula- ners. Bristol-Myers Squibb’s donations are mon- a product for a relevant disease in a country in tions, at

delivering long-term improvements and itored by the humanitarian aid organisations it scope during the period of analysis. requires monitoring and evaluation of pre-de- works with. These organisations are responsible fined objectives. The Foundation’s activities for monitoring in-country partners and for send- Limited steps taken to facilitate rational include building health workforce capacity, and ing donation reports to Bristol-Myers Squibb. In use. Bristol-Myers Squibb uses blister packs integrating medical and community-based sup- some regions, Bristol-Myers Squibb conducts to address stability needs, but does not adapt port services. on-site audits. account of language, literacy, cultural or demo- Active in building capacity outside the value Makes ad hoc donations for disaster relief and graphic needs. chain. Bristol-Myers Squibb discloses a number in emergencies. Bristol-Myers Squibb usually of relevant initiatives to build capacities outside makes ad

hoc donations via its long-term part- the pharmaceutical value chain focusing on HIV/ ners: AmeriCares, Project Hope, Direct Relief PATENTS & LICENSING AIDS, viral hepatitis and diabetes. It undertakes International and International Health Partners. RANK 3 activities in a range of countries including in Since 2014, it has donated products for disaster sub-Saharan Africa, China, India and Peru. relief in response to the 2016 Nepal earthquake. procedures in place for both domestic and inter- its brochures or packaging materials to take SCORE 3.1 One of the leaders in Patents & Licensing. Bristol-Myers Squibb holds 3rd position: it Below average in R&D capacity building. Innovation: donations for hepatitis C. Bristol- has consistently taken steps to manage its IP Bristol-Myers Squibb has an R&D capacity build- Myers Squibb is launching an innovative struc- responsibly, and has demonstrated its willing- ing partnership with Tsinghua University in

tured donation programme aimed at curing hep- ness to apply proven licensing models beyond China, focusing on novel oncology and immu- atitis C in patients co-infected with HIV and the the HIV/AIDS area. no-science targets, as well as structural biology hepatitis C virus. It works in cooperation with research to support future drug discovery. It is Americares, Clinton Health Access Initiative Policy of patent non-enforcement on anti-ret- not clear how the company targets local skills (CHAI) and Duke University. The company will be rovirals (ARVs). Bristol-Myers Squibb has a gaps through this partnership. donating free courses of daclatasvir (Daklinza®) public policy of not enforcing the patent rights across Ethiopia, Indonesia, Myanmar, Nigeria, it holds on its portfolio of HIV/AIDS medicines in Builds manufacturing capacity through the sub-Saharan Africa. MPP. Bristol-Myers Squibb commits to assess- Rwanda and Vietnam. ing needs and building capacity in relevant

counHalf of products available for licensing. Bristol- tries for in-house manufacturers only. In prac- Myers Squibb makes half of its patented port- tice, the company undertakes a relatively small folio of relevant products available for licensing. number of capacity building activities, through The licences it agrees (via the Medicines Patent the Medicines Patent Pool, including technol- Pool) are transparent, access-oriented and ogy transfers for HIV/AIDS medicine atazanavir include a comparatively high number of middle (Reyataz®) in Brazil and India. income countries with high hepatitis C and HIV/ AIDS prevalence. Weak performance in strengthening supply chains and pharmacovigilance systems. Bristol- Low transparency on trade agreements and Myers Squibb did not disclose relevant capac- patent statuses. The company does not pub- ity building activities or information sharing (e.g, lish its position on the Doha Declaration on the voluntary sharing of safety data

with authorities) TRIPS agreement and public health, and does to support the strengthening of supply chains not publish the status of its patents. and pharmacovigilance systems in countries in scope during the period of analysis. In novation: licensing outside of HIV/AIDS. Bristol-Myers Squibb has made the significant step of applying licensing to products outside of the HIV/AIDS space. Via the Medicines Patent Pool, it has now agreed licences for hepatitis C medicine daclatasvir (Daklinza®). 131 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 14 1.87 Pfizer Inc. 16 (2014) Stock Exchange: XNYS • Ticker: PFE • HQ: New York, NY, US • Employees: 97,900 Ranking by technical area Ranking by strategic pillar 5 R&D 1 .9 Pricing 1 .6 Patents 1 .0 Capacity 1 .8 Donations 3. 5 0 4 3 2 1 leader 1 2 3 4 5 average average 0.8 0. 8 2.0 Compliance 2.0 3. 4 2.1 Management Commitments Transparency Performance Innovation

0 PERFORMANCE Pfizer rises two places to 14th, having improved in specific ing. However, in access management, it does not have per- areas. It moved a high proportion of projects along its pipe- formance incentives linked to its access-related targets, and line, and provides stronger evidence that it implements its the transparency of its stakeholder engagement activities is equitable pricing strategies and monitors prices and mark limited. It performs poorly in all areas of Market Influence & ups. It has two long-standing donation programmes with wide Compliance, and was found in breach of corruption laws in a reach. It is relatively strong in strengthening supply chains, country in scope. Its patenting strategy lacks transparency and has several innovative initiatives related to health financCHANGE SINCE 2014 • Has a new strategy for its Global Established Products Business Unit, which evaluates • Moved a substantial portion of its R&D projects along the

pipeline. • Has still not set targets for registering products for high-burden diseases. assets and capabilities to address leading causes of high-burden diseases in low-and middle-income countries. • Signed the Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries • Provides price and volume-of-sales information. on Combating Antimicrobial Resistance in • Has improved its accountability for its sales January 2016. agents’ pricing practices. • Still has not published a policy on where and when it will file for or enforce patent rights. • Has implemented equitable pricing for Sayana • Has been found in breach of laws and codes of conduct multiple times since 2014. Press®, targeting 69 countries with a price of USD 1 per dose. • Has made employees available to the USAID/ Indonesia Expanding Maternal and Neonatal Survival project in partnership with NGO RTI • Has implemented a drug recall policy. International. OPPORTUNITIES Expand

its access strategy to cover more rel- clearly show where products are on and off Ensure access to relevant products gained evant products. Pfizer can expand its access patent, and when they are due to expire. through Hospira acquisition. Pfizer can imple- strategies to cover more products for diseases ment access strategies for new and exist- in scope, for example, by piloting a variety of Set access provisions for pipeline projects. ing products gained through its acquisition of healthcare interventions. Pfizer can expand equi- Pfizer can make plans for the accessibility of Hospira, particularly for products that are impor- table pricing to more products for high-burden future products early in the product develop- tant in hospital and emergency situations. diseases, and implement intra-country equitable ment process, particularly for unique products pricing in markets with high inequality and high that fill key product gaps in low- and middle-in- Ensure access

to products on the WHO EML. out-of-pocket spending on healthcare. come countries (e.g, for its pre-clinical Group B Pfizer has one of the largest numbers of prod- streptococcus vaccine candidate). ucts on the WHO Model Essential Medicines List Publish a position on where it will file for or (EML). It can evaluate access barriers to these enforce patents. Pfizer can develop and disclose Expand anonymity provisions for misconduct products in all low- and middle-income coun- a public position on how it plans to file for and reporting. Pfizer can expand its anonymity guar- tries. It can ensure their availability and afforda- enforce its patents. This would give drug pro- antee for whistle-blowers to clarify guidance to bility, aligning with demand and the availability of curement agencies and generic medicine man- employees in all countries. This would increase alternative products in specific countries. ufacturers greater confidence to act. In tandem, the chance of

misconduct being reported and Pfizer can publish the status of its patents, to tackled. 132 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Revenues by segment (2015) 506 MN 1 3,954 MN USD 48,850 MN 21 ,587 MN 1 2,803 MN Global Innovative Pharmaceutical Global Vaccines, Oncology and Consumer Healthcare Global Established Pharmaceutical In scope, has sales Other business activities Revenues by geographic area In scope, has no sales MN USD Not in scope SALES AND OPERATIONS 65,000 60,000 55,000 50,000 45,000 40,000 Pfizer operates through four segments: Global Shionogi focused solely on HIV/AIDS medicines. Innovative Pharmaceutical; Global Vaccines, In September 2015, the company completed Oncology and Consumer Healthcare; and the acquisition of Hospira, a provider of inject- Global Established Pharmaceutical. The com- able medicines, infusion technologies and bio- pany’s core therapeutic areas are: cardiovascu- similars

for approximately USD 17 bn. The com- lar and metabolic disease, immunology, inflam- pany has sales in 86 countries within the scope mation, neuroscience, oncology, vaccines, and of the Index. 35,000 30,000 25,000 20,000 1 5,000 1 0,000 5,000 0 pain and sensory. Pfizer holds a 126% stake in 2011 2012 2013 2014 2015 Emerging markets Developed rest of world Developed Europe USA ViiV Healthcare, a joint venture with GSK and PORTFOLIO AND PIPELINE Products per disease category 17 Pfizer has a large portfolio of 98 relevant prod- diseases, three non-communicable diseases ucts and a small pipeline of 10 R&D projects (NCDs) and two maternal and neonatal health that address the needs of people in countries in conditions. 26 98 scope. 2 Compared to other companies, Pfizer has moved Its products consist of medicines and vaccines, a large proportion of the products in its pipe- and cover a wide range of high-burden diseases: line from one stage of development to

another. including respiratory diseases, meningitis, dia- This includes gaining approval for Trumenba®, betes, epilepsy, HIV/AIDS and hypertensive and its meningococcal group B vaccine in October ischaemic heart disease. 2014. A low proportion of Pfizer’s R&D projects The company has medicines and vaccines in 4 49 Communicable Non-communicable Neglected tropical Multiple categories Maternal and neonatal target high-priority product gaps with low com- Pfizer’s portfolio targets all disease categories and mercial incentive. covers 32 diseases in scope. development that target four communicable Pipeline projects 1 0% 0 1 0% 10 First-line treatments and essential medicines 80% 20 29 30 40 50 In partnership, with access provisions (ap) 60 70 80 In partnership, w/o ap 90 100 Not in partnership 9 0 20 23 40 37 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other Pfizer is working via

ViiV Healthcare on an HIV/AIDS integrase inhibitor, 62% of Pfizer’s medicines and vaccines are on the WHO EML and/or are which is currently in phase II of clinical development. first-line treatments: e.g, its pneumococcal 13-valent vaccine (Prevnar 13®), ACWY meningococcal vaccine (Mencevax®) and atorvastatin (Lipitor®). Pipeline by stage of development Innovative medicines and vaccines Adaptive medicines and vaccines CD CD NTD NTD MNH MNH NCD 3 3 NCD Multiple Multiple 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 40 Phase III 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval Pfizer’s innovative pipeline includes medicines for HIV/AIDS, type 2 dia- Pfizer gained approval for self-injection of its contraceptive Sayana Press® betes, schizophrenia and ischaemic heart disease, as well as vaccines for and a multi-dose

preparation of Prevnar 13®, a conjugate pneumococcal Clostridium difficile, MRSA and group B streptococcus. vaccine. Both aim to improve access in relevant countries 133 Source: http://www.doksinet Access to Medicine Index 2016 Pfizer Inc. PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE MARKET INFLUENCE & COMPLIANCE along its pipeline in the same period. Its higher MANAGEMENT RANK 19 rank is also explained by drops in the perfor- RANK 13 SCORE 0.8 mance of some of its peers. SCORE 3.4 Poor performance across all areas. Pfizer drops Mixed performance in this area. Pfizer’s ranking two positions in this area, to rank last. The com- R&D commitments not clearly linked to need. remains the same here as in 2014. The company pany performs poorly overall, across all themes Pfizer commits to developing medicines and has a mix of strengths and weaknesses: it is test- of analysis. It was found to have breached vaccines for multiple relevant diseases,

and rec- ing a way of optimising access to its established anti-corruption laws in a country in scope ognises the need for collaborative R&D to sup- products portfolio, but the transparency of its (China). port health issues that disproportionately affect stakeholder engagement is low. It is one of the low- and middle-income countries. It is unclear, few companies with no access-related financial Ethical marketing practices lag behind industry however, whether the company’s commitments incentives for employees. average. Pfizer has a marketing code, which also are informed by a public health rationale. applies to its third parties. It states that it does Access strategy aligns with corporate strategy. not only use sales targets to incentivise employ- No policy for basing R&D collaborations on Pfizer’s access strategy includes a detailed set of ees. However, the company does not disclose pro-access terms. The company does not objectives and a business

rationale: the company any information about its marketing activities in commit to ensuring access-oriented terms considers its access programmes to be impor- countries in scope. Plus, its provisions of ano- (such as supply commitments or affordable pric- tant for building long-term value for investors by nymity for whistle-blowers do not clearly pro- ing strategies) are systematically included in its strengthening reputation and creating opportu- vide guidance to global employees. research partnerships. nities in new markets and population segments. Low transparency on lobbying activities. Pfizer High transparency around clinical trials. The Performance management system, but no discloses its policy positions on access to med- company upholds high standards of clinical trial access-related incentives. Pfizer’s newly estab- icine, in particular, those related to Universal data transparency, including providing scien- lished Global Health & Value department is

Health Coverage, Intellectual Property, and the tific researchers with access to patient-level charged with monitoring and measuring pro- Trade-Related Aspects of Intellectual Property data upon request via the company’s own portal. gress towards its access targets. However, the Rights and Free Trade agreements. However, Requests are first reviewed by an internal com- company does not have dedicated financial it does not provide information on the politi- mittee, and any denied or partially approved incentive structures in place to reward employ- cal contributions it makes in countries in scope. applications are then forwarded to an independ- ees when they achieve access-related targets. The company discloses its memberships of ent review panel. industry and trade associations, without disTransparency of stakeholder engagement is closing whether it provides financial support. Innovation: signing on to combat antimicro- limited. Although Pfizer does have a

stakeholder Furthermore, Pfizer does not provide informa- bial resistance. Pfizer signed the Declaration engagement strategy, it publishes only general tion about a conflict of interest policy for inter- by the Pharmaceutical, Biotechnology information about its related activities. It does actions with these organisations. and Diagnostics Industries on Combating Antimicrobial Resistance in January 2016, not specify how local offices engage with their stakeholders. Multiple breaches of criminal, civil law and thereby committing to investing in R&D that codes of conduct. Pfizer has been the subject of aims to meet public health needs. Innovation: approach to established products multiple settlements since 2014. It was handed portfolio. To underpin the strategy of its Global a fine of approximately USD 468,000 for cor- Sharing intellectual property across several dis- Established Products Business Unit, Pfizer has ruption involving four major pharmacies and the

eases. In 2015, Pfizer entered an agreement via evaluated its assets and capabilities for address- improper promotion of a medicine in China. WIPO Re:Search to share a compound for test- ing the leading causes of the highest-burden dis- ing against liver-stage malaria. Pfizer is also Limited performance in compliance. Pfizer has funding, providing drugs for and sponsoring enforcement processes and disciplinary meas- studies into TB, through its Investigator-Initiated Best Practice: Global Health Fellowships. ures in place to safeguard against misconduct, Research Program. Pfizer has a volunteering programme in which but provides no information about whether employees are able to engage with and sup- these processes have been applied. The com- Best practice: Moving projects along the port local stakeholders. For example, employ- pany also conducts regular audits in all countries pipeline. Compared to other companies, Pfizer ees are supporting the USAID/Indonesia

with operations, but not of all third parties. has moved a high proportion of R&D projects to eases in low-and middle-income countries. the next development stage since 2014. Expanding Maternal and Neonatal Survival project on its engagement with civil society groups. The Fellowship programme focuses on improv- RESEARCH & DEVELOPMENT ing the access, quality and efficiency of health RANK 14 SCORE 1.9 services in under-served communities. It is also used by Pfizer to gain insight into local stake- Rises three places in R&D. Since 2014, Pfizer holder needs. has doubled the size of its relevant pipeline, moving a substantial proportion of its projects 134 Source: http://www.doksinet Access to Medicine Index 2016 PRICING, MANUFACTURING & and enforcement, or to the Doha Declaration on Maternal and Neonatal Survival project in part- DISTRIBUTION the TRIPS agreement and public health. While it nership with NGO RTI International in 2014- RANK 15 takes a

comparatively open approach to licens- 15. The project aims to improve the quality of ing, this lack of transparency contributes to its emergency obstetric and neonatal care ser- low position. vices, to reduce maternal and newborn deaths SCORE 1.6 Pfizer rises one place, remains in middle group. Pfizer moves up one place from 16th. Pfizer in Indonesia. has, for the first time, provided price point and Lack of transparency in patenting strategy. volume-of-sales information to the Index to Pfizer does not have a public policy available Innovation: M-Tiba mobile wallet. Since 2015, demonstrate that it implements its pricing strat- that sets out its approach to filing for or enforc- Pfizer has partnered with PharmAccess, CarePay egies. It has now also provided details of a global ing patents in low- and middle-income countries. and Safaricom to support the development and policy for drug recalls. Neither does it publish the status of its patents. implementation of

M-Tiba®, a mobile wallet Room for improvement in equitable pric- Makes ARV patent available for licensing on Kenya. A trial in informal settlements in Nairobi ing. Pfizer has not expanded equitable pric- pro-access terms. Pfizer (as ViiV Healthcare) showed positive results: M-Tiba has now been ing to more products since 2014. The compa- has made the patent it holds on maraviroc launched more widely. ny’s equitable pricing covers a wide range of dis- (Selzentry®) available for non-exclusive volun- eases, including epilepsy, hypertensive heart dis- tary licensing. dedicated to healthcare savings and payments in Innovation: StartHealth investment pro- gramme. Pfizer is collaborating with PATH and ease, soil-transmitted helminthiasis and TB. Only some (20%) of its products have pricing strate- Limited public position on Doha Declaration. other partners to support StartHealth, an invest- gies that target priority countries (disease-spe- Pfizer publicly supports the

Doha Declaration ment programme supporting health technol- cific sub-sets of countries with a particular need on the TRIPS agreement and public health ogy start-ups in India. The programme will coor- for access to relevant products). Together, these but limits its support of compulsory licens- dinate technical support, grant funding and cap- strategies reach only some (22%) of the corre- ing to extraordinary circumstances or extreme ital investment for local entrepreneurs creat- sponding priority countries. The company con- emergency. ing affordable and effective health products and services. siders affordability when setting inter-country pricing tiers, overlooking other socio-economic factors. It has not implemented intra-country CAPACITY BUILDING PRODUCT DONATIONS equitable pricing strategies. RANK 9 RANK 5 SCORE 1.8 SCORE 3.5 Monitors prices but does not set pricing guide- Stronger in building supply chain management Rises to joint 5th place. Pfizer is one

of the big- lines. Pfizer monitors prices via an internal elec- capacity, weaker in pharmacovigilance. Pfizer gest risers, moving from 14th to joint 5th place. tronic system that tracks ex-factory prices, net demonstrates a relatively strong approach to The company’s product donations are compar- prices, wholesale prices and public prices. The strengthening supply chains, and innovative ini- atively large in scale and scope in Index coun- degree and frequency of monitoring differ per tiatives related to health financing. However, the tries. It is engaged in two structured donation country depending on local laws and policies. company’s performance in other areas is com- programmes, covering trachoma and HIV/AIDS- paratively weak, particularly in pharmacovigi- related fungal infections. Mixed registration performance. Pfizer does not lance, and it does not consistently target local provide evidence of having disease-specific tar- needs. Continues efforts to

eliminate trachoma. Pfizer supports WHO’s efforts to eliminate trachoma. gets for registering its products where they are needed. It does not publish its criteria for decid- Strengthening supply chains with a focus on During the period of analysis, Pfizer donated 128 ing where to register products, or whether and identifying falsified medicines. Pfizer is actively million treatments of azithromycin (Zithromax®) where products are registered. The company building capacity in supply chain management through the International Trachoma Initiative has filed to register more than half (60%) of its in countries in scope, including through partner- (ITI). In November 2015, it donated the 500 newest products in a few priority countries (dis- ships and information sharing. For example, to millionth dose in its structured donation ease-specific sub-sets of countries with a par- help address falsified medicines moving from programme. ticular need for access to relevant

products). Pakistan to the Philippines, the company jointly Most of these products were first launched 10 to trained authorities from the two countries. Complies with external standards. Pfizer did not disclose an overarching donations policy. It 20 years ago. Building R&D capacity, but not clear if local does state that its donations adhere to WHO Consistent recall guidelines. Pfizer has glob- needs are targeted. Pfizer has one relevant and PQMD guidelines. ally consistent guidelines for issuing drug recalls partnership with a local research organisa- in all countries relevant to the Index where its tion to build R&D capacity in countries in scope: Monitoring is mainly the responsibility of part- products are available. Pfizer does not publish with the Indian Institute of Technology, Delhi. ners. Pfizer donates through humanitarian details on drug recalls. However, it is not clear how the company targets aid organisations. These organisations moni- local

skills gaps through this partnership. tor its in-country partners and are responsible Does not facilitate rational use through pack- for sending reports of the ad hoc donation pro- aging adaptations. Pfizer does not provide evi- Weak performance in strengthening pharma- grammes to Pfizer. Pfizer has donation agree- dence that it adapts its brochures or packaging covigilance systems. Pfizer voluntarily shares ments with all NGOs that receive products from materials to address the language, literacy, envi- safety data with authorities in countries in scope the company. For its structured donation pro- ronmental, cultural or demographic needs of but does not demonstrate routine safety label grammes for trachoma, countries are required people living in countries in scope. updates or relevant activities to build pharma- to submit an annual application to receive covigilance capacity in the period of analysis. donations. Supporting maternal and neonatal survival in

Involved in humanitarian emergency-relief Indonesia. Through its Global Health Fellowships efforts. Since 2014, Pfizer has been donating Limited clarity leads to a low rank. Pfizer still volunteering programme, Pfizer contributed Prevnar 13®, a pneumococcal 13-valent conju- does not publish its approach to patent filing expertise to the USAID/Indonesia Expanding gate vaccine, in humanitarian crises. PATENTS & LICENSING RANK 14 SCORE 1.0 135 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 15 1.77 Takeda Pharmaceutical Co., Ltd 20 (2014) Stock Exchange: XTKS • Ticker: 4502 • HQ: Osaka, Japan • Employees: 31,168 (consolidated) Ranking by technical area Ranking by strategic pillar 5 R&D 2. 8 Pricing 1 .3 Patents 0. 6 Capacity 1 .8 Donations 1 .7 0 4 3 2 1 leader 1 2 3 4 5 average average 0.0 1 .8 2.0 Compliance 1 .6 3. 0 2.4 Management Commitments Transparency Performance Innovation 0 PERFORMANCE

Takeda is one of the biggest risers, moving 5 places to 15th. implemented equitable pricing strategies that differentiate Its access-to-medicine strategy aligns with its overall busi- between countries. It newly commits not to file for or enforce ness strategy. This is not yet coupled with a solid compliance patents in sub-Saharan Africa. It has not yet established system, as evidenced by cases of misconduct settled since a structured product donation programme. It improves in 2014. Takeda has strong R&D commitments related to access capacity building, particularly for R&D and pharmacovigilance. to medicine, and shares IP for leishmaniasis and Chagas disease. It also improves in pricing, where Takeda has newly CHANGE SINCE 2014 • Has launched new access strategy supported by a centralised dashboard for tracking pro- • Implements relevant inter-country equitable pricing strategies for the first time. gress and performance. • Has improved its auditing processes

related to its ad hoc product donations, which it applies to a limited selection of partners. • Does not provide price or volume-of-sales • Has been handed the largest fine following a information. case of misconduct of all companies in scope during the period of analysis. • Has supported local health services in Haiti through Access to Health Project Haiti, in part- • Improves its accountability for its sales agents’ pricing practices. nership with Partners in Health and other stakeholders. • Has improved its measures for ensuring clinical trials are conducted ethically and is more transparent with clinical trial data. • Newly commits to not filing for patents and to abandoning patents held in sub-Saharan Africa. OPPORTUNITIES Engage with stakeholders to act on commit- targets for products targeting diseases with high for hypertensive heart disease. The company ment to voluntary licensing. Takeda has a new burdens in low- and middle-income countries can

also implement intra-country equitable pric- commitment to considering the use of volun- and plans to ensure affordable pricing. ing strategies in countries with high levels of ine- tary licensing as a mechanism for addressing the quality and/or high out-of-pocket spending. affordability and supply of on-patent and pipe- Ensure the long-term sustainability of its new line products in lower-middle income countries. access strategy. Takeda can strengthen the link Join efforts to combat antimicrobial resist- It can actively seek potential partners (including between access and its corporate strategies to ance. Takeda has seven antibiotics that are on manufacturers, where relevant) to explore viable go beyond a philanthropic approach to improv- the WHO Model Essential Medicines List (EML), opportunities for turning this commitment into ing access to medicine. This would ensure the are used in clinical practice and are important action. long-term sustainability of its

strategy, as the for low-resource settings. The company can company moves ahead with an increased focus take action to increase access to these med- on access. icines, while ensuring their responsible use. Implement access plans as company expands its focus. As Takeda expands its pipeline and the Takeda can join global efforts to address anti- geographic scope of its pharmaceutical busi- Expand use of equitable pricing strategies. microbial re-sistance, for example by sign- ness, it can implement detailed plans for ensur- Takeda can expand its commitment to equita- ing the Declaration by the Pharmaceutical, ing successful new products are accessible upon ble pricing, as well as its use, to more products, Biotechnology and Diagnostics Industries on market approval. This can include registration e.g, azilsartan (Azilva®), a first-line treatment Combating Antimicrobial Resistance. 136 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in

scope Revenues by segment (2015) 78,61 3 MN 80,094 MN JPY 1,807,378 MN 1 ,648,671 MN Ethical Drugs Consumer Healthcare Other In scope, has sales Revenues by segments In scope, has no sales MN JPY Not in scope SALES AND OPERATIONS 1 ,800,000 1 ,600,000 1 ,400,000 1 ,200,000 1 ,000,000 Takeda’s core therapeutic areas are: gastrointes- Pharmaceutical Industries. This step is intended tinal diseases, oncology, central nervous system to allow Takeda to focus on developing inno- diseases and cardiovascular and metabolic dis- vative medicines, as this separate entity will eases. The company’s Ethical Drug Division market the company’s off-patent medicines and accounts for its largest share of sales, derived focus on the generic medicine market. Takeda from its small presence in the consumer health- has sales in 29 countries within the scope of the care market. In April 2016, Takeda announced Index. 800,000 600,000 400,000 200,000 0 2011* 2012* Rest of world

Japan the establishment of Teva Takeda Yakuhin Ltd, a joint venture between Takeda and Teva 2013* Russia/CIS Europe/Canada 2014 2015 Latin America Asia USA *Due to changes in company reporting practices, numbers from 2011, 2012, 2013 and 2014 are incomparable. PORTFOLIO AND PIPELINE Products per disease category 2 1 9 Takeda has a mid-sized portfolio of 50 products Takeda’s pipeline is approximately double the for diseases in scope and a mid-sized pipeline size it was in 2014. It has joined the new NTD of 24 R&D projects that address the needs of Drug Discovery Booster, and several of its ear- people in low- and middle-income countries. ly-stage innovative projects for NCDs have quali- 50 fied for analysis for the first time in 2016. Takeda’s relevant portfolio has a strong focus Takeda has moved several products along on non-communicable diseases (NCDs), cover- its pipeline since 2014, and received regula- ing diabetes, hypertensive and ischaemic

heart tory approval in Japan for trelagliptin succinate disease and unipolar depressive disorders. The (Zafatek®) for type 2 diabetes. Takeda is con- company is developing medicines and vac- ducting multiple projects targeting high-priority cines for seven communicable diseases, three product gaps with low commercial incentive. 38 Communicable Non-communicable Maternal and neonatal Multiple categories Most medicines in Takeda’s portfolio are for neglected tropical diseases (NTDs) and five NCDs. It also has several broad-spectrum antibiot- NCDs. ics for diseases in scope. 50 Pipeline projects First-line treatments and essential medicines 33% 0 17 4% 63% 10 20 30 40 50 In partnership, with access provisions (ap) 60 70 80 In partnership, w/o ap 90 100 Not in partnership 6 12 0 15 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other Takeda participates in several R&D projects

with the Global Health A comparatively high proportion of Takeda’s relevant products are listed on Innovative Technology (GHIT) Fund that require products be made available the WHO EML and/or as first-line treatments: e.g, azilsartan (Azilva®) and in relevant countries at reasonable prices or are licensed out royalty-free. candesartan for hypertensive heart disease. Pipeline by stage of development Adaptive medicines and vaccines CD 3 NTD 3 Innovative medicines and vaccines 3 CD NTD MNH MNH NCD 2 6 2 NCD Multiple Multiple 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval Takeda’s relevant pipeline concentrates on innovative medicines and vac- Takeda is adapting one product, for malaria, which targets the needs of cines. Its projects are mainly in early stages of

development, targeting 17 dis- people living in low- and middle-income countries. eases, with a focus on schizophrenia. 137 Source: http://www.doksinet Access to Medicine Index 2016 Takeda Pharmaceutical Co., Ltd PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE cials and candidates for public office where per- gies) are systematically included in its research MANAGEMENT mitted by law. Takeda has shared its policy posi- partnerships. RANK 16 tions with the Index related to the TRIPS and SCORE 3.0 the Doha Declaration. It has also disclosed infor- Comprehensive policy to ensure clinical trials Rises three positions due to new access strat- mation about its conflict of interest policy, but are conducted ethically. Takeda has policies and egy. Takeda climbs from 19th to 16th position under a non-disclosure agreement. takes measures to ensure its in-house and out- This reflects the company’s inclusion of access sourced trials are conducted ethically. Its

poli- in its business strategy and its new system for Auditing system in place. Takeda has a risk- cies are strong: they include, alongside stand- tracking access-related performance. based auditing system for measuring compliance ard measures, the consideration of scientific with its anti-bribery and anti-corruption meas- requirements and research protocols and post- Access strategy aligned with overall business ures and codes of conduct. For each country trial provisions. strategy. Takeda’s access strategy has been where it operates, audits are undertaken annu- updated, drawing on the Access to Medicine ally or every two years, depending on risk fac- High transparency around clinical trial data. The Index methodology. Specific areas of focus tors. Wherever issues are identified, an audit the company upholds high standards of transpar- within the strategy include vaccines, less devel- following year is mandatory. The company also ency concerning clinical trial

data. This includes oped healthcare markets and sub-Saharan audits some third parties. including providing scientific researchers access Africa. to patient-level data upon request, via clinicalEnforcement procedures apply to third par- studydatarequest.com New centralised performance management ties. Takeda employs a number of strategies system. Takeda has implemented a central- to ensure that third parties adhere to relevant NTD Drug Discovery Booster. Takeda shares ised access strategy dashboard. This dashboard standards of behaviour, such as due diligence intellectual property for leishmaniasis and reports on the overall implementation and pro- and monitoring. These include enforcement pro- Chagas disease via the NTD Drug Discovery gress of the company’s access initiatives. It also cedures up to contract termination in cases of Booster. The company also shares intellectual allows divisions to track the progress of key ini- non-compliance. property with

partners such as WIPO Re:Search tiatives and escalate problems to leadership if and Drugs for Neglected Diseases initiative. Settlement for misconduct relating to unethical needed. marketing. Takeda has been the subject of setAd-hoc stakeholder engagement approach tlements in two instances since 2014. In the US, PRICING, MANUFACTURING & Takeda does not have a structured approach Takeda agreed to pay up to USD 2.4 bn to settle DISTRIBUTION to stakeholder engagement. Furthermore, the U.S personal injury suits claiming that the com- RANK 16 company does not publish information related to pany did not adequately warn about the cancer its stakeholder engagement. risk of one of its diabetes medicines. The com- Rises four places due to performance in equi- pany maintains that it acted appropriately. table pricing. Takeda moves from 20th to 16th, SCORE 1.3 due to its implementation of equitable pricMARKET INFLUENCE & COMPLIANCE RANK 13 SCORE 1.8 ing strategies

for the first time, as well as to its RESEARCH & DEVELOPMENT improved performance in registering products in RANK 7 high-burden countries. SCORE 2.8 Rises two positions despite large fine for misconduct. Takeda rises to 13th place, despite Maintains performance in R&D. Takeda fell one Newly implements equitable pricing of prod- being the subject of the largest settlement in position, but remains in the top ten. This fall is ucts for high-burden diseases. Takeda imple- financial terms following a case of misconduct largely explained by improvements in the perfor- ments equitable pricing strategies for products of any company evaluated. The company has a mances of its peers. The company maintained for diabetes, hypertensive heart disease and comprehensive, risk-based auditing system and a strong performance across R&D. Its relevant chronic obstructive pulmonary disorder (COPD). enforces its procedures on third parties. pipeline almost doubled in size and

its perfor- Only a few (2%) of Takeda’s products have equi- mance in product development, clinical trial con- table pricing strategies that target priority coun- duct and data transparency also improved. tries (disease-specific sub-sets of countries with Marketing code in place, but performance incentives are sales driven. Takeda has a mar- a particular need for access to relevant prod- keting code of conduct that aligns with industry R&D commitments are oriented towards ucts). These reach just a few corresponding pri- standards. However, the company does not have access. Takeda aims to deliver its pipeline to ority countries. performance incentives for its sales employees patients with unmet needs around the world. other than sales targets. Furthermore, it only The company has a dedicated Access to Sets pricing guidelines for all sales agents. provides general information about its market- Medicine Council with specific R&D aims. Takeda provides pricing

guidelines to third-party ing practices in countries in scope. wholesalers and distributors, but does not proNo policy for R&D partnerships to include vide evidence that it monitors or audits their Low transparency regarding lobbying activi- access plans. The company does not commit pricing practices. ties. Takeda declares it may make financial con- to ensuring access-oriented terms (e.g, reg- tributions to political organisations, public offi- istration targets or affordable pricing strate- 138 Source: http://www.doksinet Access to Medicine Index 2016 Mixed performance in product registration. No public position on Doha Declaration. Takeda Donations monitored by partners. Takeda Takeda does not provide evidence that it sets has not published its position on the Doha works with international organizations to make disease-specific registration targets. It does not Declaration on the TRIPS agreement and public ad hoc donations. Third parties have the respon-

publish its criteria for making decisions about health. sibility of ensuring that donations are made suc- when or where to register its products, nor does cessfully and in compliance will local codes and it publish information about its products’ regis- laws. Takeda reserves the right to conduct inde- tration status. However, it has filed to register CAPACITY BUILDING more than half (70%) of its newest products in a RANK 10 pendent audits of third parties and recipients. SCORE 1.8 Involved in humanitarian aid programmes. few priority countries (disease-specific sub-sets of countries with a particular need for access to Showing significant improvements. Takeda is Takeda provided ad hoc donations for humani- relevant products). As most of these products one of the biggest risers since 2014. The com- tarian aid, mostly via its partner Americares. were first marketed in 2010, the company can pany has particularly improved in capacity build- consider improving its

registration in low- and ing in R&D and pharmacovigilance. However, its middle-income countries. performance is mixed: it disclosed no relevant supply chain management capacity building ini- Consistent recall guidelines. Takeda has glob- tiatives, and does not have a clear focus on local ally consistent guidelines for issuing drug recalls needs. in all countries relevant to the Index where its products are available. Takeda does not publish Strong in R&D capacity building. Takeda builds information on recalls. local R&D capacity through partnerships with and support of local research organisations in Limited brochure and packaging adaptation for countries in scope, including China and Thailand. rational use. Takeda adapts its brochures and The company has a relatively large number of packaging materials to address local language partnerships but it is unclear how it targets local and environmental needs, but does not consider skills gaps. literacy,

demographic, or cultural needs. Improved performance in strengthening pharmacovigilance systems. Takeda voluntarPATENTS & LICENSING ily shares safety data with authorities in coun- RANK 17 tries in scope. The company has activities to SCORE 0.6 build local pharmacovigilance capacity in southAmong laggards, but new policy. Takeda had east Asia, through the International Society of not published its patent filing and enforcement Pharmacovigilance. policy, the status of their patents, or their position on the Doha Declaration on the TRIPS Building manufacturing capacity with a focus in agreement and public health during the period Asia. Takeda commits to assessing and building of analysis. However, there are positive future capacity in countries in scope for in-house man- indications. It has a newly agreed IP policy, which ufacturers only. The company undertakes a rel- includes a policy of not filing patents in sub-Sa- atively small number of capacity building

activi- haran Africa, and a new preparedness to offer ties, focusing on in-house facilities in Asia (India royalty-free licensing terms for supply to low-in- and Indonesia). come countries and Least Developed Countries. Builds capacity outside the value chain in Haiti Waiving patent rights in sub-Saharan Africa. and Kenya. Takeda’s philanthropic strategy is rel- Takeda has not made its position on patents atively strong: it targets local needs and includes public, but it has disclosed to the Index that it impact measurements, but does not routinely will not file for new patents and will actively consider long-term impact. The company builds abandon existing patents in sub-Saharan Africa capacities outside the pharmaceutical value (except in South Africa). chain, focusing on local gaps in access to health services, in Haiti and Kenya. No public disclosure of patent status. Takeda does not publish the status of its patents. PRODUCT DONATIONS Commits to engaging in

licensing in the future. RANK 16 SCORE 1.7 Takeda does not engage in the non-exclusive voluntary licensing of its patented products. Rises two places. While Takeda has not yet Takeda disclosed to the Index that it will offer implemented a structured donation programme, royalty-free licences to manufacturers to supply it has risen from 18th to 16th position in this Least Developed Countries and low-income area. The company has tailored donation policies countries. and strategies, and is involved in humanitarian aid programmes. Absence of competition-related breaches. Takeda was not found to have been the sub- Respects WHO guidelines in product dona- ject of breaches, fines or judgements relating to tions. Takeda has tailored its donation strategy, competition law during the period of analysis. partly in line with the core principles of WHO Guidelines for Medicine Donations. 139 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 16 1.70

Boehringer Ingelheim GmbH 14 (2014) Stock Exchange: Privately held • Ticker: - • HQ: Ingelheim, Germany • Employees: 47,501 (average 2015) Ranking by technical area Ranking by strategic pillar 5 R&D 2. 0 Pricing 1 .1 Patents 2. 1 Capacity 1 .2 Donations 1 .6 0 4 3 2 1 leader 1 2 3 4 5 average average 0.3 1 .3 2.2 Compliance 1 .3 3. 1 1 .7 Management Commitments Transparency Performance Innovation 0 PERFORMANCE Boehringer Ingelheim falls two places to 16th. Its transpar- targets local needs. However, the company rises in R&D, with ency remains low, particularly regarding market influencing one of the largest pipelines for diseases in scope and a new and the outcome of its stakeholder engagements. Its access R&D strategy that includes measurable time-bound targets. approach does not clearly align with its corporate strategy. Plus, it has expanded its commitment not to file for or enforce It drops in donations as it no longer

has a structured dona- patents, achieving the broadest geographic scope (albeit for tion programme. In capacity building, it has fallen considera- one product) compared to peers. In pricing, its performance bly, in part by providing comparatively little evidence of how it falls and it is overtaken by peers. CHANGE SINCE 2014 • Has two new, promising pilots of innovative • Has doubled the size of its relevant pipeline. business models in low-income communities in Kenya. diseases in scope. • Has a new R&D strategy focused on open innovation via collaboration. It is not currently • Has developed an Africa Strategy, where it • Has no registration targets for products for partnering with third-parties on relevant R&D. • No longer provides price- and volume-of-sales information. acknowledges the long-term growth potential of markets in Africa. • Has the same number of products with equitable pricing strategies as in 2014. • Maintains low transparency

regarding its access strategy and stakeholder engagement • Pledges not to enforce its patent on extended-release nevirapine (Viramune XR®), including in all middle income countries. • Improves its accountability for its sales agents’ pricing practices. • Has not strengthened its compliance system. • Is less active in manufacturing capacity building (but began technology transfers with a third-party manufacturer in China in 2015). OPPORTUNITIES Prioritise R&D targets based on need. lar, it can designate certain territories where it stakeholders to jointly identify skills gaps and Boehringer Ingelheim has pledged EUR 11 bil- is not present as suitable for licensing to generic capacity building goals in other areas of the lion for R&D from 2015 to 2020. It can prioritise medicine manufacturers. pharmaceutical value chain (e.g, strengthening R&D targets based on the needs of people in supply chains). low- and middle-income countries, and engage

Improve transparency, particularly around in relevant R&D partnerships. The company can stakeholder engagement. Boehringer Ingelheim also put clear access plans in place during prod- can improve the transparency of its access strat- uct development to ensure successful innova- egies and initiatives. It can engage more with tions are accessible to relevant countries upon stakeholders worldwide, in order to learn from market approval. them and share expertise with external partners. It can disclose the outcomes of these Address access needs in markets not prior- engagements. itized in Africa Strategy. Boehringer Ingelheim has prioritsed five markets in sub Saharan Africa. Broaden capacity building efforts in response It can consider approaches for ensuring access in to local needs. Boehringer Ingelheim can draw other sub-Saharan countries, e.g, by using equi- upon its experience of long-term R&D partner- table pricing, licensing and donations. In particu-

ships with local universities, to work with local 140 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Net sales by segment (2015) 576 MN 1 ,363 MN 1 45 MN 1 ,51 3 MN EUR 14,798 MN 1 1 ,201 MN Prescription Medicines Biopharmaceuticals Consumer Health Care Industrial Customers and other sales Animal Health In scope, has sales Net sales by region In scope, has no sales MN EUR Not in scope SALES AND OPERATIONS 1 4,000 1 2,000 1 0,000 8,000 Boehringer Ingelheim has five divisions: business for Boehringer Ingelheim’s consumer Prescription Medicines, Consumer Health Care, healthcare business was announced. Boehringer Animal Health, Biopharmaceuticals and Industrial Ingelheim has sales in 23 countries within the Customers. Prescription Medicines accounts for scope of the Index. 6,000 4,000 2,000 the vast majority of its sales. The company’s key 0 areas of focus are: cardiovascular disease, met- 2011 2012 2013

Asia/Australasia/Africa abolic diseases, immunology. oncology and dis- 2014 Europe 2015 Americas eases of the central nervous system. In June 2016, an assets swap of Sanofi’s animal health PORTFOLIO AND PIPELINE Products per disease category 3 Boehringer Ingelheim has one of largest pipe- tes and kidney diseases. Since 2014, five of its lines of products: with 52 relevant projects. Its R&D projects have progressed from discovery portfolio is mid-sized, with 34 medicines, and stage to pre-clinical development, and two pro- has a strong focus on non-communicable dis- gressed from pre-clinical into clinical develop- eases (NCDs). ment. A small proportion of its pipeline targets 2 34 high-priority product gaps with low commercial Within its NCD portfolio, Boehringer Ingelheim’s 29 incentive. medicines target respiratory diseases, diabetes, Communicable and hypertensive and ischaemic heart disease. Non-communicable Maternal and neonatal This focus is also

reflected in their R&D pipeline, Boehringer Ingelheim’s portfolio is heavily focused with most candidates targeting asthma, chronic on NCDs, which account for 85% of its total obstructive pulmonary disease (COPD), diabe- portfolio. Pipeline projects First-line treatments and essential medicines 1 00% 0 10 5 4 15 10 20 30 40 50 In partnership, with access provisions (ap) 60 70 80 In partnership, w/o ap 90 100 Not in partnership 0 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other Boehringer Ingelheim does not collaborate with external organisations on its 19 of Boehringer Ingelheim’s medicines are listed on the WHO EML and/or relevant R&D projects. are first-line treatments: e.g, olodaterol (Striverdi®), telmisartan/amlodipine (Twynsta®), fenoterol (Berotec®) and nevirapine (Viramune®). Pipeline by stage of development Innovative medicines and vaccines Adaptive medicines

and vaccines CD CD NTD NTD MNH MNH NCD 37 11 3 NCD Multiple Multiple 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval Boehringer Ingelheim’s relevant pipeline has a focus on developing innova- Boehringer Ingelheim is not currently adapting any products to meet the tive medicines for non-communicable diseases. The company is developing needs of people living in low- or middle-income countries. among the largest number of innovative medicines relevant to the Index. 141 Source: http://www.doksinet Access to Medicine Index 2016 Boehringer Ingelheim GmbH PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE MARKET INFLUENCE & COMPLIANCE RESEARCH & DEVELOPMENT MANAGEMENT RANK 18 RANK 13 RANK 14 SCORE 1.3 SCORE 2.0 SCORE 3.1 Drops eight places due to

decreased trans- Improved position in R&D. Boehringer Ingelheim Rises two places despite mixed performance. parency and weak compliance. Boehringer rises five places in the R&D ranking. Its pipeline Boehringer Ingelheim moves from 16th to 14th. Ingelheim falls eight places due to an overall has more than doubled in size since 2014, due It has started several innovative access pilots drop in transparency and a below-average com- to projects that meet new inclusion criteria. Its through its best-practice platform for foster- pliance system. improved ranking is also a result of drops in the ing innovation (Making More Health). However, it performance of some of its peers. lacks transparency across access management, Lags in ethical marketing, with no clear code access outcomes and stakeholder engagement. of conduct. Boehringer Ingelheim does not New R&D strategy supported by five-year have a detailed marketing code of conduct, but investment. Boehringer

Ingelheim’s new strat- Access strategy in place, but no clear alignment refers to IFPMA principles on ethical conduct egy plans to invest EUR 11 bn into its new with corporate strategy. Boehringer Ingelheim and promotion. It is not a signatory of the United R&D programme over the next five years. This has an access strategy for its business activities Nations Global Compact and provides no details includes EUR 5 bn for pre-clinical R&D. EUR 15 in emerging markets that relate to specific ther- about its marketing programmes in countries bn will go towards collaborative R&D. When size apeutic areas: cardiovascular diseases, respira- within scope. (by revenue) is taken into account, the company tory diseases and diabetes. It has also developed is a clear leader when it comes to directing R&D an Africa Strategy. However, the company does Below average transparency in lobbying. not provide details on how its access strategy Boehringer Ingelheim has

made some of its aligns with its corporate strategy. public policy positions available on its web- Poor performance in collaborative R&D. The site, specifically related to anti-counterfeiting. company is not engaged in relevant R&D part- Performance management system in place, but In addition, the company supports the policy nerships nor intellectual property sharing. no insight into targets. Boehringer Ingelheim positions of trade associations of which it is a has a performance management system to track member. It does not disclose information about Takes measures to ensure ethical clinical trial progress toward access objectives. However, its conflict of interest policy. conduct. Boehringer Ingelheim has policies in investments towards relevant diseases. place and takes measures to ensure in-house the company is not transparent with regards to these measurements, nor does it provide Does not disclose breaches of laws or codes. and outsourced clinical

trials are conducted evidence that it has specific access-oriented Boehringer Ingelheim did not provide any infor- ethically. incentive structures in place to motivate its mation regarding breaches of codes, regulations employees. and laws, or consequent settlements. The company has been found in breach of codes of con- PRICING, MANUFACTURING & Lack of transparency in stakeholder engage- duct twice for cases related to unethical market- DISTRIBUTION ment. Boehringer Ingelheim has a stakeholder ing, during the period of analysis. RANK 18 SCORE 1.1 engagement strategy and a system in place to incorporate local stakeholder perspectives in its Some enforcement processes present. Drops four places as peers overtake on equi- access-related activities. Nevertheless, it does Boehringer Ingelheim has a process for enforc- table pricing. Boehringer Ingelheim falls four not publish its stakeholder engagement pro- ing codes of conduct that applies to all employ- places

from 14th: its equitable pricing behav- cesses, activities and related outcomes. ees and third parties. Failure to comply with iour remained static while peers improved. the company’s rules and regulations may result Additionally, unlike in 2014, the company does Innovation: two business models. PreCare is a in disciplinary action, including termination of not provide any price or volume-of-sales infor- holistic stroke care package for reaching low-in- employment or discontinuation of services. mation to demonstrate the implementation of come communities in Kenya through awareness However, the company does not disclose details its equitable pricing strategies. raising, education, innovative transport, treat- of disciplinary action taken. Laggard in equitable pricing. Boehringer ment and insurance solutions. It has also set up a coupon-based “loyalty” program, also for stroke Audit system extends to third parties. The com- Ingelheim has equitable pricing

strategies for the and which targets both patients and healthcare pany has an auditing system that is co-managed same products as in 2014: these are focused on professionals. Patients receive points for healthy by its Compliance and Internal Audit depart- ischaemic heart disease, HIV/AIDS and stroke. behaviour, and clinics and doctors receive points ments. These oversee regular audits within the However, only a few (6%) of the company’s rele- for adhering to protocols and patient tracking. company and of third parties. The system covers vant products have pricing strategies that target all countries in which the company has opera- priority countries (disease-specific sub-sets Best Practice: Making More Health. tions. Boehringer Ingelheim does not use exter- of countries with a particular need for access Boehringer Ingelheim and Ashoka (an NGO) nal resources for audits. to relevant products). Together, these target work together to develop, support and scale up

just a few (6%) priority countries. Boehringer innovative business models that address global Ingelheim is the only company without a spe- health challenges, focusing on prevention, diag- cific commitment to applying equitable pricing in nosis and treatment. countries and diseases in scope. 142 Source: http://www.doksinet Access to Medicine Index 2016 New products are registered relatively rap- Pro-access stance on trade policy. Boehringer PRODUCT DONATIONS idly. Boehringer Ingelheim has not yet set spe- Ingelheim has no publicly available position on RANK 17 cific registration targets for diseases and coun- the Doha Declaration on the TRIPS agreement tries in scope. It does not publish its criteria for and public health. However, it states that it does Drops two places. Boehringer Ingelheim has deciding when and where to register its prod- not support positions within free-trade agree- halted its nevirapine (Viramune) structured ucts, nor does it state where

products are reg- ments that would negatively impact access to donation programme for HIV/AIDS. It ended istered. However, it has filed to register all of its medicines. in January 2014 following a change in WHO SCORE 1.6 treatment guidelines. The company no longer newest products in at least some priority coun- engages in structured donation programmes and tries (disease-specific sub-sets of countries with particular need for access to relevant prod- CAPACITY BUILDING ucts). Almost half of these products were first RANK 17 drops to 17th place. SCORE 1.2 Complies with external guidelines. Boehringer launched in 2014 or 2015, making this a relatively Biggest faller in capacity building. Boehringer Ingelheim’s ad hoc donations commit to the core Ingelheim fell 13 places. It demonstrated less principles of international guidelines for dona- Consistent recall guidelines. Boehringer activity in key areas such as manufacturing, and tion programs, and follow WHO and

PQMD Ingelheim has globally consistent guidelines for was outperformed by peers in areas such as guidelines. issuing drug recalls that apply in all countries rel- pharmacovigilance and capacity building outside evant to the Index. It does not publish informa- the pharmaceutical value chain. Its targeting of Undertakes regular audits. Boehringer tion on its recalls. local needs and skills gaps is limited. Ingelheim is one of the few companies undertak- Limited brochure & packaging adaptation for Above average performance in R&D capac- rational use. Boehringer Ingelheim provides evi- ity building. Boehringer Ingelheim’s strongest dence of adapting brochures and packaging capacity building area is R&D: it has a number of Involved in humanitarian assistance. Boehringer materials to address language needs, but does partnerships with local research organisations Ingelheim typically donates ad hoc donations to not consider literacy, demographic, environmen-

to support R&D expertise in countries. All of its long-term partners AmeriCares, Direct Relief tal or cultural needs in countries in scope. its partnerships are long-term, but they do not International and MAP international. good performance. ing regular audits and requiring regular reporting from recipients on donations. clearly target local skills gaps. PATENTS & LICENSING Some activity to strengthen pharmacovigilance RANK 7 systems. Boehringer Ingelheim updates safety SCORE 2.1 labels in countries in scope but did not volunConsistent performer. Boehringer Ingelheim is tarily share other safety information with rele- a consistent performer in Patents & Licensing, vant authorities. The company has one relevant and provides clarity on where it intends to make activity to build local pharmacovigilance capac- use of its IP rights. In 2016, it improves its behav- ity: with authorities in the Middle East (including iour by expanding the geographic scope of

its Egypt and Iraq). non-assert declaration for extended-release nevirapine (Viramune XR®). Low level of activity in manufacturing capacity building. While Boehringer Ingelheim has a spe- Maintains its access-oriented approach to IP on cific system to build capacity for in-house man- anti-retrovirals (ARVs). Boehringer Ingelheim ufacturers, it disclosed only one capacity build- has a history of issuing in non-assert declara- ing activity in the period of analysis: it has begun tions on ARVs. These currently apply to extend- transferring production of HIV/AIDS medicines ed-release nevirapine (Viramune XR®) and to to a third party manufacturer in China. tipranavir (Aptivus®). Limited focus on strengthening supply chains. Waives nevirapine patent rights in MICs. Boehringer Ingelheim did not demonstrate rele- Boehringer Ingelheim has expanded its pledge vant activities to build supply chain management not to enforce its IP rights to extended-release capacity in

countries in scope. The company dis- nevirapine (Viramune XR®) to cover all middle closed a detailed approach to falsified medicines income countries. This is the broadest non-en- but did not commit to timely reporting of sus- forcement agreement noted by the Index, and pected cases. was negotiated through the Medicines Patent Pool. Local capacity-building needs for health-related skills and infrastructure outside the value No transparency on patent status. Boehringer chain are not clearly targeted. Boehringer Ingelheim does not publish the status of its Ingelheim does not demonstrate a strategic, patents. needs-based approach to philanthropy. The company undertakes capacity building activities Absence of competition-related breaches. outside the pharmaceutical value chain but does Boehringer Ingelheim was not found to have not clearly address local needs or mitigate con- been the subject of breaches, fines or judge- flicts of interest. ments relating to

competition law during the period of analysis. 143 Source: http://www.doksinet Access to Medicine Index 2016 RA N K 17 = SCO R E Eli Lilly & Co. 1.67 17 (2014) Stock Exchange: XNYS • Ticker: LLY • HQ: Indianapolis, IN, US • Employees: 41,275 Ranking by technical area Ranking by strategic pillar 5 R&D 1 .5 Pricing 1 .2 Patents 0. 9 Capacity 1 .5 Donations 2. 4 0 4 3 2 1 leader 1 2 3 4 5 average average 0.7 1 .9 1 .7 Compliance 1 .6 3. 7 2.4 Management Commitments Transparency Performance Innovation 0 PERFORMANCE Eli Lilly remains 17th. The governance of its approach to product than in 2014, and now has three donation pro- access has significantly improved: its new Going Beyond grammes. However, it has the smallest pipeline relevant to the Medicines Alone strategy combines its several initiatives Index. It has fallen back in pro-access IP management During on access. It has improved substantially in Market Influence the

period of analysis, it was judged to have breached com- & Compliance, with a more transparent approach to ethi- petition law in Mexico. Eli Lilly shows innovation in capacity cal marketing and lobbying, and a broad, risk-based approach building but does not clearly demonstrate that all its capacity to auditing. It uses equitable pricing strategies for one more building activities consistently target local needs. CHANGE SINCE 2014 • Improves its access strategy, including the development of an innovative business model building capacity outside the pharmaceutical value chain. • Still does not publish the status of its patents in countries in scope. for diabetes in China. • Has not yet set targets for registering prod• Has the smallest relevant pipeline of all 20 companies measured. • Expanded its intellectual-property-sharing Declaration on the TRIPS agreement and scope. public health. • Has not yet disclosed price or volume-of-sales partnership with the

Medicines for Malaria information to demonstrate the implementa- Venture in 2015. tion of its equitable pricing strategies. • Performs less well in building capacity in manufacturing, offset by an innovative approach to • Has no publicly available position on the Doha ucts for specific diseases or in countries in • Continues to engage in donation programmes for diabetes and mental health conditions. • Still does not provide pricing guidelines to sales agents or monitor prices or mark ups. OPPORTUNITIES Expand and strengthen its access focus. Eli Lilly R&D activities fill key product gaps by drawing Set registration targets for key diseases. Eli currently focuses its access initiatives around on its experience in understanding local product Lilly can set targets for registering products in products for diabetes and TB. It can go beyond development needs, gathered, e.g, through the countries in scope. This helps to ensure early these by drawing upon its

diverse expertise Lilly China Research and Development Centre. access to products in high-need countries. The in different disease areas and product types. As new products move into late stages of devel- company can also register existing products in Plus, given that non-communicable diseases opment, Eli Lilly can make plans for products to more countries with high burdens of disease. (NCDs) are a growing concern in low- and mid- reach poor and vulnerable populations in low- dle-income countries, Eli Lilly can strengthen its and middle-income countries. Consider access barriers for animal health products. Given the large numbers of people in approach to affordability here. Strengthen and expand capacity building low- and middle-income countries living with Mitigate mark-ups in low- and middle-income efforts. Eli Lilly can draw on its experience in livestock and other animals, Eli Lilly can leverage countries. Where legally possible, Eli Lilly can building capacity

outside the value chain and its acquisition of Novartis’ Animal Health busi- provide pricing guidance to sales agents and from its multi-drug-resistant TB (MDR-TB) part- ness to improve human health by addressing establish processes for monitoring mark-ups. nership, to strengthen and expand its activities zoonotic diseases. within the value chain. For example, it can expand Consider local needs and access during prod- its efforts to build manufacturing capacity, work- uct development. Eli Lilly can ensure more of its ing with local partners to identify shared goals. 144 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Revenues by segment (2015) 3,1 81 .0 MN USD 19,958.7 MN 1 6,777.7 MN Human pharmaceutical products Animal health In scope, has sales Revenues by geographic information In scope, has no sales 24,000 MN USD Not in scope 22,000 20,000 1 8,000 SALES AND OPERATIONS 1 6,000 1 4,000 Eli Lilly is divided into two

segments: Human The company has sales in 72 countries in scope, Pharmaceutical Products and Animal Health and approximately 15% of its revenues derive Products. Its portfolio is focused on oncology, from emerging and frontier markets. 1 2,000 1 0,000 8,000 6,000 neuroscience, men’s health, immunology, endo- 4,000 2,000 crinology and cardiovascular disease. With the 0 acquisition of Novartis’ Animal Health busi- 2011 Rest of world ness, Eli Lilly became the world’s second largest 2012 2013 Japan Europe 2014 2015 USA animal health company. PORTFOLIO AND PIPELINE Products per disease category 1 Eli Lilly has the smallest pipeline of projects, Eli Lilly’s relevant R&D project aims to develop with one R&D project that addresses the needs a VEGFR1 antibody to target diabetic nephropa- of people in countries in scope. With 14 med- thy. This product candidate has moved from dis- icines, its portfolio is also one of the small- covery stage, through

preclinical development, est of the companies in scope. Eli Lilly’s portfo- and into phase I since 2014. Eli Lilly is not target- lio includes medicines targeting ischaemic heart ing high-priority product gaps with low commer- disease, diabetes and mental health conditions. cial incentive for diseases in scope. 3 14 10 In 2014, Eli Lilly gained market approval from the Communicable FDA for dulaglutide (Trulicity®) for the treat- Non-communicable Multiple categories ment of type 2 diabetes. In addition to products for NCDs, Eli Lilly’s portfolio also contains med- Eli Lilly’s portfolio is focused on NCDs: 10 out of icines for infectious diseases: vancomycin, cefa- the 14 products in its relevant portfolio target one clor and capreomycin. or more NCDs. 14 First-line treatments and essential medicines Pipeline projects 3 36 1 00% 0 10 20 30 40 50 In partnership, with access provisions (ap) 60 70 80 In partnership, w/o ap 90 100 Not in partnership

0 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other Eli Lilly is not collaborating with external organisations on R&D for diseases Eli Lilly has eight medicines listed on the WHO EML and/or as first-line treat- in scope. ments: olanzapine, glucagon, insulin lispro, vancomycin, capreomycin, quinidine duloxetine and fluoxetine. Pipeline by stage of development Innovative medicines and vaccines Adaptive medicines and vaccines CD CD NTD NTD MNH MNH NCD NCD Multiple Multiple 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval Eli Lilly’s only relevant pipeline project is a new chemical entity (NCE): a Eli Lilly is not currently adapting any products to meet the needs of people VEGFR1 antibody targeting

diabetic nephropathy. living in low- or middle-income countries. 145 Source: http://www.doksinet Access to Medicine Index 2016 Eli Lilly & Co. PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE local governments, communities and the com- RESEARCH & DEVELOPMENT MANAGEMENT pany, through training, support and partnership. RANK 18 RANK 9 The programme aims to extend the reach and SCORE 3.7 Improvements in all areas lifts company into SCORE 1.5 impact of the company’s product portfolio to the Falls further in ranking. Eli Lilly’s pipeline of emerging Chinese middle class. products that qualify for analysis is below aver- top ten for access management. Eli Lilly moves age in size; it was not able to demonstrate how up three places into the top ten, following certain investigational products will be made improvements across all areas of measurement. MARKET INFLUENCE & COMPLIANCE accessible in relevant countries. Eli Lilly main- Its

transparency is still limited: the company RANK 12 tains a leading position when it comes to ensur- SCORE 1.9 does not yet disclose its performance toward ing that clinical trials will be conducted ethically. access targets or its approach to stakeholder Rises seven places following improved com- engagement. pliance. Eli Lilly rises into the middle group, No clear R&D targets addressing diseases and mainly due to indications that its compliance has countries in scope. Eli Lilly commits to conduct- New access strategy covering multiple pro- improved and to an increased level of transpar- ing R&D for diseases in scope, including diabe- grammes. Eli Lilly has developed a new Going ency in its lobbying activities. tes, and intends to register its products in coun- Beyond Medicines Alone Strategy, aimed at tries in scope. However, Eli Lilly does not pro- increasing access to medicine for people in low- Weak evidence of code of conduct for ensur- vide evidence

of having measurable, time-bound and middle-income countries. This strategy ing ethical marketing. Eli Lilly discloses weak strategies to operationalise this commitment. includes several programmes, such as the com- evidence that its approach to ethical marketing pany’s MDR-TB Partnership and the Expanding is consistent with industry standards. However, Commitment to R&D partnerships, but no Access for People programme for diabetes in the company provides training for its employees policy. Eli Lilly commits to engaging in R&D China. on ethical marketing. Employee incentives take partnerships to increase access to medi- more than sales performance into account, also cine. However, it has no mechanism for ensur- Performance management system in place, but looking at employee competencies, behaviours ing access-oriented terms are systematically does not publish progress. The company has a and customer value metrics. included in the terms of R&D

partnerships. that uses quantitative and qualitative measures Some transparency on lobbying activities. Eli Strong policy on clinical trial ethics. The Lilly to collect data and appraise performance across Lilly states that it does not make political contri- Bioethics Framework helps ensure Eli Lilly’s its global operations. Eli Lilly does not publicly butions in countries within scope. It discloses an trials are conducted ethically. This includes an report on its performance against access-re- overview of its policy positions related to access iterative process to ensure studies are designed lated targets. to medicine, in particular those related to free ethically, and a clear policy on providing partic- trade agreements and intellectual property. Eli ipants with continued access to investigational Incentive programme rewards teamwork, col- Lilly does not disclose any information related to medicines after a trial is complete. laboration, leadership. The company

has estab- its policy for managing conflicts of interest. centralised performance management system High transparency around clinical trials. Eli Lilly lished the Lilly Access Excellence Awards, which recognizes individuals and teams for excellence Transparent when found to be acting unethi- maintains a high level of clinical trial data trans- in access-to-medicine practices. Employees are cally. Eli Lilly is transparent with regards to dis- parency, including providing scientific research- rewarded for outstanding teamwork, cross-func- closure of its settlement reached for infractions. ers access to patient-level data upon request, via tional collaboration and leadership in meeting The company has been found in breach of a clinicalstudydatarequest.com this goal. code of conduct, related to unethical marketing, once during the period of analysis. Collaborates through intellectual property sharing. While Eli Lilly has no collaborations in Stakeholder engagement

strategy includes structured approach. Eli Lilly’s stakeholder Has system for enforcing compliance. Eli Lilly its relevant pipeline, it shares intellectual prop- engagement strategy includes a structured has a system for enforcing compliance among erty for MDR-TB via the Lilly Tuberculosis Drug approach to engaging with local stakeholders. employees and representatives, but it discloses Discovery Initiative. Its Open Innovation Drug This approach is managed from either the HQ or only general information and does not provide Discovery Program shares compounds with the local offices, depending on the type of engage- details on disciplinary actions taken. Medicines for Malaria Venture. ment and location. Nevertheless, the company does not publish information on its stakeholder Broad scope for auditing process. Audits are engagement approach. conducted annually, but the company does not PRICING, MANUFACTURING & specify whether it also uses external resources.

DISTRIBUTION Innovation: business model for diabetes in The scope extends to the entire organisation, to RANK 17 China. Lilly Expanding Access for People (LEAP) all countries of operations and to third parties, is a pilot that addresses access to diabetes care based on risk assessment. SCORE 1.2 Rises one place with an expansion of equitable in China. It uses a for-profit business model, pricing. Eli Lilly moves from 18th to 17th place, informed by a shared value approach, that cre- due to a modest increase in its use of equita- ates benefits for individuals, their families, ble pricing. The company only considers afforda- 146 Source: http://www.doksinet Access to Medicine Index 2016 bility, and no other socio-economic factors, in Limited transparency on patent status and the active pharmaceutical ingredient for capreo- either its inter- or intra-country equitable pricing trade agreements. Eli Lilly does not publish mycin (a TB medicine). strategies. It

performs poorly when it comes to the status of its patents in countries in scope, rapidly and widely filing for registration. and has not published its position on the Doha Innovation: supporting TB treatment capac- Declaration on the TRIPS agreement and public ity. Eli Lilly takes a multi-pronged, technolo- health. gy-based approach to building capacity in India Increased equitable pricing. Compared to 2014, to diagnose and treat TB patients. Its strategy Eli Lilly has one more product with equitable pricing. Its equitable pricing strategies cover No involvement in voluntary licensing. Eli Lilly includes a mobile application to support rural products for diabetes and unipolar depres- does not engage in the non-exclusive voluntary health care workers, and a web-based tool to sive disorders. A quarter (25%) of its products licensing of its patented products, and has no improve TB-case notification and treatment have equitable pricing strategies that target pri-

public stance detailing when and how it would adherence by private health services. ority countries, reaching some (27%) priority consider licensing. countries (disease-specific sub-sets of countries with a particular need for access to rele- Evidence of anti-competitive behaviour. During PRODUCT DONATIONS vant products). the period of analysis, the Mexican Supreme RANK 11 SCORE 2.4 Court of Justice confirmed a decision by the Still no pricing guidance for sales agents. As in Mexican Competition Authority that Eli Lilly Rises five places, out of the bottom group. 2014, Eli Lilly does not guide, monitor or audit (among other companies not in scope) engaged Eli Lilly has moved from 16th to 11th place. the pricing practices of its sales agents. in anti-competitive practice between 2003- With three donation programmes for NCDs, it 2006. Eli Lilly maintains it did not engage in accounts for almost half of the donation pro- inappropriate behaviour. grammes in this

category. Limited registration performance. The company has only provided registration information Has three long-term structured donation pro- for one of its products, dulaglutide (Trulicity®), for which it has filed for registration in a few pri- CAPACITY BUILDING grammes. Eli Lilly’s programmes are focused ority countries (disease-specific sub-sets of RANK 15 on mental health and diabetes. It provides insu- SCORE 1.5 lin to diabetes patients through two single-drug countries with a particular need for access to relevant products). Eli Lilly does not have dis- Focuses on capacity building outside the value donation programmes: Life for a Child (LFAC), ease-specific targets for registering its prod- chain. Eli Lilly takes a relatively strong approach in which Eli Lilly provides insulin for 13,500 chil- ucts in countries in scope, nor does it commit to to building capacity outside the pharmaceutical dren in 23 countries; and AMPATH, in which Eli a registration

timeframe. It does not publish the value chain, including innovative initiatives in this Lilly provides insulin to 1,475 adults in Western criteria it uses to decide when and where to reg- area. However, its performance in other areas is Kenya. ister its products. comparatively weak, particularly in manufacturing and in R&D partnerships with local research Improving donations supply chain. In partner- Consistent recall guidelines. Eli Lilly has glob- organisations in countries in scope. It does not ship with DHL, Eli Lilly helped to improve the ally consistent guidelines for issuing drug recalls consistently target local needs. security of shipments of donated pharmaceutical products to Kenya. Shipments included insu- in all countries in scope where its products are available. Eli Lilly does not publish information Stronger in building capacity outside the value lin, fluoxetine and olanzapine for AMPATH dona- on recalls. chain. Eli Lilly’s approach to

philanthropy is rela- tion programmes. tively strong (including long-term commitments Limited brochure & packaging adaptation for and impact measurement), but does not clearly Unclear guidelines on monitoring, audit- rational use. Eli Lilly aims to facilitate rational target local needs or specific objectives. The ing and donations. Eli Lilly states that its ad use by using blister packs for products destined company builds capacities outside the pharma- hoc and structured donation programmes are for hot and humid conditions and by ensuring ceutical value chain in relevant countries, focus- designed to comply with both internal standards packaging and labelling include text in local lan- ing on TB and diabetes. and external guidelines, including WHO guidelines. It has not, however, disclosed its policy guages for all products. Strengthening supply chains through part- The company also did not provide any informa- nerships. Eli Lilly is moderately active in build-

tion regarding the monitoring and auditing of its PATENTS & LICENSING ing supply chain management capacity in coun- donation programmes. RANK 15 tries in scope through partnerships, includ- SCORE 0.9 ing in Pakistan, Rwanda and Vietnam. However, Makes ad hoc donations following natu- Conservative approach to licensing and the company did not demonstrate that it shares ral disasters and in humanitarian crises. Eli patent transparency leads to a low ranking. information with relevant stakeholders to Lilly donates medicines that are specifically While Eli Lilly has a clear policy of not filing improve supply chains. requested by relief agencies, partnering with for or enforcing patents in Least Developed them during natural disasters and humanitar- Countries, it remains comparatively conserva- Limited strengthening of pharmacovigilance ian crises. During the period of analysis, it has tive in its approach to licensing, patent disclo- systems. Eli Lilly updates

safety labels for its donated in response to earthquakes in Haiti sure and public acknowledgement of the Doha products in relevant countries but did not dis- and Nepal, MAP international, project HOPE, Declaration on TRIPS and public health. Plus, Eli close voluntary safety data sharing with author- Americares, Direct Relief International and Lilly was the object of a negative decision con- ities. It does not build local pharmacovigilance Partners in Health. cerning anti-competitive behaviour in Mexico. capacity through partnerships. Publicly available policy of not filing for or Weaker performance in building manufacturing enforcing patents. Eli Lilly has a publicly availa- capacity. Eli Lilly makes a general commitment ble policy of not seeking, maintaining or enforc- to building manufacturing capacity in relevant ing patents in Least Developed Countries. countries. In the period of analysis, the company completed one technology transfer to a thirdparty

manufacturer in China for manufacturing 147 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 18 1.61 Daiichi Sankyo Co., Ltd 19 (2014) Stock Exchange: XTKS • Ticker: 4568 • HQ: Tokyo, Japan • Employees: 15,249 Ranking by technical area Ranking by strategic pillar 5 Management 1 .6 Compliance 1 .6 R&D 2. 6 Pricing 1 .8 4 3 2 0. 3 1 .1 0 1 2 3 4 5 average average 0.0 Donations 1 leader 1 .8 1 .7 1 .8 Capacity 1 .8 Patents Commitments Transparency Performance Innovation 0 PERFORMANCE Daiichi Sankyo rises one place, with signs of improvement ited evidence of an access-oriented approach to intellec- in several areas. The company is slightly more transparent tual property. There is also no evidence it uses performance regarding its market influence activities; it has expanded equi- measures to consistently track progress toward access-re- table pricing to one more product; it is one of the biggest lated

targets. It has no structured donation programmes and risers in Capacity Building; and it makes a clear commitment has been found in breach of civil laws governing marketing to reporting suspected falsified medicines to national author- practices. ities. Nevertheless, it drops in Patents & Licensing, with limCHANGE SINCE 2014 • Still lags in access-to-medicine management, where it lacks solid management structures • Has registered more products in high-burden countries than in 2014. and performance measurements. • Has moved a greater proportion of R&D projects through the pipeline than in the previous reporting period. • Improves its accountability for its sales agents’ • Shows some improvement in the transparency of its marketing and lobbying activities. • Has equitable pricing strategies for one more pricing practices, by providing guidelines and monitoring prices. • Provides price-point data for the first time. product than in 2014. • Has still

not disclosed a pro-access IP-management strategy. • Has improved in capacity building outside the pharmaceutical value chain and for R&D. • Its relevant pipeline is approximately 50% • Has implemented a global policy for issuing larger than in 2014. drug recalls. • Discloses the strongest commitment to reporting suspected falsified medicines, relative to peers. OPPORTUNITIES Consider future access during development. with high inequality. For example, its pricing Set registration targets. Daiichi Sankyo can set Daiichi Sankyo can make specific access plans strategy for olmesartan medoxomil (Benicar/ time-bound targets for registering new products for all relevant R&D projects (e.g, affordable Olmetec®) could be expanded to countries such for diseases in scope that prioritise low- and pricing and sufficient supply commitments) as as Indonesia and Pakistan. middle-income countries where there is a need. they move along the pipeline. Develop a public

position on IP management. Join efforts to combat antimicrobial resist- Incorporate insights from country-level mar- Daiichi Sankyo can develop and disclose a public ance. Daiichi Sankyo has two antibiotics on the keting codes into new global code. Daiichi position on where it plans to file for and enforce WHO Model Essential Medicines List (EML) that Sankyo can incorporate insights from its many patents. are used in clinical practice. The company can country-level marketing codes of conduct into take action to increase access to these med- its newly released global code. It can also expand Enlarge activities in low and middle-income icines, while ensuring their responsible use. its enforcement processes to cover all third par- countries. Daiichi Sankyo can widen its presence Daiichi Sankyo can join global efforts to address ties globally. in these countries to ensure its focus on “inno- antimicrobial resistance, for example by sign- vative business” also

delivers new products to ing the Declaration by the Pharmaceutical, Expand equitable pricing strategies. Daiichi unserved populations. It would need a detailed Biotechnology and Diagnostics Industries on Sankyo can expand existing equitable pric- access strategy that uses an appropriate range Combating Antimicrobial Resistance. ing strategies to more high-burden countries of product deployment approaches. 148 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Revenues by segment (2015) 2,756 MN 53,365 MN JPY 986,444 MN 930,323 MN Prescription drugs Healthcare (OTC) products Others In scope, has sales Revenues by geographic area In scope, has no sales MN JPY Not in scope 1 ,1 00,000 1 ,000,000 900,000 800,000 SALES AND OPERATIONS 700,000 In 2015, following its divestment of generics Daiichi Sankyo currently has sales in 44 coun- arm Ranbaxy, Daiichi Sankyo moved to a busi- tries within the scope of the Index. 600,000 500,000

400,000 ness model focused on “innovative business”. 300,000 200,000 The company’s primary focus is on discovering 1 00,000 and developing medicines for cardiovascular and 0 metabolic diseases, and oncology. The divest- 2011* 2012* 2013* India Rest of world ment has reduced the company’s exposure to 2014 Japan 2015 Europe North America developing countries. *Due to a change in company reporting practices, numbers from 2011 and 2012 are incomparable. *Includes revenues from Ranbaxy Group. PORTFOLIO AND PIPELINE Products per disease category Daiichi Sankyo has a small portfolio, of 13 medi- the treatment of venous thromboembolism. The cines and four preventive vaccines, for relevant company is developing medicines and vaccines diseases. It has a mid-sized pipeline of 20 R&D for lower respiratory infections, diarrhoeal dis- projects that address the needs of people in eases, TB, malaria, and eight NCDs. It has multi- countries in scope. ple new

discovery-stage projects. It has seven medicines targeting one or more Several projects target high-priority product non-communicable diseases (NCDs), four tar- gaps with low commercial incentive, including geting a range of infectious diseases, and one for discovery-stage projects for malaria and TB. The treating maternal haemorrhage. The company company has moved DS-2969, (for C. difficile gained marketing authorisation from the FDA in infection) from discovery into phase I trials. 4 5 17 1 7 Communicable Non-communicable Maternal and neonatal Multiple categories Daiichi Sankyo has products for communicable 2015 for edoxaban (Savaysa®) for the reduction diseases and NCDs. The latter mainly target res- of stroke risk in non-valvular atrial fibrillation and piratory and cardiovascular diseases. Pipeline projects 1 5% 0 First-line treatments and essential medicines 1 0% 75% 20 30 10 4 47 40 50 In partnership, with access provisions (ap) 60 70 80 In

partnership, w/o ap 90 100 Not in partnership 0 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other Daiichi Sankyo partners with the Medicines for Malaria Venture and the TB Of the 17 products in Daiichi Sankyo’s portfolio, 10 are listed on the WHO Alliance to conduct small molecule screening. Prices will be set on the basis EML and/or as first-line treatments. This includes four vaccines for the pre- of a no-gains, no-loss policy in most countries in scope. vention of measles, pertussis and tetanus. Pipeline by stage of development Adaptive medicines and vaccines Innovative medicines and vaccines 2 CD NTD MNH MNH NCD 5 CD NTD 2 2 NCD Multiple Multiple 0 Discovery 7 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market

Approval Two of Daiichi Sankyo’s medicines are in phase II trials: CS-3150 for hyper- Daiichi Sankyo’s adaptive pipeline includes numerous new discovery-stage tensive heart disease and DS-8500 for diabetes. projects, including projects targeting malaria and TB. 149 Source: http://www.doksinet Access to Medicine Index 2016 Daiichi Sankyo Co., Ltd PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE Some transparency around lobbying activi- eration of scientific requirements and research MANAGEMENT ties. Daiichi Sankyo states that it does not make protocols, use of placebo controls and post-trial RANK 20 any political contributions in countries in scope. provisions. SCORE 1.6 It lists its memberships of industry associaLags in this area, with limited information tions, and provides links to industry association Provide patient-level data on request; but does about access management. Daiichi Sankyo (JPMA)positions on intellectual property, TRIPS not

disclose all trial results. The company newly remains in 20th place. The company only pro- and counterfeit medicines. Nevertheless, it does provides scientific researchers with access to vides general information regarding its perfor- not disclose the financial contributions it makes patient-level data upon request (via clinical- mance management system, and limited trans- to associations it has joined. studydatarequest.com) However, it does not parency on its stakeholder engagement activi- commit to publishing the results of clinical trials ties. However, it now takes a clearer, more stra- Found to have breached civil laws governing that have negative results. Currently, it consid- tegic approach to access. ethical marketing. Daiichi Sankyo reached a set- ers responding to requests for such results on a tlement in the USA of approximately USD 39 mn, case-by-case basis. Access approach focused on three priorities. for claims regarding physician opinion and dis-

Daiichi Sankyo’s access approach focuses on: (1) cussion programmes. As part of the settlement, orphan disease treatment and global health; (2) the company entered into a Corporate Integrity PRICING, MANUFACTURING & social contributions to improve medical access; Agreement that involves enhancing its compli- DISTRIBUTION and (3) social responsibility for a sustainable ance programme. RANK 13 SCORE 1.8 society. The company does not describe how these objectives combine to form an overall Auditing process in place, but not for third par- Rises four places to join the middle ranks. access strategy. ties. Audits are conducted on a three- to five- Daiichi Sankyo rises four places. Unlike in 2014, it year basis, and the frequency may increase now provides price-point information to demon- Poor disclosure of access-related outcomes. based on risk assessments. Audit teams are strate that it implements equitable pricing strat- Daiichi Sankyo has a performance

manage- composed of in-house auditors and can include egies. It has pricing guidelines for sales agents as ment system, but does not specify which meas- external auditors. Audits are conducted in all well as drug-recall guidelines. It performs above urements it uses. Likewise, the company is not countries where the company has operations. average in registration, with improved registra- transparent about its access targets or related Third parties are not audited. tion of products in high-burden countries. progress. It does not have dedicated incentive Equitable pricing activity increases modestly structures for rewarding employees when they achieve access-related objectives. RESEARCH & DEVELOPMENT from low base. The company has equitable pric- RANK 9 ing strategies for more products than in 2014. SCORE 2.6 Not transparent about stakeholder engage- They cover products for communicable and ment. Daiichi Sankyo is not transparent about Despite high investment,

R&D commitments non-communicable diseases, including lower how it chooses which stakeholders to engage not clearly linked to need. The company respiratory infections, TB, ischaemic heart dis- with, nor about the process or outcome of these directed JPY 64,550 mn towards R&D for dis- ease, hypertensive heart disease and asthma. engagements. Furthermore, it does not provide eases relevant to the Index in 2014 and 2015, However, only some (29%) of Daiichi Sankyo’s details of its engagements with local stakehold- making up a relatively large proportion of the products have pricing strategies that target pri- ers in particular. company’s R&D investments. Daiichi Sankyo ority countries (disease-specific sub-sets of commits to conducting R&D for global health countries with a particular need for access to priorities. However, its commitments are not relevant products). Together, these strategies MARKET INFLUENCE & COMPLIANCE clearly linked to

specific needs in low- and mid- cover only a few (8%) priority countries. RANK 15 dle-income countries. SCORE 1.6 Limited consideration of socio-economic facRises five places through increased transpar- Commitment to R&D partnerships, but no tors when setting prices. Daiichi Sankyo only ency. Although Daiichi Sankyo remains in the policy. Daiichi Sankyo is involved in relevant considers affordability in its intra-country equita- bottom half of the ranking, it rose five positions. R&D partnerships, such as with the Global ble pricing strategies, but considers factors such This is mainly due to the increased transparency Health Innovation Technology Fund. However, as disease burden, competition and the country’s of its lobbying and marketing activities. the company does not have a policy that regulatory system in some of its inter-country ensures access-oriented terms are systemat- equitable pricing strategies. Marketing code of conduct of limited scope.

ically included in the terms governing these Daiichi Sankyo’s marketing code of conduct arrangements. Pricing guidelines to sales agents and some price monitoring. Daiichi Sankyo provides local applies to third parties, but only in some countries. Currently, it does not disclose marketing Comprehensive policy to ensure clinical trials sales agents with pricing in all countries in scope activities in countries in scope, but is considering are conducted ethically. Daiichi Sankyo has pol- where its products are sold. Its guidelines differ disclosing marketing payments made in some icies and takes measures to ensure its in-house depending on the pricing system in each coun- countries to healthcare professionals, medical and outsourced trials are conducted ethically. try. It also monitors prices set by distributors in a associations or patient groups. Its policies are strong: they include the consid- sub-set of relevant countries. 150 Source: http://www.doksinet

Access to Medicine Index 2016 Mixed registration performance. The company company does not demonstrate that it consist- commits to registering products for a sub-set of ently targets local needs. diseases in some lower-middle income countries but provides no time-frame for doing so. It does Active in manufacturing capacity building, not publish where its products are registered or including in China and Iran. Daiichi Sankyo has the criteria it uses to decide when and where policies in place to assess needs and build capac- to register its products. However, the company ity in relevant countries for its in-house manu- has filed to register more than half (70%) of its facturers. In practice, the company has a rela- newest products in a few priority countries (dis- tively large number of capacity building activi- ease-specific sub-sets of countries with a par- ties, including activities with unaffiliated parties ticular need for access to relevant products). in China

and Iran. Recall guidelines vary between countries. R&D capacity building in China. Daiichi Sankyo Daiichi Sankyo has a general global policy for has a long-term partnership with Fudan issuing drug recalls, but its specific guidelines University in Shanghai, China to build local R&D for recalls are different in every country. This is capacity, with a focus on pharmacology. It is not an improvement from 2014, when the company clear how the company targets local skills gaps had no stringent recall guidelines. The company through this partnership. does not publish information regarding its drug Focuses on health services when build- recalls. ing capacity outside the value chain. Daiichi Limited adaptation of brochures and packag- Sankyo’s philanthropic strategy does not clearly ing materials. Daiichi Sankyo provides evidence target local needs. However, the company dis- of adapting its brochures and packaging to take closes several initiatives to build

capacities out- account of local language and literacy needs. It side the pharmaceutical value chain in response always includes information in at least one local to local skills and infrastructure gaps, focusing language where its products are sold. In Brazil, on health services in Cameroon, China, India and for example, it also provides an audio version Tanzania. of the package insert to address varying literStrongest commitment to reporting falsified acy levels. medicines. Daiichi Sankyo commits to reporting suspected falsified medicines to relevant authorPATENTS & LICENSING ities within a week. However, the company did RANK 19 not demonstrate that it shares other information SCORE 0.3 to strengthen supply chains, or that it has partLaggard in Patents & Licensing. Daiichi Sankyo nerships to build supply chain management skills ranks last in this area: it provides limited evi- in countries in scope. dence that it takes an access-oriented approach to IP

management. No external pharmacovigilance capacity building activities. Daiichi Sankyo does not disclose Low transparency in its approach to intel- examples of safety label updates for its prod- lectual property. Daiichi Sankyo continues to ucts, voluntary safety data sharing with authori- makes no public commitment concerning its pat- ties, or external capacity building activities (such enting strategy, makes no public disclosure of as training partnerships) to strengthen pharma- patent status, and has not published a company covigilance systems in countries in scope. position on the Doha Declaration on the TRIPS agreement and public health. PRODUCT DONATIONS No consideration of voluntary licensing. Daiichi RANK 18 SCORE 1.1 Sankyo does not engage in the non-exclusive voluntary licensing of its patented products, and No structured donation programmes. Daiichi has made no public offer to consider this. Sankyo remains in the lower ranks, in 18th place, due to its very

low level of activity in this area. Absence of competition-related breaches. Daiichi Sankyo does not have a structured dona- Daiichi Sankyo was not found to have breached tion programme, and made one ad hoc donation competition law during the period of analysis. in Palestine. CAPACITY BUILDING RANK 11 SCORE 1.7 Significant improvement in capacity building. Daiichi Sankyo is one of the biggest risers in this area. It improved in capacity building outside the pharmaceutical value chain and for R&D, and has made the strongest commitment to reporting suspected falsified medicines. However, the 151 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 19 1.36 Roche Holding AG 12 (2014) Stock Exchange: XSWX • Ticker: ROG • HQ: Basel, Switzerland • Employees: 91,747 Ranking by technical area TO BE NOTED Ranking by strategic pillar Roche declined to provide data 5 2. 6 R&D 1 .4 Pricing 0. 7 Patents 1 .3 0 not in scope. The 2015

Index Methodology Report explains why, following a thorough mul- 2 ti-stakeholder consultation pro1 leader 1 2 3 4 2.3 2. 3 Donations ing part of its business – is 3 0. 3 Capacity Index, citing the fact that oncology – a major and expand- average 5 0.2 Compliance to the 2016 Access to Medicine 4 1 .6 1 .8 0.7 Management Commitments Transparency Performance Innovation cess, cancer medicines were average not included within the scope of the 2016 Index. Roche’s per- 0 formance in access to medicine has been evaluated since the first Index was published PERFORMANCE in 2008. Roche has important Roche falls seven places. It has advanced in compli- In comparison with other companies, Roche’s ance, with enforcement processes that also apply public transparency, and therefore its commitment to third parties. It lags in R&D, as its commitments to accountability and knowledge-sharing, is gen- are not linked to need within the scope of the erally

low. For example, it does not publish: infor- Index, it does not share intellectual property for mation about access commitments, performance R&D with relevant stakeholders and has no policy measurements or outcomes; outcomes of stake- of basing R&D partnerships on pro-access terms. holder engagement activities or its stakeholder It applies equitable pricing strategies to only a lim- selection process; the results of clinical trials ited portion of its products. In IP-management, within a specified timeframe; whether it commits Roche commits to not filing for or enforcing pat- to registering all trials; its criteria for making reg- ents in low-income countries, and has enabled istration decisions, or where products are filed technology transfer for HIV/AIDS treatments. for registration; whether it has issued drug recalls Roche donates products for diabetes and commits during the period of analysis; the status of its pat- to building capacity in several areas.

ents, or its position on the Doha Declaration. non-cancer products in its portfolio, including medicines for HIV/AIDS and hepatitis C, as well as diagnostics. Of these, 13 products are on the WHO Model Essential Medicines List (2015). Roche has both the capacity and the responsibility to improve access to these products. The Index also assesses companies’ overall approaches to access to medicine (not disease-specific), at the strategy-setting and governance levels. Based on these considerations, the 2016 Index evaluated Roche using data from past submissions and public sources. CHANGE SINCE 2014 For Roche only, this section reflects performance changes that are publicly disclosed. • In 2015, rolled out the Access Planning Framework, aiming to identify specific regional and national challenges, and developed more than 60 country-specific access plans. • Has improved its compliance system as well as the transparency of its lobbying activities and enforcement processes. • Has

not been found in breach of anti-competi- • Still does not prioritise access in its R&D commitments or partnerships. • Supported hepatitis C awareness raising in Vietnam for World Hepatitis Day in 2014, and in Indonesia in 2015. • Signed the Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on • In 2014, extended its partnership with the Côte d’Ivoire Ministry of Health to facilitate access to hepatitis B, C and D treatments. • Launched the Roche Pharma Africa Strategy in 2015, acknowledging the need for capacity building in sub-Saharan Africa in collaboration with local partners. Combating Antimicrobial Resistance. tion laws during the period of analysis. OPPORTUNITIES Include other diseases areas in its access small proportion of its portfolio. It can expand can ensure strong access plans are included in efforts. Roche can broaden its existing access these strategies to more diagnostics and plat- the terms and conditions of these

partnership initiatives (e.g, for cancer medicines) to improve form technologies, particularly its HCV diagnos- agreements (e.g, non-exclusivity, affordability) access to medicine for other diseases, includ- tic products, to ensure all relevant products are ing for products on the WHO Model Essential priced affordably where they are needed. Evaluate impact of capacity building efforts in sub-Saharan Africa. Through the Roche Pharma Medicines List (EML). For example, Roche could build on its cancer-focused partnerships in coun- Agree access-oriented licensing terms for Africa Strategy, the company aims to increase tries such as Gabon, Indonesia and Kenya. pipeline products. Roche has licensed dano- access to medicines for viral hepatitis and wom- previr (now in phase II development) for supply en’s cancers. As it works toward this aim, Roche Ensure affordability for more products. Roche in China. When licensing promising pipeline can help ensure effectiveness by

evaluating the implements equitable pricing strategies for a products for supply to emerging markets, Roche impact of its initiatives and publishing outcomes. 152 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Sales by division (2015) 1 0,81 4 MN CHF 48,145 MN 37,331 MN Pharmaceuticals Diagnostics In scope, has sales Sales by geographic area In scope, has no sales MN CHF Not in scope 45,000 40,000 35,000 SALES AND OPERATIONS 30,000 Roche is one of the world’s largest biopharma- ing molecular diagnostics, clinical chemistry and ceutical companies. It works in in-vitro diagnos- immunoassays, tissue diagnostics, point-of-care tics, tissue-based cancer diagnostics and diabe- diagnostics and biotech solutions. These diag- tes management. It has two divisions: pharma- nostics cover a variety of diseases in scope, ceuticals and diagnostics. Roche’s pharmaceuti- including metabolic, liver and heart diseases. As cal business

is focused on oncology, immunology, of 2014, it had sales in approximately 90 coun- ophthalmology, infectious diseases and neuro- tries in scope. 25,000 20,000 1 5,000 1 0,000 5,000 0 2011 2012 2013 Africa/Australia/Ocenia Europe science. Roche Diagnostics offers a wide range 2014 2015 Latin America Asia North America of diagnostics and platform technologies, includPORTFOLIO AND PIPELINE Products per disease category Roche has a large portfolio of products for communicable diseases, with a heavy focus on high-burden diseases, and a mid-sized pipeline viral hepatitis. Roche did not disclose products in of projects intended to address the needs of discovery or pre-clinical stages of development. 12 39 76 people in countries in scope: with 76 registered products and 14 R&D projects. 21 A small proportion of its pipeline targets high-priority product gaps with low commer- Roche has 19 medicines, 46 diagnostics and 11 cial incentive. including the hepatitis

C medicine platform technologies registered for diseases in danoprevir. The Cobas 6800/8800 system was scope. The majority target viral hepatitis, HIV/ launched in Q4 2014 and approved for HIV/AIDS AIDS or ischaemic heart disease. diagnosis by the FDA in Q4 2015. Roche com- The company is developing products for five 4 Communicable Non-communicable Maternal and neonatal Multiple categories mitted to making its Cobas system available at Approximately half of Roche’s portfolio is focused lower prices in developing countries. on communicable diseases. non-communicable diseases (NCDs) and four Pipeline projects 7% 1 4% 0 First-line treatments and essential medicines 79% 10 20 9 30 40 50 In partnership, with access provisions (ap) 60 70 80 In partnership, w/o ap 90 100 Not in partnership 44 0 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Other Roche is developing a beta-lactamase

inhibitor and two medicines for viral 79% of Roche’s medicines are listed on the EML/or as first-line treatments: hepatitis in partnership. Roche granted Ascletis rights to develop and manu- e.g, peginterferon alfa-2a (Pegasys®), ribavirin (Copegus®), alteplase facture danoprevir, in phase II for hepatitis C, in China. (Activase®) and oseltamivir (Tamiflu®). Pipeline by stage of development Adaptive medicines and vaccines 3 CD Innovative medicines and vaccines 4 CD NTD NTD MNH MNH NCD 3 NCD Multiple Multiple 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval Roche has 11 relevant innovative medicines in clinical development. Roche is adapting products that target kidney diseases and hepatitis B. Both Lebrikizumab, a late-stage product targeting chronic obstructive

pulmonary projects include trials in countries in scope, such as Brazil, Colombia and disease and severe asthma, is being tested in countries including Mexico. Mexico. 153 Source: http://www.doksinet Access to Medicine Index 2016 Roche Holding AG PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE parties. It makes no reference to incentives for patient-level data upon request, via clinicalstudy- MANAGEMENT sales agents, other than sales targets, nor does it datarequest.com RANK 19 disclose information regarding marketing activi- SCORE 1.8 ties or the payments it makes in countries within Innovation: signing on to combat antimicro- Biggest faller. Roche drops nine positions from scope. The company has not signed the United bial resistance. Roche signed the Declaration 10th. Even though it has a clear access strategy, Nations Global Compact. by the Pharmaceutical, Biotechnology it drops due to low public transparency regard- and Diagnostics Industries on

Combating ing progress toward access-related targets and Strong in transparency of lobbying practice. Antimicrobial Resistance in January 2016, stakeholder engagement. The company publishes its policy positions thereby committing to investing in R&D that related to access to medicine, including biosim- aims to meet public health needs. Clear access strategy. Roche’s access strat- ilars, anti-counterfeiting and clinical research. egy has a detailed set of objectives, namely: In its code of conduct, Roche describes its No evidence of sharing intellectual property delivering innovation; improving affordability; approach for managing conflicts of interest. This for R&D. Roche does not provide evidence that strengthening healthcare infrastructure; increas- includes the description of cases where conflicts it shared its intellectual property with research ing awareness; and supporting patients. It tai- of interest may arise, and actions employees are

institutions or neglected disease drug discovery lors its approach depending on local health- expected to take. Nevertheless, it does not dis- initiatives during the period of analysis. However, care needs. In 2015, it rolled out the Access close information related to the political contri- in April 2016, the company did review its posi- Planning Framework, aiming to identify spe- butions it may make in countries within scope. tion on R&D for neglected tropicla diseases cific regional and national challenges to provid- (NTDs), where it commits to consider sharing ing access to medicine. It has also developed the Found to have breached code of conduct. intellectual property with potential applications Roche Pharma Africa Strategy, with a focus on Roche was the subject of a settlement regarding in neglected tropical diseases with non-profit 20 sub-Saharan countries, targeting viral hepati- a breach of a code of conduct during the period organisations or other

companies who wish to tis and some types of cancer. of analysis, involving the unethical marketing of pursue such research further. a medicine in Australia. Poor transparency on access-related outcomes. Roche publishes only general information about Transparent enforcement process and discipli- PRICING, MANUFACTURING & its access-related outcomes. It does not publish nary actions. In its 2015 Annual Report, Roche DISTRIBUTION details, such as commitments, targets and per- disclosed aggregate totals of internal investiga- RANK 20 formance measures. tions into alleged violations of its code of con- Low transparency regarding stakeholder SCORE 0.7 duct, as well as of the sanctions and disciplinary Biggest faller. Roche falls 9 places to 20th, actions taken in response. mainly because it provides no information in sev- engagement. Roche publishes information eral key areas, including price and volume-ofsales data, drug recall policy, registration targets related

to stakeholder engagement, but does not publish the outcomes of these activities nor RESEARCH & DEVELOPMENT and how it attempts to facilitate the rational use its stakeholder selection process. RANK 19 of its products. SCORE 1.4 Ad hoc engagement with local stakeholders. R&D commitments not clearly linked to needs Targets needs to a degree through equitable Roche engages with local stakeholders on an ad within the scope of the Index. Roche commits pricing. Public data shows that 5% of its rele- hoc basis. It publishes only general information, to R&D that addresses unmet product needs vant products have pricing strategies that target and provides no evidence that it incorporates within the scope of the Index. Roche makes no priority countries, reaching 70% of correspond- the outcomes of these activities into its opera- commitment to meeting the specific needs of ing priority countries (disease-specific sub-sets tions and strategies. populations in

countries in scope. of countries with a particular need for access to relevant products). No policy for R&D collaborations. The company MARKET INFLUENCE & COMPLIANCE does not commit to ensuring access-oriented No guidelines for sales agents. The company RANK 4 terms are included in its research partnerships. does not have pricing guidelines or a monitoring SCORE 2.6 or auditing system for in-house or third-party Leading in market-influence transparency and Takes measures to ensure that clinical trials are compliance. Roche climbs from 12th to 4th This conducted ethically. Roche has policies in place is due to improvements in the structure of its and takes measures to ensure its in-house and No disease-specific registration targets. Roche compliance system and to its public transpar- outsourced clinical trials are conducted ethically does not report disease-specific registration tar- ency regarding lobbying activities and enforcement processes. sales agents.

gets. It does not publish its criteria for making Does not fully publish trial results; has system registration decisions, nor does it reveal where for making patient-level data available. Roche its products are filed for registeration. Mixed performance in ethical marketing. Roche does not specify a timeframe for publishing has a code of conduct that includes ethical mar- the results of its clinical trials. However, it does No drug recall policy. Roche does not report keting provisions and that also applies to third provide scientific researchers with access to having a drug recall policy. Roche does not pub- 154 Source: http://www.doksinet Access to Medicine Index 2016 lish whether it has issued drug recalls during the considers financial sustainability and includes ters to measure blood sugar levels for all chil- period of analysis. impact evaluations. The company supports dren involved. capacity building outside the pharmaceutical Facilitating rational use of

diabetes products in value chain in relevant countries, e.g, through its Commits to social responsibility. Roche pub- children. In 2014, Roche adapted the packaging Phelophepa mobile health clinic in South Africa. licly commits to acting responsibly through phil- of the glucometers and insulin pumps it donates It did not disclose how it prevents or mitigates anthropic donations and non-commercial spon- via the Changing Diabetes in Children pro- conflicts of interest in these initiatives. sorship. The company is transparent about its gramme (run with Novo Nordisk). Its adaptations policy, which aligns with WHO guidelines. take account of language, literacy and demo- Limited focus on low- and middle-income coun- Transparent about impact. Roche publishes graphic needs in ten relevant countries. In 2015, tries for R&D partnerships. Roche partners with information about several ad hoc donations, Roche supplied glucometers and testing strips 50 universities globally,

but focuses on coun- including the outcome and impact reports. to children in seven African countries. tries outside the Index scope. The company did PATENTS & LICENSING RANK 11 not disclose any relevant partnerships with local Involved in donations following natural disas- research organisations to build R&D capacity in ters. Following natural disasters, Roche pro- relevant countries in the period of analysis. vides product donations to local partners. Following the earthquake in Nepal, the company SCORE 1.3 Builds manufacturing capacity. Roche makes donated more than 180,000 vials of ceftriax- Commits to waiving patent rights in poor coun- a general commitment to build manufacturing one (Rocephin®), an antibiotic that treats a wide tries. Roche has publicly committed not to file capacity in relevant countries. The company has range of infectious diseases. for or enforce the existing patents it holds in 20 production sites globally, including in China,

Least Developed Countries and in low-income Brazil and Mexico, but did not disclose whether countries, and not to file for or enforce patents it undertook any manufacturing capacity build- for ARVs in sub-Saharan Africa. ing activities (e.g, in-house training, third-party REFERENCES technology transfers, or capacity building with Public commitment to licensing for anti-retrovi- unaffiliated partners) in the period of analysis. rals. Roche has publicly stated that it is open to Publicly available sources used to compile this the licensing of saquinavir (Invirase®), an alter- Some activity in strengthening pharmacovig- report card include: Roche Finance Report 2015; native second-line HIV/AIDS treatment, should ilance systems. Roche contributed to at least Roche Annual Report 2015; Roche corporate significant medical need be identified. Roche one workshop on pharmacovigilance in coun- website. Other references are available previously completed technology transfers

to tries in scope during the period of analysis, spe- 13 manufacturers for the supply of saquinavir cifically regarding biotherapeutic medicines in to sub-Saharan Africa and to Least Developed Ghana. The company did not disclose exam- Countries. It has granted licences for the pro- ples of safety label updates for its medicines or duction of oseltamivir (Tamiflu®) in order to pharmacovigilance-related information-sharing support increased production. (e.g, voluntarily sharing post-marketing safety surveillance data with authorities) in countries in Does not publish patent statuses. Roche does scope of the Index. not publish any information about the status of Limited disclosure about strengthening supply its patents. chains. Roche makes a public statement on Does not take a public position on the Doha counterfeiting, committing to cooperate with Declaration. Roche has not made a public state- authorities whenever a Roche product is con- ment about its position on

the Doha Declaration cerned. The company did not disclose relevant on the TRIPS agreement and public health. activities (e.g, training partnerships) or information-sharing with local stakeholders (eg, to pre- Has not been found in breach of competition vent product diversion, or improve demand fore- law. Roche has not been found to have breached casting) regarding supply chain management competition law during the period of analysis. capacity building in countries in scope during the period of analysis. CAPACITY BUILDING RANK 19 SCORE 0.3 PRODUCT DONATIONS RANK 12 SCORE 2.3 Limited disclosure regarding capacity build- Among the fallers. Roche moves from 7th to ing activities. Roche makes a strong public 12th place . The company donates blood glucose commitment to capacity building in its philan- meters (ACCU-CHEK®) in a structured donation thropic policy, including targeting local needs. programme for children with diabetes. Roche is The company supports capacity

building activi- involved in humanitarian aid donations, and has ties in countries in scope, such as training labo- a clear public commitment to engaging in prod- ratory technicians in sub-Saharan Africa through uct donations. its HIV-focused AmpliCare programme, but did not disclose details or show how it targets spe- Continues support for diabetes control. Roche cific local needs. has renewed its commitment to the Changing Diabetes in Children (CDiC) programme (which Strong approach to philanthropy. Roche’s pub- is coordinated with Novo Nordisk). In this pro- lished philanthropic strategy targets local needs, gramme, Roche provides strips and glucome- 155 Source: http://www.doksinet Access to Medicine Index 2016 RA N K SCO R E 20 1.32 Astellas Pharma Inc. 18 (2014) Stock Exchange: XTKS • Ticker: 4503 • HQ: Tokyo, Japan • Employees: 17,113 (FY2014) Ranking by technical area Ranking by strategic pillar 5 R&D 1 .6 Pricing 0. 8 Patents 1 .2

Capacity 1 .8 4 3 2 1 .1 Donations 0 1 leader 1 2 3 4 5 average average 0.0 1 .5 1 .3 Compliance 1 .3 2. 1 2.4 Management Commitments Transparency Performance Innovation 0 PERFORMANCE Astellas falls two places to 20th, despite improving in cer- capacity building, focusing on Asia. It has yet to implement an tain areas. In R&D, it commits to maintaining its investment in equitable pricing strategy for a disease in scope, and has no R&D overall at over 17% of net sales, and has clear targets to relevant registration targets. Its transparency around market- develop products for neglected tropical diseases. Its approach ing and lobbying is low, and it was found to have acted unethi- to intellectual property has improved, with a pledge not to file cally twice. It has set objectives relating to access to medi- for or enforce IP rights in select Least Developed Countries cine, but they do not clearly link to an overall access strategy. and

low-income countries. It is one of the biggest risers in Astellas does not donate products for diseases in scope. CHANGE SINCE 2014 • Still lacks a clearly defined access strategy and its stakeholder engagement activities are still its total R&D investment at more than 17% of net sales. conducted on an ad hoc basis. than in 2014. It was found to have breached supply chain management and in health-related areas beyond the production and distri- • Improves its accountability for its sales • Exhibits weaker performance in compliance • Has improved in building local capacity in agents’ pricing practices, by providing pricing bution of medicines, including building healthworker capacity in Kenya. guidelines. the UK PMCPA code twice: for providing false information and for failing to provide accurate information. • Its R&D strategy for 2015-2017 includes mul- • Still has no set targets for filing for the registration of new products in countries in scope.

• Publicly commits not to file for or enforce pat- tiple targets to develop products for the dis- ents in select Least Developed Countries or eases of poverty, and to maintain the ratio of low-income countries. OPPORTUNITIES Put access plans in place for pipeline projects. Transfer knowledge of equitable pricing strate- access to these medicines, while ensuring their Astellas can make specific access plans for each gies. Astellas can transfer its experience of equi- responsible use. It can join global efforts to R&D project for high-burden diseases: e.g, its table pricing to products for diseases in scope. address antimicrobial resistance, for example by medicines in phase I for asthma, kidney diseases This could include existing products, as well as signing the Declaration by the Pharmaceutical, and schizophrenia. This can include commit- products emerging from its pipeline. Biotechnology and Diagnostics Industries on ting, during late stages of clinical

development, Combating Antimicrobial Resistance. to registering successful innovations in countries Expand Changing Tomorrow Together pro- where they are needed. gramme. Astellas can expand this stakeholder Leverage R&D expertise in product adapta- engagement programme to low- and middle-in- tion for more diseases. Through partnerships, Build lasting improvements in local R&D capac- come countries where it has operations. This Astellas can apply its expertise in adapting exist- ity. Astellas can draw on its existing R&D activi- could lead to a structured approach to stake- ing products to meet specific needs (as exhib- ties in countries in scope to build local research holder engagement. ited in its schistosomiasis partnership) to more capacity: e.g, through institution-level partner- disease areas. ships with local public research organisations. Join efforts to combat antimicrobial resistance. This will help address local skills gaps in a sys-

Astellas has six antibiotics on the WHO EML temic and sustainable way. that are used in clinical practice and are important for low-resource settings. It can increase 156 Source: http://www.doksinet Access to Medicine Index 2016 Sales in countries in scope Sales by segment (2015) JPY 1,372,706 MN Pharmaceuticals In scope, has sales Sales by geographic area In scope, has no sales MN JPY Not in scope 1 ,200,000 1 ,000,000 SALES AND OPERATIONS 800,000 Astellas is active in five therapeutic areas: urol- Early 2016, the company acquired the regenera- ogy, oncology, immunology, nephrology, and neu- tive ophthalmology biotech Ocata Therapeutics roscience. The company aims to expand its port- for a similar amount. 600,000 400,000 folio with products for muscle diseases and 200,000 opthamology. The company has sales in 45 coun- 0 tries in scope. At the end of 2015, Astellas sold 2011* 2012 Asia/Oceania its dermatology business to LEO Pharma for Americas USD

727 mn. 2013 2014 2015 Europe/Middle East/Africa Japan *Due to a change in company reporting practices, the numbers from 2011 are incomparable with following reporting years. PORTFOLIO AND PIPELINE Products per disease category Astellas has a small portfolio of 15 medicines for Its relevant pipeline is mainly clustered in clinical relevant diseases and a small pipeline of eight development, with projects targeting lower res- R&D projects that address the needs of people piratory infections, schistosomiasis, schizophre- in countries in scope. nia, chronic kidney disease, severe asthma and 4 6 15 diabetic nephropathy. Astellas has two R&D proAstellas’ portfolio is mainly focused on infectious jects that target high-priority product gaps with diseases, and includes seven broad-spectrum low commercial incentive: for Chagas disease antibiotics registered for the treatment of multi- and schistosomiasis. Both of these projects are ple diseases in scope. In

Q1 2016, Astellas gained being conducted in partnership. Astellas’ inves- marketing authorization (FDA) for isavucona- tigative medicines for schizophrenia, chronic zonium sulfate (Cresembra®), an azole antifun- kidney disease and severe asthma moved from Astellas’ portfolio contains 15 medicines, targeting gal to be used in conditions associated with HIV/ pre-clinical into clinical development since the infectious diseases, asthma, diabetes, schizophre- AIDS. last Index. nia and hypertensive heart disease. Pipeline projects 1 3% 0 Non-communicable Multiple categories 5 36 49% 20 Communicable First-line treatments and essential medicines 38% 10 5 30 40 50 In partnership, with access provisions (ap) 60 70 80 In partnership, w/o ap 90 100 Not in partnership 0 20 40 60 80 First-line & on WHO Essential Medicines List 100 First-line only 120 140 On WHO-EML only Astellas is collaborating on drugs for Chagas disease, and (via the Pediatric

60% of Astellas’ medicines are listed on the WHO EML and/or as first- Praziquantel Consortium with Merck KGaA) for schistosomiasis. The latter line treatments. This includes nilvadipine (Nivadil®), doxycycline and includes plans for access, e.g, via manufacturing in endemic countries benzylpenicillin. Pipeline by stage of development Adaptive medicines and vaccines Innovative medicines and vaccines CD CD NTD NTD MNH MNH NCD Other 3 NCD Multiple Multiple 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval 0 Discovery 5 10 15 Pre-clinical 20 Phase I 25 30 Phase II 35 Phase III 40 45 50 55 Received Market Approval Astellas’ pipeline is highly focused on innovative projects. Alongside several Astellas, via the Pediatric Praziquantel Consortium with Merck KGaA, is medicines, it is developing an H5N1 avian influenza vaccine (in phase II) and a co-developing a new formulation for in

children under six. Features include a seasonal influenza vaccine (in phase III). less bitter taste, making the pill easier for children to take. 157 Source: http://www.doksinet Access to Medicine Index 2016 Astellas Pharma Inc. PERFORMANCE BY TECHNICAL AREA GENERAL ACCESS TO MEDICINE Breaches of code of conduct and weak enforce- No intellectual property sharing. The company MANAGEMENT ment system. Astellas was responsible for a provided no evidence that it shares intellectual RANK 18 double breach of the UK PMCPA code during property with research institutions or neglected the period of analysis: for giving a false response disease drug-discovery initiatives. SCORE 2.1 Lags behind without a clear strategy for and for failing to provide accurate information. improving access to medicine. Astellas remains On this occasion, the company’s enforcement in 18th place. The company does not have a system also failed, as proper, timely action to PRICING, MANUFACTURING

& well-defined access strategy and does not report address unethical behaviour was not taken. DISTRIBUTION on how it tracks progress toward its access tar- RANK 19 SCORE 0.8 gets. Furthermore, its stakeholder engagement Annual, risk-based auditing system. Astellas’ activities are executed on an ad hoc basis. audits draw on both internal and external Joins the laggards as it is now the only com- resources and extend to all contractors and in all pany without an equitable pricing strategy. countries that the company has operations with. Astellas has dropped four places to 19th posi- Has objectives for improving access, but they are not aligned with the core business strategy. tion. It is now the only company in the Index to have not implemented equitable pricing strat- Astellas’ discloses access objectives including: combating neglected tropical diseases (NTDs); RESEARCH & DEVELOPMENT egies for a disease in scope. It also performs preventing and

controlling non-communicable RANK 17 poorly when it comes to registering its products SCORE 1.6 for high-burden diseases. diseases (NCDs); supporting anti-counterfeiting efforts; and engaging in technology transfer. Maintains its performance while others drop Nevertheless, it does not report having an access behind. Astellas rises three positions in R&D: No efforts to facilitate its products’ rational strategy, nor does it explain how its objectives overall it has maintained its performance, and use. Astellas does not provide evidence that it align with its core business strategy. has a stronger pipeline than in 2014. adapts its brochures and packaging materials to No incentives to reward access-related perfor- R&D commitments tied to clear targets. cultural or environmental needs of populations mance. Astellas does not have dedicated incen- Astellas commits to conducting R&D for dis- from countries in scope. Such measures help tive structures in

place for rewarding its employ- eases that have been neglected for commer- ensure products are used as intended. ees when they achieve their access-related cial reasons. It acknowledges that achiev- objectives. Nor does it have measures for track- ing its R&D commitments requires long-term Pricing guidelines provided to sales agents. ing progress toward its access-related targets. efforts to improve access to health in develop- Astellas provides general pricing guidance to its ing countries. distributors and affiliates. It does not monitor address local literacy, language, demographic, Poor performance in stakeholder engage- prices or mark-ups. ment. The company does not have a structured Poor policy and transparency in collaborations. approach to stakeholder engagement in coun- The company does not commit to ensuring Lags behind when it comes to product registra- tries in scope. However, it does have some ad access-oriented terms (such as pricing or supply

tion. Astellas does not set disease-specific tar- hoc engagement activity, such as those related commitments) are systematically included in gets for registering new products within a set to its Fistula Project in Kenya, in which the com- its research partnerships. Neither does Astellas time-frame. It has not filed to register any of pany engages with local non-governmental publish such terms and conditions in relation to its newest products in any of their correspond- organisations. its ongoing research collaborations. ing priority countries (disease-specific sub-sets of countries with a particular need for access to No policy of disciplinary action where unethi- relevant products). It does not disclose its cri- MARKET INFLUENCE & COMPLIANCE cal trial conduct occurs. Astellas has policies in teria for deciding where or when to register RANK 17 place and takes measures to ensure clinical trials a product, nor does it publish the registration are conducted

ethically. However, the company status of its products. As a result, it is unclear Drops eight positions following low transpar- does not provide evidence of how it takes dis- how the company considers where and when to ency and compliance. Astellas’ transparency ciplinary action if ethical violations occur in its make its products available for sale. around its marketing and lobbying activities has trials. SCORE 1.5 Consistent recall guidelines. Astellas has glob- decreased since 2014. Its compliance record has also worsened. It was found to have breached Transparency around clinical trial data set to ally consistent guidelines for issuing drug recalls industry codes of conduct multiple times. improve. Astellas is revising its global policy for in all countries relevant to the Index where its transparency of its clinical trial data. This is cur- products are available. Astellas has not recalled Low transparency in ethical marketing and rently slated to include

the disclosure of the a product for a relevant disease in a country in anti-corruption. Astellas’ marketing code is con- results of discontinued research programmes. scope during the period of analysis, but also sistent with industry standards. Its sales agents In a new step, the company provides scientific does not have a policy of disclosing recalls on its are only assigned performance-linked incentives, researchers with access to patient-level data website. driven by sales targets. The company does not upon request via clinicalstudydatarequest.com disclose anything about its marketing activities. 158 Source: http://www.doksinet Access to Medicine Index 2016 PATENTS & LICENSING Building manufacturing capacity, e.g, in Brazil RANK 13 and Iran. Astellas commits to assessing needs SCORE 1.2 and building capacity in countries in scope for Rises six places through transparent new in-house manufacturers. In practice, the com- approach. After consecutive

Indices at the pany undertakes a number of capacity building tail end of the ranking in Patents & Licensing, activities, including with third parties, e.g, tech- Astellas rises six places. This can be attrib- nology transfers in Brazil and Iran. uted to its new public stance on patenting, and its pledge to consider non-exclusive voluntary Stronger philanthropic approach to build- licensing. ing capacity outside the pharmaceutical value chain. Astellas’ new philanthropic policy is rel- New commitment not to file for or enforce pat- atively strong – it aims to deliver sustainable ents in the poorest countries. Astellas makes improvements and includes impact evaluation a new, public commitment not to file for or – but it does not clearly target local needs. The enforce its patents in select Least Developed company discloses one relevant initiative to build Countries or in low-income countries. capacities outside the pharmaceutical value chain, focusing on

obstetric fistula in Kenya. Does not disclose the status of its patents. Astellas does not publish whether and/or where Limited approach to building R&D capacity. it holds patents. Nor does it disclose its position Astellas undertakes some activities to build R&D on the Doha Declaration on the TRIPS agree- capacity in countries in scope (e.g, to strengthen ment and public health. ability to conduct clinical trials). However, it did not disclose any relevant partnerships with local Committed to considering requests to license. universities or other public research organisa- While Astellas has not yet licensed any of its tions to build R&D capacity. products, it publicly states that it will consider requests for negotiating licences on a “case-byPRODUCT DONATIONS case basis”. RANK 19 SCORE 1.1 No breaches of competition law. Astellas was not found to have been the subject of settle- Ranks last. Astellas ranks last: it has not made ments, fines or

judgements relating to competi- any structured or ad hoc donations during the tion law during the period of analysis. period of analysis in any of the countries in scope. CAPACITY BUILDING RANK 10 SCORE 1.8 One of the biggest risers in capacity building. Astellas rose nine places The company has improved in capacity building outside the pharmaceutical value chain, and supply chain management. However, it disclosed no relevant R&D capacity building initiatives, and does not have a clear focus on local needs. Active in strengthening supply chains in Asia. Astellas is moderately active in building supply chain management capacity through partnerships and information sharing, primarily in China and south-east Asia. The company did not disclose a detailed approach to reporting suspected falsified medicines in countries in scope. Focus on Asia continues for pharmacovigilance capacity building. Astellas demonstrates that it updates safety labels in countries in scope but did not

disclose other relevant information sharing. The company has a number of activities to strengthen pharmacovigilance systems in China. 159 Source: http://www.doksinet Access to Medicine Index 2016 160 Source: http://www.doksinet Access to Medicine Index 2016 Appendices 161 Source: http://www.doksinet Access to Medicine Index 2016 Methodology scopes COMPANY SCOPE The Index assesses 20 of the world’s largest 10 years, meaning their performance can be research-based pharmaceutical companies on tracked over time. their policies and practices to improve access to medicine for people living in low- and mid- Pharmaceutical companies that exclusively pro- dle-income countries. Considering their size, duce generic medicines remain excluded from resources, pipelines, portfolios and global reach, the Index in 2016. The Access to Medicine these companies have a critical role to play in Foundation recognises that these companies improving access to medicine. play a

significant role in access to medicine, particularly in low- and middle-income countries. The 2016 Index measures the same 20 compa- Generic medicines marketed by the 20 research- nies included in the 2014 Index, facilitating trend based companies or any of their generic medi- analysis and comparability between Indices. cine subsidiaries in which they have more than The Index has measured these companies for 50% ownership are included. Company Ticker Stock Exchange Bloomberg Reuters Country MarketCap* Revenue* (billion USD) (billion USD) AbbVie Inc. ABBV New York Stock Exchange ABBV:US ABBV.N USA 94.39 19.96 Astellas Pharma Inc. 4503 Tokyo Stock Exchange 4503:JP 4503.T JPN 35.32 11.35 AstraZeneca plc AZN London Stock Exchange AZN:LN AZN.L GBR 85.44 42.98 Bayer AG BAYN Frankfurt Stock Exchange BAYN:GR BAYGn.DE DEU 117.15 56.07 Boehringer Ingelheim GmbH n/a n/a n/a n/a DEU - 17.68 Bristol-Myers Squibb Co. BMY New York Stock

Exchange BMY:US BMY.N USA 99.28 15.88 Daiichi Sankyo Co. Ltd 4568 Tokyo Stock Exchange 4568:JP 4568.T JPN 11.03 8.37 Eisai Co. Ltd 4523 Tokyo Stock Exchange 4523:JP 4523.T JPN 15.47 4.99 Eli Lilly & Co. LLY New York Stock Exchange LLY:US LLY.N USA 75.97 19.62 Gilead Sciences Inc. GILD NASDAQ GILD:US GILD.O USA 155.81 24.89 GlaxoSmithKline plc GSK London Stock Exchange GSK:LN GSK.L GBR 113.27 37.89 Johnson & Johnson JNJ New York Stock Exchange JNJ:US JNJ.N USA 279.80 74.33 Merck & Co. Inc MRK New York Stock Exchange MRK:US MRK.N USA 167.63 42.24 Merck KGaA MRK Frankfurt Stock Exchange MRK:GR MRCG.DE DEU 43.32 14.99 Novartis AG NOVN SIX Swiss Exchange NOVN:VX NOVN.VX CHE 245.07 58.00 Novo Nordisk A/S NOVO B Copenhagen Stock Exchange NOVOB:DC NOVOb.CO DNK 17.85 15.81 PFE.N Pfizer Inc. PFZE New York Stock Exchange PFE:US Roche Holding AG RO; ROG SIX Swiss Exchange RO:SW; ROG:VX ROG.VX

USA 216.67 49.61 CHE 231.16 51.88 Sanofi SAN EURONEXT Paris SAN:FP SASY.PA FRA 132.68 44.83 Takeda Pharmaceutical Co. Ltd 4502 Tokyo Stock Exchange 4502:JP 4502.T JPN 40.29 16.18 *Market cap from Bloomberg & Yahoo Finance 19 Feb 2015 (Exchange rate from www. oanda.com 19 Feb 2015) *Revenue = ttm (trailing twelve months); meaning the timeframe of the past 12 months from Annual reports 2014; for Japanese companies fiscal years from their reports in March 2015 (Exchange rate from www.oandacom 1 Apr 2014 - 31 Mar 2015 for Japanese companies and 1 Jan- 31 Dec 2014 for others) 162 Source: http://www.doksinet Access to Medicine Index 2016 GEOGRAPHIC SCOPE The geographic scope for the 2016 Access to All countries defined by the World Bank as low Index are included. This measure takes account Medicine Index comprises 107 countries. Several income or lower middle-income are included. All of how health, education and income are distrib- additional countries in

the Americas have been countries defined by the UNDP as either low or uted within each country. All Least Developed included (Jamaica, Mexico, Panama and Peru), as medium human development are included. This Countries (LDCs), as defined by the Committee well as Iran. Countries excluded include Jordan, ensures that several central measures of human for Development Policy of the UN Economic and Venezuela and Fiji, as improving socio-economic development (life expectancy, education, and Social Council (ECOSOC). conditions have moved these countries out of standard of living) are taken into account. All the Index scope. Tonga was excluded due to a countries that receive a score of less than 0.6 on lack of available data. the UN Inequality-Adjusted Human Development Country Classification East Asia & Pacific Cambodia Middle East & North Africa LIC LMIC Niger LMIC Nigeria China HiHDI Egypt, Arab Rep. Indonesia LMIC Iran, Islamic Rep. Kiribati LMIC

Iraq Korea, Dem.Rep LIC Namibia Djibouti HiHDI MHDC MHDC LIC LMIC Rwanda LIC São Tomé and Principe LMIC LMIC Morocco LMIC Senegal Lao PDR LMIC Palestine, State of LMIC Sierra Leone Micronesia, Fed. Sts LMIC Syrian Arab Rep. LMIC Somalia Yemen, Rep. LMIC South Africa LIC LIC Mongolia MHDC Myanmar LMIC Papua New Guinea LMIC Philippines LMIC Afghanistan LIC Samoa LMIC Bangladesh LMIC Tanzania, United Rep. LIC Solomon Islands LMIC Bhutan LMIC Togo LIC Thailand HiHDI India LMIC Uganda LIC Timor-Leste LMIC Maldives MHDC Zambia LMIC Tuvalu LDC South Sudan South Asia Nepal LIC Vanuatu LMIC Pakistan LMIC Vietnam LMIC Sri Lanka LMIC Armenia LMIC Angola Georgia LMIC Benin Kosovo LMIC Botswana Kyrgyz Rep. LMIC Burkina Faso Moldova LMIC Burundi Tajikistan LMIC Cameroon LMIC LMIC Swaziland LMIC Zimbabwe LIC LHDC MHDC Cape Verde LMIC LIC MHDC LIC LIC Ukraine LMIC Central African Rep. LIC

Legend Uzbekistan LMIC Chad LIC Comoros LIC LIC Congo, Dem. Rep LIC Latin America & Caribbean Belize HiHDI Congo, Rep. LMIC Bolivia LMIC Côte d’Ivoire LMIC Brazil HiHDI Equatorial Guinea Colombia HiHDI Eritrea LIC Dominican Rep. HiHDI Ethiopia LIC Ecuador HiHDI Gabon El Salvador LMIC Gambia, The Guatemala LMIC Ghana LMIC Guyana LMIC Guinea LIC Guinea-Bissau LIC Haiti LIC Sudan Sub-Saharan Africa Europe & Central Asia Turkmenistan MHDC LIC MHDC MHDC LIC Low-income country World Bank income classifications LMIC Lower-middle-income Country World Bank income classifications LDC Least Developed Country UN Human Development Index LHDC Low Human Development Country UN Human Development Index MHDC Medium Human Development Country UN Human Development Index HiHDI High Human Development Country with high inequality Honduras LMIC Kenya LMIC UN Inequality-Adjusted Human Devel- Jamaica HiHDI Lesotho LMIC opment

Index Mexico HiHDI Liberia Nicaragua LMIC Madagascar LIC Panama HiHDI Malawi LIC Mali LIC Paraguay MHDC Peru HiHDI Mauritania Suriname HiHDI Mozambique LIC Countries added to the 2016 Index Country Scope LMIC LIC 163 Source: http://www.doksinet Access to Medicine Index 2016 DISEASE SCOPE Diseases are included based on their global The disease scope for the 2016 Index has The 2016 Index includes the nine most preva- burden of disability-adjusted life years (DALYs), expanded from 47 to 51 diseases and conditions lent maternal and neonatal health conditions, in other WHO classifications, and the relevance (including contraceptives). Syphilis is the only continuing recognition of the importance of pro- of pharmaceutical interventions. Index diseases new communicable disease. Anxiety disorders, tecting mothers and neonates. are defined according to the WHO International migraine and hypertensive heart disease have Classification of Diseases (ICD-10)

codes. been added. All cancers remain excluded All 17 WHO-classified neglected tropical diseases are covered. Total DALYs (LICs & LMICs) Communicable diseases (10) Lower respiratory infections Neglected tropical diseases (17) 121,068,536 Birth asphyxia and birth trauma 63,824,424 Schistosomiasis 3,700,597 Neonatal sepsis and infections 36,107,007‡ 3,360,656 Other neonatal conditions Diarrhoeal diseases 89,536,536 Soil transmitted helminthiasis* HIV/AIDS 68,614,932 Leishmaniasis 3,196,523 Malaria 52,991,412 Lymphatic filariasis 2,810,555 Tuberculosis 36,403,940 Rabies 2,083,208 Meningitis 26,674,319 Food-borne trematodiases 1,875,000† Measles 11,194,628 Human African trypanosomiasis Syphilis 6,403,176 Dengue and chikungunya Pertussis 5,657,488 Onchocerciasis Tetanus 5,384,352 Taeniasis/cysticercosis Non-communicable diseases (14) 1,248,941 1,238,610§ 593,762 503,000† Trachoma 214,395 Leprosy 199,424 Ischaemic heart disease

70,459,863 Echinococcosis 144,000† Stroke* 56,454,095 Chagas disease 44,408 Chronic Obstructive Pulmonary disease Buruli ulcer (COPD) 52,471,475 Yaws N/A Unipolar depressive disorders 35,521,719 Dracunculiasis N/A Diabetes mellitus 26,915,498 Cirrhosis of the liver* 22,422,505 N/A Maternal and neonatal health conditions (9, Kidney diseases* 18,128,559 plus contraceptives) Asthma 16,223,415 Maternal haemorrhage Epilepsy 14,347,659 Hypertensive disorders 10,896,418 Contraceptive methods N/A * In 2014, listed as cerebrovascular disease. * Includes chronic hepatitis * In 2014, listed as nephritis and nephrosis * Referred to in ICD-10 as intestinal nematode infections † DALY counts in LICs and LMICs for these diseases were not available from the Global Health Observatory. The DALY counts given here were instead taken from the Global Burden of Disease Study 2010 (Murray et.al)20 They represent the global DALY burden and are calculated using a

different method. They are thus not directly comparable with the DALY counts provided for LICs and LMICs. § This DALY estimate only includes dengue, and not chikungunya. ‡ The DALY burden for neonatal sepsis and infections is presented separately from earlier neonatal infections and other conditions due to more detailed DALY burden analysis available from the Global Health Observatory. 3,289,000† Anxiety disorders 13,175,172 of pregnancy 2,797,000† Migraine 10,150,681 Abortion 2,138,000† Hypertensive heart disease 10,113,460 Obstructed labour 1,792,000† Diseases/conditions added to the 2016 Bipolar affective disorder 5,920,895 Maternal sepsis 1,309,000† Index Disease Scope. Schizophrenia 5,133,445 Preterm birth complications 91,782,664 Data source: Murray et al PRODUCT TYPE SCOPE The product type scope of the Index is deliber- Microbicides inhibit and kill vectors that transmit diseases ately broad in order to capture the wide-rang- These

include topical microbicides specifically relevant to the Index are included. Likewise, ing product types available to support preven- intended to prevent HIV. only biological control interventions that spe- tion, diagnosis and treatment of relevant dis- cifically aim to kill or control vectors associ- eases in the countries covered by the Index. Therapeutic vaccines ated with transmit relevant Index-relevant dis- It draws closely from the definitions provided This covers vaccines intended to treat infection. eases are included. Only veterinary vaccines spe- by the G-FINDER 2014 Neglected Disease cifically designed to prevent animal-to-human Research and Development: Emerging Trends*. Preventive vaccines transmission of diseases covered by the Index Contraceptive methods and devices are included This covers vaccines intended to prevent are included. under maternal health conditions. infection. Medicines Diagnostics Only those products directed specifically at

All innovative and adaptive medicines, branded Diagnostic tests designed for use in meeting the needs of countries covered by the generics and generic medicines used to directly resource-limited settings (cheaper, faster, more Index are included. These comprise general diag- treat the target pathogen or disease pro- reliable, ease of use in the field) are included. nostic platforms, adjuvants and immunomodula- Platform technologies cess, regardless of formulation, are included. tors and delivery technologies and devices. Medicines used only for symptomatic relief are Vector control products not included. These include pesticides, biological control compounds and vaccines targeting animal reservoirs. Only chemical pesticides intended for global public health use and which specifically aim to 164 * Policy Cures 2014. G-FINDER 2014 Neglected Disease Research and Development: Emerging Trends [pdf] http://www.policycuresorg/downloads/Y7%20

GFINDER%20full%20report%20web%20.pdf [Accessed 21Jul15] Source: http://www.doksinet Access to Medicine Index 2016 Stakeholder engagement 2015 Between January and October 2015, the Index vide the Foundation with strategic guidance Other sources of feedback engaged with a variety of stakeholders to build a with regard to the Index’s scope and indicators. The Access to Medicine Foundation remains more complete, up to date view on the changing This group ratified the methodology prior to its open to feedback from other entities willing to access to medicine landscape. publication. provide comments and suggestions. Maintaining The principles that guided the process of Expert Review Committee nerships with all the stakeholder groups is cru- stakeholder engagement were: Hans Hogerzeil - Chair cial to the long-term success, legitimacy and 1. To reflect changes in the access to medicine Sanne Frost Helt impact of the Index. openness through engaging and building part-

landscape and the role for pharmaceutical Suzanne Hill companies; Regina Kamoga No single feedback mechanism has dispro- Richard Laing portionately affected the Index methodology. grained comparison between companies’ Aurelia Nguyen Rather, the output of the survey, in depth con- performances; Eduardo Pisani sultations and other feedback processes were Dennis Ross-Degnan studied by the Expert Review Committee. We Dilip Shah maximised our efforts to ensure that all the Helena Viñes-Fiestas stakeholders receive equal representation in the 2. To preserve the capacity for fine- 3. To maintain capacity for trend analysis between successive indices; 4. To ensure data could be collected by companies. stakeholder engagement process. Technical Subcommittees A process of both internal review and external Between February and September 2015 the engagement was carried out. Foundation convened groups of experts to serve as Technical Subcommittees (TSCs) to support

Internal analyses the methodology enhancement. The Foundation’s research team reconfirmed the quality and robustness of each indicator, using These committees responded to and advised quantitative tests such as correlation, response on various proposals made by the Index team rate and distribution analyses. These tests were for enhancing the areas of Market Influence & used to pinpoint risks of redundancy, where Compliance; Research & Development; Pricing, scoring guidelines could be tightened for 2016, Manufacturing & Distribution and Patents & and where data quality could be enhanced. Licensing. The remaining Technical Areas did not convene TSCs, but did consult experts Company calls individually. The foundation offered all 20 companies evaluated in 2014 the opportunity to give their feed- Technical Subcommittees back on Index methodology and to discuss their results with the Index team. Market Influence & Compliance Michele Forzley

Stakeholder dialogue Jillian Kohler The Foundation also reached out to a broad range of experts through a targeted stakeholder Research & Development engagement exercise. Their insights helped to Jennifer Dent ensure that the methodology was up-to-date. Nick Chapman This process helped identify a consensus regarding the appropriate role for pharmaceutical com- Pricing Manufacturing & Distribution panies in addressing access to medicines. Jaime Espín Niranjan Konduri Stakeholders contacted included academic Prashant Yadav experts, investors, non-governmental organisations, governments, and multilateral organi- Patents & Licensing sations. A full list of named respondents in this Peter Beyer process is included in the Access to Medicine Esteban Burrone Index Methodology 2015. An expert meeting was Warren Kaplan held at the World Health Organization, and further engagements were conducted by teleconference, and by email. Expert Review Committee The

Foundation’s team met with the Expert Review Committee (ERC) in March, June and August 2015. The role of the ERC is to pro- 165 Source: http://www.doksinet 1 6 2 7 5 8 4 3 n/a 9 15 10 12 17 16 11 14 20 19 18 3,3 3,0 2,8 2,8 2,8 2,8 2,6 2,6 2,6 2,5 2,5 2,3 2,2 2,1 1,9 1,9 1,7 1,6 1,5 1,5 GlaxoSmithKline plc Access to Medicine Index 2016 Novo Nordisk A/S Johnson & Johnson Novartis AG Gilead Sciences Inc. Merck KGaA Merck & Co. Inc Sanofi AbbVie Inc. Bayer AG Eisai Co. Ltd Roche Holding AG Bristol-Myers Squibb Co. Boehringer Ingelheim GmbH AstraZeneca plc Pfizer Inc. Eli Lilly & Co. Astellas Pharma Inc. Daiichi Sankyo Co. Ltd Takeda Pharmaceutical Co. Ltd Ranking, scoring and review process 0 1 2 3 4 The size of each colour represents the contribution of each technical area to the overall score. The size of the bar depends on the company score for the technical area and the weight of the technical area compared to the other technical areas. Each of the color bars

comprises indicators for Commitments (15%), Transparency (25%), Performance (50%) and Innovation (10%). A score of zero is the lowest possible score in an indicator. A five is the highest possible score. A company’s overall score is an aggregate of individual indicator scores, adjusted by the respective indicator, strategic pillar and technical area weights. 5 SUMMARY OF THE SCORING PROCESS 1. Before inclusion for analysis, the Index team mission, all R&D products were evaluated (R&D; Pricing, Manufacturing & Distribution; reviewed both marketed products and products according to this standardised procedure. Patents & Licensing; and Product Donations) in company R&D pipelines. This verification was were based only on products submitted by the to ensure they were within the scope of Index Process for registered product inclusion company. Report card figures on each compa- 2016 and met relevant inclusion criteria. Registered products also went through a

ver- ny’s product portfolio include products identi- ification process. This was to assess whether fied using public information and not submitted Process for R&D pipeline product inclusion they were suitable for use under the disease by the company. For R&D products inclusion criteria were applied indication(s) as described by the company, and based upon the product type and disease target, as covered by the ICD10 codes described in the 2. Quantitative indicators, such as the portion according to the Index scopes. Methodology Report 2015. Product indications of a company’s R&D investment relevant to dis- • For medicines and vaccines in early stages were verified using information from regula- eases within the scope of the Index from a com- (discovery, pre-clinical and phase I) of devel- tory authorities (such as the FDA and EMA). Any pany’s total R&D investments, are adjusted opment, all innovative R&D projects were products that

remained unclear following this based on total revenues from 2014 and 2015, or included for all four disease classes. process were verified with the company. Further, other relevant figures indicative of company size. for the first time, products identified through Consistent with the relative ranking approach of (phase II, III and market approval) of devel- external validation that the company had not the Access to Medicine Index, the adjusted num- opment, all innovative R&D projects were submitted but appeared to be within scope were bers are then scaled for scoring from zero to included for communicable diseases and clarified with the company, with a request to five. In the case of pricing indicators, the number Neglected Tropical Diseases (NTDs). either include these products or to explain why of registered products or the number of prod- they were not within scope. ucts with equitable pricing strategies, within the • For medicines and vaccines in

late-stages • For innovative R&D for medicines and vaccines targeting non-communicable diseases scope of the Index, were used as an additional (NCD) and maternal and neonatal health con- Products were determined as being on the differentiator of company size, to that both big ditions (MNH) in late stages of development, WHO Model Essential Medicines List (EML) if and small companies’ performances were scored stricter inclusion criteria were applied. For the product (a) appeared directly on the list relative to peers of similar size. these investigational products, supporting evi- or (b) was in the same pharmacological class dence to indicate how the product would be as a product listed on the EML indicated with 3. When an indicator is not applicable to a made accessible to people living in countries a square box. Products were allocated to dis- company, neutral scoring is used. Where neu- within scope, if approved for marketing, was ease categories

(communicable, non-communi- tral scoring is a possibility this is indicated in required for inclusion (i.e, evidence of access cable, neglected tropical diseases, maternal and the scoring guidelines. Neutral scoring was provisions). neo-natal health, multiple categories) based on applied within the areas of Market Influence indications mentioned by regulatory authori- & Compliance; Research & Development; were included for all four disease classes if it ties (e.g FDA/EMA) in the product information Pricing, Manufacturing & Distribution; Patents & targeted a need in countries in the scope of Where products were noted as appropriate for Licensing and Product Donations. For example, the Index. R&D for other product types (eg, indications across more than one disease cate- when a company has no equitable pricing strat- diagnostics, platform technologies, microbi- gory, they were allocated to the class ‘multiple egies within scope, it is still

assessed for scor- cides, vector control products), projects were categories’. ing in the relevant commitment indicator (D.I1) • Adaptive R&D for medicines and vaccines included if the R&D targeted needs of popula- and the primary performance indicator on the tions in countries in the scope of the Index. Groups of medicines always excluded were med- existence of equitable pricing strategies (D.III1) • All R&D had to be ongoing during the period icines intended for treatment of cancer, painkill- It is expected to, and may have a commitment, of analysis, including products that received ers, anaesthetics and supportive medicines with- but it receives a lower score in the performance first global marketing approval during the out specific indications, such as IV fluids and indicator. However, for the transparency indica- period of analysis. blood transfusions. Products may be used for tors related to disclosure of volume of sales and multiple

diseases in scope. Products were scored price point information for products with equita- were asked for clarifications, if needed, to sup- according to diseases listed by the company. ble pricing strategies (D.II1 and DII2), and subse- port this verification process. After final sub- Scoring for product-specific Technical Areas quent performance indicator related to the con- • Following the first submission, companies 166 Source: http://www.doksinet Access to Medicine Index 2016 sideration of socioeconomic factors within exist- • For cases where most or all other sub-themes the technical area analyst, including an exten- ing equitable pricing strategies (D.III2), a neu- within the Technical Area also included indica- sive quantitative and qualitative check of each tral score is applied, as the company has already tors that were neutrally scored, the weighted indicator for each company. Further, a cross- been penalised. average of the scores of all other

Technical check was performed by a second expert from Areas that did not have any neutral scoring the Foundation team along with each technical were applied to the relevant indicator. area expert. The research managers performed 4. Neutral scoring was applied within different Technical Areas using one of three approaches. a quality assurance check on all scores to ensure The approach is determined on a case-by-case 5. Scoring was carried out based on data from consistency. Each technical area analyst then basis per company for each neutrally scored a wide range of information sources including cross-checked their technical area’s ranking, indicator. companies’ submissions; independent reports; before the final ranking was cross-checked and • In cases where no other neutrally scored indi- databases from the World Health Organization verified by the research managers. cators exist for a company within the sub- (WHO), other multilateral organisations, govern-

theme of the indicator in question, a neutral mental and non-Governmental organisations; 7. A statistical analysis has been carried out on score would be awarded to that indicator com- legal databases such as LexisNexis; and news the final scores to check for significant correla- prising a weighted average of all the indica- databases such as Bloomberg. tions between different indicators and the dis- tor scores for that company within that sub- tribution of scores for each indicator. Based on theme (excluding the indicator which receives 6. The final scoring of the companies is the the analysis of every single indicator, adjust- a neutral score). result of a multi-tiered analysis and quality assur- ments were made to some indicators’ scoring ance process beginning with scoring per com- guidelines to ensure maximum variability and an within a sub-theme needed to be neutrally pany by the technical area analyst during the appropriate distribution of scores,

depending on scored, a weighted average of all the indicators first round of the data collection period, fol- whether the indicator has an absolute or relative of all remaining sub-themes within the rele- lowed by re-scoring after companies have pro- scale. vant Technical Area for which the company did vided further clarification in areas identified by not have neutral scoring were used as a proxy. the analyst. This was followed by verification by • For cases where more than one indicator REVIEW PROCESS Following clarification and cross-check of com- Each Technical Area was reviewed by one Committee, Hans Hogerzeil. In addition to this, pany scores, the Index research team wrote the member of each of the relevant Technical an external editorial review was performed. various sections of the Index report. Subcommittees. The entire Index was finally reviewed by the chair of the Expert Review LIMITATIONS OF THE METHODOLOGY Limitations exist in every study of this

design. for the primary disease that a product targets in the case of pricing indicators, in this Index, Some major limitations specific to this study are were given credit in indicators D.III1 and DIII4, the number of products within the scope of discussed here. These and other methodological rather than including all countries within scope the Index, either in a company’s market portfo- limitations will be reviewed for the 2018 Access for every product. lio or with equitable pricing strategies, was used to Medicine Index, as part of the 2017 mul- as an additional differentiator to group compaLongitudinal comparability nies together, so that both big and small compa- Comparability between companies over succes- nies’ performances were scored relative to peers Disease and country comparability sive indices was not always possible or appro- of similar size. Companies of different sizes have The outputs analysed in this study and the find- priate, especially for

new areas of evaluation or different capacities to report information. For ings generated relate only to the geographical, where the scoring criteria of an indicator had example, larger companies may be less likely to disease, product and company scopes, as deter- been refined. During the period of analysis (1 have all data available in a centralised repository/ mined by the Expert Review Committee (ERC) June 2014 to 31 May 2016), where trend analysis database, and may have more data to report on. during the methodology review process, and was useful, the Index team compared raw data This can be further complicated where there as published in The Access to Medicine Index from 2014 with raw data from 2016. are generic medicine subsidiaries to account ti-stakeholder Methodology Review process. Methodology 2015. for. Companies have idiosyncratic systems for Company comparability recording and reporting information, which can Although the Foundation recognises that all

The objective of the Index is to produce a give rise to complications when comparing the products, diseases, countries, access and prod- standardised relative ranking of companies’ performance of different companies. For exam- uct initiatives are not the same, in general, in access-to-medicine performances. However, not ple, companies have different mechanisms for most Technical Areas in this study they are all companies are the same. Some have large calculating the value of donation programmes. treated equally. For example, in R&D, all com- portfolios and pipelines. Some have a compara- pounds are treated equally if they meet the tively narrow disease focus. Some have a com- Companies also often have individual ways of inclusion criteria, regardless of their mechanism paratively narrow scope of country operations. categorising information, for example, how dif- of action or expected efficacy. However, for the The Index uses various methods to correct for

ferent pricing strategies are referred to. In first time, the Index has used various methods these variations between companies. In several order to minimise the variability of informa- to correct for variations between products and indicators that measure quantitative elements tion sourced from companies, all companies countries within the scope of the Index. R&D (relating to pricing, R&D and patents and licens- were provided with training on the data submis- products were given additional credit if they tar- ing), in general, we make adjustments for com- sion process and the questionnaire had help text geted high-priority product gaps, as defined by pany size. These are made against the size of to provide definitions and examples for Index Policy Cures’ G-FINDER tool. In equitable pricing the relevant portfolio of products, or against jargon. In addition to this, a clarification round and filing for registration, only priority countries company revenue

for 2014 and 2015. Further, was carried out, giving companies an oppor- 167 Source: http://www.doksinet Access to Medicine Index 2016 tunity to provide additional data where there were gaps, inconsistencies identified, or clarifications necessary. Data availability Companies are sometimes unwilling or unable Identifying best practices & innovations to disclose commercially sensitive data, or, if they do, may do so only partially. For example, the full contents of voluntary licences are some- The diffusion of best practices is one of the up, or expanded, can qualify for further recog- times not shared, nor the content of R&D con- Access to Medicine Index’s mechanisms for nition as Innovation in the subsequent cycle. tracts. Occasionally, where sensitive data could supporting the pharmaceutical industry to Previously, this was limited only to Innovation be analysed, complete results could not be pub- achieving greater access to medicine. Similarly, in business

models, within General Access to lished due to legal constraints related to public recognising those companies trialling or scaling Medicine Management. Best practices, by their disclosure (e.g, price data) In other cases, col- up innovative unique-in-industry policies or ini- definition, cannot be considered innovations. lection of very specific data (e.g, volume of tiatives is an important way of acknowledging sales data for different sectors within a coun- those companies prepared to stand out from Process try) which may require disaggregation, or coun- peers and to risk new approaches. To determine which of the company’s practices try-level collection, was not always possible. would be highlighted as best practice or inno- This issue remains an obstacle to finding and Best practices vative, the Foundation’s research team evalu- reporting reliable trends and very specific rela- Best practices are ones that can be accepted ated all aspects of company

practices, compil- tionships and conclusions in several areas. as being the most effective way of achieving a ing those that met the above criteria, with addi- desired end, relative to what the industry is cur- tional criteria for each Technical Area, where Additionally, in some areas it may not be pos- rently doing in that area and what stakeholder necessary. For innovative activities, special note sible to provide a complete picture of the area expectations are. It can also be described as a was taken of activities submitted by compa- of analysis due to external constraints on the benchmark. Best practices are not new practices nies as being considered innovative. Innovative collection of data. For example, in 2016, set- – they have already been conceived of, applied, activities could also be identified outside of that tlements and judgements regarding breaches and have proven to meet at least some of the subset. The team met twice during the scoring which

occurred an where in the world were following criteria: and analysis period to agree which practices to counted when evaluating companies in the • Sustainability, define as best or innovative. Best practices and areas of ethical marketing, corruption and • Replicability, innovations were tested with members of the anti-competitive behaviour. Some breaches • Alignment with external standards/stake- Technical Sub-Committees where relevant. occurred prior to the period of analysis. Even given this expanded scope, it is not possible to holder expectations, • Proven effectiveness. be confident that all breaches were captured. Sources of data collection include Lexis-Nexis, In different areas of analysis (for exam- the websites of government departments such ple, in Research & Development vs. in Pricing as the US Department of Justice, and reg- Manufacture and Distribution) how a best prac- isters maintained and published by a selec- tice is identified may be

different. A best prac- tion of industry self-regulatory bodies: the UK, tice need not be unique amongst companies. the Netherlands, South Africa and Australia. A best practice might be an example of a ‘gold Even given the significantly expanded scope of standard’ of practice; a best-in-class policy; or investigation, we acknowledge that breaches a strategy, programme, product initiative or may have occurred which were not captured. group of behaviours closely aligned with stake- We continue to acknowledge that breaches in holder expectations. Best practices should be Index countries are likely to be under-reported. considered as the best practice identified by Similarly, a complete picture of breaches of clin- the Foundation’s research team amongst the 20 ical trial conduct is difficult to capture, due to companies in the submitted data, within the cur- the absence of a central registry of such infor- rent period of analysis. mation, the fact these incidents

are typically not routinely monitored by research ethics commit- Innovations tees, and tend not to be prosecuted. Innovations have been defined in successive iterations of the Access to Medicine Index as: Measuring Outcomes and Impacts “a novel activity/business/model/policy/strat- The study as currently designed is not intended egy being piloted/trialled by companies, which to measure the direct impact of companies’ (where relevant) has evidence of financial or access initiatives on patients and other groups. personnel resources invested in it (as proof of For example, within Capacity Building, the impact implementation).” of a company’s training activities is not measured, although the Index may consider whether a Innovative activities are often (but not always) company measures the impact of its own activ- unique amongst the set of 20 companies. An ities. Alternative measures are used as proxies exception to the requirement for uniqueness is for patient

access or considerations of impact. when multiple companies jointly co-operate in For example, within Pricing, Manufacturing & the same innovative activity. For 2016, the defi- Distribution, disclosure of the volume of sales nition of Innovation was expanded to include achieved to different sectors within a country is scaling up. Therefore, a practice which was being taken as a proxy measure of the success of an newly trialled/piloted in the previous Index cycle, equitable pricing strategy in being implemented. where evidence is shown that it has been scaled 168 Source: http://www.doksinet Access to Medicine Index 2016 Indicators and Scoring Guidelines The Scoring Guidelines are scaled accord- nies are currently doing, and a score of 0 or 1 ­represents behaviour below minimum accept- ing to either current industry practice based represents the least they are currently doing) able ­standards). on the spectrum of evidence provided (i.e, a or a ­ ccording to

stakeholder expectations (i.e, score of 5 represents the best that the compa- a score of 5 ­represents good practice and a 0 A GENERAL ACCESS TO MEDICINE MANAGEMENT A.I COMMITMENTS (15%) A.I1 Governance: Management structures (45%) tionprocess; stakeholder groups it engages with; engagement activi- The company has a governance system that includes direct board- tiesrelated to access to medicine; and key outcomes and rationales. level responsibility and accountability for its access-to-medicine 5 A.II2 Stakeholder engagement: Public reporting (55%) The company publicly discloses summaries of: its stakeholder selec- The company publicly discloses detailed information regarding initiatives. stakeholder engagement related to access to medicine includ- 5 The company has a board member or board-level committee ing: a) an overview of relevant stakeholder groups;b) its stake- responsible for its access-to-medicine approach. holder selection process;c) a summary of

relevant stakeholder The company has an executive manager or executive committee, engagement activities; andd) a summary of the key outcomes 3 that directly reports to a board member or to a board-level committee, responsible for its access-to-medicine approach. 0 and rationales for these activities. 3 The company has no board or executive level responsibility for its access-to-medicine approach. The company publicly discloses at least two out of four of the above pieces of information. 2 The company publicly discloses, or discloses via the Index, only general information regarding its stakeholder engagement activ- A.I2 Access-to-medicine strategy (55%) The company sets objectives to improve access to medicine, and ities related to access to medicine. 0 The company does not disclose publicly or via the Index informa- aligns its access-to-medicine strategy with its core business. tion on its stakeholder engagement activities related to access 5 to medicine. The company

has a clear access-to-medicine strategy with a strong business rationale, including a detailed set of objectives to improve access to medicine. A.III PERFORMANCE (50%) 3.5 The company has an access-to-medicine strategy, including a set of objectives to improve access to medicine. 2 0 A.III1 Managing for access-to-medicine outcomes: Performance man- The company has a set of objectives to improve access to medi- agement system (30%) cine but does not have an access-to-medicine strategy. The company has a performance management system to moni- The company does not have an access-to-medicine strategy and tor and measure the outcomes of its access-to-medicine activities does not set objectives for improving access to medicine. across its global operations. 5 A.II TRANSPARENCY (25%) The company has a centralised performance management system that uses quantitative and qualitative measures to collect data and appraise performance of its access-to-medicine activi- A.II1 Managing

for access-to-medicine outcomes: Public reporting (45%) ties across its global operations. 2.5 The company has a performance management system but does The company publicly reports on its commitments, objectives, tar- not collect data and appraise performance of its access-to-med- gets and performance information related to improving access to medicine. 5 icine activities across its global operations on a regular basis. 1 The company publicly discloses its commitments, objectives, access-to-medicine strategy but does not have a performance quantitative targets, qualitative targets and performance information related to improving access to medicine. The company has qualitative and quantitative targets for its management system. 0 3,5 The company publicly discloses its commitments, objectives and The company does not have targets for or measure its access-to-medicine performance. targets (quantitative and/or qualitative) related to improving access to medicine. A.III2

Stakeholder engagement (25%) 2,5 The company publicly discloses its objectives, quantitative tar- The company engages with relevant stakeholders, including univer- gets and qualitative targets related to improving access to sities, industry peers, patient groups, local governments, employees, medicine. and local and international non-governmental organisations, with The company discloses via the Index at least partial information the aim of improving access to medicine. from the above, related to improving access to medicine. 5 1 0 The company provides evidence of strategic stakeholder The company does not disclose publicly or via the Index any of engagement with reputable organisations* related to access to the above information. medicine during the period of analysis and shows how it incorporates the outcomes of these engagement activities into the strategic and operational direction of the company. 169 Source: http://www.doksinet Access to Medicine Index 2016 2

The company provides some evidence of stakeholder engage- 1 ment related to access to medicine during the period of analysis. 0 development and implementation of its access strategies on an The company provides no evidence of stakeholder engagement related to access to medicine during the period of analysis. The company includes local stakeholder perspectives into the ad hoc basis, but it does not have a system in place. 0 The company does not incorporate local stakeholder perspectives into the development and implementation of its access * Reputable organisations include governments, major international agencies, regulatory bodies, foundations, academia, PPPs/ PDPs and NGOs. strategies. A.IV INNOVATION (10%) A.III3 Governance: Performance management & incentives (30%) The company has internal incentive structures to reward the effec- A.IV1 Innovation in business models (60%) tive delivery of initiatives that improve access to medicine in coun- The company has

contributed to the development of innovative tries within the Index scope, for diseases within the scope of the (unique in the sector) businessmodels that meet the access needs Index. of patients in countries within theIndex scope. 5 5 The company has a Human Resources (HR) performance man- tive (unique in the sector) business model that improves access, evidence of financial and non-financial incentives for relevant with a focus on the needs of the poor and provides evidence of performance of directors, senior management and all other employees. 3 the model’s financial sustainability. 4 innovative (unique in the sector) business models that improves supporting processes which provide financial and/or non-finan- access, with a focus on the needs of the poor. However, there is but does not have specific incentives for senior management. limited evidence of their financial sustainability. 3 The company has contributed to the development of an innova- The company has

internal incentive structures for rele- tive (unique in the sector) business model that improves access, vant performance for at least some employees working on with a focus on the needs of the poor. However, there is limited access-to-medicine initiatives. 0 The company has contributed to the development of multiple The company has a HR performance management strategy and cial incentives for relevant performance of employees in general, 1 The company has contributed to the development of an innova- agement strategy and supporting processes; and provides clear The company does not provide incentives to reward any employ- evidence of its financial sustainability. 1 ees for the effective delivery of access-to-medicine initiatives. The company has expanded an existing financially sustainable innovative business model that focuses on the needs of the poor. A.III4 Stakeholder engagement: Local perspectives (15%) 0 No innovative business models identified in this area. The

company has a system in place to incorporate external and local perspectives on access-to-medicine needs in the development and A.IV2 Innovation in governance and stakeholder engagement (40%) implementation of its access strategies. The company has developed innovative (unique in the sector) 5 The company has a structured system in place to incorporate approaches to its access governance, its performance management local stakeholder perspectives into the development and imple- systems and/or its stakeholder engagement. mentation of its access strategies, with inputs from both head- 5 approaches to governance and/or performance management cesses for its subsidiaries or provides evidence of how subsidiar- systems and/or stakeholder engagement and supports this with ies engage with relevant stakeholders. 3 The company has developed innovative (unique in the sector) quarters and local offices. The company uses the same pro- The company has a system in place to incorporate

local stake- evidence of progress or resources. 2.5 The company has adopted existing innovative (unique in sector) holder perspectives into the development and implementa- approaches to governance and/or performance management tion of its access strategies, but provides no evidence that local offices provide input and/or provides no details about its subsid- systems and/or stakeholder engagement. 0 No innovative initiatives identified in this area. 1 The company has in place a code of conduct or policies for ethi- iaries’ stakeholder engagement process. B MARKET INFLUENCE & COMPLIANCE B.I COMMITMENTS (15%) B.I1 Governance of ethical marketing (50%) cal marketing consistent with industry standards, but is not able to demonstrate how it enforces its code of conduct across all The company commits to enforcing a code of conduct for ethical marketing practices that: extends to third parties; is consistent sales agents, including third parties. 0 with existing

industry standards; and incentivises responsible sales The company does not have a code of conduct for ethical marketing practice consistent with industry standards. practice. 5 The company has: a) an ethical marketing code consistent with B.I2 Governance of corruption & bribery (50%) industry standards; b) training related to ethical marketing; The company commits to proactively engaging in fighting corruption c) formal processes in place to ensure compliance with these through its internal policies, oversight of third parties, external com- standards by third parties and the company demonstrates that it mitments and memberships. takes enforcement action for non-compliance in countries within 5 The company meets all of the following criteria:a) a code of con- the scope of the Index; andd) sales agent incentives not driven duct that addresses anti-corruption and specifically applies to exclusively by sales targets. all employees, agents, intermediates, and third

parties, with an 2,5 The company has: a) an ethical marketing code consistent with enforcement provision for third parties;b) director-level respon- industry standards;b) training related to ethical marketing; andc) sibility with board level reporting for ethics and compliance of formal processes in place to ensure compliance with these anti-bribery/corruption practices;c) membership of the World standards by third parties and the company demonstrates that it Economic Forum’s Partnering Against Corruption Initiative takes enforcement action for non-compliance in countries within (PACI) AND/OR Signatory to the UN Global Compact; andd) the scope of the Index. whistle-blower facilities with a provision for anonymity AND a policy of non-retaliation. 170 Source: http://www.doksinet Access to Medicine Index 2016 B.II4 Ethical Marketing & Corruption: Disclosure of breaches (20%) 3 The company meets three out of four of the above criteria. 1 The company meets one or

two of the above criteria. The company publicly discloses information regarding global 0 The company meets none of the above criteria. breaches of internationally recognised codes of conduct, laws and regulations that govern ethical marketing, bribery and corruption in B.II TRANSPARENCY (25%) the last two years. 5 B.II1 Market influence: Policy positions (25%) The company publicly discloses detailed, current information (i.e location, time, year, action taken) on its website or in its The company is transparent about political contributions made, annual report, about settlements reached and cases concluded and the policy positions it seeks to promote that have an impact on during the period of analysis. This includes breaches of national access to medicine in countries within the scope of the Index. or international codes of conduct, and national laws and regula- 5 The company publicly discloses its policy positions which impact access to medicine, and its political

financial contributions which tions which cover ethical marketing, bribery and corruption. 3 impact countries within the scope of the Index, or it has a policy information related to all breaches as outlined above, either in that forbids political financial contributions. 3 The company publicly discloses its policy positions which impact its annual report or on its website. 2 access to medicine in countries within the scope of the Index. In 1 of analysis. 1 The company publicly discloses its public policy positions which 0 of analysis. 0 The company does not disclose publicly or via the Index its polit- The company either provides no information on settlements reached or cases concluded of breaches, or has been found the ical financial contributions or public policy positions which have an impact upon access to medicines in countries within the The company discloses to the Index detailed information related to some breaches and/or settlements reached during the period

impact access to medicine in countries within the scope of the Index. The company discloses via the Index information related to some breaches and/or settlements reached during the period addition, it discloses to or via the Index its political financial contributions which impact countries within the scope of the Index. The company publicly discloses aggregate numbers or limited subject of settlements but does not disclose them to the Index. NS Companies that have not been subject of any settlements for scope of the Index. criminal, civil or regulatory infractions anywhere in the world over the period of analysis receive a neutral score. B.II2 Market influence: Memberships (25%) The company publicly discloses board seats and memberships held; B.III PERFORMANCE (50%) and financial support provided to organisations through which it may advocate policies relevant to access to medicine in countries within B.III1 Ethical Marketing & Corruption: Incidence of breaches (55%)

the Index scope. The company also discloses policies for responsible The company has not been the subject of settled cases for cor- engagement and management of conflicts of interest. rupt practice, bribery or incidences of unethical marketing practice 5 The company publicly discloses:a) its financial support and mem- during the past two years. bership of all institutions, including relevant board seats held of 5 3 criminal, civil or regulatory infractions anywhere in the world and c) its policy for responsible engagement. over the period of analysis (pending cases, allegations and cases The company publicly discloses: a) its membership of all institutions (including board seats held where relevant) of the named under appeal are not included). 3 categories,* but not its financial support;b) how it manages conThe company discloses to/via the Index:a) its membership of all one breach of a code of practice anywhere in the world. 2 institutions (including board seats held

where relevant) of the named categories,* and eitherb) how it manages conflicts of The company makes no public disclosure in this area or does The company has been the subject of more than one breach of a code of practice anywhere in the world. 1 interest, orc) its policy for responsible engagement. 0 The company has not been the subject of any criminal or civil infractions anywhere in the world, but has been the subject of flicts of interest, andc) its policy for responsible engagement. 1 The company has not been the subject of any settlements for all the named categories,*b) how it manages conflicts of interest, The company has been the subject of one or more civil or criminal settlement(s) anywhere in the world. 0 The company has been the subject of at least one civil or crim- not have policies for the management of conflict of interest and inal settlement with a negative ruling in a country within the responsible external engagement. Index scope. * Trade

associations, think tanks, interest groups or other organisations. B.III2 Ethical Marketing & Corruption: Enforcement (25%) The company has clearly defined enforcement procedures and B.II3 Disclosure of marketing strategy and practice (30%) (where there has been misconduct) provides evidence of taking dis- The company publicly discloses detailed information regarding its ciplinary action against employees or third parties who have violated marketing and promotional programmes in countries within the its code of conduct for ethical marketing, bribery or corruption. The Index scope (such as payments to or promotional activities directed company provides evidence of follow-up action taken to mitigate the at healthcare professionals and opinion leaders). risk of future breaches. 5 5 The company publicly discloses detailed information related to pharmaceutical marketing and promotional programmes in disciplinary measures with regards to lobbying, corruption and countries

within the Index scope. This includes, for example, payments made to physicians and methods for incentivising health- The company has clearly defined enforcement processes and marketing, and there is no evidence of violations. 3 The company has clearly defined enforcement processes and care providers, pharmacies, and key opinion leaders, as well as disciplinary measures and provides detailed (but anonymised) decentralised activities and activities of third party sales agents. evidence that disciplinary action has been taken for lobbying, 2.5 The company discloses to/via the Index its policy approach for pharmaceutical marketing in countries within the scope of the corruption and marketing violations, in addition to evidence of follow-up action to mitigate the risk of future breaches. Index without disclosing exact contribution figures in this area. 0 The company makes no disclosure in this area. 171 Source: http://www.doksinet Access to Medicine Index 2016 1.5 The

company has defined enforcement processes and disciplinary measures for lobbying, corruption and marketing violations but does not disclose information about disciplinary actions 1 The company only has an audit process. 0 The company does not have an audit process. B.IV INNOVATION (10%) taken. 0 The company does not have clearly defined enforcement pro- B.IV1 Innovation in Market Influence & Compliance (100%) cesses and disciplinary measures or, where violations have taken The company has adopted an innovative (unique in sector) approach place, shows no evidence of action having been taken. to improving ethical business performance in countries within the scope of the Index relating to ethical marketing, lobbying, or bribery B.III3 Ethical Marketing & Corruption: Monitoring (20%) The company demonstrates that it has a regular, rigorous audit pro- and corruption. 5 The company has developed innovative (unique in the sector) cedure to ensure the application of its

codes of conduct/policies for approaches to promoting ethical behaviour and anti-corruption managing ethical marketing, corruption and bribery, using auditing which extends to countries within the scope of the Index, and resources both internal and external to the company, which extend supports this with evidence of progress and/or the human or to all countries relevant to the Index in which the company operates, and to all third parties with whom the company is engaged. 5 financial resources invested. 2,5 The company has adopted innovative (unique in the sector) The company demonstrates it has a regular audit process, which approaches to promoting ethical behaviour and anti-corrup- draws on both internal and external resources, is sensitive to tion which extend to countries within the scope of the Index, but risk, and extends to all countries and with all contractors with whom the company is engaged within the Index scope. 3 does not disclose progress or resources

invested. 0 No innovative initiatives identified in this area. The company demonstrates it has an audit process, which extends to all countries and with all contractors with whom the company is engaged within the Index scope. C RESEARCH & DEVELOPMENT C.I COMMITMENTS (15%) C.I1 Product development: Innovative and adaptive R&D (40%) countries within the Index scope in relation to the intellectual The company commits to carrying out research focusing on the property generated in partnerships for a subset of diseases in development of both innovative products and adaptive formulations scope (i.e either waives all rights over the intellectual property of its existing products for diseases within the scope of the Index generated or explicitly encourages affordable, timely and high 3.5 The company has policies in place to systematically include access-oriented principles in research contracts in a subset of with the goal of improving access to medicine in countries

within scope. 5 quality supply to relevant populations). 1,5 The company makes a general commitment to include The company makes specific commitments to conduct R&D in diseases within the Index scope for countries in scope. The access-oriented principles in its research contracts. 0 The company makes no commitments in this area. company’s commitments are based on a public health rationale, informed by evidence of public health needs and/or product 3 1 0 C.I3 Clinical trial conduct: Commitment to standards (30%) needs. The company has measurable, time-bound operationalis- The company commits to complying with standards of quality assur- ing strategies for diseases and countries within the Index scope. ance and control and ethics when conducting clinical trials in coun- The company makes specific commitments to conduct R&D tries within the Index scope. These standards are consistent with in diseases within the Index scope for countries in scope. The codes

suchas Good Clinical Practice (GCP), Good Participatory company’s commitments are based on a public health ration- Practice Guidelines (GPP), and the Declaration of Helsinki, regard- ale, informed by evidence of public health needs and/or product less of whether the trials are conducted in-house or through a third- needs. The company supports these commitments with oper- party, e.g, contract research organisation (CRO) ationalising strategies in for diseases and countries within the 5 The company provides evidence that it has policies in place in Index scope. relation to:a) ensuring compliance with Good Clinical Practice;b) The company makes a general commitment to conduct R&D has procedures in place for taking disciplinary action against any for diseases within the Index scope for countries in scope and/ violations;c) selecting third parties;d) application of codes of or has operationalising strategies in for diseases and countries conduct consistent with the

Declaration of Helsinki, with at least within the Index scope. two of the following elements present: post-trial provisions; The company has no commitments or strategies in this area. use of placebo; scientific requirements and research protocols; ande) ensuring compliance with Good Participatory Practice C.I2 Collaborative R&D: Ensuring equitable access (30%) The company commits to ensuring equitable access to products suc- Guidelines in place, if applicable. 3 in relation to: (a) ensuring compliance with Good Clinical 5 Practice;(b) has procedures in place for taking disciplinary action The company has policies in place to systematically include access-oriented principles in research contracts in all countries within the Index scope, for all diseases in scope, in relation to the against any violations; and(c) selecting third parties. 1 intellectual property generated in partnerships (i.e either waives all rights over the intellectual property