The Access to Medicine Index 2014 Access to Medicine Foundation Scheepmakersdijk 5A NL-2011 AS Haarlem the Netherlands

The Access to Medicine Index 2014 Access to Medicine Foundation Scheepmakersdijk 5a NL-2011 AS Haarlem The Netherlands

On behalf of the Access to Medicine Foundation, Please contact Jayasree K. Iyer, Head of Research E [email protected] and [email protected] T +31 (0)23 53 39 187 W www.accesstomedicineindex.org

Funders This report was made possible by financial support from the Bill & Melinda Gates Foundation, the UK Department for International Development (DFID), and the Dutch Ministry of Foreign Affairs. The Access to Medicine Index 2014

Access to Medicine Foundation

November 2014 Access to Medicine Index 2014

Acknowledgements The 2014 Access to Medicine Index 2014 is made possible through the collaborative team effort of several experts, authors, researchers and analysts.1 The Foundation is grateful for their contributions and expertise, and would like offer thanks to those individuals who provided valuable feedback throughout the development of the 2014 Index.

Funders Bill & Melinda Gates Foundation UK Department for International Development (DFID) The Netherlands Ministry of Foreign Affairs

Expert Review Committee The Access to Medicine Hans Hogerzeil (Chair) Research team Natacha Dimitrijevic Jayasree K. Iyer Marja Esveld Delphi Coppens Regina Kamoga Danny Edwards Richard Laing Tara Prasad Dennis Ross-Degnan Laurien Rook Dilip Shah Lisanne Urlings Peter Shelby Editorial team Technical subcommittees Hans Hogerzeil Peter Beyer Jayasree K. Iyer Esteban Burrone Anna Massey Jennifer Dent Ed Monchen Jaime Espin Emma Ross Michele Forzley Suzanne Wolf Javier Guzman Warren Kaplan Data collection and scoring Jillian Kohler Sustainalytics Niranjan Konduri Andrea van Dijk Prashant Yadav Teodora Blidaru Radoslav Georgiev Reviewers Hazel Goedhart Esteban Burrone Vikram Puppala Jennifer Dent Hans Hogerzeil Report Design Richard Laing Explanation Design BV Jillian Kohler Niranjan Konduri IT Efficiency Online BV Other contributors Gbola Amusa Printers Sara Brewer Drukkerij Aeroprint Theo K. Dijkstra Patrick Flochel Joost de Groot Esraa al Temimi

1 This acknowledgement is not intended to imply that the individuals and institutions mentioned above endorse the Access to Medicine Index, its final methodology, the analysis or results. Decisions regarding inclusion of all feedback were ultimately made by the Access to Medicine Foundation. Access to Medicine Index 2014

Our clearest ever picture of the industry

In recent years, significant milestones for improving access to medicine have been achieved: including important new drugs for TB and hepatitis C, and a global drive to tackle neglected tropical diseases. For me, these developments show us how much we need the entre- preneurial power of pharmaceutical companies to address access to medicine. But while it is clear that companies have a role to play, there is still no sustainable model for ensuring the poorest patients have access to the medicine they need.

With this Index, we aim to provide companies with clear guidance, by reporting on what they and their peers are already doing well, and by showing where solutions are still needed. The methodology was refined with support from academics, NGOs, investors and governments, and the companies have been more transparent with their data and more open about their challenges than ever before. The result is our clearest ever picture of the industry’s strengths, weaknesses, progress and struggles.

The industry continues to do more to address access to medicine. Leaders innovate constantly, while companies at the bottom of the Index continue to close the gap. It’s clear that all companies address access issues in different ways – and that all companies can do more. There is still much to do. Yet, I see that companies are willing to learn from each other and to share their experiences. And that gives me confidence that we will continue to see progress in the years to come.

Sincerely,

Wim Leereveld

Founder and CEO Access to Medicine Foundation Access to Medicine Index 2014 Clickable Sections

Table of Contents

8 At a glance 10 Executive Summary 14 Introduction 21 Key Findings 26 The Access to Medicine Index 2014 – Overall Ranking 27 Leaders innovate constantly 32 Pipeline and portfolio analysis

39 Technical Areas 41 A General Access to Medicine Management 42 Top findings in General Access to Medicine Management 43 How the companies perform 44 Industry analysis 45 Focus area 1: Managing for access-to-medicine outcomes 48 Focus area 2: Access-to-medicine strategy 49 Focus area 3: Stakeholder engagement 52 Innovation overview

57 B Public Policy & Market Influence 58 Top findings in Public Policy & Market Influence 59 How the companies perform 60 Industry analysis 61 Extra analysis: Breaches 63 Focus area 1: Anti-bribery and anti-corruption 64 Focus area 2: Ethical marketing 65 Focus area 3: Lobbying 67 Focus area 4: Anti-competitive behaviour 68 Innovation overview

69 C Research & Development 70 Top findings in Research & Development 71 How the companies perform 72 Industry analysis 74 Focus area 1: Product development 77 Focus area 2: Partnerships & IP sharing 79 Focus area 3: Clinical trial conduct & data transparency 82 Innovation overview

83 D Pricing, Manufacturing & Distribution 84 Top findings in Pricing, Manufacturing & Distribution 85 How the companies perform 87 Industry analysis 90 Extra analysis: Equitable pricing strategies 91 Focus area 1: Product registration and filing for marketing approval 93 Focus area 2: Equitable pricing strategies 96 Focus area 3: Brochure and packaging adaptation 98 Focus area 4: Accountability for sales agents’ pricing practices 99 Focus area 5: Drug-recall policies and practices 100 Innovation overview

6 Access to Medicine Index 2014 Clickable Sections

101 E Patents & Licensing 102 Top findings in Patents & Licensing 103 How the companies perform 104 Industry analysis 106 Analysis 1: Filing and enforcing patents 107 Analysis 2: Disclosure of patent status 107 Analysis 3: Licensing and formal non-assert declarations 108 Analysis 4: Licensing activity per company 109 Analysis 5: Access-friendly licensing terms 110 Anlaysis 6: Engaging with external brokers 111 Analysis 7: Support for the TRIPS agreement 112 Innovation overview

113 F Capability Advancement 114 Top findings in Capability Advancement 115 How the companies perform 116 Industry analysis 118 Focus area 1: Research & Development 119 Focus area 2: Quality management in manufacturing 120 Focus area 3: Supply chain management 123 Focus area 4: Pharmacovigilance 124 Focus area 5: Building capacities beyond the value chain

127 G Product Donations & Philanthropic Activities 128 Top findings in Product Donations & Philanthropic Activities 129 How the companies perform 131 Industry analysis 131 Focus area 1: Product donations 134 Timeline of ongoing donation programmes 138 Focus area 2: Sustainable Philanthropy 140 Innovation overview

141 Company Report Cards 142 GSK 158 Sanofi 172 AstraZeneca 145 Novo Nordisk 160 AbbVie 174 Pfizer 148 Johnson & Johnson 162 Bayer 176 Eli Lilly 150 Novartis 164 Eisai 178 Astellas 152 Gilead 166 Roche 180 Daiichi Sankyo 154 Merck KGaA 168 Bristol-Myers Squibb 182 Takeda 156 Merck & Co. 170 Boehringer Ingelheim

185 Appendix 186 Methodology scopes 189 Stakeholder engagement 2013 190 Ranking, scoring and review process 193 Indicators and scoring guidelines 213 Academic and technical sources 218 List of figures & List of tables 219 Definitions 223 Acronyms

7 Access to Medicine Index 2014 Clickable Sections At a glance About this report The Access to Medicine Index 2014 The fourth Access to Medicine Index report provides a finely detailed picture of how the world’s 20 largest research-based pharmaceutical companies address access to medicine. The Index reports on these companies’ access-related policies and practices based on an analysis of 95 indicators, in relation to 106 countries and 47 diseases. These two pages provide an overview of the report’s main sections, findings and analysis highlights, as well as signposts to where you can read more.

1 1 GlaxoSmithKline plc 3,3 2014 Index ranking 2 6 Novo Nordisk A/S 3,0 Key Findings 3 2 Johnson & Johnson 2,8

4 7 Novartis AG 2,8

5 5 Gilead Sciences Inc. 2,8 The 2014 Index is led by pack of six 6 8 Merck KGaA 2,8 Companies do more to improve 7 4 Merck & Co. Inc. 2,6 companies with a clear No.1 and a 8 3 Sano 2,6 access, but progress is uneven 9 n/a AbbVie Inc. 2,6 newcomer in the top three. Overall 10 9 Bayer AG 2,5 The industry is progressing on 11 15 Eisai Co. Ltd. 2,5

12 10 Roche Holding AG 2,3 scores are very close in this leading 13 12 Bristol-Myers Squibb Co. 2,2 several fronts. Yet in two important

14 17 Boehringer Ingelheim GmbH 2,1 group, but their access approaches 15 16 AstraZeneca plc 1,9 areas, the industry remains static.

16 11 Pzer Inc. 1,9 differ. Across all positions in the Index, 17 14 Eli Lilly & Co. 1,7

18 20 Astellas Pharma Inc. 1,6 no company excels at everything and 19 19 Daiichi Sankyo Co. Ltd. 1,5 Five companies are developing 20 18 Takeda Pharmaceutical Co. Ltd. 1,5 several stand out in certain specific 0 1 2 3 4 5 more than half of pipeline products areas. ›› p. 26 for developing countries The top 20 pharmaceutical companies are developing 327 relevant 20 company report cards Innovation in all areas products, with more than half Each one summarises a company’s In each of the seven areas of activity targeting the same five diseases. performance in the 2014 Index, examined, the Index has found including strengths, weaknesses, best evidence of innovative practices, More than half of companies are and innovative practices, and drivers including new pilots and models, new developing medicines for children behind ranking changes, as well as platforms for R&D collaboration and 7% of the overall pipeline is devoted tailored opportunities for increasing new approaches to equitable pricing. to “child-size” medicines, such as access to medicine. ›› p. 141 ›› p. 77 liquids, chewable tablets or new formulations.

Almost half of all product development is collaborative Pricing strategies are increasingly Products developed in tailored partnership More companies are using commer- No proof of cial pricing strategies that also take access Other provisions socioeconomic factors into account.

Based on ›› p. 21 access provisions

Pipeline and portfolio analysis

Companies are mainly developing and ways, either for the size of their marketing products for a small group marketed portfolios or the size of their of diseases in scope. The same five pipelines, while others have large ratios diseases appear in both the top ten of clinical-stage products to products targeted by R&D pipelines and the top on the market. ›› p. 32 ten by marketed products. Several companies stand out but in different

8 Access to Medicine Index 2014 Clickable Sections

The leaders

Companies have different access- related policies, practices and focuses, yet there are clear similari- ties in the approaches leaders take to improve access to medicine. The 2014 Index provides insights into what it takes to become and remain a leader in access to medicine. ›› p. 29 © Project HOPE © Mark Tuschman for Novartis AG

Top insights per area

General Access to Medicine Management Innovative business models Six companies have innovative business models that aim to improve access to © Bayer Healthcare AG medicine for underserved populations. The Index has found 10 common factors that link them. ›› p. 52 © Jon Ryter for Novo Nordisk

Public Policy & Market Influence Behaviour vs. company size The Index has mapped the relationship between company size (by revenue) and geographic reach, against the number of settlements or decisions relating to unethical behaviour. ›› p. 62 © IntraHealth© Intearnational © Novo Nordisk Research & Development R&D for high-burden diseases There is evidence of sustained commit- Capability Advancement Donations & Philanthropy ment to R&D for infectious diseases, Building capabilities in Timeline of donation programmes with companies taking patients’ needs 75 countries 15 companies are engaged in 28 dona- into account. ›› p. 72 More than two-thirds of companies are tion programmes, several of which actively building local capabilities in at have been expanded or scaled-up Pricing, Manufacturing & Distribution least one low income country. ›› p. 116 during the past two years. ›› p. 132 Analysing equitable pricing For the first time, the 2014 Index has only captured pricing strategies that explicitly take societal needs and affordability into account, revealing greater diversity and greater involvement in equitable pricing. ›› p. 87

Patents & Licensing Licensing behaviour profiles The Index has looked at companies with on-patent products, and addressed a series of questions aimed at revealing where they take a pro-access approach to IP management. ›› p. 105

9 Executive Summary Access to Medicine Index 2014

Executive Summary

Introduction An estimated two billion people still do not have access to the health-related products they need. This access-to-medicine challenge is multifaceted and dependent on many stakeholders for solutions, including the largest pharmaceutical companies. As developers and manufacturers of life-saving products, they have a crucial role to play. They control unique products that can greatly alleviate the disease burden in developing countries; they have the expertise to meet the need for new and adapted innovative products; and they have the ability to strengthen supply chains and support healthcare infrastructures.

Every two years, the Access to Medicine Index analyses the top 20 research-based pharmaceutical companies and ranks them according to their efforts to improve access to medicine in developing countries. A total of 95 indicators make up a framework within which company performances relating to 47 high-burden diseases in 106 developing countries can be compared. The Index analysis brings out best practices and examples, highlights areas where progress has been made and areas where critical action is required. The Index also acts as a benchmark where companies can compare their own contributions to improving access to medicine with their peers. While companies are held to a single standard, they are different in the way they operate and in their portfolio of investigational and marketed products. The Index is a relative ranking: scores cannot be directly compared between Indices.

Refinements to the methodology have brought additional Latin American countries, including Brazil, into the Index’s scope in 2014, as well as additional diseases, including mental health disorders and hepatitis C. The focus of the pricing analysis has shifted: it now only captures pricing strategies that explicitly take affordability into account. The 2014 Index also expanded its analysis of company breaches of codes of conduct or laws on ethical marketing, lobbying, corruption, bribery or anti-competitive behaviour to measure breaches worldwide.

This report outlines the key findings and overall ranking analysis of the 2014 Access to Medi- cine Index before presenting a detailed analysis of company performances and rankings in each of the seven areas of corporate activity the Index focuses on. The report concludes with detailed, tailored company report cards. These explain each company’s rank in the Index by providing a contextualised analysis of company access-to-medicine performance, relevant product portfolio and pipeline, and by highlighting industry-leading practices and company- specific opportunities to improve access to medicine.

2014 Key Findings • Companies are doing increasingly more to improve access to medicine in developing countries, with a raft of new initiatives, scale-ups and innovations over the last two years. Yet progress remains static in two important areas: Public Policy & Market Influence and Patents & Licensing. • The top 20 pharmaceutical companies are developing 327 relevant products, with only five companies accounting for more than half the pipeline and more than half the products targeting only five diseases. • More than half of the 20 Index companies are developing medicines tailored for children, with 7% of the overall research pipeline being devoted to “child-size” medicines. • More companies are paying attention to socioeconomic factors such as people’s ability to pay. Importantly, more are tailoring their prices to different segments of the population within countries.

10 Access to Medicine Index 2014 Executive Summary

The 2014 Index overall ranking GSK leads the Index for the fourth time. It is followed closely by Novo Nordisk, which has made a remarkable leap from 6th place in the last Index. These are followed by a cluster of four companies – Johnson & Johnson, Novartis, Gilead and Merck KGaA – that have different access profiles but close overall scores. Other than Novo Nordisk, the biggest riser was Eisai. Sanofi and Pfizer fell down the rankings most significantly, while Astellas, Daiichi Sankyo and Takeda remain at the bottom of the league (albeit in a different order than in the 2012 Index).

Refinements to the Index methodology have made it possible to draw a much clearer picture of the industry’s strengths, weaknesses, progress and struggles. Evidence shows the industry is continuing to step up its efforts to improve access to medicine in developing countries. However, progress in not equal across all areas and companies, and there are some areas where the industry as a whole remains static. The leading companies continue to perform well across most of the seven Technical Areas covered by the Index. Most notably, companies at the bottom of the Index are narrowing the gap, with higher overall scores than in 2012.

No company excels at everything and several stand out in certain specific areas: for instance, Novartis has the largest pipeline of products for developing countries, Sanofi has the most products on the market and Johnson & Johnson dominates when it comes to developing child-friendly medicines.

Figure 1 The Access to Medicine Index 2014 – Overall Ranking

1 1 GlaxoSmithKline plc 3.29 General Access to Medicine Mgmt. 2 6 Novo Nordisk A/S 3.01 Public Policy & 3 2 Johnson & Johnson 2.84 Market Inuence

4 7 Novartis AG 2.84 Research & 5 5 Gilead Sciences Inc. 2.81 Development

6 8 Merck KGaA 2.77 Pricing, Manufact. & Distribution 7 4 Merck & Co. Inc. 2.64 Patents & 8 3 Sano 2.57 Licensing

9 n/a AbbVie Inc. 2.56 Capability 10 9 Bayer AG 2.51 Advancement

11 15 Eisai Co. Ltd. 2.47 Donations & Philanthropy 12 10 Roche Holding AG 2.30

13 12 Bristol-Myers Squibb Co. 2.23

14 17 Boehringer Ingelheim GmbH 2.08

15 16 AstraZeneca plc 1.94

16 11 Pzer Inc. 1.93

17 14 Eli Lilly & Co. 1.73

18 20 Astellas Pharma Inc. 1.56

19 19 Daiichi Sankyo Co. Ltd. 1.50

20 18 Takeda Pharmaceutical Co. Ltd. 1.45

0 1 2 3 4 5

2014 2012 A score of zero means lowest and five signifies highest indicator score among the company set.

11 Executive Summary Access to Medicine Index 2014

Marketed products & pipeline analysis Companies are mainly developing and marketing products for a small group of diseases within the scope of the Index. More than 50% of the industry’s relevant pipeline targets five diseases: lower respiratory infections, diabetes, cirrhosis of the liver (mostly for hepatitis), HIV/AIDS and malaria. The same five also appear in the top 10 diseases with the most products on the market. Just four companies (Sanofi, Novartis, GSK and Pfizer) account for 53% of all products on the market, while R&D pipelines differ hugely between companies, both in size and focus.

Non-communicable diseases and communicable diseases account for the largest shares of both marketed product portfolios and the clinical-stage pipeline. While there are many pipeline products for non-communicable diseases, companies are making limited efforts to ensure they are suitable for use by people living in developing countries. Least attention is being paid to maternal and neonatal health conditions, and most products for neglected tropical diseases are still in early stages of discovery.

During the period of analysis, 30 relevant products were approved by the EMA or US FDA. They target just 11 of the 47 conditions in scope, mostly diabetes and HIV/AIDS, and are almost evenly split between being new products and adapted versions of existing products.

Top findings per Technical Area The Index measures company performance in seven main areas of corporate activity.

General Access to Medicine Management • Access to medicine is more embedded in governance structures, with all companies now having established board-level representation for their access activities. This compares with 17 companies in 2010 and 19 in 2012. • Companies use local stakeholder engagement to tailor access approaches to local needs and conditions. • The number of business models addressing the needs of the poor is growing.

Public Policy & Market Influence • Commitment to ethical behaviour does not correlate with performance. All have codes of conduct governing bribery and corruption, but 18 were the subject of settlements or fines for corrupt behaviour, unethical marketing or breaches of competition law. • There is no simple correlation between a company’s incidence of breaches and its size, which indicates that companies of all sizes can take measures to actively minimise the risk of breaches occurring. • Four companies waive rights to data exclusivity, taking steps towards facilitating the entry of generic versions of their products.

Research & Development • There is evidence of sustained commitment to R&D for relevant diseases, with most companies having an R&D strategy in place that explicitly takes patients in developing countries into account. • R&D is mainly focused on five diseases, with 54% of products under development targeting lower respiratory infections, diabetes, hepatitis, HIV/AIDS and malaria. • Consideration of access to compounds for non-communicable diseases is limited, with most companies struggling to demonstrate how new compounds targeting non-communicable diseases will be accessible to patients in countries covered by the Index. No company makes commitments to register such products in relevant countries.

12 Access to Medicine Index 2014 Executive Summary

• More companies provided strong evidence of having enforcement measures in place to ensure ethical clinical trial conduct for in-house and outsourced trails. This has increased from four in 2012 to 10.

Pricing, Manufacturing & Distribution • Companies consider affordability in their pricing strategies for one-third of all relevant marketed products. • More companies commit to or newly engage in equitable pricing, tailoring their prices to different population segments. Two companies have introduced equitable pricing between countries, but improvement in tailoring prices within countries is greater, with four companies newly implementing such schemes and three more committing to do so. • On average, products are registered in only a few relevant countries, representing 17% of the Index’s geographic scope and just 8% of low-income countries covered by the Index.

Patents & Licensing • Companies remain conservative in their disclosure of where patents are active and when they will expire – information that is very useful to medicine procurers and generic medicine manufacturers. No company independently and publicly disclosed patent statuses for products relevant to the Index. • Pro-access licensing agreements increase in number, with two more companies entering licensing agreements for products targeting relevant diseases, bringing the total to eight. • The overwhelming majority of licenses are still for HIV/AIDS products, but there are early signs that some companies are taking steps to expand voluntary licensing to other diseases. • Company support for pro-access intellectual property law is limited, but even the cautious company public stance is undermined by private lobbying against flexibilities in the TRIPS agreement.

Capability Advancement • Most companies are building a range of local capacities, but their activities are often part of short-term collaborations. • Smaller companies gain on larger peers in building local manufacturing capabilities. Since 2012, nine companies have increased efforts to build such capabilities locally. Of these, eight have annual revenues below USD25 billion. • More companies are supporting local pharmacovigilance systems, with the number of companies involved more than doubling from eight in 2012 to 17.

Product Donations & Philanthropic Activity • Neglected tropical diseases are the main focus of donations activities, with more than half of companies addressing one or more of these diseases via structured donation programmes. • Philanthropic activities are becoming more needs-based.

Conclusion The pharmaceutical industry is continuing to step up its efforts to improve access to medicine in developing countries. The number of relevant products in the pipeline has grown, companies are increasingly tailoring prices between countries and within countries, and more companies are experimenting with innovative access-oriented business models. Yet progress is uneven: companies remain conservative in their approach to patents, and all but two have been the subject of settlements or decisions relating to ethical marketing, bribery or corruption standards or competition laws in the last two years. Leaders innovate constantly and in multiple areas to maintain their top positions. Companies at the bottom continue to narrow the gap.

13 Introduction Access to Medicine Index 2014

The access to medicine landscape

Access to medicine for people living in developing countries depends on a variety of complex factors, with many stakeholders playing different roles in the issue. While progress has been made in improving access to medicine, vaccines, diagnostic tests and other health technologies, an estimated two billion people who mostly live in developing countries, still do not have access to the health-related products they need.1

Pharmaceutical industry plays a significant Figure 2 role Access to medicine depends on a number of While the access to medicine challenge is multi- factors: faceted and dependent on many stakeholders to address it jointly, the largest pharmaceutical Availability Accessibility companies have a crucial role to play They have the Ensuring that new Ensuring that expertise to develop and adapt innovative prod- products are devel- people can receive ucts, and to scale up their production. They also oped or existing the product and have several unique products on the market that products are adapted understand how to can greatly help alleviate the burden of disease for local use use it in developing countries, the ability to improve supply-and-demand challenges, and the collective Affordability Quality/Acceptability power to make a difference with their assets. Ensuring that the Ensuring that the patients, health- product works Companies bear a significant responsibility in care providers and as intended, is treading the fine balance between ensuring their governments can efficacious and safe products reach (and treat) as many people as afford the product possible, and ensuring profits to shareholders. Last century, this balance was more clearly cut: the multinationals served high income countries, where the profits were to be made. However, Industry consolidation continues a geographical shift in emphasis on pharma- The industry still shows signs of more consoli- ceutical spending is taking place: spending on dation, with some diversifying, specialising and drugs in North America, Europe and Japan will strengthening their competitive advantage in key grow by no more than 1-4% annually until 2017. areas. Recent examples are as follows: AbbVie Spending in emerging markets, however, is due became an independent company in January to jump by 10-13% a year over the same period.2 2013 after it was spun off from Abbott.3 It now Companies that know this are expanding their holds Abbott’s former research-based pharma- businesses and operations in emerging markets, ceutical business. In Feb 2014, Bristol-Myers and organising business units to suit the changing Squibb completed the divestment of its share climate. In adapting to the newer role of serving in the global diabetes business that was part emerging low-income and middle-income markets, of its collaboration with AstraZeneca.4 In April companies come face-to-face with the challenge 2014, Daiichi Sankyo sold its majority stake in of adapting their businesses to suit these new Ranbaxy to Sun Pharmaceuticals.5 Novartis and environments. This inevitably means taking a more GSK announced in April 2014 that they will swap considered approach to affordability and to scale, assets, with Novartis acquiring GSK’s oncology and thus to developing more considered pricing business and selling its vaccine division (excluding strategies and more effective use of the capacity of influenza vaccines).6 GSK and Novartis will also generic medicine manufacturers though licensing. in this arrangement combine their consumer

14 Access to Medicine Index 2014 Introduction

health divisions. In May 2014, Merck & Co. sold its middle income countries, with forecasted cumula- consumer care business to Bayer.7 Pfizer made an tive economic losses of USD7 trillion over the next unsuccessful bid to acquire AstraZeneca in May 15 years and millions of people trapped in poverty. 2014,8 and in July 2014 announced the acquisition Better public policies and lifestyle management, of Baxter’s portfolio of marketed vaccines.9 better clinical management and better access to medicine could prevent many of these diseases. Since the last Index, the landscape of access to The burden of NCDs is expected to rise dramati- medicine and international health priorities is cally over the next 20 years in low income and evolving. There has been some significant response middle income countries, and there are growing to calls and collaborative action seen since 2012. calls for greater action against NCDs. The World For the past decade, increased financing of Health Assembly endorsed the recent Global collaborative product development has catalysed Action Plan for the Prevention and Control of the testing of needed products for neglected NCDs for 2013-2020,13 which aims to achieve nine tropical diseases (NTDs), and allowed for important global NCD targets by 2025. The plan identifies a partnerships to develop, where pharmaceutical need for more affordable medicines and for new companies, NGOs and other global health stake- medicines, vaccines, diagnostics and technologies. holders work together to address gaps in product development. A recent initiative, the Global The rising burden of hepatitis poses another Health Innovative Technology Fund (GHIT),10 has challenge. Hepatitis C, a chronic infection that embarked on a series of partnerships aimed at causes liver failure in many of the approximately developing products for NTDs. In the same disease 170 million people infected, can be cured with area, several companies responded to a 2012 new treatments. Chronic hepatitis deaths will call for action called the London Declaration on soon exceed HIV/AIDS-related deaths.14 There Neglected Tropical Diseases,11 promising donations are currently many products in the pipeline for of critical medicines for the control, elimination and hepatitis C, and these will be entering the market eradication of several NTDs. Progress made under in the next few years. However, just as the cost this declaration is tracked in this Index. of antiretrovirals (ARVs) hampered access in the mid-1990s, the prohibitive cost of treatment in Lessons still being learned from HIV/AIDS this disease is a looming challenge. New mecha- efforts nisms to ensure affordable medicines, incentives The international community rallied to ensure for innovation and new mechanisms for ensuring that access to HIV/AIDS medicines was drasti- competition (such as those developed by the cally improved after the 1990s. Lessons from Medicines Patent Pool for HIV/AIDS) need to start. that effort can be applied to several other disease areas. In the rally against HIV/AIDS, organisations Over the past 15 years, the Millennium Develop- such as PEPFAR, the Global Fund to fight AIDS, ment Goals (MDGs) have provided a framework Tuberculosis and Malaria, WHO and USAID ensure for multilateral co-operation to address these and that investments in the global HIV/AIDS response other challenges. Next year, the time allowed for continue to accelerate progress. Twenty-five coun- achieving the MDGs will have elapsed, and they tries have seen a 50% drop in new HIV infections will be replaced by the Sustainable Development since 2001.12 With significant investments from Goals (SDGs). Both frameworks emphasise the many, there have been new partnerships, increased central importance of providing access to afford- knowledge and innovations in the last 10 years. able drugs in developing countries. Importantly, current proposals for the new SDGs spell out the Today, other diseases are threatening the access need for R&D to develop vaccines and medicines landscape. Non-communicable diseases (NCDs), for both communicable and non-communicable mainly cardiovascular diseases, cancers, chronic diseases that affect developing countries. Clearly, respiratory disease and diabetes, cause about 36 the role of the pharmaceutical industry will million deaths annually (63% of all deaths), and 17 continue to be a key component of the interna- million premature deaths (below age of 70). About tional framework for cooperation. 86% of these deaths occur in low income and

15 Introduction Access to Medicine Index 2014

Ebola outbreak emphasises importance affairs consultancy indicated that a strategy had of access been commissioned by IPASA, with the advice of An event that has underlined how impor- Pharmaceutical Research and Manufacturers of tant access to needed medicine is, and which America (PhRMA), in response to the government continues to be a daily tragedy in West Africa, and of South Africa proposing reforms to its intellec- a significant threat further afield, is the current tual property laws to make it harder to get patents outbreak of Ebola virus disease. This outbreak and easier for generic medicine manufacturers which started in March 2014,15 has made it clear to enter the market.18 Since the publication of that in order to innovate, rapidly scale up and treat these allegations, Novo Nordisk and Roche have scores of people effectively, regulators, global resigned from IPASA and Novartis has distanced health experts and pharmaceutical companies itself through a news release.19 must come together, and to do it quickly, and efficiently. The Index does not cover industry activity Bribery and corruption allegations around this disease because Ebola does not fall highlight need for ethics enforcement within the scope of diseases included in the Index. The recent allegations (and convictions) of bribery It is one of several emerging infectious diseases and corruption in China,20 affecting several that occur so sporadically, and in a limited number pharmaceutical companies, highlight the impor- of hotspots, that there is no clear ownership of tance of good business ethics, and company-wide control efforts and little incentive to produce enforcement while delivering quality medicine. products for it, especially given the focus on Perhaps the most-high-profile example concerned pushing harder to meet the needs for diseases on allegations of systemic corruption made against WHO’s list of neglected tropical diseases. GSK by Chinese regulators, involving inappropriate payments made to healthcare professionals. After Intellectual property reform battles the period of analysis, GSK was found guilty by continue the Chinese courts, and fined USD500 million.21 In 2013 and 2014 have been significant years in the addition, private investigators contracted by GSK debate around intellectual property and access were convicted. These cases highlight the pharma- to medicine. Emerging markets, including Brazil ceutical industry’s responsibility to maintain the and South Africa have made moves to reform highest standards in all countries it operates in. intellectual property (IP) legislation in favour of greater competition. Least Developed Countries The Access to Medicine Index evaluates company were granted exemption until at least 2021 from performance in the context of this evolving land- adhering to the minimum standards for intellec- scape, addressing issues highlighted in the above tual property legislative frameworks, as set out in discussion. the Trade Related Aspects of Intellectual Prop- erty (TRIPS) agreement.16 In addition, the United The role the Index plays States requested stronger IP protection during Every two years, the Access to Medicine Index negotiations between countries in the Asia-Pacific analyses the top 20 research-based pharmaceu- region (Trans-Pacific Partnership). tical companies that are most active in producing products for the highest-burden diseases in More than a decade ago, the South African developing countries and ranks them according government fought multinational drug companies to their efforts to improve access to medicine over access to HIV/AIDS medicines in what was in these countries. It uses an elaborate method- dubbed “Big Pharma vs Nelson Mandela”.17 This ology where almost 100 indicators make up a was a low point for the reputation of the phar- framework within which company performances maceutical industry, and also marked a turning can be compared. The Index analysis brings out point in more constructive engagement in the best practices and examples, and highlights areas treatment of intellectual property. The Innovative where progress has been made and areas where Pharmaceutical Association South Africa (IPASA) critical action is required. It also acts as a bench- case earlier this year was a reminder that these mark where companies can see the access-to- battles continue. Leaked documents from a public medicine profile of their peers and reflect on their

16 Access to Medicine Index 2014 Introduction

own contribution to improving access to medicine. ideas were rewarded differently from ad-hoc While companies are held to a single standard, initiatives. The way the Index measures how they are all different in the way they operate, and companies address affordability was overhauled. in their portfolio of investigational and marketed Previous indices measured tiered pricing and products. They each have an individual foot- price differentials as indicators of affordability. print on access to medicine and all have a unique However, after consultation with experts and opportunity to improve access to medicine. When reviewing the methodology, a shift was made to taking this into account, an Index is a significant measure equitable pricing and ways that compa- challenge, and thus we present here findings nies target the lowest paying tier of markets, with based on the standardised methodology while volume and price point disclosure as evidence appreciating the individuality of companies. of targeted strategies. Engagement in voluntary licensing was previously measured, but in this Refinements to the 2014 Index methodology Index, the quality of licenses was also measured, The methodology for the 2014 index was refined by evaluating provisions in more than 200 licenses in several ways to make it more relevant, remove the companies have issued. redundancies and to allow for a deeper analysis of certain areas. Notable were refinements to How we work the way the Index measures the extent to which The Access to Medicine Index, published by the companies truly addressed access-to-medicine Access to Medicine Foundation, is a product of a needs. For example, strict inclusion criteria were two-year process. During year one, the Founda- placed on products to ensure that products truly tion focuses on reviewing and revising the Index addressed needs, and long-term, sustainable methodology based on expert stakeholder feed-

Figure 3 2014 Index company scope

, AbbVie , , Astellas , , AstraZeneca , , Bayer , Not publicly listed Boehringer Ingelheim , , Bristol-Myers Squibb , , Daiichi Sankyo , , Eisai , , Eli Lilly , , Gilead , , GSK , , Johnson & Johnson , , Merck & Co. , , Merck KGaA , , Novartis , , Novo Nordisk , , Pzer , , Roche , , Sano , , Takeda ,

The companies covered by the Index account for more than Market cap as at Dec , Japanese companies 50% of the global pharmaceutical market. as at Mar (From Thomson Reuters ). Total revenue

17 Introduction Access to Medicine Index 2014

back. Year two is spent collecting and analysing research team undertook the final comparative pharmaceutical company data according to the analysis and writing of the Index. Experts (from latest Index methodology, with the help of an the TSCs and ERC) were consulted as reviewers, independent research partner. The results are and important discussions on corruption, innova- then published in a new Access to Medicine Index, tion, licensing and pricing were among the topics and the cycle begins again. In 2013, the Founda- discussed with the experts. All Technical Area tion conducted a thorough review and extensive chapters were reviewed by at least two indepen- consultations to ensure that the 2014 Index dent reviewers and all sections were subjected to reflects evolving access-to-medicine priorities a further round of external review. while maintaining consistency with previous Index iterations for the purposes of comparison and How we measure trend analysis. Internal analyses include both qual- The Index uses a framework that evaluates itative and statistical analyses of past indices and company activities in seven areas of activity, data. In addition to the internal analysis, external or Technical Areas, considered to be key to feedback was collected from experts, stake- enhancing access to medicine in developing holders and the public through various channels, countries, and across four important aspects of including a public online survey, calls with compa- action, or Strategic Pillars. The Technical Areas nies ranked in the 2012 Index and various stake- and Strategic Pillars are weighted according to holder meetings (See Appendix 1 for more detail). their relative importance for improving access to This external feedback was incorporated into medicine. We analysed 95 indicators across the both the qualitative and quantitative aspects of Technical Areas, and within each, indicators are the review process as well as subsequent consul- distributed among the Strategic Pillars, which tations with the Technical Subcommittees (TSCs) measure the level of commitment the company and the Expert Review Committee (ERC). Data demonstrates, how transparent it is about what collection and scoring in 2014 was performed by it is doing, what specific activities it is engaged in the research firm Sustainalytics, while the Index and how innovative its approach is.

What we measure Figure 4 The Index focuses on the top 20 research-based Methodology Framework pharmaceutical companies which comprise about 50% of the global pharmaceutical market. The 4 Strategic Pillars Index measures what these companies are doing 25 25 40 10 to bring not only medicine, but also vaccines, Commitments Transparency Performance Innovation diagnostic tests, vector control products and 10 General Access to Medicine Management health technologies to people in what the World

10 Public Policy & Market Inuence Bank considers to be low income and lower- middle income countries. In addition, widespread inequality of human development within coun- 20 Research & Development tries often inhibits access to medicine for the poorest populations segments; the Index has

7 Technical Areas 7 Technical this year added four high-human-development

25 Pricing, Manufacturing & Distribution countries that do not fall under the World Bank LIC or LMIC classification. This brings the total number of countries covered by the Index to 106.

15 Patents & Licensing The 47 diseases covered in the Index include the top 10 communicable diseases based on disease

10 Capability Advancement in Product Development & Distribution burden (disability-adjusted life years); the top 12 non-communicable diseases; 17 of the ‘neglected 10 Product Donations & Philanthropic Activities tropical diseases’ and 8 maternal conditions and neonatal infections. The Index also captures activity on contraceptives.

Total revenue 18 Access to Medicine Index 2014 Introduction

Limitations of methodology new information will be balanced with the need to As does any study, the Access to Medicine Index maintain comparability between Indices. has limitations, some of which are outlined below. A more detailed overview of limitations is in the Capturing breaches of codes of conduct Appendix. Further improvements are actively In the 2014 Index, breaches in relevant countries invited and will be made across all Technical Areas and across the globe were counted quantitatively. for the 2016 Index, to add more stringency and As some of these countries may have weaker improvements to the measures used. regulatory and enforcement resources, or out-of- court settlements may be more common, these Measuring Outcomes and Impact breaches are sometimes difficult to capture, as is The study as currently designed is not intended the level of transparency around them. to measure the direct impact of companies’ access initiatives on patients and other groups. Data availability For example, within Capability Advancement, Another limitation was the presence of sensitive the impact of a company’s training activities is data, which were provided to the Index under not measured. Alternative measures are used confidentiality agreements. All data were anal- as proxies for patient access or considerations ysed, but due to legal constraints not all data were of impact. published. This has been a significant obstacle in finding and reporting trends in certain areas. Disease Scope: Some companies may not have received credit for More details on the process of preparation and access-oriented activities targeting diseases that quality control of the 2014 Access to Medicine were not covered by the Index. The disease scope Index can be found on the website. will again be reviewed for the 2016 Index, and

For numbered references, see the Appendix.

Figure 5 Geographical Scope

World Bank income classication

UN Human Development Index

UN Inequality-Adjusted Human Development Index

New in 2013 scope

Removed from scope in 2013

19 Introduction Access to Medicine Index 2014

20 Access to Medicine Index 2014 Key Findings

Key Findings

The world’s leading pharmaceutical companies are doing increasingly more to improve access to medicine in developing countries. More companies are experimenting with innovative access-oriented business models, companies are granting more licenses for making and distributing generic versions of their products, and companies continue to improve their oversight of access policies and activities. Yet progress is uneven. The industry struggles to perform well in two important areas: companies remain conservative in their approach to patents, and all but two have been the subject of settlements or decisions relating to ethical marketing, bribery or corruption standards or competition laws in the last two years.

Regarding R&D, efforts are remarkably concentrated. More than half of all products relevant to the Index target the same five diseases. Furthermore, more than half of the overall pipeline is being developed by the same five companies. Half of Index companies are developing or adapting medicines for use by children – totalling 7% of the overall pipeline – with Johnson & Johnson developing the largest share.

Compared to 2012, pricing strategies are increasingly tailored, as more companies take account of socioeconomic factors, such as ability to pay. Importantly, more companies are setting different prices for different segments of national populations.

21 Key Findings Access to Medicine Index 2014

Companies do more to improve access, but progress is uneven

Companies are doing increasingly more to improve access to medicine in developing countries, with a raft of new initiatives, scale-ups and innovations over the last two years. Yet in two important areas, progress remains static.

Refinements to the Index have enabled a clearer Struggles picture of industry progress and struggles to However, companies struggle to perform well emerge. The leaders tended to perform well around some aspects of access to medicine, such across the majority of areas the Index tracks, as ethics breaches and disclosure of patent status. and companies at the bottom of the Index have narrowed the gap with their peers. However, while All 20 companies commit to follow at least a overall scores are converging, companies differ in minimum code of practice for ethical marketing. the areas where they perform better. The industry All have codes of conduct governing bribery and is progressing on several fronts, partly in response corruption and three-quarters report auditing to calls for action shaping the global health agenda. their codes. However, 18 companies have been the subject of settlements or decisions relating to Progress breaches in ethical marketing, bribery or corrup- More companies are experimenting with innovation standards or competition laws. Breaches can tive access-oriented business models. Three have range from paying or otherwise inappropriately introduced new models and three have expanded incentivizing doctors to prescribe their products, pilots. Examples include Merck & Co. offering to collusions delaying market entry of generic patients in 11 cities in India zero-interest loans for medicines and misrepresenting the efficacy and the purchase of one of its hepatitis medicines; safety of their products or those of their competi- and Novo Nordisk making insulin products more tors. This evidence raises questions over the accessible in India, Nigeria, Ghana and Kenya by commitment and effectiveness of company gover- identifying ways to integrate diagnosis, treatment nance of this area. and control in local communities. However, the impact of such models remains to be seen. Companies remain conservative in their disclosure of where patents are active and when they will Companies are granting more licences to devel- expire – information that is very useful to medicine oping country companies to make and distribute procurers and generic medicine manufacturers. generic versions of their medicines. Of the 16 Within the reporting period, no company indepen- companies that have patents on their products, dently and publicly disclosed its patent's statuses eight engage in voluntary licensing. This compares for any product relevant to the Index. with six companies in 2012. Some licences include groundbreaking new arrangements, such as Figure 6 tiered royalties. 2014 Index average scores per Technical Area

Policies and activities to improve access to General Access to Medicine Mgmt . medicine continue to get better organised. All 20 Public Policy & Market Inuence . companies now have established some form of Research & Development . board-level representation for access-to-medi- Pricing, Manufacturing & Distribution . cine issues (up from 19 in 2012 and 17 in 2010). Patents & Licensing . In 2014, seven companies link performance Capability Advancement . incentives for senior managers to enhancing Product Donations & Philanthropy . access to medicine, compared with three in 2012.

22 Access to Medicine Index 2014 Key Findings

Five companies are developing more than half of the products in the pipeline for developing countries

The top 20 pharmaceutical companies are developing 327 relevant products, with only five companies accounting for more than half the pipeline and more than half the products targeting only five diseases.

The 2014 Index offers a unique picture of the Least attention pipeline relevant to developing countries. In Areas with least attention from companies, both several cases, more than 35% of pipelines targets in R&D and marketed products, are the neglected the conditions covered by the Index. However, tropical diseases and maternal and neonatal research is concentrated, with Novartis, Johnson health. About 13% of the relevant pipeline is & Johnson, GSK, AbbVie and Sanofi developing devoted to neglected tropical diseases, with 54% of the products in the relevant pipeline. most of those products being in early stages of development. Investigational products in the Disease focus clinical development stage are for Chagas disease, In addition, more than half of these products rabies, trypanosomiasis, and dengue. Meanwhile, target diabetes, lower respiratory infections, maternal and neonatal health conditions, where hepatitis, HIV/AIDS and malaria. Hepatitis and the need for product development is small but diabetes have the most products in the clinical well defined, are being targeted by 4% of the stage of development. Together with diarrhoeal pipeline. diseases, tuberculosis, chronic obstructive pulmonary disorder, meningitis and Chagas disease, Moved through the pipeline these diseases account for 71% of the total pipe- Since the 2012 Index, at least 30 relevant prod- line covered by the Index. ucts from the pipeline, covering 11 diseases, have gained regulatory approval. All disease classes are being targeted to varying extents. For instance, 47% of the products target communicable diseases. However, almost all of those address just six conditions: HIV/AIDS, Figure 7 malaria, lower respiratory infections, diarrhoeal Most products are being developed for infectious diseases, tuberculosis and meningitis. diseases

Another 36% of the pipeline targets non-communicable diseases, with 83% of such products in clinical development. About half are innovative products, while the other half are adaptations for Infectious developing country markets such as heat stable insulin, a sublingual tablet for bipolar disorder, diseases fixed dose combinations for cerebrovascular disease and diabetes, long-acting formulations for Disease categories mental disorders, and several paediatric formu- Communicable Neglected tropical lations. However, plans to make these products Non-communicable Maternal & neonatal available are limited; pricing strategies for them are also limited, and lag behind those for many The majority of all R&D products are being developed for infectious diseases (communicable diseases and neglected communicable diseases. tropical diseases combined), followed by non-communicable diseases.

23 Key Findings Access to Medicine Index 2014

More than half of companies are developing medicines for children

More than half of the 20 Index companies are developing medicines tailored for children, with 7% of the overall research pipeline being devoted to “child-size” medicines.

Access to essential medicines for children is an Disease focus important element in improving child health, Sixteen (69%) of the “child-size” medicines saving children’s lives and meeting the Millen- under development target HIV/AIDS, diabetes, nium Development Goals. The needs were for the malaria, hepatitis and respiratory syncytial virus first time recognised in 2006 when the World infections. Others target a wide range of condi- Health Organization identified serious gaps in tions including cerebrovascular disease, Chagas research and several barriers to access, and disease, epilepsy, schistosomiasis, schizophrenia, indicated how to overcome them. The following soil-transmitted helminthiasis and drug-resistant year, the UN health agency launched the “Make tuberculosis. Medicines Child Size” campaign, issuing, for the first time, a WHO model list of essential medicines Leaders for children.1 The Index finds that the industry is Johnson & Johnson is the leader in the devel- responding to this need, although opportunities opment of “child-size” medicines, with eight to do more remain. products in its pipeline. AbbVie and Boehringer Ingelheim are developing three each, and Bristol- Trends Myers Squibb and Daiichi Sankyo two each. Bayer, The 2014 Index provides a unique analysis of the Eisai, Novartis, Sanofi, Merck KGaA and Astellas level of industry activity on child-tailored medi- (the latter two working together) are developing cine since the WHO call for action. It finds that 11 one paediatric product each. companies are engaged in the effort. Out of the 327 products in the research pipeline for diseases in developing countries, only 23 products are being developed for children, as liquids, chewable tablets, child-appropriate doses, or new formula- Figure 8 tions. Only one paediatric fixed-dose combination Johnson & Johnson is developing most medicines is under development for HIV/AIDS but no such for children combinations for tuberculosis although the WHO had identified this as a priority need. Fixed-dose Johnson & Johnson combinations can reduce the number of tablets AbbVie patients need to take and therefore improve Boehringer Ingelheim treatment compliance. Three of these products Bristol-Myers Squibb have gained regulatory approval since 2012. Daiichi Sankyo Bayer Eisai Merck KGaA & Astellas Novartis Sano 11 companies are developing0 231 medicines2 3 4 suited5 6 for7 children.8

24 Access to Medicine Index 2014 Key Findings

Pricing strategies are increasingly tailored

More companies are paying attention to socioeconomic factors such as people’s ability to pay. Importantly, more are tailoring their prices to different segments of the population within countries.

Pricing that focuses on the buyer’s ability to pay to 12 in 2012, to 16 in 2014. However, the propor- is a cornerstone of making medicines afford- tion of schemes that specifically target the able in developing countries. It is also a tool for poorest segment remains limited. companies to expand into new markets. When addressing disparities in the ability to pay, it is Products covered important to differentiate pricing both between Together, the industry has applied pricing strate- and within countries. gies to one-third of the 700 relevant products on the market. Use of these strategies is uneven, Progress with some companies using them in all countries The number of companies using commercial they are active in and others restricting them to pricing strategies that also take into account socio- a few countries. Similarly, some companies apply economic factors has increased from 16 in the them to a wide range of their products and others 2012 Index to 18 in 2014. Half of these companies to one or two. The proportion of products under are applying such schemes to a greater proportion pricing schemes that cover the poorest segments of their portfolio than they did two years ago. of the population in the lowest price tier is 32%.

Increasingly more companies are applying pricing Diseases covered schemes within countries, targeting different The schemes cover products for 32 diseases, segments of the population with different with HIV/AIDS having the most tailored pricing prices. The number of companies engaged in strategies applied to it. However, it is not possible such segmentation has grown substantially over to evaluate whether products have become more successive Indices, from five companies in 2010, affordable for specific patients.

Figure 9 Companies consider aordability for one-third of products

Products priced Products priced Products priced Products without equitably, based on equitably, based on equitably, based on equitable pricing a ordability a ordability targeted a ordability targeted to a speci c towards the poorest population segment segment

25 Overall Company Ranking Access to Medicine Index 2014

Figure 10 The Access to Medicine Index 2014 – Overall Ranking

1 1 GlaxoSmithKline plc 3.29

2 6 Novo Nordisk A/S 3.01

3 2 Johnson & Johnson 2.84

4 7 Novartis AG 2.84

5 5 Gilead Sciences Inc. 2.81

6 8 Merck KGaA 2.77

7 4 Merck & Co. Inc. 2.64

8 3 Sano 2.57

9 n/a AbbVie Inc. 2.56

10 9 Bayer AG 2.51

11 15 Eisai Co. Ltd. 2.47

12 10 Roche Holding AG 2.30

13 12 Bristol-Myers Squibb Co. 2.23

14 17 Boehringer Ingelheim GmbH 2.08

15 16 AstraZeneca plc 1.94

16 11 Pzer Inc. 1.93

17 14 Eli Lilly & Co. 1.73

18 20 Astellas Pharma Inc. 1.56

19 19 Daiichi Sankyo Co. Ltd. 1.50

20 18 Takeda Pharmaceutical Co. Ltd. 1.45

0 1 2 3 4 5

Position General Access to Medicine Management Access to Medicine Public Policy & Market Inuence Index 2012 Research & Development Pricing, Manufacturing & Distribution Position Patents & Licensing Access to Medicine Capability Advancement in Product Development & Distribution Index 2014 Product Donations & Philanthropic Activities

A score of zero means lowest and five signifies highest indicator score among the company set.

26 Access to Medicine Index 2014 Overall Company Ranking

Leaders innovate constantly

GSK tops the Index for the fourth time, ahead of Novo Nordisk and followed by four tightly packed companies. Overall scores are very close in this leading group of six. However, all companies approach access to medicine differently. Some focus on a few specific diseases, targeting them with deep, comprehensive programmes and initiatives. Others adopt wide-ranging, well-integrated approaches.

The top eight positions are taken by the same eight companies as in 2012, but in a different order, with Novo Nordisk making a remarkable leap into 2nd position. Sanofi and Pfizer fell down the rankings most significantly. Astellas, Daiichi Sankyo and Takeda remain at the bottom of the league, but in a different order, with Astellas rising from lowest place. Notably, despite stricter scoring criteria, these lowest-ranking companies continue to narrow the gap, with higher scores than in 2012.

In 2014, more companies are experimenting with innovative access- oriented business models and more companies take account of socioeconomic factors when setting pricing strategies. Plus, access- to-medicine activities continue to get more organised. Yet companies remain conservative in their approach to patents, and continue to breach ethical standards for corporate behaviour.

No company excels at everything and several stand out in certain specific areas: for instance, Novartis has the largest pipeline of products for developing countries, Sanofi has the most relevant products on the market and Johnson & Johnson dominates when it comes to developing child-friendly medicine. Top performers innovate constantly, usually in several areas at once, and continuously deepen and expand access programmes and initiatives.

27 Overall Company Ranking Access to Medicine Index 2014

How the industry performs

The pharmaceutical industry is continuing to step up its efforts to improve access to medicine in developing countries. However, progress in not equal across all areas or among companies, and there are some areas where the industry as a whole remains static.

The leading companies continue to perform well regulatory approval. Certain global initiatives have across most of the seven Technical Areas covered catalysed a proportion of these activities. Recent by the Index. Most notably, companies at the initiatives such as the Global Health Innovative bottom are catching up, with higher overall scores Technology Fund, the World Health Organiza- than in 2012. tion’s roadmap on NTDs, and the 2012 London Declaration on NTDs that the roadmap inspired, Access-to-medicine activities continue to get have led to more intense industry activity. more organised, creating a more systematic enabling environment. For example, all 20 compa- However, companies have struggled to perform nies now have some form of board-level repre- well in other areas. In the area of Public Policy & sentation for access-to-medicine issues. This Market Influence, the 2014 Index’s broader inves- compares with 19 in 2012 and 17 in 2010. More tigation of breaches worldwide reveals evidence companies are experimenting with innovative that almost all companies (18) were the subject access-oriented business models. Six have either of settlements or decisions relating to breaches introduced new models or have expanded pilots; for competition, bribery, unethical marketing at least three of these have built upon previous or corruption. It also reveals limited evidence of pilots. More companies are taking socioeconomic companies fighting against bad behaviour. Infor- factors, such as ability-to-pay, into account when mation on breaches in countries beyond those setting pricing strategies, and are increasingly covered by the Index has considerably increased tailoring prices to different segments of national the evidence base in this Technical Area. populations. In the field of Patents & Licensing, company In addition, more companies now show evidence behaviour has remained static across most areas of having procedures in place to enforce compli- of measurement. Companies maintain their ance with standards for conduct of outsourced conservative attitudes to disclosure of patent clinical trials; this has progressed from four status and terms of engagement. Encouragingly, companies in 2012 to 10 companies in the current pro-access company management of intellec- Index. tual property has improved, albeit mostly in one particular area: HIV/AIDS licences agreed through Together, the companies are now developing a third party, the Medicines Patent Pool. 327 products that qualify for analysis, with in some cases more than 35% of company research pipelines targeting conditions relevant to the Index. This includes 137 new product development projects since 2012, the largest proportion of which target communicable diseases. Half of the companies are developing medicines tailored for children, with 7% of the overall industry pipeline being devoted to the development of relevant child-appropriate medicine. Since the 2012 Index, at least 30 relevant new products have gained

28 Access to Medicine Index 2014 Overall Company Ranking

Leaders

The 2014 Access to Medicine Index has a clear leader and a close second, followed by a cluster of four companies that occupy the 3rd, 4th, 5th and 6th positions. These four have different access profiles but total scores that are very close to each other, demonstrating how tight the competition is for the top slots.

GSK remains in the top position for the fourth Johnson & Johnson maintains a strong perfor- consecutive Index. This is driven by robust mance in the Index, dropping one place to rank 3rd. performance across most areas, with several The company is particularly strong in R&D, with innovative practices. It has strong governance of a large and diverse pipeline of relevant products, access to medicine, an innovative business model many of which have progressed through the focused on Africa and high transparency around stages of development since 2012. The company its access-to-medicine strategy. The company ranks highly in its oversight of its access-to- also leads the Index in the area of Research & medicine approaches. It also performs well in Development, with a large relevant portfolio, a pricing, taking affordability into account for many large share of its pipeline dedicated to relevant products when setting its pricing strategies and diseases, and numerous access-oriented intellec- applies these in many countries. tual property sharing partnerships. However, it fell from its leading position in Pricing, Manufacturing & Distribution, and in Capability Advancement. It also fell in Public Policy & Market Influence, due to convictions or settlements for breaches of ethical Leaders innovate constantly marketing standards. Allegations concerning evidence of corrupt practice in China were settled Leaders usually perform well in several areas outside the period of analysis for the 2014 Index. of analysis. They have typically strong research Novo Nordisk, despite being a company focused pipelines, with access-friendly terms and only on a single disease within the scope of the conditions in partnerships, pricing strate- Index, has made a remarkable jump to 2nd place, gies that target the poor, and IP manage- after rising steadily over successive Indices, ment policies that stimulate competition. moving up from 6th place in 2012 and 8th place in Top performers innovate constantly, and in a 2010. This is partly due to its integrated approach competitive Index, usually innovate in several to access to medicine, high level of transparency Technical Areas to maintain their role as a and robust codes of conduct, for which evidence leader. Remaining a leader over time is only of auditing was provided. It renewed its access possible by showing improvements in access strategy in 2013, has applied equitable pricing policies and practices – standing still means strategies for diabetes products in the majority falling back in the Index, as other companies of relevant countries, and is one of two leaders progress. Being a leader requires contin- in rapid registration and filing for marketing uous deepening and expanding of access approval. programmes, and measuring the impact of these programmes on health and socioeco- Johnson & Johnson, Novartis, Gilead and Merck nomic outcomes; and publishing the results. KGaA occupy the 3rd, 4th, 5th and 6th places It also implies remaining open-minded to respectively. It is striking that these companies developments in the global access-to-medi- are clustered so closely together, but there is cine agenda, and continuously adapting to any substantial variation between them in their changing expectations, as reflected in refine- strengths and weaknesses across the areas the ments made to each new Index methodology. Index focuses on.

29 Overall Company Ranking Access to Medicine Index 2014

Novartis climbs three places to 4th position, Merck KGaA has also risen up the ranks over having made significant improvements in the successive Indices, from 17th place in the 2010 management of its access-to-medicine activi- Index, to 8th in the 2012, to 6th position in the ties. The company dropped in rank in Pricing, current Index. This is in part due to the develop- Manufacturing & Distribution, but a new access- ment of a strategic focus on access to medicine to-healthcare strategy, approved in 2012, shows through its revised Access to Healthcare (A2H) a clear link between its corporate strategy and strategy. The company makes a strong commit- its access approach. It has the largest relevant ment to taking a pro-access approach to IP research pipeline of all companies. Novartis is the management and licensing in a broad range of only company to voluntarily share pharmacovigi- countries, has launched new initiatives and is lance data with national authorities beyond legal overall highly transparent about its activities. requirements.

Gilead has kept its 5th place. It remains a leader in intellectual property management, issuing a wide range of access-friendly licences for its HIV/AIDS products. It also has pricing strategies that take socioeconomic factors into account. The company waives data exclusivity within its licences and was one of only two companies that were not the subject of any settlements or convictions for breaches.

Laggards

Astellas, Daiichi Sankyo and Takeda once again occupy the last three positions in the Index, although in a different order. As a group they continue to close the gap with the rest of the pack, with improvement in their overall scores.

Astellas rises two places to 18th place, partly limited extent and restricts its access activities to because it was linked to fewer breaches than philanthropy. Daiichi Sankyo notably has adopted others. It provided more evidence than previ- a more access-oriented approach to IP manage- ously regarding lobbying activities and adapts ment in this Index. brochures and packaging to ensure rational use in all disease areas where it is active, and it is Takeda has dropped two places to 20th, despite active in building local manufacturing capabilities. improvements in several areas. It performs well However, it still has no clear access-to-medicine in R&D, but in several areas its performance is strategy and does not clearly commit to equitable significantly weaker than that of its peers. While pricing. It did not disclose its relevant research it demonstrates a stronger focus on access to pipeline, which resulted in a low score in Research medicine than in 2012, Takeda does not have a & Development. clear access strategy yet and has no pro-access approach to intellectual property. It has a new Daiichi Sankyo remains in 19th place, despite commitment to intra-country equitable pricing improved performance in some areas. It engages but this has not been translated into strategies for in more product development partnerships based products relevant to the Index. on access provisions, but it has no clear access- to-medicine strategy, manages access issues to a

30 Access to Medicine Index 2014 Overall Company Ranking

Risers

Overall individual company movement between the 2012 Index and the 2014 Index is limited. The same companies occupy the top eight positions in the 2014 Index as in the 2012 Index, although Novo Nordisk is a newcomer in the top three. Likewise, the bottom three companies remain the same as in 2012.

The biggest risers in 2014 are Novo Nordisk and more organised approach to access to medicine. Eisai. Novo Nordisk, rising four places from 6th to Compared with peers, Eisai makes the most prog- 2nd, has made the most progress, improving in five ress in pricing, with a new global pricing strategy of the seven areas the Index analysis focuses on that will cover all new products. (all except Research & Development and Patents & Licensing). It is now the leader in building local Other risers include Novartis, Boehringer Ingel- capabilities (Capability Advancement) and in heim, Merck KGaA, Astellas and AstraZeneca. Product Donations & Sustainable Philanthropy. Eisai has risen steadily with each Index. It ranks 11th, up four places from 15th in the 2012 Index, and up five places from 16th in 2010. It performs well in several areas, and rises in four. Eisai’s centralised access department shows the company’s

Fallers

The biggest fallers in 2014 are Sanofi and Pfizer. Neither has provided evidence of significant improvement in access to medicine since 2012, and have been overtaken by other companies that demonstrate progress.

Sanofi has dropped five places from 3rd to 8th. Pfizer has fallen five places from th11 to 16th. It It fell in ranking in all areas except for Patents & retained its 2012 position in General Access to Licensing and Capability Advancement, where it Medicine Management and Capability Advance- retains its strong position. It has also lost ground ment, but has been overtaken by companies in transparency. It is a leader in product develop- performing better in other areas. The Index has ment, and shows commitment to engaging in identified limited evidence that Pfizer’s equitable partnerships on access-oriented terms in certain pricing strategies target the poorest segments disease areas, but not in all the disease areas in of populations. The share of its pipeline relevant which it is involved. It is also less transparent than to the Index is relatively small, and has shrunk leading companies about terms and conditions further since the 2012 Index. of the partnerships it does engage in. It has the most relevant products in the market and applies Other companies that have fallen in rank include equitable pricing strategies to many of them. But Merck & Co., Eli Lilly and Roche. Roche has fallen for a bulk of its products, there is limited evidence over successive indices, from 6th in 2010, to 10th in of equitable pricing. 2012, to 12th in this Index.

31 Pipeline & Portfolio Analysis Access to Medicine Index 2014

Pharmaceutical companies focus mainly on 5 diseases: lower respiratory infections, diabetes, cirrhosis of the liver (hepatitis), HIV/AIDS and malaria. Figure 11 Products in the pipeline and on the market

Communicable diseases Lower respiratory infections Diarrhoeal diseases HIV/AIDS Tuberculosis Malaria Measles Meningitis Pertussis Tetanus Chlamydia Non-communicable diseases Unipolar depressive disorders Ischaemic heart disease Cerebrovascular disease Chronic obstructive pulmonary disorder (COPD) Diabetes mellitus Schizophrenia Asthma Osteoarthritis Bipolar aective disorder Cirrhosis of the liver (Hepatitis) Nephritis and nephrosis Epilepsy Neglected tropical diseases Lymphatic lariasis Soil transmitted helminthiasis Leishmaniasis Food-borne trematodiases Schistosomiasis Trypanosomiasis Rabies Trachoma Dengue Cysticercosis Chagas disease Onchocerciasis Leprosy Echinococcosis Yaws Buruli Ulcer Dracunculiasis Maternal & neonatal health conditions Prematurity and low birth weight Birth asphyxia and birth trauma Neonatal infections and other infections Abortion Maternal sepsis Maternal haemorrhage Obstructed labour Hypertensive disorders of pregnancy Contraceptive methods

Marketed Pipeline Products Products Diseases are ordered according to disease class and DALY burden.

32 Access to Medicine Index 2014 Pipeline & Portfolio Analysis

Pipeline and portfolio analysis – where is the industry focusing?

Five diseases appear in both the top ten targeted relevant pipeline targets just five diseases: lower by R&D pipelines and the top ten targeted respiratory infections, diabetes, cirrhosis of the by marketed products. Within the scope of liver (mostly for hepatitis), HIV/AIDS and malaria. the Index, companies are mainly developing The same five also appear in the top ten diseases and marketing products for a small group of with the most products on the market. diseases. More than 50% of the industry’s

The ten diseases with the most marketed products cover markets. Of all 17 neglected tropical diseases in scope, 62% of all relevant products on the market: in order, lower only Chagas disease, rabies, African trypanosomiasis and respiratory infections, ischaemic heart disease, diabetes, dengue have products in clinical-stages of development HIV/AIDS, epilepsy, cirrhosis of the liver (mostly for hepa- from relevant companies. titis), malaria, asthma, unipolar depressive disorders and cerebrovascular disease. For non-communicable diseases, there is a need for products that are suitable for use in developing coun- The top ten diseases targeted by R&D pipelines account tries (as well as for other solutions that are beyond the for 72% of all pipeline products captured by the Index: in remit of pharmaceutical companies, such as improved order, lower respiratory infections, diabetes, cirrhosis of lifestyle management and health-system strengthening)1. the liver (mostly for hepatitis), HIV/AIDS, malaria, diar- The Index observes that while there are many pipeline rhoeal diseases, tuberculosis, chronic obstructive pulmo- products for non-communicable diseases, companies are nary disease (COPD), meningitis and Chagas disease. making limited efforts to ensure they are suitable for use by people living in developing countries. There are limited The least attention is being paid to maternal and neonatal plans to make new products available there, should they health conditions and to neglected tropical diseases. gain approval. There are limited equitable pricing strate- Regarding maternal and neonatal health conditions, this gies relating to non-communicable diseases, particularly is at least partly explained by the fact that there is less compared to the range of strategies for many commu- need for product development, and it is specific to local nicable diseases. Access-oriented licensing strategies needs and conditions. For neglected tropical diseases, remain mostly limited to HIV/AIDS, but there are signs that most pipeline products are in early-stage development, other disease areas are beginning to be addressed. which means it will take years before new products reach

Figure 12 Top ve diseases in clinical stage pipeline

Diabetes Cirrhosis of the liver (Hepatitis) Lower repiratory infections HIV/AIDS Malaria

Clinical stages also focus on same five diseases Cirrhosis of the liver (mostly for hepatitis) and diabetes receive comparatively less attention from these compa- receive the most attention: for both diseases, companies. Considering the number of products in clinical nies have 33 products in clinical stages. This reflects development, it is important to ensure that plans are both the market opportunity and the medical need put in place to bring these products to people living in for such products. Other non-communicable diseases developing countries.

For numbered references, see the Appendix.

33 Pipeline & Portfolio Analysis Access to Medicine Index 2014

Industry focuses on non-communicable and communicable diseases

The largest shares of products in the market Sanofi has the most relevant products on the market target non-communicable diseases (49%) and Sanofi, Novartis, GSK and Pfizer together account for communicable diseases (36%). Similarly, these 53% of all products on the market.a Sanofi is the only two disease categories account for the largest one of these four to not have products for all disease shares of the clinical-stage pipeline (47% and classes in scope. It does, however, have the largest 44% respectively). overall marketed portfolio, and the most products for communicable diseases and the most for non-commu- Sanofi, Novartis, GSK and Pfizer have the most nicable diseases. Novartis has the most marketed relevant products on the market (accounting for products for maternal and neonatal health conditions and for neglected tropical diseases. Almost all of the 53% of all marketed products in scope). Novartis, 20 companies measured by the Index have products GSK and Sanofi are also in the top five with the for multiple disease classes. Only Astellas and Novo largest R&D pipelines, together with Johnson & Nordisk are active in a single disease class in scope. Johnson and AbbVie: these five account for 54% The majority of marketed products target either non- of the overall pipeline. communicable or communicable diseases.

Johnson & Johnson and Boehringer Ingelheim stand out for having a large ratio of clinical-stage pipeline products to products on the market: both have average numbers of relevant marketed products, yet are among the top three companies with the most medicines and vaccines in clinical-stages of development. Others have low ratios: Pfizer has very few relevant products in clinical development, yet is among the top five when it comes to Novartis has the highest number of products in the the number of relevant products on the market. pipeline Pipelines differ hugely between companies, both in size and focus. Novartis has the largest pipeline within scope. Johnson & Johnson, Boehringer Ingelheim, GSK and Sanofi have large clinical-stage pipelines. Novartis, Johnson & Johnson, AbbVie and Eisai have large early- stage relevant pipelines (not shown in chart).

a This count includes products with multiple indications across disease classes. The number may be higher than the total number of individual products.

34 Access to Medicine Index 2014 Pipeline & Portfolio Analysis

Figure 13 Products on the market

Sano Novartis GSK Pzer Roche Merck KGaA AstraZeneca Bayer Merck & Co. Johnson & Johnson Boehringer Ingelheim Daiichi Sankyo Industry total Bristol-Myers Squibb Eisai AbbVie Takeda Novo Nordisk

Eli Lilly Gilead Astellas

Communicable Non-communicable Neglected tropical Maternal & neonatal

Marketed products include medicines, vaccines, diagnostics, vector control products and platform technologies. Products that are indicated for use in multiple diseases are included more than once.

Figure 14 Products in clinical development

Novartis Boehringer Ingelheim Johnson & Johnson GSK Sano AbbVie Daiichi Sankyo Takeda Bristol-Myers Squibb AstraZeneca Gilead Merck & Co. Industry total Roche Merck KGaA Eisai Eli Lilly Novo Nordisk Bayer Pzer Astellas

Communicable Non-communicable Neglected tropical Maternal & neonatal

The clinical stage pipeline includes medicines (including microbicides) and vaccines only. Products that are being investigated for use in multiple diseases are included more than once.

35 Pipeline & Portfolio Analysis Access to Medicine Index 2014

Regulatory approvals in the last 2 years

During the period of analysis, 11 companies including both adapted and innovative products. gained regulatory approval by the EMA or the US For HIV/AIDS, this includes a new child-dose FDA for at least 30 relevant products targeting tablet from Johnson & Johnson, a new paediatric 11 diseases in scope: COPD, diabetes, epilepsy, indication for an existing drug from Bristol- hepatitis, HIV/AIDS, lower respiratory infections, Myers Squibb, and a once-a-day treatment meningitis, tetanus, pertussis, schizophrenia from Gilead. The latter is supported by licences and tuberculosis. Most of these approvals are allowing the distribution of generic versions in for products that target diabetes and HIV/AIDS, 100 developing countries.

Figure 15 Johnson & Johnson leads in the number of regulatory approvals

Johnson & Johnson Gilead Novartis AstraZeneca Bristol-Myers Squibb Eli Lilly GSK Novo Nordisk Sano Boehringer Ingelheim Eisai

Figure 16 Most approvals are for diabetes and HIV/AIDS

Non-comunicable diseases Diabetes Cirrhosis of the liver (Hepatitis) Chronic Obstructive Pulmonary Disorder (COPD) Epilepsy Schizophrenia

Communicable diseases HIV/AIDS Lower respiratory infections Meningitis Tuberculosis There have been no new Combination of disease approvals for neglected tropical diseases and Neglected tropical diseases maternal & neonatal health conditions since 2012. Maternal & neonatal health conditions

36 Access to Medicine Index 2014 Pipeline & Portfolio Analysis

Table 1 30 products have been approved since 2012 Almost half of the products approved since 2012 are adaptations of existing products.

Company Brand name (INN) [adaptation] Index Disease Product type Johnson & Intelence® (etravirine) - [new dosage strength: 25 mg – paediatric indication] HIV/AIDS Medicine Johnson Prezista® (darunavir) - [new dosage strength: 800 mg] HIV/AIDS Medicine Sirturo® (bedaquiline) Tuberculosis Medicine Invega® (paliperidone) - [paediatric indication] Schizophrenia Medicine Invokana® (canagliflozin) Diabetes mellitus Medicine Vokanamet® (metformin/canagliflozin) -[Fixed-dose combination] Diabetes mellitus Medicine Incivo® (telaprevir) - [new dosage strength: 1125 mg] Cirrhosis of the liver (Hepatitis C) Medicine Olysio® (simeprevir) Cirrhosis of the liver (Hepatitis C) Medicine

Gilead Sovaldi® (sofosbuvir) Cirrhosis of the liver (Hepatitis C) Medicine Harvoni® (sofosbuvir/Ledipasvir) – [Fixed-dose combination] Cirrhosis of the liver (Hepatitis C) Medicine Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) HIV/AIDS Medicine – [Fixed-dose combination] Vitekta® (elvitegravir) HIV/AIDS Medicine Tybost® (cobicistat) HIV/AIDS Medicine

Novartis Bexsero® (meningococcal group B) Meningitis Vaccine Ultibro® Breezhaler (indacaterol, glycopyrronium) – [Fixed-dose combination] COPD Medicine Seebri® Breezhaler (glycopyrronium bromide) – [new inhaler] COPD Medicine

Astra- Fluenz Tetra® (live attenuated influenza) Lower respiratory infections Vaccine Zeneca Zinforo® (ceftaroline) Lower respiratory infections Medicine

Bristol- Reyataz® (atazanavir) - [paediatric indication] HIV/AIDS Medicine Myers Daklinza® (daclatasvir) Cirrhosis of the liver (Hepatitis C) Medicine Squibb

Eli Lilly Abasria® (insulin glargine) Diabetes mellitus Medicine Trulicity® (dulaglutide) Diabetes mellitus Medicine

GSK Fluarix® Quadrivalent (influenza) Lower respiratory infections Vaccine Nimenrix® (meningococcal group ACWY conjugate) Meningitis Vaccine

Novo Xultophy® (insulin degludec/liraglutide) – [Fixed-dose combination] Diabetes mellitus Medicine Nordisk Ryzodeg® (insulin degludec/insulin aspart) – [Fixed-dose combination] Diabetes mellitus Medicine

Sanofi Hexaxima® (hexavalent vaccine) – [fully liquid vaccine] Meningitis, cirrhosis of the liver Vaccine (Hepatitis B), tetanus and pertussis [outside Index Disease scope: diphtheria and polio] Lyxumia® (lixisenatide) Diabetes mellitus Medicine

Boehringer Jardiance® (empagliflozin) Diabetes mellitus Medicine Ingelheim

Eisai Fycompa® (perampanel) Epilepsy Medicine

There are at least seven other products that are either in the process of registration or for which registration files are publicly unavailable.

37 Pipeline & Portfolio Analysis Access to Medicine Index 2014

38 Access to Medicine Index 2014 Technical Areas

Technical Areas

Analysis Chapters

The Index evaluates the world’s largest pharmaceutical companies using a framework of seven areas of activity. Called Technical Areas, these areas are considered key to enhancing access to medicine in developing countries. Within the framework, the Index analyses company behaviour in four further dimen- sions, called Strategic Pillars: commitments, transparency, performance and innovation. The following section of this report comprises seven analysis chapters, one for each Technical Area.

Each chapter follows a similar structure and is based on the same set of building blocks. The first block frames the chapter’s context of analysis. The second includes a separate company ranking supported by an analysis of how the individual companies performed. This is followed by an analysis of how the industry as a whole addresses the area in question, and then a series of more focused analyses of company policies and practices. For example, the chapter on R&D also includes focused analyses of company pipelines, of how companies engage in partnerships and of how they approach clinical trial conduct and data transparency.

Company Ranking per Technical Area 1 = 1 2 3 2014 Index position 3 6 4 n/a 2012 Index position 5 = 5 6 17 7 12 Four strategic pillars: 8 4 9 2 Commitments 10 7 11 8 Transparency 12 18 13 14 Performance 14 16 Innovation 15 13 16 9 17 11 18 20 19 10 20 19 A score of 0 means the lowest and 5 signifies the 2014 2012 0 1 2 3 4 5 highest possible score among the company set. Commitments Transparency Performance Innovation

39 Technical Areas Access to Medicine Index 2014

40 Access to Medicine Index 2014 General Access to Medicine Management

A General Access to Medicine Management

As pharmaceutical companies search for new opportunities in developing countries, they have a responsibility to also increase access to their products for people on lower incomes. Achieving this balance requires companies to view access to medicine as a strategic issue, and to manage it as such.

To give scope and direction, companies need clear access-to-medicine strategies supported by strong rationales and commitment from top management. Companies are more likely to achieve long-term access goals if they formulate medium-term objectives supported by measurable, time-bound targets that are monitored on a regular basis.

Local stakeholder engagement can help companies tailor their strategies to local needs, increasing the chances of success. Engagement with stakeholders both globally and locally provides additional guidance, and helps companies to identify and respond to risks, opportunities and concerns.

In this chapter, the Index reports on how companies integrate access to medicine into their business strategies, governance structures, management systems and incentive structures. It examines how companies engage with stakeholders to share knowledge, identify risks and address access-related challenges and opportunities. In addition, it looks for innovative business models that improve access to medicine in a financially sustainable way.

Four areas of analysis

Managing for access-to-medicine outcomes Reporting on how companies establish responsibility and accountability for access to medicine, and how they measure, manage and incentivise associated performance.

Access-to-medicine strategy Reporting on the transparency of companies’ access strategies and rationales, and on their alignment with corporate strategies.

Stakeholder engagement Reporting on the extent and quality of stakeholder engagement, including senior management involvement and whether local stakeholder perspectives are incorporated into access-to-medicine approaches.

Innovation in business models Reporting on whether companies are developing new business models that also address the needs of the poorest patients.

41 General Access to Medicine Management Access to Medicine Index 2014

Top findings in General Access to Medicine Management

Access to medicine becomes more Companies use local stakeholder engage- embedded in governance structures ment to tailor access approaches For the first time, all companies have estab- Newly measured this year, the Index finds that lished some form of board-level representation pharmaceutical companies are engaging with for their access approach, compared to 17 in local stakeholders to tailor their approaches 2010 and 19 in 2012. Companies are starting to to local needs and conditions. Eight companies establish dedicated cross-functional senior-level engage with local stakeholders in a struc- committees that are responsible for defining, tured, targeted way that informs their access overseeing and reviewing access strategies and approaches. Several companies have best prac- initiatives. Four companies have established tices in this area. such committees.

More business models addressing the needs More dedicated units responsible for of the poor managing access approaches The number of business models addressing the Since 2012, three companies have newly needs of the poor is growing. Companies are established divisions or units responsible for expanding models to include more countries, developing, managing and implementing their products and patients and new models are access to medicine strategies and initiatives. being developed. Newly measured in this Index, These units or divisions are engaged in a range six companies provided evidence of piloting or of activities that have an influence on access to expanding innovative models. medicine, from R&D to stakeholder engagement to pricing. In total, six companies now have such divisions.

42 Access to Medicine Index 2014 General Access to Medicine Management

How the companies perform

As reported in 2012, companies score Figure 17 relatively well in this area, with a large Company Ranking General Access to Medicine Management leading group. Increasingly, companies view access to medicine as a strategic 1 = 1 GSK 4,9 issue, and embed access more firmly 2 8 Novartis 4,8 in their governance and organisational 3 = 3 Novo Nordisk 4,7 structures and business strategies, 4 2 Johnson & Johnson 4,4 and there is progress in the way 5 6 Merck & Co. 4,3 they manage for access-to-medicine 6 9 Merck KGaA 3,8 outcomes. Encouragingly, companies are expanding innovative pilots and 7 4 Sano 3,3 models to include more countries, 8 11 Eisai 3,3 patients and products. 9 7 Gilead 2,9 10 12 Roche 2,7 The leaders score in innovation 11 5 Bayer 2,7 In this area, four groups of roughly the 12 16 Eli Lilly 2,6 same size can be identified, with the 13 = 13 P zer 2,1 highest variation in scores occurring in the leading group of six companies. 14 10 AstraZeneca 2,1 As in 2012, GSK tops the ranking of 15 n/a AbbVie 1,9 this area. Novo Nordisk and Johnson 16 17 Boehringer Ingelheim 1,6 & Johnson also remain among the 17 14 Bristol-Myers Squibb 1,6 leaders. Novartis and Merck & Co. 18 20 Astellas 1,0 complete the top five, replacing Sanofi 19 18 Takeda 1,0 and Bayer. Merck KGaA rose to 6th 20 19 Daiichi Sankyo 0,7 place, closely behind Merck & Co. The 2014 2012 leading six companies score highly in all 0 1 2 3 4 5 areas, and moreover are the only ones Commitments Transparency Performance Innovation to receive credit for their innovative business models.

Large middle group AbbVie, Boehringer Ingelheim and thropy, rather than of business. This The next group consists of six compa- Bristol-Myers Squibb. Although their is reflected in the way in which access nies with mixed scores across the transparency levels are comparable to is organised here. In these companies, board: Sanofi, Eisai, Gilead, Roche, the upper-middle group, they exhibit there is also a lack of strong manage- Bayer and Eli Lilly. They all have lower levels of commitment and ment systems overseeing access to clear board-level responsibility and performance, particularly in the areas medicine (such as mechanisms for accountability for their access-to- of performance management and local measuring performance and tracking medicine approaches, and all show stakeholder engagement. progress). some evidence of having performance management systems in place to Laggards: no senior access ownership Biggest risers: Novartis and Eli Lilly monitor access-related behaviour. As in 2012, the bottom rankings are Novartis is the most notable riser in this However, they are generally less occupied by Astellas, Takeda and area, climbing six places to rank 2nd. In transparent than the leaders about Daiichi Sankyo. These three companies 2012, the Novartis Board of Directors their access-to-medicine strategies, have no executive committee or execu- approved a new access-to-healthcare rationales, targets and outcomes. tive individual that is clearly responsible strategy. Since then, the company has for their company’s approach to access implemented a centralised perfor- There are five companies in the lower- to medicine. In this group, access mance management system that middle group; Pfizer, AstraZeneca, mainly remains a question of philan- includes detailed, measurable targets,

43 General Access to Medicine Management Access to Medicine Index 2014

as well as both mid-term and short- Steady risers since 2010 past Bayer due to their disclosure of term goals. Progress against these Merck KGaA and Eisai continue to rise. new approaches in the area of strate- targets is measured on a regular basis. In 2012, Merck KGaA climbed from 16th gies, performance management and Novartis publicly discloses its access- position to 9th, and has now risen to 6th. incentives. to-healthcare targets and any associ- Eisai jumped from 19th position to 11th ated progress on its website and in its in 2012, and is now ranked 8th. Since AstraZeneca also fell relatively far, annual report. The company engages the 2010 Index, these companies have dropping four places, from 10th to 14th, with a wide range of stakeholders at significantly improved the organisation due to a lack of progress and stricter the global and local level and uses the of their access approaches, further Index measurement criteria in the area outcomes to guide its access approach. integrating their access strategies and of stakeholder engagement. Although establishing divisions responsible for the company engages with some stake- Eli Lilly has also risen markedly, by four managing their access approaches. holders, higher scoring companies places to 12th. Since the last Index, show a more targeted and proactive the company has implemented a new Furthest fallers: Bayer and approach. In addition, the company performance management system AstraZeneca showed limited evidence of managing that includes access-related targets. Bayer has fallen the furthest in rank, and incentivising access-related For relevant senior managers, perfor- from 5th to 11th, partly as a result of performance. mance-related pay is linked to whether stricter Index measurement criteria they meet these targets. and new aspects of measurement. In addition, other companies have moved

industry

More companies view access to medicine as a business issue

There is evidence that companies most companies have yet to make real It is encouraging to see that compa- continue to increasingly view access progress when it comes to systemati- nies are experimenting and expanding to medicine as a business issue and cally setting quantitative targets and innovative access-oriented models to align their access strategies with integrating them into their formal include more countries, more patients their overall business objectives and performance management systems. and more products. Although the priorities. Access is becoming more number of truly innovative models embedded in governance and organ- With regard to stakeholder engage- in the sector remains rather limited, isational structures. Board-level ment, more companies are engaging companies are exploring opportunities representation is now standard and with stakeholders as a strategic tool in a variety of ways. This indicates that companies are starting to establish to help shape access approaches there is no ‘one-size-fits-all’ model: committees for defining, overseeing and initiatives. Companies employ tailored approaches are required, and reviewing access strategies and a variety of methods and processes based on specific, local conditions as initiatives. for engaging with stakeholders, such well as on the company’s product port- as partnerships and collaborations; folio, strategic focus and capabilities. The industry is also showing some dialogues with individual organisations progress with regard to target setting or groups of stakeholders; and confer- and incentivising access-oriented ences, panels and other platforms. performance compared to 2012. All There is still significant potential for companies set qualitative targets and the industry to continually engage with the majority sets some time-bound, local stakeholders when developing measurable quantitative targets for at and implementing access strategies in least some of their initiatives. However, resource-limited settings.

44 Access to Medicine Index 2014 General Access to Medicine Management

focus area 1

Managing for access-to-medicine outcomes Board-level representation now standard

Why this matters

The success of an access-to-medicine as well as appropriate governance at whether companies disclose their strategy largely depends on whether structures to drive and oversee targets, performance measures and performance is measured, managed, implementation. progress; at whether targets are motivated and rewarded: companies supported by performance manage- need to underpin their access strate- Here, the Index analyses whether ment systems; and at whether relevant gies with performance management companies have established board- performance is incentivised. systems supported by meaningful level responsibility and accountability targets and performance measures, for access to medicine. It also looks

How the companies perform

All 20 companies have now established robust centralised systems in place Figure 18 some form of board-level representa- for measuring and appraising relevant Access to medicine increasingly tion for access-to-medicine issues, performance. In addition, one-third discussed in boardrooms indicating that access is increas- of companies provide evidence that ingly discussed in boardrooms. This incentives for senior managers are tied compares with 17 companies in 2010 to access-related goals and targets. All 20 companies have and 19 in 2012. Looking over succes- established some form of board-level sive Indices, there are indications that The next step for many companies representation for establishing support and account- would be to set access-related targets access issues. 2010 2012 2014 ability for access-to-medicine issues at more systematically, integrate them board- and executive levels can act as a into formal, centralised performance starting point for more active and stra- management systems, and reward tegic approaches to access to medi- their achievement accordingly. cine. In addition, a number of compa- committees that serve as governance nies are establishing committees for Leaders approach access as business bodies for their access approaches. defining, overseeing and reviewing issue This clearly signals the strategic impor- access strategies and initiatives that The leader in this area is GSK, followed tance of access to medicine within are comprised of senior managers from very closely by Novartis and Novo these companies. different business units. Nordisk, Eisai, and then Merck & Co. and Johnson & Johnson. These Companies set targets, but not Companies are now more transparent companies all approach access as a systematically about their targets and performance business issue and manage it as such. When it comes to target setting, GSK measures and the progress of access They set detailed qualitative targets and Merck & Co. are in the lead. For the initiatives. In this regard, all companies and measurable quantitative targets, vast majority of their access initia- set qualitative targets and the majority and use performance measures or tives, they set detailed qualitative sets some time-bound, measurable Key Performance Indicators (KPIs) to targets and time-bound quantitative quantitative targets for at least some track progress. Furthermore, they use targets; use pre-selected performance of their initiatives. However, only a centralised performance management measures (KPIs) to evaluate perfor- limited number provide evidence that systems and incentives to manage and mance; and regularly track progress they set them for the majority of their reward performance. towards targets. These companies initiatives. have a clear idea of what they want In addition, these companies have to achieve with their initiatives and In terms of performance manage- strong governance structures in place manage performance proactively. ment and incentives regarding access, that ensure the integration of access to there is a lot of room for improvement. medicine in their decisions and opera- All companies set qualitative targets Only one-third of companies have tions, with all except for Eisai having related to their access initiatives.

45 General Access to Medicine Management Access to Medicine Index 2014

Currently, however, it is less common systems that reward specific execu- Novartis established its Access to for them to systematically set time- tives and directors based on the Medicine Committee in 2014. It will be bound, quantitative targets and achievement of access objectives. responsible for assessing opportuni- performance measures, or to monitor Eli Lilly has implemented a new ties for expanding access, setting and progress. Most companies either set performance management system monitoring access-related targets quantitative targets for only some of throughout the company that includes and sharing best practices across the their initiatives, or not at all. performance metrics related to access company. It is chaired by the Chief for relevant senior managers. Compen- Executive Officer and includes other Range of mechanisms for perfor- sation for several vice presidents (VPs), senior-level representatives from its mance management senior directors and dedicated teams businesses. One-third of the companies track at Eli Lilly is also now dependent on access-related performance using achieving access-related objectives. Novo Nordisk’s Health Policy centralised performance management Committee oversees the renewed systems. These companies systemati- One-quarter of companies demon- Novo Nordisk Strategy for Access to cally monitor and report on progress strate no evidence of providing Diabetes Care. It is chaired by the Presi- and performance against targets incentives for relevant performance. dent and Chief Operating Officer, and and KPIs. Companies use a variety of Companies can improve by starting includes two Executive Vice Presidents mechanisms, including regular update to set personal objectives around and senior management representa- meetings (internal or with external promoting access for employees who tives from China, Africa, Asia, the Gulf partners), online performance- are directly involved in the execution of and Latin America. management and monitoring tools, access initiatives. reports from partners (including Johnson & Johnson’s Global Pharma- distributors) and product specific ceutical Access Committee (GPAC) observation metrics. At Merck & Co., Novartis and supervises the operational aspects of Novo Nordisk access objectives are market access and pricing decisions, included on the companies’ corporate Companies starting to establish including access to medicine related (balanced) scorecards, and are thus senior-level access committees performance metrics. It is chaired owned at executive level. There is still by the VP of Global Market Access, a lot of room for improvement in the Merck & Co., Novartis, Novo Nordisk Commercial Strategy Operations & industry: almost one-third of compa- and Johnson & Johnson have estab- Global Public Health, and includes nies provide no evidence of how they lished dedicated senior-level commit- members of the Group Operating manage and measure performance tees that act as separate governance Committee (the most senior gover- with regard to their access strategy. bodies for defining, overseeing and nance body in the pharmaceutical reviewing their access strategies and division). Incentivising performance improves initiatives. Committee members come since 2012 from various business units, ensuring There is only one company, AbbVie, The next important element of involvement from different parts of with a dedicated Executive Council for managing for access outcomes is the business. a specific group of diseases: neglected incentivising access-related perfor- diseases. The Council coordinates mance. In an improvement since 2012, 4 companies efforts on neglected diseases across for senior management, one-third of Merck & Co., Novartis, Novo Nordisk, the company and submits progress the companies now have clear finan- Johnson & Johnson reports and recommendations to the cial and non-financial incentives tied Executive Board. AbbVie is consid- to this area, compared to only three in Merck & Co. established its Emerging ering the establishment of an Execu- 2012. Boehringer Ingelheim is the most Markets Access Committee in 2013. It tive Council on Access that would be notable riser in this area: for relevant is responsible for driving the company’s responsible for developing and aligning senior managers, part of their perfor- access strategy and for implementing its access approach and would oversee mance-based pay is now dependent its Access to Health Guiding Principles. the operational aspect of its access on the achievement of access-related It brings together senior executives strategy and decisions. goals. Employees involved in access- from Global Responsibility, Global related activities in relevant countries Pricing, Global Policy, Manufacturing, also have access goals related to their Supply Chain Management and performance-based remuneration. Regional Presidents of the Emerging Markets. Merck KGaA and Eisai have also improved, implementing incentive

46 Access to Medicine Index 2014 General Access to Medicine Management

observation Gilead’s Access Operations and Johnson & Johnson launched Janssen Emerging Market Division is respon- Global Public Health (GPH) in January More dedicated access divisions sible for the day-to-day execution of 2014. This new group is responsible activities intended to increase access for the research, development and Six companies now have a dedi- to the company’s medicines in low- and delivery of pharmaceuticals, diag- cated division or unit responsible for middle income countries. This includes nostics and services for diseases that managing and implementing their the management of manufacturing, affect resource-limited countries and access-to-medicine approaches. It product registration, distribution, emerging markets. In addition, it is is interesting to note that all these pharmacovigilance, medical educa- responsible for developing, creating and companies are in the top 10 for tion, stakeholder engagement and implementing new access strategies. general access-to-medicine manage- partnerships with the Medicines Patent ment. Pool and Indian and African generics Merck KGaA established its Access to licensees. Health (A2H) unit at Merck Group level 6companies in 2013. The unit is in charge of driving Eisai, Gilead, GSK, Johnson & GSK is building on the success of its the A2H strategy across all regions and Johnson, Merck KGaA, Sanofi Developing Countries and Market divisions, to ensure that it is integrated Access unit by establishing a new Africa within the company’s business units, Eisai created its Global Access Strate- and Developing Countries Unit in March offices and actions. gies division in 2010 with the objective 2014, which covers more countries of developing and implementing new and aims to expand the company’s Sanofi’sAccess to Medicine Depart- policies, initiatives and business models business in sub-Saharan Africa. The ment is charged with developing inno- that will improve access to healthcare unit brings together the company’s vative models that provide sustainable and products in developing countries. commercial and access-related efforts access to healthcare and medicines at in low- and middle income countries in differentiated prices. Its programmes sub-Saharan Africa, and aims to invest focus on diseases for which Sanofi has for growth in high-potential markets expertise, including malaria, tuber- and to support development in less- culosis, neglected tropical diseases, developed markets. mental disorders and epilepsy.

best practice GSK – Strong senior sponsorship for access activities

For access-to-medicine strategies, GSK demonstrates a best practice in ments has a Corporate Executive Team success depends on receiving atten- this area, with strong senior sponsor- sponsor and lead business owner that tion throughout the company, and on ship for its access activities throughout works with the business to ensure the senior managers being made respon- the company. For example, in its 2012 delivery of the commitment. This will sible for its execution. Corporate Responsibility report, the help ensure that plans are implemented company published ten ‘Health for All’ and that progress is monitored and commitments. Each of these commit- reported.

best practice Novo Nordisk – Integrated performance management and incentives for access

Performance management systems, Novo Nordisk manages performance the executive management includes together with relevant incen- related to its new Access to Diabetes two access-related KPIs that are linked tive schemes for managers and Care strategy at the business-unit directly to the company’s Long-Term employees, can be key drivers for the level through the balanced scorecard; Incentive programme that is offered to successful implementation of access- and at the employee level through its the top-720 managers (corporate VPs, to-medicine strategies. People, Performance, Process system VPs and Directors). (known as 3P), including the 3P of two Executives (Corporate VP for Corpo- rate Stakeholder Engagement and the Executive VP for Corporate Relations). Its corporate balanced scorecard for

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focus area 2

Access-to-medicine strategy More integration: access strategies join business strategies

Why this matters

By disclosing their access strategies, access-to-medicine approach. The Index reports on whether companies’ targets, activities, and related progress, Index reports on the transparency of access-to-medicine strategies are companies enable their stakeholders to companies’ access strategies, under- aligned with business objectives and reflect on the company’s performance lying rationales, and related objectives, priorities, as this tends to increase their and gain insight into the future of its targets and progress. Furthermore, the chances of sustainability.

How the companies perform

Almost all companies publicly disclose The leaders in this area are GSK, Merck transparent about their access strate- information about their access-to- & Co., Johnson & Johnson, Novartis gies, including the disclosure of general medicine approaches and strategies. and Sanofi, followed closely by Novo objectives and more specific, measur- However, when it comes to goals, Nordisk. These companies show a clear able and time-bound targets. objectives and targets, the majority link between their access-to-medicine only disclose long-term objectives. The strategies and business strategies. observation industry can significantly improve here In addition, they all publicly disclose by publicly disclosing shorter-term detailed information on their access targets that are more measurable, as strategies and activities, including Regularly assessing access well as related progress. associated objectives and quantita- strategies tive targets. In its annual report, for Almost one-third of companies are example, Novartis discloses past and Since the 2012 Index, three companies developing access-to-medicine strate- future targets and results relating to have reassessed and revised their gies that are more integrated and its Access to Healthcare approach, access-to-medicine strategies and aligned with their business objectives providing more detail on its website. approaches: Merck KGaA, Novartis and priorities. This is reflected in the For the first time, Sanofi published and Novo Nordisk. way companies report on these strate- access-related objectives in its 2013 gies and related progress metrics. sustainability report, which will help 3 companies stakeholders to monitor progress. Merck KGaA, Novartis, Novo Nordisk Leaders' high disclosure reveals relevance of access Laggards disclose less about objec- Merck KGaA has significantly restruc- Compared with other companies, tives and targets tured its Access to Healthcare (A2H) companies performing well in this area Companies performing less well in this strategy, moving from a mainly philan- publicly disclose more detailed infor- area disclose far less about their access thropy-driven approach to one that is mation regarding their access-to-medi- strategies and provide limited evidence more strategic. Its A2H strategy is now cine strategies, for example in annual that their access approaches are part aligned with business objectives and reports, corporate social responsibility of wider strategies. For example, priorities across divisions. Its strategy reports and on their websites. They although AstraZeneca reports on focuses on the availability, accessibility, clearly demonstrate the relevance its access-to-healthcare strategy affordability of health solutions and of access to their core businesses, and long-term objectives, it does creating awareness. and that their access strategies are not publicly disclose clear, measur- integrated with wider business strate- able, time-bound targets related to Novartis reassessed its access-to- gies. In addition, they publicly disclose this strategy. Furthermore, although healthcare strategy in 2012. This relevant short-term measurable Boehringer Ingelheim has significantly strategy is part of its overall corporate targets, against which they systemati- increased its disclosure to the Index in strategy and is based on three objec- cally measure and report progress, just this regard, its disclosure to the public tives: 1) pioneering new business and as they do for their overall corporate remains very limited compared to that delivery models to reach underserved strategies. of its industry peers. Lower performers patients; 2) controlling and eliminating in this area can improve by being more disease, with a focus on leprosy and

48 Access to Medicine Index 2014 General Access to Medicine Management

malaria; and 3) finding new treatments Care in 2013. The company has with diabetes with its diabetes care and adaptive solutions for diseases of published on its website a detailed products by 2020 and will scale up the developing world. This strategy document in which it outlines the its efforts to: 1) reach the base of the will be reviewed periodically to ensure strategy’s rationale, purpose, and pyramid; 2) contribute to the global progress against these objectives. ambitions, as well as how it is inte- education of healthcare professionals; grated with Novo Nordisk’s overall and 3) promote health for the next Novo Nordisk outlined its renewed business strategy. It has set the generation. strategy for Global Access to Diabetes target of reaching 40 million people

focus area 3

Stakeholder Engagement Local engagement becomes a strategic tool

Why this matters

Systematically and proactively with stakeholders can serve as a means Figure 19 engaging with a wide range of global to identify common agendas, and help Do companies engage locally and local stakeholders enables compa- stimulate the co-development of solu- when developing and implementing nies to better understand different tions that maximise value for all parties access strategies? needs, perspectives and concerns involved. As local stakeholders are relating to key access-to-medicine closest to the patients, engagement No evidence that Systematically engage issues. This can help ensure the with these stakeholders allows compa- local views are in a way that informs sustainability, relevance and effective- nies to better understand their needs incorporated their access approaches ness of companies’ access approaches and local factors inhibiting access. and strategies. In addition, engagement

How the companies perform Some engagement, but no evidence All companies engage with stake- commonly organised around: it is structural holders to some extent, and most • Specific disease areas, such as engage with a variety of stakeholders diabetes or neglected tropical both on a global and a local level. diseases; However, the extent and quality of this • Specific access issues, such as health- They engage proactively with a broad stakeholder engagement varies widely. care system strengthening; range of stakeholders, from local Companies increasingly seem to • Certain products or product types, communities to multilateral organisa- recognise the importance of engaging such as vaccines or HIV treatments; tions, and for the vast majority of their with stakeholders on the ground • Access initiatives. access initiatives. The outcomes of this when developing and implementing engagement are used to shape their their access strategies. Still, there is Leaders have clear strategies and global and local access approaches. significant room for improvement, as platforms for engagement They recognise that the factors inhib- only eight companies provide evidence GSK, Johnson & Johnson, Novartis and iting access differ widely from location of engaging with local stakeholders in a Novo Nordisk are the leaders in this to location, and, as a consequence, structured, targeted way that informs area, followed very closely by Merck that effective access strategies require their access approaches. KGaA, Sanofi, Merck & Co. and Roche. at least some degree of localisation. They have a clear strategy and strong Therefore, they use local stakeholder Companies employ a variety of processes and platforms for stake- engagement to tailor their approaches methods and processes for engaging holder outreach, which indicates that, to local needs and conditions. In addi- with stakeholders, such as partner- for these eight companies, engaging tion, these companies actively share ships and collaborations; dialogues with stakeholders is a strategic tool information and stimulate dialogue with individual organisations or groups they use to understand strategic with stakeholders around access issues, of stakeholders; and conferences, opportunities and risks. including via their senior managers. panels and other platforms. These are

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GSK, Johnson & Johnson, Novartis, Low engagement from laggards Merck KGaA has taken a more active Novo Nordisk and Sanofi also lead Takeda, Daiichi Sankyo and Astellas approach to dialogue and knowledge at actively facilitating dialogue and occupy the lowest rankings. These sharing since 2012 through the launch knowledge sharing. Compared with companies have demonstrated limited of its Merck Access Dialogue Series. other companies, they are more pro- evidence of stakeholder engagement This is a platform for sharing informa- active when it comes to organising, related to countries or diseases that fall tion and best practices as well as for supporting or hosting various confer- within the scope of the Index. This may discussing ways of removing barriers to ences, symposia, workshops and other be partly explained by the fact that their access. So far, the company has hosted platforms, with participation by senior presence in these countries and focus dialogues on pricing, intellectual prop- management. Plus, their approaches on these diseases are more limited erty and supply chains and is planning tend to be institutionalised. compared to many of their industry further dialogues on access metrics, peers. They can improve by reaching universal health coverage and health Middle group engage less systemati- out to a broader range of stakeholders literacy. cally in a more constructive way. In this area, there is a large middle Novartis has organised a substantial group of companies with mixed perfor- number of relevant meetings and mance across indicators. Although observation events, including in Africa, mainly there is evidence that they engage with through the Novartis Foundation for stakeholders, their approaches tend to Companies establish platforms for Sustainable Development. Topics be less systematic and more limited in wide dialogue discussed include health in Africa, breadth and scope, which signals that malaria, leprosy and child health, and they see engaging with stakeholders as Access to medicine is a complex issue involve a wide range of stakeholders, less of a strategic tool. that involves a wide range of stake- such as multilateral organisations, holders. Companies can take an active patient organisations, academic insti- role in solution-finding by bringing tutions, governments and NGOs. together the many stakeholders involved.

best practice Novo Nordisk – Integrated approach to stakeholder engagement

Involving and stimulating ongoing Novo Nordisk focuses its business The company advocates for better dialogue with stakeholders can help model on diabetes, and has developed diabetes care through its “Changing companies to better understand the a holistic approach to stakeholder Diabetes Leadership Forums & Policy needs and concerns of stakeholder engagement for this disease. Internally, Roundtables”, which it organises at groups. it uses the findings from its outreach the international, regional and national activities to shape its access strategy. levels. At these events, the company Externally, it uses them to advocate aims to encourage payers, policy- for better diabetes care. It is the only makers and other parties to drive company that reports having a dedi- change in diabetes care. It convenes cated corporate VP for Global Stake- policy-makers, patient organisations, holder Engagement, which reflects the healthcare professionals, and NGOs, strategic importance of stakeholder among others, in order to discuss engagement for the company. solutions for alleviating the burden of diabetes and diabetes care. Since 2005, the company has organised 85 Diabetes Leadership Forums and Roundtables in more than 30 countries.

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best practice Merck & Co. – Structured approach to engagement with key stakeholders

Regular engagement with important In 2013, Merck & Co. launched its provides a structured way of regularly stakeholders can help to develop ‘Strategic Relationship Leaders engaging with key stakeholders in mutually beneficial solutions. (SRLs)’ approach, with the objective order to better understand their objec- of enhancing engagement with key tives and needs, and to help develop external stakeholders, including inter- mutually beneficial solutions. Primary national funding organisations, NGOs therapeutic areas for engagement and government aid agencies. The role include HIV/AIDS, hepatitis, vaccines, of an SRL is to develop and implement family planning and maternal and child a strategic plan for engaging with health. an international organisation. This

best practice Merck & Co. and Johnson & Johnson – Local engagement to overcome local barriers

Local stakeholders, from govern- Merck & Co.: on-the-ground engage- Johnson & Johnson: Systematic ments to NGOs and patient groups, ment in sub-Saharan Africa engagement in South America have the best understanding of the Merck & Co. has established an Insti- In Johnson & Johnson, local and local needs and hurdles to better tutional Business Africa unit. Through regional teams engage with a range healthcare. this unit, the company engages with of stakeholders to obtain a better key stakeholders to evaluate and understanding of conditions and needs address local public health needs. It on the ground. For example, in 2013 works on the ground in sub-Saharan the company undertook a strategic Africa with national governments, initiative to understand how to better international donors and NGOs to serve and expand access to medi- help ensure the successful delivery cine in Colombia. The initiative took of healthcare services, vaccines and five months and involved more than contraceptives. The unit creates stra- 30 members of staff from different tegic partnerships and provides policy functional areas. These employees and technical guidance to countries in performed in-depth interviews with the areas of family planning, maternal multiple stakeholders, ranging from health, HIV/AIDS, hepatitis and customers, physicians and government vaccines. Activities include stimulating officials, to representatives of scientific scientific dialogue; providing medical societies, healthcare provider facilities, education to healthcare workers payers and patient advocacy groups. In regarding HIV/AIDS, vaccine-prevent- another example, Johnson & Johnson able diseases and family planning; and carried out more than 500 interviews providing oversight and certification to with women in Brazil to gather their capacity-building initiatives. views on contraception. The company used this engagement to help define its strategy for improving women’s health.

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innovation New models are expanding: more countries, patients, products

With mature markets stagnating, Table 2 pharmaceutical companies are expanding their focus to developing markets and lower-income population 10 factors linking innovative access models segments. Conditions and circumstances in these markets are vastly For the 2014 Index, companies submitted numerous business models for different, due, for example, to a lack analysis. On examination, the Index identified six models that are innovative, of healthcare infrastructure and have an explicit goal of improving health and access to medicine for under- trained health workers. In order to served populations, and can be shown to be capable of generating financial be successful here, it is argued that returns for the company. Despite their significant differences, the Index has companies have to move away from found 10 factors that occur repeatedly across these models. the traditional business model. Organisational factors There is a need for new, more inclusive 1 A connection between the model and the overall business strategy business models that have the poten- 2 A long-term investment horizon tial to increase access to medicine 3 A clear vision of what the model aims to achieve, supported by objectives, while also being financially sustain- targets and regular progress monitoring able. In a new area of investigation, the 4 Senior-level support 2014 Index has found six companies with evidence of piloting or expanding Localisation mechanisms innovative models. Our analysis shows 5 A thorough understanding of regional and local factors that inhibit access to that most of these models were first healthcare in general and medicine in particular, as well as underlying causes piloted in India. 6 An overarching potentially replicable model that allows for localisation 7 A tailored product offering based on local needs and disease prevalence The six companies are exploring oppor- 8 Substantial investments to build local capacities, healthcare infrastructure tunities in a variety of ways, indicating development and awareness there is no ‘one-size-fits-all’ model. Tailored approaches are required, Stakeholder engagement based on specific, local conditions as 9 The involvement of local communities beyond the patient level well as on the company’s product port- 10 Cooperation with local partners throughout the lifecycle of the programme folio, strategic focus and capabilities.

Although more companies are experi- 6 companies with new or expanding models menting with innovative, access- GSK Africa and Developing Countries Unit oriented models, the number of truly Novartis Healthy Family programme innovative models remains limited. Novo Nordisk Base of the Pyramid innovation project Nevertheless, it is encouraging to see Merck KGaA Su Swastha that pilots are expanding to include Merck & Co. Programme Sambhav more countries, more patients and more Johnson & Johnson Impact bonds products. In some cases, companies are continuing with ongoing roll-outs, while other companies have started to expand & Co., whose innovative models are Index acknowledges this is challenging their pilots since 2012. potentially successful, but it is unclear and requires significant commitment, at this stage whether they are finan- investment and time. In addition, despite GSK, Novartis, Novo Nordisk and Merck cially sustainable. the potential of these models, it remains KGaA provide evidence of adopting or unclear whether and to what extent expanding innovative business models The expansion of several of these busi- they improve health outcomes or health that improve access to medicine for ness models gives a clear signal that it impact. The Index encourages compa- underserved populations in countries is possible to develop new models that nies to explore how health outcomes relevant to the Index. They are followed both increase access and are potentially and impacts of these programmes can by Johnson & Johnson and Merck financially sustainable. However, the be measured effectively.

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innovation

GSK – Africa and Developing Novartis – Healthy Family Novo Nordisk – Base of the Countries Unit Programme Pyramid (BOP) innovation project

• Covers all countries in sub- • Programmes in India, Kenya, • Programmes in India, Nigeria, Saharan Africa Vietnam and Indonesia Ghana and Kenya • Builds on DCMA unit • Focus on prevention, awareness • Improving diabetes care for • Active approach throughout value and treatment working poor chain • Programmes tailored to local • Replicable model, tailored to local • Includes wide range of products health priorities and customs conditions • Includes wide range of essential • Formulates clear targets for the In 2014, GSK announced the establish- medicines future ment of its new Africa and Developing Countries Unit. This builds on the Through its Social Business Group, In 2011, Novo Nordisk established its success of its Developing Countries Novartis has considerably expanded Base of the Pyramid (BOP) innovation and Market Access (DCMA) unit, which its “Healthy Family” programme, project. It aims to identify solutions for was the company’s fastest growing which focuses on expanding access to an integrated approach to diagnosis, business unit between 2010 and 2013. medicine, medical professionals and treatment and diabetes control for the The unit covers all African Less Devel- healthcare education for people living working poor in developing countries. oped Countries that were previously at the bottom of the income pyramid. Since then, the project has expanded: covered by the DCMA unit, as well as It covers a wide range of products and it is running in India, Nigeria, Ghana and all sub-Saharan countries, including focuses on prevention and awareness, Kenya, and working to, for example, Ghana, Kenya and South Africa. The as well as treatment. It was launched establish an effective supply chain, five core strategies of the unit are: in India in 2007 (Arogya Parivar) and reduce the need to travel for treatment 1) Create an Africa portfolio to target was expanded in 2012 to include Kenya and build capacity for treating diabetes: Africa-specific health needs; 2) Expand (Familia Nawiri) and Vietnam (Cung • In India, travel costs and the loss of local manufacturing, optimise supply, Song Khoe). More recently, three wages due to travel are the biggest design innovative distribution models; pilots have been initiated in Indonesia reasons patients do not have access 3) Develop a long-term Africa talent (Keluarga Sehat). Each local version to diabetes care or treatment. As a portfolio; 4) Support the development of the programme is unique: they are result, the company is working with of local healthcare infrastructure; 5) adjusted to fit local health priorities a social business model for making Create an Africa-specific operating and customs. For example, in each insulin available at the doorstep model. country, the product portfolio and through flexible services. health education on offer is tailored to • In Nigeria and Ghana, patients often The model has the potential to signifi- local disease burdens. have to visit multiple locations to cantly improve access to medicine receive diabetes care. The company throughout sub-Saharan Africa. In The collective reach of the programme has developed ‘One-Stop Diabetes addition, because it aims to include a is wide: according to the company, it Support Centres’, where patients wide range of medicines, vaccines and has brought health education to more can access all aspects of diabetes consumer products, it has the potential than 4.5 million people in rural areas in care. This concept was successfully to address a wide range of needs. 2013, up from 2.5 million in 2012. More piloted in 2013 in Nigeria. It is now than 230,000 people have received being scaled up there and replicated diagnosis or treatment through its in Ghana. health camps. Furthermore, the products involved include a wide range of Through this model, Novo Nordisk has essential medicines, and the project increased access to diabetes care and has proven to be financially sustainable: treatment. Its approach is replicable it broke even within 30 months and while leaving significant room for sales have increased 25-fold since then. tailoring to local conditions and needs. In addition, the company has formu- lated clear targets for the future and is monitoring progress. By 2015, the company aims to roll out this project to additional African countries.

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innovation

Merck KGaA – Su-Swastha Merck & Co. – Programme Sambhav Johnson & Johnson – Impact bonds

• Pilot running in two states in India • Programme in 11 cities in India • In early phases of development • Increasing access to healthcare in • Financing model offering zero- • Exploring new financing models rural areas interest, no-collateral loans based on DIBs and SIBs • Focus on awareness • Focus on hepatitis C • Focus on health outcomes

In 2013, Merck KGaA launched its In 2012, Merck & Co. launched its pilot Part of Johnson & Johnson, Janssen Su-Swastha (‘Good Health’) pilot in Hepatitis Financing Mechanism, or Global Public Health is currently two provinces of India (Bihar and Uttar ‘Programme Sambhav’, in the state launching a number of pilot schemes Pradesh). The project aims to increase of Punjab in India. In-depth market designed to expand its efforts to access to quality healthcare products research revealed that a lack of cash measure the economic impact, at an affordable price in rural India flow meant many patients could not effectiveness and sustainability of and addresses the lack of health- manage the cost of treatment for new access and funding models. The care infrastructure in rural areas. It hepatitis C. In response, for patients company is exploring how Developing offers community-level meetings and with limited or no insurance coverage, Impact Bonds and Social Impact Bonds educational health programmes run the company developed an innova- (DIBs and SIBs) can be used to finance by healthcare professionals, as well as tive financing model for its hepatitis R&D in the healthcare sector. DIBs and products based on needs in its target C medicine, peginterferon alfa-2b SIBs1 are outcome-based contracts areas and with adapted price bands. (PegIntron®). The programme offers in which the public sector or interna- In addition, it aims to improve access zero-interest, no-collateral loans for tional donors provide funding on the to primary healthcare by distributing eligible patients and a disease manage- proviso that projects lead to significant referral cards that enable patients ment option. Enrolment increased improvements in social outcomes (e.g., to reach doctors. As part of this from just 21 patients at the end of health outcomes). programme, the company is working 2012 to 450 by 2013. This represents with international NGOs on diarrhoea about 30% of all patients under treat- In 2012–2013, Janssen’s Social Impact management and safe drinking-water ment in the State of Punjab. Due to its Bonds Team completed the first phases programmes. When scaling up, the success, the company has expanded of a multi-phased, multi-year strategy company is planning to expand the the programme to 11 cities across four to develop DIBs and SIBs in a health- range of products to target additional states in India. care context. Together with the Centre diseases. for Global Development, the company In addition, the company is planning is exploring how this financing Although it is still a relatively small to expand it to more states in India, mechanism can be applied to support pilot, the programme has the poten- Vietnam and the Philippines, and healthcare delivery in resource-limited tial to increase access to treatment to include more products. An initial settings, with special attention to in rural areas in India. To increase its analysis phase for launching a similar improving access to medicines. potential impact, the Index encourages programme for vaccines is underway. the company to increase its scope to This project is still in a very early include more products and extend its Through this model, there is significant phase and its effectiveness still has to geographic reach. potential for more patients to gain be proven, in particular in countries access to treatment. However, microfi- relevant to the Index. Nevertheless, nance has received significant criticism the model represents a potentially new and opinions about its effectiveness way to make investments in healthcare differ widely. The Index encourages more efficient and more impactful. Merck & Co. to measure the impact of this programme to ensure that it is financially sustainable for the patients enrolled.

For numbered references, see the Appendix.

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innovation

GSK - Africa and Developing Countries Unit The unit covers all sub-Saharan countries, including these Novartis - Healthy Family Programme offices in Lagos, Nigeria. Children in Vietnam's Nghê An province receive a general health check. © GSK © GSK © Nguyen Tran Hung for Novartis AG © Merck KGaA © Novo Nordisk

Merck KGaA – Su-Swastha Novo Nordisk - Base of the Pyramid project The programme includes community-level meetings such as this Novo Nordisk works with faith-based organisations in Kenya to limit one in Shiv poojan lala, a village in rural India, which is being run price mark-ups. with government health and social workers.

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56 Access to Medicine Index 2014 Public Policy & Market Influence

B Public Policy & Market Influence

Pharmaceutical companies operate in an environment where low R&D success ratesa, the pressure to maintain profits and a fiercely competitive landscape can increase the temptation to engage in inappropriate, unethical behaviour. Since 2012, multiple serious cases of bribery, lobbying, anti-competitive practices and improper marketing have occurred. Such activities risk harm and a negative impact on access to medicine: for example, by misrepresenting drug efficacy and safety; by offering inappropriate incentives to doctors; or by delaying the market entry of generic competition.

All companies measured by the Index operate in countries with increasingly stringent controls on behaviour: in the US, companies are now required to publicly disclose financial relationships with healthcare professionals.1 Wher- ever companies operate, the Index expects them to meet the same standards as in more highly regulated countries, taking the initiative to expand existing policies and enforcement mechanisms to countries with weaker regulation.

The Index examines how companies self-regulate their behaviour, and reports on whether companies have been found in breach of relevant laws and standards in all countries in which they operate. The Index views breaches wherever they occur as an indication of whether company-wide policies and codes are functioning.

Five areas of analysis

Lobbying Reporting on lobbying activity, particularly in relation to the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement.2

Competitive behaviour Reporting on how companies support competition, for example by waiving rights to data exclusivity.

Ethical marketing Reporting on improper marketing practice, and whether companies have training, auditing and enforcement mechanisms in place.

Anti-corruption and anti-bribery Reporting on incidences of bribery and corruption and company measures for addressing and preventing such behaviour.

Innovation in Public Policy & Market Influence Reporting evidence of innovation to ensure ethical behaviour across the breadth of company operations.

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Top findings in Public Policy & Market Influence

Commitment to ethical behaviour does not No company discloses payments to health- correlate with good performance care professionals in countries in scope All 20 companies commit to following at least a There has been a significant shift toward greater minimum code of practice for ethical marketing transparency in the US, as companies are and all have codes of conduct governing bribery now legally required to disclose their financial and corruption. Three-quarters report auditing relationships with healthcare professionals. their codes. However, 18 out of 20 compa- However, no company discloses the equivalent nies were the subject of settlements or fines information in countries relevant to the Index. for corrupt behaviour, unethical marketing There is some indication of movement towards or breaches of competition law. Collectively, improving internal monitoring of these practices companies were found to have been accountable in Index countries, but greater public scrutiny for almost 100 separate breaches. would be valuable, especially in the wake of continuing evidence of unethical behaviour.

No simple correlation between a company’s incidence of breaches and its size Four companies waive rights to data exclu- Due to their size and geographic reach, larger sivity companies may be exposed to greater risk Four companies have waived rights to data of breaches of regulations or laws governing exclusivity for some products under certain ethical corporate behaviour. However the Index conditions. One other has shown readiness to finds that companies’ incidences of breaches do do so, describing the situations where it would not directly increase with size and geographic waive such rights. This is a constructive, albeit reach, indicating that companies of all sizes can limited, approach towards facilitating the entry take measures to actively minimise the risk of of generic competition. breaches occurring.

58 Access to Medicine Index 2014 Public Policy & Market Influence

How the companies perform

Scores are generally low in this Figure 20 chapter, particularly for transparency Company Ranking Public Policy & Market Influence and innovation. Furthermore, there is a clear gap between companies’ stated 1 10 Gilead 2,8 commitment to ethical behaviour 2 3 Novo Nordisk 2,7 and what actually happens in prac- 3 4 Bristol-Myers Squibb 2,4 tice. Almost all companies have been 4 n/a AbbVie 2,4 the subject of settlements or deci- 5 2 GSK 2,1 sions relating to corruption, ethical 6 11 Eisai 1,8 marketing or competition, despite almost all having codes of conduct to 7 19 AstraZeneca 1,7 govern employee behaviour. 8 13 Bayer 1,7 9 16 Astellas 1,6 Only two companies not in breach 10 20 Boehringer Ingelheim 1,4 In general, the highest-scoring compa- 11 7 Novartis 1,4 nies in this chapter incurred very 12 8 Roche 1,4 few fines and settlements relating to 13 15 P zer 1,4 improper marketing, bribery, corruption or anti-competitive behaviour. 14 12 Merck KGaA 1,3 For only two companies, Gilead and 15 17 Takeda 1,3 AbbVieb (a relatively young company), 16 9 Merck & Co. 1,3 were no fines or settlements identi- 17 5 Johnson & Johnson 1,1 fied during the period of analysis. 18 1 Sano 1,0 The higher scoring companies also 19 6 Eli Lilly 0,8 share information about breaches 20 18 Daiichi Sankyo 0,4 where they occur, and are able to 2014 2012 demonstrate how they take swift 0 1 2 3 4 5 action against employees who commit Commitments Transparency Performance Innovation offences.

Leaders share information, support competition, enforce policies In 2nd place, Novo Nordisk demon- compliance with relevant codes of Gilead is the overall leader in this strates a comparatively high level practice. chapter, performing well across most of transparency about its various focus areas. As well as having incurred memberships and policy positions. These companies also incurred fewer no fines or settlements, it audits its fines or settlements during the period codes of practice and shows evidence In 3rd place, Bristol-Myers Squibb of analysis than others (AbbVie of having enforcement procedures in also clearly articulates its support for incurred none). Where breaches place, should a breach occur. In tandem competition, and discloses more than did occur, those that were reported with this, Gilead shows evidence most companies about the financial by companies or identified by the of supporting greater competition contributions it makes to organisations Index took place outside of countries through its approach to licensing and based in countries within the scope of relevant to the Index. by waiving rights to data exclusivity for the Index. its HIV/AIDS portfolio. Large, low-scoring middle group In 4th place, AbbVie publicly shares There is a large middle group with Following Gilead in the ranking are detailed information about its board- variable performances across the four AbbVie, Bristol-Myers Squibb and Novo level membership of different organ- areas of investigation relating to Public Nordisk. These companies all exhibit isations. It also appears to be unique Policy & Market Influence. For example, good practice in different areas. in conducting external audits of its GSK is in 5th place and is comparatively

59 Public Policy & Market Influence Access to Medicine Index 2014

transparent about some of its policy subject of settlements and decisions. Biggest fallers: Sanofi, Eli Lilly, positions. There is also evidence that it For all except Sanofi, at least one of Johnson & Johnson supports competition, and is working these took place in a country within the Sanofi is the biggest faller, dropping towards greater disclosure of its scope of the Index. from 1st to 18th place. It is followed by global marketing activities. However, Eli Lilly and Johnson & Johnson, which the company has been the subject of Daiichi Sankyo occupies the last posi- drop 13 and 12 places respectively. Each multiple breaches. tion. It has provided the Index with company was the subject of multiple limited evidence of how its internal settlements or decisions during the Eisai, in 6th place, shares comparatively codes of conduct address the issue of period of analysis. For Sanofi and detailed information about the mecha- ethical marketing. It refers to compli- Johnson & Johnson, these included nisms it employs to enforce its codes ance with the IFPMA code of conduct,3 incidences of both corruption and of conduct and about the action it has but leaves unclear how it monitors anti-competitive practice. For Eli Lilly taken following incidences of miscon- third-party contractors and enforces and Johnson & Johnson, at least one duct. However, it is also one of the their compliance with these standards. took place in a country within the Index few companies that has not yet joined scope. the United Nations Global Compact Biggest risers: AstraZeneca, (UNGC). AstraZeneca, in 7th place, Boehringer Ingelheim, Gilead In 2014, Sanofi also failed to disclose has a lack of lobbying transparency, The biggest risers are AstraZeneca, information about its attitude towards but does demonstrate commitment Boehringer Ingelheim and Gilead, data exclusivity, and shares limited to reforming its sales incentives, and which climb 12, 10 and nine places information about its marketing takes a more open approach to data respectively. In 2014, AstraZeneca programmes in countries within scope. exclusivity in certain circumstances. disclosed a more constructive stance Eli Lilly shares limited information towards data exclusivity than in 2012, about its lobbying activities, including Further down the ranking, in 16th and and also demonstrated how it enforces payments made and memberships 17th place respectively, Merck & Co. and its codes of conduct and applies held. Johnson & Johnson does not Johnson & Johnson have been involved marketing regulations to third parties. demonstrate how (or whether) it has in multiple breaches, and, in the case Boehringer Ingelheim has markedly taken action against members of of Johnson & Johnson, with at least improved in transparency since 2012, staff who have breached its codes of one in a country within the scope of the sharing, for example, more compre- conduct. Index. Merck & Co. remains, however, hensive information about its code the only company in the Index that has of conduct for marketing, as well as Notably, GSK has fallen out of the joined the Partnership against Corrup- how it is enforced and applied to third top three. It was placed 1st in 2010, tion Initiative (PACI.) parties. Like AstraZeneca, Gilead has and 2nd in 2012. It is now in 5th place. also shown evidence of commitment The 2012–2014 drop is attributable Laggards breach multiple standards to waiving its rights to data exclusivity, to evidence of breaches relating to The companies at the lower end of the and was not found to have breached unethical marketing gathered during ranking are Sanofi, Eli Lilly and Daiichi relevant codes or laws. the reporting period.c Sankyo. These companies were the

industry Clear gap between commitments and practice

In general, companies conform to a was found to have been in breach of Increasing transparency baseline of performance. Regarding relevant laws or regulations at least There are signs of a more progres- corruption and bribery, for example, all once during the period of analysis. sive attitude towards the disclosure companies provide evidence of a code Company performance across the area of specific actions, transactions, of practice, 75% provide evidence that of Public Policy & Market Influence is memberships and stances among they audit and enforce such codes, and poor, especially when seen in the light some companies. Bristol-Myers Squibb all have whistleblower protection facili- of progress made in other areas of publicly discloses some payments made ties in place. focus. The industry needs to consider- to various organisations, including ably improve to ensure full compliance in some countries in scope. Roche However, there is a clear gap between with the law, and there is ample room discloses financial support provided to what the majority of companies to demonstrate greater proactivity to patient groups, including some in Index commit to doing, and what occurs in address failings. countries. However, most companies practice: almost every company (18) provide only limited or aggregate data.

60 Access to Medicine Index 2014 Public Policy & Market Influence

Publicly available transaction-level of trade associations, think tanks, and A small group of companies (Astra- information is scarce, and usually only interest groups could have a self- Zeneca, Bristol-Myers Squibb, Gilead, disclosed where required by law. With regulatory effect by ensuring greater ViiV Healthcare (GSK and Pfizer)) respect to lobbying, companies tend to external scrutiny of company behaviour. actively support competition, all publicly disclose only high-level global waiving, or committing to waive, their policy positions, rather than specific Companies generally do not publicly rights to data exclusivity in limited lobbying activities. Johnson & Johnson endorse competition: most (16) limit circumstances. Eisai’s commitment on is a notable exception, disclosing some themselves to committing to obeying data exclusivity has weakened. Previ- information (albeit limited, and only to the law and to not engaging in anti- ously it had committed not to pursue the Index) about political lobbying in competitive practices. Regarding data exclusivity in least developed some Index countries. Greater public commitments, Roche and Pfizer stand countries, but in 2014 it no longer gives disclosure by companies about their out, providing more detail than others this assurance. lobbying activities and memberships about their positions on competition.

extra analysis Analysis of breaches: Majority of companies subject of settlements or decisions

Breaches of legal or regulatory marketing, corruption, bribery and requirements are the differentiating lobbying; as well as at breaches of Figure 21 factor in this chapter. Higher scoring industry codes of conduct for good Most breaches relate to companies generally have the lowest marketing practice. marketing behaviour incidence of confirmed breaches. Where breaches have occurred, higher When assessing company perfor- scoring companies have voluntarily mance, the Index only takes into disclosed them and demonstrated account fines levied and decisions that they have taken action to mitigate taken against the company in question. against the risk of similar breaches within the period of analysis.d This is occurring in the future. referred to as the company’s incidence of breaches. Sometimes the settle- Breaches identied Breaches identied Research indicates that, in the public ments reached and decisions taken relating to anti- related to marketing, competitive behaviour bribery and corruption sector at least, there is a relationship against the company relate to reports between lower levels of corruption and of misconduct prior to the period of having a code of conduct in place – so analysis, and thus corrective action long as it is accompanied by processes taken by companies may not be fully for communicating its contents, is captured within the 2014 analysis. manage and apply standards and embedded in a supportive environ- auditing and enforcement mechanisms, ment, and supported by adequate In countries relevant to the Index, the 2014 Index also scores, for the first enforcement and auditing processes evidence of breaches of codes of time, breaches that occur in countries aimed at ensuring compliance. 4,5,6,7 conduct and legislation is scarce and outside of the scope of the index. The Index views breaches of legal often limited to high-profile cases. requirements and associated stan- It should be noted that the breaches Only two companies with no breaches dards as an indication that a company’s captured by the Index are also a func- Apart from Gilead and AbbVie, all approach to communicating and tion of the nature and rigour of the companies measured by the 2014 enforcing its codes of conduct and various regional and national legal Index were the subject of settlements related policies is not functioning opti- and regulatory frameworks. As such, or decisions regarding breaches of mally, and that it is not able to foster an fewer breaches are likely to be identi- at least one standard or requirement environment that shows zero tolerance fied in countries with weaker or absent somewhere in the world during the to corruption. reporting systems and judicial controls. period of analysis. In total, almost 100 separate breaches were captured or The Index captures information about This is the case in many of the coun- self-reported. The majority of these fines and settlements, as well as about tries that fall within the geographic (89%) concerned improper marketing, allegations and on-going cases. It scope of the Index. To give a better bribery and corruption. The remaining looks at breaches of laws relating to sense of how effectively companies breaches relate to anti-competitive

61 Public Policy & Market Influence Access to Medicine Index 2014

behaviour. This balance is not and its annual revenue, or with its should not be straightforwardly char- surprising considering the breadth of geographic spread. Some smaller acterised as a cost of doing business marketing activity in this sector, the companies were implicated in breaches that increases with company size and overlap of breaches concerning uneth- more often than larger peers. Simi- geographic reach. ical marketing practice and bribery, and larly, some companies with wider because specific regulatory structures geographic reach, such as Roche, were There are specific actions that every in some jurisdictions (e.g., the US, the implicated in comparatively fewer company can take to mitigate the risk UK) mean that breaches of marketing breaches than peers with more limited of a breach: assign clear responsibility codes and laws are more likely to be operational spheres. and accountability at the highest reported, and settlements publicly levels; encourage clear standards of disclosed. Risk can be mitigated behaviour at all levels; conduct external This indicates that, although some audits; conduct relevant training; and There is no simple correlation between companies may be exposed to greater impose penalties for non-compliance. a company’s incidence of breaches risk of breaches, breaches cannot and

Figure 22 No clear relationship between company behaviour and size

Of the 20 companies analysed, only Gilead and AbbVie were not found to have been the subject of settlements or decisions somewhere in the world during the period of analysis. AbbVie is a relatively young company. All incidences included in this gure are treated equally. In total, almost 100 separate breaches were identied or self-reported. Number of countries in scope where company has sales

0 AbbVie Gilead Number of settlements/ Eisai Bristol-Myers Squibb decisions Novo Nordisk Daiichi Sankyo

Astellas Merck KGaA Takeda Johnson & Johnson

GSK Eli Lilly Boehringer Roche Ingelheim

AstraZeneca

Novartis

Merck & Co.

Bayer

Sano

Pzer

In its analysis of breaches, the 2014 Access to Medicine Index nds no simple correlation between the size of a company, its geographic reach and the number Circle size represents of settlements or decisions concerning corruption, bribery, improper marketing company revenue and anti-competitive behaviour. This indicates that breaches cannot simply be characterised as a cost of doing business that increases with a company’s size and reach. Further, as both large and small companies are found to have lower incidences, it appears that companies of all size and scale can take mitigating action.

62 Access to Medicine Index 2014 Public Policy & Market Influence

focus area 1

Anti-bribery and anti-corruption Standards and policies in place, but more needs to be done

Why this matters

Corruption and bribery can compro- menting and enforcing robust self- anti-corruption policies and codes mise patient safety, increase costs regulatory policies (such as auditing) of conduct that include monitoring to the public purse, damage reputa- to complement external regulatory and enforcement mechanisms. As an tions and financial returns, and cost requirements; assigning board- indication of the effectiveness of these companies significantly in fines and level responsibility for compliance measures, the Index examines how and settlements.e Where the will exists, issues, and creating an atmosphere where anti-corruption and anti-bribery companies can take a range of actions of trust in which whistleblowers can laws and regulations are breached, and to mitigate the risk of corruption and come forward. The Index looks for whether disciplinary action is taken. bribery occurring, including imple- strong, transparent anti-bribery and

How the companies perform

As noted in 2012, it is standard prac- feel able to report corruption or Figure 23 tice for all companies to have in bribery: all companies have a whistle- More companies audit compliance place codes of conduct prohibiting blower protection facility in place. The corruption and bribery. The majority majority (17) explicitly report having Number of companies of companies (15) continue to partici- a policy of non-retaliation against reporting internal auditing of adherence to codes of pate in at least one global initiative complainants. Board-level owner- conduct for bribery and that combats corruption. Change in ship of compliance issues is a strong corruption. 2012 2014 company behaviour regarding bribery indication that allegations are taken and corruption is limited to one area: seriously and are dealt with in a timely in 2014, seven additional companies and transparent manner. However, no reported that they audit adherence company shares definitive information Gilead and Roche. Johnson & Johnson to their codes of conduct for bribery about how responsibility for breaches is the only new member of the UNGC and corruption – 15 in total, up from is taken at the board level. The most since 2012. Merck & Co. remain the nine in 2012. Five companies (Roche, common arrangement is for a senior only pharmaceutical company to also Sanofi, Takeda, Daiichi Sankyo and compliance staff member to report be a member of the World Economic Astellas) did not provide evidence of on compliance issues to the board. Forum’s Partnership against Corrup- auditing their code. In almost all (14) of Ten companies (Sanofi, AbbVie, Bayer, tion (PACI). these cases, evidence indicates that Eli Lilly, Merck KGaA, Novartis, Novo audits are conducted internally. AbbVie Nordisk, Bristol-Myers Squibb, Astra- Allegations in China also reports the existence of external Zeneca, Eisai and Gilead) disclose their During the period of analysis, the Index audits, the results of which tend to approaches for ensuring employees also identified multiple allegations have more credibility. comply with their codes of conduct of breaches, including several high- for corruption, bribery and ethical profile allegations in 2013 of bribery by Leaders do not breach standards marketing. They also provide evidence companies operating in China. Some of The leaders in this area are Gilead and of whether or not they took disciplinary these allegations concern healthcare AbbVie. They are the only two compa- action in the event of misconduct. professionals being given direct incen- nies not found to have breached laws tives to influence sales (GSK was fined and regulations related to bribery and By joining international agreements USD500 million by China in 2014).8,9,10 corruption. In addition, they both have against bribery and corruption, compa- There appears to be a disconnect clearly defined policies and procedures nies publicly commit to combating between having anti-corruption for taking action were a breach to occur. unethical conduct. In total, 15 compa- measures on paper and successfully nies are now members of the United enforcing them in different countries Whistleblower policies now standard Nations Global Compact (UNGC).f Five and contexts. Encouragingly, companies recognise companies have not yet signed up to the importance of ensuring employees it: AbbVie, Boehringer Ingelheim, Eisai,

63 Public Policy & Market Influence Access to Medicine Index 2014

focus area 2

Ethical marketing More transparency from leaders and promise of third-party monitoring

Why this matters

Improper marketing tactics can facturers (IFPMA) and whether they tions made by the European Federa- increase the risk of irrational meet national regulations or standards, tion of Pharmaceutical Industries and prescribing and misinformed where they exist. Associations (EFPIA)11, companies are purchasing decisions, reduce drug now required to publicly disclose their efficacy and lead to adverse drug reac- The Index examines whether compa- financial relationships with healthcare tions. The Index looks at companies’ nies have training, auditing and professionals in these regions. The codes of conduct and mechanisms for enforcement mechanisms in place. As a Index looks at whether companies enforcing ethical marketing behav- proxy for company compliance across also take the initiative by disclosing iour. In the absence of independent the breadth of operations, the Index equivalent information in countries international guidelines, the Index captures reported breaches of ethical relevant to the Index. In addition to examines whether companies’ codes marketing guidelines and evidence of helping regulate behaviour, this would and mechanisms at least align with the litigation wherever they occur. enable stakeholders to explore how Code of Pharmaceutical Marketing such activity affects local access to Practices set out by the International With the signing of the Sunshine Act medicine. Federation of Pharmaceutical Manu- in the US and similar recommenda-

How the companies perform

All companies commit to meeting the Department of Justice. Among these sales agents. These companies are legal requirements of countries in were USD3 billion and USD2.2 billion AbbVie, AstraZeneca, Boehringer which they operate, and to applying settlements against GSK and Johnson Ingelheim, Eli Lilly, Gilead, GSK, either their own marketing code, or at & Johnson respectively for promoting Johnson & Johnson, Merck KGaA, least to following the most recent code drugs for unapproved uses in the early Merck & Co., Novartis, Novo Nordisk, of the IFPMA. However, the volume and part of the last decade. Roche and Sanofi. Sixteen companies nature of unethical marketing practices provided evidence of auditing their captured during the period of analysis Leaders extend policies to third marketing codes of practice (those that indicate that company commitments parties did not were Astellas, Bayer, Daiichi are in conflict with evidence that shows Gilead and AbbVie are the leaders in Sankyo and Takeda). a continuing non-compliance with this area: they were found to have standards. either no or very few breaches of The remaining companies, despite ethical marketing requirements in having relevant codes, did not provide All companies except Gilead and countries within the scope of the similar evidence of this level of internal AbbVie were found to have been the Index or beyond. In addition, they have monitoring, control and review. At the subject of settlements or decisions clearly defined and audited policies bottom of the ranking, Daiichi Sankyo relating to ethical marketing laws and and procedures in place for taking is the only company to provide no regulations somewhere in the world disciplinary action, which they extend evidence of having an internal code or during the period of analysis. not only internally but also to third- policy that specifically addresses ethical party suppliers. These companies also marketing. However, it does state that Marketing breaches captured by demonstrate transparency, for example it complies with IFPMA guidance and the 2014 Index include breaches of by sharing information about payments national regulations in this area. industry-regulated codes of conduct in made to healthcare professionals. countries such as the UK12, Australia13, No disclosure of payments to doctors South Africa14 and the Netherlands15. 13 companies were able to provide in countries in scope They also include more high-profile evidence of having policies, procedures The Physician Payment Sunshine Act legal settlements brought in the US and monitoring systems that also (2010) is a US law requiring pharmaceu- under the False Claims Act by the US related to the behaviour of third-party tical companies to declare payments

64 Access to Medicine Index 2014 Public Policy & Market Influence

and gifts made to physicians and As a result of these changes, many publishing aggregate global figures of teaching hospitals in the US in a public companies are implementing more such payments. database. The database, which became rigorous systems for tracking and operational in September 2014, allows reporting payments made to health- In order to make these leading prac- the public to scrutinise the financial care professionals. The Index looked tices, companies need to capture trans- relationships between the industry at whether any company went further, action-level information in countries and the medical profession in the US. and disclosed equivalent information in within scope, and publish the resulting Its intent is to limit undue “influence countries within the scope of the Index. reports – whether or not local legisla- of industry on research, education No company provided evidence of this tion requires it. Currently, no company and clinical decision making” and to level of transparency. However, Novo provides detailed information about “stop conflicts of interest which harm Nordisk is working towards rolling out transaction-level payments made to patients and their care”. In a related a comparable system in some countries healthcare professionals in countries development, the EFPIA Disclosure relevant to the Index. Bristol-Myers relevant to the Index, preventing Code (approved June 2013) states that Squibb is also evaluating an initiative external evaluation of their appropri- member companies should publicly that would also make disclosure of ateness. disclose “transfers of value” to health- these kinds of payments possible. In care professionals. the same vein, GSK is working towards

focus area 3

Lobbying Companies reluctant to share lobbying activities

Why this matters

The Index defines lobbying as any similar interactions, making it difficult disclose their lobbying positions, activity carried out to influence the to record and review. Country-level policies regarding political contribu- policies and decisions of a government lobbying to influence national legis- tions, and trade-association and board or institution in favour of a specific lation can be easier to track where memberships. It also investigates cause or outcome. Even when allowed countries have requirements in place specific reported incidences of inap- by law, lobbying can give companies for registering or disclosing lobbying propriate lobbying that occurred during inappropriate influence that can distort activity. In the multilateral policy- the period of analysis, including via markets and affect access to medi- making arena, for example in UN trade organisations. cine. For example, companies lobby institutions, this type of influence can governments to strengthen intellectual be more difficult to monitor. Because companies can also exert their property protection beyond what is influence for the benefit of patients internationally agreed to be reason- Transparency about lobbying sheds and access to medicine, the Index also able. This can have a direct impact on light on relationships and positions examines whether companies engage access to medicine by delaying the that could have an impact on access in multi-stakeholder advocacy activi- entry of generic competition to the to medicine. Furthermore, it enables ties in support of access to medicine. market. stakeholders to hold companies and Collaborating with a range of actors the recipients of their financial support helps ensure that these activities are Much lobbying activity occurs during publicly accountable. The Index needs-based, and not solely geared private lunches, informal meetings and reports on whether companies publicly towards a company’s interests.

How the companies perform

Little has changed in this area since regard, either publicly or to the Index: the positions of relevant trade associa- 2012: companies generally do not share namely AbbVie, Astellas, AstraZeneca, tions. None disclose political contribu- information about lobbying positions or Boehringer Ingelheim, Eisai, Eli Lilly, tions in countries within scope. political contributions that may affect Gilead, Merck KGaA and Takeda. Other countries relevant to the Index. Nine companies simply referred to general The leader in this area, Johnson & volunteered no information at all in this policy statements, or statements about Johnson, shows that greater degrees

65 Public Policy & Market Influence Access to Medicine Index 2014

of transparency about lobbying in sure. They publicly share details of KGaA all provide public information countries within the scope of the Index their membership of interest groups; of about their board-level memberships are possible, although disclosure in this board seats they hold; policies around of industry associations and advisory case was only to the Index, rather than political payments; and about certain bodies related to access issues for public. lobbying positions held in countries countries and diseases within the relevant to the Index. scope of the Index. During the period of analysis, most companies were implicated in a single, The leading companies in this area are Other companies remain conserva- high-profile allegation. This involved Johnson & Johnson, GSK, Merck & Co., tive about sharing details of the board the Innovative Pharmaceutical Asso- Novartis and Sanofi. These companies seats they hold, the lobbying activities ciation of South Africa (IPASA) and publicly share general global public they undertake, the memberships of Pharmaceutical Research & Manufac- policy positions that could have an and contributions made to interest turers of America (PhRMA). Evidence impact on access to medicine – for groups. The poorest performers in this emerged in early 2014 of a strategy example, their orientation towards area (AstraZeneca, Pfizer and Takeda) aimed at delaying the South African compulsory licensing. Johnson & share limited information about board Government’s planned reform of its Johnson also shares with the Index memberships and payments made intellectual property legislation.16 more detailed information about the to interest groups, and were unclear lobbying activities it has undertaken in about their lobbying activities. Where The South African reform proposals countries relevant to the Index. disclosed, information was limited to include strengthening of patentability countries outside the scope of the criteria, and implementing both pre- While some companies disclose Index. and post-grant opposition of patents specific political contributions that and several TRIPS flexibilities, including they have made in the US and the Broad evidence of harmful lobbying enabling compulsory licensing where EU, this disclosure does not extend All companies included in the 2014 there is a lack of indigenous manufac- beyond what is either legally required Index are members of trade associa- turing capacity. or mandated by the industry body. tions (most commonly EFPIA, IFPMA, Roche and Novartis go slightly further, IPASA and PhrMA). Via this member- Companies continue to provide also disclosing aggregate amounts ship, they have all been connected to evidence of engaging in multi- of political contributions made in the lobbying of national or regional stakeholder advocacy activities in Switzerland, where such disclosure is governments for stronger intellectual support of access to medicine. For not legally required.17 No companies property protection. The IPASA case example, several companies continue disclose political contributions made mentioned above is the most high- to participate in the Uniting to Combat in Index countries. Bristol-Myers profile and involves the most compa- Neglected Tropical Diseases (NTDs) Squibb publicly discloses its company nies. Since the publication of these Initiative, a result of the 2012 London policy not to make such payments allegations, Novo Nordisk and Roche Declaration on NTDs. This initiative outside of the US, and GSK has publicly have resigned from IPASA and Novartis draws attention to the need for greater committed to making no political has distanced itself through a news focus on the elimination or control of contributions in any country. release.18, 19 neglected tropical diseases. Boehringer Ingelheim, Novo Nordisk Company behaviour can improve in all and Roche show a more confident aspects of lobbying captured by the approach to sharing information about Index. In particular, there is a need for their memberships of, and specific greater transparency, beyond legal payments made to, a variety of interest requirements, and about transaction- groups, trade associations and think level payments to interest groups and tanks. However, they stop short of trade associations, especially where providing equivalent information these payments occur in lower income related to countries within the scope of countries. the Index.

Disclosure: low, but improving Bristol-Myers Squibb goes further, Although no companies publish their disclosing information to the Index lobbying positions and activities fully about its memberships of and contri- and frankly, the better performers in butions to interest groups based in this area demonstrate a more confi- countries relevant to the Index. AbbVie, dent approach towards public disclo- Astellas, Bayer, Eisai, GSK, and Merck

66 Access to Medicine Index 2014 Public Policy & Market Influence

focus area 4

Anti-competitive behaviour Small group actively supports competition

Why this matters

It is generally accepted that competi- generic competitors are then required a commitment to obey the law. tion supports lower prices. Companies to repeat clinical trials unnecessarily, can stifle competition through various should they want to continue devel- The Index looks at whether the means: by paying generic manufac- opment. Under the declaration of company has been found to have turers to delay the market entry of Helsinki, such unnecessary repetition is breached competition law; and competing products; colluding with considered unethical.20 whether and under which circum- peers on pricing; or insisting on their stances companies waive rights to data rights to data exclusivity. In this area, the Index looks for clear exclusivity to facilitate greater access statements of support for compe- in countries covered by the Index. Data exclusivity refers to a company’s tition with both generic medicine How companies facilitate competition right to prevent generic competitors manufacturers and research-based through other mechanisms, such as from using the company’s clinical trial peers. Company policy should include licensing, is addressed in the chapter data when registering generic equiva- a commitment to refrain from under- on Patents & Licensing. lents. It can delay the entry of the taking activities that would undermine generic equivalent to the market, as competition, but should also go beyond

How companies perform

As in 2012, the majority of companies All companies can do more across the 4 companies waive rights to data give limited public support to the value board. A more proactive approach to exclusivity, albeit in limited of competition. For the 2014 Index, a competition is possible, for example, circumstances: small group of two leaders provided through licensing, or by taking a more Bristol-Myers Squibb clear and precise company-wide poli- nuanced approach to data exclusivity, Gilead cies that endorse competition with by waiving its application across a GSK (ViiV Healthcare) both their research-based peers and broader range of products and in a Pfizer (ViiV Healthcare) with the generic medicine industry. broader range of countries. However, remaining companies restricted themselves either to broad Willingness to share data value of both generic and research- statements in support of competi- The leaders in 2014 go beyond commit- based competition, and commit to tion (three companies) or limited their ting to adhere to competition law, and avoiding anti-competitive practice, commitment to adherence to the law have clear and precise policies that demonstrating evidence of how this is (15 companies). Breaches related to describe the benefits of competi- enforced. Many (15) others have poli- anti-competitive behaviour were iden- tion for patients. They show evidence cies in place, but do not go beyond a tified in slightly under half (nine) of the of waiving opportunities to extend commitment to adhere to the law. companies. market monopolies, for example by formalising exemptions to data Bristol-Myers Squibb also clearly Concerning data exclusivity, it is exclusivity in certain cases in certain articulates its support for competition encouraging to see a small group of countries. Company performance is within its company policies. In addition, companies prepared to relax their insis- critical – to lead there needs to be it is one of a group of five companies tence on the maximum periods of data no evidence of negative judgements to provide evidence of supporting exclusivity available for some diseases concerning competition law over the competition in practice, albeit in limited in countries in scope. However, reporting period. cases: it has used the President’s Emer- lobbying for stronger standards of gency Plan for Aids Relief’s (PEPFAR) data exclusivity appears to be industry- Pfizer and Roche go further than most tentative approval process to facili- wide: most companies were connected companies, publishing commitments tate access to its clinical trial data for to evidence of this kind of lobbying in at that endorse the value of competi- generic medicine manufacturers, least one relevant country. tion. They explicitly endorse the expediting the development of generic

67 Public Policy & Market Influence Access to Medicine Index 2014

versions of its HIV medicines.21 entry of generic competitors in areas Figure 24 GSK and Pfizer (through ViiV Health- of need. When compared with 2012, Pay-for-delay to stall competitors care), together with Gilead, are the most companies have not significantly other three companies that show changed their commitments to waiving Companies implicated 10 breaches identi ed leading behaviour. These companies data exclusivity rights in support of in breach of competition law report having waived their rights to generic competition. data exclusivity in certain cases in certain countries relevant to the Index. Seven companies in breach In the case of Gilead, these commit- Company behaviour is more important ments were made directly to Indian than commitment. During the period of generic medicine manufacturers the analysis, the Index identified negative company had partnered with, and rulings involving seven companies over through the terms of separate agree- the period of analysis (Daiichi Sankyo, implicated pay for delay ments with the Medicines Patent Pool. Johnson & Johnson, Merck KGaA, not implicated other breaches of In the case of GSK and Pfizer, commit- Novartis, Pfizer, Roche and Sanofi). competition law ments relate to the terms of licences This includes breaches that occurred agreed between ViiV Healthcare and in two countries within the scope of Seven companies were implicated in 10 the Medicines Patent Pool. In addition, the Index (China and India) and involve breaches of competition law: Daiichi Sankyo, Johnson & Johnson, Merck KGaA, Novartis, AstraZeneca has committed to waiving Johnson & Johnson and Daiichi Sankyo. P zer, Roche and Sano . Out of these, four its rights to data exclusivity for prod- In the case of Daiichi Sankyo this was relate to pay for delay, where companies either ucts for specific conditions, including related to its generic pharmaceuticals made or received payments to delay entry of generic medicine competitors to the market. malaria, tuberculosis, lymphatic fila- subsidiary, Ranbaxy. These instances riasis and leishmaniasis. were both related to steps companies took to affect pricing. The Index Other companies either disclosed captured multiple (four) instances of can take to ensure their stated policies no specific position in this area, or pay-for-delay, where companies either are better specified and disseminated emphasised the general need for data made or received payments to delay across the company, and how they can exclusivity to protect clinical trial data. the entry of generic competitors onto be better audited and enforced across They did not acknowledge the possi- the market. Companies associated with the breadth of their operations. bility that a more flexible approach to any sort of breach of competition law data exclusivity would facilitate market should ask what additional actions they

innovation Innovation follows allegations

Over successive Indices, there has been AstraZeneca and GSK are reforming sionals that it has invited to speak at or very limited evidence of innovation the way they incentivise their sales attend medical conferences. in the area of Public Policy & Market agents. Incentive schemes that are Influence. Companies involved in based entirely on sales targets inten- Movements towards greater transpar- breaches need to address their failings, sify an organisation’s focus on sales ency of activities in countries within and to do so proactively, rather than figures while potentially undermining scope are welcomed. Novo Nordisk reactively. However, sometimes novel the appropriate, rational and more has disclosed to the Index plans for practices arise in reaction to reports or cost-effective use of medicine. achieving greater internal oversight allegations of negative practice. They and closer monitoring of payments nevertheless represent innovation and GSK has – uniquely – announced that, in selected lower income countries. are valued as such. by the start of 2016, it will stop making Public disclosure of this information direct payments to healthcare profes- would be unique.

For numbered references, see the Appendix. b Two settlements were made against AbbVie during e Recent settlements under the Foreign Corrupt Practices the period of analysis. However, they both related to Act in the US include USD45 mn and USD29 mn involving a Recent estimates suggest 10.4% of drug candidates transgressions that occurred before the company was Pfizer and Eli Lilly, respectively (www.sec.gov/spotlight/ entering clinical development in phase 1 will achieve FDA divested and became a separate legal entity. fcpa/fcpa-cases.shtml approval in the US: Clinical development success rates for investigational drugs, Nature 2013. c The period of analysis is from 1 June 2012 to 30 May 2014 f The United Nations Global Compact is a UN administered agreement that encourages businesses to align with 10 d The 2014 GSK conviction related to China, for example, principles of responsible behaviour, including fighting will be addressed in the 2016 Index. corruption. However, it is not a performance-assessment tool, and is not enforceable.

68 Access to Medicine Index 2014 Research & Development

C Research & Development

In the pharmaceutical industry, the current R&D model is facing considerable challenges.1 Since the 1990s, new product approvals have been relatively rare while costs have continued to rise.2 With mature markets stagnating, companies are looking elsewhere for growth. There is huge demand for R&D that targets the needs of people living in developing countries: needs for new products for certain diseases, and for adapted versions of existing products for specific populations and conditions. However, the pharmaceutical markets in many of these countries are fragile. As companies look to develop products with viable markets, it seems likely that certain diseases, conditions and patient groups will continue to be overlooked.

In this chapter, the Index reports on how companies are meeting the demand for new and adapted products in these countries through research and development. It also looks at how companies are engaging in new partnership models that aim to pool the risks associated with R&D.3

The Index examines how company pipelines target 47 high-burden diseases, grouped into four categories: communicable diseases; non-communicable diseases; neglected tropical diseases, and maternal & neonatal health conditions. Compared with 2012, the 2014 Index raises the bar, incorporating new areas of investigation, demanding higher standards of evidence and using more stringent scoring guidelines.

Four areas of analysis

Product development Reporting on companies’ approaches to product development for diseases covered by the Index.

Collaborations and IP sharing Reporting on whether and how companies engage in R&D partnerships, and whether the underlying agreements are based on access-oriented terms and conditions.

Clinical trial conduct and data transparency Reporting on clinical trial codes of conduct, evidence of oversight and enforcement mechanisms for these codes and on breaches of clinical trial conduct in countries within scope. It also examines transparency around clinical trials and whether companies share clinical trial data.

Innovation in R&D Reporting any innovative, sustainable or open business model that addresses current gaps in product development for diseases within scope.

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Top findings in Research & Development

Evidence of sustained commitment to R&D Substantial proportion of R&D takes place for relevant diseases in access-oriented partnerships Most companies have an R&D strategy in place Approximately 40% of all product development that explicitly takes patients in developing occurs in collaboration, with either publicly countries into account. The Index captured 327 funded, privately funded or a mix of partners. R&D products that target high-burden diseases More than a third (39%) of these product devel- for countries within scope, a large proportion of opment partnerships are based on research which are new to the 2014 Index. Most compa- contracts that include access provisions. Since nies have also successfully moved products the 2012 Index, the total number of R&D part- along their pipelines: nerships has increased by 35%, mainly due to an 11 companies have been granted regulatory increase in drug-discovery and early-stage part- approvals for 30 new products, collectively nerships targeting neglected tropical diseases, covering 11 of the 47 conditions within scope. malaria and tuberculosis.

R&D is mainly focused on five diseases Limited consideration of access to More than half of all products in development compounds for non-communicable diseases (54%) target five diseases: diabetes, lower Most companies struggle to demonstrate how respiratory infections, hepatitis, HIV/AIDS and innovative compounds targeting non-communi- malaria. These same diseases also have the cable diseases will be accessible to patients living most products in clinical development. The most in countries within scope. While there are several notable gaps are for maternal and neonatal such compounds in clinical development, there health conditions: there is a lack of products is no implementation strategy that addresses being adapted for safe and effective use by these patients. No company makes commitments pregnant women and neonates. The majority to registering such products in relevant coun- of products for neglected tropical diseases are tries. The terms and conditions of partnerships early drug-discovery projects or pre-clinical for non-communicable product development are studies. It will be some time before any of these not disclosed to the Index or to the public. products are on the market.

Movement towards stronger ethical clinical Companies devote large pipeline shares to trial standards and enforcement relevant diseases More companies provided strong evidence of Almost half of companies are devoting signifi- having enforcement measures in place to ensure cant shares of their pipelines to diseases within ethical clinical trial conduct for in-house and scope for patients living in countries within outsourced trials that are in line with guidelines scope. For three companies this reaches over on good clinical practice (ICH-GCP). This has 35%. Another six companies devote more than increased from four companies in 2012 to ten. 20% of their pipeline to relevant R&D projects. In Seven companies incorporate aspects specific total, the industry is developing more than 300 to the Declaration of Helsinki in their clinical trial products for relevant diseases. codes of conduct.

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How the companies perform

Companies receive a wide spread Figure 25 of scores in this area, driven largely Company Ranking Research & Development by their performances in product development. Companies with the 1 = 1 GSK 3,7 strongest relevant pipelines also have 2 3 Johnson & Johnson 3,3 strong R&D strategies that are based 3 6 Merck KGaA 3,0 on meeting the needs of patients in 4 n/a AbbVie 3,0 countries within scope. Once again, 5 = 5 Novartis 3,0 the industry is developing a substantial 6 17 Takeda 2,6 number of products for high-burden diseases, most of which are in clinical 7 12 AstraZeneca 2,5 development. 8 4 Merck & Co. 2,5 9 2 Sano 2,5 In R&D, the companies are divided into 10 7 Eisai 2,4 three distinct groups. There are two 11 8 Novo Nordisk 2,4 companies in the lead, separated by 12 18 Daiichi Sankyo 2,2 a small margin – GSK and Johnson & 13 14 Bristol-Myers Squibb 2,2 Johnson. A pack of three companies follow close behind – Merck KGaA, 14 16 Bayer 2,1 AbbVie and Novartis. The following ten 15 13 Gilead 2,1 companies comprise the second group. 16 9 Eli Lilly 2,0 Although the scores in this group 17 11 Pzer 2,0 decrease gradually, there is a major 18 20 Boehringer Ingelheim 1,9 difference between the highest- and 19 10 Roche 1,8 lowest-ranked company. Another five 20 19 Astellas 1,6 companies lag behind. 2014 2012 0 1 2 3 4 5

Leaders score highly across the board Commitments Transparency Performance Innovation All the top five companies in R&D score highly for product development, measured across several parameters, including R&D strategies, R&D invest- sive relevant pipeline that includes from Abbott. Novartis has the largest ments and how much of their overall numerous adapted formulations, relevant pipeline of all companies, with pipeline is devoted to developing prod- including fixed-dose combinations and a strong focus on malaria, vaccines and ucts relevant to the Index. paediatric formulations. Compared to maternal and neonatal health condi- its peers, it has moved the most prod- tions. In 1st place, GSK remains the overall ucts through its pipeline phases. leader for R&D. As well as scoring Tied in 3rd place, Merck KGaA, AbbVie The leaders are developing many of highly for product development, it and Novartis have strong scores their products on access-oriented scores the highest for collaborations, across the board. Merck KGaA focuses terms, as shown in the terms of IP sharing and innovation. It has a far- on developing medicines for non- their product development partner- reaching R&D strategy, which specifi- communicable diseases. Its R&D ships. This illustrates a strong level of cally addresses unmet needs relating strategy includes operationalisation commitment to tackling diseases with to neglected diseases, anti-microbial strategies for relevant countries that the highest burdens in countries with resistance and non-communicable cover multiple diseases, including the poorest patients. diseases in Africa. diabetes and asthma. AbbVie also has a strong position in product develop- The leaders also go beyond compli- In 2nd place, Johnson & Johnson leads ment relating to the Index disease ance with the International Conference in product development, with an exten- scope, including products inherited on Harmonisation guideline for Good

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Clinical Practice (ICH-GCP)4 in their having access-oriented R&D partner- Daiichi Sankyo has also risen consid- codes of conduct for clinical trials, ships, yet also have small relevant erably, from 18th to 11th place. This is and are moving towards compliance pipelines. partly because, for the first time, it with the Declaration of Helsinki.5 Their disclosed to the Index the relevant codes of conduct include ethical study- Laggards have smaller pipelines investigational products it obtained design considerations, post-trial access Eli Lilly, Pfizer, Boehringer Ingelheim, via the acquisition of Ranbaxy. Daiichi to drug candidates and provisions Roche and Astellas occupy the bottom Sankyo also shares proprietary for offering compensation following of the ranking. For these companies, compounds for testing via the Global serious adverse events. only a small share of their pipelines Health Innovative Technology Fund target diseases and countries within (GHIT). Partnerships push newcomers into the scope of the Index, and they middle group provide little evidence of taking access Furthest fallers: Roche, Eli Lilly, Sanofi There is a large middle group of ten into account during R&D. Boehringer Roche and Eli Lilly both fall from the companies with varying performances Ingelheim stands out from the other middle of the ranking to the bottom across all parameters. AstraZeneca laggards for rising two places since (falling nine and seven places, respec- and Takeda have risen to the top of this 2012. tively) due to low scores across the group since 2012, and both engage in board. In addition, relatively small a substantial number of R&D partner- Biggest risers: Takeda, Daiichi Sankyo, proportions of their pipelines qualify ships. Merck & Co. follows, with little AstraZeneca for analysis. movement along its relevant pipeline Takeda and AstraZeneca climb 11 and since 2012. Sanofi has a large number five places respectively. Both engage in Sanofi also dropped seven places, of relevant investigational products. numerous IP-sharing partnerships and despite its large pipeline. It is less However, when engaging in product incorporate access provisions into a transparent than the leaders about the development partnerships, it falls large proportion of their R&D partner- terms and conditions of its product- behind when it comes to taking access ships. Takeda is involved in a product development partnerships, and it into account. development partnership with the does not explicitly commit to including Medicines for Malaria Venture that has access-oriented terms. Additionally, it Eisai, Bristol-Myers Squibb and Gilead reached the clinical stage of develop- did not disclose its criteria for selecting also have large relative pipelines, but ment. During the period of analysis, third parties when outsourcing clinical do not meet the same standards as the AstraZeneca shared IP with numerous trials. Sanofi was also pushed out of leaders for clinical trial conduct and partners through the WIPO Re:Search the top five and into the middle group transparency. Novo Nordisk has strong initiative.a AstraZeneca and Takeda by strong performances from Merck ethical codes of conduct and proce- comply with the WHO’s standards for KGaA, AbbVie, AstraZeneca and dures in place for its clinical trials, yet a registering trials and publishing results, Takeda. small relevant pipeline. Daiichi Sankyo and consider sharing patient-level data and Bayer both provide evidence of on a case-by-case basis.

industry Evidence of sustained commitment to R&D for relevant diseases

Large shares of companies’ R&D pipeline are medicines and vaccines Other projects have been discontinued pipelines target conditions covered by being tested in clinical trials. since 2012, possibly due to compound the Index – over 35% in several cases. failure or divestment. The proportion In total, companies are developing 327 Since 2012, there has been a lot of of the pipeline that is due to the expan- products that target diseases relevant movement in the industry pipeline, sion of the Index disease scope and to the Index. Most products in devel- illustrating the industry’s ongoing pipeline inclusion criteria accounts for opment target infectious diseases. commitment to the development of 25% of the industry pipeline. Communicable diseases account innovative and adaptive products. for 47% of the pipeline, followed by Looking only at the scope of the Most companies have also successfully non-communicable diseases (36%), 2012 Index, 42% of pipeline projects moved products along the pipeline. neglected tropical diseases (13%), captured in 2014 are new. Most target Eleven companies have been granted and maternal and neonatal health communicable diseases, followed by regulatory approvals for 30 products, conditions (4%). It is promising that non-communicable diseases. 33% of collectively covering 11 of the 47 condi- approximately 64% of all investigational pipeline products captured by the tions in scope. products included in the Index 2014 2014 Index were also captured in 2012.

72 Access to Medicine Index 2014 Research & Development

Figure 26 Figure 27 Figure 28 Most products are being developed Products in development, Comparing the 2014 pipeline for infectious diseases by disease category and phase to the 2012 pipeline Within 2012 scope captured in 2012 Products in clinical trials Infectious Products in . diseases early-stage . development Captured due Within 2012 scope to expanded new in 2014 Communicable Neglected tropical Communicable Neglected tropical 2014 criteria Non-communicable Maternal & neonatal Non-communicable Maternal & neonatal

The majority of all R&D products are being The majority of R&D products are in clinical The 2014 pipeline shows substantial movement developed for infectious diseases (communica- trials, indicating that the risk of failure is compared to the 2012 pipeline. Many new ble diseases and neglected tropical diseases relatively low. projects have been newly added, while others combined), followed by non-communicable qualify for inclusion this Index. diseases.

Companies generally take patients in Approximately 75% of companies are Most companies set high standards in relevant countries into account when engaged in at least one partnership their codes of conduct for clinical trials. developing products for communi- on access-oriented terms. Six compa- Going further, almost one-third have cable diseases and neglected tropical nies have signed access-oriented ethical aspects from the Declaration diseases. However, most struggled agreements for more than half of all of Helsinki5 in their codes of conduct. to demonstrate how innovative their relevant partnerships, including Codes of conduct generally apply to compounds for non-communicable product development partnerships and all trials, in-house and outsourced. diseases will reach these patients. IP-sharing partnerships. These typically However, for outsourced trials, only involve publicly funded organisations, half of companies provided evidence of In total, 40% of products in this analysis and mainly target malaria, tubercu- having robust auditing and monitoring are being developed in partnerships. losis or neglected tropical diseases. It procedures. The majority of companies engage in remains unclear whether partnerships product development partnerships. with privately funded organisations Since 2012, companies have improved For seven of them, this covers over include access provisions, as compa- significantly in sharing clinical trial data. 10% of their total pipelines. Compa- nies remain bound by confidentiality Many companies have implemented nies are also collectively more trans- agreements. Nevertheless, with so systems for sharing patient-level data parent about the terms and conditions many companies agreeing to access with trusted partners. The European attached, revealing whether they provisions, there is certainly potential Medicines Agency’s new policy on data contain pro-access provisions, such as for them to move in this direction when sharing has contributed to this trend. price caps or non-exclusive licensing engaging with private partners. rights in specified territories.

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focus area 1

Product development R&D is mainly focused on five diseases

Why this matters

There is huge demand for R&D that the Indexb, firstly with new compounds All products that target communi- targets the needs of people living in and products, and secondly, with new cable diseases and neglected tropical developing countries: both for new versions of existing products, adapted diseases are included in this analysis. products for certain diseases, and for to local populations and conditions. The For new products targeting non- new versions of existing products that Index also looks at how frequently the communicable diseases and maternal have been adapted for specific popula- company drives products through the and neonatal health conditions, tions, different age groups and local different phases of its R&D pipeline. It however, the Index looks for additional conditions. checks whether companies’ R&D strate- evidence that companies specifically gies take relevant health priorities into target R&D efforts towards people For each company, the Index determines account and are supported by mean- living in relevant countries, for example what proportion of its entire R&D pipe- ingful targets, sufficient investment and through registration targets or patent line targets diseases within the scope of other resources. and pricing strategies.

How the companies perform

In total, the companies covered by the Figure 29 Index are developing 327 products that Top 10 diseases targeted by the overall industry pipeline qualify for analysis, of which, some are being developed for multiple diseases. Respiratory infections More than half of these (54%) target Diabetes five diseases: diabetes, lower respira- Chronic hepatitis tory infections, hepatitis, HIV/AIDS and HIV/AIDS malaria. Malaria Diarrhoeal diseases Since 2012, companies have gained Tuberculosis regulatory approval for a variety of COPD products targeting 11 diseases or condi- Meningitis tions: diabetes, hepatitis, HIV/AIDS, Chagas disease lower respiratory infections, chronic 0 10 20 30 40 50 obstructive pulmonary disorder, Collectively, the industry is developing 327 products for diseases within epilepsy, schizophrenia, meningitis, scope, including all stages of development. More than half (54%) target the top 5 diseases. pertussis, tetanus and tuberculosis.

Companies devote large shares of their pipelines to meeting the needs this activity. Johnson & Johnson leads eight have an R&D strategy that specif- of patients with diseases in scope and when it comes to adapting existing ically targets multiple disease areas living in countries within scope. For products, dedicating 25% of its overall and is supported by specific operation- some of the leaders, this reaches as pipeline to this. In general, within alisation strategies. much as 35% of the investigational scope, more companies focus on devel- products in their overall pipeline. oping new products than on adapting More than half of companies provided existing ones to meet local needs. aggregate figures for their investments Looking closer, these relevant shares in R&D for diseases the Index covers. vary when it comes to how and where Comprehensive access-focused R&D However, they calculate these figures companies focus their efforts. AbbVie strategies still not common in various ways. Without an industry- leads when it comes to developing new Most companies have an R&D strategy wide standard for such calculations, it compounds and products, dedicating in place that, to an extent, targets remains difficult to assess how compa- more than 25% of its overall pipeline to diseases within scope. However, only nies prioritise relevant R&D activities.

74 Access to Medicine Index 2014 Research & Development

With greater transparency and stan- Figure 30 dardisation, the wider R&D community Proportion of products in clinical trials, by disease category would be better able to identify and target funding gaps. Communicable diseases Non-communicable diseases Substantial R&D efforts for high- Neglected tropical diseases burden communicable diseases Maternal & neonatal health conditions 0 20 40 60 80 100 Most companies are developing multiple products for communicable Compounds can be used for multiple diseases, Clinical trials (medicines & vaccines) referred to as multiple indications. Products diseases, accounting for the largest Early stage & technology development captured by the Index are being tested for 353 proportion (47%) of products included indications in total. in this analysis. Almost all of these products target just six conditions: HIV/AIDS, malaria, lower respiratory infections, diarrhoeal diseases, tuber- Substantial early-stage development reduce the enormous disease burden culosis and meningitis. Of all products for neglected tropical diseases on these groups in low income and that target communicable diseases, Twelve companies are involved in middle income countries. 40% are in early-stage development product development for the most (discovery and pre-clinical phases). prevalent neglected tropical diseases Leaders: strong pipelines, clear (NTDs); in total, 13% of all products strategies Non-communicable diseases lack included in this analysis target NTDs The leaders in product development implementation strategies and are mostly in early-stage develop- are Johnson & Johnson, AbbVie, Merck Most companies are also developing at ment. Promisingly, this includes nine KGaA, Novartis, GSK and Sanofi. Their least one product for a non-communi- medicines and vaccines in the clinical scores are very close to each other, and cable disease. In total, 36% of all prod- stage of development that target as a group, they distinguish themselves ucts included in this analysis target this dengue, rabies, Chagas disease and by dedicating large proportions of group of diseases, 65% of which target trypanosomiasis. their R&D pipelines to patients with diabetes and hepatitis, of which the relevant diseases in relevant countries. latter is linked to cirrhosis of the liver. Pregnant women and newborns Together, their six pipelines account Conversely, osteoarthritis, epilepsy overlooked for 57% of all relevant products being and nephritis and nephrosis receive Companies collectively are investing developed. little attention. However, for many marginal efforts in maternal and innovative compounds that target neonatal health conditions. Only four These strong pipelines are supported non-communicable diseases, there is companies are active in this area: by R&D strategies that are clearly no clear strategy for ensuring that they • Novartis is the only company that linked to global health priorities and will reach patients living in developing is developing products that target supported by robust operationalisa- countries. Considering this gap, it is maternal sepsis, maternal haemor- tion schemes for achieving set targets. unsurprising that no company has rhage and hypertensive disorders of This includes having dedicated units registration commitments for coun- pregnancy. that oversee product development for tries within scope for products that • Novartis and GSK are developing neglected diseases, engage in partner- target non-communicable diseases.c products specifically for neonatal ships and define targets for registra- health: to prevent prematurity and tion and investment. Three companies were able to infections through maternal immuni- demonstrate how their R&D efforts sation or by prolonging pregnancy. Except Novartis, these companies also for schizophrenia, bipolar affective • AbbVie is the only company that specify aggregate amounts of R&D disorder and unipolar depressive disor- is developing a medicine that is investments for most of the diseases ders would be accessible to patients intended to be administered to covered by the Index. living in countries in scope, accounting premature infants directly (for lower for only 2% of the overall pipeline. This respiratory infections). Compared to other companies in the is of particular concern considering • Merck & Co. is developing contracep- Index, Johnson & Johnson dedicates the high prevalence of these diseases tives. the largest share of its overall pipeline globally and the general lack of under- to adapting existing products to meet standing of local needs. Demand for product development health needs in relevant countries. It remains. Research and development of also successfully drove the highest products adapted for pregnant women number of investigational products and neonates is needed in order to from one phase of the pipeline to the

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next during the period of analysis, products in its pipeline. However, it relevant countries. As these strategies including gaining regulatory approval does not provide detailed information are not in place yet, most of their NCD for HIV/AIDS, tuberculosis, diabetes about its relevant R&D investments. products were excluded from this anal- and hepatitis medicines. Together, ysis. However, by implementing these these factors push it into the lead in The middle group: large pipelines but strategies, these two companies have product development. weaker strategies substantial potential to improve access Following this group are Bristol-Myers to medicine for patients suffering from Close behind, AbbVie dedicates the Squibb, Gilead, Eisai, Merck & Co. and non-communicable diseases in devel- largest share of its overall pipeline to AstraZeneca. These five companies oping countries. developing innovative products that also dedicate large shares of their pipe- target diseases within the Index’s lines to developing relevant products. Laggards have small relevant pipelines scope. GSK, Sanofi and Novartis also They have potential to strengthen Roche, Pfizer and Eli Lilly lag in product dedicate large proportions of their their R&D strategies by including, for development. Relatively small propor- pipelines to innovative R&D products. example, specific time-bound targets tions of their pipelines target diseases and operationalisation strategies. In relevant to the Index. In addition, Eli Merck KGaA has fewer relevant addition, Gilead and Merck & Co. did Lilly provided little evidence of how its investigational products than other not provide evidence of how much they R&D efforts for non-communicable leaders, yet they account for a signifi- invest in R&D for diseases within scope. diseases target patients in relevant cant proportion of its total pipeline. Novo Nordisk, Bayer, Daiichi Sankyo, countries. The company also publicly discloses its Takeda and Boehringer Ingelheim also pipeline beyond the clinical phase, and fall into the middle pack, but dedicate Astellas performs poorly in product it was the only company to specify its smaller shares of their overall pipelines development due to low disclosure R&D investments for all diseases within to diseases and countries in scope. across all parameters. However, it does the scope of the Index. demonstrate expertise in developing Both Boehringer Ingelheim and Takeda adapted formulations. For example, it Novartis performs well across all are developing strategies for ensuring is engaged in a partnership to develop parameters, and of all companies, it has that new products for non-communi- a paediatric formulation for treating the highest total number of relevant cable diseases (NCDs) reach patients in schistosomiasis.

best practice Johnson & Johnson – Adapting products for paediatric use

Children of different ages and weights • Johnson & Johnson has paediatric Figure 31 need differing dosages and dosing medicines in development for HIV/ Johnson & Johnson is developing forms (such as oral liquids) to ensure AIDS, hepatitis, diabetes, multi-drug- most medicines for children effectiveness, safety and compliance. resistant tuberculosis and soil-transmitted helminthiasis. Johnson & Johnson Of all companies, Johnson & Johnson • Since 2012, it has gained regulatory AbbVie is adapting the most products for approval for a lower-dose tablet for Boehringer Ingelheim paediatric use that target diseases HIV/AIDS and for treating adoles- Bristol-Myers Squibb within the scope of the Index. The cents with schizophrenia with one of Daiichi Sankyo company has a strong commitment its medicines. Bayer to targeting unmet needs, and has • It worked in partnership to ensure Eisai separate departments for promoting its childhood vaccine for meningitis, Merck KGaA & Astellas the wellbeing of children: its Janssen pertussis, tetanus and hepatitis Novartis Child Health Innovation Leadership B could be used in a new delivery Sano 0 1 2 3 4 5 6 7 8 Department (CHILD), Paediatric device developed for use in remote, 11 companies are developing 23 medicines suited for children. Center of Excellence, Paediatric resource-limited areas. The device is Advisory Committee and members of designed so that community health its Compound Development teams. workers can use it with reduced risk Johnson & Johnson is investing of errors. approximately USD70 million in 2014 to support paediatric projects of these groups.

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focus area 2

Partnerships & IP sharing More R&D partnerships and increased transparency

Why this matters

In recent years, new partnership models and at whether the underlying R&D To accelerate early drug-discovery have emerged that draw on both public contracts include pro-access provi- and development, companies can also and private funds to pool the risks of sions including, for example, setting share their compound libraries and R&D and share the benefits.3 As these price caps, ensuring supply, waiving expertise with external parties. The partnerships become more common, patent rights, royalty-free provisions Index looks at whether companies the impact of their terms and condi- and non-exclusive field or terri- engage in such IP-sharing partnerships tions on access will also grow. tory rights. The Index also examines to target diseases covered by the Index. whether companies have policies for The Index looks at how and when systematically including access provi- companies engage in collaborations, sions while engaging in IP negotiations.

How the companies perform

Companies are developing almost 40% than half of companies report basing Figure 32 of their relevant products in partner- one or more of their product develop- Almost half of all product development ships. Most of these partnerships ment partnerships on access provi- is collaborative target communicable diseases (57%), sions. Together, these partnerships Products developed in followed by neglected tropical diseases account for approximately 39% of all partnership (21%) and non-communicable diseases product development partnerships. Of (19%). The six conditions targeted most the total pipeline, they account for 16% No proof of access Other frequently by partnerships are malaria, of all product development. provisions lower respiratory diseases, HIV/AIDS, hepatitis, diabetes and tuberculosis. Public partners correlate with access Based on access provisions provisions Six companies drive increase in part- For most communicable diseases, most nerships notably for HIV/AIDS and lower respira- Compared with 2012, there has been a tory infections, companies engage with 35% increase in the number of relevant a mix of publicly and privately funded product development partnerships and organisations. A large proportion of the this type of partnership accounts for IP-sharing partnerships.d Nine compa- private partnerships targeting commu- just 19% of all partnerships. This is to be nies now engage in more partnerships nicable diseases focus on developing expected as products for non-commu- than they did in 2012, with six compa- vaccines. Companies provide little nicable diseases typically have func- nies accounting for the majority of the evidence that these partnerships are tioning markets, at least in developed increase; AstraZeneca, Daiichi Sankyo, based on access provisions. countries and in the private sector in Eisai, GSK, Novartis and Takeda each low income and middle income coun- engaged in at least five more R&D For malaria and tuberculosis, compa- tries. While this reduces the need for partnerships than they did in 2012. nies typically engage in partnerships risk sharing via product-development Conversely, nine companies decreased with publicly funded organisations partnerships, it does not guarantee that their number of partnerships since based on access-oriented terms and the resulting products are accessible to 2012. This may be due to the failure of conditions. This is also the case for the poor or the public sector, especially the compounds in question, to strategic the majority of partnerships targeting considering they are often needed for choices or as a result of divestments. neglected tropical diseases. chronic treatment.

Since the last Index, companies have For non-communicable diseases, there Without the involvement of publicly dramatically increased their transpar- are far fewer partnerships, and compa- funded organisations, companies ency around partnerships and their nies engage exclusively with other are reluctant to disclose the under- terms and conditions. Overall, more privately funded organisations. Overall, lying terms and conditions of their

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partnership agreements, making it Figure 33 difficult to gauge the accessibility of Public partners correlate with greater transparency and access provisions resulting products. Communicable diseases Leaders agree to access provisions Neglected tropical diseases The best-performing companies in Non-communicable diseases partnerships and IP sharing are rela- Maternal & neonatal health 0 10 20 30 40 50 60 70 80 tively transparent about the underlying terms and conditions of their R&D Public partners Partnerships with publicly funded organisations contracts, revealing that they regularly tend to target R&D for infectious diseases, Private partners include access provisions. As a result, a where market incentives are lacking. Mixed large proportion of their partnerships are based on access-oriented terms. The leaders also engage in numerous IP-sharing collaborations. participate in WIPO Re:Search: GSK, of systematically incorporating access Pfizer, Novartis, Sanofi, Merck & Co., provisions for certain diseases in its IP There are eight companies in the Eisai and Merck KGaA. agreements. leading group: GSK, AbbVie, Merck KGaA, Takeda, Johnson & Johnson, Takeda performs well in partnerships Roche, Bristol-Myers Squibb and AstraZeneca, Eisai and Novartis. and IP sharing, earning it a high posi- Astellas do not commit to incorpo- tion in R&D. It collaborates with three rating access provisions, and perform GSK and AbbVie both develop large product development partners (PDPs): less well in other areas. Roche does proportions of their pipelines in the TB Alliance, Medicines for Malaria not engage in IP sharing, and Bristol- collaboration, and are highly trans- Venture and the Drugs for Neglected Myers Squibb and Astellas develop parent about the related terms and Diseases initiative. Takeda is among just small shares of their pipelines in conditions. GSK is the only company the leaders when it comes to disclosing partnership. Eli Lilly and Bristol-Myers that systematically includes access the terms and conditions of its part- Squibb disclosed only that they engage provisions in research contracts for nerships: Takeda joins AbbVie, Merck in public, access-oriented partnerships, a range of diseases and countries: all KGaA, Johnson & Johnson and Astra- instead of disclosing details of the projects at its Tres Cantos labora- Zeneca in publicly disclosing the access terms and conditions. tory in Spain that target tuberculosis, provisions that underpin a number of malaria and neglected tropical diseases its partnerships. The laggards: limited partnerships and follow WIPO Re:Search principles, less transparency with royalty-free provisions applicable Johnson & Johnson, Eisai and Novartis The laggards are Boehringer Ingel- in Least Developed Countries and also develop large shares of their heim and Novo Nordisk. Boehringer in materials-transfer or IP-transfer overall pipelines in partnership, engage Ingelheim reports that it engages in agreements. Other companies can in IP-sharing partnerships and provide relevant partnerships, but does not improve by moving in this direction. No evidence of incorporating access disclose the terms and conditions. It company provided evidence of system- provisions in the terms and conditions. also has a comparatively large focus on atically incorporating access provisions However, they did not provide evidence non-communicable diseases, where into its contracts for a wider range of of systematically applying access- there are fewer partnerships and less diseases and countries. oriented principles. transparency in general. Its potential lies in ensuring that its in-house devel- When it comes to IP sharing, Astra- Lack of consistency from middle group opments will be accessible in relevant Zeneca and GSK provided many more Merck & Co., Gilead, Pfizer, Daiichi countries. Novo Nordisk did not report external researchers with access to Sankyo, Sanofi and Bayer all either engaging in any relevant R&D partner- their compound libraries than other develop large proportions of their pipe- ships. Drawing on its knowledge and companies did. In January 2013, GSK lines in partnership, incorporate access expertise in diabetes care, the company placed information about potential hits provisions in R&D contracts or engage could increase its impact on access for tuberculosis in the public domain, in numerous IP-sharing partnerships. to medicine by collaborating with triggering many new research projects. None of these six companies do all partners with a greater understanding During the period of analysis, Astra- three consistently, and compared with of local needs. Both companies have Zeneca engaged in the most IP sharing the leaders, they disclose less informa- the potential to increase access to through WIPO Re:Search.a It withdrew tion about the terms and conditions medicine by opening their compound from the initiative in September 2013. of their R&D contracts. Merck & Co. libraries to external researchers Seven other companies in the Index stands out for implementing a policy looking for potential new hits.

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best practice GSK – Partnering for neonatal health

Drug development targeting neonatal health is scarce.

GSK is one of two companies that is developing medicines for neonatal health conditions. It is the only company working in partnership to develop products expressly meant for use in resource-limited settings. Via its partnership with Save the Children, GSK is developing products for neonatal health conditions with an initial focus on neonatal sepsis. Such partnerships enable companies to match their product development expertise with a partner’s knowledge of ©Ivy Lahon/Save the Children the ©Ivy Lahon/Save issues on the ground. Via its PRIME project, GSK trains frontline healthworkers and refurbishes health centers such as this one in DRC.

focus area 3

Clinical trial conduct & data transparency Core group demonstrates higher ethical standards

Why this matters

Companies are responsible for ments. As the Declaration of Helsinki By sharing patient-level clinical data, ensuring that their clinical trials are is the gold standard for trial ethics, the companies can improve the efficiency conducted ethically and to high quality Index also assesses whether compa- of product development, improve its standards. When assessing companies nies comply with that standard. cost-effectiveness, enable comparative in this regard, the Index refers to two analyses, and help prevent studies from documents: the ICH-GCP standards4 Increasingly, clinical trials are being repeated unnecessarily.9 The for good clinical practice and the Decla- conducted in multiple locations and industry, patients, healthcare profes- ration of Helsinki5. regions,6 in countries where regula- sionals, regulators and the scientific tory oversight may be weak, and by community can all benefit if such ICH-GCP was designed with quality third-party clinical research organisa- data-sharing systems are implemented assurance in mind and includes basic tions (CROs). Working with CROs can responsibly, with respect for commer- ethical considerations, such as proce- save companies time and money while cial interests and data confidentiality. dures for gaining informed consent. bringing local capacity and expertise The Declaration of Helsinki was on board. However, adding layers of In this regard, the Index looks at designed to ensure patient safety and management to global clinical trials whether companies share patient-level ethical trial conduct. Compared with raises questions about safety and data with external partners. The Index ICH-GCP, it includes a larger proportion quality.7 Oversight is crucial to prevent also measures companies against the of ethical considerations. misconduct.8 The Index reports on standards set out in the WHO’s 2005 companies’ processes for monitoring Technical Consultation on Clinical Trial The Index views compliance with compliance and for taking disciplinary Registration Standards.10 These stan- ICH-GCP as a baseline for quality action when necessary, for both dards ensure clinical trials are regis- assurance, looking for codes of in-house and outsourced trials. It tered centrally, and that their results conduct and procedures for monitoring also examines companies’ criteria for are published, regardless of outcome. and auditing that align with its require- selecting CROs.

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How the companies perform

Companies generally set high standards whether they are conducted in-house trials, in order to improve its oversight for clinical trial conduct and transpar- or outsourced. of CROs. ency. All comply with ICH-GCP, with seven moving towards compliance with When trial results show that a new Middle rankers slip on data transpar- the Declaration of Helsinki (Novartis, product is beneficial and safe, compa- ency and the Declaration of Helsinki Merck & Co., GSK, Merck KGaA, Eli nies can provide trial participants with There is a large middle group with Lilly, Novo Nordisk and Pfizer). These continued access to the study drug until high ethical standards for clinical trial companies all incorporate two or more the new product is on the market. While conduct, yet varying performances aspects of the Declaration of Helsinki ten companies demonstrate commit- across other parameters. Toward the into their codes of conduct: including ment to such post-trial access, none top of this group are Merck KGaA, Eli ensuring participants can access exper- provided evidence of having provided Lilly, Novo Nordisk and Pfizer, which imental drugs post-trial; ethical study it in practice. The Index encourages incorporate principles unique to the design considerations; and compensa- companies to improve transparency Declaration of Helsinki in their clinical tion in case of injury or other serious concerning the implementation of their trial codes of conduct. However, they adverse events. For comparison, in policies on post-trial access. have lower standards than the leaders 2012, multiple companies committed when it comes to clinical trial data to adhering to ethical aspects of the The leaders: systems for ensuring high transparency. Following them, Boeh- Declaration of Helsinki, generally standards of ethical conduct ringer Ingelheim, Johnson & Johnson, without providing specifics. Novartis, Merck & Co. and GSK lead in AstraZeneca and Takeda have codes this area, with high transparency about of conduct that comply with ICH-GCP, Novartis, Merck & Co., GSK, Boehringer their clinical trials and strong clinical but show levels of data transparency Ingelheim and Johnson & Johnson are trial codes of conduct. similar to that of the leaders. the only five companies that provided evidence of having systems in place for Their clinical trial codes of conduct go Bayer, Roche and AbbVie all comply sharing patient-level data with external beyond compliance with ICH-GCP to with ICH-GCP and have lower stan- parties and they comply with the WHO incorporate elements of the Declara- dards of clinical trial data transpar- standards for trial registration and tion of Helsinki. Furthermore, when ency than leaders. Takeda, Roche and publication of results. The Index views selecting CROs, they apply criteria AbbVie could also be more transparent such developments as an important designed to ensure quality assur- about their monitoring and auditing step forward for healthcare worldwide. ance and quality control in line with procedures. ICH-GCP. In case of violations, these Signs of movement toward higher companies also have procedures in Lower ethical standards at the bottom ethical standard place for taking disciplinary action. Six companies lag when it comes to A few companies approach the higher clinical trial conduct and transparency: standards looked for by the Index for These top three companies comply Sanofi, Daiichi Sankyo, Bristol-Myers enforcing ethical conduct in clinical with the standards set out by the WHO Squibb, Eisai, Astellas and Gilead. trials. They provide evidence of exten- for registering trials and publishing They all have codes of conduct that sive auditing and monitoring proce- results regardless of the outcome. In comply with ICH-GCP, but lack the dures for ensuring ICH-GCP compliance addition, they have systems in place level of clinical trial transparency of the for both in-house and outsourced trials. for sharing patient-level clinical study leaders. In addition, they are missing They also have disciplinary procedures reports (CSRs) with trusted third either policies for taking disciplinary in place. However, they generally could parties, such as academics. action or criteria for selecting CROs. not demonstrate how they imple- Bristol-Myers Squibb and Sanofi mented the ethical considerations they GSK and Merck & Co. also provided stand out due to their data sharing draw from the Declaration of Helsinki. detailed auditing and monitoring policy, and Sanofi has robust oversight information that shows how they mechanisms that extend to CROs. In 2012, the Index reported that only enforce ICH-GCP standards in their Daiichi Sankyo stands out due to its four companies provided evidence trials, whether in-house or outsourced. procedures for selecting CROs and of having procedures for enforcing In addition, they provided evidence of disciplinary action. Conversely, Bristol- compliance in outsourced trials. In having procedures for taking disci- Myers Squibb and Gilead can improve 2014, ten companies provided strong plinary action, also for both in-house the transparency of their monitoring evidence of enforcing compliance and outsourced trials. Novartis, and auditing procedures. through monitoring and auditing however, could extend its auditing and procedures for their trials, regardless of monitoring procedures to outsourced

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observation Notices, lawsuits and fines poor rural areas in Latin America, Two companies received notices from including Colombia. The fine totalled Limited evidence of breaches authorities that supervise ethical USD220,000. clinical trial conduct: Bayer and Sanofi. In general, the industry has endorsed Both are related to clinical trials Three companies are involved in and enforced ICH-GCP compliance as conducted in India. ongoing lawsuits: the baseline for clinical trial conduct. • Bayer received a notice for not paying • Merck & Co. and GSK are both While this shows commitment, it compensation following the deaths involved in a lawsuit in India doesn’t give any indication as to how of clinical trial participants. Providing concerning studies of their cervical effective companies’ policies, prac- compensation due to serious adverse cancer vaccines and whether the tices and codes of conduct actually events is included in the Declaration studies included adequate safety are. To provide this, the Index checks of Helsinki. Bayer’s code of conduct and efficacy tests. The studies were whether companies are involved does not show evidence of these undertaken by PATH, an NGO. in lawsuits relating to clinical trial ethical aspects. • Pfizer is the subject of a lawsuit conduct in relevant countries or • Sanofi received a notice for not related to the Trovan trial that took have been issued regulatory notices reporting safety issues that arose place in Nigeria in 1996 under Wyeth or fines. Investigations and legal during an outsourced trial. Sanofi has (later acquired by Pfizer). The latest processes can be very lengthy, so the mechanisms in place for enforcing in a series of lawsuits relating to this Index reports on rulings and lawsuits ICH-GCP compliance for outsourced trial, it relates to alleged breaches of from the past five years. trials. This breach indicates that there the original settlement. is still room for misconduct even In countries in scope, evidence of when enforcement mechanisms are In addition to these notices, rulings and breaches of codes of conduct and legis- in place. fines, there are numerous allegations lation is scarce and often limited to high- of violations of ethical clinical trial stan- profile cases. It should be noted that the One company was fined for a breach of dards, mainly involving study designs breaches captured by the Index are also clinical trial conduct: that include unethical placebo groups. a function of the nature and rigour of • GSK was fined by an Argentinian However, for these cases, no lawsuits the various regional and national legal court in January 2012 for not have been brought to date. and regulatory frameworks. As such, following procedures for securing fewer breaches are likely to be identi- informed consent in a trial of a fied in countries with weak reporting pneumonia vaccine. The trial involved systems and judicial controls. approximately 15,000 babies from

best practice Eli Lilly and Daiichi Sankyo – Actively ensuring ethical study designs

The lack of strong regulatory over- Eli Lilly and Daiichi Sankyo go furthest, sight in countries such as India and having put mechanisms in place to South Africa creates an environ- ensure study protocols and designs are ment in which companies and CROs ethical. Both have established commit- are left to decide whether clinical tees for reviewing study protocols trial conduct is ethical or not. A few for both in-house and outsourced companies are attempting to stan- trials. For example, Eli Lilly’s review dardise highly ethical clinical trial committees routinely ensure that study conduct by incorporating aspects of protocols adhere to its standards and the Declaration of Helsinki into their offer an internal consultation service codes of conduct. on ethical study design and conduct.

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innovation

Innovation characterised by collaboration and partnership

With its high costs and high risks, the efforts for high-burden diseases in models must explicitly target the needs traditional R&D model has histori- these countries while rebalancing the of patients living in countries relevant cally discouraged companies from risks and incentives for the companies to the Index. The Index also looks for developing products specifically for that adopt them. The Index captures innovative practices that improve the diseases that disproportionally affect any innovative, sustainable or open transparency of patient-level data or patients living in developing countries. business model that addresses facilitate ethical clinical trial conduct in To fill the resulting gaps, new models current gaps in product development countries within the geographic scope for research and development are for diseases within the scope of the of the Index. needed – models that facilitate R&D Index. To qualify for this analysis, these

Innovation in product development

GSK is investing GBP25 million GHIT is a new multi-stakeholder TransCelerate is a new joint initia- (USD41 million) to establish its second collaboration co-established by four tive, launched in 2012, for accelerating Open Lab, which will focus on non- Japanese companies – Eisai, Takeda, and simplifying drug development communicable diseases in Africa. Daiichi Sankyo and Astellas – together processes through collaboration.13 These diseases are increasingly seen as with the Japanese government and Twelve of the companies measured by the next potential public health crisis the Bill & Melinda Gates Foundation.12 the Index are involved in TransCelerate, in developing countries. Research will GHIT is a new funding mechanism that which could have an impact on access aim to understand African variations in provides funding to three product to medicine, for example, by making non-communicable disease types as development partnerships (PDPs): the the processes related to clinical trials well as specific treatment needs.11 TB Alliance, the Medicines for Malaria more efficient. The companies involved Venture and the Drugs for Neglected are: AbbVie, Astellas, AstraZeneca, Diseases Initiative. Through GHIT, Boehringer Ingelheim, Bristol-Myers these four companies have significantly Squibb, Eli Lilly, GSK, Johnson & improved their contributions to R&D Johnson, Merck KGaA, Pfizer, Roche for neglected tropical diseases. and Sanofi.

Innovation in clinical trial conduct and transparency

Eli Lilly has developed a Bioethics Johnson & Johnson has worked with Framework that proscribes a higher Yale University to establish an inde- level of ethical clinical trial conduct pendent external review committee of than all other companies. It is the only academics to oversee the sharing of its company that supports its clinical trial patient-level data. code of conduct with mechanisms for enforcing the ethical behaviour provisions drawn from the Declaration of Helsinki.

For numbered references, see the Appendix. b See the Appendix for the full Access to Medicine Index 2014 Disease Scope. a WIPO Re:Search is a consortium that aims to build partnerships around companies’ intellectual property c See chapter D Pricing, Manufacturing & Distribution. assets and resources to advance the development of products for neglected tropical diseases, malaria and d Comparison based on analysis criteria from 2012. tuberculosis.

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D Pricing, Manufacturing & Distribution

Pharmaceutical companies regularly come under pressure to lower their prices for patients living in developing countries, where medicine remains dispropor- tionately out of reach for many. Yet reducing prices from mature-market levels does not guarantee affordability. Affordability depends on who is going to pay – whether it is the patient or another stakeholder in the local healthcare system. In low income countries, up to 90% of people pay for medicine out of their own pockets.1 Different populations and groups have different incomes and expenses and it is important for pharmaceutical companies to recognise this when pricing their products.

In this chapter, the Index analyses how companies take patients’ ability to pay into account when developing pricing, manufacturing and distribution strategies, reporting on: whether companies file for wide and rapid registration in relevant countries, according to need; how companies ensure products are priced equitably, particularly for the poorest population segments; and how companies’ manufacturing and distribution practices help ensure quality and price are not compromised as products move along the supply chain (referring specifically to brochure and packaging adaptation, pricing guidelines for sales agents and policies and practices relating to drug recalls).

Methodology evolution in pricing

Following a careful methodology review, the Index no longer captures purely commercial tiered pricing strategies. Instead, it captures pricing strategies that explicitly take societal needs and affordability into account (referred to as ‘equitable pricing strategies’). This includes tiered pricing that aims to ensure affordability for the poorest population segment, and single prices or discounts targeted at a specific payer or population segment. The Index only analyses strategies where companies provide a strong, detailed affordability rationale.

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Top findings in Pricing, Manufacturing & Distribution

Companies consider affordability for one- On average, products are registered in only third of all relevant marketed products a few relevant countries One-third of products captured by the 2014 Individual products are registered in an average Index are covered by equitable pricing strategies of only three low income countries and six of the that include affordability rationales. This equals other countries in scope. Combined, this repre- 230 out of 700 products captured. In turn, sents just 17% of the Index’s entire geographic almost one-third of these products (74 out of scope, and just 8% of low income countries in 230) are targeted towards the poorest popula- scope. tion segment.

Companies lack universal pricing guidelines Greater involvement in equitable pricing, for sales agents particularly intra-country segmentation The majority of companies have yet to set clear, Compared to 2012, more companies commit to universal pricing guidelines for their sales agents or newly engage in equitable pricing, tailoring in countries in scope, and most do not monitor their prices to different population segments. mark-ups. Even where guidelines are in place, no Two companies have newly implemented inter- company trains its agents on their implementa- country equitable pricing. Yet, the improvement tion. No company has guidelines that universally in intra-country equitable pricing is greater, apply to third-party distributors, wholesalers albeit from a lower baseline: three companies and retailers. newly commit to such strategies, while four have newly implemented them. Companies implement stringent drug-recall policies and procedures Six companies are innovating to improve In general, the industry commits to consistently affordability high standards in drug recalls: 14 companies have Evidence of innovation included a micro- stringent policies on drug recalls that comply financing project, a differential pricing strategy with WHO Good Manufacturing Practice (GMP) with a clustered approach to segmentation, guidelines in all relevant countries. This is an micro health-insurance products, quality improvement on 2012, when only three compa- monitoring in distribution, smaller-dose insulin nies reported equivalent policies and country products, and innovative production techniques, coverage, and a further seven reported policies including a soft-chew tablet and semi-synthetic that covered only some relevant countries. artemisinin production.

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How the companies perform

The pack is divided into four densely Figure 34 clustered groups, separated mainly by Company Ranking Pricing, Manufacturing & Distribution performances in two areas: equitable pricing strategies, and accounting for 1 = 1 Gilead 3,8 sales agents’ pricing practices. Since 2 n/a AbbVie 3,4 2012, more companies have imple- 3 4 Novo Nordisk 3,3 mented equitable pricing strategies, 4 12 Bayer 3,2 with more companies implementing 5 3 Johnson & Johnson 3,2 multiple pricing tiers in specific coun- 6 8 Merck & Co. 3,1 tries. 7 2 GSK 3,0 Leaders target lowest tiers 8 7 Sano 3,0 The leading group comprises six 9 13 Merck KGaA 2,9 companies: Gilead leads by some 10 16 Eisai 2,9 margin, followed by AbbVie, Novo 11 10 Roche 2,9 Nordisk, Bayer, Johnson & Johnson and 12 11 Bristol-Myers Squibb 2,6 Merck & Co. Of these, AbbVie, Bayer 13 6 Novartis 2,6 and Merck & Co. have all joined this group since 2012, replacing GSK (now 14 15 Boehringer Ingelheim 2,5 7th) and Novartis (now 13th). 15 19 Astellas 2,3 16 9 Pzer 1,8 st Gilead takes 1 place in this area for 17 18 Daiichi Sankyo 1,7 the second Index in a row, thanks to 18 14 Eli Lilly 1,5 its leading performance in equitable 19 17 AstraZeneca 1,3 pricing and strong performance in 20 = 20 Takeda 1,1 other key areas. The company commits 2014 2012 to equitable pricing both between 0 1 2 3 4 5 countries (inter-country) and within Commitments Transparency Performance Innovation countries (intra-country) and has equitable pricing strategies in place that take affordability into account. Further- more, by disclosing volumes of sales countries. Its strategies include an Developed Country governments at and price points for relevant products, affordability rationale and are targeted 20% of the price offered in developed Gilead indicates it is targeting lower- towards lower/lowest-income popula- markets. income population segments in an tion segments, including preferential organised manner. pricing for public health systems in Top six strong in all areas some low income countries and lower- The six leading companies generally Gilead is also among the leaders for middle income countries. perform strongly in all areas, although brochure and packaging adaptation, Johnson & Johnson is the only one to and issued no drug recalls during the Similarly, Novo Nordisk in 3rd place has stand out when it comes to account- period of analysis. In a change from both inter-country and intra-country ability for sales agents’ pricing prac- 2012, Gilead now provides evidence of equitable pricing strategies covering tices. compliance with WHO GMP guidelines some of its diabetes products in the for drug recalls. majority of relevant countries. Its strat- Regarding equitable pricing strate- egies include an affordability rationale gies, the leaders display varying levels In 2nd place, AbbVie has both inter- and are targeted towards the lowest of commitment to inter-country and country and intra-country equitable tier. For example, under its differen- intra-country equitable pricing. In pricing strategies for its HIV/AIDS tial pricing policy, the company has practice, a relatively high proportion of products in a large number of relevant committed to offering insulin to Least their relevant products are covered by

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equitable pricing strategies that take products’ price points and of volumes Eisai is another notable riser, climbing affordability into account, including of sales at the lowest pricing tiers for from 16th place to 10th. The company for poor population segments. They equitably priced products. Eisai has has performed particularly well in also disclosed tracer producta price moved up six places since 2012, in the area of commitments, overtaking points and volumes of sales to these part due to its new equitable pricing all other companies in this regard. population segments. Of the leaders, strategy. Roche is one of the leaders in For example, compared with other AbbVie and Merck & Co. join Gilead product registration, having registered companies, Eisai makes one of the in issuing no drug recalls during the the majority of its products in relevant most expansive commitments to equi- period of analysis. When drug recalls countries. table pricing: it commits to equitable are required, all six leaders commit pricing in relevant countries for all to complying with the relevant WHO These five are followed by Bristol- new relevant products going forward. guidelines. Myers Squibb, Novartis, Boehringer Since 2012, it has newly implemented Ingelheim and Astellas. Bristol-Myers equitable pricing in one country within Merck & Co., Bayer and Novo Nordisk Squibb delivers a strong equitable the scope of the Index. are the only leaders to provide pricing performance in terms of the evidence of innovation in pricing, proportion of products and territories Furthest fallers: Pfizer and Novartis manufacturing and distribution: Merck covered; how it takes affordability into Pfizer and Novartis have dropped the & Co. leads in innovation due to a account; and for targeting the lowest furthest in this area, both falling seven unique micro-financing project; Bayer population segment. Novartis and places: Pfizer from 9th position to 16th, is piloting a new differential pricing Boehringer Ingelheim both perform and Novartis from 6th to 13th. model; and Novo Nordisk sells single- well in disclosure, revealing tracer cartridge packages of insulin to enable product price points, volumes of sales For Pfizer, this is in part because it did patients to spread the cost of treat- at the lowest pricing tier, and how they not score well in new areas of evalua- ment over time. Novo Nordisk has also make registration decisions. Astellas tion, including disclosure of tracer price reduced the unit price of a single vial has climbed into this group from 19th points, volume of sales at the lowest to only 12% above the unit cost, and position, partly because it improved its pricing tiers, and the level of targeting has started offering the accompanying disclosure of drug recalls and product and affordability rationale included in insulin delivery device (durable pen) registration status. its equitable pricing strategies. free of charge.b Laggards slip in all areas Novartis has earned the same score Large middle group The five lowest ranking companies are as it did for the 2012 Index, but has The upper-middle group consists of Pfizer, Daiichi Sankyo, Eli Lilly, Astra- dropped rank as other companies have five companies: GSK, Sanofi, Merck Zeneca and Takeda. These companies improved their performances. In addi- KGaA, Eisai and Roche occupy posi- have low scores across all measures. tion, although Novartis has increased tions 7 to 11. In general, these compa- None of the laggards receives credit the geographic coverage of equitable nies score above average for transpar- for innovation in this area. pricing, fewer of its products qualify ency, as well as for their commitments for analysis due to the more stringent to inter-country and intra-country Biggest risers: Bayer and Eisai evaluation methods employed in the equitable pricing and to ensuring that Bayer has risen the furthest, jumping 2014 Index. product packaging and brochures are from 12th to 4th position and into the adapted to facilitate rational use.c leading group. Compared with 2012, Bayer has a more concrete, specific Compared with the leaders, these and comprehensive commitment to five have more mixed performances, inter-country equitable pricing. In addi- although they all stand out in one tion, it now facilitates the rational use regard or another. GSK has refined of all its relevant products, rather than its approach to vaccines pricing by a subset, by adapting brochures and increasing the number of pricing tiers. packaging. For the first time, Bayer has It now has seven tiers (the lowest committed to registering some of its tier corresponds to countries eligible relevant products in low income coun- for GAVI) and bases its tiers on GNI tries, according to need. Bayer also per capita. Sanofi has registered the performed well in one of the new areas majority of its products in the majority of evaluation: it disclosed the volume of of relevant countries. Along with sales at the lowest pricing tier for each Gilead, Merck KGaA leads in new areas of its equitably priced products. of evaluation: the disclosure of tracer

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industry

Greater diversity and greater involvement in equitable pricing

The industry continues to show diver- Figure 35 sity and greater involvement in the area Companies consider aordability for one-third of products of equitable pricing, manufacturing and distribution. Compared to 2012, the number of companies that implements equitable pricing has increased from 16 to 18.

Compared with 2012, more companies disclose stronger commitments to Products priced Products priced Products priced equitable pricing, and provide more Products without equitably, based on equitably, based on equitably, based on detail about their equitable pricing equitable pricing aordability aordability targeted aordability targeted strategies: three disclosed commit- to a specic towards the poorest ments to equitable pricing for the first population segment segment time, while one other (Bayer) made a stronger, more specific commitment in this regard. Such commitments will be ‘Targeting’ is demonstrated where a company sets out how it segments a particularly relevant when new prod- hypertension, ischaemicmarket heart and disease,then implements In turn,its strategy almost based one-third on an assessment of these of ucts enter the market. New areas of cerebrovascular disease,aordability lower respirafor one or- moreproducts population are segments. targeted towards the evaluation reveal that companies take tory infections, lymphatic filariasis, poorest population segment (when affordability into account in most of the malaria and tuberculosis. Products all marketed products analysed by the strategies they classify as equitable. A for family planning are also included. 2014 Index are taken into account, this significant number of these strategies Almost half of the companies, however, amounts to 11%). (32% of equitable pricing strategies) do not provide evidence that they have target poor population segments, specific targets when making registra- There is still significant room for within both low income and lower- tion decisions. companies to improve to ensure that middle income countries. existing equitable pricing strategies More, more varied strategies are targeted towards poor population Regarding registration and stringent Compared with the 2012 Index, the segments. There is also potential for approval, the data indicate that there 2014 Index has captured a larger companies to broaden the application has been improvement (the scopes of number (309) and broader range of of equitable pricing: for 67% of relevant the underlying indicators have changed equitable pricing strategies for the marketed products, companies do not since 2012). Fifteen companies now countries within its scope. This reflects provide evidence of having equitable seek stringent approval from special new areas of evaluatione and the pricing strategies in place. regulatory schemes for the majority of broader geographic scope of the 2014 their relevant products that target the Index. Most strategies set prices per country diseases covered by these schemes. In total, 18 companies engage in equi- In addition, 16 companies now register In total, for the 2014 Index, companies table pricing. Yet there is huge diversity the majority of their relevant products reported 345 equitable pricing strate- in the range and extent of their activi- in a large number (>50%) of the coun- gies for 263 products. All strategies ties in this area. tries covered by the Index. were assessed to ensure that they • Companies have between one and did in fact meet the criteria set by the more than 80 strategies each, which 11 companies (AbbVie, Bayer, Daiichi Index of an equitable pricing strategy. cover between one and more than 50 Sankyo, Eisai, Johnson & Johnson, Out of these, 309 equitable pricing products (when each inter-country, Merck & Co., Merck KGaA, Novartis, strategies included an affordability intra-country, and other type of Novo Nordisk, Sanofi and Takeda) rationale and therefore qualified for strategy is counted separately). demonstrate that they have specific our analysis. These covered 230 of the • Companies have equitable pricing targets to register products for certain 700 products that qualified for analysis strategies for between 8% and 85% of diseases primarily based on disease in the 2014 Index (33% of all relevant their relevant product portfolio (31% burden or prevalence. The diseases in products). on average). question include diabetes, HIV/AIDs,

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• Companies have equitable pricing • Factors such as disease prevalence, of all equitable strategies captured. for between 1% and 100% of the existence of licensing arrangements, HIV/AIDS has the highest number of countries where they have sales and level of healthcare or payer infra- equitable pricing strategies (33 out of that are within the scope of the Index structure and economic develop- 230 products) of all conditions within (62% on average). ment; and the scope of the Index. This is to be • Whether it is in sub-Saharan Africa expected considering the large-scale Before analysis, we expected to find (which is often treated as a special donor financing available from institu- a strong positive correlation between regional case). tions such as the Global Fund, PEPFAR, the size of a company’s portfolio and the World Bank and UNAIDS. the number of products for which it has Mixed strategies, which include both equitable pricing. However, on analysis inter-country and intra-country Far fewer strategies apply to prod- of the six companies with the largest segmentation, accounted for approxi- ucts for neglected tropical diseases portfolios (more than 50 relevant prod- mately 15% of all strategies captured. (3%). Again, to an extent, this is to be ucts), only two had equitable pricing Strategies with only intra-country expected, as these products are most strategies covering the majority of segmentation accounted for the often the focus of mass-administration their portfolios. These companies also smallest portion (6%). Combining these donation programmes that aim to had some of the highest proportions of categories, strategies that incorpo- eliminate the disease in question. products covered by equitable pricing rate intra-country tiers (21%) cover a strategies. The other four companies diverse range of 23 diseases, the most There are also very few strategies for with large portfolios did not fit this significant being HIV/AIDS, diabetes products for maternal health prob- pattern. They had equitable pricing for and chronic obstructive pulmonary lems and neonatal infections (7% of between 10% and 25% of their relevant disorder. all strategies). This is partly because portfolios. companies in the Index have very few Intra-country strategies target their products that target these conditions Extent of equitable pricing, per pricing tiers to governments, public (7% of total relevant products on the portfolio hospitals, and insurance schemes, market from all companies’ portfolios), There is large variation in the coverage as well as to patients directly. They which in itself is a reflection of the low of equitable pricing strategies across take the form of direct discounts to priority the industry has assigned to company portfolios: 13 companies have governments and patients (including these high-burden conditions. such strategies for 1-10 products, three not-for-profit and below-cost recovery for 10-30 products and two for 30-60 prices), competition for tenders, Gaps in equitable pricing activity products. This is in part due to diversity negotiations with governments to add Many products can be used to treat in company portfolio size. Compared products to the national reimburse- multiple conditions. Taking this into to the 2012 Index, nine companies ment list, patient access programmes account, the Index has examined per have increased the proportion of their (including volume-based discounts and disease the proportion of relevant portfolio for which they have equitable patient co-pay cards) and dual brands. products that are marketed using pricing strategies. However, companies In general, companies employ a mix of equitable pricing strategies. For certain of all sizes can still do more. these strategies across their portfolios. diseases, this reveals clear gaps in the coverage of equitable pricing activity. In 2012, most strategies took the form Innovation beyond pricing tiers of inter-country tiered pricing schemes The Index also captured other types Products for neglected tropical (which set one price per country or of strategies, which account for 28% diseases are subject to the least equi- cluster of countries). In 2014, these of the total. Many of these represent table pricing activity as they are the strategies still account for the largest innovation, and range from micro- focus of mass donation programmes. proportion: more than half of all financing; insurance-type initiatives; There is also a gap in pricing activity equitable pricing strategies the Index and financing for wholesalers; to for non-communicable diseases, captured were based on inter-country patient-based programmes, which particularly for unipolar depressive pricing tiers (51%). involve increasing patients’ ability to disorder, schizophrenia, bipolar affec- pay, rather than reducing prices. tive disorder, cerebrovascular disease, Under these schemes, companies set epilepsy, diabetes, ischaemic heart different prices for different countries Strategies by disease category disease and lower respiratory infec- according to, for example: Collectively, companies disclosed an tions. In addition, companies target • Income level, by GDP or GNI/capita, almost equal number of strategies for the poorest people in a population sometimes adjusted for PPP; products for communicable diseases with their lowest price tier in only 25% • Country classification by the World as for non-communicable diseases, of their pricing strategies for non- Bank, UN, GAVI, PAHO or similar; comprising 48% and 42% respectively communicable diseases. The Index

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recognises that the need for a specific Figure 36 product in a specific country depends Breakdown of equitable pricing strategies on multiple factors, such as disease prevalence, product patent status and alternative therapies. However, based Strategies by disease category Strategies by type on the growing burden of non-communicable diseases in developing countries, this gap is particularly concerning. It is important that companies increasingly ensure that relevant products are Non-communicable Inter-country affordably priced. diseases account for targeting most most equitable common strategy pricing strategies. type Looking downstream The majority of companies (17) do Communicable Inter-country targeting not set universal pricing guidelines or Non-communicable Inter- and intra-country targeting provide training for local sales agents, Neglected tropical Intra-country targeting including third-party wholesalers or Maternal & neonatal Other distributors and retailers. Out of those 17, ten also do not audit or monitor ‘Targeting’ is demonstrated where a company sets out how it segments a market and then implements downstream pricing practices. its strategy based on an assessment of aordability for one or more population segments.

The majority of companies with tiered pricing strategies adapt packaging for Figure 37 different tiers to prevent lower-priced HIV/AIDS products have the most equitable pricing strategies variants being diverted away from The top 10 diseases with the most equitable pricing strategies low-income populations. Most companies also facilitate the rational use of certain products by adapting product HIV/AIDS brochures and packaging to conform Lower respiratory infections with local regulatory requirements. Ischaemic heart disease A small group (Bayer, Bristol-Myers Diabetes mellitus Squibb and Roche) go further than Pertussis regulatory requirements and adapt Asthma their packages for specific high-need Cirrhosis of the liver groups, to address demographic, Epilepsy Inter-country segmentation environmental, language and literacy COPD‘Targeting’ is demonstrated where a company sets outIntra-country how it segments segmentation a considerations. Malariamarket and then implements its strategy based on an Otherassessment strategy type of aordability for one or more population segments. In the area of drug recalls, the majority of companies issued drug recalls for Figure 38 relevant products in relevant coun- Gap in equitable pricing activity0 for10 non-communicable20 30 diseases40 50 60 tries during the period of analysis. In general, the industry commits to high standards in drug recalls: 14 companies Communicable diseases have stringent policies on drug recalls Maternal & neonatal health that are either aligned or compliant Non-communicable diseases with WHO Good Manufacturing Prac- Neglected tropical diseases There is a gap in 0 20 40 60 80 100 tices guidelines for drug recalls in all equitable pricing for products for non- % of products with equitable pricing relevant countries. communicable % of products without equitable pricing diseases. This is more concerning than the gap for neglected tropical diseases which is oset by the presence of mass donation programmes.

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extra analysis A new approach to analysing pricing strategies

In 2012, the Index analysed companies’ strategies could not be included in this can be customised to the needs of tiered pricing strategies. Specifi- analysis. target population groups in terms of cally, it looked at the proportion of affordability and other socioeconomic each company’s relevant portfolio Socioeconomic factors drive equitable factors. Such strategies are the result that was sold via tiered pricing in the pricing strategies of companies having deliberately and countries within scope. The Index also The Index captures many different strategically taken affordability into attempted to capture the difference types of equitable pricing strate- account. between the price for mature markets gies, due to the diversity of products, and the price for the poorest markets. diseases, countries and companies However, large differences between included in its scope of analysis. It anal- pricing tiers do not guarantee afford- ysed whether pricing strategies were ability. comprehensive, and used price points and volumes of sales as evidence that Following a careful methodology companies are organised, targeted and review, the 2014 Index no longer deliberate when implementing equi- captures purely commercial tiered table pricing strategies. pricing strategies. Instead, it captures pricing strategies that explicitly take Based on this highly varied data, societal needs and affordability into the Index finds that comprehensive account (referred to as ’equitable equitable pricing strategies take pricing strategies’). This includes tiered multiple factors into account and pricing that explicitly aims to ensure affordability for the poorest population Table 3 segment and single prices or discounts targeted at a specific payer or popula- Socioeconomic factors drive equitable pricing strategies tion segment. To enable access for low-income groups, elements of a comprehensive equitable pricing strategy include: The Index only analyses strategies where companies provide a strong, A clear set of criteria for deter- Understanding of how unit and detailed affordability rationale, for mining the population segments to single-dose prices affectoverall cost example, for setting and targeting be targeted, including low-income of treatment (for example, taking prices toward specific population groups (for example, income level, treatment duration into account) segments, while taking account of their or human development indices) ability to pay. The Index recognises that companies can employ a range Clear tactics for targeting low- Comprehensive approach to of approaches for the same product income groups (for example, using improve health-seeking behaviours in different countries or for different discounts) (for example, ensuring rational use, population segments. It looks at how patient awareness programmes) companies customise their strategies based on product and market charac- Robust assessment or calculation Consideration of supply-side issues teristics and dynamics. of affordability for low-income (for example, local manufacturing population segments (for example, capabilities and ways to reduce The application of the new method- by using multi-dimensional factors cost of production) ology has shown that companies are and engaging in affordability research willing to disclose supporting details into target segments) of their equitable pricing strategies, including: affordability rationales, the Analysis of how price relates to Measures for preventing product poorest population segment targeted, ability to pay for people in specific diversion from target populations price points for at least some products groups (for example, consid- and volumes of sales at the lowest ering probable mark-ups and pricing tiers. Where companies did reimbursements) not clearly provide such detail, their

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focus area 1

Product registration and filing for marketing approval Per-product registration limited to a few countries

Why this matters

Registration is the first step in making Prequalification, tentative approval income countries and/or lower-middle a new product available in a particular from the US Food & Drug Adminis- income countries. country. The Index looks for companies tration or review by the European to file for wide and rapid registration in Medicines Agency. The Index examines As a measure of performance, the relevant countries, according to need. whether and how companies follow Index identifies where companies have these steps, and looks at the criteria registered their products relative to Companies can facilitate registration, used to decide where to register prod- the geographic scope of the Index and particularly in countries without strong ucts. The Index also captures whether disease occurrence. It also identifies national regulatory authorities, by companies have disease-specific, what proportion of each company’s applying for stringent approvals, for time-bound targets for registering new relevant portfolio has been registered example (for certain products) WHO products in sub-Saharan Africa, low in relevant countries.

How the companies perform

Most companies have applied for However, individual products are regis- set specific targets for registering stringent approvals for the majority tered in an average of only three low most of their products for relevant of their relevant products. Since 2012, income countries (8% of all relevant diseases within 12 months of receiving 13 companies have strengthened low income countries) and only six of EU approval in relevant low income or expanded their commitments to the other relevant countries (9% of and lower-middle income countries. registering products in relevant coun- countries). To speed up registration, both compa- tries. Of these, nine have either made nies have applied for approval from a their commitments more specific, The need for registration is related to stringent regulatory authority for all or expanded them to include more disease prevalence and the presence or relevant products. disease areas. Two companies have lack of generic and alternative thera- newly disclosed commitments where pies. For most of the products the 2014 Furthermore, Novo Nordisk and Roche previously they provided none; Roche Index captures, this registration need have disclosed the registration status has improved the timeframe within is high. The industry can scale up its of the majority of their products, which it has committed to registering efforts to register relevant products in revealing that both companies have its products in relevant countries, and countries in need. registered the majority of their prod- Novartis has provided a more specific ucts (relative to overall portfolio size) geographic commitment for Africa. Companies have the potential to in the majority of relevant countries. improve in this regard, particularly in In practice, 16 companies have regis- terms of setting more targets that are Bayer, GSK, Johnson & Johnson and tered more than 50% of their products more specific, as well as more time- Sanofi also perform well in this aspect. in more than 50% of relevant countries. frames for registering their products in These four companies have registered However, four still have not. This could countries where need is highest. the majority of their products in the be for a variety of reasons: for example, majority of relevant countries. They there may be generic equivalents Leaders have comprehensive, detailed have also provided details of their already on the market, or targeted registration strategies registration decision-making process diseases may not be widely prevalent. The best performances in this area and criteria, and have applied for come from Novo Nordisk and Roche. stringent approvals for the majority Where are products registered? Both companies have a comprehensive of their relevant products. They have On average, companies have registered strategy for registering new products, all committed to registering a sub-set 76% of their products in at least one and provide details of their decision- of products for relevant diseases in country within the scope of the Index. making criteria. These include needs- a subset of low income countries. based criteria such as epidemiology However, they have not specified a and disease burden. They have both timeframe.

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observation Middle performers’ commitments are products, which are registered in a few less specific, less ambitious low income and lower-middle income Beyond these six companies, perfor- countries. However, this is a relatively Basing registration decisions on mances are more mixed, with compa- small proportion of relevant countries need and disease burden nies generally only registering their compared to their peers. relevant products in a subset of Companies base their registration countries within the Index’s scope. In Neither company has filed for stringent decisions on a wide range of factors. general, although companies commit approvals, despite having at least two Encouragingly, many companies take to registering their products in relevant eligible products. patient need and disease burden into countries, they do not report specific account to some extent, as well as targets. Their performances are mixed health systems and socioeconomic observation regarding the disclosure of registration conditions of the countries in criteria and product-level registration question. status. At the time of data collection, Setting timeframes for Eisai is the only company that provides registration 8 companies no evidence of having registered Bayer, GSK, Johnson & Johnson, relevant products in any low income By setting and disclosing clear AstraZeneca, Boehringer Ingelheim, country (although it has done so in timeframes for registration, compa- Merck KGaA, Novartis, Sanofi certain lower-middle income countries). nies give a clear signal that they plan to make new products available and Bayer uses the following criteria for Commitments to registration are accessible in certain countries. its registration strategy: market-size, particularly relevant as they give an potential customer base, ease of indication of companies’ intentions to 3 companies registration, market attractiveness ensure the accessibility of new prod- Novo Nordisk, Roche, Gilead and access, target price and afford- ucts in low-income markets. ability, highest disease burden, and Novo Nordisk says it aims to provide geographic importance of disease in Lack of commitments from laggards, national authorities in Index coun- different countries (for malaria, tuber- despite registration activity tries with its marketing authorisa- culosis and contraceptive products). The weakest performances in this tion applications for newly launched area come from Eli Lilly and Takeda. In products within 12 months of gaining GSK bases decisions to register general, these two companies show EU approval. products on an assessment of patient little commitment to registering their needs, the quality of local health products in relevant countries. Eli Lilly’s Roche commits to filing for registra- systems (i.e., whether patients can be commitment is limited to lower-middle tion in all countries within the scope of diagnosed and treated), the existence income countries. Takeda does commit the Index within six months of gaining of a regulatory system, and whether, to registering products in a sub-set EU or Swiss approval. Its locally based during development, GSK conducted of low income countries, including representatives assess the need for related clinical studies in that country. sub-Saharan Africa, but has not yet registration based on epidemiology, set a specific timeframe. Neither of disease burden, market access and Johnson & Johnson prioritises registra- these companies publicly discloses its available infrastructure. The company tion decisions based upon high-disease decision-making process or criteria uses these assessments to plan and burden, disease prevalence, quality for registration, nor do they provide prioritise countries for registration. of local healthcare infrastructure, clear evidence of using access-related maturity of treatment programmes, the criteria for making product registration Gilead reports that its goal is to existence of global and/or multilateral decisions. register new products in relevant coun- programmes, economic vulnerability, tries as fast as practicably possible. and immediate patient need. Prior to In practice, Eli Lilly and Takeda do This includes registering new products the launch of a compound in resource- provide evidence that they register approved by the FDA or EMA in as many limited countries, Johnson & Johnson relevant products in countries within relevant countries as possible within assesses whether a specific access the Index’s scope. Eli Lilly provides 12 months. It prioritises countries for programme is needed. the registration status of all of its registration using a tiered approach relevant products, revealing that based on disease prevalence. AstraZeneca generally employs the they are registered in some low same regulatory strategy for coun- income countries and lower-middle tries within the scope of the Index as income countries. Takeda provides for other emerging and developing the registration status for some of its countries. Where appropriate, it bases

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registration decisions on an assess- Merck KGaA evaluates medical need Sanofi bases decisions on unmet ment of unmet needs. for individual products based on abso- medical needs and engages in early lute and relative prevalence, diagnosis registration programmes, focusing on Boehringer Ingelheim bases its and treatment rates, and high-risk products that have existing approval in strategy on whether there is a public factors or sub-groups. other countries. health need identified by, for example, governments or organisations such as Novartis bases decisions on the needs the WHO, UNICEF or UNAIDS, as well of local health authorities and level of as the state of infrastructure in coun- infrastructure including for distribution. tries in scope.

focus area 2

Equitable pricing strategies More companies tailor equitable pricing strategies to specific groups

Why this matters

Equitable pricing strategies that target conventional inter-country and intra- factors are included in affordability specific population segments can help country equitable tiered pricing. assessments; and whether strategies overcome local and global inequalities. target specific population segments Pharmaceutical companies can play Standards for exclusion: Pricing or the poorest segment explicitly. a major role here, as they determine strategies that lack evidence of a clear • Volume of sales at the lowest tier and influence the price of medicine affordability rationale, and/or are For each equitable pricing strategy, along key sections of the supply chain, not clearly and specifically targeted the Index asks companies to disclose whether they sell their products to towards a relevant (low-income) popu- the volume of sales at the lowest the public or private sectors. Such lation segment were excluded. pricing tier of its pricing structure. strategies may comprise tiered pricing The proportion of equitable pricing schemes, which stipulate different The Index reports on: strategies for which a company can prices for different countries or • Inter-country and intra-country provide this information is a measure population segments. They also can equitable pricing of its focus on this tier. take affordability into account by other The Index measures whether compa- • Price points for tracer products means, such as by offering volume- nies commit to equitable pricing The Index also asks companies to based discounts, patient-assistance strategies, either inter-country or disclose price points for a maximum cards and targeted discounts. The intra-country. The Index matches the of ten products called tracer prod- Index recognises that setting the end- breadth of each company’s commit- ucts. It does not compare companies price is often beyond the control of the ment against its total geographic based on the price points themselves, company. Nevertheless, the prices set reach and relevant portfolio relative only on their disclosure, for the period by companies are important determi- to the scope of the Index. of analysis (2012 and 2013). This nants here. • The reach of equitable pricing, per information provides evidence that company; companies are targeting the lowest How we measure As a measure of performance, the tiers in practice. In this analysis of equitable pricing strat- Index also assesses where each egies, the Index looks at how companies company has equitable pricing strate- Although these metrics do not reveal employ equitable pricing strategies for gies in place, relative to its entire whether products are affordable on diseases and countries that fall within relevant portfolio and geographic the ground, they enable the Index to the scope of the Index. It is important to reach. assess the extent of companies’ pricing note that the standards for evaluation • How equitable pricing strategies strategies, and how they are being have changed since the 2012 Index: take affordability into account implemented. Per company, the Index examines Standards for inclusion: The 2014 anal- the rationales that underpin these All data on pricing is provided under ysis included more types of strategies, strategies, looking at: proportion a blanket non-disclosure agreement including tenders, and single-product, of strategies that take affordability and cannot be published or otherwise single-country discounts, in addition to into account in general terms; what made available.

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How the companies perform

More companies are implementing range of countries for which companies Figure 39 more equitable pricing strategies in have equitable pricing strategies. 6 companies have newly implemented relevant countries for products that inter- or intra-country equitable target relevant diseases. A total of 18 A lack of data, a lack of control pricing strategies since 2012 companies now report having at least When it comes to defining pricing one equitable pricing strategy. In 2012, strategies, one size does not fit all – not New strategy 16 companies reported having at least for products, diseases, geographies nor AstraZeneca inter one tiered pricing scheme. healthcare systems. Pricing strategies Boehringer Ingelheim intra should ideally reflect local conditions Bristol-Myers Squibb intra Increased focus on intra-country tiers and the needs of local communities. In Eisai inter When it comes to inter-country addition, to ensure that medicines reach Gilead intra pricing, two companies have newly target populations at target prices, Merck KGaA intra implemented such strategies: Astra- strategies need processes for moni- Zeneca and Eisai. When it comes to toring mark-ups and for preventing intra-country pricing, the improve- product diversion between tiers. ment is greater. Four companies have newly implemented them: Boehringer However, devising such pricing its equitable pricing strategies in an Ingelheim, Bristol-Myers Squibb, structures and monitoring processes organised manner, including targeting Gilead, Merck KGaA. Astellas is the only requires data on patients’ ability to pay, lower-income population segments. company not to provide evidence of which are unavailable in many Least either committing to or implementing Developed Countries. This makes it Following Gilead, six other companies equitable pricing strategies for difficult for companies to appropriately deliver good performances: Johnson & relevant products. segment their markets. Despite these Johnson, Novo Nordisk, Bristol-Myers difficulties, almost all companies are Squibb, AbbVie, GSK and Eisai. These Across the industry, companies applying segmented pricing in an effort companies have made specific commit- are employing varied and changing to ensure their products are priced ments to implementing equitable pricing strategies for a diverse range equitably. pricing strategies for the majority of products and countries, and which of their products in the majority of contain a large variety of methods Seven companies deliver good perfor- relevant countries, specifying differing and mechanisms for taking account of mances combinations of disease areas and affordability for the poorest population The best performance in this area geographic regions. segments. comes from Gilead. The company commits to both inter-country and Going beyond commitments, all of Evidence of innovation intra-country equitable pricing. It these companies’ equitable pricing Companies are also employing novel already has equitable pricing strategies strategies take affordability into strategies. For example, several are in place that cover some products and account, including for the poorest attempting to add more pricing tiers the majority of its relevant geographic population segments. Apart from Eisai, to target their strategies more toward reach. In general, these strategies take they all have equitable pricing strate- specific population segments, and are affordability into account using multiple gies for either the majority of their using more relevant factors to define factors, including disease prevalence. relevant products or the majority of these tiers. Companies are also finding For one of its HIV/AIDS and one of its their relevant geographic areas, and ways of helping patients spread the hepatitis B products, Gilead states not necessarily for both the majority of cost of medicines, either through that the lowest pricing tier covers only products and geographic areas. insurance schemes or by changing the production costs and includes no profit unit size of certain products. Micro- margin in a considerable number of As an indication of implementation, all financing is being employed in certain countries. six companies provide some data on countries in partnership with other their relevant sales volumes, and most stakeholders. Gilead has fully disclosed its volumes also disclose price points for a set of of sales to its lowest pricing tiers for its tracer products. Companies have scope for improve- equitably priced products, as well as the ment in the area of equitable pricing, price points for a set of tracer products. Limited or no strategies from laggards particularly regarding the disease areas Based on these data, and, to an extent, There are four companies that lag in they target, proportion of products on the fact that it is actively collected, this area: Astellas, Pfizer, AstraZeneca covered, level of segmentation and it seems that Gilead is implementing and Takeda.

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observation Although Pfizer and AstraZeneca both Eisai has a new Global Pricing Policy have equitable pricing strategies in that applies to all new products and place, they only provide evidence that Commitments to equitable pricing uses both inter-country and intra- they cover a limited range of relevant strategies country segmentation to set prices in countries, and do not provide evidence different markets. Based on an analysis of targeting the poorest segments of Two companies have new commit- of Eisai’s late-stage R&D pipeline, this local populations. Furthermore, these ments to equitable pricing strate- policy can be expected to influence companies disclose only limited data gies. Sanofi uses equitable pricing for access to medicine in the following about relevant sales volumes, and no leishmaniasis and schizophrenia. disease areas in the short-to-medium tracer product price points. Since 2012, term: cirrhosis of the liver, epilepsy and AstraZeneca has implemented inter- Sanofiis the only company to provide Chagas disease. country equitable pricing. evidence of using equitable pricing strategies to market products for Bayer has developed a new differential Astellas and Takeda have no equitable leishmaniasis and is one of the few to pricing framework, which is currently in pricing strategies for any of their rele- have equitable pricing strategies for the pilot phase. Its rationale for pricing vant products or relevant countries. schizophrenia (newly in scope). differentiation is based on a combina- Since 2012, however, Takeda has made • Meglamine (Glucantime®) for leish- tion of access objectives and commer- a general commitment broadening maniasis: Sanofi charges a single, cial objectives. Based on the outcomes access to its products via intra-country fixed, low price of USD1.20 for a 5ml of the pilots, Bayer intends to roll out equitable pricing. It provides some ampoule (excluding local taxes and this model in additional countries. evidence that it does so for products shipping costs) in all low income and outside of the scope of the Index in middle income countries, including in relevant countries. Latin America, the Middle East, Africa and Asia. Astellas remains the only company that • Chlorpromazine (Largactil®) for has neither committed to nor provided schizophrenia: Sanofi applies intra- evidence of implementing an equitable country segmentation in low income pricing strategy within the scope of the and middle income countries, Index. charging a preferential price to Minis- tries of Health compared with that for customers from the private sector.

A child in Brazil is treated for leishmaniasis. Sanofi is the only company to use equitable pricing for this disease. © Gil Corre

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focus area 3

Brochure and packaging adaptation Little packaging adaptation – and little momentum

Why this matters

Packaging or brochure adaptation can In this section, the Index examines The Index also reports on whether help ensure medicine is taken correctly, whether brochures and packaging companies use different packaging for and even by the right person.2 For information comply with require- each pricing tier or country, to help example, the directions for use may be ments set by the national drug regula- prevent product diversion (focusing re-written in a local language or for an tory authorities. It also asks whether on products that are both on the 2013 appropriate literacy level. Adaptations companies go beyond these minimum WHO Model Essential Medicines List can also help ensure lower-priced vari- standards by implementing additional (EML) and have equitable tiered pricing ants are not diverted from the low- adaptations that target specific local strategies).3 income patients targeted and sold to populations. wealthier patients able to pay more.

How the companies perform

There is still room for improvement in requirements. In total, the brochures All 20 companies can, as a minimum, this area of analysis, both regarding and packaging for 37% of all products follow local regulatory requirements adaptations to prevent product diver- included in this analysis have not been for ensuring the rational use of all their sion and to ensure rational use. adapted to facilitate rational use in products on the market. Ten compa- relevant countries. Regarding product nies follow regulatory requirements for The analysis reveals that, for several diversion, eight companies are showing all products, three of which go beyond diseases with many marketed prod- the way ahead, routinely adapting local requirements for populations in ucts, companies are adapting pack- brochures and packaging materials for need. A further five follow local regula- aging for less than 50% of products a wide range of products and countries. tory requirements for the majority of in order to align with local regulatory products, while three do so for a subset

New strategy Figure 40 AstraZeneca inter Adapting packaging can minimise the risks associated with improper use Boehringer Ingelheim intra Bristol-Myers Squibb intra Products with no adaptation Risks Eisai inter Tubercolosis Drug resistance and spread of disease Gilead intra Epilepsy Overdose and dangerous drug interactions Merck KGaA intra Diabetes Unmanaged disease and dosing risks Lower respiratory infections Drug resistance and spread of disease Contraceptive products Unplanned pregnancies

Figure 41 Three companies take speci c patients' needs into account

While most companies follow local regulatory companies do not companies follow companies follow companies follow companies follow requirements report on brochure & local regulatory local regulatory local regulatory local regulatory for at least the packaging adaptation requirements requirements requirements requirements majority of prod- to ensure rational use for a subset for the majority for all for all ucts, only three (<50%) of products (>50%) of their (100%) products (100%) products & go companies go products beyond for some further and take (7%-40%) products specific patients' need into account.

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With Novo Nordisk, of products. Two companies do not 12 Ninatumiaje glukometa yangu? ‹ report on this at all. Roche has developed Ili kupima sukari yangu ya damu ninahitaji kuandaa illustrated packaging baadhi ya vitu. Ninahitaji: sabuni, kifaa cha kukatia, na kisu kidogo, glukometa na utepe, pamoja na kitabu cha that is easier to Kupima sukari kumbukumbu cha kisukari. Packaging adaptation to prevent yangu ya damu understand. ni muhimu na rahisi.

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M © Novo Nordisk products to prevent diversion. Almost Taarifa inayotolewa sio mbadala wa ushauri kutoka kwa wataalamu wa huduma ya afya. Wasiliana na daktari au nesi wako kupata ushauri sahihi kuhsu tiba yako. half (7) of these companies adapt their observation brochures and packaging materials bodies of water and to encourage the for all EML products that qualify for washing of protective clothing each Going beyond local requirements analysis. Five companies do so for day during a spraying campaign. for populations in need some products, while three do not adapt their relevant materials at all. Three companies also adapt packaging Local regulatory requirements and brochures to prevent product for packaging adaptation form an Compared with 2012, there is little diversion for all of their products that important baseline for performance. momentum toward adapting more are on the WHO Model Essential Medi- However, populations in need often packaging to prevent product diver- cines List (and have equitable tiered require adaptations that go beyond sion. Out of the 15 companies relevant pricing) and for the lowest pricing tier this baseline. A small group of to this analysis, 14 also qualified in 2012. for their other relevant tiered-pricing companies is showing the way ahead, Of these 14 companies, six companies products. Another three companies adapting their materials for some do the same amount of packaging adapt materials for at least 75% of products to facilitate rational use by adaptation, four do more and four do their essential medicines and for the specific high-need groups, such as less. poorest population segment for least children, and to cater to local literacy some of their other relevant equitable levels and languages. Leaders go beyond regulatory require- tiered-pricing products. Five of these ments companies align their brochures and Bayer uses a combination of text and Regarding packaging adaptation, the packaging information with standards pictograms to inform patients about best performer is Bayer. To prevent set by relevant drug regulatory authori- the safety aspects and environmental product diversion, the company tags ties for all their relevant products. considerations related to a subset of or packages its products differently for One company does so for a subset products, and to give directions for all of its products that are both on the of relevant products. Bristol-Myers their proper use. WHO Model Essential Medicines List Squibb and Roche join Bayer in also and have equitable tiered pricing. For adapting their materials for some prod- Bristol-Myers Squibb packages all of its other products with equitable ucts to facilitate rational use by specific certain products in blister packs in six tiered pricing that target relevant high-need groups. countries where stability is a concern: diseases, Bayer has also adapted the Philippines, Indonesia, Vietnam, China, packaging for the lowest pricing tier, The laggards: Eisai and Takeda India and Thailand. helping to ensure these medicines Eisai and Takeda lag in this area. Eisai reach the poorest patients. To facilitate does align its brochures and pack- Roche has produced material for rational use, the company adapts its aging materials with local regulations diabetes diagnostic products, in packaging in line with the standards set for the majority of its relevant prod- conjunction with Novo Nordisk, as part by local national regulatory authorities ucts. Takeda discloses no informa- of the Changing Diabetes in Children for all of its relevant products (i.e., its tion about packaging adaptations, programme, which uses material that entire portfolio of relevant products on either for preventing drug diversion is simple, colourful, image-led and easy the market). For some products, Bayer or for ensuring rational use. Neither for children and their families to read goes further, adapting its brochures company reports using tiered pricing and understand. It is available in Bangla- and packaging information for specific strategies for relevant products, so are desh, Cameroon, Democratic Republic high-need groups. For example, Bayer not expected to adapt packaging to of Congo, Ethiopia, Guinea, India, Kenya, uses pictograms to warn against prevent drug diversion. Pakistan, Tanzania and Uganda. washing treated bed nets in natural

97 Pricing, Manufacturing & Distribution Access to Medicine Index 2014

focus area 4

Accountability for sales agents' pricing practices Broad lack of universal pricing guidelines

Why this matters

Whatever prices companies charge, not possible for companies to legally The Index examines whether compa- other parties affect the price patients control the resale price charged by nies issue sales agents in relevant pay. Their mark-ups can have a signifi- distributors. In regulated markets, countries with pricing guidelines, and cant effect on the product’s affordability. prices are monitored by governmental whether these guidelines also apply to Although companies have some ability authorities, and maximum retail prices third-party distributors, wholesalers to influence mark-ups, this is limited by are set by regulation. Nevertheless, and retailers. The Index also looks for the number of steps between them and companies can still provide their sales processes and mechanisms including the patient, and by local laws and regula- agents with pricing guidelines, and for monitoring mark-ups and sales tions that guard against price fixing. monitor and audit compliance with agents’ training, and for auditing sales these guidelines, other contractual agents’ pricing practices. For example, in countries where there obligations and applicable local laws. is a free market for medicines, it is

How the companies perform

This is generally a low-scoring area. provides evidence and details of global More than half of the companies have monitoring processes and auditing dropped in performance due to stricter mechanisms. Johnson & Johnson scoring requirements: pricing guide- comes close to this performance: it lines are now only seen by the Index as also has pricing guidelines in place, but a baseline for performance. audits and monitors compliance to a less specific degree. A lack of attention The majority of companies have yet to Since 2012, Eisai, Astellas and one set clear and universal pricing guide- other company have gone from having lines for their sales agents. Most do no pricing guidelines to having general not monitor the pricing practices their guidelines in place. agents employ. Even where guidelines are in place, no company trains There are opportunities for improve- its sales agents on how to implement ment in this area for uniformly setting them. Only a few companies monitor pricing guidelines and implementing mark-ups. No company has guidelines monitoring and auditing processes for that universally apply to third-party all relevant products’ supply chains distributors, wholesalers and retailers. at national levels (within the limits of Where companies do issue guidelines companies’ influence). In countries and monitor pricing practices, prac- where local regulation requires/allows tices vary between companies and it, companies can set recommended types of countries. In part, this is due maximum retail prices to control mark- to differences between supply chains ups. They can also contractually agree and legal requirements in different on certain provisions and require- countries. ments, with distributors, against which companies can monitor and audit Signs of positive movement performance. Sanofi satisfies the most criteria here, with widespread use of pricing guidelines for its sales agents. In a change from 2012, it now also

98 Access to Medicine Index 2014 Pricing, Manufacturing & Distribution

focus area 5

Drug-recall policies and practices Drug-recall policies consistently meet high standards

Why this matters

Companies are responsible for ensuring systems are not functioning optimally, asks whether companies track prod- products meet high quality standards. and captures evidence of recalls of ucts, as this can facilitate effective When sub-standard products do reach products targeting diseases in scope, recalls. To raise awareness of potential the shelves, the company that produced in countries in scope. It looks for risks, it also expects companies to them must swiftly and effectively recall companies to commit to drug-recall publicly disclose where, when and why them and remove them from the market. standards, and to implement stringent a drug recall has taken place for both drug-recall policies and procedures packaging-related and product-quality The Index views drug recalls as aligned with WHO Good Manufacturing issues. evidence that quality-management Practice (GMP) guidelines. The Index

How the companies perform

In general, the industry commits to Most companies issued product recalls where their products are available. consistently high standards in drug in the last two years, more than 70 in However, neither has processes for recalls: fourteen companies have strin- total: twelve companies were involved tracking products. gent policies on drug recalls in all rele- in recalls related to product-quality vant countries. This is an improvement: issues; one to a packaging-related Merck KGaA, AbbVie and Merck & Co. in 2012, three companies reported recall. Seven companies issued no follow close behind. None issued a equivalent policies and country relevant recalls during the period of relevant product recall in the past two coverage, and a further seven reported analysis: Eisai, Gilead, Merck KGaA, years. Merck & Co. and Merck KGaA policies with narrower coverage. AbbVie, Merck & Co., Roche and Pfizer. also have drug-recall guidelines and For five of these (Pfizer, Merck KGaA, product-tracking procedures. In 2014, four companies (Boehringer Merck & Co., Eisai and Roche), this is an Ingelheim, Merck & Co., Eli Lilly and improvement since 2012, when they did Laggards: no public disclosure Sanofi) provided evidence of tracking issue recalls. Daiichi Sankyo and Bristol-Myers products and complying with WHO Squibb deliver the weakest perfor- GMP standards in all relevant countries Leaders: no recalls; strict guidelines mances in this area. Not only did they where their products are available: they The leaders in this area are Eisai and both issue relevant product recalls provided details of decision-making Gilead. Neither has recalled relevant during the past two years, they also processes and procedures for investi- products in relevant countries during provided limited evidence compared gating and responding to complaints. the period of analysis. Both have to peers on the extent to which they Only two others (Merck KGaA and committed to publicly disclosing the comply with WHO GMP guidelines. Roche) reported product-tracking details of recalls, should they occur. They do not publicly disclose recalls. systems or mechanisms for effective Eisai and Gilead both apply guidelines recalls. for drug recalls in all relevant countries

best practice Eli Lilly – Tracking batches to facilitate recalls

Product recalls must be carried out transactions involving its products more efficient recall and market-with- swiftly and effectively to ensure that worldwide. At the time of writing, drawal response time. unsafe products are removed from the company was finalising a module the market. that would enable it to pull relevant AbbVie has an IT system in place and information from the ERP software in Merck KGaA is putting in place an IT Eli Lilly has an Enterprise Resource a timely manner. The intended system system for tracking and monitoring Planning (ERP) software to track all is expected to promote a significantly shipments to relevant countries.

99 Pricing, Manufacturing & Distribution Access to Medicine Index 2014

innovation Diversification in innovation on supply and demand sides

By innovating in pricing, manufacturing pricing; and for new and more efficient Six companies received credit for inno- and distribution, companies have real technologies, processes or produc- vation in this area in the 2014 Index: scope to bring more products at more tion techniques for manufacturing Merck & Co. earns the most points, affordable prices to more people. The or distributing products to increase followed by Bayer, GSK, Sanofi, Merck Index looks for innovative ways of affordability and/or reduce cost KGaA and Novo Nordisk. Compared simultaneously addressing demand- without compromising quality. with 2012, innovative practices in this and supply-side issues that affect area are now more diversified.

Innovation in equitable pricing

Merck & Co. has piloted an initiative insurance product that patients can plans to produce 50 to 60 tons of in India that combines reduced cost maintain via mobile phone top-ups. artemisinin on the new line each year, of treatment with a micro-financing The partnership is in an early stage and starting in 2014. This corresponds to option. Called Project Sambhav, the is planned to run for three years. 80-150 million treatments. initiative supports patients with no or limited insurance coverage in accessing Innovation in manufacturing and Merck KGaA uses heat and humidity its hepatitis C medicine and is now distribution sensors to monitor the transportation under expansion to 11 cities across four conditions of all its products shipped Indian states. Merck & Co. is developing an innovative from Europe to the rest of world (in soft-chew tablet. Because soft-chew its “Temptation Project”). It uses the Bayer is currently piloting a new tablets can be taken without water, data collected in a centralised system differential pricing model that can be patients do not need access to a clean to ensure product quality, and improve considered innovative and unique in the water supply. In addition, they can be transport routes. sector. Under this strategy, Bayer bases produced using simple formulations pricing decisions on a comparatively and a simple manufacturing process, Novo Nordisk has tested the viability comprehensive combination of criteria which reduces manufacturing costs of single-dose products for people that include assessing local needs and and potentially increases affordability. living in low income countries. The affordability. The company has defined Merck & Co. has spent approximately programme began in 2011, with Paki- different clusters, based on market USD90,000 on process equipment. stan as the first pilot country. For use type and product type, each with a with devices, insulin is normally sold in distinct objective and strategic intent. Sanofi has established a large-scale packs of five cartridges, each containing The rationale for price differentiation production line for semi-synthetic 300 IU. Novo Nordisk assessed the is based on a combination of access artemisinin in Italy. It has been estab- barriers to access to insulin in Pakistan objectives and commercial objectives. lished through Sanofi’s partnership and began selling its insulin Penfill® with PATH and in affiliation with cartridges in single-cartridge packages. GSK has entered into a three-year part- OneWorld Health (both NGOs active This enabled patients to spread the nership with Barclays with the aim of in global health). Artemisinin is used to cost of treatment over time, making increasing access to affordable health- treat malaria, and the botanical supply it more affordable. Novo Nordisk also care and medicines in Zambia. Inter- of this compound is inconsistent. reduced the cartridge unit price to ventions and pilots include affordable The new large-scale product line will 12% above the unit cost of the vials financing for wholesalers and distribu- significantly strengthen the artemis- needed for the vial-and-syringe insulin tors who are willing to pass savings on inin supply chain, contribute to a more delivery method. Novo Nordisk also to patients, and the development of an stable price, and ultimately ensure began offering its insulin delivery device around a dollar-a-month micro-health- greater availability of treatment. Sanofi (durable pen) free of charge.

For numbered references, see the Appendix. c ‘Rational use’ entails patients receiving the appropriate e The 2014 Index measured all equitable pricing strate- medicine in the proper dose, for an adequate period of gies, rather than only tiered pricing strategies (as was a Companies were asked for price points for up to ten time, and at a cost that is affordable to them and their measured in 2012). products that account for highest sales revenue in community. countries in scope for which equitable pricing strategies f This graph captures the number of strategies per dis- are available. These are referred to as tracer products. d 'Targeting' is demonstrated where a company sets ease. Each product may have multiple strategies. out how it segments a market and then implements its b It is not known how long Novo Nordisk will continue to strategy based on an assessment of affordability for one g This chart shows the percentage of products without provide the pen free of charge. or more population segments. packaging adaptation out of all products captured by the 2014 Index for these 5 diseases.

100 Access to Medicine Index 2014 Patents & Licensing

E Patents & Licensing

One of the more polarising debates in access to medicine relates to patents and centres on whether intellectual property protection stimulates innovation or unduly stifles competition. Where products remain on patent, companies benefit from monopoly rights and, in turn, reduced competition, which can limit access to affordable medicine. There is no guarantee that patent-holders will take low income patients into account when setting prices.

Companies can limit the impact of patent monopolies on low income patients by applying a nuanced approach to IP management and taking steps that support the entry of generic medicine manufacturers. They can refrain from patenting or from enforcing existing patents in certain territories. They can ensure they register products where they are needed. Where generic medicine markets are absent, they can modify prices to stimulate market creation. Where there is market potential, they can enter pro-access licensing arrangements. They can also provide an overview of where patents are active and where they will be enforced (which would support both generic medicine manufacturers and procurement agencies), and disclose whether licensing agreements exist, as well as their terms and conditions.

The ability of a company to pursue certain IP strategies depends on its portfolio and range of on-patent products. Nevertheless, companies with few or no relevant on-patent products can still take a range of actions to support competition from generic medicine manufacturers. For example, they can publicly disclose whether and where patents have expired; denounce patenting tactics designed to extend monopolies; and indicate what their IP approach will be to medicines in their pipelines.

In this chapter, the Index addresses a series of questions about how company approaches to IP-management enable competition from generic medicine manufacturers:

1 Do companies pledge not to file or enforce patents in relevant countries? 2 Do companies publicly disclose patent status? 3 Which companies pledge to engage in licensing or issue formal non-assert declarations? 4 How do companies compare in licensing behaviour? 5 Which companies are transparent and use access-friendly terms in licence agreements? 6 Do companies engage with external brokers? 7 How do companies support the TRIPS agreement?

101 Patents & Licensing Access to Medicine Index 2014

Top findings in Patents & Licensing

Limited support for pro-access IP law, Early signs that licensing can be expanded undermined by private policy positions to more diseases Publicly, companies generally give only qualified The overwhelming majority (93%) of licences support to the flexibilities intended to protect identified remain related to antiretrovirals public health set out in the internationally agreed (ARVs) for HIV/AIDS. However, there are early intellectual property framework (TRIPS).1 signs that some companies are making steps However, even this cautious public stance is toward expanding voluntary licensing practices undermined by evidence of efforts to lobby beyond this disease, for example to cytomegalo- against these flexibilities in private. virus and hepatitis C.

Pro-access licensing agreements increase in number Since 2012, two more companies have entered licensing arrangements for products for diseases in scope, bringing the total to eight. The Index captured evidence of almost 250 licences relating to diseases in scope. Compared to 2012, a larger proportion of licences include pro- access terms and are publicly available. Innova- tion is also apparent, with the Medicines Patent Pool playing a key role: for example in the use of tiered royalties in middle income countries.

102 Access to Medicine Index 2014 Patents & Licensing

How the companies perform

Overall, company performance is low Figure 42 in Patents & Licensing. Despite this, Company Ranking Patents & Licensing a small group of companies exhibit leading performance in licensing 1 = 1 Gilead 2,8 practice, including some striking 2 3 GSK 2,8 examples of innovation for reaching 3 11 Bristol-Myers Squibb 2,6 more middle income countries. 4 14 Merck KGaA 1,9 5 17 Eisai 1,9 Leaders show innovation, openness, 6 7 Novartis 1,9 and balance Gilead and GSK lead within this chapter. 7 8 Roche 1,8 These companies commit to taking a 8 9 Bayer 1,8 more balanced approach to IP manage- 9 20 Daiichi Sankyo 1,7 ment, and acknowledge the pressing 10 = 10 Sano 1,7 need for companies to explore new 11 16 Pzer 1,6 ways of using licensing to improve 12 6 Novo Nordisk 1,5 access to medicine for low income 13 5 Boehringer Ingelheim 1,5 people in middle income countries. 14 13 Eli Lilly 1,4 Both companies have patented prod- 15 2 Johnson & Johnson 1,3 ucts that target relevant diseases in 16 12 AstraZeneca 1,2 relevant countries, and have engaged 17 n/a AbbVie 1,2 in voluntary licensing to facilitate the 18 4 Merck & Co. 0,9 production of generic versions of a 19 18 Astellas 0,8 comparatively high percentage of them 20 19 Takeda 0,6 (Gilead: 80%, GSK: 28%). 2014 2012 0 1 2 3 4 5

Both companies engage in licensing Commitments Transparency Performance Innovation bilaterally and through the Medicines Patent Pool. Agreements under the latter cover the broadest geographic scope and include the largest degree Gilead and GSK both publicly state Gilead’s and GSK’s performance in of flexibility for licensees. GSK’s ViiV their support for the TRIPS agreement this area is not only a reflection of Healthcare licences, which also involve and Doha Declaration, acknowledging their readiness to engage in licensing, Pfizer and were brokered by the the right of countries to limit patent but also of the number of relevant Medicines Patent Pool, stand out here. protection in order to improve access patented products in their portfolios Importantly, both companies have also to medicine for their populations. and of the availability of licensees. Not licensed very new HIV/AIDS medicines Importantly, the leaders’ behaviour all companies are able to engage in with comparatively long patent terms appears to be in accord with their licensing on the same scale. remaining. Gilead, showing best prac- public policy positions – with some tice, also includes a pipeline ARV in its of their licences, they permit supply Ranking 3rd, Bristol-Myers Squibb also licensing commitment. to countries that issue compulsory belongs with the leaders. It pledges to licences. refrain from filing or enforcing patents, As part of these negotiations, both albeit in a limited range of countries Gilead and GSK agreed to the terms and These two companies could perform and for a limited range of products. It conditions of the agreements brokered better still by further specifying their also engages in licensing agreements through the Medicines Patent Pool commitment to engaging in licensing, for some relevant products. The terms being published on the MPP’s website. and whether, how and where they of its agreements brokered by the pledge not to file or enforce patents. Medicines Patent Pool are publicly

103 Patents & Licensing Access to Medicine Index 2014

available, include access-friendly condi- a limited commitment to disclosing to refrain from patenting in certain tions and cover a broader range of patent status, and only gives qualified groups of countries. Eisai has a clear countries. support to the TRIPS flexibilities. public stance against evergreening. Neither of these companies were iden- Merck KGaA has climbed ten places to Boehringer Ingelheim, in 13th place, tified as being involved in any IP-related fourth position by demonstrating good discloses limited information about anti-competitive practice. practice in other areas: its commitment its patenting strategy, but there is not to seek or enforce patents covers supporting evidence that it has issued Laggards lack clear commitment the widest range of countries among non-assert declarations in practice Astellas and Takeda occupy the its peers, and it pledges to consider (on request), which have been actively bottom positions. Although Astellas licensing across the widest range of used by generic medicine manufac- and Takeda have relevant patented potential products and countries, turers. However, the product relating products, they do not make the same including both communicable and to these declarations is no longer on level of commitment to refraining non-communicable conditions within patent, and the company’s transpar- from seeking or enforcing patents in the scope of its commitment. Merck ency concerning the detail of these relevant countries. Neither do they KGaA also stands out for being the declarations is limited to disclosure to commit to engaging in licensing. They only company to commit to publishing the Index (as well as to the manufac- take a comparatively conservative its global patent statuses (which had turers that made the original request). stance on the flexibilities set out in the indeed been made available at the time This limits the value of the non-assert TRIPS agreement. of writing on the company’s website). declarations for other stakeholders. Merck KGaA is also among the ten Similarly, Novo Nordisk, in 12th place, Johnson & Johnson and Merck & Co. companies that have more progressive makes a comparatively clear commit- have both dropped substantially since attitudes towards the TRIPS agreement concerning where it patents, but 2012. They both exhibit low levels of ment and the Doha Declaration. does not make a clear commitment to disclosure and have weaker policies on considering licensing. patenting in countries of interest to the Middle group delivers mixed results Index. Although they both engage in Compared to Gilead, GSK and Bristol- Eisai and Daiichi Sankyo are signifi- voluntary licensing, they do so propor- Myers Squibb, the middle pack of cant risers within this chapter. While tionally less than their peers, and are companies deliver more mixed perfor- this can, in part, be attributed to the opaque about the terms of engage- mances. Sanofi, for example, which application of neutral scoring in some ment. In addition, they pledge limited remains in tenth place, has a considered indicators,a these two companies have support for the flexibilities set out in policy on patenting that takes account shown strong performance in certain the TRIPS agreement, which is compli- of the Human Development Index of the areas in 2014. Daiichi Sankyo, for cated further by evidence of lobbying. country concerned. However, it makes example, has an enhanced commitment

industry Conservative attitude remains, but movement in licensing

Since 2012, company behaviour has ments, particularly those negotiated As mentioned, the most novel of these remained static across most areas of with the Medicines Patent Pool. arrangements the Index analysed were investigation. In many areas, compa- negotiated with the Medicines Patent nies are maintaining their conservative Of 16 companies that are arguably in Pool. These include some ground- attitude, particularly when it comes a position to issue voluntary licences, breaking arrangements that extend to disclosing patent status in relevant eight now provide evidence of doing favourable licensing terms to more countries. Yet there is some evidence so – an increase of two since the 2012 middle income countries in new ways. that companies are taking a more Index. The 2014 Index found evidence They also include products with signifi- considered approach to intellectual of almost 250 licences in total. Compa- cant patent terms remaining, as well as property management as it relates to nies provide more evidence of devel- ones that are still in company pipelines. access to medicine. oping novel licensing strategies, of considering licensing products for Such advances demonstrate that Notable movement, for example, conditions other than HIV/AIDs, and of companies are able to manage their occurs in licensing: since 2012, compa- moving into a wider range of countries intellectual property rights in ways nies have agreed to significantly more, with different levels of development. that support access to medicine. In the and more progressive, licensing agree- context of licensing, for example, it

104 Access to Medicine Index 2014 Patents & Licensing

supports the view that patents can be Limited disclosure Figure 43 seen as tools that enable their owners Disclosure remains limited across More companies are engaging to more confidently share intellectual the board. Over the reporting period, in voluntary licensing capital with external parties. there was no significant improvement

compared with equivalent perfor- Out of 20 companies, Most companies are also involved to mances in 2012: there was no evidence 16 companies in 2014 have some extent in technology transfer. of companies voluntarily publishing on-patent products within Index scope. 8 now provide Exceptions include Merck & Co., which the status of patents in countries evidence of engaging in does not disclose any information in within the scope of the Index. Notably, voluntary licensing for such 2012 2014 this regard, while Roche and Boehringer following the end of the reporting products, up from 6 in 2012. Ingelheim indicated that they had not period, Merck KGaA disclosed its global engaged in technology transfer. patent statuses. This will be taken into account in future Indices. Of those companies with relevant were linked via their membership of patents in force, the leaders (Gilead and There is more movement in disclosure South African pharmaceutical trade GSK) not only clearly commit to consid- around licensing, with some companies association IPASA to proposals for ering licensing, but also issue them in sharing greater detail of their bilat- influencing intellectual property law practice, and across a relatively large eral licensing arrangements with the reform. proportion of their patented products. Index and others going further still by Importantly, they share the details publishing complete licences agreed of the licences publicly, and include via a third party (the Medicines Patent access-friendly terms and condi- Pool). tions. The leaders are also prepared to engage with neutral brokers to Companies continue to give limited facilitate licence negotiations. Only one support to the flexibilities afforded to such broker is currently in operation: countries in the TRIPS/Doha inter- the Medicines Patent Pool. national framework of IP legislation. Where companies do voice support Based on an analysis of the licences for these provisions, their words are available for examination, those negoti- in general at odds with their behav- ated via the Medicines Patent Pool iour, as many companies continue to provide licensees with the highest level attempt to influence the application of flexibility and broadest geographic of those flexibilities in practice. During scope. the period of analysis, most companies

Investigating seven key questions

All companies can approach intel- 1 Do companies pledge not to file or enforce patents in relevant countries? lectual property in a manner more 2 Do companies publicly disclose patent status? supportive of access, whether or 3 Which companies pledge to engage in licensing or issue formal non-assert not they have on-patent prod- declarations? ucts. In the following sections, 4 How do companies compare in licensing behaviour? the Index addresses a series of 5 Which companies are transparent and use access-friendly terms in licence questions aimed at revealing where agreements? companies take a pro-access 6 Do companies engage with external brokers? approach, and where they remain 7 How do companies support the TRIPS agreement? conservative:

105 Patents & Licensing Access to Medicine Index 2014

analysis 1 Do companies pledge not to file or enforce patents in relevant countries?

As a baseline, the Index expects compa- AstraZeneca previously stated that it covers all relevant products. According nies to refrain from patenting in coun- would enforce patents in Least Devel- to current data, this covers 46 countries designated by the UN as Least oped Countries. Both now specifi- tries, including almost all Least Devel- Developed Countries. Internationally cally commit to refrain from filing or oped Countries and several low income agreed guidelines have granted these enforcing patents in certain countries. and lower-middle income countries. countries exemptions from protecting patents until at least 2021.2 The Index Companies that take a more conserva- Conversely, AbbVie, Bristol-Myers also examines whether companies tive approach to filing and enforcing Squibb, GSK and Johnson & Johnson go beyond this to publicly commit to patents also have relevant products take a narrower approach: their refrain from patenting in a broader on patent in a subset of countries commitments apply to a subset of rele- range of countries, including low- and of interest to the Index. How these vant products and subsets of countries. lower middle-income countries. companies apply either licensing or pricing strategies to facilitate access is GSK discloses that its overall approach The 2014 Index identified a wide important when analysing their support varies over time and is dependent on range of attitudes towards filing and for access to medicine in general. the products, countries, and disease enforcing patents in relevant countries. burden concerned, among other Four further companies commit not factors. Roche and Merck KGaA stand out to file or enforce patents in Least here: they are the only companies Developed Countries and a subset of The poorer performing companies in with relevant patented products that low income countries for all products this regard are Astellas, Gilead, Pfizer pledge not to file or enforce patents in relevant to the Index: AstraZeneca, and Takeda. They make no specific any Least Developed Country, any low Bayer, Eli Lilly and Novartis. Eisai, Novo commitment not to file or enforce income country and most lower-middle Nordisk and Merck & Co.’s equivalent patents in a particular grouping income countries. commitments cover the Least Devel- of countries. These companies all oped Countries. currently have at least one patented Variable approaches to patent filing product relevant in Index countries.b Two companies have improved Sanofi’s commitment in this regard is their stances since the 2012 Index: tied to whether or not a country has a AstraZeneca and Daiichi Sankyo. low Human Development Index and it

Figure 44 Variations exist in company patent ling and enforcement Gilead and GSK exhibit leading performance in licensing

Subset of products All patented products 1 No specic Subset of countries LDCs LDCs LDCs, This diagram shows 1 commitment and a subset of LICs LICs, some LMICs the dierent 2 geographic areas 3 where companies have committed not 4 to le, or not to Astellas AbbVie Eisai AstraZeneca Roche 5 enforce patents Gilead Bristol-Myers Squibb Novo Nordisk Bayer Merck KGaA 6 Pzer Johnson & Johnson Merck & Co Eli Lilly 7 Takeda Novartis Low HDI This barchart shows the relative performance of the companies who have engaged in voluntary licensing. The ranking is constructed from licensing indicators which measure licensing commitment, transparency of licences, frequency of licensing and licence content. Sano

GSK discloses a variable approach, taking into account country, disease and disease burden Approach subject to non-disclosure agreement: Daiichi Sankyo, Boehringer Ingelheim

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analysis 2 Do companies publicly disclose patent status?

By disclosing where patents are their company websites. It is notable sure, and/or to clearly disclose the active, companies give generic medi- in these instances that disclosure of steps interested parties should take to cine manufacturers added clarity where patents are active goes beyond request this information. on whether to enter a market, and the countries listed in the licences for procurement agencies greater confi- supply, and includes the patent status Only Merck KGaA stated that it planned dence as to whether they can deliver in a range of other countries. to disclose information on the patent generic products in these markets. status of all its products, including Absence of industry-led transparency basic information about associated Only Bristol-Myers Squibb, Gilead and in patent status licences it enters into. Merck KGaA GSK (ViiV Healthcare) disclose infor- Performance in this area remains poor has demonstrated that this level of mation relating to patent status, and compared to equivalent company transparency is possible: outside of then only limited information for a behaviour captured by the 2012 Index. the period of analysis, it has published limited subset of their products. Their Companies provide various reasons patent information on its company disclosure relates to HIV/AIDS prod- for not disclosing patent information. website.3 The Index encourages ucts and occurs only in the context of Considering the potential positive companies to meet and to exceed this licences negotiated with the Medicines impact of such disclosure, the Index level of transparency. Patent Pool. They do not make this encourages companies to investigate disclosure directly, for example on the feasibility of at least partial disclo-

analysis 3 Which companies pledge to engage in licensing or issue formal non-assert declarations and where?

Non-assert declarations and licensing Bristol-Myers Squibb, Gilead, GSK, licensing or issuing non-assert-decla- agreements provide generic medi- Johnson & Johnson and Pfizer. rations. While a public commitment to cine manufacturers with a high • Boehringer Ingelheim commits to engage in licensing is welcomed by the degree of clarity and confidence for considering non-assert declarations Index, and useful for generic medi- engaging in the manufacture and for HIV products. cine manufacturers, actual company supply of patented products. This • Bristol-Myers Squibb commits to engagement in multiple, access- analysis looks at whether and where considering non-assert declarations friendly licensing agreements is what companies pledge to consider issuing and voluntary licensing for HIV prod- counts. licences, and at similar pledges made ucts. concerning non-assert declarations. • Gilead commits to considering licensing for its HIV and hepatitis Merck KGaA stands out, having in place products. the broadest policy to consider issuing • Johnson & Johnson, Pfizer and GSK of licences across its entire present and commit to considering licensing for potential product range, including both HIV products. communicable and non-communicable diseases. Nine companies commit to considering licensing on case-by-case basis: Small group of companies show AbbVie, AstraZeneca, Bayer, Eisai, Eli commitment to licensing Lilly, Novartis, Roche, Sanofi and Daiichi Six companies have policies in place Sankyo. to consider voluntary licensing or non-assert declarations for subsets of The remaining companies make no their products: Boehringer Ingelheim, specific commitments to considering

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analysis 4 How do companies compare in licensingGSK discloses a behaviour?variable approach, taking into account country, disease and disease burden Approach subject to non-disclosure agreement: Daiichi Sankyo, Boehringer Ingelheim

The Index has analysed whether Figure 45 companies with relevant patented Gilead and GSK exhibit leading performance in licensing products actually engage in voluntary licensing agreements. The Index makes the assumption that the more 1 Gilead This barchart shows the relative performance of a company engages in licensing, with 1 GSK the companies who have 2 more partners, the greater the poten- Bristol-Myers Squibb engaged in voluntary tial impact on competition and access 3 Boehringer Ingelheim licensing. The ranking is constructed from to medicine. 4 Johnson & Johnson licensing indicators which 5 Pzer measure licensing Wide range of licensing behaviour 6 Roche commitment, transparency of licences, frequency There are 18 companies with relevant 7 Merck&Co of licensing and licence patented products. Eight of them content. engage in voluntary licensing or issue Table 4 formal non-assert declarations, issuing Company licensing0 profiles1 2 3 4 5 almost 250 licenses in total. The overwhelming majority (93%) relate to Gilead GSK • Licences for 80% of relevant • Licences for 28% of relevant patented products for HIV/AIDs. However, there patented products. products. are signs this practice can be, and is • > 60 licences for 6 products • > 100 licences for 13 products. being extended to other conditions. (all for HIV). • Some complete licences (ViiV Healthcare) • Complete licences (both MPP and publicly disclosed via MPP. For example, GSK shows evidence of non-MPP) publicly disclosed. • Broad geographic coverage; having issued voluntary licences for • Broad geographic coverage; pro-access terms. products targeting lower respiratory pro-access terms. • Innovative licence (ViiV Healthcare) • MPP licence includes pipeline product. includes market segmentation. tract infections, measles, mumps and rubella, and Roche for Avian influenza. Roche has indicated through Bristol-Myers Squibb • Licences for 15% of relevant patented products. an agreement with the Medicines • 5 licences for 1 patented product (Reyataz). Patent Pool that it will in future license • Complete licence publicly disclosed via MPP. valganciclovir (Valcyte®),4 a product • Licences include pro-access terms. • Immunity from suit agreements for several HIV products. that targets cytomegalovirus (an opportunistic infection associated Boehringer Ingelheim with HIV/AIDS). In addition, Gilead has • 8 non-assert declarations for 33% of relevant patented products. • 68% of relevant countries included. agreed licensing terms for sofosbuvir • Terms (some pro-access) disclosed to the Index. (Sovaldi®) and for pipeline product ledipasvir with seven Indian generic Johnson & Johnson • Licences for 15% of relevant patented products. manufacturers for supply in 91 devel- • 6 licences for 2 products. c,5 oping countries. Of all companies, • Discloses (near) complete terms of rilpivirine (Edurant®) licences. Gilead issues licences for the largest • Limited evidence of pro-access terms. • Licences agreed prior to FDA approval. proportion of its relevant products. P zer Companies with relevant on-patent • 2 licences (to MPP, via ViiV Healthcare) for 2 products. • Complete licence publicly disclosed via MPP. products that do not engage in • Broad geographic coverage; pro-access terms. licensing: AbbVie, Astellas, Astra- • Innovative licence (ViiV Healthcare) includes market segmentation. Zeneca, Daiichi Sankyo, Eisai, Merck Roche KGaA, Novartis, Novo Nordisk, • 2 licences for 2 products. Sanofi and Takeda. AbbVie is the • Licences for 6% of relevant products. only company with ARVs that has not • Partial disclosure of terms. engaged in licensing. It is, however, Merck & Co. negotiating licensing terms for • 10 licences for 2 products. paediatric ARV formulations with • Licences for 15% of relevant products. • No disclosure of terms. the Medicines Patent Pool.

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analysis 5 Which companies are transparent and use access-friendly terms in licence agreements?

Transparency in this area enables Table 5 stakeholders, including the Index, to investigate the potential of each Pro-access licensing terms licence for increasing access to medicine. It should be noted that compa- The Index has identified six licensing terms as important in creating nies are not always legally able to access-friendly licences: disclose the terms, even under a non- disclosure agreement with the Index. Non-exclusivity Absence of no-challenge clauses The agreement is not limited to one Licensees are free to challenge the Licence agreements can be very or more specific generic medicine validity of the licensor’s patent) restrictive for licensees (generic manufacturers. medicine manufacturers), limiting to whom they can supply and from where No restriction on licensees supplying The ability for licensees to terminate they can source, for example, active to countries that issue compulsory the agreement for any reason at pharmaceutical ingredients (APIs). licences any time However, this does not have to be the case. Licensing agreements can also The ability to supply where patents The ability to manufacture and be based on access-enabling terms. are not in force source APIs from licensees anywhere in the world Third parties key in influencing licensing practice Breadth of geographic scope is also important in determining whether a Companies appear to only fully disclose licence is pro-access. the terms and conditions when they have been brokered by a third party (i.e., the Medicines Patent Pool). Gilead once again sets itself apart by publishing Of the licences that are publicly avail- Although based on a small sample of the details of an additional bilateral able for scrutiny, those from ViiV five companies, this analysis shows licensing agreement on its website. Healthcare (GSK, Pfizer) appear to companies are willing and able to give the greatest amount of flexibility. agree on flexible terms for volun- Whether a licensing agreement These included all six terms the Index tary licensing. The Index encourages has potential to improve access to looks for. companies to be pro-active in this area. medicine depends on its terms and conditions6,7,8 such as the scale of the Gilead, Bristol-Myers Squibb and Boeh- any royalties, the geographic scope, ringer Ingelheim follow closely behind, and whether it includes restrictions on including an average of five of the where the manufacturer may source terms in each of the licences available its APIs. for analysis.

Pro access terms work in different In terms of geographic scope, the ViiV ways. For example, non-exclusivity Healthcare licences (GSK and Pfizer) clauses ensure that multiple manufac- perform well once again, covering more turers are able to agree licences for than 90% of the countries within the the same product, supporting greater scope of the Index. Importantly, this competition. Other clauses provide includes many middle income countries. greater flexibility to generic medicine manufacturers: regarding, for example, Bristol-Myers Squibbs’ and Gilead’s the countries they are permitted to licences cover 86% of relevant coun- supply to, whether they can terminate tries. Boehringer Ingelheim’s non- components of licences, and whether assert declarations for Nevirapine they are permitted to challenge the cover 68% of countries within the validity of the licensor’s patents. scope of the Index.

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analysis 6 Do companies engage with external brokers?

The presence of an external broker Very few companies with ARVs remain GSK) have all concluded agreements. who can ‘pool’ patents can be an outside the MPP AbbVie, Boehringer Ingelheim and important mechanism for agreeing As shown in other sections of this Merck & Co. were in active negotiations transparent, pro-access terms under chapter, licensing activity, as well as at the time of writing. which generic medicine manufac- the transparency and flexibility of turers are permitted to manufacture terms and conditions, is highest when Johnson & Johnson is the only and distribute patented products. a third-party broker is involved, namely company with relevant products that Further, in disease areas where fixed- the Medicines Patent Pool (MPP). remains both outside the MPP, and not dose combinations are needed, such The Index encourages all companies in active negotiations. For two ARVs as in HIV/AIDS, and where multiple engaged in voluntary licensing to meet – darunavir (Prezista®) and rilpivirine companies hold patents on relevant the high standards demonstrated in (Edurant®) – Johnson & Johnson components, pooling patents is the MPP agreements. engages in limited bilateral licensing particularly important for enabling agreements with generic medicine generic medicine manufacturers to There are nine companies with relevant manufacturers. However, the terms of make combination treatments. At products: GSK, Johnson & Johnson, the licences have not been made fully present, only one such external broker Pfizer, Gilead, Bristol-Myers Squibb, available for analysis. During the period is in operation: the Medicines Patent Boehringer Ingelheim, AbbVie, Merck & of analysis, the company pledged Pool (MPP), which currently focuses Co. and Roche. At the time of the 2012 not to enforce patents on darunavir on HIV/AIDs. Index, Gilead was the only one of these (Prezista®) in certain countries. companies to have reached a licensing Rilpivirine (Edurant®) and etravirine agreement via the Medicines Patent (Intelence®), however, are not subject Pool. Since then, there has been signifi- to the same pledge, and the non- cant movement: Bristol-Myers Squibb, enforcement declaration applies only Roche and ViiV Healthcare (Pfizer and to limited geographic areas.

best practice

Gilead – Including pipeline products within licence agreements

The inclusion of pipeline products Within licensing agreements reached Earlier in 2014 a similar agreement was within licensing agreements can through the Medicines Patent Pool, reached with the MPP for tenofovir significantly accelerate the arrival of Gilead has included pipeline products alafenamide. Gilead has also included generic medicines onto the market. on several occasions: in 2011 with cobi- pipeline product ledipasvir (hepatitis cistat (Tybost®), elvitegravir (Vitekta®), C) within recently bilaterally agreed and with a combination of these licences. products and emtricitabine (Emtriva®) in a single pill known as the “Quad.” (Stribild®). Technology transfer terms were included in the agreement, meaning transfer could be engaged in prior to stringent regulatory approval. As a result, when regulatory approval was finally achieved, access to generic versions could be accelerated.

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analysis 7 How do companies support the TRIPS agreement?

Within the TRIPs framework, WTO- Do they support TRIPS in practice? member countries have respon- During the last two years, the majority sibilities for protecting the intel- of companies have at some point acted lectual property of organisations against the spirit of the TRIPS agree- that operate within their borders. ment and Doha declaration. In the most However, they also have the right to well-known example, members of the balance these responsibilities with Innovative Pharmaceutical Association public health priorities.9 of South Africa (IPASA) were implicated in a lobbying proposal to delay As in 2012, companies continue to reform of South African intellectual take a conservative stance on TRIPS property legislation. The planned legis- and the Doha Declaration. Although lation was designed in part to make it most are supportive of the agreement easier for South Africa to take advan- overall, very few explicitly endorse tage of TRIPS flexibilities, such as the specific flexibilities granted to World right to issue compulsory licences and Trade Organization (WTO) members to engage in parallel importation. regarding IP protection legislation. Furthermore, the majority of compa- More than half of companies (14) were nies have been implicated in allegations members of IPASA while this proposal of lobbying or court cases involving the was reportedly under discussion:, application of TRIPS in certain coun- AbbVie, AstraZeneca, Bayer, Boeh- tries. ringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Merck Inconsistent company support for & Co., Merck KGaA, Novartis, Novo TRIPS agreement Nordisk, Pfizer, Sanofi and Takeda. The companies are divided into two low-performing groups in this area. Roche and Novo Nordisk resigned The higher-performing group consists from IPASA shortly after the allega- of ten companies that provide conser- tions were made public, and Novartis vative support to a subset of flexibili- released a statement distancing itself ties set out in the TRIPS agreement. from the proposal.10,11 They do not, for example, completely acknowledge the situations where In addition, in 2013, Novartis and Bayer compulsory licensing is permissible. were involved in court cases in India These companies are: Bayer, Eisai, Eli relating to the application of TRIPS Lilly, Gilead, GSK, Johnson & Johnson, flexibilities: Merck KGaA, Novartis, Novo Nordisk and Sanofi. Of this group, Eisai, Eli Lilly • The patentability of Novartis’ cancer and GSK are the most supportive of drug imatinib (Gleevec®) was denied TRIPS flexibilities, explicitly supporting by the Indian Supreme Court on the multiple flexibilities. basis that it was a modification of an existing drug that brought no signifi- The remaining ten companies are even cant additional efficacy.12 more conservative, disclosing either • Bayer’s challenge against a compul- limited, non-specific policies relating to sory licence issued by India was also these agreements, or no policy at all. unsuccessful. The compulsory licence These companies are: AbbVie, Astellas, was India’s first, and was issued for AstraZeneca, Boehringer Ingelheim, sorafenib (Nexavar®), a liver and Bristol-Myers Squibb, Daiichi Sankyo, kidney cancer medication.13 Merck & Co., Pfizer, Roche and Takeda.

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innovation Tiered royalties bring licensing to more middle income countries

The 2014 Index looked for unique Index welcomes the readiness of some disease burden is concentrated,14 and approaches to intellectual property companies to test novel approaches to because it is also in these countries management that take affordability licensing that will enable the exten- where companies have typically main- into account. Although such innova- sion of licensing agreements to more tained a more conservative stance on tion remains scarce, there is evidence middle income countries. This is impor- intellectual property management. of progress in the domain of licensing, tant because it is the middle income led by the Medicines Patent Pool. The countries where the bulk of the world’s

Targeting poor patients in richer countries

GSK and Pfizer, via their joint-venture The royalties vary depending on the ViiV Healthcare, signed two licensing income level of the countries. In Least agreements for HIV drug dolutegravir Developed Countries, low income (Tivicay®) with the Medicines Patent countries and sub-Saharan-Africa, Pool.15,16 One of these is novel because licensees can manufacture and sell it segments between public and private dolutegravir (Tivicay®) without paying markets and introduces a tiered royalty royalties. In the six additional middle structure in order to enable more income countries mentioned, a tiered middle income countries to benefit royalty structure based upon each from access to generic medicine. This country’s GDP applies, and sales are applies in six middle income countries: restricted to public markets (funded by namely Egypt, India, Indonesia, the Governments, UN organisations, and Philippines, Turkmenistan and Vietnam. NGOs). ViiV Healthcare reserves the In addition, the licence also covers all right to operate in the private market. countries in Sub-Saharan Africa, Least Developed Countries and low income Through its tailored approach to countries, and allows manufacturers different markets and their ability to to sell in 50 additional countries. This pay, this licence has the broadest scope means the licence could benefit 93.4% of any licence for an adult medicine of adults living with HIV. examined by the Index.

For numbered references, see the Appendix. c These agreements were announced on September 15 2014 - outside of the reporting period. a Neutral scoring is discussed more fully in the Appendix. d Related to nevirapine (Viramune®), the compound pat- b Poor performance in patenting commitments should ent of which has recently expired. also be read in the light of whether or not, and how broadly, the companies licence their products. (GSK e It is relevant to note that the patents on efavirenz, which and Gilead, for example, engage in substantial licensing some of these licensing agreements relate to, have practice across their HIV/AIDS portfolios which cover a largely expired during 2013. broad geographic spread of countries)

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F Capability Advancement

Some of the highest barriers to access to medicine relate to gaps in local healthcare infrastructure and supply chains. Large multinational pharmaceutical companies often have both the know-how and a long-term strategic incentive to help fill these gaps. Companies can draw on their capabilities andexpertise to increase the availability of quality-assured, safe and effectivemedicine and healthcare, while simultaneously helping to build and strengthen future markets.

The Index looks for long-term, systemic company engagement with local stakeholders that is aligned with local needs and aims to strengthen the skills, competencies and abilities of people living in relevant countries, while taking potential conflicts of interest into account. Low income countries generally have the greatest need for capability advancement, consequently the Index places a higher value on activities carried out in these countries.

In general, capability advancement activities are voluntary. In some countries, companies are legally required to invest in local capabilities to some degree (for example in quality management and pharmacovigilance).

Five areas of analysis

Research & Development Reporting on how companies work with local partners to build capabilities in basic, applied and clinical research.

Quality management in manufacturing Reporting on how companies are improving local quality management skills, to help ensure locally produced medicines meets (international) quality standards.

Supply chain management Reporting on how companies are addressing poorly functioning supply chains.

Pharmacovigilance Reporting on how companies are actively working to strengthen national pharmacovigilance systems.

Activities beyond the value chain Reporting on how companies are building other local capacities, for example, by training healthcare workers, building health infrastructure and supporting health-awareness or stigma-reduction campaigns.

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Top findings in Capability Advancement

Most companies are building a range of local Most companies build supply chain capaci- capacities ties, but long-term initiatives remain scarce Most companies are building local capabilities In 2014, 17 companies were found to be building in each of the five focus areas. However, their local capacities in supply chain management (up activities are often part of short-term collabora- from 15 in 2012). In this area, these 17 companies tions. The industry is actively building capacities are active in 67 out of 106 countries in scope. in a wide range of countries. More companies However, most of their activities are short-term are active in China than any other country within in nature. Long-term initiatives are more likely to scope, followed by Indonesia, and India. More produce sustainable improvements in the supply than two-thirds of companies are active in at of medicines. least one low income country.

18 companies are building local R&D capaci- Smaller companies gain on larger peers in ties, in four distinct ways building local manufacturing capabilities As in 2012, 18 companies are helping to build Since 2012, nine companies have increased their local research capacity: with a focus on China, efforts to build local manufacturing capabili- followed by Brazil, Kenya, South Africa and ties. Of these, eight have annual revenues below Uganda. Their efforts fall into four distinct USD25 billion. Their larger peers, with annual categories: revenues above USD40 billion, provide no • Collaborating on drug discovery with local evidence of expanding or deepening their activi- organisations. ties in this area. Only one of these larger compa- • Providing training on clinical trial conduct. nies increased its activities in this area. • Providing research grants, fellowships and exchange placements. • Promoting and enabling scientific careers. More companies are supporting the development of national pharmacovigilance systems In 2012, eight companies provided evidence that they are supporting the efforts of certain countries to build national pharmacovigilance systems. In 2014, this has more than doubled: 17 companies are now actively contributing in this area, in a total of 39 countries. Ghana, India and Vietnam receive the most attention from companies.

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How the companies perform

Most scores are largely comparable to Figure 46 2012, although the companies at the Company Ranking Capability Advancement bottom are making greater progress. Most companies are building local 1 4 Novo Nordisk 3,9 capabilities in each of the five focus 2 = 2 Sano 3,8 areas and companies are more active 3 7 Novartis 3,8 in the areas of quality management in 4 12 Boehringer Ingelheim 3,5 manufacturing, supply chain manage- 5 1 GSK 3,5 ment and pharmacovigilance. 6 3 Johnson & Johnson 3,3

Leaders engage in a long-term 7 8 Merck & Co. 3,3 systemic manner 8 17 AstraZeneca 3,1 Novo Nordisk, Sanofi and Novartis 9 6 Bayer 3,0 comprise the leading group. They 10 5 Merck KGaA 3,0 engage with local stakeholders in a 11 = 11 P zer 2,9 long-term, systemic manner, and are 12 n/a AbbVie 2,8 among the leaders in all five of the 13 9 Roche 2,6 areas the Index examines. 14 10 Gilead 2,5 Novo Nordisk has moved up from 4th 15 16 Eli Lilly 2,0 to 1st position in this area. It performs 16 14 Eisai 2,0 particularly strongly in R&D, quality 17 13 Takeda 2,0 management in manufacturing, supply 18 = 18 Bristol-Myers Squibb 1,8 chain management and areas outside 19 = 19 Astellas 1,5 of the value chain. It disclosed clear 20 = 20 Daiichi Sankyo 1,2 access rationales for its R&D partner- 2014 2012 ships in relevant countries. The need 0 1 2 3 4 5 for additional capacities is potentially Commitments Transparency Performance Innovation highest in low income countries. Novo Nordisk engages with governments of several low income countries regarding supply chain management and at least bility building. It is the only company Roche and Gilead. In general, they are one local manufacturer. to provide evidence of sharing post- active in all areas of capability advance- marketing safety reports with authori- ment, but do not consistently demon- Sanofi follows in 2nd place with strong ties in relevant countries beyond legal strate alignment with local needs or performances in capability advance- requirements. structured, long-term engagement ment for R&D, supply chain manage- with partners. AstraZeneca and Boeh- ment and activities beyond the value Middle group: less alignment with ringer Ingelheim are both new to the chain. It is also innovating: the Sanofi local needs middle group. They are both engaged in Espoir Foundation is working with The leaders are followed closely by a large programmes to raise awareness the International Confederation of pack of 11 companies, the majority of and increase access to healthcare for Midwives (ICM) on an online platform which also ranked in the middle group marginalised communities. for midwives to address maternal and in 2012. Eight of these 11 companies newborn mortality worldwide. increased their scores since 2012, Little activity from one-third of bringing them closer to the leading companies Novartis jumps from 7th place to 3rd, companies. These companies are: Six companies are ranked toward the close behind Sanofi, due in part to its Boehringer Ingelheim, GSK, Johnson bottom: Eli Lilly, Eisai, Takeda, Bristol- leading and improved performance in & Johnson, Merck & Co., AstraZeneca, Myers Squibb, Astellas and Daiichi the area of pharmacovigilance capa- Bayer, Merck KGaA, Pfizer, AbbVie, Sankyo. These companies are the least

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active in capability advancement in all areas, but particularly when it comes Companies build capabilities in 75 out of to pharmacovigilance, supply chain 106 countries management and activities beyond the value chain. This map shows the number of companies per relevant country actively contributing to the development of local capabilities in at least one of four areas within the value chain, i.e. R&D, quality management in manu- Biggest risers: AstraZeneca and facturing, supply chain management and pharmacovigilance.b Boehringer Ingelheim Both AstraZeneca and Boehringer Ingelheim rose significantly compared to 2012: up nine and eight places respectively. Both companies showed increased activity in the areas of pharmacovigilance and quality management in manufacturing. In addition, they both expanded large programmes to raise awareness and increase access Companies are enhancing local manu- to healthcare for marginalised commu- facturing capabilities in nities. Novartis is another big riser, only countries moving up four places with evidence 19 that it has increased its activities in the area of pharmacovigilance.

Furthest faller: Merck KGaA Merck KGaA falls the furthest (five places from 5th to 10th). Roche, Gilead and Takeda each fell four places. While these companies improved slightly since 2012, other companies overtook them. GSK also dropped four places, losing its leading position in capability advancement in the 2012 Index due to stricter scoring criteria and changes in R&D hubs: 5 countries a Figure 47 methodology. with the most companies ≥ 10 companies active strengthening R&D capacities: 5 to 9 companies active China, Brazil, Kenya, South Africa, Uganda 3 or 4 companies active 1 or 2 companies active no companies active country out of scope

Most companies are building a range As in 2012, one-third of companies of local capabilities provided evidence of innovation in Most companies are building local capability advancement, particularly capabilities in each of the five focus when it comes to building capabili- areas. However, their activities are ties in supply chain management and often part of short-term collabora- beyond the value chain. tions. Most of their activities relate to quality management in manufacturing, The industry is actively building capaci- which is to be expected as this is the ties within the value chain (i.e., in R&D, area where companies carry the most quality management in manufacturing, responsibility. Activity in the areas of supply chain management and pharma- quality management in manufacturing, covigilance) in a wide range of countries. supply chain management and pharma- More companies are active in China covigilance has increased since 2012. than any other country within scope:

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industry

countries with the most 6 capacity building activity: China, Indonesia, India, Philippines, Morocco, Kenya.

Last mile challenge: In sub-Saharan Africa, companies mostly focus on supply chain management, then 9 countries in pharmacovigilance. sub-Saharan Africa where no companies are helping to build supply chains. East Asia & Pacic 12 Benin, Burundi, Sub-Saharan Africa 6 Cape Verde, Europe & Central Asia 4 Chad, Comoros, Latin America & Caribbean 4 Equatorial South Asia 4 Guinea, Guinea- Middle East & North Africa 1 Bissau, Niger, Centre of donut 31 São Tomé and Principe. 31 countries in scope where no companies are building capacities in the four areas linked to the value chain

17 are engaged in capacity building here Middle East & North Africa in at least one area measured by the South Asia East Asia & Pacic Index. This is followed by Indonesia, with 13 companies, and India, with 11. Latin America & Caribbean More than two-thirds of companies Europe are active in at least one low income & Central Asia Sub-Saharan Africa country (companies not active in low income countries are AstraZeneca, Bristol-Myers Squibb, Daiichi Sankyo, Eisai, Roche and Takeda), mainly Kenya, where ten companies are active, Uganda (seven companies) and Ethiopia (six companies).

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focus area 1

Research & Development Almost all companies build local R&D capabilities

Why this matters

Where there is more local R&D and clinical research. They can fund The Index looks at how often compa- capacity, there is a greater chance research projects, build and participate nies engage in activities to build local that new products will be suitable for in knowledge-sharing initiatives, or R&D capacity. It also examines whether local people. Through partnerships provide training for clinical, scientific these activities are long term, and and involvement with local research or technical researchers and managers, whether they are supported by an institutes or universities, pharma- such as data managers and clinical trial access rationale that takes gaps in the ceutical companies can help build managers. local labour market into account. local capabilities in basic, applied

How the companies perform

In general, the industry is reason- Figure 48 ably active in this area. This is to be Four main approaches to building R&D capabilities expected as companies benefit directly Number of companies engaging in each activity from the new products that result from research collaborations. As in 2012, Drug discovery collaborations 18 companies engaged in at least one Clinical trial conduct training relevant activity. Only two companies Research grants, fellowships and exchanges provide no evidence of building R&D Promoting and enabling scientic careers 0 3 6 9 12 15 capabilities in any relevant country. In total, the Index identified 48 separate initiatives for building local R&D capacities, including collaborations term partnership. The laggards are companies are active here: Boeh- with universities and public institutes. Daiichi Sankyo and Eli Lilly, which ringer Ingelheim, Eisai, GSK, Johnson Of these initiatives, 11 were long term provided no evidence of relevant & Johnson, Merck & Co., Merck KGaA, (≥ 5 years). Companies are most active activity. Novartis, Novo Nordisk and Sanofi. in China, where eight companies are • Providing research grants, fellow- actively building R&D capacity. Other Companies build R&D capacities in ships and exchange placements for countries where companies are rela- four distinct ways researchers, laboratory technicians, tively active are Brazil, Kenya, South When it comes to strengthening R&D managers and students from relevant Africa and Uganda. capabilities, Index analysis shows that countries. Eight companies are active companies engage with local stake- here: AbbVie, Astellas, Gilead, GSK, Companies frequently take local needs holders in four ways: Pfizer, Roche, Sanofi and Takeda. and labour gaps into account when • Collaborating on drug discovery with • Promoting and enabling scientific engaging in this type of activity. Of the local organisations, such as universi- careers, for example by hosting 18 companies active in this area, nine ties, hospitals or health authorities. lectures and training workshops, in provided access rationales for at least 13 companies are active here: AbbVie, relevant countries. Four companies half of their collaborations and seven AstraZeneca, Bayer, Boehringer are active here: AbbVie, Eisai, Merck provided evidence of this for all their Ingelheim, Bristol-Myers Squibb, GSK, KGaA and Novartis. R&D initiatives. Johnson & Johnson, Merck & Co., Merck KGaA, Novartis, Novo Nordisk, Boehringer Ingelheim, Gilead, Novartis Pfizer and Roche. and Novo Nordisk are in the lead here. • Providing training on clinical trial These companies all engage in at least conduct, for example on Good Clin- one relevant activity, disclosed clear ical Practices (GCP), when conducting access rationales for their relevant trials in relevant countries with initiatives and had at least one long- publicly funded organisations. Nine

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focus area 2 Quality management in manufacturing Smaller companies gain on larger peers in building local manufacturing capabilities

Why this matters

The WHO has provided a blueprint in its and lower-middle income countries, in-house manufacturers in relevant Good Manufacturing Practices, or GMP, companies can help improve the quality countries to help them implement for ensuring that products are consis- of medicines. In some countries, local Good Manufacturing Practices and/ tently produced to high quality stan- governments may require companies to or to help build or strengthen quality dards. With their broad global reach, engage in local production as a condi- management systems. The Index looks companies have extensive experience tion of their operating license. at, for example, training initiatives, in meeting these international stan- workshops, consultancies and tech- dards. By transferring their knowledge The Index examines whether compa- nology transfers. to local manufacturers in low income nies work with both third-party and

How the companies perform

All companies commit to supporting the area of quality management in innovation in-house and third-party manufac- manufacturing, comparatively smaller turers in adhering to international companies are gaining on their larger Merck KGaA – Global support for manufacturing standards. Collectively, peers (i.e., those with annual revenues local plant managers 19 companies provided evidence of 99 above USD40 billion). Only one of these relevant engagements with local manu- larger companies increased its activi- By transferring their knowledge to facturers in 19 countries covered by the ties in this area. local manufacturers, companies can Index, including training initiatives and help improve the quality of locally technology transfers. Roughly 74% of Boehringer Ingelheim, Merck & Co. and produced medicines, and harmonise these were with third-party manufac- Novo Nordisk are the best performing processes to improve manufacturing turers. Only three companies engaged companies in this area. They each efficiency. with manufacturers in low income provided more than five examples of Merck KGaA is creating a ‘Virtual Plant countries, where the need is most likely engagements with local manufac- Team’ to support its global contract- highest. turers to improve quality management, manufacturing network in achieving including in low income countries. and upholding local and global quality Compared to 2012, nine companies Bayer, GSK, Merck KGaA, Novartis and standards for manufacturing. Once up have increased activity in this area, Roche also support manufacturers and running, this platform will provide eight of which have annual revenues in these countries, but provided no local plant managers with support, below USD25 billion,c making them evidence of doing so in technology expertise and regular training in order comparatively smaller than other transfers and training initiatives. to harmonise manufacturing standards companies in the Index. As such, in across all its in-house and third-party At the other end of the spectrum are manufacturers. AbbVie and Bristol-Myers Squibb. Figure 49 AbbVie commits to providing support Most technology/knowledge transfers in this area, but discloses no detailed with third-parties evidence that it does so in practice. Bristol-Myers Squibb expects third- With in-house party manufacturers to adhere to local facilities manufacturing standards and makes no commitment to providing support here. However, it does commit to a With third-party technology-transfer support package manufacturers via the Medicines Patent Pool.

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focus area 3

Supply chain management Most companies active, but few initiatives are long-term

Why this matters

Poorly functioning supply chains can The Index examines how companies • Demand forecasting – increasing the create significant barriers to access. engage with governments and regula- ability of national and international They can increase the risk that health- tors, distributors and stakeholders authorities, distributors and local care providers cannot keep sufficient from up and down the supply chain in healthcare providers to estimate stocks, lead to over-purchasing and order to strengthen local capabilities in demand quality deterioration, and facilitate supply chain management. Specifically, • Stock management – helping to the infiltration of spurious, falsely- it looks at whether companies provide prevent or reduce stock-outs and labelled, falsified, counterfeit prod- on-the-ground training and whether product deterioration, and ensure ucts. It can also lead to the diversion they share information on any of the that products remain available of lower-priced brand variants away following six elements of supply chain • Product diversion – helping to from the low-income populations they management: prevent lower-priced brand variants target. Many organisations are already from being diverted toward higher- working to improve pharmaceutical • Drug regulation – strengthening income populations (at a mark-up) supply chains, and the companies that regulatory frameworks and away from their target market make the products have much to add • Supply chain alignment – supporting • Counterfeiting – helping to to their efforts. Not only would this the integration or alignment of prevent and detect the export, benefit patients, but the resulting processes up and down the supply import and smuggling of spurious, improvements in forecasting and chain falsely-labelled, falsified, counterfeit procurement management would also products. benefit companies.

How the companies perform

This Index, 17 companies provided evidence of activities to strengthen Figure 50 local capabilities in supply chain Industry mostly focuses on reducing counterfeiting management (up from 15 companies Number of companies active in on-the-ground training per area of the supply chain in 2012). As in 2012, initiatives regularly cover multiple aspects of supply Counterfeiting chain management, yet they are Stock management usually ad hoc and small scale. Only Supply chain management three companies provide evidence of Supply chain alignment long-term engagement (≥ 5 years) with Demand forecasting relevant partners. Three companies Product diversion do not engage in capacity building in Drug regulation supply chain management. Collectively, 17 companies cover 67 countries (out of 106 countries in scope), including 24 low income countries. The most by training on supply chain0 manage2 - 4 Sharing6 information8 10to align supply companies are active in: China (7); ment, stock management and how to chains Kenya (6); Nigeria (5). safeguard product quality. Regarding Ten companies are active in this area: information sharing, companies mostly AbbVie, Eisai, Gilead, GSK, Johnson & The majority of the on-the-ground focus on increasing supply chain Johnson, Merck & Co., Merck KGaA, training relates to counterfeitingd alignment and improving demand Novo Nordisk, Sanofi and Pfizer. They commonly involving teaching govern- forecasting, with product diversion focus on different aspects and employ ment officials how to recognise receiving the least company attention. a range of approaches: authentic products. This is followed

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observation • Working with national governments innovation to study local supply chains and support their redesign Skills transfer to aid detection of Forward integration of supply • Working with international and local counterfeit medicines chains organisations to improve, redesign or align supply chains Counterfeit or falsified medicines Forward integration of supply chains • Engaging with other companies to are deliberately and fraudulently involves company collaboration with align demand forecasting and the mislabelled. They can harm patients warehouses, distributors, health supply of donated medicines because they may include the wrong facilities and other downstream part- • Combining technology transfers with ingredients, the wrong amounts of ners. Sharing of accurate information the training of procurement agencies active ingredient or come in fake pack- with these partners in a timely manner aging, which may, for example, have can help ensure supply chains function Sharing information to improve misleading directions for use. smoothly. demand forecasting Regarding demand forecasting, compa- Novo Nordisk is working with the Merck & Co. participated in an innova- nies take a much more homogenous Bangladesh government to train staff tive pilot led by IntraHealth and funded approach. Eight companies share at its National Drug Control Laboratory by the Bill & Melinda Gates Foundation information on this with global agen- on relevant regulations and laboratory aimed at the forward integration of cies (including procurement agencies), techniques. Such activities can help supply logistics. Under this ‘Informed national governments and local distrib- increase a country’s ability to detect Push Model’, trained logistics staff visit utors. Broadly speaking, they either counterfeit medicines. health facilities to review inventories in focus on improving stock management order to plan for the timely restocking systems, or contribute to the exchange GSK has a programme for coordinating of contraceptives. The pilot was and aggregation of relevant data. donations of scientific equipment by conducted in two districts in Senegal, pharmaceutical companies and for and reduced stock-out percentages Leaders strengthen multiple links in ensuring that the skills needed to for two types of contraceptives from supply chain operate the equipment is transferred 86% and 57% to 0% in one district. Such Pfizer takes the lead in this area, to laboratory staff. The company a pro-active approach can also free followed by Merck & Co., Novo Nordisk conducts audits to check that equip- medical staff from logistics planning. and Sanofi. These four companies all ment has arrived and is being imple- actively build capacities in supply chain mented safely. This approach was Merck KGaA has developed a software management in three or more of the piloted in Pakistan in collaboration tool that can improve stock manage- areas covered by the Index. Pfizer leads with other companies, the WHO, the ment. The tool is integrated with Merck because it shares information on the Pakistan pharmaceutical industry KGaA’s order management system, so most elements of supply chain manage- body, drug regulatory authorities and that customers can enter their orders ment (namely, supply chain alignment, Ministry of Health. The company plans directly into the company’s internal demand forecasting, product diversion, to expand this programme to African system. This integrated ordering stock management and counterfeiting). countries. process improves price transparency Novo Nordisk and Sanofi follow close and reduces lead time and miscommuni- behind. They both provide evidence of Merck KGaA works with the Global cation. The company has recently tested engaging in long-term programmes, Pharma Health Fund (GPHF) to this tool in Sudan and Ethiopia and plans but across fewer elements. support its MiniLabs programme, to expand it to more countries. which provides portable, compact The laggards in this area are Astellas, laboratories for conducting rapid, Boehringer Ingelheim and Daiichi in-the-field verification of drug quality Sankyo. These three companies and for the detection of counterfeit provided no evidence of relevant medicines. Since 2012, the number of capacity building activities. medicines that the MiniLab can test has expanded. The company also provided training seminars and courses on how to use the GPHF MiniLab and participates in external research with the aim of further increasing the variety of medicines that the MiniLab can test.

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observation ‹ Merck & Co. - Informed Push Alignment of supply and demand Model A Senegalese healthworker checks stock Misalignment of supply (e.g., manufac- levels as part of an turers) and demand (e.g., procurers, initiative to improve stock management. healthcare facilities) can result in incorrect demand forecasting, long lead times, and, eventually, stock-outs at the health facility level. Collabora-

tion can improve alignment and reduce IntraHealth© International supply interruptions and stock-outs. ‹ GSK - Vodafone Merck & Co.: During the technology partnership transfer of an ARV, Merck & Co. A healthworker included training initiatives on supply in Mozambique registers an infant's chain management. In addition, the latest vaccination company has shared best production in the partnership's practices with the Chinese authorities database. and government officials. This type of activity can improve communication between the supplier and procurer, resulting in fewer supply interruptions. © GSK

innovation ‹ Pfizer - Global Health Fellows GSK: GSK is collaborating with A Global Health Vodafone in Mozambique to assess Fellow provides whether mobile technology can on-the-ground assis- increase vaccination rates. Through tance to strengthen the supply chain in SMS messaging, the company aims to Nairobi, Kenya. encourage mothers to use vaccination services. The pilot also aims to increase accurate demand forecasting and reduce vaccine stock-outs by sending

reminders to healthcare facilities to © Pfizer, Inc. report on vaccine stock levels.

best practice Pfizer – Optimizing supply chains

Supply chains are complex, and often Through Pfizer’s Global Health Fellows The plan defines quality standards unique to specific products and programme, the company has sent for health commodity providers and regions. A case-by-case approach that its supply chain experts to address addresses information needs across targets multiple aspects up and down breakdowns in the supply chain. Its the supply chain. the supply chain can improve access to experts have worked with organisa- medicine. tions in Kenya and Tanzania to improve procurement and stock management; to maintain supply chain integrity; and to improve quality control management. For example, Pfizer provided expertise to the NGO Management Sciences for Health to help it develop a master supply-chain plan in Kenya.

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focus area 4 Pharmacovigilance Majority of companies support national pharmacovigilance systems

Why this matters

Even after a medicine or vaccine systems are either lacking or inefficient. The Index looks for long-term engage- has received market approval, much Establishing these systems is primarily a ments that are aligned with national remains unknown about its risks and government responsibility. Yet compa- or regional plans, and for companies benefits – particularly when used in nies can make a considerable contribu- to voluntarily disclose their post- certain populations for the first time, tion by drawing on their knowledge and marketing surveillance data to national or in resource-limited conditions. experience of collecting and reporting governments in relevant countries. In mature markets, comprehensive safety data. The Index looks for compa- Such voluntary data sharing can help national pharmacovigilance systems nies to engage with local authorities build strong central information reposi- ensure medicine use is efficiently moni- and other stakeholders, when possible, tories where more robust pharmaco- tored and evaluated, and that the results to help establish and support national vigilance systems are lacking. are communicated and acted upon in a pharmacovigilance systems. This timely fashion. However, in many of the support could take the form of second- countries covered by the Index, such ments, consultancy or training.

How companies perform

Most companies engage in this kind tries. Governments play a key role in Figure 51 of capability building to some extent: enabling companies to take on this role. Large increase: 9 additional companies 17 companies (up from 8 in 2012) The data captured by the Index indicate contribute to national pharmacovigi- are active in this area, in a total of that companies are responding to lance systems 39 countries: opportunities, although there is scope • 11 low income countries; for improvement, particularly in the • 16 lower-middle income countries; voluntary sharing of post-marketing

• 12 upper-middle or high income surveillance data. countries. The highest numbers of companies The leaders in this area are Novartis, 2012 2014 are active in: China (seven companies), Bayer and Johnson & Johnson, Brazil, Ghana, India and Vietnam (each followed by Sanofi and GSK. These four companies). companies engage with governments evidence. AbbVie, Bayer and Pfizer on a regular basis and in a wide range indicate they are willing to share safety Companies typically engage in training of relevant countries. data beyond legal requirements upon initiatives, roundtables and consultan- request from authorities. cies with national health authorities. The laggards in this area are Gilead, These are mostly conducted ad hoc Takeda and Eli Lilly, which provided Merck & Co. is notable for its extensive, rather than as part of a structured long- no evidence of engaging with govern- long-term collaborations with inter- term engagement programme. Johnson ments or other relevant stakeholders national partners and local NGOs. For & Johnson, Sanofi and Merck & Co. to help build national pharmacovigi- example, the company engages with the stand out for engaging in multiple initia- lance systems. African Comprehensive HIV/AIDS Part- tives, including long-term activities (≥5 nership (ACHAP) in Botswana to collect years). Seven companies take a positive Notable practices safety data on the company’s ARVs. stance towards voluntary data sharing. Novartis is the only company that However, only Novartis provided provided evidence of voluntarily GSK is piloting a new crowd-sourcing evidence of engaging in such activity. sharing post-marketing safety reports platform: it enables patients in relevant with authorities in relevant countries. countries to report adverse events Due to local factors, companies are not GSK, Johnson & Johnson and Merck using low-tech solutions, such as SMS able to engage in pharmacovigilance & Co. state that they voluntarily share or telephone calls. GSK aims to roll out capability building in all relevant coun- data but do not provide supporting this platform in Africa.

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focus area 5

Building capacities beyond the value chain Most companies build capacities beyond the value chain

Why this matters

There are many ways for companies tion campaigns. Such activities can work directly with patient organisa- to build local capabilities beyond the improve access to medicine directly, for tions or healthcare professionals. To value chain. These can be classified into example by improving and supporting identify potential conflicts of interest, three broad groups: training doctors, diagnosis and treatment, and indirectly, the Index asks whether initiatives pharmacists, lab technicians and other for example by improving treatment- involve reputable organisations, such healthcare workers; building health seeking behaviour. as the WHO, established NGOs or infrastructure, such as laboratories governments. and treatment centres; and supporting Conflict of interest can be an issue health-awareness or stigma-reduc- here, in particular when companies

How the companies perform

The industry is collectively building engaging in five or more relevant initia- At the bottom of the pack, four compa- capacities in all areas measured here tives: Boehringer Ingelheim, GSK, Novo nies provided no evidence of relevant (training, infrastructure improve- Nordisk and Sanofi. Companies’ initia- capability advancement initiatives ment and awareness raising). A total tives are often disease-specific and that met all of the criteria for inclu- of 16 companies engage in at least often combine elements of training and sion: Astellas, Daiichi Sankyo, Eisai and one initiative beyond the value chain. awareness raising. Gilead. Four companies show leadership by

‹ Sanofi - The Connecting Midwives platform Sanofi's platform supports midwives in rural areas. Here, a midwife teaches a young mother in Ethopia about hygiene. © AMREF Flying Doctors

‹ AstraZeneca - The Young Health Programme A Zambian student from an area impacted by HIV/ AIDS learns about sexual and reproductive health. © Paolo Black

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observation innovation innovation

Improving diabetes care with SMS Raising awareness among margin- Supporting healthcare providers services alised communities to improve maternal and neonatal health Diabetes patients using insulin Educating communities on disease often require support from health- recognition and prevention and on Two of the UN Millennium Develop- care providers to better manage improving healthcare seeking behav- ment Goals aim to reduce maternal their disease and improve disease iour can have beneficial effects on and child mortality. Training midwives outcomes. health and disease outcomes. and tracking disease and outcome rates can contribute to reaching these 2companies AstraZeneca’s Young Health goals. Sanofi, Novo Nordisk Programme focuses on disease prevention and awareness raising The Sanofi Espoir Foundation has set Together with Vodacom, Sanofi has among adolescents, and involves Plan up, in collaboration with the Inter- created a support programme for International and the Johns Hopkins national Confederation of Midwives, diabetes patients living in Africa. This Bloomberg School of Public Health. It a global forum called Connecting programme is based around a mobile- covers four countries within the scope Midwives. This online platform allows phone application that enables patients of the Index (Brazil, China, India and midwives to share experiences, to interact with their healthcare Zambia). It is relatively innovative in ideas, projects and innovations, and providers in real time. Once the patient that it targets marginalised segments to propose field projects that aim to has been introduced to the Vodacom of local populations. The programme reduce maternal and neonatal death or platform in a face-to-face session, they aims to improve awareness of hygiene, improve maternal and neonatal health receive regular messages, tips and sexual and reproductive health, infec- in the most underserved areas. The advice via SMS to help them manage tious diseases and environmental harm Sanofi Espoir Foundation will provide their diabetes. Nurses track patients’ due to water and air pollution. financial support to ten such local progress via a smartphone app, while initiatives in 2014. doctors use a web-based platform. Boehringer Ingelheim’s Making More Patients are encouraged to respond Health Initiative (MMH) is a fellow- AbbVie has supported the develop- to questions regarding their diabetes ship programme that provides support ment of a national neonatal registry management via free text messaging. to individuals who are implementing for the Philippines, in collaboration new ideas for improving health in their with the Philippine Society of Newborn Novo Nordisk partners with the communities. These individuals are Medicine. In line with national needs, Copenhagen School of Global Health all members of Ashoka, a network the registry is the first step toward and Airtel in a similar project, ‘SMS organisation of ‘social entrepreneurs’, controlling disease among newborns, diabetes’, in Gabon. It provides a free Boehringer Ingelheim’s partner in providing the potential to track disease SMS service for patients to use to ask MMH. The aim of the programme is and outcome rates. their doctor questions about their to combine Boehringer Ingelheim’s diabetes. Patients receive a reply business knowledge and the social within 24 hours. This approach frees knowledge of Ashoka and its members. time for the few diabetes specialists in MMH contains components of capacity the country. building and philanthropy, and covers several countries within the scope of the Index. It is also relatively innovative for its focus on marginalised and stigmatised communities and socially sensitive subjects, such as mental health and sanitation.

a This analysis is partly based on new and refined c Revenues are based on 2013 Annual Reports and cover d This only includes activities relating to improving the indicators. See the Appendix for more information on all business segments. Revenues not reported in USD skills of local organisations and people working in this Scoring Guidelines. were converted using exchange rates on 4th September field. It does not include implementing anti-counter- 2014. Within the Index scope eight companies have feiting technologies, such as overt and covert features, b This analysis excludes regional initiatives for which no annual revenues above USD40 billion and 12 companies forensic techniques and serialisation. separate countries were specified. This equals 5.0 % of have annual revenues below USD25 billion. initiatives.

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126 Access to Medicine Index 2014 Product Donations & Philanthropic Activities

G Product Donations & Philanthropic Activities

For millions of people worldwide, donation may represent their only chance of gaining access to the medicines they need – particularly if they live in poor, rural and isolated regions where healthcare systems do not function. Pharmaceutical companies have been involved in product donations for many years, and the magnitude and impact of individual programmes on access to medicine can be substantial.

The Index distinguishes between two types of donation programmes: ad hoc programmes (which respond to acute, short-term needs, such as emergency situations); and structured programmes (which target specific diseases over a longer period). For all donation programmes, the Index looks for compliance with the WHO Interagency Guidelines for Medicine Donation (Revised 2010).1

In resource-limited countries or regions, companies can also improve access to medicine through sustainable philanthropy, namely by providing grants for improving local healthcare capabilities. These can be targeted towards prevention and healthcare for certain diseases, or toward healthcare infrastructure improvements and general patient education programmes.

In this Index, more emphasis is placed on strategic and integrated approaches towards donations and philanthropic activities, with a focus on needs-based initiatives and impact assessments that determine effectiveness.

Three areas of analysis

Product donations Reporting on whether companies engage in product donations that aim to eradicate, eliminate, or control a disease.

Sustainable philanthropy Reporting on companies’ philanthropic activities that align with national and/or international health priorities.

Innovation in donations and sustainable philanthropy Reporting on innovation in donation and philanthropic activities and approaches that can improve their efficiency and impact.

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Top findings in Product Donations & Philanthropic Activities

Neglected tropical diseases are the main Philanthropic initiatives are becoming focus of donations activities more needs-based More than half of the companies in the Index are Compared to 2012, more companies are taking a engaging in structured donation programmes, more strategic, needs-based approach to their amounting to 28 programmes in total. Collec- philanthropic activities. All of the philanthropic tively, they target some communicable and non- activities captured by the Index align with either communicable diseases, as well as ten neglected international health priorities, such as the Millen- tropical diseases. The latter stand out for their nium Development Goals, or to national health long-term commitments and wide geographic priorities. The best performing companies often scopes, frequently covering large proportions of have a separate foundation to manage their endemic regions. Since 2012, four new struc- initiatives, and conform with the best practices tured donation programmes have been initiated. identified by the Index.

Majority of companies ensure donation programmes meet high standards More than half of companies have donation policies that fully adhere to the WHO Interagency Guidelines for Medicine Donations (Revised 2010), with another five companies approaching these standards. Furthermore, most companies that engage in product donations have policies or procedures for ensuring quality along the entire supply chain Five companies have newly implemented such procedures or policies since 2012.

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How the companies perform

The industry performs even better in Figure 52 product donations and philanthropy Company Ranking Product Donations & Philanthropic Activities than in 2012. New structured donation programmes have been initiated, while 1 4 Novo Nordisk 3,6 others have been scaled up. The 2012 2 5 Merck & Co. 3,5 London Declaration on Neglected 3 1 GSK 3,4 Tropical Diseases has proved a cata- 4 6 Merck KGaA 3,4 lyst for action, with many companies 5 8 Novartis 3,3 subsequently extending their commit- 6 3 Johnson & Johnson 3,1 ments and scaling up efforts to tackle these diseases. 7 15 Roche 2,8 8 9 Bayer 2,8 Leaders donate on a large scale 9 10 Eisai 2,7 The top six positions are held by 10 2 Sano 2,6 Novo Nordisk, Merck & Co., GSK, 11 16 AstraZeneca 2,5 Merck KGaA, Novartis, and Johnson & 12 11 Gilead 2,4 Johnson. In terms of scores, these six 13 n/a AbbVie 2,3 companies are tightly packed. 14 7 P zer 2,1 Regarding their structured dona- 15 12 Boehringer Ingelheim 2,0 tion programmes, they all deliver 16 14 Eli Lilly 2,0 top performances across several 17 13 Bristol-Myers Squibb 1,7 parameters, including programme 18 = 18 Takeda 1,7 value, scale and scope, and on the 19 = 19 Astellas 1,4 integration of outcome measures and 20 = 20 Daiichi Sankyo 1,3 impact assessments. In addition, these 2014 2012 companies are all engaged in numerous 0 1 2 3 4 5 sustainable philanthropic activities Commitments Transparency Performance Innovation that adhere to the highest standards examined by the Index. These activities characteristically target local needs, are long term and have specific targets hensive monitoring and reporting Furthermore, these companies score and integrated outcome measures or process. The company is among the particularly highly for their commit- impact assessments. leaders in all areas, including philan- ment level, pledging to support their thropy, and is particularly transparent. structured donation programmes Adherence to the highest standards: until 2020, or until the target disease Novo Nordisk Leaders provide sustainable access is eradicated. These companies also Novo Nordisk is the overall leader for neglected tropical diseases perform well in philanthropy. when it comes to product donations The next three positions are taken by and sustainable philanthropy. Although Merck & Co., GSK and Merck KGaA. All Merck KGaA provides the most its Changing Diabetes in Children three are very close behind Novo Nordisk evidence of innovation regarding programme is not the largest dona- and run a large structured donation donation and philanthropy. Together tion programme in terms of scale and programme that meets the highest stan- with a partner, it is piloting a study scope, the company performs the most dards set by the Index (donations of iver- to investigate needs for sanitation to consistently across all parameters. Its mectin, albendazole, and praziquantel, prevent infection with schistosomiasis structured donation programme meets respectively). These are all mass-drug (in support of its praziquantel donation the highest standards set by the Index, administration programmes that are programme). The pilot is taking place including strict adherence to the WHO referred to in the 2012 London Declara- in Senegal and involves people infected Interagency Guidelines and a compre- tion on Neglected Tropical Diseases.2 with schistosomiasis or living in regions

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where the disease is present. The into account, these four companies to the relevant WHO Interagency results are due in 2014. Merck KGaA is delivered less consistent performances Guidelines. They also have stringent also one of the members of the NTD than the leaders did. Sanofi and Gilead monitoring policies and procedures Supply Chain Forum, together with have large, high-value structured dona- for guaranteeing the delivery of their GSK, Johnson & Johnson, Pfizer, Merck tion programmes, and Sanofi is among donated products to the intended & Co. and Eisai.3 This is a new collab- the leaders in philanthropy. However, recipients. Yet, while they disclosed orative initiative working to improve Sanofi slips out of the leading group details of these ad hoc donations to the delivery of drugs and supplies to for its lack of transparency regarding the Index, they do not make this detail more than 70 countries affected by its decision-making processes for its publicly available. neglected tropical diseases. structured donation programmes and the specifics of its ad hoc programmes. Takeda, Daiichi Sankyo, and Astellas Assessing effectiveness Gilead did not provide evidence of a did not provide any evidence that they Novartis and Johnson & Johnson take donation policy, nor evidence that it donated products to relevant countries 5th and 6th position respectively. They engaged in ad hoc donations. Astra- during the period of analysis. Takeda both stand out for having multiple Zeneca does not have on-going does have a policy governing product structured donation programmes. structured donation programmes, but donations that includes elements of Novartis runs one of the oldest is among the leaders in philanthropy. the WHO Interagency Guidelines. donation programmes, which aims AbbVie took over two structured Astellas provided evidence that its to eliminate leprosy globally, while donation programmes from Abbott in donations in Japan comply with Johnson & Johnson runs one of the 2012. However, it lags other companies elements from the WHO Interagency few large donation programmes that when it comes to including outcome Guidelines. However, it does not have targets HIV/AIDS. Neither company, measures and impact assessments. a global policy for product dona- however, demonstrates that it consis- tions. Daiichi Sankyo states it does tently includes impact assessments or Laggards less involved in large-scale not engage in product donations, as it outcome measures in its programmes. activities does not have systems for meeting the Pfizer, Boehringer Ingelheim, Eli Lilly, standards set by the WHO. If it does Biggest riser: Roche Bristol-Myers Squibb, Takeda, Astellas donate products in emergency situa- Roche is the biggest riser in this area, and Daiichi Sankyo occupy the lowest tions, it relies on partner organisations climbing from 15th to 7th position. This rungs, with a significant spread of to manage distribution. is largely because of the wider scope of scores. the Index, which means that its ongoing structured donation programme quali- Pfizer has two structured programmes, fies for inclusion in this analysis for the but does not fully adhere to the WHO first time. It is a smaller-scale structured Interagency Guidelines and did not donation programme that targets hepa- provide evidence of conducting impact titis. It aligns with WHO Interagency assessments. Boehringer Ingelheim Guidelines and includes measures for had a single structured donation monitoring the supply chain right up to programme that was wound up during the patient. Roche would have climbed the period of analysis following revi- even higher had it demonstrated sions to the WHO’s treatment guide- long-term commitment and provided lines.4 Both Pfizer and Boehringer a rationale for deciding what level of Ingelheim lag in philanthropy. Eli Lilly assistance to provide to each region. has two small structured programmes that target diabetes and mental health. Less consistency from the middle The Index encourages the continuation performers and expansion of these programmes, Bayer and Eisai also stand out for the or a shift to other more sustainable scope and quality of their structured solutions, such as equitable pricing donation programmes. However, they strategies. achieved some of the lowest scores for philanthropy, which kept them out of Bristol-Myers Squibb, Takeda, Astellas the leader group. and Daiichi Sankyo do not have ongoing structured donation programmes. Joining these two in the middle ranks Bristol-Myers Squibb did provide are Sanofi, AstraZeneca, Gilead, and evidence of donating products ad hoc AbbVie. When all parameters are taken for emergency relief while adhering

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industry High performance in product donations and philanthropic activities

As in 2012, companies perform are supported by substantial levels of Compared to 2012, five more compa- strongly in this Technical Area. The commitment and that have clear objec- nies have improved their commitments majority (15) are engaged in long-term tives, integrated outcome measures to ensuring delivery up to the patient by structured donation programmes that and impact assessments. implementing procedures or policies. align with national or international health priorities. In total, 28 such One-third of companies (seven) In practice, this high compliance means programmes were ongoing during the provided evidence of innovation in this that companies are generally working period of analysis, half of which target area, in relation to structured dona- in collaboration with either the WHO, neglected tropical diseases, with the tion programmes and with the aim national governments and/or local rest targeting communicable diseases of improving supply chain efficiency, stakeholders to align their donation and non-communicable diseases. impact on public health, and the programmes with local needs and involvement of local communities. health practices. This approach is being The majority of companies (15) donated applied against neglected tropical products ad hoc for emergency relief, High standards in donation policies diseases, for example, where multiple typically via humanitarian aid-relief and practices stakeholders are combining forces to organisations such as the Red Cross, The industry continues to set high achieve maximum outcomes. Compa- MSF and Project HOPE. During the standards for its product donation nies can have an even greater impact period of analysis, this included emer- programmes. More than half have on public health by integrating their gency relief for Syrian refugees and policies or codes in place that adhere respective donation programmes, people hit by typhoon Haiyan. Only six to all aspects of the relevant WHO thereby addressing multiple disease companies publicly disclose informa- Interagency Guidelines, including areas in relevant regions. tion relating to the type, volume and ensuring the quality and usability of destinations of the products they have their donated products. A further 25% Wide scale and scope of structured donated ad hoc for emergency relief. have codes that are partially compliant. donation programmes These companies are Novo Nordisk, Only Daiichi Sankyo and Astellas have Many structured donation programmes Novartis, Roche, Merck KGaA, Bayer no relevant policies or guidelines in cover much of the area where the and Johnson & Johnson. place. These companies do not typically targeted diseases are endemic, donate products outside of Japan. In especially where neglected trop- All companies in the Index are addition, the majority of companies ical diseases are targeted: these involved in philanthropic activities in engaged in donation have policies programmes typically have wide some respect. Eleven are engaged in and procedures in place for ensuring geographic scopes and are expected to numerous philanthropic activities that quality along the entire supply chain. last more than five years.

focus area 1

Product donations Longer commitments and increased efforts in product donations

Why this matters

Structured programmes are defined time-scale and resources; ongoing Glivec International Patient Assistance as gifts that include medicines or during the period of analysis; active in Program). vaccinesa that are strategically set up countries within the scope of the Index; to target local health priorities and and aligned with national or interna- The Index looks at if and how compa- aim to control, eradicate, or elimi- tional health priorities. Donated prod- nies monitor and assess the effective- nate diseases within the scope of the ucts that fall outside the disease scope ness of their donation operations, Index.b To qualify for this analysis, are excluded, despite that the fact that using either outcome measures programmes must be supported with they may have a substantial impact on (designed to give feedback on the substantial commitments in terms of public health (such as the Novartis’ efficiency of supply chains) and/or

131 Product Donations & Philanthropic Activities Access to Medicine Index 2014

impact assessments (designed to give mine a company’s potential capacity the Index uses each programme’s feedback on the programme’s impact to donate. As companies use many intended duration and geographic on public health). For each structured different measures to calculate the scope to categorise it as either a large programme, its monetary value and the value of donations, this figure is not or small structured programme. company’s revenue is used to deter- used to compare programmes. Instead,

How companies perform

In total, 28 structured donation Figure 53 programmes were ongoing during the Neglected tropical diseases are the main focus of donations programmes period of analysis, four of which were Neglected tropical diseases are the focus of the highest number of structured donations initiated since 2012. Three of these new programme, and by far the highest number of large-scale programmes. programmes target neglected tropical diseases and one targets HIV/AIDS. Communicable diseases Non-communicable diseases Increasing access to medicine for Neglected tropical diseases Large neglected tropical diseases Maternal & neonatal health conditions Small Half of all structured donation Number of donation programmes programmes target neglected tropical diseases, namely trypanosomiasis, Figure 54 Chagas disease, lymphatic filariasis, Majority of companies engage in structured donations programmes leishmaniasis, soil-transmitted helminthiasis, onchocerciasis, schis- Novartis 15 companies run tosomiasis, food-borne tremato- Bayer structured donation programmes, with Johnson & Johnson diases, leprosy and trachoma. The eight companies majority of these programmes (11) Merck & Co. running more than were set up before 2012 and are linked AbbVie one (although the scale and scope Eli Lilly to the 2012 London Declaration on di ers from 2 Neglected Tropical Diseases. These Pzer programme to 11 programmes are run by Bayer, GSK, Sano programme). Johnson & Johnson, Merck & Co., Boehringer Ingelheim Merck KGaA, Novartis, and Pfizer. They Eisai all meet the highest standards set by Gilead the Index, and all companies involved GSK met the shipment targets set out in the Merck KGaA London Declaration.3 Novo Nordisk Roche Three companies initiated other Astellas programmes targeting neglected AstraZeneca Communicable tropical diseases since 2012: one Bristol-Myers Squibb Non-communicable targets leishmaniasis and was initiated Daiichi Sankyo Neglected tropical by Gilead; the other targets lymphatic Takeda Maternal and neonatal filariasis and was initially set up by Number of donation programmes Sanofi before being transferred to Eisai in 2013. Eisai has committed to significantly scale it up and started shipping to the WHO in October 2013. & Co. and Novartis. Each one has an Improved access to antiretroviral extended timeframe and corresponds medicine Small-scale donations for malaria, to national health priorities. They aim HIV/AIDS is the only communicable tuberculosis to reach specific populations living in disease, as well as the only chronic When it comes to communicable relatively small geographic regions, disease, to be targeted by both small- diseases, companies generally engage and target lower respiratory infections, scale and large-scale programmes. in smaller-scale donation programmes. malaria, tuberculosis, and HIV/AIDS. It is the focus of three large-scale There are six such programmes, run programmes in total, run by Boehringer by AbbVie, Johnson & Johnson, Merck Ingelheim, Johnson & Johnson, and

132 Access to Medicine Index 2014 Product Donations & Philanthropic Activities

observation Pfizer. However, Boehringer Ingel- outcomes along the entire supply heim wound up its programme in 2013 chain, up to the patient, in all their following revisions to the WHO’s treat- structured donation programmes. The London Declaration: ment guidelines.4 Of the other two, Nine of these companies go further, coordinating efforts to combat one has been initiated since 2012 and by integrating health impact assess- neglected tropical diseases. provides medicines to children in sub- ments into the strategy underpinning Saharan Africa (Johnson & Johnson), some or all donation programmes. For The signing of the London Declaration while the other provides treatment the majority, impact assessments are in 2012,2 as a response to the WHO for opportunistic infections related to carried out by independent partners Roadmap,5 marked a turning point HIV/AIDS for patients in 63 countries such as the WHO. for millions of patients suffering from (Pfizer). neglected tropical diseases. Since The leaders then, companies have scaled up their Local support for non-communicable The leaders in product donations are: donation programmes enormously. In diseases Novo Nordisk, Merck & Co., Merck 2013, the industry donated approxi- There are no large ongoing structured KGaA, Eisai, GSK, Bayer, Johnson & mately 1.35 billion treatments – an donation programmes that target Johnson and Novartis. All structured increase of 35% compared to 2011.3 non-communicable diseases. However, donation programmes run by the there are five smaller programmes top six companies are supported by Ten companies included in the Index targeting diseases in this group, measures for assessing outcomes endorsed the London Declaration and namely epilepsy (AbbVie), mental and impact. These measures provide have committed to donating products: health disorders (Eli Lilly), hepatitis feedback for improving supply chains Bayer, Eisai, Gilead, GSK, Johnson & (Roche) and diabetes (Novo Nordisk and the programmes’ impacts on public Johnson, Merck KGaA, Merck & Co., and Eli Lilly). These programmes aim health. The leaders’ programmes Novartis, Pfizer and Sanofi. These to reach specific populations living in are managed to very high standards, companies all run structured dona- confined geographic regions where which helps to guarantee quality. They tion programmes that together target needs are high. They offer temporary also include procedures for ensuring lymphatic filariasis, trachoma, soil- relief to patients facing high barriers donated products reach the intended transmitted helminthiasis, onchocer to access to medicine. Most of these communities. ciasis, schistosomiasis, leprosy, programmes were initiated before leishmaniasis, Chagas disease, trypano- 2010: only Roche’s programme was The middle group somiasis and food-borne trematodiasis. launched relatively recently (in 2011). In the middle group of companies are Roche, Sanofi, Eli Lilly, Gilead, All ten companies fulfilled the commit- Maternal and neonatal health Boehringer Ingelheim, Pfizer and ments they made when signing the conditions not targeted by product AbbVie. London Declaration. As a result, the donations supply of medicines no longer needs to There are no structured donation All of these companies run substantial be a barrier to controlling or eliminating programmes that target maternal and and worthwhile structured dona- these diseases. The programmes run neonatal health conditions. These tion programmes. However, when all by Merck & Co., Merck KGaA, and GSK conditions have high disease burdens parameters are taken into account, the have the highest levels of commitment: that disproportionally affect people in leaders deliver stronger, more consis- the companies pledge to continue poor, rural areas, making them appro- tent performances. their donation programmes until the priate candidates for the donation diseases they target are eliminated. models used to combat neglected trop- The laggards ical diseases. The Index encourages The lagging companies are: Astra- Due to their large size and scope, these companies to explore opportunities Zeneca, Bristol-Myers Squibb, Takeda, donation programmes require a collab- for improving maternal and neonatal Daiichi Sankyo and Astellas. None run orative approach to ensure that prod- health through their existing systems any structured donation programmes. ucts reach patients. Their implementa- and supply chains for structured donation and coordination is managed by tion programmes. the United to Combat NTDs consortium, with various stakeholders coming Partners and WHO drive outcomes together in a working group (with GSK and impact measurements representing the industry) to enable Of the 15 companies that engage in greater accountability. Progress is structured donations, 11 provided monitored using scorecards and mile- evidence of having monitoring or stone tables, facilitating continuous reporting procedures for measuring problem solving.3

133 Product Donations & Philanthropic Activities Access to Medicine Index 2014

Timeline of 28 structured donation programmes

For people living in poor, rural and Companies have been engaged in important mechanism for ensuring isolated regions without appropriate product donations for many years. access to medicine. Other, smaller healthcare infrastructure, structured Some programmes go back as far as scale programmes, which are ongoing donation programmes may provide the 1980s. Such long-term durations, in a selection of countries, provide the only chance of access to medicine. combined with wide geographic reach access to medicine for pockets of Moreover, conditions typical to these and commitments to continue for at patients where there is a high need. regions make it relatively easy for least five years or more, make large infectious diseases to spread. structured donation programmes an

Figure 55 Neglected Tropical Diseases 1990 2000 2010 2014 2020

Bayer Trypanosomiasis (type rhodesiense) Suramin (Germanin®) All endemic countries (Africa) Bayer Trypanosomiasis (type gambiense) Nifurtimox (Lampitv) All endemic countries (Africa) Bayer Chagas disease Nifurtimox (Lampit®) All endemic countries (Latin-America) Eisai Lymphatic filariasis Diethylcarbamazine citrate (DEC) 26 countries (Latin-America, Africa, and Asia) Gilead Leishmaniasis Amphotericin B (AmBisome®) 5 countries (highly endemic) GSK Lymphatic filariasis and soil-transmitted helminthiasis until elimination goals Albendazole (Zentel®) 58 countries (LF); 45 countries (STH) Johnson & Johnson Soil-transmitted helminthiasis Mebendazole (Vermox®) 16 countries (Latin-America, Africa, and Asia) Merck & Co. Onchocerciasis and lymphatic filariasis until elimination goals Ivermectin (Mectizan®) 35 countries (onchocerciasis endemic) Merck KGaA Schistosomiasis until elimination goals Praziquantel (Cesol®) 18 countries (endemic) Novartis Leprosy Multi antibiotic treatment Global (Latin-America, Africa, and Asia) Novartis Food-borne trematodiases Triclabendazole (Egaten®) Global (Latin-America, Africa, and Asia) Pfizer Trachoma Azithromycin (Zithromax®) 28 countries (Africa and Asia) Sanofi Trypanosomiasis Melarsoprol (Arsobal®), pentamidine (Pentacarinat®), eflornithine (Ornidyl®) Sub-Saharan Africa Sanofi Lymphatic filariasis Diethylcarbamazine citrate (DEC) 6 countries (Africa and Asia)

134 Access to Medicine Index 2014 Product Donations & Philanthropic Activities

1990 2000 2010 2014 2020 Communicable Diseases

AbbVie Lower respiratory infections end unspecified Clarithromycin (Biaxin®) Tajikistan, Cambodia Boehringer- HIV/AIDS Ingelheim Nevirapine (Viramune®) 59 countries (Latin-America, Africa, and Asia) Johnson & Johnson HIV/AIDS (paediatric) Darunavir (Prezista®), etravirine (Intelence®) Sub-Saharan Africa Johnson & Johnson HIV/AIDS (IV drug users) Rilpivirine (Edurant®) China Merck & Co. HIV/AIDS Efavirenz (Stocrin®), raltegravir (Isentress®), Atripla® Botswana Merck & Co. Lower respiratory infections Pneumovax® 23 (pneumococcal vaccine) Nicaragua and Honduras Novartis Malaria Artemether/lumefantrine (Coartem®) 10 countries (Millennium Villages in Africa) Novartis Tuberculosis Clofazimine (Lamprene®) Tanzania until elimination goals Pfizer HIV/AIDS as long as there is need Fluconazole (Diflucan®) 63 countries (Latin-America, Africa, and Asia)

until elimination goals Non-communicable Diseases

AbbVie Epilepsy end unspecified until elimination goals Valproate semisodium (Depakote®) Cambodia Eli Lilly Diabetes (paediatric) end unspecified Insulin lispro (Humalog®) 23 countries (Latin-America, Africa, and Asia) Eli Lilly Mental disorders + diabetes end unspecified Olanzapine (Zyprexa®), fluoxetine hydrochloride (Prozac®), insulin lispro (Humalog®) Kenya Novo Nordisk Diabetes (paediatric) Multiple human insulins (Actrapid®, Insulatard®, Mixtard®) 9 countries (Africa and Asia) Roche Hepatitis end unspecified Pegylated interferon alfa-2a (Pegasys®), ribavirin (Copegus®) 9 countries (Africa and Asia)

135 Product Donations & Philanthropic Activities Access to Medicine Index 2014

Donation programmes in action

Donation programs aim to control, eliminate or eradicate ‹ Sleeping sickness specific diseases. Medicines are preferably oral, to make in Africa them easier to administer correctly, and their use requires A healthworker acceptance by people in local communities, as well as screens for trypanosomiasis, as part of correct monitoring and diagnosis. It is also important to Sanofi's donation ensure donated products can reach people in remote areas, programme. packaged in a way that enables health workers to store and administer them appropriately. © Matias Boem / Bayer HealthCareAG

‹‹ Helminthiasis in Cameroon A child in Cameroon receives mebendazole from Johnson & Johnson.

‹ Helminthisiasis in Africa Children in Lomé, Togo, receive albendazole donated by GSK. © Eric Don-Arthur, 2007 Don-Arthur, Eric © © Marcus Perkins

‹‹ Trypanosomiasis in Africa Donations of suramin for trypanosomiasis from Bayer come through the Omugo Health Center in Uganda. ‹ Lymphatic filariasis Eisai donates Diethycarbamazine Citrate (DEC), in a programme started © Eisai © Pere Simarro by Sanofi.

‹‹ Onchocerciasis in CAR Merck & Co.'s Mectizan® programme reaches rural Gbatong in the Central African Republic.

‹ Vaccination in Nicaragua and Honduras Vaccines from Merck & Co. must travel by horseback through the © Mectizan Donation Program Donation Mectizan © © Project HOPE Nicaraguan mountains.

136 Access to Medicine Index 2014 Product Donations & Philanthropic Activities

‹‹ Schistosomiasis in Africa Determining dosage for schistosomiasis, which Merck KGaA tackles with the WHO.

‹ Diabetes in Bangladesh A nurse administers insulin donated by Novo Nordisk to a child with type 1 © Chantal Hermanns for Merck © Jon Ryter for Novo Nordisk diabetes in Dhaka.

‹‹ Trachoma in Africa Pfizer donates treatment for this blinding infection in many African and Asian countries.

‹ Chagas disease in Latin America Bayer ships donated nifurtimox to El Salvador for further processing. © Pfizer Inc. © Bayer Healthcare AG

‹‹ Hepatitis in Pakistan Roche supports awareness raising initiatives to encourage screening and prevention.

‹ TB in Tanzania Tuberculosis medicine donated by Novartis accounts for 25% of the WHO's annual supply. © Roche © Christian Flierl / Novartis Foundation

‹‹ HIV/AIDS in Uganda A newborn receives a donated HIV/AIDS treatment from Boehringer Ingelheim.

‹ Epilepsy in Cambodia Via this hospital in Cambodia, AbbVie's donations reach children with epilepsy or lung infections from © Boehringer Ingelheim Boehringer © © William Vazquez for AbbVie rural areas.

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focus area 2 Sustainable Philanthropy Philanthropy aligned with health priorities

Why this matters

The Index looks for philanthropic activ- To this end, the Index examines must be long-term, align with national ities that are sustainable and targeted whether activities are supported or international health priorities, and towards improving local healthcare by needs-based, cohesive strate- include specific targets and integrated capabilities and access to medicine gies and long-term commitments. outcome measures and impact in the long term. For example, philan- The Index also measures companies’ assessments. thropic activities can aim to improve level of disclosure regarding resulting healthcare infrastructure, to enhance outcomes and impact reports, as well Philanthropy refers to the provision the capabilities of local organisations, as allocated resources. of financial assistance to local or strengthen disease-prevention or organisations. Where other resources healthcare-promoting initiatives. To meet the highest standards set are contributed, the Index views this by the Index, philanthropic activities as Capability Advancement.

How the companies perform

In general, companies perform well assessments and resources associated allocated to all of its activities, as well when it comes to sustainable philan- with the majority of their philanthropic as their objectives and outcomes. Novo thropy: all companies are involved in activities. Nordisk integrates its philanthropic philanthropic activities to some extent. activities with its business activities. The quantity and quality of their activi- Novartis: Through its Foundation for ties differs substantially. Sustainable Development, Novartis is GSK: The company invests 20% of its engaged in numerous philanthropic profits from Least Developed Coun- The strongest performing compa- activities that connect to other access tries in philanthropic activities, which nies are involved in numerous initia- initiatives and capacity building projects. are strongly aligned with national tives that meet the highest criteria Its approach to philanthropy focuses on health priorities and designed to have examined by the Index. The leaders strengthening local organisations and a sustainable impact on local human often have a separate foundation that introducing business tools for planning, capital and healthcare infrastructures. manages philanthropic activities in implementation and evaluation. Its In particular, GSK has a strong focus multiple fields and in alignment with activities generally focus on improving on strengthening local capacity for international health priorities, such as care for patients with specific diseases front-line community-based work. The the Millennium Development Goals. or conditions, including malaria, leprosy company partners with international Instead, weaker performing companies and tuberculosis. Novartis’ initiatives NGOs such as Save the Children and are involved in fewer long-term activi- are mainly active in Africa, are all long CARE International. The company ties without clear targets, outcome term (>5 years), have clear targets and regularly assesses the impact of its measures or impact assessments. include outcome measures. Novartis programmes on public health, and discloses the resources allocated to discloses aggregate resources allo- High standards of needs-based philan- these activities. cated to numerous specific projects. thropic approaches from the leaders Seven companies deliver strong Novo Nordisk: Through its World AbbVie: The AbbVie Foundation performances in this area: Novartis, Diabetes Foundation, Novo Nordisk supports numerous activities, including Novo Nordisk, GSK, AbbVie, Sanofi, supports numerous projects that aim health education programmes, to AstraZeneca, and Roche. They all take to improve diabetes care, including improve care for patients with specific a needs-based, sustainable and long- national diabetes programmes in five diseases, namely hepatitis, HIV/AIDS term approach to philanthropy, and African countries. These programmes and neglected tropical diseases. Its adhere to the best practices set by the are very sustainable, due to the approach aligns with national and inter- Index for philanthropy. Their trans- involvement of national authorities and national health priorities. The company parency is also high, as they publicly long timescales. The World Diabetes discloses resources and outcome disclose the outcome measures, impact Foundation discloses the resources measures for each activity.

138 Access to Medicine Index 2014 Product Donations & Philanthropic Activities

Sanofi: The Sanofi Espoir Founda- assess impacts, by not disclosing how and outcome measures for some of its tion supports numerous sustainable much they invest in these activities, or initiatives. philanthropic activities. It sets targets by having shorter-term activities. and regularly evaluates the health, Bristol-Myers Squibb: The Bristol- social, and economic benefits of its Johnson & Johnson: Johnson & Myers Squibb Foundation manages activities for the communities involved. Johnson is engaged in more than 500 two initiatives: one that focuses on These evaluations include progress philanthropic activities. They align improving care for patients with checks against national and interna- with national priorities and are mainly hepatitis in Asia, and one that focuses tional health priorities. Sanofi discloses centred on the Millennium Develop- on care for patients with HIV/AIDS in detail the allocated resources and ment Goals to reduce child mortality, in Africa. Called Delivering Hope and outcomes for all of its activities. improve maternal health and improve Secure the Future, these initiatives care for patients with HIV/AIDS, involve numerous activities in several AstraZeneca: The company takes a malaria and other diseases. However, countries. detailed approach to managing its the company did not provide evidence philanthropic activities, conducting of systematically integrating outcome Laggards lack outcome measures and feasibility studies, impact assess- measures or impact assessments into long-term objectives ments, capacity assessments and its activities. Bayer, Takeda, Daiichi Sankyo, Boeh- sustainability measurements. Its ringer Ingelheim, Pfizer, Eli Lilly, and activities align with health priori- Merck & Co.: The company focuses its Eisai lag in sustainable philanthropy. ties and are increasingly focused on philanthropic efforts on strengthening Compared to the leaders, these non-communicable disease preven- healthcare systems and building local companies are engaged in fewer long- tion. Through the AstraZeneca Young healthcare capacities (particularly term activities that generally lack clear Health Programme, the company the latter), for example through the objectives or processes for measuring funds a range of activities, from global Millennium Villages Community Health outcomes. Only Boehringer Ingelheim research and advocacy to education Worker training programme. However, stands out some way, for disclosing and health skills training, with the Merck & Co. does not disclose the allo- aggregate resources and outcome aim of improving the health of young cated resources for all its activities. measures for some activities. Bayer people worldwide. AstraZeneca and Daiichi Sankyo take a sustain- discloses the resources it allocates to Astellas: The philanthropic activities able approach to philanthropy that is philanthropy. run by Astellas focus on the Millennium evidenced in multiple short-term activi- Development Goals (MDGs). Although ties. Pfizer has initiatives to improve Roche: In its philanthropic activities, they are not long term, they contribute human capacity through its volun- Roche focuses on their sustainability. strategically to achieving the long-term teering programmes – these qualify The company aligns its philanthropic objectives of the MDGs. The company for analysis in the chapter on Capability efforts with the Millennium Develop- discloses the allocated resources, Advancement. ment Goals, and most of its activities outcome measures and targets per are long-term with integrated outcome project. measures. Its activities relate to many different areas, including disaster Gilead: HIV/AIDS is the emphasis of relief and local humanitarian organisa- Gilead’s philanthropy. It focuses on tions that work with disadvantaged improving HIV/AIDS care by strength- populations. Roche discloses the type ening healthcare infrastructure and of resource per activity and outcome reducing stigma. Gilead’s activities assessments associated with the include a mobile communications majority of its reported philanthropic service for healthcare providers. activities. Compared to leading companies, it has fewer long-term strategies. Its activi- Less sustainability and consistency in ties approach the highest standards set the middle group by the Index, but are not long term. Following the leading group are Johnson & Johnson, Merck & Co., Merck KGaA: Merck KGaA engages Astellas, Gilead and Merck KGaA. These in numerous philanthropic activi- five companies are also engaged in ties, some of which are long term. Its numerous philanthropic activities, but approach ensures individual projects tended to drop points for not demon- align with broader long-term goals, strating how they track outcomes or and it disclosed aggregate resources

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innovation Increasing localisation to achieve elimination goals

Where donation programmes aim to ture limitations. The 2014 Index found eradicate, eliminate or control certain evidence of three innovative initiatives diseases, there is an increased need for that are addressing problems unique to innovative approaches tailored to over- local conditions. coming local challenges and infrastruc-

Innovation to decrease disease transmission

Merck KGaA started a pilot study Novartis has launched an innovative through its Merck Praziquantel Dona- strategy to interrupt leprosy trans- tion programme that involves local mission. Leprosy is a disabling and communities in Senegal, particularly stigmatised disease that mainly affects people infected by schistosomiasis the poorest of the poor. Its leprosy and others living in regions where the elimination programme has provided disease is present. People can become treatment to millions, but its impact infected through exposure to infested has plateaued. To reach its elimination water, with poor sanitation increasing goal, Novartis has developed a new the risk of infection. Through a partner, approach that involves early diagnosis Merck KGaA is working to build a better and treatment, as well as contact understanding of the processes related tracing and surveillance, paying more to prevention and the need for sanitary attention to the people close to leprosy solutions. patients. © Paroma Basu/Novartis Paroma © Foundation

A child is examined at a leprosy camp in India, part of Novartis' programmes for leprosy Innovation in product donation supply chain tracking and prevention.

The Neglected Tropical Diseases tion, as well as studies to identify new Supply Chain Forum (NTDSCF) was strategies and planning approaches formed following the signing of the for ‘last-mile’ distribution, from central London Declaration on Neglected warehouses to the intended communi- Tropical Diseases.2 It is a new collabor- ties and patients. ‘Last-mile’ solutions ative platform for identifying problems will be critical in reaching the targets and inefficiencies associated with the set out in the London Declaration.3 supply and delivery of products that GSK leads this initiative and partners have been donated for treating NTDs. with Johnson & Johnson, Pfizer, Merck A common issue is delays between & Co., Merck KGaA, and Eisai. NTDSCF ports and central warehouses due to members also receive credit in the custom clearances. Forum members, Capability Advancement chapter. including DHL, are piloting initiatives to enhance this ‘first-mile’ distribu-

For numbered references, see the Appendix. b For the full 2014 index Disease Scope, see the Appendix. a Donation of other product types, such as diagnostics and vector control products, have been excluded from this analysis, unless integrated with the donation of medicine.

140 Access to Medicine Index 2014 Company Report Cards

Company Report Cards

The 2014 Access to Medicine Index includes a set of 20 company report cards, which each provide a contextualised analysis of one company’s performance in the 2014 Index. This includes a summary of its strengths and weaknesses, any best and innovative practices, as well as the drivers behind changes in its ranking. Each report card includes overviews of the company’s portfolio and pipeline, and identifies tailored opportunities for it to increase access to medicine. The report cards are divided into six sections:

Company overview Sales and operations Graphical overview and explanation of the General description of the company’s company’s overall Index rank and scores in operations, revenue per region and each area, with a summary of notable new geographical reach. developments and drivers behind changes in its ranking. Portfolio and pipeline Analysis of the company’s portfolio of Performance update marketed products and pipeline of R&D Update on the company’s access-to- products that fall within the scope of the medicine performance, including new Index, in line with specific inclusion and commitments and new and/or expanded exclusion criteria (see the Appendix for strategies, activities and programs. more information).

Best practices Opportunities for improving access to Overview of all best and innovative prac- medicine tices identified by the 2014 Index for this Tailored opportunities for the company to company. Practices are included here if they: improve access to medicine, taking account can be considered best in the industry; solve of its R&D pipeline, product portfolio, a problem in access to medicine; represent current equitable pricing strategies and innovation where progress is needed and/or approach to IP management, among other where a clear gap exists; or could potentially factors. have a significant impact in any of the areas measured.

141 Company Report Cards Access to Medicine Index 2014

rank score 1 = 3.3 GlaxoSmithKline plc 1 (2012)

5 2,9 Management 4,9

2,8 Public Policy 2,1 4

2,1 R&D 3,7 3.4 3,4 3 3.2 3,8 Pricing 3,0 3,0

2,8 Patents 2,8 2

2,5 Capability 3,5 1 2,4 Donations 3,4 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

GSK is in 1st place for the fourth time, performing strongly GSK no longer leads in Capability Advancement or Pricing, across the board and with several innovative practices. It has Manufacturing & Distribution. While it has equitable pricing a large relevant portfolio and leads in R&D, dedicating a large for many relevant products, it does not always provide pipeline share to diseases in scope. It is developing many detailed evidence of how it targets its strategies toward products in partnerships based on access provisions. It also affordability for the lowest tier. GSK also falls in Public Policy participates in numerous IP-sharing partnerships and leads & Market Influence, with evidence of multiple breaches. in access-to-medicine management.

Performance update

Found in breach of ethical standards Leads in R&D partnerships and IP sharing. Advancing adverse-event reporting in multiple times. GSK has been found in breach GSK engages in a high number of product Africa. GSK is piloting a crowd-sourcing plat- of marketing standards and legislation multiple development partnerships, accounting for the form that enables patients to report adverse times. Allegations also arose of systemic cor- majority of its relevant pipeline. It also engages events using low-tech solutions (SMS, phone ruption in China during this period. Since then, in numerous IP-sharing partnerships. calls). GSK has been found guilty and fined USD500 million (the conviction occurred outside the Among the leaders in marketing approval/ period of analysis). registration policies and practices. The company has registered the majority of its relevant Implementing new compensation system products in the majority of relevant countries. for sales teams. In 2013, GSK announced a new It decides where to register products based compensation system for sales employees on patient needs, local health systems and the who work directly with prescribing health- existence of a regulatory system. care professionals. Instead of individual sales targets, they will be evaluated and rewarded for Has equitable pricing strategies for wide their technical knowledge, how they support range of products and many countries. It is improved patient care and for GSK’s overall one of four companies with equitable pricing business performance. GSK aims to have this strategies for the majority of its products in the new system in place in all countries by 2015. majority of in-scope countries where it is present. In absolute terms, it has the second-highest Demonstrates strong oversight of CROs number of products with equitable pricing and shares patient-level data. GSK goes strategies. beyond baseline standards and incorporates elements of the Declaration of Helsinki in its Has diverse and over-arching equitable pric- clinical trial code of conduct. To enforce compli- ing strategies. For example in Least Developed ance, GSK has strong monitoring and auditing Countries, GSK has capped the prices of pat- procedures for both in-house and outsourced ented medicines and vaccines at no more than trials. It complies with WHO standards for 25% of the price for the UK or France (provided registering trials and publishing results, and that it covers manufacturing costs). Plus, GSK has systems for sharing patient-level Clinical has used tiered pricing for vaccines for over 20 Study Reports with trusted third parties (e.g., years. In 2013, it increased the number of pricing academics). tiers for vaccines to seven, basing price ranges on Gross National Income per capita. The lowest tier corresponds to GAVI-eligible countries.

142 Access to Medicine Index 2014 Company Report Cards

Best practices

Implementing Africa-focused business Partnering for neonatal health. In partner- model. In 2014, GSK announced that it will ship with Save the Children, GSK is developing Aligning supply and demand to increase establish a new Africa and Developing Coun- products for neonatal health conditions vaccination rates. GSK and Vodafone are test- tries business unit which will bring together with an initial focus on neonatal sepsis. It is ing whether mobile technology can help align its commercial and access-related efforts in a unique partnership in which GSK and Save vaccine supply and demand in Mozambique. The all sub-Saharan African countries. In high- the Children can combine their expertise and pilot uses SMS to encourage mothers to access potential markets, this unit aims to invest for resources to target leading causes of child vaccination services, and to remind healthcare growth; in less-developed markets it aims to mortality. facilities to report on vaccine stock levels, support development. The new unit builds on improving demand forecasting and reducing GSK’s Developing Countries and Market Access Increasing access to affordable financing vaccine stock outs. (DCMA) unit. and insurance. GSK is partnering with Barclays to increase access to affordable healthcare and Assigns strong senior sponsorship of ac- medicines in Zambia. Initiatives include: afford- cess to medicine throughout the company. For able financing for wholesalers and distributors example, in its 2012 Corporate Responsibility willing to pass savings to patients; and the report, the company published ten ‘Health for development of an around a dollar-a-month All’ commitments. Each one has a Corporate micro health insurance product maintained via Executive Team sponsor and lead business mobile phone. owner that works with the business to ensure the commitment is fulfilled. Takes a proactive approach to IP management. GSK is one of the leaders when it comes Establishing innovative Open Lab for Africa to licensing its patented products, having issued for NCDs. Building upon its first Open Lab in a comparatively high number of licences, some Spain, GSK is establishing a second Open Lab of which are transparent and include pro- for Africa. This lab aims to improve understand- access terms. Through ViiV Healthcare and the ing of NCD variations seen in the African setting Medicines Patent Pool, it engages in a novel to inform prevention and treatment strategies licensing arrangement that includes tiered of NCDs in African patients. Understanding royalties based on country income level. local disease variations is essential to address needs that are specific to Africa.

Sales and operations Sales in countries in scope

GSK is a diversified company, offering pharmaceuticals, vaccines and consumer healthcare products. It has products for numerous diseases and operates in over 150 countries. Sales in emerging markets account for about 25% of total sales. It holds a 77.4% stake in ViiV Healthcare, a joint venture with Pfizer focused solely on the research, development and commercialisation of HIV/AIDS medicines. It is acquiring Novartis’ vaccine business (excluding influenza vaccines) and divesting its marketed oncology portfolio to In scope, has sales

Novartis. It will create a new consumer health- In scope, has no sales care business with Novartis, retaining majority Not in scope control.

General information Turnover by division (2013) Turnover by region Pharmaceuti- Consumer , , mn GBP cals , mn GBP Medical Devices and , London Stock Exchange Vaccines,mn Diagnostics , , , GSK GBP Pharmaceuti- Japan Headquarters GBP , Consumer , ,mn cal , Brentford, UK Pharmaceuticals , Europe Healthcare, mn , Total sales , Number of employees Vaccines , US GBP 99,451 Consumer Healthcare ROW 2009 2010 2011 2012 2013 Total

sales,mn GBP

143 Company Report Cards Access to Medicine Index 2014

GlaxoSmithKline plc (continued)

Portfolio and pipeline

Focus Marketed products Pipeline products Within the scope of the Index, GSK focuses on Has medicines and vaccines for 23 diseases Its clinical pipeline targets 12 diseases in scope, infectious diseases and respiratory diseases. in scope, including many childhood vaccines. with a focus on vaccines for lower respiratory Its medicines portfolio is strong in respiratory infections, malaria, HIV/AIDS and TB. It includes Hepatitis is included under cirrhosis of the liver diseases, malaria, HIV/AIDS and antibiotics. medicines for HIV/AIDS, malaria, cerebrovas- and counted as a non-communicable disease. cular disease, COPD, asthma and diabetes. Notably, it is also developing medicines for neonatal infections and prematurity. Its early-stage pipeline targets neglected diseases. GlaxoSmithKline plc

Product types 57 Products per disease category 13 Clinical pipeline per disease category 37 4 4 0 3 2 On the market Pipeline 101 19 Medicines

Vaccines Communicable Diagnostics Non-communicable Communicable Vector control products Neglected tropical Non-communicable

Platform technologies Maternal and neonatal Maternal and neonatal

Opportunities for improving access to medicine

Improve enforcement of anti-corruption and Continue to expand equitable pricing, and Maintain commitment to adapting products anti-bribery codes of conduct. The company target the poorest population segments in for developing countries. There is an op- can consider developing strict enforcement more strategies. The company has equitable portunity for GSK to fill gaps for much-needed measures for its anti-corruption and anti-brib- pricing for the majority of its relevant products. products by maintaining its commitment ery codes of conduct that apply equally across For some of its equitably priced products, GSK to adapting products to meet the needs of the breadth of its operations. takes affordability into account and targets the patients in developing countries: for example, lowest tier. It can expand these practices to all formulations for non-communicable diseases, of its products. heat-stable vaccines, and solutions for anti- microbial resistance.

144 Access to Medicine Index 2014 Company Report Cards

rank score 2 3.0 Novo Nordisk A/S 6 (2012)

5 4,8 Management 4,7

1,4 Public Policy 2,7 4

3,0 R&D 2,4 3,6 3 3,2 3.1 2,6 Pricing 3,3

1,9 Patents 1,5 2

3,8 Capability 3,9 1 1,0 3,3 Donations 3,6 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Novo Nordisk climbs four places to 2nd place, having risen Plus, its equitable pricing strategies extend across most steadily since 2010. Within the scope of the Index, it relevant countries it has a presence in, and it is among the addresses diabetes only, but has an integrated strategy leaders when it comes to rapidly registering new products for improving access to diabetes care, plus good gover- and applying for stringent approvals. It leads in Donations nance, access management and stakeholder engagement. & Philanthropy and in Capability Advancement. However, Compared to peers, it is highly transparent, has robust codes it does not commit to licensing and has issued no relevant of conducts, and audits compliance in countries in scope. licences.

Performance update

Integrates access to medicine with core Countries at a maximum of 20% of the price in Strongly integrates philanthropy with busi- business. Novo Nordisk has renewed its Global the western world. It implements diverse pric- ness activities. Through the World Diabetes Access to Diabetes Care strategy, connecting models that are appropriate to local needs in Foundation, Novo Nordisk supports numerous ing access to its overall business strategy. It different countries within scope. projects that aim to improve diabetes care, has a new long-term target of reaching 40 including national diabetes programmes in five million people with diabetes by 2020, including Leads in building local capacities. In China, African countries. Its activities are deemed patients at the base of the pyramid. It aims to the company engages in multiple public-private sustainable because they involve national support the education of healthcare profes- partnerships to enhance local R&D capabilities. authorities and are long-term. sionals and patients globally, and to promote In Bangladesh, it engaged in technology trans- health for mothers and children. It is overseen fer with a local manufacturer and is training by a dedicated senior-level committee. staff from the National Drug Control Labora- tory to help detect counterfeit medicines. It is Took a strong public stance against im- also engaged in several activities, for example proper lobbying. Novo Nordisk resigned from to improve cold-chain storage, that aim to build the South African Pharmaceutical Industry As- capacities in supply chain management. sociation following allegations that IPASA was considering a strategy for influencing South Donates to children and meets local needs. Africa’s intellectual property legislation. It is one of two companies to provide insulin via donations: its Changing Diabetes in Children Has robust codes of practice. The com- programme (established in 2009) provides pany’s codes of ethics are supported by mecha- access to care for over 11,500 children with type nisms for monitoring and enforcing compliance 1 diabetes in several countries in scope, and that apply across its operations, and extend to includes elements of capacity building. In addi- third parties. It provides evidence of auditing tion to providing treatment, it meets other local compliance with these codes in several Index needs. It helps adapt local systems for tracking countries. insulin distribution and to ensure that cold chains function. The programme will run until Remains a leader in pricing, manufacturing 2017. and distribution. The company is one of the leaders in equitable pricing due to its strategies that take affordability for the poorest population segment into account through targeted pricing and product mixes. The company provides insulin to all 49 Least Developed

145 Company Report Cards Access to Medicine Index 2014

Novo Nordisk A/S (continued)

Best practices

Expands Base of the Pyramid project. The access-to-medicine key performance indicators Forums & Policy Roundtables” (international, project is working toward an integrated ap- (KPIs), related to its new Access to Diabetes regional and national gatherings of policy- proach to diagnosis, treatment and diabetes Care strategy, into its formal performance makers, healthcare professionals and NGOs, control for the working poor in developing management systems. For example, two among others) to discuss alleviating the burden countries. Since its inception in 2011, it has ex- access-related KPIs are linked to the company’s of diabetes and diabetes care. Since 2005, it panded: it is currently running in India, Nigeria, Long-Term Incentive programme, which is of- has organised 85 such events in more than 30 Ghana and Kenya. The company is working to, fered to the top-managers (corporate VPs, VPs countries. for example, establish an effective supply chain, and Directors). reduce the need to travel for treatment and to Increased affordability of insulin. One of the build capacity for treating diabetes. It aims to Strong in stakeholder engagement for leaders in equitable pricing, the company began roll the project out in more African countries. diabetes. Novo Nordisk uses stakeholder selling insulin in single-cartridge packages, engagement to shape its access strategy and piloted in Pakistan. This innovative approach to Integrates access-linked incentives into to advocate for better diabetes care: e.g., by packaging enables patients to spread the cost of performance management. It has integrated organising its “Changing Diabetes Leadership treatment over time, making it more affordable.

Sales and operations Sales in countries in scope

Novo Nordisk operates in three business segments: Diabetes Care, Obesity and Biopharma- ceuticals. It is a world leader in diabetes care, offering products for type 1 and type 2 diabetes at various stages of progression. It has a broad geographic scope and over 20% of sales come from emerging markets, with a particularly strong position in the Chinese insulin market. To support growth in some of these key markets, the company is investing in building local health- In scope, has sales care capacity for providing diabetes care. In scope, has no sales

Not in scope

General information Net sales by segment (2013) Net sales by region

, mn DKK

, Copenhagen Stock Exchange , NVO B , Japan & Korea Headquarters DKK ,mn , Bagsværd, Denmark Europe Number of employees , Diabetes Care , North America

40,000 Biopharmaceuticals ROW 2009 2010 2011 2012 2013

146 Access to Medicine Index 2014 Company Report Cards

Portfolio and pipeline

Focus Marketed products Pipeline products Within the scope of the Index, Novo Nordisk Has medicines for one disease within scope: Within scope, its clinical pipeline targets dia- addresses diabetes only. diabetes. The majority of its medicines are in- betes, and includes a fixed-dose combination sulins, while others are specifically used to treat and new formulations that aim to offer clinical type 2 diabetes. benefits. It also has relevant diabetes products in earlier stages of development. Novo Nordisk A/S Product types Products per disease category Clinical pipeline per disease category 0 10 0 0 On the market Pipeline 10 Medicines Vaccines Diagnostics

Vector control products Platform technologies Non-communicable Non-communicable

Opportunities for improving access to medicine

Continue to develop diabetes treatments suit- Extend commitment not to file for patents able for use in resource-limited settings. As a to a broader range of Index countries. Novo market leader in diabetes care, Novo Nordisk Nordisk continues, as for 2012, to have a clear has significant potential to develop diabetes commitment not to patent in the LDCs. It can treatments that are more suitable for use in consider extending this commitment to gener- low-income settings, such as heat-stable or oral ate greater clarity for a wider range of countries insulin treatments that would increase compli- in scope. ance. It is currently looking at developing insulin in tablet form.

Develop access strategies during R&D process. Novo Nordisk is developing various innovative products for diabetes, but has not provided specific strategies for how they will be made available, accessible and affordable in developing countries, if successful. Novo Nor- disk can start taking such factors into account earlier in the development process to ensure access to new products for patients in developing countries.

Extend equitable pricing to more products. Novo Nordisk can expand existing equitable pricing strategies to include a wider range of diabetes treatments.

Consider developing a clear public approach to licensing. It can investigate the potential for licensing its present and future portfolio of patented products as a strategy for supporting access. There is a growing market for diabetes products in many countries in scope. Licensing could prove a viable mechanism to increase access to its newer diabetes products.

147 Company Report Cards Access to Medicine Index 2014

rank score 3 2.8 Johnson & Johnson 2 (2012)

5 4,9 Management 4,4

2,1 Public Policy 1,1 4

3,7 R&D 3,3 3 3.3 3,4 3,0 Pricing 3,2 2,7 2 2,8 Patents 1,3

3,5 Capability 3,3 1

3,4 Donations 3,1 0.9 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Johnson & Johnson falls one place to 3rd, as competition for taking affordability into account and targeting the poorest the top places increases. It is particularly strong in R&D: its segment. Johnson & Johnson has newly committed not to relevant pipeline is large and diverse, with significant move- enforce its darunavir (Prezista®) patents in specific coun- ment since 2012. Compared to peers, it has greater over- tries, but provided limited evidence of issuing pro-access sight of its access approach. Its Global Public Health Group licences with broad geographic scope. It was found in breach manages R&D and access strategies for several diseases in of ethical standards multiple times, including in a country in scope. It leads in equitable pricing strategies, with strategies scope.

Performance update

Establishes group focused on unmet health regulatory approvals: notably for a first-in-class sub-Saharan Africa and LDCs. It issues limited needs. In January 2014, the company launched tuberculosis treatment and a new hepatitis C voluntary licences (for ARV products), with Janssen Global Public Health (GPH), respon- medicine. It is in the process of globally register- partial disclosure of terms. Licences have a sible for the research, development, delivery ing two adapted ARVs. smaller geographic scope and less flexibility and access strategies of pharmaceuticals, than those agreed by peers. It has not yet joined diagnostics and services for diseases that im- Engages in comparatively high number of the Medicines Patent Pool. pact resource-limited countries and emerging product development partnerships. However, markets. it provides no proof that the majority include Remains a leader in building national phar- provisions for ensuring access. macovigilance systems. Johnson & Johnson Found in breach of ethical standards engages with multiple health authorities/gov- multiple times. Johnson & Johnson has been Leads in equitable pricing strategies. The ernments to help build national pharmacovigi- found in breach of ethical marketing standards company’s equitable pricing strategies include lance systems. and competition law. It was ordered to pay multiple factors for taking affordability into compensation in China following a case (2010) account, and are targeted towards the poorest Donating to reach children. Johnson & concerning anti-competitive behaviour. population segment. Its pricing model is based Johnson has two structured donation pro- on gross national income per capita, at purchas- grammes for children. Children Without Worms Leads in product development. Johnson & ing power parity. targets soil-transmitted helminthiasis, and the Johnson has an extensive pipeline of products company has pledged to scale it up significantly relevant to the Index, with many in clinical Takes a mixed approach to IP management. by 2015. Its second programme started in 2014 development. Since 2012, it has progressed Johnson & Johnson newly commits to not and provides ARV treatment to children for the most products and received the most enforcing its patent for darunavir (Prezista®) in whom first-line treatment is failing.

Best practices

Engages strategically with local stakehold- Piloting results-based financing models. Developing a large paediatric pipeline. Of ers. Johnson & Johnson engages with local The company’s GPH group is launching a num- all relevant investigational paediatric medicine, stakeholders to better understand needs, ber of pilots to measuring the economic impact Johnson & Johnson has the largest share: in- incorporating findings in access-to-medicine and sustainability of new access and funding cluding for hepatitis, HIV/AIDS, and multi-drug- strategies and plans. In Colombia and Brazil, models. It is exploring how Developing Impact resistant tuberculosis. Since 2012, it has gained it tailored its approaches following extensive Bonds and Social Impact Bonds can support regulatory approval of one of its medicine for interviews with multiple stakeholder groups. healthcare delivery in resource-limited set- use in adolescents with schizophrenia. It has col- tings. laborated to develop a childhood vaccine with a new delivery device for use in remote areas.

148 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Johnson & Johnson operates in three segments: Consumer, Pharmaceutical, and Medical Devices & Diagnostics. Its pharmaceutical segment offers products in the areas of anti-infective, anti-psychotic, cardiovascular, contraceptive, gastrointestinal, haematology, immunology, neurology, oncology, pain- management, thrombosis, infectious diseases, metabolic conditions and vaccines. It has more than 250 operating companies located in 60 countries worldwide and markets its products In scope, has sales in almost all relevant countries. In scope, has no sales

Not in scope

General information Sales by segment (2013) Sales by region Consumer , Pharmaceuti- , mn USD Medical Devices and cal,

New York Stock Exchange Diagnostics, Animal, Health, , Europe JNJ Pharmaceuti- , Consumer Pharmaceutical US Headquarters USD , cal, ,mn Care , New Brunswick, NJ, US Medical Devices W. Hemisphere , Total sales , , Other , Number of employees and Diagnostics (excl. US) Total sales , 128,100 Consumer Asia-Pacific, Africa 2009 2010 2011 2012 2013

Portfolio and pipeline

Focus Marketed products Pipeline products Johnson & Johnson has a very diverse portfolio The company has products for 14 diseases in Its clinical pipeline mainly comprises medicines and pipeline. It is strong in contraceptives, HIV/ scope. Its medicines focus is on contracep- and targets nine diseases, mainly HIV/AIDS and AIDS, mental health and hepatitis. tives, mental health and HIV/AIDS. It also has a hepatitis, as well as diabetes, schizophrenia first-in-class tuberculosis medicine: bedaquiline and depression. It is developing vaccines for Hepatitis is included under cirrhosis of the liver (Sirturo®), vaccines for hepatitis B, cholera tuberculosis and rabies, and microbicides for and counted as a non-communicable disease. and typhoid fever and a pentavalent childhood HIV/AIDS. Johnson & Johnson vaccine.

Product types 11 Products per disease category 8 Clinical pipeline per disease category 12 11 1 1 6 0 On the market Pipeline 30 20 Medicines Vaccines Communicable Diagnostics Non-communicable Communicable Vector control products Neglected tropical Non-communicable Platform technologies Maternal and neonatal Neglected tropical

Opportunities for improving access to medicine

Extend its engagement in licensing. Johnson & Develop access strategies for relevant Systematically agree to access-oriented Johnson can extend the number, range, scope, investigational products. The company has terms for product development partnerships. and transparency of the licences it issues, based an extensive pipeline of products relevant Johnson & Johnson can develop and implement on terms that are designed to facilitate access to countries in scope. Many are in the clinical a policy for including a standard set of access- for poorer patients, including in more middle phase of development, meaning that they could oriented terms and conditions in its research income country markets. It could also consider reach markets relatively soon. Through its GPH contracts. engaging in negotiations with the Medicines group, the company has significant potential Patent Pool in order to boost access to the to make them widely available, accessible and three ARVs in its portfolio (etravirine (Intel- affordable. It can develop specific pro-access ence®); rilpivirine (Edurant®); darunavir (Prez- strategies for product registration, equitable ista®)) in a wider range of countries in scope. pricing, and patenting and licensing.

149 Company Report Cards Access to Medicine Index 2014

rank score 4 2.8 Novartis AG 7 (2012)

5 3,8 Management 4,8

1,3 Public Policy 1,4 4

3,0 R&D 3,0 3 3.3 3.2 2,9 Pricing 2,6 2,9

2 1,9 Patents 1,9

3,0 Capability 3,8 1

3,4 Donations 3,3 0,5 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Novartis rises three places to 4th. It has significantly covigilance data with national authorities. The company is improved in access-to-medicine management: in 2012, it conservative when it comes to waiving data exclusivity rights approved a new access-to-healthcare strategy that clearly and was found in breach of ethical standards several times links with its corporate strategy. It has the largest relevant during the period of analysis, but did report taking action pipeline and is targeting many diseases in scope. It also has against people responsible. It falls in the Pricing, Manufac- two donation programmes that address neglected tropical turing & Distribution area, despite performing well in new diseases. It is the only company to voluntarily share pharma- areas of pricing disclosure.

Performance update

Strong governance and management of Conducting needs-based R&D for infec- shown promise in reducing training time and access to medicine. Since 2012, Novartis has tious diseases. Novartis’ pipeline includes costs of scaling up. Novartis is co-developing a approved a new access-to-healthcare strategy many products that target medical needs in similar tool for maternal health. and implemented a centralised performance low-income countries. This is driven by three of management system for access. It has strong its own research institutes. Its pipeline includes Supporting national pharmacovigilance ownership of access-to-healthcare targets. vaccines for meningitis, diarrhoeal diseases and plans and sharing safety reports. Novartis Novartis has also established an Access to rabies, as well as medicines for malaria, Chagas leads in the area of capacity advancement in Medicine Committee, chaired by the CEO. disease and dengue. pharmacovigilance, and has worked with health authorities across a wide range of countries. It Takes public stance against improper lob- Files for more stringent approvals. Com- is the only company to provide evidence of vol- bying. In a public statement, Novartis distanced pared to 2012, Novartis has filed for stringent untarily sharing post-marketing safety reports itself from the Innovative Pharmaceutical As- approval from regulatory schemes (WHO pre- with authorities in relevant countries. sociation of South Africa following allegations qualification, FDA or EMA tentative approval) that it was lobbying to influence South Africa’s for a larger proportion of products: this now Extends commitments to tackling neglect- reform of IP legislation. comprises the majority of its products. ed tropical diseases. Novartis has committed to supporting two of its donations programmes Filling product gaps to improve maternal Co-develops e-training on paediatric until 2020. One aims to control fascioliasis and and neonatal health. Novartis is developing and maternal care. The tool addresses the paragonimiasis; the other to eliminate leprosy the most products to improve maternal and integrated management of childhood illness, and has already helped cure over five million neonatal health, mainly vaccines targeting neo- is globally free of charge and was developed people. It now aims to reach an additional natal health (some divested to GSK). Others are under the WHO strategy to reduce infant and 850,000 people by 2020. medicines that target hypertensive disorders of childhood mortality. It was initially adapted for pregnancy and maternal haemorrhage. use in Tanzania, Peru and Indonesia, and has

Best practices

Expands business model that addresses pyramid. It covers a wide range of products and Novartis is revising the strategy of its donation health of underserved populations. Through focuses on prevention and awareness, as well programme. This includes expanding its focus its Social Business Group, Novartis has consid- as treatment. to people surrounding patients in order to erably expanded its “Healthy Family” pro- minimise further transmission of the disease. It gramme, which focuses on expanding access to Revising its strategy to interrupt leprosy involves early diagnosis and treatment, contact medicine, medical professionals and healthcare transmission. To support the goal of eliminat- tracing and surveillance. education for people living at the bottom of the ing leprosy set out in the London Declaration,

150 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Novartis is a highly diversified company, with divisions for pharmaceuticals, generics and vaccines and diagnostics, and offering patented prescription medicines in various areas. Through Sandoz, it offers prescription medicines and pharmaceutical and biotechno- logical substances. Novartis’ focus is currently changing: it is divesting its vaccine business (excluding influenza vaccines) to GSK and acquiring GSK’s marketed oncology portfolio. It will sell its Animal Health division to Eli Lilly. It operates In scope, has sales in over 140 countries, and about 25% of sales In scope, has no sales come from emerging markets. Not in scope

General information Net sales by segment (2013) Net sales by region

, mn USD

, Europe SIX Swiss Exchange , Pharmaceuticals , US NOVN , USD Sandoz Canada and Headquarters , , ,mn Basel, Switzerland Vaccines and Diagnostics , Latin America , , Number of employees Alcon , Asia/Africa/

135,696 Consumer Health Australasia 2009 2010 2011 2012 2013

Portfolio and pipeline Hepatitis is included under cirrhosis of the liver and counted as a non-communicable disease.

Focus Marketed products Pipeline products Novartis has a large, diverse portfolio and pipe- Has products for 34 diseases in scope, mainly Its clinical pipeline targets 14 diseases in scope, line, covering many diseases, including a focus medicines, notably for mental health (including mainly vaccines for influenza, meningitis and ra- on maternal and neonatal health conditions. It epilepsy) and neglected tropical diseases, and a bies, and medicines for malaria and cardiovas- is divesting much of its vaccine portfolio and large vaccines portfolio. cular disease. Earlier stages include medicines pipeline.Novartis AG for dengue and Chagas disease.

Product types 35 Products per disease category 20 Clinical pipeline per disease category 51 8 22 2 22 8 On the market Pipeline 130 38 Medicines Vaccines Communicable Communicable Diagnostics Non-communicable Non-communicable Vector control products Neglected tropical Neglected tropical Platform technologies Maternal and neonatal Maternal and neonatal

Opportunities for improving access to medicine

Measure impact and support the development Continue to develop new medicine for gies specifically target the poorest population of access initiatives. Novartis is highly active neglected diseases. The divestment of its segments. It can increasingly leverage the in setting up new access initiatives and models vaccines business reduces Novartis’ focus on in- potential of its generics division to ensure its around the world. Its Malaria Initiative, donation fectious diseases. However, it has medicines in products are affordable and accessible for the programme for leprosy, and Social Business development for malaria and neglected tropical poor. Its leading position in biosimilars also Group serve as examples for the industry. To diseases, as well as products for maternal and offers a way to meet the growing demand for increase effectiveness, the company can embed neonatal health conditions. The company can affordable biologics. outcome measuring and impact assessments continue to invest in these R&D activities and to into its initiatives. Novartis’ expertise in manag- maintain and utilise its scientific expertise of its Develop a more access-oriented IP strategy. ing programmes of such large scale, together own R&D institutes in this area. Novartis has potential to develop a more nuan- with its extensive portfolio, creates oppor- ced approach to IP management: for example, tunities to initiate projects focusing on other Improve affordability of more products, in by extending its commitment to refraining disease areas. more countries. Novartis can expand its equi- from patenting in Least Developed Countries table pricing strategies to cover more relevant to other countries, or by licensing to multiple products. Plus, it can ensure its existing strate- external partners to boost generic competition.

151 Company Report Cards Access to Medicine Index 2014

rank score 5 = 2.8 Gilead Sciences Inc. 5 (2012)

5 2,6 Management 2,9

0,8 Public Policy 2,8 4

2,0 R&D 2,1 3,6 3 1,5 Pricing 3,8 2,8 2,7 2 1,4 Patents 2,8

2,0 Capability 2,5 1

2,0 Donations 2,4 0 0,0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Gilead is in 5th place for the second time. It remains a leader disease, via a structured donation programme. With its new in IP management and equitable pricing, demonstrated by a hepatitis C treatment and additional promising candidates in range of licences and equitable pricing strategies that take development, it has a unique role to play in making hepatitis affordability into account. It waives data exclusivity for its treatment available, accessible, and affordable in developing HIV/AIDS portfolio. Plus, it is one of only two companies not countries. found in breach of any standards or law during the period of analysis. It tackles leishmaniasis, a neglected tropical

Performance update

One of only two companies not found in Newly implements intra-country equitable access-friendly terms and covering a compara- breach of ethical standards. During the period pricing strategy. Gilead now has equitable tively broad geographic scope. of analysis, the Index found no evidence that pricing strategies that include different prices Gilead had received convictions or settlements for the public and private markets of some Collaborates on global level to improve relating to corrupt practice, incidences of brib- countries in scope, e.g., for HIV/AIDS products supply chains. Gilead collaborates with global ery, breaches of ethical marketing standards or in South Africa. agencies, such as the Global Fund and the PEP- breaches of competition law. FAR Partnership for Supply Chain Management, Leader in drug-recall policy and practices. e.g., to help create demand-forecasting tools. Innovator in hepatitis C. Gilead has gained Since 2012, Gilead has developed more strin- regulatory approval for the first of a new class of gent standard operating procedures relating to Extends commitments to eliminating treatment for hepatitis C. Sofosbuvir (Sovaldi®) drug recalls. It also adopted a drug-recall policy leishmaniasis. Gilead now commits to donating is used in the first interferon-free oral regimen. that complies with WHO GMP guidelines. It is- 550,000 vials of amphotericin B (AmBisome®) It shows improved efficacy, reduced side effects sued no drug recalls in countries in scope during until 2020. Its donation programme runs in and improved patient tolerance. the period of analysis. highly endemic countries.

Engages in access-oriented IP sharing. Expands licensing, increasing access to HIV/ Gilead shares IP relating to tenofovir (Viread®) AIDS portfolio. Gilead has expanded its range with CONRAD and the International Partner- of licences relating to HIV medicines by actively ship for Microbicides to develop microbicides engaging with different partners to facilitate that can prevent sexually transmitted HIV broader access. Gilead has licensed the largest infections. proportion (80%) of its portfolio, incorporating

Best practices

Sets registration timeframes for new Agrees licensing terms on investiga- ments with the MPP for tenofovir alafenamide, products. Gilead aims to register new products tional products. In 2012, Gilead (through the and bilaterally for ledipasvir (hepatitis C). within 12 months of gaining approval from the Medicines Patent Pool - MPP) included three FDA or EMA in as many relevant countries as investigational HIV medicines within licences. possible. It prioritises countries for registration Technology transfer was able to commence based on disease prevalence. during the period of analysis prior to them gaining stringent regulatory approval. These measures enable accelerated access to generic versions. In 2014, Gilead reached similar agree-

152 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Gilead is a biopharmaceutical company that operates through one segment: Human Therapeutics. It originally focused on developing fixed-dose combination antiretroviral treatments, and still specializes in HIV/AIDS treatment. Partly through acquisitions, Gilead is now also present in other therapeutic areas, including liver disease (hepatitis) and serious cardiovascular and respiratory diseases. It has a broad geographic reach, due, at least in part, to its diverse licensing structures. In scope, has sales

In scope, has no sales

Not in scope

General information Revenues by segment (2013) Revenues by region Biopharmaceuti- Pharmaceuti- , mn USD cals, cals , mn GBP , NASDAQ Vaccines, mn , GILD GBP USD Headquarters , ,mn Consumer Foster City, CA, US , Europe Healthcare, mn Number of employees , US GBP 6,100 Biopharmaceuticals ROW Total 2009 2010 2011 2012 2013

sales, mn GBP Portfolio and pipeline

Focus Marketed products Pipeline products Gilead is focused on HIV/AIDS and hepatitis. Has medicines for three diseases in scope: HIV/ Its clinical pipeline targets three diseases in AIDS, cirrhosis of the liver (hepatitis B and C) scope: it is developing fixed-dose combinations Hepatitis is included under cirrhosis of the liver and leishmaniasis. The majority of its medicines for HIV/AIDS, innovative medicines and fixed- and counted as a non-communicable disease. are ARVs for HIV/AIDS. It has a recently ap- dose combinations for hepatitis, and a medicine ® Gilead Sciences Inc. proved hepatitis C drug: sofosbuvir (Sovaldi ). for lower respiratory infections.

Product types Products per disease category Clinical pipeline per disease category On the market Pipeline Medicines Vaccines Diagnostics Communicable Vector control products Non-communicable Communicable

Platform technologies Neglected tropical Non-communicable

Opportunities for improving access to medicine

Incorporate market segmentation in licensing Expand access to new hepatitis treatment. strategies in middle income countries. Gilead’s Through sofosbuvir (Sovaldi®), Gilead has a licences for its HIV/AIDS portfolio do not always unique position to improve hepatitis care. In cover a broad range of middle income countries. 2014, it agreed a broad licensing strategy with Patients from low-income segments living in seven Indian manufacturers covering 91 coun- these countries often fall outside these access tries, and announced it would offer sofosbuvir mechanisms. Gilead can consider whether to some middle income countries at reduced and how licensing can boost access in these prices. While the expected price of Sovaldi® in markets, e.g., by identifying new approaches to India, for example, is significantly lower than the public/private market segmentation. US price, it is uncertain whether it is affordable. Gilead can consider more clearly how it targets the poor in its pricing strategies, as well as how to expand licensing agreements to include a wider range of middle income countries.

153 Company Report Cards Access to Medicine Index 2014

rank score 6 2.8 Merck KGaA 8 (2012)

5 4,3 Management 3,8

1,3 Public Policy 1,3 4

2,5 R&D 3,0 3 3,2 3,4 3,1 Pricing 2,9 2.5 2 0,9 Patents 1,9

3,3 Capability 3,0 1 1,2 3,5 Donations 3,4 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Merck KGaA rises two places to 6th. It has revised its Access tive initiative to increase local manufacturing capabilities. It to Healthcare (A2H) strategy and has committed to taking performs strongly in R&D: a substantial share of its pipe- a pro-access approach to IP management and to licensing line targets local needs for non-communicable diseases, products in a broad range of countries. It is overall very including diabetes and cardiovascular disease, and it has transparent and has launched new initiatives since 2012, strategies to ensure these medicines will reach patients in including a pro-access business model in India and an innova- relevant countries.

Performance update

Takes multi-dimensional approach Takes more active approach to dialogue commits to file for registration of most of its to schistosomiasis. This includes: a long-term and knowledge-sharing. Through its Merck products in relevant countries. donation programme that aims to eliminate the Access Dialogue Series, Merck KGaA shares disease; strengthening local R&D capacities; information and best practices and assesses, Improved targeting of pricing strategies. developing a new diagnostic tool and paediatric with stakeholders, ways of removing barriers to Merck KGaA now has relevant equitable pricing formulation; and piloting local solutions for access. It has hosted dialogues on pricing, intel- strategies that include intra-country segmen- better sanitation. lectual property and supply chains. tation. It performs strongly in new areas of disclosure. Moves from philanthropy-driven to stra- Develops tailored marketing code of tegic approach. Merck KGaA has significantly practice. Merck KGaA has developed internal Leads in commitment to pro-access IP revised its A2H strategy: it focuses on R&D for controls and audits, including ‘country compli- management. It publicly takes an access- local and unmet needs; strengthening supply ance officers’ in each country of operation. friendly stance on IP management and has chains; assisting patients unable to afford policies to determine access to future on-patent healthcare (among other areas), and is driven Aligns R&D strategy with developing products in the widest range of countries. It has by a newly established A2H unit. It revised and country needs. Merck KGaA provides detailed committed to not filing for or enforcing patents broadened its A2H Charter, publicly disclosing evidence of how its pipeline products for in a broad range of countries, and considers its stance on a range of areas, including pricing chronic diseases target patients in relevant licensing in several disease categories. Uniquely, and IP. countries. It is one of the few companies to it has extended its commitment to products for provide product registration targets. It also non-communicable diseases.

Best practices

Piloting pro-access business model in India. data collected in a centralised system to ensure tual Plant Team’ will provide support, expertise The Su-Swastha programme aims to increase product quality, and improve transport routes. and regular training to the local third-party access to healthcare products at an affordable plant managers, in order to harmonize manu- price in rural India. It offers community-level Addressing forward integration of supply facturing standards across all its in-house and meetings and educational health programmes, chains. It has tested a software tool that can im- third-party manufacturers. as well as products based on local needs. prove stock management in Sudan and Ethiopia. Integrated with Merck KGaA’s order manage- Piloting local solutions for better sanita- Innovates in distribution to ensure product ment system, it improves price transparency tion. As part of its praziquantel donation quality. Merck KGaA uses heat and humidity and reduces lead time and miscommunication. programme, Merck KGaA started a pilot study sensors to monitor transportation conditions of in Senegal that aims to build a better under- all its products shipped from Europe to the rest Developing platform to ensure local quality standing of sanitation needs to improve disease of world (in its ‘Temptation Project’). It uses the manufacturing standards. Merck KGaA’s ‘Vir- prevention.

154 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Merck KGaA is a diversified company that operates through four divisions: Merck Serono, Con- sumer Health, Merck Millipore and Performance Materials. Merck Serono provides prescription medicines for treating cancer, multiple sclerosis, infertility, growth disorders, cardiovascular and metabolic diseases and allergies. Through Merck Millipore, it offers tools and laboratory chemicals. Through its partnership with Dr Reddy’s, the company is growing in the biosimi- MerckSerono , mn EUR lars market. About one-third of its sales are In scope, has sales Merck Millipore`,mn EUR generated in emerging markets. In scope, has no sales Performance Materials,mn EUR Not in scope Consumer Healthmn EUR Due to a change in segment reporting, numbers were Total sales,mn EUR General information Sales by division (2013) Sales by region incomparable between 2010 and 2011. , mn EUR , Frankfurt Stock Exchange , , MRK EUR MerckSerono , Europe Headquarters ,mn Darmstadt, Germany , , Merck Millipore , North America Number of employees Performance Materials , ROW

38,847 Consumer Health Emerging Markets 2009 2010 2011 2012 2013

Portfolio and pipeline

Focus Marketed products Pipeline products Within scope, the company focuses on non- Has products for 16 diseases in scope, mainly Its clinical pipeline targets five diseases, includ- communicable diseases. In addition, it has a medicines for diabetes, cardiovascular disease ing medicines for ischaemic heart disease, dia- strong portfolio of antibiotics. and antibiotics. Its medicine praziquantel betes, and osteoarthritis. It is also developing targets three neglected tropical diseases: a diagnostic tool for HIV/AIDS and schistoso- schistosomiasis, cysticercosis and food-borne miasis. In pre-clinical stages it has a paediatric Merck KGaA trematodiases. formulation of praziquantel.

Product types 20 Products per disease category Clinical pipeline per disease category 32 4 0 On the market Pipeline 56 Medicines Vaccines Diagnostics Communicable Vector control products Non-communicable Platform technologies Neglected tropical Non-communicable

Opportunities for improving access to medicine

Continue R&D to address local needs. Merck Follow through on pro-access IP and licensing Measure impact of newly launched models KGaA can continue to focus on adapting exist- stance. When launching new products, the and initiatives. Merck KGaA has launched ing medicines and developing innovative company can fulfil its pledge not to file for or several new models and initiatives that aim to compounds to meet medical needs in countries enforce patents in certain countries and to increase access to medicine. By measuring their in scope. It can continue to integrate the devel- issue voluntary licences where there is a need economic and public health impact, it can deter- opment of medicines and diagnostic tools. and opportunity. mine whether to expand models to more countries and products and whether to turn projects into long-term sustainable programmes.

155 Company Report Cards Access to Medicine Index 2014

rank score 7 2.6 Merck & Co. Inc. 4 (2012)

5 4,4 Management 4,3

1,1 Public Policy 1,3 4

3,3 R&D 2,5 3 3,2 Pricing 3,1 3,0 2,9

2 1,3 Patents 0,9 2.3

3,3 Capability 3,3 1,6 1

3,1 Donations 3,5 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Merck & Co. drops three places to 7th. It performed strongly its disclosure is limited, it offers narrow support for the flex- in donations due to its Mectizan® programme, as well as in ibilities set out in the TRIPS agreement, has issued fewer access-to-medicine management, with a new approach to voluntary licences than some peers and is opaque about stakeholder engagement and having embedded access-to- their terms. In Research & Development, it has been over- health principles in its operations and strategies. It performs taken due to limited movement of compounds along its pipe- well in the Pricing, Manufacturing & Distribution area. Its line, and for not disclosing investments in relevant activities. performance in Patents & Licensing has dropped, however:

Performance update

Has strong governance and management of Approaches licensing and data exclusivi- ed an online system for researchers to submit access to medicine. The company has embed- ty with limited access-orientation. Merck & Co. requests for access to its clinical trial data. ded access to medicine into its governance takes a limited pro-access approach to licensing structures, business strategies and manage- and is opaque about the terms of the agree- Has broad scope of equitable pricing strate- ment systems, including in a newly established ments it has reached. It discloses no examples gies. Including new areas of investigation, there Emerging Markets Access Committee, respon- where it would waive rights to data exclusiv- is evidence that it has implemented equitable sible for driving its access strategy and imple- ity. Through its membership of the Innovative pricing for more products than in 2012. Equi- menting its Access to Health Guiding Principles. Pharmaceutical Association of South Africa, it table pricing strategies cover the majority of was linked to an alleged attempt to undermine its products and the majority of countries it has Remains only company that is a member patent reform in South Africa. a presence in. It takes numerous factors into of PACI. As in 2012, it is the only Index com- account in its pricing decisions. pany in the Index to have joined PACI: the A leader in clinical trial conduct and data World Economic Forum’s Partnering Against transparency. The company’s code of clini- Commits to eliminating onchocerciasis Corruption Initiative. It thereby commits to cal trial conduct includes elements from the and lymphatic filariasis. The Merck Mectizan® a zero tolerance policy towards bribery and Declaration of Helsinki, with strong monitoring Donation Program started in 1987 and will corruption and to establishing an internal and enforcement mechanisms for in-house and continue until these diseases are eliminated in anti-corruption programme. outsourced clinical trials. In 2014, it implement- all endemic countries.

Best practices

Taking a strategic approach to stakeholder Developing an innovative financing manufacturing process, reducing costs and engagement. In 2013, Merck & Co. launched its model for hepatitis C. In 2012, Merck & Co. potentially increasing affordability. Strategic Relationship Leads approach in order launched a pilot in India to support patients with to enhance its engagement with key external no or limited insurance coverage in accessing Taking an integrated approach to supply stakeholders regarding HIV/AIDS, hepatitis C, its hepatitis C medicine, peginterferon alfa-2b chain alignment. The company combined a vaccines, family planning and maternal and child (PegIntron ®). The programme offers zero- technology transfer with supply chain trainings, health. It also has a dedicated unit for engaging interest, no-collateral loans to eligible patients, enhancing communication between suppli- with stakeholders in sub-Saharan Africa and for as well as a disease-management option. ers and procurer resulting in reduced supply evaluating and addressing local public health interruptions. It also participated in a pilot to needs that works with governments, interna- Innovating in manufacturing to improve proactively manage contraceptive supply in tional donors and NGOs on the ground to help affordability. It is developing a soft-chew tablet Senegal to reduce stock-outs. ensure the delivery of healthcare services, vac- that can be taken without water. It may be pro- cines and contraceptives. duced using simple formulations and a simple

156 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Merck & Co. develops prescription medicines, vaccines, biologics and animal health products. Its pharmaceuticals and vaccines businesses offer products for diabetes, obesity, women’s health, oncology, ophthalmology and immunology, as well as respiratory, cardiovascular, en- docrine, inflammatory and infectious diseases. It has various joint ventures and collaborations in India, China, Brazil and South Africa, and an Asia R&D HQ in China. It has increased its focus on emerging markets and about a third of its In scope, has sales employees now work in emerging markets. It In scope, has no sales sold its consumer care business to Bayer in May Not in scope 2014.

In 2009 Merck & Co. General information Sales by segment (2013) Revenues by region and Schering-Plough Pharmaceuti- , mn USD merged , cal , , , New York Stock Exchange Animal Health , , Japan MRK Consumer , USD Pharmaceutical Europe, Middle East Headquarters Care, ,mn , Whitehouse Station, NJ, US Animal Health and Africa Other, Number of employees , Consumer Care , US Total sales, 76,000 Other ROW 2009 2010 2011 2012 2013

Portfolio and pipeline

Merck & Co. is diversified with a strong pres- Marketed products Pipeline products ence in contraceptives and HIV/AIDS. Has products for 16 diseases in scope, with a Its clinical pipeline targets seven diseases, with range of contraceptives, HIV/AIDS products tetanus and pneumococcal vaccines, medicines Hepatitis is included under cirrhosis of the liver and products for non-communicable diseases, for diarrhoeal diseases, HIV/AIDS, diabetes, and counted as a non-communicable disease. plus a rotavirus (RotaTeq®) and pneumococcal asthma and Chagas disease, and a notable ® Merck & Co., Inc. (Pneumovax 23) vaccine (among others). contraceptives pipeline.

Product types 10 Products per disease category Clinical pipeline per disease category 12 3 7 On the market Pipeline 32 Medicines Vaccines Communicable Communicable Diagnostics Non-communicable Non-communicable

Vector control products Neglected tropical Neglected tropical Platform technologies Maternal and neonatal Maternal and neonatal

Opportunities for improving access to medicine

Expand innovative financing mechanisms and (Isentress®)) through the Medicines Patent addresses family planning and two leading pricing strategies. The company has taken Pool. It is currently in negotiations with the causes of maternal mortality. The company’s steps to target its equitable pricing strategies MPP regarding potential licences on paediatric expertise and products can contribute to toward the poorest segments. If pilots in India formulations of raltegravir. It can also begin improving maternal health in resource-limited can be shown to have positive outcomes and im- discussing licences for other formulations, settings. pact, it can further implement these strategies including efavirenz products. for other relevant products, for more diseases, Improve transparency of activities to influence patients and regions. Leverage strong position in reproductive markets. Merck & Co. can increase its transpar- health. The company is committed to develop- ency regarding activities to influence policy Take a more access-oriented approach to ing products that address maternal mortality and gain market access in relevant countries. licensing. The company can be more transpar- in resource-limited settings and has adaptive It can extend its current disclosure to include ent about its licensing agreements and can take contraceptive methods in late-stage develop- marketing activities and board seats it holds at a more access-oriented approach to licens- ment, including a heat-stable contraceptive associations and organisations with relevance ing its ARVs (efavirenz (Stocrin®); raltegravir ring. Through its Merck for Mothers program, it to countries and diseases in scope.

157 Company Report Cards Access to Medicine Index 2014

rank score 8 2.6 Sanofi 3 (2012)

5 2,7 Management 3,3

1,4 Public Policy 1,0 4

1,8 R&D 2,5 3 2,9 Pricing 3,0 3,0 2,7 2,6 2 1,8 Patents 1,7

2,6 Capability 3,8 1 1,1 2,8 Donations 2,6 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Sanofi falls from 3rd to 8th place. Despite a broad range of limited commitment to partnering on access-oriented terms. relevant products, it makes comparatively little progress and It drops significantly in Public Policy & Market Influence, has lost in the area of transparency. It retains its strong posi- with low disclosure of its marketing activities in countries tion in Capability Advancement, performing well in all areas, in scope and multiple breaches. Its equitable pricing initia- and with an innovative solution for maternal health. In R&D, tives cover a limited proportion of its relevant products and it is a leader in product development, but is less transparent countries it has presence in. than others about the terms of its R&D partnerships, with

Performance update

Has wide range of access initiatives. No- Has equitable pricing strategies for a their healthcare providers in real time. Patients tably, this includes initiatives for epilepsy and relatively narrow proportion of its products. receive regular messages and advice via SMS mental health that focus on cross-sector part- Considering its geographic spread and the size and are encouraged to provide information nerships and collaborations, training healthcare of its portfolio, Sanofi’s equitable pricing focus regarding their diabetes management. Nurses professionals in diagnosis and treatment, com- is limited. However, its strategies are targeted and doctors can track patients’ progress. bating stigmatisation and applying preferential towards the lowest tier and apply to diseases pricing policies in a range of countries. Also, it where there is limited equitable pricing from Commits to eliminating trypanosomiasis. has an initiative focused on paediatric care, with the industry, such as leishmaniasis and schizo- Sanofi has a large structured donation pro- three goals: to develop a portfolio of products phrenia. gramme that aims to eliminate trypanosomiasis adapted for children, strengthen the training by 2020. The medicine it donates is made avail- of healthcare professionals, and inform the Strongly committed to production and able where needed, through the WHO. general public about paediatric diseases. It also capacity building in Africa. 60% of Sanofi prod- has initiatives focused on capacity building, ne- ucts distributed in Africa are produced locally, glected tropical diseases, malaria and diabetes. shortening supply chains. With the opening of a new production site in Algeria in 2017, it aims to Taking steps to improve health in resource- increase this to 80%. It also has a strong focus limited settings. It engages in IP-sharing on building capacities outside the value chain in partnerships targeting tuberculosis and Africa. neglected tropical diseases, and has a vaccine for dengue and a medicine for trypanosomiasis Improves diabetes care with mobile ser- in late-stage development. It contributes to vices. Together with Vodacom, Sanofi has cre- malaria resistance research by providing data to ated a mobile-phone application that enables WorldWide Antimalarial Resistance Network. diabetes patients in Africa to interact with

Best practices

Strengthening malaria medicine supply. Supporting healthcare providers to improve maternal and neonatal health in underserved Sanofi has established a large-scale produc- maternal and neonatal health. The Sanofi areas. In 2014, ten initiatives will receive finan- tion line for semi-synthetic artemisinin. This Espoir Foundation has set up an online platform cial support. will significantly strengthen the artemisinin called ‘Connecting Midwives’ in collaboration supply chain, contribute to a more stable price with the International Confederation of Mid- and ultimately ensure greater availability of wives. It allows midwives to share experiences treatment. and ideas and propose field projects to improve

158 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Sanofi is a diversified company that offers prescription- and over-the-counter drugs, including generics, human vaccines and animal health drugs in over 100 countries. Its main areas of research include multiple sclerosis, diabetes, oncology, rare diseases, cardiometabolic diseases, immunology and vaccines. About one-third of its sales comes from emerging markets. The company holds a strong position in the diabetes market and is one of the largest vaccine manufacturers worldwide in terms of In scope, has sales sales, through subsidiary Sanofi Pasteur. In scope, has no sales

Not in scope

General information Revenues by segment (2013) Net sales by region

, mn EUR

, EURONEXT Paris , , , SAN , EUR Japan Headquarters ,mn , Pharmaceuticals Western Europe Paris, France , , Vaccines US Number of employees ,

112,128 Animal Health ROW 2009 2010 2011 2012 2013

Portfolio and pipeline Hepatitis is included under cirrhosis of the liver and counted as a non-communicable disease.

Focus Marketed products Pipeline products Within scope, Sanofi has a large, diverse port- Has products for 26 diseases in scope, mainly In clinical stage, Sanofi targets ten diseases in folio and pipeline that focuses on medicines for medicines, with a strong presence in cardio- scope including medicines for trypanosomiasis, mental health and diabetes and products for vascular disease, diabetes, mental health and diabetes and malaria, and vaccines for dengue, neglected diseases. antibiotics. It has a large range of medicines for HIV/AIDS, TB, meningitis, lower respiratory

Sano neglected tropical diseases, TB and malaria. infections and diarrhoeal diseases.

Product types 64 Products per disease category 10 Clinical pipeline per disease category 69 6 12 2 0 0 On the market Pipeline 145 18 Medicines Vaccines Diagnostics Communicable Communicable Vector control products Non-communicable Non-communicable

Platform technologies Neglected tropical Neglected tropical

Opportunities for improving access to medicine

Include access provisions in more R&D agree- Develop more specific pro-competitive The company can increase access to its more ments. Sanofi does not commit to systemati- policies. Sanofi can extend its approach to advanced diabetes products in lower-income cally incorporating access provisions in R&D facilitating competition beyond adherence to settings through, for example, expanding exist- agreements: it provides proof that a limited relevant competition laws in relevant countries. ing equitable pricing strategies. number of R&D partnerships (those targeting It can develop policies that support timely mar- malaria, tuberculosis, and neglected tropical ket access of generics, e.g., by waiving specific Leverage strong position in vaccines. Through diseases) are based on access provisions. It can rights to data exclusivity, or developing a clear its large vaccine pipeline and portfolio, Sanofi incorporate these provisions in a broader range policy on engaging in voluntary licensing. can play an important role in preventing com- of partnerships and diseases. municable diseases, including HIV/AIDS, Continue developing diabetes products for tuberculosis, and dengue. Both for products Expand equitable pricing programmes. As it use in countries in scope. Sanofi is a leader in developed in-house and in partnership, the has a broad portfolio of relevant products and adaptive R&D for diabetes and can play an im- company can take access into consideration a broad geographic spread, it can expand its portant role in developing products and devices during the development process, for example, equitable pricing strategies to include a wider that are tailored to local conditions, such as by ensuring terms and conditions include access range of products and countries. heat-stable insulin or insulin delivery devices. provisions.

159 Company Report Cards Access to Medicine Index 2014

rank score 9 2.6 AbbVie Inc. New in 2014 Index

5 Management 1,9

Public Policy 2,4 4

R&D 3,0 3 Pricing 3,4 2,9 3.0

2 2,5 Patents 1,2

Capability 2,8 1

Donations 2,3 0,25 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

New to the Index, AbbVie is in 9th place. It shows promise constructing its pricing strategies, but there is room for it when it comes to improving access to medicine, particularly to expand this approach to a much greater proportion of as it is among the leaders in developing new treatments for its portfolio. It has entered negotiations with the Medicines neglected tropical diseases, hepatitis and HIV/AIDS. Its pipe- Patent Pool, however it has no specific policy of engaging in line consists both of products inherited from Abbott, and licensing. of new projects, including access-oriented collaborations. AbbVie has considered poorest population segments when

Performance update

Provides strong evidence of applying and Among leaders in pro-access pipeline Low commitment to access-oriented enforcing marketing code of conduct. AbbVie partnerships and product development. A IP management. AbbVie does not specifically provides detailed information about its code of large share of AbbVie's pipeline is developed commit to not filing for patents in Least Devel- conduct for ethical marketing, demonstrating in partnerships based on access provisions. It oped Countries, or to considering licensing to how it is enforced and extended to third parties. also stands out for sharing compound libraries support competition. It is, however, negotiating It is the only company to report using external for screening studies targeting tuberculosis, licences with the Medicines Patent Pool. parties to audit its code of conduct against cor- malaria, and various neglected tropical disease ruption and bribery. pathogens. Does not engage in knowledge- or technology transfers. AbbVie is the only company Comparatively broad disclosure of lobbying Performs strongly in equitable pricing. to not disclose evidence of increasing local activities. AbbVie discloses board seats and AbbVie employs inter-country pricing segmen- production capabilities, either of third-party or memberships it holds of organisations that can tation across a comparatively broad geographic its own manufacturing facilities, in countries in influence access to medicine in countries in scope. It also employs intra-country segmenta- scope. scope or that focus on diseases in scope. tion. When defining segments, it takes account of national income and disease burden. Its eq- Actively enhances paediatric HIV/AIDS care Strong commitment to neglected tropi- uitable pricing strategy takes affordability into in Africa. Working with two NGOs engaged in cal diseases. AbbVie is the only company with account and actively targets poorest population paediatric HIV/AIDS care, AbbVie has helped a dedicated Executive Council for Neglected segments. train more than 21,000 health workers in 17 Af- Tropical Diseases. It coordinates company ef- rican countries on the use of ARVs in treatment- forts regarding neglected diseases, reporting naïve patients, pregnant women and children. to the Executive Board. AbbVie works with a range of external partners in this area.

Best practices

Supporting healthcare providers to improve neonatal health. AbbVie worked with the Philippine Society of Newborn Medicine in developing a national neonatal registry in the Philippines. The registry makes it possible to track disease and outcome rates, the first step toward controlling disease among newborns.

160 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

AbbVie became an independent, publicly traded company on January 1, 2013, following the spin-off from Abbott Laboratories, holding Ab- bott’s former research based pharmaceutical business. It has one segment, pharmaceutical products, which focuses on immunology, kidney diseases, hepatitis C, neuroscience, oncology and women’s health.

In scope, has sales

In scope, has no sales

Not in scope Historical financials are General information Sales by segment (2013) Sales by region derived from AbbVie’s Pharmaceuticals financial statements. , mn USD New York Stock Exchange ,. bn JPY ABBV Total, sales ,. Japan Headquarters bn JPY USD , Major European North Chicago, IL, US ,mn Markets Number of employees , 25,000 US Pharmaceutical Products ROW 2009 2010 2011 2012 2013

Portfolio and pipeline

Focus Marketed products Pipeline products Within the scope of the Index, AbbVie focuses Has products for seven diseases in scope. For AbbVie’s clinical pipeline targets four diseases on HIV/AIDS and neonatal health, with medi- communicable diseases, this includes ARVs for in scope, with hepatitis and HIV/AIDS getting cines for hepatitis in development. HIV/AIDS and an anti-malarial medicine. For most attention. It is developing paediatric neonatal health, it has medicines for respira- medicines for HIV/AIDS and lower respiratory Hepatitis is included under cirrhosis of the liver tory distress syndrome and lower respiratory infections, and is involved in R&D for neglected andAbbVie counted Inc. as a non-communicable disease. infections. tropical diseases.

Product types 5 Products per disease category 6 Clinical pipeline per disease category 2 9 0 0 4 0 On the market Pipeline 11 15 Medicines Vaccines Diagnostics Communicable Vector control products Non-communicable Communicable Platform technologies Maternal and neonatal Non-communicable

Opportunities for improving access to medicine

Centralise and co-ordinate access-to- Develop access strategies for relevant pipeline Engage in licensing. AbbVie has several medicine management. AbbVie is considering products. AbbVie’s pipeline represents a sig- products that are of significant value to public developing an executive council responsible nificant proportion of R&D activities captured health, particularly for paediatric HIV/AIDS for developing, aligning and streamlining a by the 2014 Index, particularly in hepatitis, and (lopinavir (Aluvia®/Kaletra®), ritonavir (Nor- targeted approach to its access-to-medicine neonatal health. The company can develop vir®)). Completing licensing negotiations with strategy and activities. Such stronger oversight strategies ensuring they are as widely available, the Medicines Patent Pool for these products could support the integration of the company’s affordable and accessible as possible once they will help ensure they are more widely available. access-to-medicine strategy with its business reach markets. AbbVie can consider expanding licensing to activities, and the development of stronger other products where there is generic market performance management of its access ap- Expand equitable pricing strategy across port- potential (particularly for its pipeline products proach. Especially considering AbbVie’s strong folio. AbbVie can extend its existing equitable for hepatitis) and develop a clearer, public, ap- relevant portfolio and pipeline, such a change pricing practices to more of its relevant port- proach to licensing in general. could significantly improve its overall impact on folio, particularly to ensure that forthcoming access to medicine. hepatitis treatments are priced equitably.

161 Company Report Cards Access to Medicine Index 2014

rank score 10 2.5 Bayer AG 9 (2012)

5 2,1 Management 2,7

1,7 Public Policy 1,7 4

2,5 R&D 2,1 3 3,1 1,3 Pricing 3,2 2.6 2,6 2 1,2 Patents 1,8

3,1 Capability 3,0 1

2,5 Donations 2,8 0.6 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Bayer falls one place to 10th position. Despite maintaining its pricing is now more concrete, specific and comprehensive access-to-medicine management approach, it was overtaken than reported in the 2012 Index. Compared to peers, Bayer by other companies that implemented new approaches or is more supportive of the Doha Declaration’s IP flexibilities, models. Plus, having received many market approvals during explicitly endorsing several elements. It is also notable for the 2012 Index, its relevant pipeline for the 2014 Index is having three large structured donation programmes. relatively empty. It does, however, stand out for its equitable pricing strategies. Its commitment to inter-country equitable

Performance update

Linked to multiple breaches of ethical ensure products are used rationally. For malaria in developing their pharmacovigilance systems. marketing standards. Bayer has been found in and schistosomiasis, it uses a combination of It is among the leaders in building local capabili- breach of ethical marketing standards multiple text and pictograms to give directions for use ties in pharmacovigilance. times during the period of analysis, and twice and information about safety and environmen- in relation to improper marketing practices in tal considerations. Increases support for eliminating and con- South Africa. trolling neglected tropical diseases. Bayer now Maintains access-oriented approach to commits to eliminating trypanosomiasis and Co-developing TB treatment to help limit family planning. Bayer has strong equitable controlling Chagas disease by 2020 (via dona- drug-resistance. Since 2005, Bayer has been pricing strategies for several contraceptive tions). It is currently also developing a paediatric co-developing moxifloxacin for shorter treat- products. It also works with multiple partners formulation for Chagas disease. This product ment regimens for drug-susceptible tubercu- training healthcare professionals and raising could play an important role in treating children losis (patients are more likely to comply with awareness of family planning and contracep- with this disease. shorter regimens, in turn helping to limit drug tives among women in rural and urban areas of resistance). Clinical trial results were expected countries within scope. It has expanded these at the time of writing, with the submission of efforts in a broad range of African countries. registration dossiers planned for November 2014. The first sales are expected early 2015. Continues to improve national pharmacovigilance systems in Asia. The company Adapts packaging to meet local literacy continues to work with the WHO Uppsala needs. Bayer is one of several leaders in adapt- Monitoring Center and International Society of ing product packaging to meet local needs and Pharmacovigilance to support Asian countries

Best practices

Piloting a leading equitable pricing strategy. Bayer is piloting a new differential pricing model that takes into account both access and commercial objectives. It is a leading practice in terms of the level of clustering and the combination of criteria it considers.

162 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Bayer has three subgroups: HealthCare, CropScience and MaterialScience. HealthCare is divided into consumer health and pharmaceuticals. The latter offers prescription pharmaceuticals, including hormonal contraceptives, haemophilia treatments, anticoagulants, and for multiple sclerosis, cancer, hypertension, diabetes and infectious diseases. CropScience has a broad portfolio of pest-control products, including for controlling and preventing vector- borne diseases. It has a broad geographic In scope, has sales presence and over one-third of its sales are in In scope, has no sales emerging markets. Bayer is acquiring Merck & Not in scope Co.’s Consumer Care business.

General information Sales by subgroup (2013) Sales by region

, mn EUR ,

Frankfurt Stock Exchange , Europe BAYN , , EUR HealthCare North America Headquarters , ,mn , Leverkusen, Germany CropScience Latin America/ Number of employees , MaterialScience , Africa/Middle East

113,200 Reconciliation Asia/Pacific 2009 2010 2011 2012 2013

Portfolio and pipeline

Focus Marketed products Pipeline products Bayer has a strong contraceptive portfolio, Has products for 13 diseases in scope, mainly Within scope, Bayer’s clinical pipeline targets with an additional focus on neglected tropical medicines. This includes contraceptives and two diseases: it has a paediatric medicine for diseases and vector control products. medicines for Chagas disease, trypanosomiasis Chagas disease and a medicine for tuberculosis. and schistosomiasis. It has many vector-control Plus, it is improving a treated bed-net to provide products relevant to dengue, malaria and schis- longer-lasting protection against mosquitos tosomiasis. and sandflies.

Bayer AG Product types Products per disease category Clinical pipeline per disease category 13 6 11 5 On the market Pipeline 35 Medicines Vaccines Communicable Diagnostics Non-communicable Vector control products Neglected tropical Communicable Platform technologies Maternal and neonatal Neglected tropical

Opportunities for improving access to medicine

Adopt a more access-oriented approach for on using bed nets. It can apply its knowledge vector-control products. Bayer has broad and technological expertise in vector-control expertise with a portfolio that includes both cu- products to facilitate innovation. It can also rative therapies and preventive vector-control make its vector-control products, including new products. While it already has a comprehen- ones, more widely available and affordable. sively access-oriented approach for its contraceptive products, it has scope to adopt a more access-oriented approach for its vector-control products. These play an essential role in reducing the global burden of diseases spread by in- sects. Bayer is already involved in educating and raising awareness among children in rural Africa

163 Company Report Cards Access to Medicine Index 2014

rank score 11 2.5 Eisai Co. Ltd. 15 (2012)

5 0,7 Management 3,3

0,4 Public Policy 1,8 4

2,2 R&D 2,4 3 1,7 Pricing 2,9 3,0

2 2,4 2,5 1,7 Patents 1,9

1,2 Capability 2,0 1

1,3 Donations 2,7 0,6 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Eisai rises four places to 11th, driven by improvements in for relevant diseases. It is one of the more supportive various areas: it rewards specific senior managers for companies regarding TRIPS/Doha (although its score is still achieving access objectives; in Public Policy & Market Influ- low), has taken a public stance against the evergreening of ence, it was linked to fewer breaches than others (none in patents, and commits not to file for patents in Least Devel- competition law); it has implemented an equitable pricing oped Countries. Eisai has a large pipeline of products for strategy in a country within scope; and commits to imple- neglected tropical diseases. menting equitable pricing strategies for all new products

Performance update

Discloses little about policy positions and inter- and intra-country pricing tiers. For the Commits to eliminating a neglected tropical lobbying practices. As in 2012, Eisai continues first time, it has implemented an equitable pric- disease. In 2012, Eisai took over a donation to disclose limited information about policy ing strategy that meets criteria set by the Index. programme that aims to eliminate lymphatic positions and the scale and scope of its lobbying filariasis by 2020. Eisai has pledged to signifi- activities. However, it has improved its disclo- Develops more supportive stance towards cantly scale up this programme, aiming to ship sure with regard to board seats and member- IP. Eisai has a clear public stance against ever- 2.2 billion diethylcarbamazine citrate (DEC) ships of organisations that influence access to greening. It was also not involved in any identi- tablets to the WHO by 2020. It began shipping medicine in relevant countries. fied incidences of IP-related anti-competitive treatments in October 2013. The geographic practice. In addition, Eisai has a comparatively scale of the programme was defined by Pipeline targets relevant diseases. Eisai has supportive stance on the public health flex- the WHO, based on elimination targets for achieved considerable movement of relevant ibilities within the TRIPS agreement. However, lymphatic filariasis. Distribution, storage and products along its pipeline toward more ad- it has no clear commitment to considering administration are periodically reviewed in vanced stages of development. It is involved in licensing and provides no evidence of engaging collaboration with the WHO. R&D for a range of neglected tropical diseases, in licensing. tuberculosis and malaria. A large share of its pipeline products are being developed in part- More active in building local production ca- nerships, some of which are based on access pabilities. Since 2012, Eisai has engaged in more provisions. knowledge and/or technology transfers with in-house and third-party manufacturers, in rela- Improves significantly in equitable pricing tion to quality and manufacturing standards. commitment and implementation. Eisai now has a Global Pricing Policy that includes both

Best practices

Contributes strongly to R&D for neglected tropical diseases. Eisai is also developing a sub- tropical diseases. Eisai is a founding member of stantial pipeline of medicines and vaccines for the Global Health Innovative Technology Fund leishmaniasis, lymphatic filariasis, and Chagas (established with other Japanese pharmaceuti- disease. cal companies, the Japanese government and the Bill & Melinda Gates Foundation). Known as GHIT, this is a new scheme that funds early discovery research, including for neglected

164 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Eisai operates through two segments, with its pharmaceuticals business offering prescription pharmaceuticals, consumer healthcare, diagnostic products and generic medicines. It focuses on oncology, neurology, auto-immune diseases and over-the-counter products. It has a limited presence in countries in scope and has limited sales in countries outside Japan and the US. However, as a proportion of sales overall, sales beyond these territories are steadily growing. In scope, has sales

In scope, has no sales

Not in scope

General information Revenues by segment (2013) Revenues by region Pharmaceutical Human , bn JPY Business . bnJ- Pharmaceutical . Tokyo Stock Exchange PYOther Products,

4523 Business .bn Animal Health, JPY Japan Headquarters JPY .bn Total Tokyo, Japan Europe Total revenue, Pharmaceutical Business US Number of employees . revenue .bn 10,495 Other Business ROW 2009 2010 2011 2012 2013

Portfolio and pipeline

Focus Marketed products Pipeline products Within the scope of the Index, Eisai is strong in Has medicines for six diseases in scope, with a Its clinical pipeline targets three diseases in epilepsy and is diversifying its portfolio to in- strong focus on non-communicable diseases, scope: cirrhosis of the liver, epilepsy and Chagas clude products for neglected tropical diseases. particularly epilepsy. In 2013, it received WHO disease. It has a large pre-clinical pipeline that prequalification for a medicine for lymphatic includes medicines and vaccines for leishmani- Hepatitis is included under cirrhosis of the liver filariasis. asis, lymphatic filariasis, Chagas disease, lower and counted as a non-communicable disease. respiratory infections and malaria. Eisai Co., Ltd.

Product types 0 Products per disease category Clinical pipeline per disease category 11 1 0 On the market Pipeline 12 Medicines Vaccines Diagnostics Vector control products Non-communicable Non-communicable Platform technologies Neglected tropical Neglected tropical

Opportunities for improving access to medicine

Engage with stakeholders more proactively Expand registration plans, develop licensing products. In addition, it can follow through on and strategically. While Eisai already engages policies, and implement pricing schemes for its commitment to implementing equitable with a range of relevant stakeholders, it can do pipeline compounds. Eisai is actively develop- pricing schemes for relevant new products so more proactively and strategically, e.g., to ing products for epilepsy, cirrhosis of the liver once they reach the market. understand risks and opportunities related to and a number of neglected tropical diseases. access to medicine and to support the imple- There are several steps it can take to help mentation of access strategies on a global and ensure they become accessible in relevant local level. markets. For example, it can incorporate access provisions in more R&D partnerships and expand the geographic scope of registration targets. Eisai can also develop a policy that sets out when and how it would consider licensing arrangements for current and future on-patent

165 Company Report Cards Access to Medicine Index 2014

rank score 12 2.3 Roche Holding AG 10 (2012)

5 2,1 Management 2,7

1,4 Public Policy 1,4 4

2,0 R&D 1,8 3 1,8 Pricing 2,9 3,0

2 2,4 1,6 Patents 1,8 2,3

2,9 Capability 2,6 1

2,1 Donations 2,8 0,2 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Roche drops to 12th place. It is developing products for performed well in product donations, as its donation diseases in scope, most notably for hepatitis, yet this programme targeting hepatitis qualifies for inclusion in the accounts for a relatively small share of its total pipeline. Index for the first time. Roche performs less well regarding Roche reached a unique agreement with the Medicines Public Policy & Market Influence. Alongside many others, it Patent Pool for a medicine that treats an opportunistic was found to have breached regulations and standards. infection associated with HIV/AIDS. Compared to 2012, it has applied equitable pricing strategies to more products. It has

Performance update

Moves closer to integrating access and These strategies cover a relatively small pro- blindness. Roche has reached agreement with business strategies. From 2013, all country and portion of its portfolio, but this has increased the Medicines Patent Pool to lower prices of regional business plans must have a dedicated since 2012. valganciclovir (Valcyte®) in 138 countries. It also access strategy approved at headquarters. In commits to negotiating terms for licensing and addition, it is establishing a centralised system Commits to filing for registration of new technology transfer to enable generic produc- for tracking access-related metrics. products in short time-frame. It pledges to reg- tion. ister new products in countries in scope within Took strong public stance against improper six months of gaining EU or Swiss approval. Building local diagnostic capacity. Ampli- lobbying. Roche publicly distanced itself from Roche has local representatives to assess Care, the company’s access initiative focused the Innovative Pharmaceutical Association registration need and prioritises based on epi- on improving HIV/AIDS diagnostic testing, has of South Africa following allegations that it demiology, disease burden, market access and enabled the creation of diagnostic centers planned to undermine reform of South Africa’s available infrastructure. in Africa and Asia. For example, Roche has intellectual property legislation. established its Roche Scientific Campus in Adapts packaging for rational use. Roche South Africa. Run in partnership with the U.S. Developing products to meet high unmet donates products via Novo Nordisk’s Changing President’s Emergency Plan for AIDS Relief needs. Roche has several possibly safer, more Diabetes in Children programme, and adapts (PEPFAR), the Campus provides technical and efficacious oral hepatitis C medicines in its the packaging to help ensure rational use in ten lab-management training, and offers health and pipeline (vs. interferon-based regimens). It relevant countries. Materials are simple, more scientific education. is also developing an antibiotic and is testing illustrative and easy for children and families to schizophrenia medicines in clinical trials. It is understand. This packaging adaptation exceeds Donates to improve hepatitis care. Roche adapting a diagnostic platform that will cut reli- requirements set by national regulatory au- donates several products in nine countries to ance on trained professionals. thorities. hepatitis C patients: a diagnostic test and two medicines, peginterferon alfa-2a (Pegasus®) Taking affordability into account. Roche Collaborating to improve access to treat- and ribavirin (Copegus®). has equitable pricing strategies that target the ment of cytomegalovirus. This virus commonly poorest population segments’ affordability. affects people living with HIV/AIDS, causing

Best practices

The 2014 Index has not identified any best practices from Roche.

166 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Roche is a leader in in-vitro diagnostics, tissue- based cancer diagnostics and diabetes management. Roche has two divisions: pharmaceuticals and diagnostics. It offers medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience, as well as a wide range of diagnostics. It has sales in a significant number of countries in scope, including in Least Devel- oped Countries.

In scope, has sales

In scope, has no sales

Not in scope

General information Sales by segment (2013) Sales by region

, mn CHF

, SIX Swiss Exchange , RO; ROG , CHF Japan Headquarters ,mn , Basel, Switzerland Europe , Number of employees Pharmaceuticals , North America

85,080 Diagnostics ROW 2009 2010 2011 2012 2013

Portfolio and pipeline Hepatitis is included under cirrhosis of the liver and counted as a non-communicable disease.

Focus Marketed products Pipeline products Within the scope of the Index, Roche has a Has products for 14 diseases within scope. Its Its clinical pipeline targets four diseases in strong presence in medicines for HIV/AIDS and medicines portfolio is diversified, targeting nine scope (mainly medicines for schizophrenia and hepatitis, plus a range of diagnostics. diseases including HIV/AIDS and hepatitis. It hepatitis). It is also developing a number of has a large focus on diagnostics, mainly for HIV/ platform technologies, including a diagnostics Roche Holding AG AIDS, hepatitis and maternal health conditions. platform.

Product types 30 Products per disease category Clinical pipeline per disease category 30 0 8 On the market Pipeline 68 Medicines Vaccines Diagnostics Communicable Vector control products Non-communicable Communicable Platform technologies Maternal and neonatal Non-communicable

Opportunities for improving access to medicine

Ensure wide access to new hepatitis medi- Expand implementation strategies during R&D these strategies to cover a larger proportion of cines. Roche is developing hepatitis medicines phase. For some investigational products for its portfolio, including technologically advanced that target a variety of virus genotypes and chronic diseases, Roche lacks implementation medicines. have different mechanisms of action. If efficacy strategies that specifically address relevant and safety is sufficient (vs. other recently ap- countries. This includes products for asthma Expand oncology access structures to other proved hepatitis medicines), this could enable and unipolar depressive disorder. As chronic therapeutic areas. Beyond the scope of the In- a range of interferon-free regimens. If they diseases are on the rise in developing countries, dex, Roche is pursuing a range of access-related gain regulatory approval, they could lead to a Roche can develop implementation strategies activities for oncology, e.g., collaborating with more competitive market with lower prices during the R&D stage to ensure coverage of a healthcare insurance companies in Brazil and and increased accessibility. Roche can apply its wider range of countries. China. Roche can engage in similar activities to experience with HIV/AIDS and other products increase access to medicine in other therapeu- by implementing similar pricing and licensing Expand equitable pricing strategies. Roche's tic areas. strategies to ensure these new class hepatitis existing equitable pricing strategies already medicines are affordable and available in suf- take affordability for the poorest population ficient quantities. segment into account. The company can expand

167 Company Report Cards Access to Medicine Index 2014

rank score 13 2.2 Bristol-Myers Squibb Co. 12 (2012)

5 1,6 Management 1,6

1,4 Public Policy 2,4 4

1,9 R&D 2,2 3 2,5 Pricing 2,6 2.6 2,6 2 1,5 Patents 2,6 2,0 3,5 Capability 1,8 1

2,0 Donations 1,7 0,2 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Bristol-Myers Squibb drops from 12th to 13th place, with a implemented intra-country equitable pricing. In other areas, mixed performance. Since 2012, it has disclosed more about it was overtaken by stronger performers: its donations its memberships, board seats and payments made to organ- approach remains ad hoc, while others engage in structured isations that influence access to medicine. It also negotiated programmes. Access-to-medicine management lags behind pro-access licences for the ARV atazanavir (Reyataz®) with the average, with no evidence that it is embedded in corpo- the Medicines Patent Pool. It successfully moved several rate strategy. HIV/AIDS medicines along its pipeline. It has also newly

Performance update

Entered new IP-sharing partnership. After New implementation of intra-country Facilitating access to atazanavir (Reyataz®). signing the London Declaration on Neglected segmentation. For the first time, the company The company has reached a licensing agree- Tropical Diseases in 2012, Bristol-Myers Squibb employs intra-country equitable pricing within ment with the Medicines Patent Pool covering began pooling IP with the Drugs for Neglected the scope of the Index. Previously, it developing countries. Atazanavir is on-patent, Diseases Initiative (DNDi, a not-for-profit only engaged in inter-country arrangements. and viewed by the WHO as an important product development partnership) to spur drug Within the geographic scope of the Index, it second-line HIV/AIDS treatment. Via the agree- discovery for leishmaniasis, dengue and Chagas has expanded its equitable pricing strategies ment, licensees also gain a technology-transfer disease. to a larger proportion of countries where it package to help ensure quality. is present. Moving HIV/AIDS products along its pipe- Focuses philanthropy on hepatitis and HIV/ line. Bristol-Myers Squibb devotes a large share Packaging standards support rational use AIDS. The Bristol-Myers Squibb Foundation of its pipeline to relevant diseases and showed of medicines. For some products, the com- runs two initiatives that both include numerous substantial movement of HIV/AIDS medicines pany’s packaging standards go beyond what is activities in multiple countries. Delivering Hope to more advanced stages compared to 2012. It required by national drug regulatory authorities focuses on hepatitis B and C in Asia. Secure the moved three antiretroviral drugs from earlier to ensure rational use. For example, blisters are Future focuses on developing and replicating stages of development into clinical develop- used in countries with a stability need, including sustainable solutions for people living with ment. Plus, it gained stringent approval for the Philippines, Egypt, Brazil, South Africa, HIV/AIDS in sub-Saharan Africa. This includes paediatric use of atazanavir (Reyataz®). Indonesia, Vietnam, China, India, and Thailand. providing technical assistance and transferring skills related to existing community resources.

Best practices

The 2014 Index has not identified any best practices from Bristol-Myers Squibb.

168 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Bristol-Myers Squibb produces biopharmaceuticals, primarily for cancer, cardiovascular disease, hepatitis B, HIV/AIDS, rheumatoid arthritis and psychiatric disorders. In February 2014, it completed the divestment of its share in the global diabetes business that was part of its collaboration with AstraZeneca.

In scope, has sales

In scope, has no sales

Not in scope

General information Revenues by segment (2013) Revenues by region Biopharmaceuti- Daiichi Sankyo , mn USD cals, Group bn JPY , New York Stock Exchange Ranbaxy

BMY Groupbn, JPY USD Headquarters ,mn Total, New York, NY, US Europe revenue, bn Number of employees , US JPY 24,000 Biopharmaceuticals ROW 2009 2010 2011 2012 2013

Portfolio and pipeline

Focus Marketed products Pipeline products Within the scope of the Index, Bristol-Myers Has medicines for seven diseases in scope, half Its clinical pipeline targets five diseases in Squibb focuses on HIV/AIDS. Its pipeline in- of which are ARVs for HIV/AIDS. Its portfolio scope, mainly hepatitis and HIV/AIDS. It is also cludes several new medicines for hepatitis. for non-communicable diseases is diversi- developing products for diabetes, diarrhoeal fied, including one medicine that can treat diseases, and nephritis and nephrosis. Hepatitis is included under cirrhosis of the liver bipolar disorder, schizophrenia and depressive and counted as a non-communicable disease. disorders. Bristol-Myers Squibb Co.

Product types 5 Products per disease category 4 Clinical pipeline per disease category 7 7 0 0 0 0

On the market Pipeline 12 11 Medicines Vaccines Diagnostics Vector control products Communicable Communicable Platform technologies Non-communicable Non-communicable

Opportunities for improving access to medicine

Develop access strategies for pipeline hepati- segments (building on its existing equitable Expand incentives for access-related perfor- tis products. Bristol-Myers Squibb has a strong pricing strategies). mance. Employees in the company’s Founda- pipeline of hepatitis products. To ensure more * After the period of analysis, the company launched an tion and Global Access programme are already patients can access these products as soon access strategy for hepatitis C aimed at addressing need in assessed using access-related performance as possible, the company can already start lower income countries. objectives. These objectives could be extended developing access strategies, and evaluate the to employees who work in departments outside most effective ways to ensure products are Collaborate on combination therapies. For the of these programmes, and tailored to the busi- affordable in many countries. Strategies could HIV/AIDS products in its pipeline, the company ness activities of those areas. include licensing agreements (building on its li- can already start considering which partnership censing experience with atazanavir (Reyataz®)), (new or existing; with either generic medicine or a mix of inter- and intra-country equitable manufacturers or research-based partners) pricing strategies, with a strong emphasis could lead to new, accessible combination on affordability for the poorest population regimens of ARVs.

169 Company Report Cards Access to Medicine Index 2014

rank score 14 2.1 Boehringer Ingelheim GmbH 17 (2012)

5 2,7 Management 1,6

1,7 Public Policy 1,4 4

2,1 R&D 1,9 3 3,2 Pricing 2,5

2 1,8 Patents 1,5 2,3 2,3 2,0 3,0 Capability 3,5 1

2,8 Donations 2,0 0,7 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Boehringer Ingelheim rises from 17th to 14th place, substan- not to enforce patents in Least Developed Countries, and tially improving its disclosure and widening its access although it has issued non-assert declarations in the past, focus beyond HIV/AIDS. It performs strongly in Capability it has not made the terms public. It has no clear access-to- Advancement, particularly in quality management and medicine strategy or performance management system, and manufacturing standards, and it has newly implemented much of its pipeline for non-communicable diseases lacks intra-country equitable pricing strategies. Yet, in Patents & strategies for reaching patients in relevant countries. Licensing, its performance drops: it does not clearly pledge

Performance update

Widened access approach beyond HIV/ Has new policy and improved disclosure Addressing HIV/AIDS and pregnancy. AIDS. It has established an internal committee on product recalls. It has provided detailed It works with the Antiretroviral Pregnancy responsible for discussing wider access issues, evidence of its guidelines and policy for product Register to collect safety data on the use of and is reviewing its access-to-medicine strat- recalls, which align with the WHO GMP guide- its antiretrovirals by pregnant women. Via its egy for its products. lines. nevirapine (Viramune®) donation programme, it treated HIV-positive pregnant women to Improves transparency, still lags behind. More active in building local production prevent transmission to their unborn babies. Despite disclosing more to the Index, the capabilities. It is among the leaders in build- As part of this programme, the company also company remains less transparent than peers ing local capabilities in Quality Management worked closely with local organisations to on its access-to-medicine strategy, activities Systems and manufacturing standards, and has enhance local capacity for care and to develop and policies. It shares relatively little on policy engaged in multiple knowledge- and/or tech- national HIV/AIDS guidelines, policies and positions, yet discloses more than in 2012 about nology transfers to third-party manufacturers, activities to reduce stigma. The programme memberships held and participation in advisory including in low income countries. ended in 2013 when WHO treatment advice was bodies. updated. Continues to build local research capaci- Expands equitable pricing strategies. The ties. The company facilitates the training of proportion of its portfolio for which it applies researchers in Botswana and South Africa, on, equitable pricing strategies has increased e.g., clinical trial conduct, epidemiology and since 2012. Such strategies now cover more health systems research in relation to HIV/AIDS products, beyond ones for HIV/AIDS. For the and respiratory diseases, including tuberculo- first time in the Index, it applies intra-country sis. equitable pricing strategies.

Best practices

Stimulating social entrepreneurship to tries in scope. It is innovative for focusing on improve health. Boehringer Ingelheim’s Mak- marginalised communities and socially sensitive ing More Health Initiative (MMH) supports subjects, such as mental health and sanitation. local social entrepreneurs working to improve health in their communities. It is a fellowship programme run with the network organisation Ashoka, contains elements of capacity building and philanthropy, and covers several coun-

170 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

The company has five divisions: Prescription Medicines, Consumer Health Care, Animal Health, Biopharmaceuticals and Industrial Customers. The vast majority of its sales are prescription medicines. It has products for respiratory diseases, cardiometabolic disorders, oncology, central nervous system diseases, immunology and infectious diseases. Over half of its sales are generated in the US, Japan and Germany, yet sales in emerging markets (Rus- In scope, has sales sia, Brazil, India, China and Africa) are growing In scope, has no sales in significance. Not in scope

General information Revenues by segment (2013) Net sales by region Biopharmaceuti- , mn EUR cals, Prescription Medicines Privately held , , , Biopharmaceuticals Headquarters , EUR Consumer Health Care Europe Ingelheim, Germany ,mn , Number of employees Animal Health Americas , 47,492 Industrial Customers , Asia, Australia,

and Other Sales Africa 2009 2010 2011 2012 2013

Portfolio and pipeline

Focus Marketed products Pipeline products Within scope, Boehringer Ingelheim focuses on Has products for seven diseases in scope, all Its clinical pipeline targets seven diseases in HIV/AIDS, respiratory diseases and cardiovas- medicines. Most are for non-communicable scope, mostly for COPD, diabetes, and HIV/ cular disease. diseases, mainly cardiovascular and respiratory AIDS. It is testing suitability of a number of diseases. It has two antiretroviral drugs for medicines for use in children, including for Hepatitis is included under cirrhosis of the liver HIV/AIDS. cerebrovascular disease and HIV/AIDS. It has in- andBoehringer counted asIngelheim a non-communicable GmbH disease. vested in the development of a malaria vaccine.

Product types 2 Products per disease category 3 Clinical pipeline per disease category 25 17 0 0 1 0 On the market Pipeline 28 20 Medicines Vaccines Diagnostics Communicable

Vector control products Non-communicable Communicable Platform technologies Maternal and neonatal Non-communicable

Opportunities for improving access to medicine

Align access-to-medicine approach with core Take access into account during R&D process. Build on experience with IP access mecha- business. The company can develop a more The company is developing a new approach for nisms. Boehringer Ingelheim can consider specific access-to-medicine strategy that is making new and existing products available. As where in its patented portfolio IP access mech- more clearly aligned with its core business and part of this approach, it can start to take access anisms can be an appropriate strategy to boost that focuses on improving access to its current into account earlier in the product development access. It can proactively offer its experience and future portfolio. It can also start to formu- process. In combination with a broader access- in technology transfer and consider expand- late more specific targets that both reflect what to-medicine strategy and corresponding initia- ing its non-assert declarations to include more the company wants to achieve and facilitate the tives, this will help ensure that newly developed countries where patents remain in place for the implementation of its access strategy. By imple- products will be available, accessible and paediatric and extended-release formulations menting performance management systems affordable in countries in scope. As the majority of this product. It can complete negotiations that include access-related targets, the com- of its pipeline focuses on non-communicable with the Medicine Patent Pool regarding poten- pany can measure and monitor performance diseases, the company has particular potential tial licences. and progress. for increasing access to medicine for diseases like asthma, COPD and diabetes.

171 Company Report Cards Access to Medicine Index 2014

rank score 15 1.9 AstraZeneca plc 16 (2012)

5 1,0 Management 2,1

1,6 Public Policy 1,7 4

1,6 R&D 2,5 3 2,3 Pricing 1,3

2 2,4 0,8 Patents 1,2 2,1 1,8 1,5 Capability 3,1 1

1,4 Donations 2,5 0.7 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

AstraZeneca rises one place to 15th, improving in several advancement activity. However, it falls in other areas. Its areas. It strengthens its commitment to equitable pricing, management of access-related performance is weaker than and has strong clinical trial codes of conduct. It was linked to its peers. It has no specific policy on licensing, and has not no breaches in countries in scope. It has a relevant pipeline issued licences for its relevant on-patent products. for respiratory diseases, and engages in numerous IP-sharing partnerships with access provisions. It states cases where it would waive data exclusivity, and increased its capability

Performance update

Supportive of generic market entry for cer- procedures for managing misconduct for both Significantly improves in local capacity tain diseases. The company commits to waiving in-house and outsourced trials. building. It has particularly improved efforts rights to data exclusivity for specific diseases to build capacities in quality management sys- within scope, including malaria, tuberculosis, Implements equitable pricing initiatives. tems, manufacturing standards and pharmaco- lymphatic filariasis and leishmaniasis. It has equitable pricing strategies for products vigilance. For example, its Responsible Business and countries within the scope of the Index for Plan explores opportunities to share and use Engaged in leading number of access- the first time. At the end of 2012, AstraZen- AstraZeneca’s pharmacovigilance knowledge oriented IP-sharing partnerships. During the eca established a dedicated team within its and best practices with developing countries. period of analysis, the company was one of two International Region business unit (covering all leaders in this area, with numerous partner- emerging markets and developing countries), ships based on access provisions. However, which is responsible for its approach to broad- it withdrew from a large proportion of its IP- ening affordability, replicating best practices sharing partnerships in September 2013, when and expanding the number of programmes in it ended its participation in WIPO Re:Search. Its these markets. remaining partnerships target tuberculosis and neglected tropical disease drug discovery. Does not engage in licensing, lacks commitment. The company lacks a policy for Strong enforcement of clinical trial code of considering non-exclusive voluntary licences, conduct, in-house and outsourced. It provides and provides no evidence of having signed any extensive evidence that it has processes for licensing agreements, despite having relevant monitoring and auditing the enforcement on-patent products. of its code of clinical trial conduct, including

Best practices

Raises awareness among marginalised youth. AstraZeneca’s Young Health Programme focuses on awareness-raising and prevention of non-communicable diseases amongst adolescents in marginalized communities in Brazil, China, India and Zambia.

172 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

The company operates through one business segment, biopharmaceuticals, with activities in five main areas: it focuses primarily on cardiovascular and metabolic disease; oncology; and respiratory disease, inflammation and autoim- munity; followed by infectious disease; and neuroscience and gastrointestinal disease. In 2013, revenues rose in emerging markets, with particularly strong growth in China.

In scope, has sales

In scope, has no sales

Not in scope

General information Sales by segment (2013) Sales by region Biopharmaceuti- , mn USD cals, , Total sales, London Stock Exchange ,

AZN , USD Japan Headquarters ,mn , Europe London, UK , North America Number of employees ,

51,500 Biopharmaceuticals ROW 2009 2010 2011 2012 2013

Portfolio and pipeline

Focus Marketed products Pipeline products Within the scope of the Index, AstraZeneca AstraZeneca has medicines for 11 diseases in Its clinical pipeline targets four diseases, mainly focuses on respiratory diseases, cardiovascular scope, mostly for non-communicable diseases, respiratory diseases, and includes antibiotics disease and metabolic disorders. particularly cardiovascular and respiratory and a vaccine for lower respiratory infections, diseases. a medicine for COPD, and a medicine for tuberculosis (including resistant strains). It is also AstraZeneca plc developing medicines for diabetes.

Product types 6 Products per disease category 6 Clinical pipeline per disease category 48 4 0 0 1 0 On the market Pipeline 55 10 Medicines Vaccines Diagnostics Communicable Vector control products Non-communicable Communicable Platform technologies Maternal and neonatal Non-communicable

Opportunities for improving access to medicine

Align business and access-to-healthcare Ensure accessibility of new products for Expand access programs for breast-cancer priorities. In April 2013, the company reviewed respiratory diseases. AstraZeneca is develop- treatment and care to other high-burden its Responsible Business Approach and named ing novel treatments for COPD and asthma. diseases. The company has two breast-cancer Access to Healthcare one of its three main However, it could not provide evidence of initiatives in South Africa and Kenya that focus strategic responsible business priorities. The making provisions for developing countries, on creating awareness, enabling early diagno- company can do more to align its business and where the prevalence of these diseases is rising. sis, improving access to treatment and building access-to-healthcare priorities by formulating The company can impact public health in these effective support networks. It can build on its additional, more specific access-related goals, countries positively by developing strategies to experience with these programs and implement targets and key performance indicators. It can make these products available and accessible, similar programmes for other therapeutic focus also start incentivising relevant performance for example by not filing for patents and taking areas, for example, respiratory diseases. among employees. affordability into account when setting pricing strategies.

173 Company Report Cards Access to Medicine Index 2014

rank score 16 1.9 Pfizer Inc. 11 (2012)

5 4,7 Management 2,1

2,7 Public Policy 1,4 4

2,4 R&D 2,0 3 3,3 Pricing 1,8

2 1,5 Patents 1,6 2,3 2,0 1,7 3,9 Capability 2,9 1 1,0 3,6 Donations 2,1 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Pfizer falls from 11th to 16th place, driven by a relative lack for many products, it is not clear whether the majority of of progress, particularly regarding R&D and pricing. Pfizer its strategies are targeted towards the poorest population dedicates a relatively small share of its overall pipeline to segments or take account of whether prices are affordable relevant diseases and countries, with fewer products in for these groups. Pfizer has two long-term structured dona- development than in 2012. Regarding pricing, its peers have tion programmes. performed well in new areas of disclosure, yet Pfizer has not proved forthcoming. Although it has equitable pricing

Performance update

Found in breach of ethical standards, imple- Has fewer relevant R&D activities. This is in Improves support for generic competition. mented new anti-bribery policy. Pfizer was some cases due to compound failure, in other Pfizer increasingly recognises the value of found in breach of ethical marketing standards cases, projects have been handed over to third generic competition for access. Through ViiV multiple times over the period of analysis. In parties, resulting in a smaller relevant pipeline Healthcare, it has engaged in licensing with the 2012, it settled allegations related to prior inci- than in 2012. Pfizer continues to develop Medicines Patent Pool. dences of bribery in China, India and Pakistan. medicines for neglected diseases, including for In 2013, Pfizer rolled out a new version of its lymphatic filariasis and onchocerciasis. Extends commitment to eliminate tra- international anti-bribery and anti-corruption choma. Pfizer has committed to eliminating policy and procedures, supported by a manual Has equitable pricing strategies for a wide trachoma by 2020, by scaling up its donations and online interactive training. It also imple- product and disease scope. Pfizer has the high- of azithromycin through the International mented new electronic systems and processes, est number of products with equitable pricing Trachoma Initiative, or ITI (an independent non- country by country, which set out regulations strategies, but it is not clear how targeted they profit organization co-established by Pfizer). and limitations for gift-giving. are towards the poorest segment. ITI has a wide geographic scale, and in 2013, distributed 51.2 million doses. Since the programme began in 1998, 340 million treatments have been donated.

Best practices

Signed novel licensing agreement, boosting quality-control management. It supported an ARV availability in middle income countries. NGO in developing a master supply-chain plan The agreement includes tiered royalties based in Kenya. The plan defines quality standards on country income level, and achieves a broad for health commodity providers and addresses coverage of adults living with HIV/AIDS. The information needs across the supply chain. licence has been issued by ViiV Healthcare (Pfizer’s joint venture with GSK), which negotiated the licence with the Medicines Patent Pool.

Optimising supply chains. Through its Global Health Fellows programme, Pfizer has sent supply chain experts to Kenya and Tanza- nia to, for example, improve stock management, maintain supply chain integrity, and improve

174 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Pfizer operates through four segments: Prima- ry Care; Specialty Care & Oncology; Established Products & Emerging Markets and Consumer Healthcare. It offers products for various therapeutic and disease areas including Alzheimer’s disease, cardiovascular disease, erectile dysfunction, genitourinary disease, major depressive disorder, pain, respiratory disease and smoking cessation. It holds a 12.6% stake in ViiV Healthcare, a joint venture with GSK focused solely on the research, development and com- In scope, has sales mercialisation of HIV/AIDS medicines. In July In scope, has no sales

2014, it was announced that Pfizer will acquire Not in scope Baxter’s portfolio of marketed vaccines.

General information Revenues by segment (2013) Revenues by region In 2009, Pfizer completed Primary Care , mn USD the acquisition of Wyeth. Specialty Care and , New York Stock Exchange , , , Oncology PFE , Established Products Developed ROW Headquarters USD , ,mn , and Emerging Markets Developed Europe New York, NY, US , , US Number of employees Consumer Healthcare ,

77,700 Other Emerging Markets 2009 2010 2011 2012 2013

Portfolio and pipeline

Focus Marketed products Pipeline products Within the scope of the Index, Pfizer has a large, Has products for 21 diseases in scope, mostly Its clinical-stage pipeline targets one disease in diverse portfolio. Its pipeline focuses on infec- medicines, with a strong focus on cardiovascu- scope: tuberculosis (including resistant strains). tious diseases. lar disease, antibiotics, mental health products In earlier stages, it has medicines for lymphatic (including epilepsy) and HIV/AIDS. Its pneumo- filariasis, onchocerciasis and malaria, and is Hepatitis is included under cirrhosis of the liver coccal 13-valent conjugate vaccine (Prevenar adapting its pneumococcal vaccine. ® andP zer, counted Inc. as a non-communicable disease. 13 ) is the world’s best-selling vaccine.

Product types 28 Products per disease category Clinical pipeline per disease category 36 4 6 On the market Pipeline 74 Medicines Vaccines Communicable Diagnostics Non-communicable Vector control products Neglected tropical

Platform technologies Maternal and neonatal Communicable

Opportunities for improving access to medicine

Improve internal governance and management Improve enforcement of codes of conduct. gies to explicitly target the poorest population of access to medicine. Given its broad portfolio The company can consider developing stricter segment and to ensure that affordability for this of relevant products and wide geographic pres- enforcement measures for its codes of conduct group of patients is taken into account. ence, Pfizer can leverage its existing resources for ethical marketing and anti-corruption, to improve its access-to-medicine footprint and ensuring they are effective across the breadth Engage in greater range of licensing agree- performance in general. Although it has estab- of its operations. ments. Pfizer has on-patent products relevant lished board-level representation for access- to countries in scope. Building on its experience to-medicine issues, it can develop a strong Improve targeting of existing equitable pricing with ViiV Healthcare and the Medicines Patent governance structure with executive-level strategies. Although Pfizer has the highest Pool, Pfizer can consider engaging in a broader responsibility for access-to-medicine issues. It number of relevant products with equitable range of licensing arrangements, to boost can also implement a centralised system that pricing, it is not clear to what extent these strat- access. During negotiations, it can consider monitors access-related performance against egies target the poorest population segments. including knowledge and technology transfers. set targets. The company can deepen its existing strate-

175 Company Report Cards Access to Medicine Index 2014

rank score 17 1.7 Eli Lilly & Co. 14 (2012)

5 3,3 Management 2,6

1,8 Public Policy 0,8 4

2,4 R&D 2,0 3 2,9 Pricing 1,5 2,6 2 1,9 Patents 1,4 1,7 2,0 Capability 2,0 1 1,3 1.0 2,7 Donations 2,0 0 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Eli Lilly drops three places to 17th, with moderate to poor to-medicine management, it has improved since 2012: its performance in all areas. It dedicates a comparatively small new performance-management system includes access- share of its pipeline to relevant diseases, and engages in based targets that are linked to the pay of some senior equitable pricing for a limited proportion of its products. managers. It is the only company to report addressing mental It is also comparatively less transparent about its pricing health in sub-Saharan Africa through donations. practices, the terms of R&D partnerships and relevant policy positions and marketing activities. Nevertheless, in access-

Performance update

Assigns cross-functional access team. In Subject of settlements or decisions for Now adapts packaging to help facilitate 2013, Eli Lilly assigned a team to explore oppor- unethical marketing. One incident involves a rational use. Eli Lilly now adapts the packaging tunities for expanding access to Eli Lilly’s medi- settlement with the US government during the of the majority of its relevant products to align cines in countries in scope. The team includes period of analysis concerning prior allega- with local regulatory requirements and takes representatives from finance, manufacturing, tions relating to unethical marketing in some language needs into account. marketing and corporate affairs. countries within scope. Following this, Eli Lilly reports taking corrective action (including Continues to increase access to MDR-TB Includes access-related objectives in new disciplinary measures and improving internal products through capability advancement. performance management system. The ac- controls). Remaining incidents include breaches Since 2003, Eli Lilly has increased access to its cess-related objectives link to its Global Health of ethical marketing standards as monitored by products for drug-resistant TB (MDR-TB), in- and Expanding Access to People programs. All self-regulatory bodies. cluding transferring technology and expertise to employees with responsibilities for expanding manufacturers in China, India and South Africa. access have personal access objectives integrat- Continues to support the development of ed into their performance management plans. new TB products. Eli Lilly continues to work Supporting mental health in Africa. Via its with the Infectious Disease Research Institute partner AMPATH, Eli Lilly donates products for Remains reluctant to disclose influence on (IDRI) to develop new drugs for communicable mental health conditions in Western Kenya, public policy and markets. As in 2012, the com- diseases, particularly TB. It has given the IDRI reaching approximately 500,000 people. It pany does not go beyond legal requirements access to 800,000 compounds in its library. donates an anti-depressant and anti-psychotic for reporting lobbying and marketing activities (among others), for treating, e.g., unipolar de- (disclosing financial contributions made in the pressive disorder, bipolar affective disorder and US, but not in countries within scope). schizophrenia.

Best practices

Sets higher standards for clinical trials. Enhancing product recall. Using its existing Eli Lilly has developed a Bioethics Framework software that tracks all transactions involving that facilitates a higher level of ethical clinical its products globally, Eli Lilly is developing a trial conduct than other companies demon- module for accessing this information more strate. Its review committees routinely ensure rapidly, resulting in a faster, more efficient recall that study protocols adhere to ethical stan- response. dards drawn from the Declaration of Helsinki, and it has an internal service for consulting on ethical study design and conduct.

176 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Eli Lilly operates through two segments: Human Pharmaceutical Products and Animal Health Products. It has products in the areas of neuroscience, endocrinology, oncology and cardiovascular diseases. It holds a strong position in the diabetes market. In April 2014, it signed an agreement to acquire Novartis Animal Health.

In scope, has sales

In scope, has no sales

Not in scope

General information Revenues by segment (2013) Revenues by region Human Biopharmaceuti- , mn USD Pharmaceutical cals, , New York Stock Exchange Products , ,

LLY Animal Health , , Japan Headquarters USD Total ,mn , Indianapolis, IN, US Human Pharmaceutical Europe revenue , Products , US Number of employees ,

39,236 Animal Health ROW 2009 2010 2011 2012 2013

Portfolio and pipeline

Focus Marketed products Pipeline products Eli Lilly has a strong mental health portfolio and Has medicines for six diseases in scope. Its port- Within the scope of the Index, its clinical pipe- is active in diabetes. folio for non-communicable diseases includes line targets diabetes. This includes four new medicines for mental health conditions and medicines. diabetes. It also has a tuberculosis medicine: Eli Lilly and Company capreomycin.

Product types Products per disease category Clinical pipeline per disease category On the market Pipeline Medicines Vaccines Diagnostics Vector control products Communicable Platform technologies Non-communicable Non-communicable

Opportunities for improving access to medicine

Adapt diabetes products for use in develop- Develop access strategies for products in Develop and expand sustainable long-term ing countries. Eli Lilly has strong expertise in development. Eli Lilly can already begin consid- access strategies in addition to donation diabetes drug development. While it has already ering how best to ensure products in develop- programmes. Eli Lilly has two important dona- shown interest in developing products for the ment will be accessible to patients in countries tion programmes that target chronic diseases: Chinese market, it can improve diabetes care in scope, once they reach markets. It could, for diabetes and mental health. While the Index en- across a broader range of developing countries example, extend their use of equitable pricing courages Eli Lilly to continue and expand these by adapting its diabetes products by targeting strategies. programmes, it can also look for opportunities the medical needs of the poorest population to implement strategies that are more sustain- segments. able (such as equitable pricing, or licensing), across a broader range of Index countries.

177 Company Report Cards Access to Medicine Index 2014

rank score 18 1.6 Astellas Pharma Inc. 20 (2012)

5 1,9 Management 1,0

2,4 Public Policy 1,6 4

3,0 R&D 1,6 3 3,4 Pricing 2,3

2 1,2 Patents 0,8 2.1 1.8 2,8 Capability 1,5 1 1.1 2,3 Donations 1,4 0 0.5 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Astellas rises two places to 18th, partly because it is linked to strategy, and only manages access issues to a limited extent. fewer breaches (none related to competition) than others. It It does not clearly commit to equitable pricing, nor takes a also adapts brochures and packaging to ensure rational use pro-access approach to IP: it has not pledged to consider in all disease areas where it is active; its disclosure of product licensing or to refrain from patenting in relevant countries. registration status is good; and it actively builds local manu- Astellas did not disclose its relevant pipeline in clinical devel- facturing capabilities. However, its activities remain philan- opment. thropy-driven. Astellas still has no clear access-to-medicine

Performance update

Continues to approach access via philan- development partnership. Astellas is also Engages in technology transfer. An thropy. Astellas discloses no clear link between involved in a drug-discovery partnership for improvement on 2012, Astellas now provides its approach to access to medicine and its dengue with a Japanese university. evidence of at least one technology transfer to core business, raising questions about the increase local production capabilities. sustainability of its efforts to increase access to Provides no evidence of a commitment or medicine. implementation of relevant equitable pricing strategies. This makes it the only company Discloses little about its influence on without at least one or the other. markets. As in 2012, Astellas does not disclose policy positions that could have an impact on Has conservative approach to access- access to medicine. It also makes no disclosure oriented IP management. Astellas does not of the financial contributions it makes to politi- pledge to refrain from filing or not enforce cal organisations. patents in specific countries. Neither does it commit to considering licensing as a mechanism Increased drug-discovery for neglected for boosting access to its products. Further- tropical diseases. Astellas participates in more, the company offers very narrow support drug-discovery consortia focused on various for the flexibilities within the international IP neglected tropical diseases, including one framework (TRIPS). addressing Chagas disease, leishmaniasis and trypanosomiasis with Japanese research institutes and the DNDi, a not-for-profit product

Best practices

Participates in the Global Health Innovative Technology Fund. Astellas provides funding to the GHIT Fund, a new funding scheme for early discovery research for neglected tropical diseases that it co-established with the Japanese government, the Bill & Melinda Gates Foundation and other Japanese pharmaceutical companies. Astellas’ role is limited to funding.

178 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Astellas develops pharmaceuticals, focusing on urology, immunology (including transplanta- tion) and infectious diseases, oncology, neuroscience, diabetes mellitus complications and kidney diseases. It has sales in a limited number of countries within the scope of the Index.

In scope, has sales

In scope, has no sales

Not in scope

General information Sales by segment (2013) Sales by region Pharmaceuticals Biopharmaceuti- , bn JPY ,. bn JPY cals , , Tokyo Stock Exchange Total sales ,. Total sales , 4503 bn JPY JPY Japan Headquarters ,.bn Tokyo, Japan EMEA Number of employees Americas

17,454 Pharmaceuticals Asia & Oceania 2009 2010 2011 2012 2013

Portfolio and pipeline

Focus Marketed products Pipeline products The majority of Astellas’ overall portfolio and Has antibiotic medicines for two conditions Astellas did not disclose any relevant medicines pipeline addresses diseases beyond the scope within scope: lower respiratory infections and or vaccines that are currently in clinical stages of the Index. Within scope of the Index, Astellas’ diarrhoeal diseases. of development. Astellas is working in partner- focus is on infectious diseases. ship to develop a paediatric formulation for Astellas Pharma Inc. schistosomiasis.

Product types Products per disease category Clinical pipeline per disease category On the market Pipeline Medicines Vaccines Diagnostics

Vector control products Platform technologies Communicable No products in pipeline

Opportunities for improving access to medicine

Strengthen management of access-to-medi- Engage with local stakeholders. Astellas can Leverage expertise in adapting existing cine activities. Astellas can engage employees engage more actively with relevant stakehold- products. Astellas can help address unmet in its access-to-medicine approach by, e.g., ers beyond Japan, particularly in countries needs for adapted products, for example setting company-wide targets; measuring where it is present, in order to better under- paediatric formulations. It can collaborate with and incentivising relevant activities; and by stand local needs and tailor its activities. additional partners to leverage its expertise in implementing performance-management this area (it developed a paediatric formulation systems that include access-related objectives Match portfolio with opportunities to increase of praziquantel with one of its technologies). and targets. access to medicine. Astellas could use several mechanisms to ensure access to its products. Following its peers, it can (commit to) implement equitable pricing strategies. In addition, it can introduce more nuanced IP policies and engage in licensing agreements.

179 Company Report Cards Access to Medicine Index 2014

rank score 19 = 1.5 Daiichi Sankyo Co. Ltd. 19 (2012)

5 1,6 Management 0,7

2,4 Public Policy 0,4 4

2,2 R&D 2,2 3 2,6 Pricing 1,7

2 2,6 Patents 1,7 1,6 1,6 1,8 Capability 1,2 1,6 1

1,7 Donations 1,3 0 0,5 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Daiichi Sankyo remains in 19th place, despite increasing pipeline qualified for analysis for the first time (Ranbaxy has performance in some areas. It has adopted a more access- since been divested). Although it discloses more, it is not oriented approach to IP management, now pledging not to as transparent as peers. It has no clear access-to-medicine file or enforce patents in a comparatively broad range of strategy, only manages access issues to a limited extent, and countries. The company engages in more R&D partnerships its activities remain philanthropy driven. based on access provisions. The Index captured a larger relevant pipeline than in 2012, as it's subsidiary Ranbaxy’s

Performance update

Approach remains philanthropy driven. the IFPMA code of conduct, leaving unclear, More active in building local production Daiichi Sankyo’s access-to-medicine approach for example, how it monitors and enforces capabilities. Since 2012, it increased its lacks a clear business rationale and has no clear compliance with these standards by third-party activities building manufacturing capabilities senior-level governance of access to medicine. contractors. in relevant countries, and engaged in several Its approach to expanding access to health knowledge- and/or technology transfers remains very general. Access-related objectives Improves transparency, still lags behind. to third-party manufacturers in Asia (e.g., are neither part of the company’s performance Daiichi Sankyo’s transparency in several areas provided training at the Center for Research management systems nor does it have any of measurement is below average. For example, and Production of Vaccines and Biologicals incentive structure in place for rewarding rel- while it discloses more patent and registration- (POLYVAC) in Vietnam). evant performance. related information to the Index than in 2012, its overall disclosure is comparatively poor. Linked to multiple breaches. Daiichi Sankyo was fined for anti-competitive practices in India Adopts more access-oriented approach during the period of analysis, and was subject to IP protection. Since 2012, the company has to a settlement in the US related to corrupt adopted a more access-oriented approach to IP practices. Both cases concerned Ranbaxy. protection. It now pledges to refrain from filing or enforcing existing patents in a comparatively Remains only company with no tailored broad scope of countries. However, it does not marketing code of practice. It provides limited publicly support the use of TRIPS flexibilities. evidence of how its internal codes of conduct address ethical marketing: it refers only to

Best practices

Participates in Global Health Innovative Daiichi Sankyo provides funding, collaborates in Technology Fund (GHIT) Daiichi Sankyo is a research and shares IP. founding member of the Global Health Innova- tive Technology Fund (established with other Has measures to ensure study designs are Japanese pharmaceutical companies, the ethical. Daiichi Sankyo has established a com- Japanese government and the Bill & Melinda mittee that is responsible for reviewing study Gates Foundation). Known as GHIT, this is a new protocols for in-house and outsourced clinical scheme that funds early discovery research trials to ensure ethical conduct. for neglected tropical diseases. Through GHIT,

180 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Daiichi Sankyo has two business segments: Daiichi Sankyo Group and Ranbaxy Group. The Daiichi Sankyo Group focuses mainly on oncology, cardiovascular and metabolic disorders. It has announced that Ranbaxy will merge (through a share swap) with generic manufacturer Sun Pharmaceutical Industries by the end of 2014, whereby Ranbaxy will be absorbed by Sun Pharma. This move will reduce its exposure to developing countries. Over 60% of Daiichi Sankyo’s revenue comes from its home market, In scope, has sales

Japan. In scope, has no sales

Not in scope

General information Revenues by segment (2013) Revenues by region Daiichi Sankyo Pharmaceutical , bn JPY Group bn JPY Business .bnJ- , Tokyo Stock Exchange Ranbaxy PYOther Japan 4568 Groupbn JPY Business . bn JPY Europe Headquarters Total ,bn JPY Tokyo, Japan North America revenue, bn Total Number of employees Daiichi Sankyo Group Ranbaxy JPY revenue.bn 32,229 Ranbaxy Group ROW 2009 2010 2011 2012 2013

Portfolio and pipeline

Focus Marketed products Pipeline products Within the scope of the Index, Daiichi Sankyo Daiichi Sankyo has products for 11 diseases Its clinical pipeline comprises medicines for (including Ranbaxy’s portfolio and R&D pipe- in scope. For non-communicable diseases, eight diseases, mainly non-communicable dis- line) is strong in antibiotics and non-communi- almost half are antibiotics that can treat eases, HIV/AIDS and malaria. It is developing a cable diseases. infections leading to kidney disease. Ranbaxy broad spectrum antibiotic and has a vaccine for has a new, synthetic anti-malarial medicine: norovirus in early-stage development. arterolane+piperaquine (Synriam™). Daiichi Sankyo Co., Ltd.

Product types 11 Products per disease category 9 Clinical pipeline per disease category 13 5 0 0 0 0 On the market Pipeline 24 14 Medicines Vaccines Diagnostics Vector control products Communicable Communicable

Platform technologies Non-communicable Non-communicable

Opportunities for improving access to medicine

Develop more-targeted access-to-medicine and address their needs, and to understand its est segments into account. strategy. Daiichi Sankyo can assign clearer own potential role (and strategic opportuni- senior management responsibility for its ties) for improving access to medicine. E.g., it Develop product registration plans for pipe- access-to-medicine strategy and start to set can collaborate with governments to advance line compounds. Daiichi Sankyo has commit- more detailed, time-bound targets and KPIs capacities in pharmacovigilance; and it can ted to assessing where to register its pipeline related to improving access to medicine. Such engage with stakeholders along supply chains products in countries within scope. It can targets would allow the company to regularly to increase efficiencies. extend these studies and start implementing track progress and performance. registration plans that help ensure relevant new Expand pricing strategies. Daiichi Sankyo can compounds for non-communicable diseases Expand local stakeholder engagement beyond expand its pricing strategies to cover more become available in countries in scope. philanthropic initiatives. The company can products (both existing and in its pipeline) and engage with local stakeholders in a more countries it has a presence in. Within its pricing structured way, both to better understand strategies, it can take affordability for the poor-

181 Company Report Cards Access to Medicine Index 2014

rank score 20 1.5 Takeda Pharmaceutical Co. Ltd. 18 (2012)

5 3,3 Management 1,0

1,0 Public Policy 1,3 4

2,5 R&D 2,6 3 3,0 Pricing 1,1

2 1,7 Patents 0,6 2,0 3,8 Capability 2,0 1,5 1 1,3 2,6 Donations 1,7 0 0,5 0 1 2 3 4 5 Commitments Transparency Performance Innovation Average Company overview

Takeda drops to 20th place, yet has improved in several areas. 2012, but no clear access-to-medicine strategy, managing It performs well in R&D, with a reasonable pipeline share access issues to a limited extent. It does not take a pro- targeting relevant diseases and it engages in IP sharing and access approach to IP management, nor pledge not to file product development partnerships based on access provi- for or not to enforce patents in countries in scope. It does sions. It newly commits to intra-country equitable pricing, not state support for TRIPS flexibilities, nor run donation but has not yet implemented such strategies for products in programmes in countries in scope. scope. It has a stronger focus on access to medicine than in

Performance update

Strengthens its internal focus on access-to- Provides limited evidence of monitoring Approaches IP and data exclusivity with medicine issues. Takeda has set up an Access and enforcement mechanisms. While Takeda’s limited access orientation. The company does to Medicine working group that aims to build a clinical trial codes of conduct comply with ICH- not share any instances where it would waive complete picture of each department’s access- GCP, it shows limited evidence of strong over- data exclusivity, has not committed to refraining to-medicine activities and start monitoring sight of outsourced trials. It also demonstrates from filing or enforcing patents in countries in them. It is also considering a range of activities limited evidence that company standards for scope and does not publicly support the flexibili- and developing an internal policy on access to ethical marketing extend to third parties. ties as set out in the TRIPS trade agreement. medicine. To promote future access-related activities and ensure their successful implementa- Newly committed to intra-country equi- tion, the company is establishing a centralised table pricing. The company has made a new, Access to Medicine Office. general commitment to engaging in intra-country equitable pricing. It already has equitable Significantly enhanced portfolio for diseas- pricing strategies in place, but not currently for es in scope. Takeda has significantly enhanced products that fall within the scope of the Index. its product and pipeline portfolios for diseases in scope through partnerships and acquisitions. It shows movement of relevant compounds to different phases of its R&D pipeline since 2012.

Best practices

Actively involved in drug discovery for neglected tropical diseases. Takeda is involved in a number of GHIT Fund activities with product development partnerships, e.g., collaborations with the Global Alliance for TB Drug Develop- ment, with the Medicines for Malaria Venture and with the Drugs for Neglected Diseases initiative. GHIT is a public-private partnership between the government of Japan and other Japanese pharmaceutical companies. It offers a new funding scheme for early discovery research for neglected tropical diseases.

182 Access to Medicine Index 2014 Company Report Cards

Sales and operations Sales in countries in scope

Takeda provides products in various therapeutic areas, including cardiovascular and metabolic, oncology, central nervous system, respiratory and immunology, and gastrointestinal and genitourinary, as well as vaccines. Through its acquisition of Nycomed, Takeda has significantly expanded its operations and sales in Europe and emerging markets, with particularly strong growth in Russia/CIS, Brazil and China. It recently expanded its presence in the vaccines industry by acquiring LigoCyte In scope, has sales

Pharmaceuticals Inc. (in 2012) and Inviragen Inc. In scope, has no sales

(in 2013). Not in scope

General information Revenues by segment (2013) Revenues by region

, bn JPY . .

Tokyo Stock Exchange , Japan 4502 Europe & Headquarters JPY Ethical Drugs , ,.bn Osaka, Japan Consumer Healthcare Russia/ CIS US Number of employees ,. Other business &

30,481 Adjustments ROW 2009 2010 2011 2012 2013

Portfolio and pipeline

Focus Marketed products Pipeline products Takeda is strong in diabetes and is strengthen- Has products for eight diseases in scope. Its Its clinical pipeline targets nine diseases in ing its vaccine portfolio. medicines portfolio is strong in the area of dia- scope. It includes a medicine for malaria and betes. It also has a small portfolio of childhood vaccines for pertussis and tetanus. Notably, it vaccines for pertussis, tetanus and measles. also includes a medicine for bipolar affective disorder and a vaccine for dengue.

Product types 3 Products per disease category 10 Clinical pipeline per disease category 8 2 0 1

On the market Pipeline 0 0 Medicines 11 13 Vaccines Diagnostics Communicable Vector control products Communicable Non-communicable Platform technologies Non-communicable Neglected tropical

Opportunities for improving access to medicine

Continue internal and external discussion Develop access-oriented strategies as expan- access-oriented approach to data exclusivity about access to medicine. Through its pipeline sion into emerging markets continues. and IP. For products that are still in develop- and product portfolio, Takeda has much to offer Since 2012, the company has paid increasing at- ment, it can start to consider mechanisms for to patients living in developing countries. It can tention to growth in emerging markets and new early access, such as registration targets, to continue its internal discussions about how it segments, particularly in the area of vaccines. ensure that these products, mainly for diabetes can contribute to improving access to medicine As yet, its footprint in developing countries and mental health conditions, become acces- and develop a clearer access-to-medicine ap- remains limited. If Takeda pursues this strategy, sible to patients in developing countries soon proach. It has potential to engage with a wider and expands its presence in these markets, it after stringent approval. range of stakeholders, who can help build and can have many opportunities to expand access shape its approach to access to medicine. The to medicine. For marketed products, it can ex- company can start to set targets that stimulate pand its commitment and implement equitable the company-wide implementation of a more pricing strategies for a wider range of products, access-oriented approach. including for products within the scope of the Index. In addition, it can consider taking a more

183 Company Report Cards Access to Medicine Index 2014

184 Access to Medicine Index 2014 Appendix

Appendix

Methodology Report 2013 Methodology Report 2013 for the 2014 Access to Medicine Index The Methodology Report 2013 is a separate, comprehensive report detailing what and how we measure. It details the review and refinement of the indicators, a process which involved a thorough technical feedback process. Within these appendices, only abbreviated essential components of this process are detailed, alongside the indicators, the scoring guidelines, key references, definitions and acronyms.

185 Appendix Access to Medicine Index 2014

Methodology scopes

1 Company Scope

Index 2014 evaluates 20 research-based companies covered by the Index facilitates 2014 Index. AbbVie, however, is a new inclusion pharmaceutical companies, 19 of which were comparability and trend analyses over time. for 2014. included in Index 2012. At the beginning of 2013, Abbott’s research- As in 2012, generic companies were not Companies included are those with the highest based pharmaceuticals business separated captured in the 2014 Index. For the first market capitalisation, and product portfolios into an independent, publicly traded biophar- time, however, companies were allowed to most relevant to the countries and diseases maceutical company: AbbVie. Given Abbott is submit relevant data related to their generic covered by the Index. Maintaining, as closely no longer part of the research-based pharma- subsidiaries. as possible, the 2012 list of research-based ceutical industry, the company is not part of the

Table 6 2014 Index Company Scope

Company Ticker Stock Exchange Bloomberg Reuters Country Market Cap* Revenue** (billion USD) (billion USD) AbbVie Inc. ABBV New York Stock Exchange ABBV:US ABBV.N USA 83.83 18.79 Astellas Pharma Inc. 4503 Tokyo Stock Exchange 4503:JP 4503.T JPN 26.90 11.47 AstraZeneca plc AZN London Stock Exchange AZN:LN AZN.L GBR 74.40 25.71 Bayer AG BAYN Frankfurt Stock Exchange BAYN:GR BAYGn.DE DEU 107.67 51.29 Boehringer Ingelheim GmbH n/a n/a n/a n/a DEU n/a 17.96 Bristol-Myers Squibb Co. BMY New York Stock Exchange BMY:US BMY.N USA 87.22 16.39 Daiichi Sankyo Co. Ltd. 4568 Tokyo Stock Exchange 4568:JP 4568.T JPN 12.05 11.01 Eisai Co. Ltd. 4523 Tokyo Stock Exchange 4523:JP 4523.T JPN 11.29 5.91 Eli Lilly & Co. LLY New York Stock Exchange LLY:US LLY.N USA 56.96 23.11 Gilead Sciences Inc. GILD NASDAQ GILD:US GILD.O USA 115.23 11.20 GlaxoSmithKline plc GSK London Stock Exchange GSK:LN GSK.L GBR 117.65 39.86 Johnson & Johnson JNJ New York Stock Exchange JNJ:US JNJ.N USA 258.34 71.31 Merck & Co. Inc. MRK New York Stock Exchange MRK:US MRK.N USA 146.52 44.03 Merck KGaA MRK Frankfurt Stock Exchange MRK:GR MRCG.DE DEU 36.16 13.67 Novartis AG NOVN SIX Swiss Exchange NOVN:VX NOVN.VX CHE 193.43 60.08 Novo Nordisk A/S NOVO B Copenhagen Stock Exchange NOVOB:DC NOVOb.CO DNK 90.07 14.30 Pfizer Inc. PFZE New York Stock Exchange PFE:US PFE.N USA 196.00 51.58 Roche Holding AG RO; ROG SIX Swiss Exchange RO:SW; ROG:VX ROG.VX CHE 219.48 48.53 Sanofi SAN EURONEXT Paris SAN:FP SASY.PA FRA 130.08 42.54 Takeda Pharmaceutical Co. Ltd. 4502 Tokyo Stock Exchange 4502:JP 4502.T JPN 38.04 16.66

* Market cap as at 31 Dec 2013 Japanese companies as at 31 Mar 2014 From Thomson Reuters 2014

** Total 2013 revenue

Company newly included in the 2014 Index scope Exchange rate used from irs.gov, 2013 avg

186 Access to Medicine Index 2014 Appendix

2 Geographical scope

The 2014 Index focuses on 106 countries, defining its geographical scope. All low income In 2014, the Index has added countries that adding five new countries in comparison to countries (LICs) and lower-middle income score below 0.55 on the UN Inequality-Adjusted 2012 – Brazil, Colombia, Ecuador, South Sudan countries (LMICs) fall into the Index scope. Human Development Index (IHDI)3, recognising and Venezuela – and removing two – Algeria that inequality inhibits access to medicine for and the Marshall Islands. The Index also uses the most recent UN Human the poorest population segments. Development Index (HDI)2 to capture further The 2014 Index uses the 2013 World Bank countries which may have lower levels of devel- country classifications1 as the base criteria for opment despite comparably higher incomes.

Table 7 List of countries included in the 2014 Access to Medicine Index – 106 countries

Country Classification Country Classification Country Classification Country Classification

East Asia & Pacific Suriname MHDC Liberia LIC Countries removed since Cambodia LIC* Venezuela, RB HiHDI Madagascar LIC* 2012 Index China MHDC Malawi LIC* Algeria HHDC Fiji MHDC Middle East & North Africa Mali LIC* Marshall Islands UMIC Indonesia LMIC Djibouti LMIC* Mauritania LMIC* Kiribati LMIC Egypt, Arab Rep. LMIC Mozambique LIC* Korea, Dem. Rep. LIC Iraq MHDC Namibia MHDC Lao PDR LMIC* Jordan MHDC Niger LIC* Micronesia, Fed. Sts. LMIC Morocco LMIC Nigeria LMIC Mongolia LMIC Syrian Arab Rep. LMIC Rwanda LIC* Myanmar LIC* West Bank and Gaza LMIC São Tomé and Principe LMIC Papua New Guinea LMIC Yemen, Rep. LMIC Senegal LMIC* Philippines LMIC Sierra Leone LIC* Samoa LMIC* South Asia Somalia LIC Solomon Islands LMIC* Afghanistan LIC South Africa MHDC Thailand MHDC Bangladesh LIC* South Sudan LIC Timor-Leste LMIC Bhutan LMIC Sudan LMIC Tonga MHDC India LMIC Swaziland LMIC Tuvalu LDC Maldives MHDC Tanzania LIC* Vanuatu LMIC* Nepal LIC* Togo LIC* Vietnam LMIC Pakistan LMIC Uganda LIC* Sri Lanka LMIC Zambia LMIC* Europe & Central Asia Zimbabwe LIC Armenia LMIC Sub-Saharan Africa Georgia LMIC Angola LHDC* Kosovo LMIC Benin LIC* Kyrgyz Rep. LIC Botswana MHDC LIC: Low-income Country Moldova LMIC Burkina Faso LIC* World Bank income classification Tajikistan LIC Burundi LIC* Turkmenistan MHDC Cameroon LMIC LMIC: Lower-middle-income Country Ukraine LMIC Cape Verde LMIC World Bank income classification Uzbekistan LMIC Central African Rep. LIC* Chad LIC* LDC: Least Developed Country Latin America & Caribbean Comoros LIC UN Human Development Index Belize MHDC Congo, Dem. Rep. LIC* Bolivia LMIC Congo, Rep. LMIC LHDC: Low Human Development Country Brazil HiHDI Côte d’Ivoire LMIC UN Human Development Index Colombia HiHDI Equatorial Guinea MHDC Dominican Rep. MHDC Eritrea LIC MHDC: Medium Human Development Country Ecuador HiHDI Ethiopia LIC UN Human Development Index El Salvador LMIC Gabon MHDC Guatemala LMIC Gambia, The LIC* HiHDI: High Human Development Country with high inequality Guyana LMIC Ghana LMIC UN Inequality-Adjusted Human Development Index Haiti LIC* Guinea LIC* Honduras LMIC Guinea-Bissau LIC* * LDC with WTO membership Nicaragua LMIC Kenya LIC 5 Countries newly included countries in the 2014 Index scope Paraguay LMIC Lesotho LMIC* 2 Countries removed from the Index scope

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3 Disease scope

Diseases are included based on their global The disease scope for the 2014 Index has neglected tropical diseases are covered. burden of disability-adjusted life years (DALYs), expanded from 33 to 47 conditions. Chlamydia In continuing recognition of the importance of other WHO classifications, and the relevance of is the only new communicable disease; cir- protecting maternal and neonatal health from pharmaceutical interventions. Index diseases rhosis of the liver has been expanded to include conception through to childbirth, the number are defined according to the WHO International chronic viral hepatitis. Schizophrenia and of maternal and neonatal health conditions Classification of Diseases (ICD-10) codes.4 bipolar affective disorder have been added. All covered by the Index has been increased cancers remain excluded. All 17 WHO-classified since 2012.

Table 8 List of diseases included in the 2014 Access to Medicine Index - 47 diseases

Communicable diseases (10) Neglected tropical diseases (17) Maternal and neonatal health conditions (8) Lower respiratory infections 94.511 Lymphatic filariasis 5.941 Abortion 7.424 Diarrhoeal diseases 72.777 Soil transmitted helminthiasis 4.013 Maternal sepsis 6.535 HIV/AIDS 58.513 Leishmaniasis 1.974 Maternal haemorrhage 4.439 Tuberculosis 34.217 Food-borne trematodiases 1.875 Obstructed labour 2.882 Malaria 33.976 Schistosomiasis 1.707 Hypertensive disorders of 1.888 Measles 14.853 Trypanosomiasis 1.673 pregnancy Meningitis 11.426 Rabies 1.462 Prematurity and low birth weight 44.307 Pertussis 9.882 Trachoma 1.334 Birth asphyxia and birth trauma 41.684 Tetanus 5.283 Dengue 670 Neonatal infections and 40.433 Chlamydia 3.748 Cysticercosis 503 other conditions Chagas disease 430 Contraceptive methods NA Non-communicable diseases (12) Onchocerciasis 389 Unipolar depressive disorder 65.472 Leprosy 194 Ischaemic heart disease 62.587 Echinococcosis 144 Cerebrovascular disease 46.591 Buruli ulcer N/A Chronic obstructive pulmonary 30.196 Yaws N/A disorder [COPD] Dracunculiasis N/A Diabetes mellitus 19.705 Schizophrenia 16.769 Asthma 16.317 Osteoarthritis 15.586 Bipolar affective disorder 14.425 Cirrhosis of the liver 13.640 Nephritis and nephrosis 9.057 Epilepsy 7.854 14 Diseases/conditions added to or expanded in the 2014 Index scope

4 Product scope

The product type scope for Index 2014 remains Microbicides global public health use and which specifically necessarily broad to capture the wide-ranging These include topical microbicides intended to aim to inhibit and kill vectors that transmit dis- product types available to support prevention, prevent HIV. eases relevant to the Index are included. Like- diagnosis and treatment of Index Diseases in wise, only biological control interventions that the Index countries. Therapeutic vaccines specifically aim to kill or control vectors that This covers vaccines intended to treat infection. transmit Index-relevant diseases are included. It draws closely from the definitions provided Only veterinary vaccines specifically designed by the G-Finder 2012 Neglected Disease Re- Preventive vaccines to prevent animal-to-human transmission of search and Development: A Five Year Review,5 This covers vaccines intended to prevent infec- diseases covered by the Index are included. and remains unchanged from the 2012 and 2010 tion. Indices. Platform technologies Diagnostics Only those products directed specifically at Medicines Diagnostic tests designed for use in resource- meeting the needs of countries covered by the All innovative and adaptive medicines, branded limited settings (cheaper, faster, more reliable, Index are included. These comprise general generics and generic medicines used to directly greater ease of use in the field) are included. diagnostic platforms, adjuvants and immu- treat the target pathogen or disease process, nomodulators, and delivery technologies and regardless of formulation, are included. Medi- Vector control products devices. cines used only for symptomatic relief are not These include pesticides, biological control included. compounds and vaccines targeting animal res- ervoirs. Only chemical pesticides intended for

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Stakeholder engagement 2013

Between January and October 2013, the Index Expert Review Committee Other sources of feedback engaged with a variety of stakeholders to The Foundation team met with the Expert The Access to Medicine Foundation remains build a more complete, up-to-date view on the Review Committee (ERC) in April, June and open to feedback from other entities willing to changing access-to-medicine landscape. September 2013. The role of the ERC is to provide comments and suggestions. Maintain- provide the Foundation with strategic guidance ing openness through engaging and building The goal of this process was to: with regard to the Index’s scope and indicators. partnerships with all the stakeholder groups is • Adjust the methodology to reflect changing crucial to the long-term success, legitimacy and global health priorities The Access to Medicine Index team remains impact of the Index. • Refine and improve the methodology based ultimately responsible for decisions on the final on lessons learned from past Indices methodology associated with the reporting No single feedback mechanism has dispro- material, and the findings of the Access to Medi- portionately affected the Index methodology. Feedback survey and company results calls cine Index. Following collection of the stake- Rather, the output of the survey, in depth In early 2014, the Foundation invited the Index holder feedback through the aforementioned consultations and other feedback processes readership, contributors and selected organisa- processes, the methodology was updated by were studied by the Expert Review Committee. tions to provide feedback on the development the Access to Medicine Foundation. We maximised our efforts to ensure that all the and execution of the 2012 Index. 134 people rep- stakeholders receive equal representation in resenting seven stakeholder groups responded. Expert Review Committee the stakeholder engagement process. • Hans Hogerzeil, University of Groningen, The foundation also offered all 20 companies Switzerland evaluated in 2012 the opportunity to give their • Marja Esveld, Ministry of Health, feedback on Index methodology and results in The Netherlands individual conference calls with the Index team. • Richard Laing, World Health Organization (WHO), Switzerland Strategic access-to-medicine workshop • Dennis Ross-Degnan, Harvard University, USA In May 2013, company representatives gathered • Regina Kamoga, Community Health and near Amsterdam to discuss how more inclusive Information Network (CHAIN), Uganda business models can be developed to incor- • Natacha Dimitrijevic, Hermes Equity porate access strategies into core company Ownership Services, UK business. • Peter Shelby (2013/2014), Mario Ottiglio (2014) International Federa- Stakeholder dialogue: Ensuring quality and tion of Pharmaceutical Manufacturers & affordable medicines in developing countries Associations (IFPMA), Switzerland In June 2013, members of the Index team • Dilip Shah, Indian Pharmaceutical Alliance, travelled to Accra, Ghana, to host a multi- India stakeholder dialogue to discuss two key issues: how to define and measure affordability, and Technical Subcommittees the best ways to monitor safety and quality of Public Policy & Market Influence medicines. • Michele Forzley, Georgetown University Law Center, USA Investor dialogue • Jillian Kohler, University of Toronto, Canada In September 2013, Foundation members attended a series of meetings in Paris with rep- Research & Development resentatives of both mainstream and socially • Jennifer Dent, Bio Ventures for Global Health, responsible investment firms. The discussions USA focused on how the Index can be used as a tool • Javier Guzman, Policy Cures, UK for investors to better understand potential risks and opportunities for access to medicine Pricing Manufacturing & Distribution in low and middle income countries. • Jaime Espin, Andalusian School of Public Health, Spain Technical Subcommittees • Niranjan Konduri, Management Sciences for Between February and September 2013, the Health, USA Foundation convened groups of experts to serve • Prashant Yadav, University of Michigan, USA as Technical Subcommittees (TSCs) to support methodology enhancement. These committees Patents & Licensing responded to and advised on various proposals • Peter Beyer, World Health Organization made by the Index team for enhancing the areas (WHO), Switzerland of Public Policy & Market Influence; Research • Esteban Burrone, Medicines Patent Pool, & Development; Pricing, Manufacturing & Switzerland Distribution and Patents & Licensing. Remaining • Warren Kaplan, Boston University, USA Technical Areas did not convene TSCs, but did consult experts individually.

189 visitekaartje

1 1 GlaxoSmithKline plc Appendix 3,3 Access to Medicine Index 2014 2 6 Novo Nordisk A/S 3,0 3 2 Johnson & Johnson 2,8 4 7 Novartis AG 2,8 5 5 Gilead Sciences Inc. Ranking, scoring and2,8 review process 6 8 Merck KGaA 2,8 7 4 Merck & Co. Inc. 2,6 8 3 Sano 2,6 9 n/a AbbVie Inc. 2,6 The size of each colour represents the contribution of each Technical 10 9 Bayer AG 2,5 Area to the overall score. The size of the bar depends on the company 11 15 Eisai Co. Ltd. 2,5 score for the Technical Area and the weight of the Technical Area 12 10 Roche Holding AG 2,3 compared to the others. 13 12 Bristol-Myers Squibb Co. 2,2 14 17 Boehringer Ingelheim GmbH 2,1 Each of the coloured bars comprise indicators for Commitments (25%), 15 16 AstraZeneca plc 1,9 Transparency (25%), Performance (40%) and Innovation (10%). 16 11 Pzer Inc. 1,9 17 14 Eli Lilly & Co. 1,7 A score of zero is the lowest possible score in an indicator. A five signifies 18 20 Astellas Pharma Inc. 1,6 the highest indicator score. A company’s overall score is an aggregate of 19 19 Daiichi Sankyo Co. Ltd. 1,5 individual indicator scores, adjusted by the respective indicator, strategic 20 18 Takeda Pharmaceutical Co. Ltd. 1,5 pillar and Technical Area weights. 0 1 2 3 4 5

Summary of the scoring process

1 Before inclusion for analysis, the Index team this process were verified with the company. a case-by-case basis per company for each reviewed both marketed products and prod- Groups of medicines always excluded were neutrally scored indicator. ucts in company R&D pipelines. This verifica- medicines intended for treatment of cancer, • In cases where no other neutrally scored tion was to ensure they were within the scope painkillers, anaesthetics and supportive indicators exist for a company within the of Index 2014 and met relevant inclusion medicines without specific indications, such sub-theme of the indicator in question, a criteria. as IV fluids and blood transfusions. Products neutral score would be awarded to that may be used for multiple diseases in scope. indicator comprising a weighted average of all Process for R&D pipeline product inclusion Products were only assessed for diseases the indicator scores for that company within For R&D products, inclusion criteria were listed by the company. that subtheme (excluding the indicator which applied based upon the disease class the receives a neutral score). product targets. All products were included 2 Quantitative indicators, such as a company’s • For cases where more than one indicator for adaptive R&D for all four disease classes, R&D investment relevant to the Index Diseases within a subtheme needed to be neutrally as were innovative R&D products that from a company’s total R&D investments, are scored, a weighted average of all the indica- target either communicable diseases (CD) adjusted based on total revenues, or other rel- tors of all remaining subthemes within the or neglected tropical diseases (NTD). For in- evant figures indicative of company size, such relevant Technical Area for which the com- novative R&D products that target non-com- as the total size of the pipeline. Consistent pany did not have neutral scoring were used municable diseases (NCD) or maternal and with the relative ranking approach of the Ac- as a proxy. neonatal health conditions (MNH), stricter cess to Medicine Index, the adjusted numbers • For cases where most or all other subthemes criteria applied for inclusion. For these prod- are then scaled for scoring from zero to five. within the Technical Area also included ucts, supporting evidence to indicate how the indicators that were neutrally scored, the product would be made accessible to people 3 When an indicator is not applicable to a com- weighted average of the scores of all other living in countries within scope was required. pany, neutral scoring is used. Where neutral Technical Areas that did not have any neutral All R&D had to be ongoing during a part or scoring is a possibility this is indicated in the scoring were applied to the relevant indicator. the entire period of analysis. Following the scoring guidelines. Neutral scoring was ap- first submission, companies were asked plied within the areas of Research & Develop- 5 Scoring was carried out based on data from a for clarifications, if needed, to support this ment; Pricing, Manufacturing & Distribution; wide range of information sources, including verification process. After final submission, Patents & Licensing and Product Donations companies themselves, independent reports, all R&D products were evaluated according to & Philanthropic Activities. For example, databases from the World Health Organiza- this standardised procedure. when a company has no structured donation tion (WHO), other multilateral organisations programmes, it receives a lower score in com- and non-governmental organisations, legal Process for market product inclusion mitment for the relevant indicator. However, databases such as LexisNexis, and news da- Marketed products also went through a veri- for the transparency indicator related to tabases such as Bloomberg. Where relevant, fication process. This was to assess whether disclosure of the processes and criteria for publicly available registers were checked, they were suitable for use under the disease deciding drug types and destinations, and such as the PCPMPA’s record of marketing indication(s) as described by the company, the performance indicators related to the code breaches in the United Kingdom, and and as covered by the ICD10 codes described outcome and impact of structured donation equivalent databases in South Africa, the in the Methodology Report 2013. Product programmes, a neutral score is applied, as the Netherlands and Australia. indications were verified using information company has already been penalised. from regulatory authorities (such as the 6 The final scoring of the companies is the FDA and EMA), WHO treatment guidelines, 4 Neutral scoring was applied within dif- result of a multi-tiered analysis and quality company websites and scientific publications. ferent Technical Areas using one of three assurance process beginning with scoring by Any products that remained unclear following approaches. The approach is determined on the company analyst during the first round

190 Access to Medicine Index 2014 Appendix

of the data collection period, followed by re- cal Area expert from the Foundation team 7 A statistical analysis has been carried out scoring after companies have provided further along with each Technical Area expert on the on the final scores to check for significant clarification in areas identified by the analyst. Sustainalytics team. The project management correlations between different indicators and This was followed by verification by the Sus- (PM) team engaged in quality assurance and the distribution of scores for each indicator. tainalytics Technical Area analyst, including an scoring verification to ensure consistency. Based on the analysis of every single indica- extensive quantitative and qualitative check tor, adjustments were made to some indica- of each indicator for each company. Finally, a tors’ scoring guidelines to ensure maximum cross-check was performed by the Techni- variability.

Review process

Following clarification of company data and review, a member of the Expert Review Com- Committee, Hans Hogerzeil. In addition to this, cross-check of company scores, the Index mittee (Richard Laing) reviewed each Technical an external editorial review of the entire Index research team wrote the various sections of the Area. Company report cards were reviewed was performed. Index report. Each Technical Area was reviewed by an external consultant from the invest- by at least one member of each of the relevant ment community. The entire Index was finally Technical Subcommittees. Following this initial reviewed by the chair of the Expert Review

Limitations of the methodology

Study Limitations number of patented products of interest to the pricing strategies are referred to. Limitations exist in every study of this design. Index. Some have a comparatively narrow scope Some major limitations specific to this study are of country operations. Others have generic In order to minimise the variability of informa- discussed here. These and other methodologi- pharmaceuticals subsidiaries. tion sourced from companies, all companies cal limitations will be reviewed for the 2016 were provided with training on the data submis- Access to Medicine Index, as part of the multi- The Index uses various methods to correct for sion process. In addition to this, a clarification stakeholder Methodology Review process. either a company’s size or disease coverage, round was carried out, giving companies an relative to its peers. In indicators that measure opportunity to provide additional data where Data Comparability quantitative elements (relating to pricing, there were gaps, inconsistencies identified, or The outputs analysed in this study and the R&D and patents and licensing), in general, we clarifications necessary. findings generated relate only to the geographi- make adjustments for company size. These are cal, disease, product and company scopes, as made against the size of the relevant portfolio Data availability determined by the Expert Review Committee of products (whether in the pipeline or on the Companies are sometimes unwilling or unable (ERC) during the 2013 Methodology review market), the portfolio of patented products, or to disclose commercially sensitive data, or, if process, and as published in the Methodology against company revenue for 2012 and 2013. As they do, do so only partially. For example, the Report 2013. an example of adjustment for disease coverage, full contents of voluntary licences are often not when evaluating R&D, companies that have a shared, nor the content of R&D contracts. Occa- Although the Foundation recognises that all focus on one or two diseases within scope are sionally, where sensitive data could be analysed, products, diseases, countries and access and required to have a higher proportion of their complete results could not be published due to product initiatives are not the same, in general pipelines dedicated to diseases relevant to the legal constraints related to public disclosure they are treated equally in this study. For exam- Index than companies with more diversified (e.g., pricing data). In other cases, collection of ple, in R&D, all compounds are treated equally pipelines. very specific data (e.g., R&D investment) which if they meet the inclusion criteria, regardless of required dis-aggregation, or country-level col- their mechanism of action or expected efficacy. Companies of different sizes also have different lection, was not always possible. capacities to report information. For example, During the period of analysis (1 June 2012 to 30 larger companies may not have all data available While company disclosure has improved signifi- May 2014), where trend analysis was useful, the in a centralised repository/database, and may cantly in 2014, this issue remains an obstacle to Index team compared raw data from 2012 with have more data to report on. This can be further finding and reporting reliable trends and very raw data from 2014. Comparability between complicated where there are generic medicine specific relationships and conclusions in several companies over successive indices was not al- subsidiaries to account for. areas. ways possible or appropriate, especially for new areas of evaluation or where the scoring criteria Companies have idiosyncratic systems for Additionally, in some areas it may not be pos- of an indicator had been refined. recording and reporting information, which can sible to provide a complete picture of the area give rise to complications when comparing the of analysis due to external constraints on the Company comparability performance of different companies. For exam- collection of data. For example, in 2014, settle- The objective of the Index is to produce a ple, companies have different mechanisms for ments and judgements regarding breaches standardised relative ranking of companies’ calculating the value of donations made and the which occurred anywhere in the world were access-to-medicine performances. However, costs associated with philanthropy. Companies counted when evaluating companies in the not all companies are the same. Some have also often have individual ways of categorising areas of ethical marketing, corruption and large portfolios and pipelines, and a greater information, for example, how different types of anti-competitive behaviour. Some breaches

191 Appendix Access to Medicine Index 2014

occurred prior to the period of analysis. Even given this expanded scope, it is not possible to be confident that all breaches were captured. Sources of data collection included Lexis- Nexis, Bloomberg, the websites of government departments such as the US Department of Justice, and registers maintained and published by a selection of industry self-regulatory bodies: the UK, the Netherlands, South Africa and Australia. Even given the significantly expanded scope of investigation, we acknowledge that breaches may have occurred which were not captured. We continue to acknowledge that breaches in Index countries are likely to be under-reported.

Similarly, a complete picture of breaches of clinical trial conduct is difficult to capture, due to the absence of a central registry of such information, the fact these incidents are typically not routinely monitored by research ethics committees, and tend not to be prosecuted.

Measuring Outcomes and Impacts The study as currently designed is not intended to measure the direct impact of companies’ access initiatives on patients and other groups. For example, within Capability Advancement, the impact of a company’s training activities is not measured. Alternative measures are used as proxies for patient access or considerations of impact. For example, within Product Donations & Sustainable Philanthropy, while the Index does not look at whether or not a company’s programme is, in practice, effective, we evaluate whether or not impact evaluation is part of the company’s approach to donation activities. Within Pricing, Manufacturing & Distribution, disclosure of the volume of sales achieved to specific population segments is taken as a proxy measure of the success of an equitable pricing strategy in reaching target patients.

192 Access to Medicine Index 2014 Appendix | Indicators and Scoring Guidelines

Indicators and Scoring Guidelines

The Scoring Guidelines are scaled according to the least they are currently doing) or according either current industry practice based on the to stakeholder expectations (i.e., a score of 5 spectrum of evidence provided (i.e., a score of represents good practice and a 0 represents 5 represents the best that the companies are behaviour below minimum acceptable currently doing, and a score of 0 or 1 represents standards).

A General Access to Medicine Management

A.I Commitments (25%) A.II Transparency (25%) A.II.2 Strategy: policies & practices A.I.1 Governance: management structures A.II.1 Strategy: policies & practices 50% The company discloses goals and 55% The company has a governance system 50% The company reports on its access targets (both qualitative and quantita- that includes direct board-level to medicine strategy and discloses tive) and performance measures for its responsibility and accountability for its its overall rationale for its access to access to medicine practices related to access to medicine initiatives for Index medicine activities. the Index countries. countries. 5 The company publishes publicly 5 The company discloses qualita- 5 The company has a board-level available information on its access tive AND measurable quantitative process and representation and an to medicine strategy, including poli- targets AND performance mea- executive committee or an execu- cies and activities; rationale; long- sures AND progress for most of its tive role (such as a VP). term objectives; short-term targets relevant access initiatives. 2,5 The company has a board-level and performance (either as part of 4 The company discloses 3 out of 4 process and representation and a its annual report/CSR report or a of the above criteria for most of its director. separate report) AND the access relevant access initiatives. 1 The company has board-level strategy is part of a wider corporate 2.5 The company discloses 2 out of 4 representation but no director or strategy. of the above criteria for most of its executive. 4 The company publishes publicly relevant access initiatives. 0 No representation in the company’s available information on its access 1 The company discloses long-term senior governance bodies. to medicine strategy, including poli- objectives for its relevant access cies and activities; rationale; mea- initiatives. A.I.2 Stakeholder engagement surable targets and performance 0 The company discloses none of the 45% The company commits to work with (either as part of its annual report/ above. relevant stakeholders, including univer- CSR report or a separate report) sities, patient groups, local govern- AND the access strategy is part of a A.III Performance (40%) ments, employees, local and interna- wider corporate strategy. A.III.1 Governance: management structures, tional NGOs and peers with the aim of 3 The company publishes publicly 40% performance management & improving access to medicine. available information on its access incentives 5 The company has a strategy and to medicine strategy, including The company has a performance platform for outreach to relevant some information on policies and management system including stakeholders and there is strong ev- activities; rationale; objectives quantitative targets to implement and idence of stakeholder engagement AND some information on short/ monitor its access to medicine strategy for most of its access initiatives. long-term targets and performance in the Index countries. 4 The company has a strategy and (either as part of its annual report/ 5 The company has a centralised platform for outreach to relevant CSR report or a separate report). performance management system stakeholders and there is strong evi- 2 The company publishes publicly that uses quantitative and qualita- dence of stakeholder engagement available information on its access tive measures to collect data and for some of its access initiatives. to medicine strategy including appraise performance across its 2.5 The company has a broad strategy policies and activities and long-term global operations. and platform for outreach to rel- objectives but no information on 2.5 The company has a broad perfor- evant stakeholders and provides short-term targets or performance mance management system but some evidence of relevant stake- (either as part of its annual report/ progress is not monitored on a regu- holder engagement. CSR report or a separate report). lar basis AND/OR not centralised. 1 The company has some stakeholder 0 The company does not include 1 The company has qualitative and engagement but there is no evi- any of the above information in its quantitative targets for its access dence of a strategy and platform for public reporting. to medicine strategy but no specific outreach to relevant stakeholders. performance management system. 0 The company has no relevant stake- 0 The company does not provide any holder engagement. evidence of managing and measuring access to medicine performance.

193 Appendix | Indicators and Scoring Guidelines Access to Medicine Index 2014

A.III.2 Stakeholder engagement A.III.3 Governance: performance perspectives in the development 25% Senior management participates 25% management & incentives and implementation of its access in public debate and engages with The company has internal incentive strategies and there is evidence different stakeholder groups with the structures to reward effective delivery that this is structural. goal of dialogue and knowledge sharing of initiatives that improve access to 2.5 There is some evidence that the aimed at improved access to products medicine in the Index countries for the company includes local stakeholder for the Index Diseases in the Index Index Diseases. perspectives in the development countries (the company organises/ 5 The company has an HR/ perfor- and implementation of its access facilitates/ hosts relevant conferences, mance management strategy and strategies, however, there is no symposia, workshops etc. attended by supporting processes, and provides evidence this is structural. senior management). clear evidence of financial and 0 There is no evidence of local 5 The company (including senior non-financial incentives for relevant stakeholder engagement when de- management) plays a significant performance of directors and veloping and implementing access role in dissemination of knowledge senior management. strategies. (for example an agenda develop- 2.5 The company has a broad HR/ ment role/ participation on organis- performance management strategy A.IV Innovation (10%) ing committee) at more than 10 and supporting processes which A.IV.1 Innovation in general access to reputable* conferences/ symposia/ provide financial and non-financial 100% medicine management workshops/ meetings/ working incentives for relevant performance The company has contributed to the groups. and there is evidence that this is development of innovative business 4 The company engages in 5 - 10 of active. models that meet the needs of patients the above. 1 There is some evidence of internal in Index countries. 2.5 The company engages in 2 - 4 of the incentive structures for relevant 5 The company has developed a above. performance for employees work- financially sustainable innovative 1 There is no evidence of more than 1 ing on access initiatives. model that focuses on the needs of of the above. 0 The company does not provide any the poor. 0 The company does not provide any evidence that it provides incentives 4 The company has adopted or evidence of the above. for relevant performance. expanded a financially sustainable * Reputable events are considered to be innovative business model that those which feature strong repre- A.III.4 Strategies, stakeholder engagement focuses on the needs of the poor. sentation from organisations such 10% The company has a system in place to 2.5 The company has developed an as governments, major international incorporate external and local (market) innovative model, however, there agencies, regulatory bodies, founda- perspectives on access to medicine is limited evidence concerning its tions, academia, PPPs/ PDPs and needs in the development and imple- (financial) sustainability. NGOs. mentation of access strategies. 0 No innovative models identified in 5 The company has a system in place this area. to incorporate local stakeholder

B Public Policy & Market Influence

B.I Commitments (25%) 4 The company publicly discloses its B.I.2 Non-pursuit of data exclusivity B.I.1 Endorsement of competition commitment related to competition 25% The company’s policies and practices 35% The company commits to endorse and with its peers (both research-based surrounding data exclusivity do not support competition and to refrain from and generic) which endorses com- impede access for products related to anti-competitive practices or pursue petition AND commits not to adopt the Index Diseases in the Index coun- arrangements with generic medicine practices that hamper competition. tries. manufacturers that might delay their 2.5 The company discloses to the Index 5 The company systematically com- market entry in the pharmaceutical its commitment related to competi- mits not to utilise or to waive data markets in the Index countries for prod- tion with its peers (both research- exclusivity laws for all its products ucts related to the Index Diseases. based and generic) which endorses related to Index Diseases in Index 5 The company publicly discloses its competition AND commits not to countries. commitment related to competition adopt practices that hamper com- 4 The company commits not to utilise with its peers (both research-based petition. / commits to waiving its right to and generic manufacturers) which 1 The company publicly discloses a data exclusivity periods for specific endorses competition AND com- general statement in support of conditions and/or diseases in Index mits not to adopt practices that competition. countries. hamper competition AND explicitly 0 The company does not make any 0 No policy statement on data ex- commits not enter into arrange- policy statements in this area. clusivity / negative stance on data ments with competitors or generic exclusivity. medicine manufacturers for de- layed product entry to the market.

194 Access to Medicine Index 2014 Appendix | Indicators and Scoring Guidelines

B.I.3 Ethical marketing 3 The company has internal and/or B.II.2 Influence 20% The company commits to enforce a external auditing of its anti-bribery/ 15% The company discloses membership code of conduct regarding ethical anti-corruption codes and has 3 out and financial support of trade associa- marketing practices for all sales agents of 5 of the above. tions, think tanks, interest groups, or and local third party distributors and 2 The company has no internal and/or other organisations, including any contractors consistent with its own external auditing of its anti-bribery/ potential governance conflict of inter- internal standards and any existing anti-corruption codes but has dem- ests, through which it might advocate industry standards. onstrated at least 3 of above. its public policy positions at regional, 5 The company has processes in place 1 The company has no internal and/or national or international levels where to monitor marketing practices and external auditing of its anti-bribery/ relevant to access to medicine in the enforce ethical marketing codes of anti-corruption codes but has dem- Index countries. practice by all its sales agents (third onstrated at least 2 of the above. 5 The company discloses its financial party distributors*) in the Index 0 The company makes none of the support and membership of all insti- countries, which includes auditing above commitments. tutions of all the named categories* of the agent’s practices. for the Index countries. 2,5 The company has specific ethical B.II Transparency (25%) 4 The company makes detailed trans- marketing codes of practice for B.II.1 Lobbying action level disclosure on payments all its sales agents (third party 15% The company is transparent about its made to different stakeholders, but distributors) in the Index countries, lobbying positions, political contribu- provides no Index Country report- but has no auditing, monitoring or tions and positions it seeks to promote ing. enforcement mechanisms. where it has an impact on access to 2.5 The company makes partial 0 The company has no provisions in medicine in Index countries, either disclosure in this area OR provides place with regards to the marketing directly or indirectly. aggregate figures only. behaviour of its local sales agents. 5 The company is publicly transparent 0 The company makes no disclosure *Third parties include local distribu- with regard to its lobbying activities in this area. tors, sales agents, wholesalers, clinics and public policy positions and *Categories include: trade associations, and pharmacies, faith based hospitals, political (financial) contributions think tanks, interest groups, or other pharmacy retail units/chains, private impacting access to medicine in organisations. health facilities, transport providers, Index countries. customs service providers, contract 4 The company is transparent upon B.II.3 Influence research organisations, public affairs, engagement with regard to its 10% The company discloses its board seats events companies or marketing con- lobbying activities, its public policy at industry associations and advisory tractors, consultants, etc. positions and its political (financial) bodies related to health access issues contributions which have an impact for the Index Diseases and the Index B.I.4 Anti-bribery/anti-corruption upon access to medicine in Index countries. 20% The company commits to proactively countries. 5 The company publicly discloses engage in fighting corruption through 3 The company is publicly transpar- through its own channels all the its internal anti-bribery and anti- ent with respect to either relevant board seats and memberships that corruption codes of conduct, external lobbying activities, or its political it holds in different organisations/ commitments and memberships. contribution, or its public policy institutions related to access to 5 The company has internal and/or positions which have an impact medicine in the Index countries external auditing of its anti-bribery/ upon access to medicine in Index including in organisations operating anti-corruption codes AND has all countries. in the Index countries. of the following: 2 The company is transparent upon 3.5 The company discloses upon a) is a member of the World Eco- engagement with regard to either engagement or on third party nomic Forum’s Partnering Against its lobbying activities, or its political websites, all the board seats and Corruption Initiative (PACI) (financial) contributions or its public memberships that it holds in differ- b) is a signatory to the UN Global policy positions which have an ent third party institutions related Compact impact upon access to medicines in to access to medicine in the Index c) has a code of conduct that ad- Index countries. countries including in organisations dresses anti-corruption which 1 The company discloses (publicly or operating in the Index countries. specifically applies to all employees, upon engagement) its public policy 2.5 The company makes partial disclo- agents and intermediates or lobbying positions which have an sure of memberships (publicly or d) has board level ownership/direct impact upon access to medicines in otherwise) that it holds in different responsibility for ethics and compli- Index countries via a general state- third party institutions related ance of anti-bribery/corruption ment. to access to medicine in Index practices 0 The company is not transparent or countries, including organisations e) has whistle-blower facilities and makes no statement with regards to operating in Index countries. protection policies. transparency in its lobbying activi- 0 The company makes no disclosure 4 The company has internal and/or ties or political (financial) contri- in this area. external auditing of its anti-bribery/ butions or public policy positions anti-corruption codes and has 4 out which have an impact upon access of 5 of the above. to medicines in Index countries.

195 Appendix | Indicators and Scoring Guidelines Access to Medicine Index 2014

B.II.4 Endorsement of competition B.II.6 Ethical marketing, anti-bribery/ *Pending cases and allegations are not 30% The company discloses policies related 10% anti-corruption considered breaches. If a ruling is ap- to competition in areas such as data The company voluntarily discloses all pealed, the most recent verdict is taken exclusivity, patent extensions or other information regarding its breaches of into consideration. arrangements with generic companies internal and internationally recog- that might delay their market entry for nised codes of conduct for ethical B.III.2 Endorsement of competition Index products in the Index coun- marketing, lobbying, bribery and/or 35% There is evidence* of the company’s tries. corruption in any country in the last anti-competitive behaviour** that 5 The company publicly and precisely two years, including litigations related impacts access to medicine based on discloses its stance on competition to marketing practices in the Index fines or litigation records during the and has provided evidence of pro- countries. past two years. moting competition in ways such as 5 The company publicly discloses 5 The company has not been the data exclusivity waivers, arrange- detailed, current information (i.e., subject of any settled cases.*** ments with generics companies location, time, year) in its an- 1 The company has been the subject which support their market entry, nual report, including cases which of a challenge/litigation in non-In- etc. occurred in the Index countries, dex countries with negative rulings/ 2,5 The company publicly and precisely in relation to breaches of the fol- settlement with payment or regula- discloses its stance on competition lowing codes of conduct: IFPMA tory proceedings with fines.*** but provides no evidence of any Ethical Marketing Guidelines, DHHS 0 The company has been the subject pro-competitive activities. Code of Conduct, PhRMA Code of of at least 1 litigation in an Index 0 The company makes no disclosure Conduct; EFPIA codes of conduct; Country with negative rulings/ in this area. WHO ethical criteria and relevant settlement with payments or regu- anti corruption codes such as PACI latory proceedings with fines.*** B.II.5 Ethical marketing and the UN Global Compact. *Evidence to refer to fines or reports/ 20% The company publicly discloses 4 The company discloses detailed, controversies. detailed information regarding current information of the above, **Excluding all IP anti-competitive its marketing and promotional but only on engagement. practices. programmes in the Index countries, 3 The company publicly discloses ***Pending cases and allegations are such as payments to or promotional minimal or aggregate numbers re- not considered breaches. If a ruling is activities directed at physicians or lated to breaches as outlined above appealed, the most recent verdict is other key healthcare professionals or as part of its annual report. taken into consideration. opinion leaders. 2 The company discloses minimal or 5 The company publicly discloses aggregate numbers related to the B.III.3 Lobbying, ethical marketing, detailed information related to breaches or litigations outlined 10% anti-bribery/anti-corruption pharmaceutical marketing and pro- above, but only on engagement. Part a – The company has taken motional programmes in the Index 0 The company makes no disclosure disciplinary action against third parties countries. For example, payments in this area. or employees who violate its code made to physicians and methods for of conduct for ethical marketing or incentivising healthcare providers, B.III Performance (40%) lobbying and anti-corruption. pharmacies, key opinion leaders, B.III.1 Lobbying, ethical marketing, and others. This includes decentral- 35% anti-bribery/anti-corruption Part b (qualitative-no scoring) – ised activities and third party sales The company has been in breach of The company has established strin- agents. any national or international codes gent enforcement mechanisms for 4 The company discloses upon of conduct in any country in relation disciplinary action against third parties engagement information related to to lobbying, ethical marketing and/or or employees that violate its codes pharmaceutical marketing and pro- bribery and corruption. of conduct for ethical marketing or motional programmes in the Index 5 The company has not been the lobbying and anti-corruption. countries. For example payments subject of any settled cases.* 5 The company has clearly defined to physicians and methods for 2 The company has been the subject enforcement processes and incentivising healthcare providers, of at least one litigation/chal- disciplinary measures with regards pharmacies, key opinion leaders, lenge in a non-Index Country with to lobbying/corruption and/or and others. negative ruling/settlement with marketing, and there is no evidence 2.5 The company discloses on en- payment or regulatory proceeding of violations . gagement its policy approach for with a fine.* 2,5 The company has clearly defined pharmaceutical marketing in Index 1 The company has been the subject enforcement processes and countries without disclosing exact of several litigations/challenges in disciplinary measures and provides contribution figures and perfor- non-Index countries with negative evidence that disciplinary action has mance information in this area. rulings/settlement with payment or been taken for lobbying/corruption 0 The company makes no disclosure regulatory proceedings with fines.* and/or marketing violations, with in this area. 0 The company has been the subject disclosure made that action was of at least one litigation/challenge taken. in an Index Country with negative 1 The company does not have clearly ruling/settlement with payment or defined enforcement processes regulatory proceeding with a fine.* and disciplinary measures and/or

196 Access to Medicine Index 2014 Appendix | Indicators and Scoring Guidelines

its codes of conduct do not apply to its trade associations or industry increasing access to medicine such as third parties. groups has engaged in lobbying marketing, advocacy, lobbying, anti- 0 The company has abrogated its own activities for TRIPS + measures. corruption, and pro-competition. internal whistleblower policy, for 1 There is at least one incident where 5 The company has adopted in- example, retaliating against an em- the company directly or through any novative (unique in the sector) ployee for whistleblowing action; of its trade associations or industry approaches to promoting ethical, or has not taken disciplinary action groups has lobbied for TRIPS + pro-competitive and anti-corrup- with regard to violations. measures. tion behaviour in relation to Index 0 The company directly or through Disease products in Index countries, B.III.4 Lobbying any of its trade associations or and supports this with evidence 20% Is there evidence that the company industry groups has more than one of progress and/or the human or lobbies national or regional govern- instance of lobbying for TRIPS + financial resources invested. ments, or other companies and their measures. 2,5 The company has adopted in- trade associations, either directly novative (unique in the sector) or through third parties, to adopt B.IV Innovation (10%) approaches to promoting ethical, additional measures to protect intel- B.IV.1 Innovation in public policy & market pro-competitive and anti-corrup- lectual property and/or patent systems 100% influence tion behaviour in relation to Index beyond the minimum standard outlined The company has adopted an innova- Disease Products in Index countries in the TRIPS agreement (e.g. data tive (unique in the sector), sustain- but does not disclose progress or exclusivity, etc.)? able approach to improving ethical resources inputs. 5 There is no evidence that the business performance and interactions 0 No innovative initiatives identified company directly or through any of in Index countries in areas relevant to in this area.

C Research & Development

C.I Commitments (25%) disease areas. explicitly encourages affordable, C.I.1 Innovative and adaptive R&D for Index 2 The company makes specific com- timely and high quality supply to 40% Diseases mitments supported with a strong relevant populations). The company commits to carry out rationale (alignment with health 1.5 The company applies principles of research focusing on the development priorities), OR has specific opera- access-oriented research contracts of both innovative and new remedies tionalisation strategies in place, in in relation to the intellectual prop- for the Index Diseases and adaptive multiple disease areas. erty generated in partnerships for a new formulations of its existing prod- 1 The company makes a general com- subset of relevant products in only a ucts for the Index Diseases with the mitment in a few disease areas. subset of the relevant countries on goal of improving access to medicine in 0 The company makes no commit- an ad hoc basis. the Index countries. ments in this area. 0 The company makes no commit- For companies that have only one or ments in this area. two Index disease focus: tiers 1 and 3 C.I.2 Collaborative R&D are not applicable, scored according to 30% The company commits to ensuring equi- C.I.3 Clinical trial conduct tiers 2 and 4 or 5. table access to products successfully 30% The company commits to compliance 5 The company makes specific com- developed through R&D partnerships. with quality assurance and control, plus mitments supported with a strong 5 The company systematically ethical standards when conducting rationale (alignment with health commits to policies for inclusion clinical trials in Index countries, priorities) and specific operational- of access-oriented principles in consistent with codes such as Good izing strategies (including respon- research contracts in all relevant Clinical Practice and the Declaration sibilities of partners), including countries, for all relevant diseases of Helsinki (regardless of whether measurable time-bound targets, in in relation to the intellectual prop- the trials are conducted in-house or multiple disease areas related to the erty generated in partnerships (i.e. through a third-party, e.g. CRO). development of relevant innovative either waives all rights over the IP 5 The company provides evidence and/or adaptive products. generated or explicitly encourages that it has policies in place in rela- 4 The company makes specific com- affordable, timely and high quality tion to mitments supported with a strong supply to relevant populations). a) selecting third parties rationale (alignment with health 3.5 The company systematically b) application of codes of conduct priorities) and specific opera- commits to policies for inclusion consistent with the Declaration of tionalizing strategies (including of acces-oriented principles in Helsinki responsibilities of partners) in research contracts in a subset of c) ensuring compliance with Good multiple disease areas related to the relevant countries in relation to Clinical Practice development of relevant innovative the intellectual property gener- d) has procedures in place for tak- and/or adaptive products. ated in partnerships for a subset of ing disciplinary action against any 3 The company makes a specific com- relevant diseases (i.e. either waives violations . mitment as above, but only in a few all rights over the IP generated or 3.5 The company provides evidence

197 Appendix | Indicators and Scoring Guidelines Access to Medicine Index 2014

that it has policies in place in rela- provisions on an engagement basis. process in place for sharing clinical tion to 2 The company discloses the exis- trial data with qualified third parties a) selecting third parties tence of relevant collaborations (e.g. universities). b) ensuring compliance with Good plus included pro-access provisions 4 The company a) discloses all Clinical Practice for the majority of its agreements relevant country-conducted clini- c) has procedures in place for taking on an engagement basis. cal trials (in-house or by CROs) to disciplinary action for any violations. 1 The company discloses the exis- a standard not lower than that 1.5 The company provides evidence tence of relevant collaborations on recommended in the WHO’s 2005 that it has policies in place in rela- an engagement basis. Technical Consultation on Clinical tion to 2 out of 4 above-mentioned 0 The company makes no disclosure Trial Registration Standards, with elements (from score 5). in this area. respect to: trial registration in an 1 The company provides evidence NS Companies without relevant part- ICMJE approved registry and result that it has policies to ensure compli- nerships receive a neutral score. disclosure within one year, and b) ance with Good Clinical Practice. has a positive stance towards clini- 0 The company makes no commit- C.II.3 R&D for Index Diseases suitable to cal trial data transparency. ments in this area. 10% Index countries’ needs 3 The company a) discloses all The company discloses its research relevant country-conducted clini- C.II Transparency (25%) pipeline related to both in-house cal trials (in-house or by CROs) to C.II.1 Resources towards R&D research and collaborations targeting a standard not lower than that 30% The company discloses the resources Index Diseases (where disclosure is not recommended in the WHO’s 2005 dedicated to its research and develop- legally required). Technical Consultation on Clinical ment activities conducted in-house 5 The company publicly discloses Trial Registration Standards, with and/or in collaboration for Index its a) research and development respect to: trial registration and Diseases suitable for Index countries. pipeline (phase I, 2 and 3), for all result disclosure OR b) discloses 5 The company discloses investments products, with diseases/indications the majority of trials to a standard for all Index Diseases for which it specified) plus b) areas of basic/ not lower than the WHO 2005 carries out R&D. pre-clinical activity for all relevant standards and has a mechanism/ 3.5 The company discloses investments diseases and products related to process in place for sharing clinical for a subset of Index Diseases for its in-house and c) collaborative trial data with qualified third parties which it carries out R&D. research, and d) technology devel- (e.g. universities). 1.5 The company discloses investments opment. 2 The company registers trials and for one or a minority of Index Dis- 4 The company publicly discloses publicly discloses to a similar (or eases for which it carries out R&D. three of the above four elements of slightly lower) standard than that 1 The company discloses its ag- its R&D pipeline. recommended in the WHO’s 2005 gregate investments for Index Dis- 3 The company publicly discloses two Technical Consultation on Clinical eases, without specifying targeted of the above four elements of its Trial Registration Standards, with disease areas. R&D pipeline. respect to: trial registration and 0 The company makes no disclosure 2 The company publicly discloses one results disclosure, but there is no in this area. of the above four elements. evidence that this applies to all trials. 1 The company discloses on an en- 1 There is no evidence that disclosure C.II.2 Collaborative R&D gagement basis only. goes beyond legal requirements. 30% The company discloses the licensing 0 The company makes no disclosure 0 The company makes no disclosure details pertaining to its research collab- in this area. on either issue detailed above. orations related to the Index Diseases Corrected for companies without (with regard to Intellectual Property relevant collaborations or technology C.III Performance (40%) rights, access provisions etc.). development C.III.1 Resources towards R&D 5 The company publicly discloses 15% Portion of financial R&D investments the existence and mandate of C.II.4 Clinical trial data dedicated to Index Diseases out of the all relevant collaborations plus 30% The company discloses information company’s total R&D expenditures. included pro-access provisions (e.g. and results of all of its clinical trials 5-1 Each company’s R&D investments non-exclusivity in fields/territories, conducted in Index countries, regard- for diseases within scope is divided royalty free provisions, waivers of less of the outcome and whether by total R&D investments. Revenue- patents, price caps, commitments the trial was conducted in-house or standardised number (2012 & 2013) to ensure sufficient supply). through a third-party (e.g. CRO). is scaled across all companies and 4 The company publicly discloses 5 The company a) discloses all relevant scored. partial information on the existence country-conducted clinical trials (in- 0 The company makes no disclosure and mandate of its relevant collabo- house or by CROs) to a standard not in this area. rations and provides partial details lower than that recommended in the of pro-access provisions relating to WHO’s 2005 Technical Consulta- C.III.2 R&D for Index Diseases suitable to at least one of its collaborations. tion on Clinical Trial Registration 20% Index countries’ needs 3 The company partially publicly dis- Standards, with respect to: trial Share of research pipeline reflecting closes the existence and mandate registration in an ICMJE approved ‘new molecules’ for Index Diseases of its relevant collaborations and registry and result disclosure within including in-house and collaborative discloses the included pro-access one year, and b) has a mechanism/ research.

198 Access to Medicine Index 2014 Appendix | Indicators and Scoring Guidelines

For companies that have multiple Index dedicated to adapted products and 1 The share of the company’s relevant disease focus: technologies for relevant diseases is pipeline that is developed in col- 5 The share of the company’s pipeline between 15-25% of its total pipeline. laboration for relevant diseases is dedicated to new molecules for 3 The share of the company’s pipeline less than 5%. relevant diseases is greater than or dedicated to adapted products and 0 The company has no active relevant equal to 25% of its total pipeline. technologies for relevant diseases is product development collabora- 4 The share of the company’s pipeline between 10-15% of its total pipeline. tions during the survey period. dedicated to new molecules for rel- 2 The share of the company’s pipeline evant diseases is between 15-25% of dedicated to adapted products and For companies that have only one or its total pipeline. technologies for relevant diseases is two Index disease focus: 3 The share of the company’s pipeline between 5-10% of its total pipeline. 5 The share of the company’s relevant dedicated to new molecules for 1 The share of the company’s pipeline pipeline that is developed in col- relevant diseases is between 10-15% dedicated to adapted products and laboration for relevant diseases is of its total pipeline. technologies for relevant diseases greater than 50%. 2 The share of the company’s pipeline is less than 5% of its total pipeline. 4 The share of the company’s relevant dedicated to new molecules for 0 The company has no adapted prod- pipeline that is developed in col- relevant diseases is between 5-10% ucts/technologies with respect to laboration for relevant diseases is of its total pipeline. R&D for relevant diseases. between 25-50%. 1 The share of the company’s pipeline 2.5 The share of the company’s relevant dedicated to new molecules for For companies that have only one or pipeline that is developed in col- relevant diseases is less than 5% of two Index disease focus: laboration for relevant diseases is its total pipeline. 5 The share of the company’s pipeline between 10-25%. 0 The company has no molecules/ dedicated to adapted products and 1 The share of the company’s relevant activity with respect to R&D for technologies for relevant diseases is pipeline that is developed in col- relevant diseases. greater than 50% of its total pipeline. laboration for relevant diseases is 4 The share of the company’s pipeline less than 10%. For companies that have only one or dedicated to adapted products and 0 The company has no active relevant two Index disease focus: technologies for relevant diseases is product development collabora- 5 The share of the company’s pipeline between 25-50% of its total pipeline. tions during the survey period. dedicated to new molecules for 2.5 The share of the company’s pipeline relevant diseases is greater than dedicated to adapted products and C.III.5 R&D for Index Diseases suitable to 50% of its total pipeline. technologies for relevant diseases is 5% Index countries’ needs 4 The share of the company’s pipeline between 10-25% of its total pipeline. Number of candidates relating to Index dedicated to new molecules for rel- 1 The share of the company’s pipeline Diseases moving through research evant diseases is between 25-50% dedicated to adapted products and and development life cycle from early of its total pipeline. technologies for relevant diseases research phases to more advanced 2.5 The share of the company’s pipeline is less than 10% of its total pipeline. phases. dedicated to new molecules for rel- 0 The company has no adapted prod- 5-1 For each company, its R&D pipeline evant diseases is between 10-25% ucts/technologies with respect to submitted in Index 2012 was com- of its total pipeline. R&D for relevant diseases. pared with its R&D pipeline submit- 1 The share of the company’s pipeline ted for Index 2014 to determine the dedicated to new molecules for C.III.4 Collaborative R&D number of medicines and vaccines relevant diseases is less than 10% of 10% R&D partnerships in which the that progressed to different stages its total pipeline. company has been involved, with the in each company’s pipeline, as a pro- 0 The company has no molecules/ aim of developing products or formula- portion of the company’s total R&D activity with respect to R&D for tions for Index Diseases specifically pipeline. Progress from discovery relevant diseases. targeting access issues in Index to pre-clinical, pre-clinical to clini- countries (adjusted for the number of cal and from clinical to regulatory C.III.3 R&D for Index Diseases suitable to molecules in the company’s research approval is weighted, scaled and 20% Index countries’ needs pipeline). scored. Share of research pipeline and prod- For companies that have multiple Index 0 The company did not provide ucts registered reflecting ‘adapted disease focus: evidence of molecules progressing products or new technologies’ specific 5 The share of the company’s relevant through the pipeline. to an Index Disease and an unmet need pipeline that is developed in col- in an Index Country, including in-house laboration for relevant diseases is C.III.6 Collaborative R&D and collaborative research. greater than or equal to 25%. 10% The company provides evidence For companies that have multiple Index 4 The share of the company’s relevant that the terms and conditions of its disease focus: pipeline that is developed in col- research collaborations are conducive 5 The share of the company’s pipeline laboration for relevant diseases is to improving access to Index Disease dedicated to adapted products and between 10-25%. products in the Index countries for the technologies for relevant diseases 2.5 The share of the company’s relevant individuals with significant financial is greater than or equal to 25% of its pipeline that is developed in col- barriers to access. total pipeline. laboration for relevant diseases is 5 All agreements in relation to the 4 The share of the company’s pipeline between 5-10%. company’s relevant research collab-

199 Appendix | Indicators and Scoring Guidelines Access to Medicine Index 2014

orations have pro-access provisions clinical trial conduct, the case occurred outsourced trials OR provides included in the terms and conditions. in a relevant country, the legal case, or general statements on auditing and 4 More than 50% of the company’s regulatory notice occurred in the last monitoring procedures and proce- agreements in relation to the compa- 5 years and it was brought against the dures for disciplinary actions for ny’s relevant research collaborations company itself or one of its third-par- any violations of guidelines/codes have pro-access provisions included ties for whom it was legally responsible. of practice. in the terms and conditions and the *‘Major’ is defined as possibility to set a 1 The company makes a general company has provided evidence of precedent. statement concerning monitoring engagement in other access-orient- or auditing its clinical trial conduct. ed partnerships (of which terms and C.III.8 IP sharing 0 The company provides no evidence conditions are non-disclosed). 10% The company provides evidence of of monitoring or enforcement of 2.5 Fewer than 50% of the company’s sharing its intellectual capital (e.g. ethical behaviours for in-house or agreements in relation to the compa- molecules library, patented compounds, outsourced clinical trials. ny’s relevant research collaborations processes or technologies) with have pro-access provisions included research institutions and neglected C.IV Innovation (10%) in the terms and conditions and the disease drug discovery initiatives (e.g. C.IV.1 Innovation in R&D company has provided evidence of WIPO Re: Search, CDD, OSDD) that 100% The company has adopted innovative engagement in other access-orient- develop products for Index Diseases (unique in the sector), sustainable or ed partnerships (of which terms and on terms most conducive to access to open business models to further the conditions are non-disclosed). medicine for the Index countries. global R&D agenda for the develop- 1 The company has been engaged in 5-1 The total number of instances of ment of products for Index Diseases. partnerships with access-oriented the company providing third-party 5 The company has provided evi- organisations (e.g. WIPO Re: Search, access to its relevant disease- dence that it invested in designing PDPs), without providing evidence related intellectual property on new innovative (unique in the sec- of pro-access terms and conditions. access-orientated terms during tor) R&D approaches or business 0 The company has been involved the survey period is divided by total models , including open approaches in partnerships, but there is no company revenue in 2012 and 2013. to IP, for relevant diseases with sig- evidence of engagement in access- The number of IP sharing instances nificant potential to improve ATM oriented partnerships. is divided by revenue and scaled and has demonstrated significant NS Companies without R&D partner- across all companies. resources and progress. ships in scope receive a neutral 0 The company did not provide evi- 4 The company has adopted innova- score. dence of IP sharing. tive (not unique in the sector) R&D approaches or business models, C.III.7 Clinical trial conduct C.III.9 Clinical trial conduct including open approaches to IP, for 5% Has the company been the subject 5% The company provides evidence relevant diseases with significant of any breach of international codes of ensuring compliance with Good potential to improve ATM and has or lawsuits related to its clinical trial Clinical Practice and the Declaration demonstrated significant resources practices in the Index countries during of Helsinki when conducting trials in and progress. the last five years? Index countries, regardless of whether 2.5 The company has adopted innova- 5 The company has not been the the trial was conducted in-house or tive (not unique in the sector) R&D subject of any regulatory notices or through a third-party (e.g. CRO). approaches or business models, legal cases related to its clinical trial 5 The company provides evidence including open approaches to IP, for conduct. that it relevant diseases with significant 4 The company has been the recipient a) has measures to comply with the potential to improve ATM, but did of a couple of regulatory notices. Declaration of Helsinki not provide evidence of dedicated 3 The company has been the subject b) audits and monitors clinical trial resources and progress. of one or two legal cases (without a conduct to comply with ICH-GCP 1 The company is involved in a col- ruling) or more than two regulatory c) where relevant, applies pro- laborative, industry-wide effort notices were issued to the company. cesses for disciplinary action for to develop new common R&D 2 The company has been the subject any violations of guidelines/codes approaches or business models for of one or two legal cases (with of practice for BOTH in-house and relevant diseases with significant negative rulings) but no precedent- outsourced trials. potential to improve ATM. setting cases. 4 The company provides evidence 0 No innovative initiatives discovered 1 The company has been the subject that it for the company in this area. of at least one significant legal case a) audits and monitors clinical trial (with negative ruling) that could set conduct to comply with ICH-GCP a precedent. b) where relevant, applies pro- 0 The company has been the subject cesses for disciplinary action for of several significant legal cases any violations of guidelines/codes and at least one major* case with a of practice for BOTH in-house and negative ruling. outsourced trials. For companies with no operations in 2.5 The company provides evidence relevant countries the score will be 5. that it audits and monitors clinical For each of the above scores it is as- trial conduct to comply with ICH- sumed: the case was with respect to its GCP for BOTH in-house and

200 Access to Medicine Index 2014 Appendix | Indicators and Scoring Guidelines

D Pricing, Manufacturing & Distribution

D.I Commitments (25%) small number of relevant countries. compliance with WHO GMP guide- D.I.1 Equitable pricing strategies 1 The company makes a general lines for drug recalls as described 25% The company commits to implement commitment to implement intra- above in all relevant countries equitable inter-country pricing models country equitable pricing. where its products are available for the products related to the Index 0 The company makes no intra-coun- AND it commits achieve the highest Diseases in the Index countries to try equitable pricing commitments. possible standards BUT does not ensure affordability. have processes to track products to 5 The company commits to apply D.I.3 Accountability for sales agents’ ensure effective recalls. inter-country equitable pricing 20% pricing practices 2.5 The company provides evidence of models in all the countries it oper- The company adopts clear policies to compliance with WHO GMP guide- ates in which are relevant to the control the pricing practices of its local lines for drug recalls in some of the Index, for all its products relevant to sales agents with the aim of improving relevant countries where it makes the Index. affordability and accessibility of the its products available and commits 4 The company commits to apply products. to achieve the highest possible inter-country equitable pricing 5 The company has pricing guidelines standards. models in the majority of relevant for its local sales agents (third party 1 The company has general guidelines countries for a majority of its rel- wholesalers and distributors) AND for drug recalls and provides evi- evant products. the company has a pricing monitor- dence of tracking procedures 3 The company commits to apply ing process including mark-up moni- 0 The company makes no commit- inter-country equitable pricing toring, training and audit mecha- ment in this area. models in a majority of relevant nisms for all its products relevant to *WHO GMP guidelines includes written countries for at least one of its the Index in countries it operates in. procedures describing the action to be relevant products or for a majority 4 In addition to pricing guidelines, the taken, including the need to con- of relevant products in at least one company has a pricing monitoring sider a recall in the case of a complaint relevant country. process including mark-up monitor- concerning a possible product defect; 2 The company commits to apply ing and training OR audit mecha- processes for an investigation and inter-country equitable pricing nisms for its sales agents (third evaluation of a complaint; and appro- models to at least one product in a party wholesalers and distributors) priate follow-up action, possibly includ- small number of relevant countries. for some relevant products and ing product recall; storage of recalled 1 The company makes a general relevant countries. products; periodic evaluation of recall commitment to implement inter- 3 The company has general pricing processes. country equitable pricing. guidelines for its sales agents and 0 The company makes no commit- monitors mark-ups. D.I.5 Brochure & packaging adaptation ments in this area. 2.5 The company has general pricing 10% The company commits to needs-based guidelines for its sales agents but (facilitation of rational use) brochure D.I.2 Equitable pricing strategies does not monitor mark-ups. and packaging adaptation for its prod- 20% The company commits to implement 1 The company provides evidence of ucts destined for Index countries (at equitable intra-country pricing models monitoring mark-ups but does not least equal to local regulatory require- for the products related to the Index have pricing guidelines. ments). Diseases in the Index countries to 0 The company has no pricing guide- 5 The company discloses that its ensure affordability. lines, and does not monitor pricing product brochure and packaging 5 The company commits to apply practices or markups applied by information is consistent with that intra-country equitable pricing local sales agents. approved by the country’s drug models in all the countries relevant regulatory authority for all of the to the Index it operates in, for all its D.I.4 Drug recalls relevant diseases for which its products for diseases relevant to 10% The company has in place the policies, products are sold AND for some the Index. procedures and resources needed products its product brochures and 4 The company commits to apply to carry out effective drug recalls packaging information go beyond intra-country equitable pricing (product and packaging) in the Index those required by the country’s models in a majority of relevant countries where it operates. drug regulatory authority, with the countries for the majority of its 5 The company provides evidence of aim of facilitating rational use for relevant products. compliance with WHO GMP guide- societies in need, at various levels of 3 The company commits to apply lines* for drug recalls in all countries the health system.* intra-country equitable pricing relevant to the Index where its 4 The company discloses that its models in a majority of relevant products are available, AND com- product brochure and packaging countries for at least one of its mits to achieve the highest possible information is consistent with that relevant products. standards AND has processes to approved by the country’s drug 2 The company commits to apply track products to ensure effective regulatory authority for all of the intra-country equitable pricing recalls. relevant diseases for which its models to at least one product in a 4 The company provides evidence of products are sold, with the aim of

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facilitating rational use. of the above information such as tiers for its product. 3 The company discloses that its regional or representative figures 2.5 The company discloses details of product brochure and packag- for all of its relevant products OR how it takes affordability into ac- ing information is consistent with discloses full volume data for the count for the majority of its relevant that approved by the country’s majority (greater than 50%) of products covered by equitable drug regulatory authority for the relevant products. pricing programmes AND discloses majority of the relevant diseases for 3 The company discloses a subset of the price point offered to the lowest which its products are sold, with the the above information such as re- tiers for a subset of relevant tracer aim if facilitating rational use. gional or representative figures for products covered by equitable pric- 2.5 The company discloses that its the majority (greater than 50%) of ing programmes. product brochure and packaging its relevant products OR discloses 1 The company discloses details information is consistent with that full volume data for a subset (less of how it takes affordability into approved by the country’s drug than 50%) of relevant products. account for its equitable pricing regulatory authority for a sub-set 2.5 The company discloses a subset strategy sufficiently for all of its (or one) of the relevant diseases for of the above information such as relevant products covered by equi- which its products are sold, with the regional or representative figures table pricing programmes but does aim of facilitating rational use. for less than 50% of its relevant not disclose the price point offered 0 The company makes no disclosure products. to the lowest tiers for any products in this area or has no packaging 0 The company has equitable pric- covered by equitable pricing pro- adaptation to facilitate rational use. ing strategies for products and grammes. *Including at point of dispensing and at countries relevant to the Index, but 0 The company has equitable pric- use level makes no disclosure in this area. ing strategies for products and NS Companies without any relevant countries relevant to the Index, but D.I.6 Filing for marketing approval/ equitable pricing strategies receive makes no disclosure in this area. 15% registration a neutral score. NS Companies without any relevant The company commits to file for equitable pricing strategies receive marketing approval or product regis- D.II.2 Equitable pricing schemes a neutral score. tration of its products for the Index 35% For equitably priced products relating *The lowest price point within a com- Diseases in the Index countries in to the Index Diseases in the Index pany’s equitable pricing structure. This need. countries, the company discloses price is offered to the poorest segment 5 The company has specific targets target prices for the lower tiers and (i.e., to the poorest population group to register most of its products for how it determines these prices. within a country, or to the poorest diseases relevant to the Index in 5 Companies with multi-product country (or countries) within a larger Sub-Saharan Africa and all Low- equitable pricing: The company group of countries). This includes the Income Countries within 12 months discloses details of how it takes af- price at which products are sold to the of market launch. fordability of the lowest tier of each public sector within a poor country or 4 The company has specific targets to pricing strategy into account for all sales to LICs and/or LDCs. register most of its products for rel- of its products relevant to the Index evant diseases in Sub-Saharan Af- covered by equitable pricing pro- D.II.3 Filing for marketing approval/ rica and all Low-Income Countries grammes AND discloses the price 25% registration but has committed to no timeframe. point offered to the lowest tiers* for The company discloses its decision- 2.5 The company has committed to all relevant tracer products covered making process regarding registration register a sub-set of its products for by equitable pricing programmes. (marketing approval) and also the relevant diseases in a subset of LICs Companies with single product status of marketing approvals for each but has committed to no timeframe. equitable pricing: The company dis- product related to Index Diseases in 1 The company has committed to closes FULL details of its equitable the Index countries. register its products for relevant pricing strategy AND discloses the 5 The company publicly discloses the diseases in LMICs. price point offered to the lowest criteria used in its decision making 0 The company makes no commit- tiers* for its product. process for obtaining marketing ment to register its products for rel- 4 Companies with multi-product approval and discloses the registra- evant diseases in countries relevant equitable pricing: The company dis- tion status of almost all its products to the Index. closes details of how it takes afford- for relevant diseases in relevant ability into account for the majority countries. D.II Transparency (25%) of its relevant products covered by 4 The company publicly discloses the D.II.1 Equitable pricing schemes equitable pricing programmes AND criteria used in its decision making 30% The company discloses the volume discloses the price point offered to process for obtaining marketing of its sales to the lower tiers covered the lowest tiers for the majority of approval and the registration status under equitable pricing programs to relevant tracer products covered by of the majority of its products for ensure affordability. equitable pricing programmes relevant diseases in relevant coun- 5 The company discloses the volume Companies with single product tries. of sales covered by equitable pricing equitable pricing: The company dis- 3 The company publicly discloses at programmes to the lowest tier for all closes SOME details of its equitable least partial criteria AND partial of its products relevant to the Index. pricing strategy AND discloses the information about the registra- 4 The company discloses a subset price point offered to the lowest tion status of the majority of its

202 Access to Medicine Index 2014 Appendix | Indicators and Scoring Guidelines

products for relevant diseases in at least 75% of the company’s rele- equitable pricing: Less than 50% relevant countries. vant market is covered by equitable of the company’s equitably priced 2.5 The company publicly discloses pricing programmes for between products both targets the poorest the criteria OR partial information 50-75% of relevant products. segment and takes into account about the registration status of its 2.5 Less than 50% of the company’s rel- affordability for this segment products for relevant diseases in evant market is covered by equita- 2 Companies with multi-product eq- relevant countries. ble pricing programmes for greater uitable pricing: The majority of the 2 The company discloses the criteria than 75% of relevant products or company’s products have equitable used in its decision-making process greater than 75% of the company’s pricing that takes into account af- for obtaining marketing approval relevant market is covered by equi- fordability and is targeted. and the registration status of all its table pricing programmes for less Companies with single product eq- products for the relevant diseases than 50% of relevant products. uitable pricing: Has a single product in relevant countries on engage- 2 Less than 50% of the company’s that takes into account affordability ment. relevant market is covered by and is targeted. 1 The company discloses partial equitable pricing programmes for 1 Companies with multi-product information concerning the above between 50-75% of relevant prod- equitable pricing: The majority of areas on engagement. ucts or between 50-75% of the com- products take into account afford- 0 The company makes no disclosure pany’s relevant market is covered by ability and a subset of products are in this area. equitable pricing programmes for targeted. less than 50% of relevant products. Companies with single product eq- D.II.4 Drug recalls 1 Less than 50% of the company’s uitable pricing: Has a single product 10% The company publicly discloses relevant market is covered by equi- that takes into account affordability. information about the drug recalls and table pricing programmes for less 0 Companies with multi-product breaches it has been involved in related than 50% of relevant products equitable pricing: None of the com- to drug quality issues in the Index 0 Less than 5% of the company’s pany’s equitably priced products countries. relevant market is covered by equi- are targeted. 5 The company publicly discloses the table pricing programmes for less NS Companies without any relevant date, location and the reason for than 5% of relevant products equitable pricing strategies receive drug recalls it has been involved in NS Companies without any relevant a neutral score. during the period of analysis and equitable pricing strategies receive *The lowest-income population seg- how it responded to the recall in an a neutral score. ment within a given country, or the integrated accessible way. poorest country (or group of countries) 3.5 The company publicly discloses D.III.2 Equitable pricing strategies worldwide. The poorest segment a the mentioned data in aggregate 20% Does the company take into consider- company sells a product to may be a format only. ation needs-based affordability when lower-income population segment, and 2.5 The company discloses detailed making pricing decisions for relevant not the lowest-income segment within information on engagement. products targeted at the poorest a country. 1 The company discloses aggregated population segments* in relevant coun- information on engagement. tries? D.III.3 Filing for marketing approval/ 0 The company provides no disclo- 5 Companies with multi-product 15% registration sure with regard to product recalls equitable pricing: At least 75% of Has the company attempted to register or the company has had drug recalls equitably priced products both (obtain marketing approval for) its but does not disclose them to the target the poorest segment and products for Index Diseases in the Index. take into account affordability for Index countries in need? NS Companies without any drug recalls this segment.* 5 The company has registered the during the period of analysis receive Companies with single product eq- majority of its products (relative a neutral score. uitable pricing: Has a single product to company portfolio size) in the in multiple countries relevant to the majority of countries in scope on a D.III Performance (40%) Index that both targets the poorest needs-basis. D.III.1 Equitable pricing strategies segment and takes into account af- 4 The company has either registered 20% Do the company’s equitable pricing fordability for this segment.* the majority of its products in some programmes for products relating to 4 Companies with multi-product relevant countries or has registered Index Diseases cover all or a significant equitable pricing: At least 50% of some of its products in the majority percentage of Index countries? equitably priced products relevant of relevant countries on a needs- 5 At least 75% of the company’s to the Index both target the poorest basis. market within the scope of the segment and take into account af- 3 The company has registered at least Index is covered by equitable pric- fordability for this segment half of its products in at least half of ing programmes for at least 75% Companies with single product eq- the relevant countries on a needs- of products related to diseases uitable pricing: Has a single product basis. relevant to the Index. in one relevant country that both 2.5 The company has either registered 4 Between 50-75% of the company’s targets the poorest segment and at least half of its products in a few relevant market is covered by eq- takes into account affordability for relevant countries or has registered uitable pricing programmes for at this segment. a few of its products in at least half least 75% of relevant products OR 3 Companies with multi-product of the relevant countries.

203 Appendix | Indicators and Scoring Guidelines Access to Medicine Index 2014

2 The company has registered less the mentioned approvals for some prices. Only innovative projects for than half of its products in less than of its qualifying products. which either progress made, or hu- half of relevant countries. 0 The company has not filed for any man and/or financial resources are 0 The company’s makes no disclosure of the mentioned approvals but has disclosed are taken into consider- in this area, or the company’s reg- eligible products. ation. istration efforts were less than the NS Companies without relevant prod- 2.5 The company has adopted in- above indicating that the company’s ucts eligible for stringent approvals novative (unique in the sector) behaviour in this area may be a bar- receive a neutral score. business models related to pricing rier to access. and affordability of Index Diseases D.III.6 Equitable pricing schemes products in Index countries but NO D.III.4 Drug recalls 15% Do products for Index Diseases progress or inputs disclosed. 20% Have drug recalls occurred due to destined for Index countries for which 0 No innovative initiatives discovered product or packaging quality issues tiered pricing is used have special in this area. in the Index countries for products packaging or other distinct markers to produced by the company, its licencees prevent product diversion? D.IV.2 Innovation in manufacturing & or other manufacturing partners 5 All products for which the company 50% distribution during the past two years? If so, how has equitable tiered pricing and The company has introduced innova- has the company dealt with them? which are on the 2013 WHO Model tive approaches (unique in the sector) 5 There is no evidence that the com- Essential Medicines List (EML) are to manufacturing and distribution of pany or any of its licensee/manu- tagged or packaged differently and products for the Index Diseases which facturing partner(s) have issued all products not on WHO EML that may help with sustainable delivery of product recalls related to quality have tiered pricing are packaged such products for the Index Diseases in issues during the past 2 years in differently for the poorest segment. the Index countries. any of the countries relevant to the 4 At least 75% of equitable tiered 5 The company has adopted innova- Index. pricing products that are on the tive (unique in the sector) manu- 2.5 There is no evidence that the EML are tagged or packaged differ- facturing & distribution practices company has issued drug recalls ently BUT relevant products not on related to increasing affordability but there are cases of its licensee/ the EML that have tiered pricing are and availability of products relevant manufacturing partners issuing not packaged differently. to the Index, countries within the drug recall(s) due to quality issues in 2.5 Less than 50% of relevant products scope. Only innovative projects for relevant countries were discovered on the EML are tagged or packaged which either progress made, or hu- OR the company has issued drug differently. man and/or financial resources are recalls due to packaging issues, not 1 Less than 20% of relevant products disclosed are taken into consider- due to quality issues. on the EML are tagged or packaged ation. 1 The company makes no disclosure differently. 2.5 The company has adopted innova- in this area OR has issued drug 0 The company does not have special tive (unique in the sector) manu- recalls but dealt with them rapidly tagging or packaging for any of its facturing & distribution practices and effectively. products and has equitable tiered related to increasing affordability 0 The company has issued drug pricing. and availability of Index Disease recall(s) related to quality issues NS Companies without relevant prod- products in Index countries but NO with company produced products in ucts with tiered pricing receive a progress or inputs disclosed. relevant countries during the past 2 neutral score. 0 No innovative initiatives discovered years. in this area. D.IV Innovation (10%) D.III.5 Filing for marketing approval/ D.IV.1 Innovation in equitable pricing 10% registration 50% The company has introduced innova- The company files for WHO Prequali- tive approaches (unique in the sector) fication list, tentative approval of to equitable pricing which help with US Food and Drug Administration, sustainable delivery of the products European Medicines Agency or other for Index Diseases to individuals in the stringent regulatory authority approval Index countries who face the highest for its eligible products for the Index financial barriers to access. Diseases. 5 The company has adopted innova- 5 The company has applied for any of tive (unique in the sector) business the following stringent approvals: models related to pricing and WHO Prequalification, tentative affordability of products relevant approval from the US Food and to the Index, countries within Drug Administration or European the scope of the Index, which are Medicines Agency (Article 58) for all expected to result in increased af- of its qualifying products. fordability and accessibility of these 4 The company has applied for any products, including sustainable of the mentioned approvals for the financing mechanisms and pricing majority of its qualifying products. schemes that ensure products 2.5 The company has applied for any of reach target consumers at target

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E Patents & Licensing

E.I Commitments (25%) exclusive voluntary licensing (EVL), items, but company is indirectly in- E.I.1 Patent filings demonstrating the engagement of volved in negative lobbying through 50% The company commits to not file for or its legal/IP team on such matters. membership of industry associa- enforce patents related to its products 4 The company has in place a policy to tions. for the Index Diseases in LDCs, LICs consider non-exclusive, voluntary 0 The company makes no disclosure and LMICs. licensing with pro-access* terms of support for the Doha Declara- 5 The company makes a general com- or binding non-assert declarations, tion, makes a statement in support mitment not to patent, to abandon demonstrating that such tools have of the Special 301 Watch List, or existing patents or to issue non- been considered by its legal/IP evidence of lobbying against the assert declarations on all IP relating team. use of TRIPS flexibilities (either to products for Index Diseases in 3 The company has in place a policy directly or indirectly through trade all Least Developed Countries (as to consider voluntary licensing for a associations or lobbying groups). defined by the United Nations), LICs sub-set of its products but does not (as defined by the World Bank) and mention their non-exclusive nature E.II.2 Patent filings LMICs. and not for all products. 45% The company discloses the patent 4 The company makes a general com- 2.5 The company does not have in status of its products for the Index mitment not to patent, to abandon place a policy to consider voluntary Diseases in the Index countries. any existing patents or to issue non- licensing but has equitable pricing 5 The company publicly discloses assert declarations on all IP relating for Index Disease products for the the patent status for all patents for to products for Index Diseases in all Index countries or it considers it as all the products concerning Index LDCs, LICs, and most LMICs. an option where it is appropriate. Diseases in all the Index countries. 3 The company makes a general com- 0 The company has neither commit- 3 The company makes partial public mitment not to patent, to abandon ments regarding non-exclusive disclosure of patent status for some any existing patents or to issue non- pro-access licensing nor equitable products. assert declarations on all IP relating pricing in place for pharmaceuti- 0 The company makes no public to products for Index Diseases in cal products related to the Index disclosure about patent status. LDCs or LICs. Diseases for the Index countries. 2 The company makes a general com- *No challenge, ability to supply to coun- E.II.3 IP strategies mitment not to patent, to abandon try issuing compulsory license, ability 30% The company discloses detailed any existing patents or to issue non- to supply where no patents in force, information about the voluntary assert declarations on IP relating termination for any reason at any time, licensing activities it is engaged in to products for Index Diseases for a ability to manufacture and source APIs and its binding non-assert clauses for sub-set of its products in LDCs and from any licensee. products related to the Index Diseases LICs. for the Index countries (such as licence 1 The company makes a general com- duration, licence territory, technology mitment not to patent, to abandon E.II Transparency (25%) transfer, etc.). any existing patents or to issue E.II.1 TRIPS flexibilities 5 The company publicly discloses non-assert declarations on IP relat- 25% The company discloses its explicit complete information regarding the ing to relevant products for Index support of usage of TRIPS flexibilities terms* of its voluntary licences for Diseases in certain regions (such as based on the Doha Declaration on all relevant Index Disease products. Sub-Saharan Africa) TRIPS and public health. 4 The company publicly discloses 0 The company makes no commit- 5 The company discloses explicit complete information regarding the ment in this area. support for the Doha Declaration terms* of its voluntary licences for a and usage of the following TRIPS subset of its relevant Index Disease E.I.2 IP strategies flexibilities (compulsory licences, products. 50% The company commits as part of a parallel imports, bolar provisions, 3 The company publicly discloses wider access-oriented strategy to and exemptions for least developed partial information on the terms* issue non-exclusive voluntary licensing countries) in relation to the Index for a subset of its licensees and (NEVL) or binding non-assert declara- countries. products. tions (NAD) for manufacturing and 4 The company discloses support 2 The company discloses all relevant supply of the patented product. for the Doha Declaration and the information about the licences it 5 The company has in place a policy to majority of the above-mentioned has issued for a subset of products, engage in non-exclusive volun- items. on engagement only. tary licensing that is pro-access* 3 The company discloses support for 1 The company discloses partial with qualified manufacturers for two of the above- mentioned items. information on a subset of products products for Index Diseases for 2 The company discloses support for on engagement only. which third party production is one out of the above-mentioned 0 The company makes no disclosure deemed conducive to increased items. in this area. affordability and accessibility or to 1 The company discloses support for NS Companies without any voluntary use binding non-assert clauses for one out of the above-mentioned licences receive a neutral score.

205 Appendix | Indicators and Scoring Guidelines Access to Medicine Index 2014

*Including the name/location of the of its licensing agreements, and they were able to be examined) licensee, the exclusive/non-exclusive provides some evidence of the fol- include three of the five designated nature of the license, includes manu- lowing: quality assurance terms, no clauses. facturing as well as distribution, license additional royalties, opt-out clauses 2.5 For companies with voluntary li- duration, territory, scope/application, and public health oriented. cences in place, the licences (where TT agreements and conditions, royalty 3 The company has technology trans- they were able to be examined) terms, pricing clauses, production fer agreements in place but makes include two of the five designated information (supply units), where APIs no disclosure around the terms. clauses, or the company does not can be sourced, No challenge clauses, 0 The company has no technology have applicable licences. ability to supply to country issuing com- transfer agreements in place. 1 For companies with voluntary li- pulsory license, ability to supply where NS Companies without any patented cences in place, the licences (where no patents in force, termination for any products receive a neutral score. they were able to be examined) reason at any time. include one of the five designated E.III.3 IP strategies clauses. 20% The company supports patent pools 0 For companies with voluntary li- E.III Performance (40%) such as The Medicines Patent Pool cences in place, the licences (where E.III.1 IP strategies for development of new/adaptive they were able to be examined) do 20% Does the company actively engage in remedies for the Index Diseases in the not include any of the above access- issuing multiple non-exclusive volun- Index countries. oriented provisions, or the company tary licences and/or use legally binding 5 The company has concluded licens- has not disclosed the information. non-assert declarations/clauses for ing agreements with the MPP for NS Companies without any voluntary the Index countries for its products relevant products in its portfolio licences receive a neutral score. related to the Index Diseases? which reach all relevant populations *No challenge, ability to supply to coun- 5 The company has issued more than in Index countries. try issuing compulsory license, ability or equal to five non-exclusive vol- 4 The company has concluded licens- to supply where no patents in force, untary licences and/or non-assert ing agreements with the MPP for termination for any reason at any time, declarations to generic manufac- products in its portfolio which ability to manufacture and source APIs turers for more than 80% of its rel- reach relevant populations in 90% from any licensee. evant products for Index Diseases. of Index countries. 4 The company has issued less 3 The company has concluded licens- than five non-exclusive voluntary ing agreements with the MPP for E.III.5 IP strategies licences and/or non-assert declara- at least one relevant product for a 20% Is there evidence that the company tions to generic manufacturers subset of Index countries OR has employs an IP strategy that is condu- for between 25-100% of relevant made a formal commitment to the cive to access to affordable products products for Index Diseases. MPP to enter into licensing agree- for Index Diseases in the Index coun- 3 The company has issued less than ments for a relevant product. tries (e.g. actively engage in pro- five non-exclusive, voluntary licenc- 2.5 The company is in negotiations with competitive approaches by avoiding es and/or non-assert declarations the MPP. anti-competitive practices such as for less than 25% of its products. 0 The company has not engaged in evergreening, thicketing, protection of 2 The company provides some evi- negotiations with the Medicines research tools etc.)? dence of non-exclusive, voluntary Patent Pool. 5 No evidence is found that the com- licensing activity. NS Companies without any HIV prod- pany is involved in IP-related anti- 0 The company has relevant patented ucts on-patent receive a neutral competitive practices in relation to products but has not issued any non score. access to medicines.* exclusive voluntary licences. 3 Evidence is found that the company NS Companies without any patented E.III.4 IP strategies is involved in IP-related anti-com- products receive a neutral score. 20% Are the contents of the non-exclusive petitive practices that restrict voluntary licensing and/or legally access to medicines,* but the E.III.2 Technology transfer binding non-assert declarations/ company has provided evidence of 20% Does the company have technology clauses access-oriented for its prod- supporting pro-competitive IP poli- transfer agreements that accelerate ucts related to the Index Diseases in cies and practices. and facilitate generic product develop- Index countries? 0 The company has been involved in ment? 5 For companies with voluntary li- anti-competitive IP related prac- 5 The company has technology cences in place, the licences (where tices*. transfer agreements in place, either they were able to be examined) *Including patenting in Least Developed as know-how agreements or as part include all five of the designated Countries; evergreening of products for of its licensing agreements, and access-oriented clauses*. Index Diseases to protect new applica- provides evidence of all of the fol- 4 For companies with voluntary li- tions for use that extend their patented lowing: quality assurance terms, no cences in place, the licences (where life; creating patent thickets to deter additional royalties, opt-out clauses they were able to be examined) R&D in certain technological areas re- and are public health oriented. include four of the five designated lated to Index Diseases; extending pat- 4 The company has technology trans- clauses. ent application dates to prevent public fer agreements in place, either as 3 For companies with voluntary li- disclosure; anti generic campaigns; us- know-how agreements or as part cences in place, the licences (where ing patent challenge clauses in licenses;

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interventions at regulatory agencies to increased affordability and accessibility this with evidence of progress and/ delay generic registrations; advocacy of medicine to individuals with financial or the human or financial resources tactics to undermine public confidence barriers to access (e.g. adopted innova- invested. in generic products and acting against tive socially responsible licensing prac- 3 The company has adopted innova- usage of TRIPS flexibilities by the Index tices aiming at increased effectiveness tive, sustainable programs aimed countries based on the Doha Declara- of its licensing programmes). at decreasing the potential public tion on TRIPS and Public Health). 5 The company has adopted innova- health impact of the exclusivity tive, sustainable programs aimed conferred by patent protection E.IV Innovation (10%) at decreasing the potential public (decreased affordably, for e.g.), E.IV.1 Innovation in patents and health impact of the exclusivity but does not disclose progress or 100% licensing conferred by patent protection resource inputs. The company has engaged in innova- (decreased affordability, for e.g.). 0 No innovative initiatives discovered tive (unique in the sector), sustainable For (e.g., adopted innovative pro- in this area. programmes aimed at decreasing the access licensing practices aiming at impact of the exclusivity conferred by increasing the effectiveness of its patent protection that could result in licensing programs) and supports

F Capability Advancement in Product Development & Distribution

F.I Commitments (25%) F.I.2 Capacity building in pharma F.II Transparency (25%) F.I.1 Capacity building in QMS and 50% covigilance F.II.1 Capacity building in pharma 50% manufacturing standards The company commits to support the 25% covigilance The company commits to assist Index development and/or implementa- The company discloses details of its Country manufacturers in building tion of national pharmacovigilance capability advancement activities quality management systems aimed programmes in the Index coun- related to the development and/or at achieving international quality tries. implementation of national phar- standards (e.g. FDA, EMA, WHO Good 5 The company commits to and is macovigilance programmes and the Manufacturing Practices or recognised found to have > 2 examples of en- company discloses post-marketing national certifications) and ensure that gagement with local stakeholders surveillance data to Index Country local staff employed at in-house facili- to support and establish national governments. ties operating in Index countries follow pharmacovigilance systems in at 5 The company discloses information the same standards. least one Index country, including about the financial OR technical OR 5 The company demands quality stan- disclosure of detailed mechanisms human resources dedicated to its dards from its third party manu- OR human or financial inputs in-house activities and collabora- facturers AND in-house facilities in (including training, consultancies, tions aimed at improving national low income countries and commits secondments; inputs to develop- pharmacovigilance systems in the to provide them with the training ment of national programme). Index countries AND the company and tools needed to maintain drug 4 The company commits to and is discloses post-marketing surveil- quality consistent with international found to have one or two examples lance data to Index Country govern- standards. of engagement with local stake- ments where not legally required, 4 The company commits to all of the holders to support and establish na- and provides examples. above except only in respect of tional pharmacovigilance systems in 3.5 The company discloses information Index countries which are not low at least one Index country, including about the financial OR technical OR income countries. disclosure of detailed mechanisms human resources dedicated to its 3 The company either provides qual- OR human or financial inputs as in-house activities and collabora- ity training & tools as listed above or above. tions aimed at improving pharma- demands specific quality manage- 2.5 The company has provided evi- covigilance systems in the Index ment requirements as listed above dence such as a detailed approach countries. from its third party manufacturer or towards supporting national 2.5 The company discloses its approach at its in-house facilities. pharmacovigilance programmes OR to improving national pharmacovigi- 2 The company makes a broad com- human or financial inputs as above lance systems in Index countries but mitment, but provides no detailed in at least one Index country. no disclosure related to human or information on how third-party 1 The company has provided financial resources. manufacturers and/or in-house evidence of internal pharmacovigi- 1 The company discloses information facilities are supported. lance in one or more Index country. about its internal pharmacovigi- 0 The company makes no such com- 0 The company does not engage in lance in Index countries. mitment. pharmacovigilance in Index coun- 0 The company makes no disclosure tries. in this area. Emphasis here is on national pharma- Emphasis here is on national pharmacovigilance programmes (vs. global covigilance programmes (vs. global programmes). programmes).

207 Appendix | Indicators and Scoring Guidelines Access to Medicine Index 2014

F.II.2 Capacity building in QMS and F.II.4 Capacity building in supply chain 2.5 There is evidence of one example 25% manufacturing standards 25% management of training workshops or consultan- The company discloses details of The company discloses details of cies and/or technology transfers in its local in-house facilities’ quality how it is transparent with other at least one Index country with the standards and details of contracts stakeholders across the supply chain aim of achieving compliance with with local manufacturers (including to enhance local capabilities by WHO GMP or equivalent internal licencees and contract manufacturers) preventing product diversion, stock- standards in Index countries. that evidence obligations to maintain outs, counterfeiting, information gaps 0 The company provides no examples good quality standards similar to those and improving demand forecasting and of activities in this area. it applies internally in developed coun- drug regulation. tries or at least consistent with inter- 5 The company discloses details of F.III.2 Capacity building in R&D national standards such as the FDA, how it improves capacity building 20% Is there evidence that the company EMA and/or WHO Good Manufacturing in Index countries (ICs) by sharing participates in local partnerships with Practices. information across the supply chain public sector research institutes or 5 The company discloses details of and is found to do so in at least 5 universities in the Index countries with how it ensures QMS for its prod- elements of the supply chain* . the aim of increasing local capacity for ucts produced in Index countries 3.5 The company discloses details of health research (including clinical trials (ICs), both in-house AND through how it improves 3 - 4 elements of capacity) and product development? third-parties through provision supply chain capacity building in ICs 5 The company has >5 active long- of detailed evidence such as audit by sharing information across the term (>5 year) engagements in data, review process, (parts of) supply chain. capacity building initiatives with contracts, etc. 2.5 The company discloses details of local research institutions such as 3.5 The company discloses details of how it improves 1- 2 elements of building clinical trials capacity* how it ensures QMS for its products supply chain capacity building in ICs OR other research capacities** produced in ICs as above except by sharing information across the OR human capital development*** only in respect of in-house facilities. supply chain. OR funding initiatives such as 2.5 The company makes a general 0 The company makes no disclosure sponsorships. statement about how it ensures in this area. 4 The company is engaged in 5 of the QMS for its products produced in *The six elements of the supply chain above-mentioned initiatives ICs, both at in-house facilities and captured by the Index are preventing (<5 years) with the aim of transfer- through third-parties. drug diversion, implementing anti- ring research capacity to Index 1 The company makes a general counterfeiting measures, preventing country organisations AND/OR statement about how it ensures stockouts, improving demand forecast- <5 long-term initiatives. QMS for its products produced in ing, supply chain alignment and drug 2.5 The company is engaged in 2-4 of ICs, except only with respect to in- regulation the above-mentioned initiatives house facilities. (<5 years) with the aim of transfer- 0 The company makes no disclosure F.III Performance (40%) ring research capacity to Index in this area. F.III.1 Capacity building in QMS and country organisations. 20% manufacturing standards 1 The company is engaged in one of F.II.3 Capacity building in R&D Is there evidence that the company the above-mentioned initiatives 25% The company discloses details of its assists local Index Country manu- (<5 years) with the aim of transfer- partnerships/collaborations with facturers or in-house manufacturing ring research capacity to Index Index Country public sector research facilities to achieve international good country organisations. institutes or universities evidencing manufacturing standards* in the Index 0 The company provides no examples how they aim to create local research countries through training or technol- of activities in this area. capacity and product development for ogy transfer? *E.g., training in data management, Index Diseases. * Such as FDA, EMA or the WHO Good ethical review board management, 5 The company discloses evidence Manufacturing Practices or equally software provision. of an access rationale* for all its recognised national certifications. **E.g., transferring hardware and capacity building Public-Private- 5 The company has conducted >5 know-how through training, confer- Partnerships (PPPs) training workshops or consultan- ences, exchanges, secondments, 2.5 The company discloses evidence of cies and/or technology transfers co-authorship of papers. an access rationale* for at least half across Index countries with the ***Human capital development of its capacity building PPPs. aim of achieving compliance with includes training of technicians/phar- 0 The company makes no disclosure WHO GMP or equivalent internal macists/other technical skills, including in this area. standards including in at least one community-level trainings. *An access rationale is a statement of low income country. how the company aims to increase 4 The company has provided at least local R&D capacities through this part- 2-4 training workshops or consul- nership tancies and/or technology transfers in at least one Index country with the aim of achieving compliance with WHO GMP or equivalent internal standards in Index countries.

208 Access to Medicine Index 2014 Appendix | Indicators and Scoring Guidelines

F.III.3 Capacity building in supply chain infrastructure/materials) to sup- 2.5 The company has adopted in- 20% management port the implementation of phar- novative (unique in the sector ) ap- The company is engaged in macovigilance systems, for only proaches to local capacity advance- programmes/partnerships with Index specific disease areas or products ments in quality and supply chain Country governments (e.g. MoH/ or a sub-set of countries. management (including activities procurement, logistics and distribu- 0 The company provides no examples described above) and/or research & tion agencies) and other distributors of activities in this area. product development capacity and/ to develop locally appropriate supply *Leading institutions may include: na- or capacities beyond the value chain chain capabilities with the aim of tional pharmacovigilance committees, but does NOT disclose progress or improving affordability, accessibility health and drug regulatory authorities, resources input. and quality of the delivered Index local pharmaceutical representatives, 0 No innovative initiatives discovered Disease products. health services and decision making in this area. 5 The company is engaged in at least agencies. 5 programmes/partnerships with Index country governments and/or F.III.5 Initiatives to build other capacities other distributors in Index countries 20% The company carries out other initia- to develop locally appropriate sup- tives (where there is no conflict of ply chain capabilities* OR at least interest) with potential for improving one long-term (>5 years) collabora- capacity of Index Country organisation to achieve the same. tions to address access to medicine in 4 The company is engaged in 2-4 pro- those countries. grammes/partnerships with Index 5 The company shows evidence of country governments and/or other 5 or more examples of activities distributors to develop locally ap- involving reputable* international propriate supply chain capabilities.* or national organisations and/or 2.5 The company is engaged in at least contributing money to a fund run one programme/partnership with by reputable organisations that Index country governments and/or run programmes which build other other distributors to develop locally capacities outside the pharmaceuti- appropriate supply chain capabili- cal value chain, and where conflict ties.* of interest is fully absent. 0 The company provides no examples 3.5 The company shows evidence of of activities in this area. 2-4 examples of activities as above. *Supply chain capabilities include 2.5 The company has one example of efforts to prevent product diversion, activities as above. deterioration, stock outs or counter- 0 The company provides no examples feiting and improve overall forecasting of activities in this area. and procurement management. * For example, the WHO, iNGOs, or local NGOs. F.III.4 Capacity building in pharma 20% covigilance F.IV Innovation (10%) The company is actively engaged F.IV.1 Innovation in capability advancement in developing and implementing 100% The company has introduced innova- national pharmacovigilance-related tive (unique in the sector) approaches programmes in the Index coun- to local capacity advancement, working tries. with Index Country organisations to 5 The company is engaged in >2 improve the quality and accessibility of active long-term engagements products for Index Diseases. (>5 years) with leading institutions 5 The company has adopted inin country* to build pharmaco- novative (unique in the sector) vigilance capacity according to a approaches to local capacity national/regional plan, with the advancements in quality and sup- aim of improving the effectiveness ply chain management (including of pharmacovigilance systems in a securing pharmaceutical supply- large number of relevant countries chain, demand forecasting, where it operates. pharmacovigilance, and local quality 4 The company is engaged in two management) and/or research & active long-term engagements as product development capacity and/ listed above. or capacities beyond the value chain 3 The company is engaged in one with significant potential to improve active long-term engagements as access to medicine and supports listed above. this with evidence of progress and/ 2 The company is engaged in ad hoc or human or financial resources activities (e.g. providing resources/ invested.

209 Appendix | Indicators and Scoring Guidelines Access to Medicine Index 2014

G Product Donations & Philanthropic Activities

G.I Commitments (25%) standards set out in the WHO G.I.3 Sustainable philanthropy G.I.1 Drug donations Guidelines for Medicine Donations 30% The company commits to and explains 10% The company commits to comply with - Revised 2010 AND b) has internal its rationale for investing in health the WHO Guidelines for Medicine monitoring/reporting procedures infrastructure-related philanthropic Donations – Revised 2010 in the Index in place to ensure delivery to the projects (outside of the standard value countries for all its drug donation intended patients. chain) in the Index countries and their activities. 4 The company has both a) stringent relevance to long-term sustainable 5 The company has both a donation regular monitoring processes or re- access to medicine in Index coun- policy and makes a commitment porting policies (e.g. financial, sup- tries. to respect the WHO Guidelines for ply chain, storage, administration 5 The company has a sustainable, Medicine Donations - Revised 2010 monitoring/reporting) to ensure long-term approach to supporting OR commits to ALL of the core that the product donations which health care infrastructure/capacity components of the guidelines: are donated directly or through advancement in Index countries, a) meeting local needs (national intermediaries reach the targeted set out in specific statements of treatment policies, essential medi- communities in need, based on its strategic approach, which a) is cines list) standards set out in the WHO integrated with other activities of b) participatory approach (commu- Guidelines for Medicine Donations - the company b) targets local public nication and collaboration) Revised 2010 AND b) rely on trusted health needs, c) has specified objec- c) optimised drug donation qual- partners that guarantee delivery to tives and d) contains outcome and/ ity (formulation, GMP standards, the intended patients AND report- or impact assessment. matching expiry dates) ing is requested (e.g. financial, sup- 4 The company has a sustainable, d) appropriate labelling, packaging ply chain, storage, administration). long-term approach to supporting and shipment NB: if company only donates health care infrastructure/capacity e) affordable value setting and through the WHO, tier 5 applies. advancement in Index countries, supply chain costs coverage, in all 3 The company has policies to ensure set out in specific statements of its its donations activities, AND is a that the product donations which strategic approach, which a) targets member of Partnership for Quality are donated directly or through local public health needs, b) has Medical Donations (PQMD) intermediaries reach the targeted specified objectives and c) includes 4 The company has a donation policy communities in need, based on outcome and/or impact assess- AND makes a commitment to either standards set out in the WHO ment. respect the WHO Guidelines for Guidelines for Medicine Dona- 3 The company has a sustainable, Medicine Donations - Revised 2010 tions - Revised 2010, but has not long-term approach to supporting OR commits to ALL of its core demonstrated that there are any health care infrastructure/capacity components above, but is NOT a monitoring or reporting procedures advancement in Index countries, member of the PQMD. in place. set out in specific statements of its 2.5 The company’s commitment 2.5 The company has internal monitor- strategic approach, which a) targets in this area is partial or condi- ing/auditing procedures in place local public health needs and b) has tional or based on an internal code to ensure delivery to the intended specified objectives. equivalent to the WHO Guidelines patients, but no policies in place to 2 The company has an approach for for Medicine Donations - Revised ensure that the product dona- philanthropic activities in Index 2010 and contains at least three of tions which are donated directly or countries, but specific evidence the five areas of the guidelines as through intermediaries reach the which indicates sustainability and outlined above. targeted communities in need. targeting of local public health 0 The company has not committed 2 The company does not have a policy needs are not provided. to respect the WHO Guidelines for to ensure delivery to the intended 1 The company discloses only a gen- Medicine Donations - Revised 2010. patients but illustrates examples of eral statement in this area without monitoring performance and cer- providing details on the areas of its G.I.2 Drug donations tifying that the donations activities strategic focus or rationale for in- 30% The company commits to ensuring that carried out on its behalf incorpo- frastructure building or objectives. donated products are administered to rate standards set out in the WHO 0 The company’s philanthropic patients in the Index countries. Guidelines for Medicine Donations activities are not focused on bring- 5 The company has a) stringent regu- - Revised 2010. ing about sustainable, long-term lar monitoring processes or report- 1 The company has a guideline for its change in the target Index coun- ing policies (e.g. financial, supply donations programmes and dona- tries. chain, storage, administration tion management intermediaries monitoring/reporting) to ensure but does not regularly monitor per- that the product donations which formance and certify the donations are donated directly or through activities carried out on its behalf. intermediaries reach the targeted 0 The company makes no commit- communities in need, based on ments in this area.

210 Access to Medicine Index 2014 Appendix | Indicators and Scoring Guidelines

G.I.4 Single-drug donations criteria including drug types and at the aggregate level and b) out- 30% The company commits to delivering volumes of its single-drug dona- come measures or impact assess- single-drug donation programmes, in tions on an engagement basis only. ments for a subset of its philan- line with the WHO Guidelines for Medi- 0 The company did not provide thropic activities OR the company cine Donations – Revised 2010. information nor disclosed upon discloses resources only for each of 5 The company commits to >2 engagement. its philanthropic activities. single-drug donation programmes NS Companies without single-drug 1 The company discloses resources AND commits to follow the WHO donation programmes receive a of its philanthropic activities in ag- Guidelines for Medicine Donations - neutral score. gregate format only. Revised 2010 or all of the following 0 The company makes no disclosure 5 conditions: a) meeting local needs G.II.2 Drug donations in this area. (national treatment policies, es- 40% The company discloses detailed infor- sential medicines list), b) participa- mation about the type, volume and G.III Performance (40%) tory approach (communication and destination of products that are part of G.III.1 Drug donations collaboration), c) optimised drug its multi- drug donation programmes 25% The company monitors outcomes donation quality (formulation, GMP donated in the Index countries. and impact of single-drug donation standards, matching expiry dates), 5 The company publicly discloses the programmes during the reporting d) appropriate labelling, packaging type, volume and destination (or- period. and shipment, e) affordable value ganisation or country) of products 5 The company provides evidence setting and supply chain costs cov- that are part of multi-drug donation of integrating impact assessments erage. programmes donated in Index coun- on public health (e.g. number of 4 The company commits to 2 tries. patients reached, epidemiology) single-drug donation programmes 4 The company publicly discloses two into its drug donation program(s) AND commits to follow the WHO of three of the items above. (external or in-house evaluations), Guidelines for Medicine Donations 3 The company publicly discloses one and evidence of monitoring and au- - Revised 2010 or all of the 5 condi- of three of the items above. diting delivery of supply units until tions stated above. 2 The company discloses the equiva- the end user, for all drug donation 3 The company commits to 1 single- lent of score 5 on engagement basis programs. drug donation programme AND only. 4 The company provides evidence commits to follow the WHO Guide- 1 The company discloses the equiva- of integrating impact assessments lines for Medicine Donations - Re- lent of score 3 or 4 on engagement on public health (e.g. number of vised 2010 or all of the 5 conditions basis only. patients reached, epidemiology) stated above. 0 The company makes no disclosure into a subset of their drug donation 2 The company commits to single- in this area. program(s) (external or in-house drug donation programmes but NS Companies without any donation evaluations), and evidence of does not declare that this is the programmes receive a neutral monitoring and auditing delivery of preferred mode of making drug score. supply units to the recipient(s) for donations or all of the conditions all drug donation programs. stated above. G.II.3 Sustainable philanthropy 3 The company provides evidence of 0 No evidence of any commitment to 20% The company discloses the amount of monitoring and auditing outcome single-drug donation programmes. resources dedicated to and achieve- measures beyond its own supply ments resulting from its philanthropic chain for all drug donation pro- G.II Transparency (25%) activities in the Index countries. grams. G.II.1 Drug donations 5 The company discloses a) resources 2 The company provides evidence of 40% The company discloses the process and b) outcome measures or impact monitoring and auditing delivery and criteria for deciding the drug types assessments for all of its philan- of supply units to the end user for a and destinations for its single-drug thropic activities (e.g. improved subset of drug donation programs, donation programmes in the Index allocation of public resources; and until delivery to recipient(s) for countries. improved capabilities in sector other drug donation programs. 5 The company publicly discloses de- including numbers of qualified per- 1 The company provides evidence of tails about drug donation selection sonnel to complete tasks; improved monitoring and auditing outcome criteria including drug types and hardware to enable tasks to be measures along its own supply chain volumes for ALL of its single-drug undertaken). for all drug donation programs. donations programmes carried out 4 The company discloses a) resources 0 The company has single-drug directly by the company or through and b) outcome measures or impact donation programmes, but does intermediaries in the relevant coun- assessments for the majority of not provide evidence of outcome/ tries for the relevant diseases. its philanthropic activities (e.g. impact assessment. 2.5 The company publicly discloses de- improved allocation of public NS Companies without single-drug tails about drug donation selection resources; improved capabilities in donation programmes receive a criteria including drug types and sector including numbers of quali- neutral score. volumes of some of its single-drug fied personnel to complete tasks; donations. improved hardware to enable tasks 1 The company discloses details to be undertaken). about drug donation selection 2.5 The company discloses a) resources

211 Appendix | Indicators and Scoring Guidelines Access to Medicine Index 2014

G.III.2 Drug donations G.III.4 Sustainable philanthropy G.IV Innovation (10%) 25% The value of donated products which 25% There is evidence that the company’s G.IV.1 Innovation in product donations were donated based on targeted, philanthropic activities (excluding drug 50% The company has introduced innova- needs-based strategic donations donation programmes) are aligned tive (unique in the sector), sustainable programmes to the Index countries with and support implementation of and impactful approaches to managing during the period of analysis (single- national health system development drug donations, which may result in drug donations adjusted for the plans and stated health priorities in the increased effectiveness and effi- company size). Index countries. cacy. 5 - 1 Divide value of single-drug 5 The company provides evidence of 5 The company has designed and donations during Index period by multiple (>10) philanthropic activi- implemented innovative (unique in company total revenue 2012 & 2013. ties that a) are explicitly linked to the sector) approaches to managing Revenue-standardised number is national and/or international health product donations with significant scaled and scored. priorities, b) are long-term engage- potential to improve access to 0 The company did not provide the ments, c) have specific objectives medicine and supports this with value of its single-drug donation AND d) the company provides evidence of progress and/or human programme(s). evidence of outcome measures or or financial resources invested. NS Companies without single-drug impact assessment (in-house or 2.5 The company has implemented donation programmes receive a outsourced) for some activities. innovative (unique in the sector) neutral score 4 The company provides evidence of approaches to managing drug 1-10 philanthropic activities that a) donations but does NOT disclose G.III.3 Drug donations are explicitly linked to national and/ progress or resources inputs. 25% The scale and scope of donated prod- or international health priorities, b) 0 The company has no innovative ucts to the Index countries during the are long-term engagements, c) have initiatives discovered in this area. period of analysis. specific objectives AND d) the com- 5 The company has multiple long- pany provides evidence of outcome G.IV.2 Innovation in sustainable philan- term (> 5 years - unlimited) single- measures or impact assessment 50% thropy drug donation programmes that are (in-house or outsourced) for some The company has introduced innova- strategically set up for eradication activities. tive (unique in the sector) approaches or control of Index Diseases, for 3 The company provides evidence to philanthropic programmes to make which there is a public health need of multiple (>10) short-term it more sustainable and linked to better that aligns with national or interna- philanthropic activities that a) are health outcomes in the Index countries, tional health priorities (corrected explicitly linked to national and/ which may result in sustainable health for company size). or international health priorities improvements. 4 The company has one long-term and b) have specific objectives that 5 The company has designed and im- (> 5 years - unlimited) single-drug support a strategic longer term plemented innovative (unique in the donation programmes that is stra- objective specified by the company. sector) approaches to philanthropic tegically set up for eradication or 2 The company provides evidence of programmes in relevant countries control of Index Diseases, for which 1-10 philanthropic activities that a) which may result in sustainable there is a public health need that are explicitly linked to national and/ health improvements and supports aligns with national or international or international health priorities, this with evidence of progress and/ health priorities (corrected for b) are long-term engagements OR or human or financial resources company size). support a strategic longer term invested. 3 The company has at least one or objective specified by the company. 2.5 The company has implemented more long-term single-drug dona- 1 The company provides evidence of innovative (unique in the section programme(s)(> 5 years) that short-term philanthropic activi- tor) approaches to philanthropic reach only a subset of patients in ties that a) are explicitly linked to programmes in relevant countries Index countries. national and/or international health which may result in sustainable 2 The company has at least one priorities. health improvements but does NOT or more single-drug donation 0 The company provides no evidence disclose progress or resources programme(s) that reach only a sub- that philanthropic activities are inputs. set of patients in Index countries for related to national and/or interna- 0 The company has no innovative a short duration (< 5 years). tional health priorities. initiatives discovered in this area. 1 The company has multi-drug donation programme(s) that comply with the WHO Guidelines for Medicine Donations - Revised 2010. 0 The company has no product donation programmes.

212 Access to Medicine Index 2014 Appendix

Abridged Summary of Academic and Technical Sources in the Methodology Development and Data Analysis of Index 2014

Introduction 16 WTO “The least developed get eight years more leeway on protecting 1 WHO “The World Medicines Situation” WHO, 2004. intellectual property” 12 June 2013. Web. Oct 14 2014. www.who.int/medicines/areas/policy/world_medicines_situation/ www.wto.org/english/news_e/news13_e/trip_11jun13_e.htm en/ 17 CPTech “Pharmaceutical company lawsuit (42 applicants) against the 2 IMS Institute for Healthcare Informatics “The Global Use of Medicines: Government of South Africa (ten respondents)” Web. 23 Oct 2014. Outlook through 2017” Web. 23 Oct 2014. http://www.cptech.org/ip/health/sa/pharmasuit.html www.imshealth.com/ 18 Schumpeter “The new drug war continued: leaky Pharma” Jan 27 3 Abbott “Abbott Completes Separation of Research-Based 2014. Web. Oct 23 2014. Pharmaceuticals Business” Web. 23 Oct 2014. http://www.economist.com/blogs/schumpeter/2014/01/new-drug- www.abbott.mediaroom.com/2013-01-02-Abbott-Completes- war-continued Separation-of-Research-Based-Pharmaceuticals-Business 19 “Roche Follows Novo-Nordisk out of Ipasa.” Business Day Live. 31 Jan 4 AstraZeneca “AstraZeneca to acquire Bristol-Myers Squibb share of 2014. Web. 14 Oct. 2014. global diabetes alliance assets” Web. 23 Oct. www.bdlive.co.za/business/healthcare/2014/01/31/roche-follows- www.astrazeneca.com/Media/Press-releases/Article/20121218-- novo-nordisk-out-of-ipasa AstraZeneca-acquire-Bristol-Myers-Squibb-share-global-diabetes- 20 Jourdan A, Ruwitch J “Big Pharma beware: GSK China case may be alliance-assets/ just the beginning” Reuters. May 18 2014. 23 Oct 2014. 5 Daiichi Sankyo “Announcement Regarding Merger Between Sun www.reuters.com/article/2014/05/18/gsk-china-corruption- Pharma and Daiichi Sankyo’s Subsidiary Ranbaxy and Resulting idUSL3N0O145X20140518 Change in Subsidiary” Web. 14 Oct 2014. 21 Bradsher K, Buckley, C “China Fines GlaxoSmithKline Nearly $500 www.daiichisankyo.com/media_investors/media_relations/press_ Million in Bribery Case” New York Times. Sep 19 2014. Web. Oct 23 releases/detail/006111.html 2014. 6 Financial Times “Novartis buys GSK business for up to 16bn in www.nytimes.com/2014/09/20/business/international/gsk-china- restructuring” The Financial Times, Apr 22 2014. Web. 23 Oct 2014. fines.html?_r=0 www.ft.com/intl/cms/s/0/2bc1c1c0-c9e6-11e3-ac05-00144feabdc0. html Key findings 7 Merck “Merck Completes Sale of Consumer Care Business to Bayer 1 Finney E “Children’s medicines: A Situational Analysis” WHO, 2011. AG for $14.2 Billion” Web. 23 Oct 2014. www.who.int/childmedicines/progress/CM_analysis.pdf www.mercknewsroom.com/news-release/consumer-care-news/ merck-completes-sale-consumer-care-business-bayer-ag-142-billion Product & pipeline analysis 8 Pfizer “Announcement Regarding AstraZeneca” May 26, 2014. Web. 1 Shantanu N, Edith H “New technology needs for non-communicable 23 Oct 2014. diseases in developing countries: a landscaping study” Results for www.pfizer.com/news/press-release/press-release-detail/ Development Institute 2012. Web. 24 Oct, 2014. announcement_regarding_astrazeneca_plc www.healthresearchpolicy.org/assessments/new-technology- 9 Baxter “Baxter Announces Divestiture of Commercial Vaccines needs-noncommunicable-diseases-landscaping-study Business to Pfizer” July 30, 2014. Web. 23 Oct 2014. www.baxter.com/press_room/press_releases/2014/07_30_14_ General Access to Medicine Management vaccines.html Sources used to support 2014 technical area analysis 10 GHIT “Global Health Innovative Technology Fund” 1 Introduction to Social Impact Bonds. Social Finance, 2010. Web. 20 www.ghitfund.org Oct 2014. 11 Uniting to Combat NTDs “London Declaration” Web. 23 Oct 2014. www.socialfinance.org.uk/work/sibs www.unitingtocombatntds.org/resource/london-declaration 12 UNAIDS “AIDS by the numbers” UNAIDS, 2013. Web. 23 Oct 2014. Background sources www.unaids.org/en/media/unaids/contentassets/documents/ • Peterson K, Matthew R, Stamp M, Kim S. Competing by Saving Lives: unaidspublication/2013/JC2571_AIDS_by_the_numbers_en.pdf How Pharmaceutical and Medical Device Companies Create Shared 13 WHO “Global Action Plan for the Prevention and Control of NCDs Value in Global Health. FSG, 2012. 2013-2020” Web. 23 Oct 2014. • Haupt S, Krämer A. Bringing Medicines to Low-income Markets: www.who.int/nmh/events/ncd_action_plan/en/ A guide to creating inclusive business models for pharmaceutical 14 Médicins sans Frontières Access Campaign “Hepatitis C: The Hidden companies. GIZ, 2012. Epidemic” Web 23 Oct, 2014. • Investing for Life: Meeting poor people’s needs for access to www.msfaccess.org/sites/default/files/MSF_Access_HEP_C_Issue_ medicines through responsible business practices. Oxfam, 2007. Brief.pdf 15 WHO AFRO “Ebola Virus Disease in Guinea” 23 Mar 2014. Web. 23 Oct Public Policy & Market Influence 2014. Sources used to support 2014 technical area analysis www.afro.who.int/en/clusters-a-programmes/dpc/epidemic-a- 1 Centers for Medicare & Medicaid Services. “Open Payments.” Web. 14 pandemic-alert-and-response/outbreak-news/4063-ebola-virus- Oct. 2014. disease-in-guinea.html www.cms.gov/Regulations-and-Guidance/Legislation/National- Physician-Payment-Transparency-Program/index.html

213 Appendix Access to Medicine Index 2014

2 World Trade Organization. “Declaration on the TRIPS Agreement and 20 WMA. “WMA Declaration of Helsinki - Ethical Principles for Medical Public Health.” Web. 14 Oct. 2014. Research Involving Human Subjects”. Web. 14 Oct 2014 www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_ www.wma.net/en/30publications/10policies/b3/ trips_e.htm 21 PEPFAR. “The United States President’s Emergency Plan for AIDS 3 IFPMA “IFPMA Code of Practice.” IFPMA, 2012. Web. 14 Oct. 2014. Relief.” Web. 23 Oct 2014. www.ifpma.org/ethics/ifpma-code-of-practice/ifpma-code-of- www.pepfar.gov practice.html 4 Money, Politics, Power: Corruption Risks in Europe. Transparency Background sources International, 2011. Web. 14 Oct. 2014. • “Bad Medicine: Pharmaceuticals’ Prescription for Profit over People.” www.transparency.org/enis/report Alliance for a Just Society, September 2013. 5 Skelcher, C., Snape, S. “Ethics and Local Councillors: Modernising • “Medicines: Corruption and Pharmaceuticals.” WHO, 2009. Standards of Conduct” Parliamentary Affairs, 2011. Web 20 Oct 2014. • “Transparency in the Corporate Reporting: Assessing the World’s 6 David-Barrett E “Nolan’s Legacy – Regulations Parliamentary Largest Companies.” Transparency International, 2012. Conduct in Democratising Europe.” Parliamentary Affairs, 2014. • Cohen, J. “Pharmaceuticals and Corruption.” World Bank, 2005. 7 Ford, R, Richardson, W “Ethical Decision-Making - a Review of the • Baghadadi-Sabeti, G., & Serhan, F. “WHO Good Governance for Empirical Literature.” Journal of Business Ethics, 1994. Medicines Program: An Innovative Approach to Prevent Corruption 8 Barboza, David. "In China, British Investigator Hired by Glaxo, and in the Pharmaceutical Sector (No. 25).” World Health Report Wife, Sentenced to Prison." The New York Times. The New York Background Paper. WHO, 2010. Times, 08 Aug. 2014. Web. 14 Oct. 2014. • Fugh-Berman, A and Ahari, S, “How Drug Reps Make Friends.” PLOS www.nytimes.com/2014/08/09/business/international/in-china- Medicine, April 2007. british-investigator-hired-by-glaxo-and-his-wife-are-sentenced-to- • Davis, C. “Is there a cure for corporate crime in the drug industry?” prison.html?_r=0 BMJ, 2013. 9 GlaxoSmithKline. “GSK China Investigation Outcome.” Web. 14 Oct. • Light, D. “Pharmaceutical Research and Development: What do we get 2014. for all that money?” BMJ, 2012. www.gsk.com/en-gb/media/press-releases/2014/gsk-china- • Mintzes B, et al. “Pharmaceutical sales representatives and patient investigation-outcome/ safety: a comparative prospective study of information quality in 10 Fletcher, Nick “GlaxoSmithKline to pay £297m fine over China bribery Canada, France and the United States.” J Gen Intern Med. 2013. network.” The Guardian. The Guardian. 19 Sep. 2014. • Engelberg, J et al. “First, Do No Harm: Financial Conflicts in Medicine.” www.theguardian.com/business/2014/sep/19/glaxosmithkline-pays- August 13, 2013 297m-fine-china-bribery • JPMA. “JPMA Code of practice” Web. 14 Oct 2014. 11 EFPIA “The EFPIA Code.” EFPIA. Web. 14 Oct. 2014. www.jpma.or.jp/english/policies_guidelines/pdf/code_practice.pdf www.transparency.efpia.eu/the-efpia-code-2 • “Ethical Criteria for Medicinal Drug Promotion.” WHO, 1988. 12 PMCPA “Prescription Medicines Code of Practice Authority.” Web. 14 Oct 2014. Research & Development www.pmcpa.org.uk/Pages/default.aspx Sources used to support 2014 technical area 13 Medicines Australia “Medicines Australia Code of Conduct.” Medicines 1 Scannel J, et al. “Diagnosing the decline in pharmaceutical R&D Australia. Web. 14 Oct. 2014. efficiency.” Nature Reviews, 2012. www.medicinesaustralia.com.au/code-of-conduct 2 “Promoting access to medical technologies and innovation.” WHO, 14 MCA “Marketing Code Authority South Africa.” Web. 14 Oct 2014. WIPO, WTO 2012. www.marketingcode.co.za www.wto.org/english/res_e/booksp_e/pamtiwhowipowtoweb13_e. 15 Stichting CGR, “Stichting CGR” Web. 14 Oct 2014. pdf www.cgr.nl/en-GB/Home 3 “Developing new drugs & vaccines for neglected diseases of the poor. 16 “S.Africa Slams Big Pharma in Generic Drugs Row.” Thomson Reuters, The Product Developer Landscape.” BIO Ventures for Global Health, 17 Jan. 2014. Web. 14 Oct. 2014. 2012. Web. 14 Oct 2014. www.reuters.com/article/2014/01/17/safrica-pharma- www.bvgh.org/Portals/0/Reports/2012_03_developing_new_ idUSL5N0KR08220140117 drugs_and_vaccines_for_neglected_diseases.pdf 17 IDEA “Institute for Democracy and Electoral Assistance.” Web. 14 Oct 4 “ICH Harmonised Tripartite Guideline. Guideline for Good Clinical 2014. Practice E6(R1).” International Conference on Harmonisation, 1996. www.idea.int/political-finance/country.cfm?id=42 www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ 18 “Roche Follows Novo-Nordisk out of Ipasa.” Business Day Live. 31 Jan Guidelines/Efficacy/E6/E6_R1_Guideline.pdf 2014. Web. 14 Oct. 2014. 5 WMA. “WMA Declaration of Helsinki - Ethical Principles for Medical www.bdlive.co.za/business/healthcare/2014/01/31/roche-follows- Research Involving Human Subjects”. Web. 14 Oct 2014 novo-nordisk-out-of-ipasa www.wma.net/en/30publications/10policies/b3/ 19 “Novartis, Roche Deny Backing Plan to Resist Patent Law Changes.” 6 “Clinical trials submitted in marketing-authorisation applications to Business Day Live. Jan 30, 2014. Web. 14 Oct. 2014. the European Medicines Agency. Overview of patient recruitment and www.bdlive.co.za/national/health/2014/01/30/novartis-roche- the geographical location of investigator sites. “ EMA, 2013. deny-backing-plan-to-resist-patent-law-changes www.ema.europa.eu/docs/en_GB/document_library/ Other/2009/12/WC500016819.pdf 7 “The Clinical Trials Industry in South Africa: Ethics, Rules and Realities. “ WEMOS, 2012. www.wemos.nl/files/Documenten%20Informatief/Bestanden%20 voor%20'Medicijnen'/Clinical_Trials_Industry_South_Africa_2013_ v3.pdf

214 Access to Medicine Index 2014 Appendix

8 Ana J, et al. “Research Misconduct in Low- and Middle-Income 3 “WHO Model List of Essential Medicines. 18th list (Final Countries.” PLOS Medicine, 2013. Amendments).” WHO, 2013. 9 Eichel, P, Pignatti, R “Access to Patient-Level Trial Data – A boon to www.who.int/iris/bitstream/10665/93142/1/EML_18_eng.pdf?ua=1 Drug Developers.” N Engl J Med 2013. 10 “Technical consultation on Clinical Trials Registration Standards.” Background sources WHO, 2005. • “Measuring medicine prices, availability, affordability and price www.who.int/ictrp/news/ictrp_meeting_april2005_conclusions.pdf components – 2nd Edition” WHO and HAI, 2008 11 GlaxoSmithKline. “GSK announces new strategic investments in Africa www.who.int/medicines/areas/access/OMS_Medicine_prices.pdf to increase access to medicines, build capacity and deliver sustainable • Frye, J “International Drug Price Indicator Guide” Management growth.” GSK, 2014. Web. 14 Oct 2014. Sciences for Health, 2012 www.us.gsk.com/en-us/media/press-releases/2014/gsk- http://apps.who.int/medicinedocs/documents/s20208en/ announces-new-strategic-investments-in-africa-to-increase-access- s20208en.pdf to-medicines-build-capacity-and-deliver-sustainable-growth • Cameron, A “Understanding access to medicine in low- and middle- 12 GHIT “Global Health Innovative Technology Fund” Web. 14 Oct 2014. income countries through the use of price and availability indicators” www.ghitfund.org PhD thesis, Utrecht University, 2013. 13 Transcelerate BioPharma Inc. “Transcelerate BioPharma Inc.“ Web. 14 www.igitur-archive.library.uu.nl/dissertations/2012-1207-200444/ Oct 2014. cameron.pdf www.transceleratebiopharmainc.com • Caldera A, Zarnic Z “Affordability of Pharmaceutical Drugs in Developing Countries” Kiel Institute for World Economics, working Background sources paper. • “Reflection paper on ethical and GCP aspects of clinical trials of www.econ.kuleuven.be/public/ndcalc9/Caldera_Zarnic_WP_IFW.pdf medicinal products for human use conducted outside of the EU/ • Yadav, P. “Differential Pricing for Pharmaceuticals: Review of Current EEA and submitted in marketing authorisation applications to the EU Knowledge, New Findings and Ideas for Action.” DFID, 2010. Regulatory Authorities.” EMA, 2012. www.dfid.gov.uk/Documents/publications1/prd/diff-pcing-pharma. www.ema.europa.eu/docs/en_GB/document_library/Regulatory_ pdf and_procedural_guideline/2012/04/WC500125437.pdf • “International Medicine Price Guides. Amsterdam: Health Action • “International Standards for Clinical Trial Registries.” WHO, 2012. International.” HAI, 2010. http://apps.who.int/iris/ www.haiweb.org/medicineprices/internationalmedicine-prices- bitstream/10665/76705/1/9789241504294_eng.pdf sources.php • “Protecting citizens’ health: Transparency of clinical trial data on • Daems, R, Maes, E & Ramani, V. “Global Framework for Differential medicines in the EU.” HAI, 2013. Pricing of Pharmaceuticals.” Working Paper. Maastricht: United www.haieurope.org/wp-content/uploads/2013/10/HAI_Protecting- Nations University, 2010. citizenshealth-transparency-of-clinical-trial-data-on-medicines-in- the-EU.pdf Patents & Licensing • “G-Finder 2012 Neglected Disease Research and Development: A Five Sources used to support 2014 technical area Year Review” Policy Cures, 2012. 1 WTO “TRIPS and pharmaceutical patents: fact sheet” WTO. Web. Oct www.policycures.org/g-finder2012.html 14, 2014. • “New technology needs for non-communicable diseases in developing www.wto.org/english/tratop_e/trips_e/factsheet_pharm00_e.htm countries: a landscaping study.” Results for Development Institute, 2 WTO “The least developed get eight years more leeway on protecting 2012. intellectual property” WTO, 2013. Web 14 Oct 2014. www.healthresearchpolicy.org/assessments/new-technology- www.wto.org/english/news_e/news13_e/trip_11jun13_e.htm needs-noncommunicable-diseases-landscaping-study 3 Merck Group “Charter on Access to Health in Developing Countries” • “Research and Development to Meet Health Needs in Developing Web. Oct 14, 2014. Countries: Strengthening Global Financing and Coordination.” WHO, www.merckgroup.com/company.merck.de/en/images/Merck-A2H- 2012. Charter-06-_Intellectual_Property-__July_2014_tcm1612_84384. www.who.int/phi/CEWG_Report_5_April_2012.pdf pdf?Version= • Pedrique B, et al. “The drug and vaccine landscape for neglected 4 Medicines Patent Pool “Medicines Patent Pool and Roche Sign HIV diseases (2000-11): a systematic assessment.” Lancet Public Health, Medicines Agreement: Focus on Preventing Blindness in People Living 2013. with HIV” MPP, 2013 • Hogerzeil HV, Mirza, Z. “The World Medicines Situation 2011. Access to www.medicinespatentpool.org/medicines-patent-pool-and-roche- essential medicines as part of the right to health” WHO, 2011. sign-hiv-medicines-agreement-focus-on-preventing-blindness-in- • “Status Report –Pharmaceutical Industry R&D for Diseases of the people-living-with-hiv/ Developing World – 2010.” IFPMA, 2010. 5 Gilead “Gilead Announces Generic Licensing Agreements to Increase • "Publication and access to clinical-trial data", EMA (draft policy) 2013. Access to Hepatitis C Treatments in Developing Countries” Gilead www.ema.europa.eu/docs/en_GB/document_library/ 2014. Web. Oct 14. 2014. Other/2013/06/WC500144730.pdf www.gilead.com/news/press-releases/2014/9/gilead-announces- generic-licensing-agreements-to-increase-access-to-hepatitis-c- Pricing, Manufacturing & Distribution treatments-in-developing-countries Sources used to support 2014 technical area 6 Cox, K. “The Medicines Patent Pool: Promoting Access and Innovation 1 “Medicine Pricing and Financing.” WHO, 2013. for Life-Saving Medicines Through Voluntary Licenses” Hastings www.who.int/medicines/areas/access/en/index.html Science & Technology Law Journal, 2012. 2 “Medicines: Rational use of medicines.” WHO, 2010. www.hstlj.org/articles/the-medicines-patent-pool-promoting- www.who.int/mediacentre/factsheets/fs338/en access-and-innovation-for-life-saving-medicines-through-voluntary- licenses/

215 Appendix Access to Medicine Index 2014

7 Stevens, A “Valuation and Licensing in Global Health” IP Handbook, • Syam, N et al. “The Doha Declaration on TRIPS and Public Health Ten 2007. Years Later: The State of Implementation.” South Centre, 2011. 8 AUTM “AUTM Global health Toolkit: Examples of Executed License www.southcentre.org/index.php?option=com_content&view=ar Clauses”. Web. Oct 14, 2014. ticle&id=1657%3Asb58&catid=144%3Asouth-bulletin-individual- www.autm.net/AM/Template.cfm?Section=Global_ articles&Itemid=287&lang=es Health&Template=/CM/ContentDisplay.cfm&ContentID=8010 • WTO “Declaration on the TRIPS Agreement and Public Health. 9 WTO “Declaration on the TRIPS Agreement and Public Health. Ministerial Conference Fourth Session” Doha, 2001. Ministerial Conference Fourth Session” Doha, 2001. www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_ www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_ trips_e.pdf trips_e.pdf 10 “Roche Follows Novo-Nordisk out of Ipasa.” Business Day Live. 31 Jan Capability Advancement in Product Development & 2014. Web. 14 Oct. 2014. Distribution www.bdlive.co.za/business/healthcare/2014/01/31/roche-follows- Background sources novo-nordisk-out-of-ipasa • “Ensuring the Quality of Medicines in Resource-Limited Countries” 11 “Novartis, Roche deny backing plan to resist patent law changes” The United States Pharmacopeia Drug Quality and Information Business Day Live. 30 Jan 2014. Web 14 Oct. 2014. Program, 2007 www.bdlive.co.za/national/health/2014/01/30/novartis-roche- www.usp.org/sites/default/files/usp_pdf/EN/dqi/ deny-backing-plan-to-resist-patent-law-changes ensuringQualityOperationalGuide.pdf 12 “Novartis Loses Glivec Patent Battle in India” Wall Street Journal. 1 • Clements, B, Coady, D, and Gupta, S. “The Economics of Public Health Apr 2014. Web. Oct 14, 2014. Care Reform in Advanced and Emerging Economies” IMF, 2012 http://online.wsj.com/news/articles/SB1000142412788732329650 • WHO “Pharmaceutical Production and Related Technology Transfer’ 4578395672582230106?mg=reno64-wsj&url=http%3A%2F%2F WHO 2011. Web, Oct 14, 2014. online.wsj.com%2Farticle%2SB100014241278873232965045783 www.who.int/phi/publications/Local_production_and_access_to_ 95672582230106.html medicines.pdf 13 “Bayer loses appeal in Indian compulsory licence case” Pharma Times, • “Pharmaceutical Manufacturing Plan for Africa Business Plan”, 13 Mar 2013. Web Oct 14, 2014. African Union Commission (AUC) and the United Nations Industrial www.pharmatimes.com/article/13-03-05/Bayer_loses_appeal_in_ Development Organization (UNIDO), 2012 Indian_compulsory_licence_case.aspx www.unido.org/fileadmin/user_media_upgrade/Resources/ 14 Glassman, A. “New data same story: disease still concentrated in middle Publications/Pharmaceuticals/PMPA_Business_Plan_Nov2012_ income countries” Centre for Global Development, 2013. ebook.PDF www.international.cgdev.org/blog/new-data-same-story-disease- • Olsson S, Pal SN, Stergachis A, Couper M. “Pharmacovigilance still-concentrated-middle-income-countries activities in 55 low- and middle-income countries: a questionnaire- 15 MPP “MPP and ViiV Agreement” MPP. Web. Oct 14, 2014. based analysis.” Drug Safety, 2010. www.medicinespatentpool.org/wp-content/uploads/MPPF-ViiV_ www.who-umc.org/graphics/24845.pdf Agreement_Adults_online.pdf • Taylor, D W. “Pharmaceutical Access in Least Developed Countries: 16 ViiV Healthcare “ViiV Healthcare announces new initiatives to improve on-the-ground Barriers and Industry Successes.” Cameron Institute, access to dolutegravir: licence to the Medicines Patent Pool” Web. Oct 2010. 14, 2014. www.cameroninstitute.com/attachments/043_Pharmaceutical%20 www.viivhealthcare.com/media/press-releases/2014/april/ Access%20in%20Least%20Developed%20Countries.Fall2010. viiv-healthcare-announces-new-initiatives-to-improve-access-to- Draft-1.pdf dolutegravir-licence-to-the-medicines-patent-pool.aspx Product Donation & Philanthropic Activities Background sources Sources used to support 2014 technical area • MPP “Medicines Patent Pool: Patent Status of ARVs” MPP. Web. Oct 1 WHO “Interagency Guidelines for Medicine Donation - Revised 2010” 14, 2014. WHO, 2010. Web. Oct 14, 2014. www.medicinespatentpool.org/patent-data/patent-status-of-arvs/ www.who.int/medicines/publications/med_donationsguide2011/en/ • “Promoting Access to Medical Technologies and Innovation: index.html Intersections between public health, intellectual property and trade” 2 WHO “Uniting to combat NTDs 2012. London Declaration on WHO WIPO WTO, 2013. Neglected Tropical diseases.” WHO, 2010. Web. Oct 14, 2014. www.wto.org/english/tratop_e/trips_e/trilat_5feb13_e.htm www.who.int/neglected_diseases/London_Declaration_NTDs.pdf • Beyer, P “Developing socially responsible intellectual property 3 Uniting to Combat NTDs “Uniting to combat NTDs 2014. Delivering on licensing policies” Research Handbook on Intellectual Property Promises and Driving Progress.” Web. Oct 14, 2014. Licensing. Edward Elgar Publishing, 2013 www.unitingtocombatntds.org/sites/default/files/document/NTD_ • “Pharmaceuticals and Public Health: Access to Drugs in Developing report_04102014_v4_singles.pdf Countries.” Edward Elgar, 2011. 4 WHO “Consolidated Guidelines on The Use of Antiretroviral drugs for • MPP “Addressing Innovation and Access through Voluntary Licensing” Treating and Preventing HIV Infection. Recommendations for a public MPP, 2012. health approach.” WHO, 2013. Web. Oct 14, 2014. www.medicinespatentpool.org/wp-content/uploads/The- www.apps.who.int/iris/bitstream/10665/85321/1/9789241505727_ Medicines-Patent-Pool-Introductory-Presentation-July-2012.pdf eng.pdf • MSF “Untangling the Web of ARV price reductions” MSF, 2014 5 WHO “Accelerating work to overcome the global impact of neglected www.utw.msfaccess.org/ tropical diseases. A roadmap for implementation” WHO, 2012. Web Oct 14, 2014. www.who.int/neglected_diseases/NTD_RoadMap_2012_ Fullversion.pdf

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Background sources • Uniting to Combat NTDs “Uniting to combat NTDs 2013. From promises to progress. The first annual report on the London Declaration on NTDs.” Web Oct 14, 2014. www.unitingtocombatntds.org/reports/promises-to-progress-EN.pdf • Dye C et al. “WHO and the future of disease control programmes.” Lancet, 2013. • PQMD “PQMD 2011. Principles and Standards.” Web Oct 14, 2014. www.pqmd.org/assets/PDFs/pqmd%20principles%20and%20 standards%202011.pdf • Barry, S, Mistry et al. “Global trends in neglected tropical disease control and elimination: impact on child health.” Arch Dis Child, 2013. • WHO 2010. Interagency Guidelines for Medicine Donations - Revised 2010. www.who.int/medicines/publications/med_donationsguide2011/en/ index.html

References cited in the development of the 2013 Methodology For references used in the development of the 2013 Methodology, please refer to: • Access to Medicine Foundation “Methodology Report 2013” ATM Foundation, 2013. www.accesstomedicineindex.org/sites/www. accesstomedicineindex.org/files/methodology_report_2013_for_ the_2014_access_to_medicine_index_6.pdf

References cited in the Appendices 1 World Bank “The World Bank, data, Countries and Economies.” The World Bank, 2013. www.data.worldbank.org/country/ 2 United Nations Development Programme. “Human Development Report 2013. The Rise of the South Human Progress in a Diverse World” UNDP, 2013. www.hdr.undp.org/en/media/HDR_2013_EN_complete.pdf 3 United Nations Development Programme. “Human Development Report 2013. The Rise of the South: Human Progress in a Diverse World, Inequality-adjusted Human Development Index, Human Development Statistical Annex.” UNDP, 2013. www.hdr.undp.org/en/media/HDR2013_EN_Statistics.pdf. 4 WHO “International Classification of Diseases, ICD-10 codes.” WHO, 2010. www.who.int/classifications/icd/en/. 5 “G-Finder 2012 Neglected Disease Research and Development: A Five Year Review” Policy Cures, 2012. www.policycures.org/downloads/GF2012_Report.pdf.

217 Appendix Access to Medicine Index 2014 Clickable Sections

List of figures List of tables

11 Figure 1 The Access to Medicine Index 2014 – Overall Ranking 37 Table 1 30 products have been approved since 2012 14 Figure 2 Access to medicine depends on a number of factors 52 Table 2 10 factors linking innovative access models 17 Figure 3 2014 Index company scope 90 Table 3 Socioeconomic factors drive equitable 18 Figure 4 Methodology Framework pricing strategies 19 Figure 5 Geograpical Scope 108 Table 4 Company licensing profiles 22 Figure 6 2014 Index average scores per Technical Area 109 Table 5 Pro-access licensing terms 23 Figure 7 Most products are being developed for infectious diseases 186 Table 6 2014 Index Company Scope 24 Figure 8 Johnson & Johnson is developing most medicines for children 187 Table 7 List of countries included in the 2014 25 Figure 9 Companies consider affordability for one-third of products Access to Medicine Index – 106 countries 26 Figure 10 The Access to Medicine Index 2014 – Overall Ranking 188 Table 8 List of diseases included in the 2014 32 Figure 11 Products in the pipeline and on the market Access to Medicine Index - 47 diseases 33 Figure 12 Top five diseases in clinical stage pipeline 35 Figure 13 Products on the market 35 Figure 14 Products in clinical development 36 Figure 15 Johnson & Johnson leads in the number of regulatory approvals 36 Figure 16 Most approvals are for diabetes and HIV/AIDS 43 Figure 17 Company Ranking General Access to Medicine Management 45 Figure 18 Access to medicine increasingly discussed in boardrooms 49 Figure 19 Do companies engage locally when developing and implementing access strategies? 59 Figure 20 Company Ranking Public Policy & Market Influence 61 Figure 21 Most breaches relate to marketing behaviour 62 Figure 22 No clear relationship between company behaviour and size 63 Figure 23 More companies audit compliance 68 Figure 24 Pay-for-delay to stall competitors 71 Figure 25 Company Ranking Research & Development 73 Figure 26 Most products are being developed for infectious diseases 73 Figure 27 Products in development, by disease category and phase 73 Figure 28 Comparing the 2014 pipeline to the 2012 pipeline 74 Figure 29 Top 10 diseases targeted by the overall industry pipeline 75 Figure 30 Proportion of products in clinical trials, by disease category 76 Figure 31 Johnson & Johnson is developing most medicines for children 77 Figure 32 Almost half of all product development is collaborative 78 Figure 33 Public partners correlate with greater transparency and access provisions 85 Figure 34 Company Ranking Pricing, Manufacturing & Distribution 87 Figure 35 Companies consider affordability for one-third of products 89 Figure 36 Breakdown of equitable pricing strategies 89 Figure 37 HIV/AIDS products have the most equitable pricing strategies 89 Figure 38 Gap in equitable pricing activity for non-communicable diseases 94 Figure 39 6 companies have newly implemented inter- or intra-country equitable pricing strategies since 2012 96 Figure 40 Adapting packaging can minimise the risks associated with improper use 96 Figure 41 Three companies take specific patients' needs into account 103 Figure 42 Company Ranking Patents & Licensing 105 Figure 43 More companies are engaging in voluntary licensing 106 Figure 44 Variations exist in company patent filing and enforcement 108 Figure 45 Gilead and GSK exhibit leading performance in licensing 115 Figure 46 Company Ranking Capability Advancement 116 Figure 47 Companies build capabilities in 75 out of 106 countries 118 Figure 48 Four main approaches to building R&D capabilities 119 Figure 49 Most technology/knowledge transfers with third-parties 120 Figure 50 Industry mostly focuses on reducing counterfeiting 123 Figure 51 Large increase: 9 additional companies contribute to national pharmacovigilance systems 129 Figure 52 Company Ranking Product Donations & Philanthropic Activities 132 Figure 53 Neglected tropical diseases are the main focus of donations programmes 132 Figure 54 Majority of companies engage in structured donations programmes 134 Figure 55 Donations programme timeline

218 Access to Medicine Index 2014 Appendix

Definitions

For the sources used in determining these Anti-competitive practice • Phase IV: These are studies that are con- definitions, please contact the Access to Any practice by a company or group of com- ducted after market approval. Typically, they Medicine Foundation. panies that has, is intended to have, or is likely investigate risks, benefits and optimal use in a to have, the effect of restricting, distorting or large population. Access provisions/Access orientated terms preventing competition in order to maintain or and conditions increase their market position and/or profits. Code of conduct [Working definition, used for analysis] Anti-competitive behaviour leads to disadvan- Statement of principles, values and rules that A provision to ensure that public health needs tage or detriment of competitors, customers establishes a set of expectations and standards are taken into consideration during the R&D and suppliers such that higher prices, reduced on responsible practices by an organisation, phase. A pro-access R&D agreement will have output, less consumer choice, loss of economic government body, company, affiliated group explicit terms embedded within it that facilitate efficiency and misallocation of resources (or or individual. This includes minimal levels of availability, accessibility and affordability for combinations thereof) are likely to result. compliance and disciplinary actions for the patients in Index countries (e.g., non-exclusivity organisation, its staff and volunteers in specified territories, price caps, licensing Balanced scorecard strategies, supply guarantee, waiving patent A strategic planning and management system Competition law rights, royalty-free provisions). that is used to align business activities to the Competition law seeks to promote or maintain mission, vision and strategy of the organisation, a competitive marketplace by regulating anti- Access rationale (for R&D capacity building) improve internal and external communications, competitive behaviour by companies. In the [Working definition, used for analysis] and monitor organisation and business unit sphere of pharmaceutical regulation, competi- A statement of how the company aims to in- performance against strategic goals. tion law can often involve different actions crease local R&D capabilities and address local taken by companies to delay or hamper the labour market gaps through its public-private Beyond the (pharmaceutical) value chain entry to market of generic competition. partnerships (PPPs) in Index countries. [Working definition, used for analysis] Activities beyond the scope of the company’s Compulsory licence Adaptive research/products normal operations and distribution channels. A formal ruling set by law or arbitration by a [Working definition, used for analysis] government to allow a third party (e.g., pharma- Adapting existing/registered New Chemical Breaches ceutical manufacturer) to produce a patented Entities (NCEs), New Biological Entities (NBEs) Acts that are in violation of or non-compliant product or use a patented process without or other relevant medicines, therapeutic and with laws, rules, guidelines or codes. needing to obtain consent of the patent owner. preventative vaccines, diagnostics, vector control products and microbicides to address Breaches of clinical trial conduct Conflict of interest an unmet need in the Index countries e.g., new Acts that are in violation/disregard of or non- A situation where a professional or a company demographic segments (e.g., infants/children, compliant with laws, rules, guidelines or codes. has a vested interest that creates a risk that pregnant women), environmental conditions professional judgement or actions will be (e.g., heat-resistant formulations), or new for- Clinical-stage development unduly influenced. The interests at stake could mulations (e.g., fixed-dose combinations). Clinical-stage development refers to medi- be, for example, money, status, knowledge or cines, microbicides and vaccines that are under reputation. Ad hoc donation programmes investigation in one or more of the clinical trial [Working definition, used for analysis] phases. These phases in medical research and Data exclusivity A gift of products for which there is no clear, drug development generate safety and efficacy Protection of originator pharmaceutical com- defined long-term strategy to control, elimi- data in humans. pany’s data preventing other parties from using nate, or eradicate a disease. This may include a • Phase I: In these studies a study health these data for a commercial purpose. Concrete- company donating a range of medicines based intervention (e.g., medicine) is investigated ly, this protection prevents generic product on stock availability, based on the explicit needs in a small group of healthy volunteers. This manufacturers from proceeding to clinical trials of a country. Donations made during emer- phase is to determine the safety profile of and health authorities from evaluating generic gency situations, such as conflict situations and the intervention (and how medicines can be product market authorisation applications dur- natural disasters, are included here. metabolised and excreted). ing this period. • Phase II: In these initial studies a study medi- Affordability cine is investigated in a small group of pa- Data transparency [Working definition, used for analysis] tients to determine efficacy to treat a specific Sharing patient level clinical study reports A measure of the payer's ability to pay for a condition and determine safety profiles. (CSRs) with trusted external parties (e.g., product (whether or not they are the end user). • Phase III: During this phase the efficacy and universities, research institutes). This refers to The Index takes this into account when assess- safety of a health intervention (e.g., medicine) sharing data for research purposes only. ing pricing strategies for relevant products. is studied in different large patient popula- Pharmaceutical companies use many different tions. Different doses are tested and its criteria to assess affordability. efficacy and safety are compared to other therapeutic agents. When favourable results are demonstrated in this phase, regulatory approval for marketing can be obtained.

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Declaration of Helsinki Equitable pricing quality standards. It is designed to minimise the A set of principles regarding human experimen- [Working definition, used for analysis] risks involved in any pharmaceutical production tation developed for members of the medical A targeted pricing strategy that ensures the that cannot be eliminated through testing the community. This code of conduct is for ethical poor gain access to medicine by affordable pric- final product. WHO has established detailed clinical trial conduct, and essential principles ing that is locally appropriate, implemented on a guidelines for GMP. Many countries have formu- revolve around respect for the individual and case-by-case basis. lated or harmonised their own requirements for the right to make informed decisions. It aims national GMP, often based on WHO GMP. to protect the rights and wellbeing of the Ethical clinical trial conduct individual participating in human research. The Guidelines regarding ethical and scientific Healthcare infrastructure Declaration of Helsinki was initially adopted in quality standards for designing, conducting, re- Basic physical and organisational structures 1964 as a reaction to the lack of a general according, and reporting findings from trials that needed to deliver health care. This extends cepted code of conduct for human research and involve participation of human subjects. Rights, from healthcare-related services provided to is frequently updated (last update: 2013). safety, and well-being of the trial subjects are communities, hospitals and other healthcare- the most important considerations and should related facilities. Doha Declaration (on the TRIPS Agreement prevail over interests of science and society. and Public Health) Principles from Good Clinical Practice and the Impact assessment An agreement between governments affirming Declaration of Helsinki, among others, are used Evaluating the effects that a policy, programme that the TRIPS agreement should not prevent as guidelines to guarantee ethical clinical trial or activity has on the health of a population, TRIPS member countries from protecting conduct and the distribution of those effects within the public health interests. The Doha Declaration population. This includes the effect on patient (14 November 2001) clarified the flexibilities of Ethical marketing outcomes, epidemiology, healthcare infra- TRIPS member states in navigating pharma- Promotional activities that are aimed at the structure and other effects that relate to public ceutical patents. It granted member states general public, patients, healthcare profes- health. It can include also wider socio-economic the right to grant compulsory licences; to deter- sionals/students and opinion leaders in such impacts. It can be performed by a company or mine what constitutes a national emergency or a way that transparency, integrity, accuracy, by a third party. extreme urgency; and that each member is free clarity and completeness of information can be to establish its own regime for the exhaustion ensured. Innovative research/products of intellectual property rights. [Working definition, used for analysis] Evergreening Development of New Chemical Entities (NCEs), Drug diversion Patent clusters around an existing medicine New Biological Entities (NBEs) or other medi- Channelling lower-priced medicines from de- is patenting of new forms or other minor cines, therapeutic and preventative vaccines, veloping countries into developed countries or variations of existing products that have no ad- diagnostics, vector control products, and from lower-income segments to high-income ditional therapeutic value and display limited in- microbicides. segments, or from public to private sector, ventiveness. This can be used to prolong patent within a country. protection in an inappropriate manner, creating Inter-country equitable pricing a negative effect on access to medicines, as well A targeted pricing scheme that differentiates Drug recall as on further innovation – a strategy referred prices between countries and takes into ac- Actions taken by a company or medicine regula- to as ‘evergreening’. The Commission on Intel- count affordability of the poorest countries. tory authority to remove from the market prod- lectual Property Rights, Innovation and Public ucts or batches of products that are found to be Health (CIPIH) defined evergreening as a term International Conference on Harmonisation either defective or potentially harmful. Recalls popularly used to describe patenting strategies Guideline for Good Clinical Practice (ICH-GCP) include those due to both packaging and qual- “when, in the absence of any apparent addi- An international ethical and scientific quality ity or safety issues. The Index captures those tional therapeutic benefits, patent holders use standard for designing, conducting, recording recalls of products that are subject to GMP stan- various strategies to extend the length of their and reporting trials that involve the participa- dards, i.e., medicines, vaccines, microbicides and exclusivity beyond the 20-year patent term”. tion of human subjects. Compliance with this other medicinal products for human use. standard provides public assurance that the False Claims Act rights, safety and well-being of trial subjects Early-stage development The False Claims Act is a piece of federal are protected, consistent with principles that Early-stage research and development refers legislation in the US which imposes penalties have their origin in the Declaration of Helsinki, to discovery and pre-clinical research. on people or companies who defraud govern- and that the clinical trial data are credible. GCP • Discovery research: Basic research and ment programs. In the pharmaceutical sector, is set up by The International Conference on screening methods (target identification, there have been several large scale settlements Harmonisation of Technical Requirements for target validation, target to hit, hit to lead, and agreed under this Act for activities involving Registration of Pharmaceuticals for Human Use lead optimization). off-label promotion, amongst other things. (ICH) that aims to harmonise technical require- • Preclinical research: Research aimed at as- ments for registration of medicines for human sessing potential efficacy and toxicity prior to Forward integration (of the supply chain) use globally. testing a product. Typically, both in vitro and Integration of processes down the supply chain, in vivo tests are performed. During in vitro for example through collaboration with ware- Intra-country equitable pricing tests data is collected to determine chemical houses, distributors, health facilities and other A targeted pricing scheme where a company and biological properties of products in an downstream partners. has different pricing tiers within a country isolated laboratory setting. When results are based on the socioeconomic profiles of differ- positive, in vivo tests are used to determine Good Manufacturing Practices (GMP) ent population segments, taking into account toxicity and ability to treat or prevent a partic- Guidelines for ensuring that products are con- affordability for the poorest segments in the ular disease or symptom in living animals. sistently produced and controlled according to country.

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IP sharing partnerships vigilance system should include efficient sur- Performance management systems [Working definition, used for analysis] veillance, effective communication methods, Formal and informal mechanisms, tools, pro- Sharing of intellectual property (e.g., compound and collaboration with the relevant stakehold- cesses and networks used by organisations to libraries, patented compounds, processes or ers to ensure pharmacovigilance activities are manage and reward performance in line with technologies) by a company to an external party incorporated. corporate and functional strategies and goals. (e.g., WIPO Re:Search, DNDi, MMV, TB Drug This includes performance measurement, i.e., Accelerator) that use the IP for R&D targeting Non-assert declaration collecting, analysing and reporting information Index Diseases. A legally binding commitment that contains an regarding the performance of an individual, explicit set of conditions, including permitted group or organisation in order to track progress Key Performance Indicator actions and designated territories, for which towards set goals. Quantifiable measures that are used to mea- the patent owner commits not to enforce pat- sure progress against set goals and targets ent rights. This allows for a generic version of Performance measures and/ or critical success factors. a patent protected product to be produced in a Indicators used to assess progress towards set resource-limited setting. goals and targets. Licensing agreement A contract in which the patent holder allows Off-label promotion Period of analysis the contracting party to use the patent, either Off-label use is defined as use for indication, [Working definition, used for analysis] against a payment of royalties or free of charge dosage form, dose regimen, population or other For the 2014 Index, the time period for which for a defined period of time. use parameter not mentioned in the FDA ap- data will be analysed covers fiscal years 2012 proved label. It is a violation of the False Claims and 2013, where company activities must be Lobbying Act (in the US) for pharmaceutical companies ongoing between June 2012 and the end of May Any activity carried out to influence a govern- to promote pharmaceuticals for off-label use. 2014, as this is the cycle of the Index. Pro- ment or institution’s policies and decisions in grammes that have ended before June 1st 2012 favour of a specific cause or outcome. Direct Outcome measures are not included. Additionally, any activities that lobbying occurs via communication with a [Working definition, used for analysis] were already assessed in the 2012 Index will legislator, legislative staff, legislative body or Evaluating measures that are related to opera- not be scored as innovative or new in relevant government employee who may participate tionalisation of a donation programme. This indicators. The Index team assesses most in the formulation of legislation. Grassroots includes quality control along the entire supply recent policies, codes and stances, up to final lobbying is an attempt to influence legislation chain from manufacturing site to recipients submission. by encouraging the public to contact legislators and from recipients to the end-user. Report- about a specific issue. Even when allowed by ing or monitoring are common procedures for Pharmacovigilance law, these acts can become distortive if dispro- evaluating outcome measures. Outcomes can The science and activities relating to the portionate levels of influence exist. be measured by the company or provided by detection, assessment, understanding and recipients of the donated products. prevention of adverse effects or any other Lowest pricing tier drug-related problem. Medicines need to be [Working definition, used for analysis] Parallel importation monitored, and any adverse drug reactions The lowest price point within a company’s equi- Import of a patented or trademarked product need to be remedied in a timely manner through table pricing structure. This price is offered to from a country where it is marketed, usually to pharmacovigilance systems. the poorest segment (i.e., to the poorest popu- obtain a lower price. lation group within a country, or to the poorest Poorest segment country (or countries) within a larger group Partnering Against Corruption Initiative [Working definition, used for analysis] of countries). This includes the price at which (PACI) The lowest-income population segment within products are sold to the public sector within a A voluntary multi-stakeholder initiative set a given country, or the poorest country (or poor country or sales to LICs and/or LDCs. up under the banner of the World Economic group of countries) worldwide. The poorest Forum. It aims to address corruption through segment a company sells a product to may be a Medicines Patent Pool raising business standards and seeking com- lower-income population segment, and not the An organisation that aims to increase access to pany commitment to meet certain standards of lowest-income segment within a country. priority HIV medicines. It invites patent holders behaviour. to negotiate licences allowing other to develop Price point adapted formulations or sell generic version of Patent [Working definition, used for analysis] patented medicines in developing countries. An intellectual property right providing an The price of a product at a particular point in It sub-licenses to other manufacturers to de- inventor with a legal monopoly to prevent the supply chain. For example, wholesaler/ex- velop, produce and sell medicines under strict others from making, using, or selling the new factory/ex-manufacturing/pre-tax/list price/ quality assurance. invention for a defined period of time, subject marginal cost/Maximum Retail Price, etc. to a number of exceptions. Also includes the ob- National pharmacovigilance systems ligation to publish the invention. A patent does Pro-access Nationwide systems or projects (in Index coun- not automatically mean the product is safe for [Working definition, used for analysis] tries) to establish and support a database of consumers or that it can be supplied. Patented An adjective to ensure positive provisions that adverse drug reactions for informed regulatory medicines still have to go through rigorous address public health needs. A pro-access li- decision making; and to improve the rational testing and approval before they can receive cence will have explicit terms embedded within and safe use of medical drugs, the assessment market authorisation. it that ensure timely medicine development and and communication of the risks and benefits market registration, safe and acceptable prod- of drugs on the market, and the education of ucts delivered to populations who need them. patients. A comprehensive national pharmaco-

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Product development partnership • Similarly, the WHO Prequalification Pro- Trade Related Aspects of Intellectual Property Research and development of compounds/ gramme works in close cooperation with (TRIPS) Agreement products performed jointly by more than two national regulatory agencies and partner A multilateral agreement that was issued to parties where knowledge and/or expertise organizations, with the aim of making quality protect Intellectual Property rights around and resources are shared towards one or more priority medicines (for diseases such as HIV/ the world under international rules, where all common goals. This could involve academic AIDS, malaria, tuberculosis and for reproduc- countries must make patents eligible for phar- institutions, government agencies and divisions, tive health, amongst others) available for the maceutical products and processes. The World pharmaceutical companies, biotechnology com- benefit of those in need. Trade Organization’s TRIPS Agreement covers panies and other public or private organisations. five broad issues: Structured donation programmes • How basic principles of the trading system Product donation programmes [Working definition, used for analysis] and other international intellectual property [Working definition, used for analysis] A gift of products for which a defined strategy agreements should be applied Gifts of products (medicines and vaccines only) exists as to the type, volume, and destination • How to give adequate protection to intellec- that are ongoing during the period of analysis. of donated products. Structured donations tual property rights These are subdivided into structured donation programmes are based on long-term, targeted • How countries should enforce those rights programmes and ad hoc donation programmes. donation programmes based on country needs, adequately in their own territories usually targeted to control, eliminate, or eradi- • How to settle disputes on intellectual prop- Rational use cate a disease. erty between members of the WTO The scientifically sound use of medicines. • Special transitional arrangements during Rational use requires that patients receive the Subsidiary the period when the new system is being appropriate medicine, in the proper dose, for an [Working definition, used for analysis] introduced. adequate period of time, and at a cost which is A company that is owned or controlled by affordable to them and their community. another firm or company; subsidiaries include TRIPS Flexibilities firms in which a company owns more than 50% In the context of public health, these typically Special 301 Watch List of the outstanding voting stock, as well as firms refer to the flexibilities within the TRIPS Agree- The Special 301 Report is prepared annually by in which a company has the power to direct or ment confirmed by the Doha Declaration (2001) the Office of the United States Trade Represen- cause the direction of the management and that allow WTO members to implement TRIPS tative (USTR) under Section 301 as amended policies. in a “manner supportive of WTO members' of the Trade Act of 1974. The reports identify right to protect public health…”, and to use the trade barriers to US companies and products Sustainable philanthropy measures within TRIPS for this purpose. For due to the intellectual property laws, such as [Working definition, used for analysis] example, countries may permit manufacturers patents, in other countries. The annual report Providing grants to other organizations to to use a patented invention to obtain marketing contains a ‘Priority Watch List’ and a ‘Watch improve local healthcare capabilities. It includes approval before expiry of the patent and with- List’, identifying countries whose intellectual the donation of financial assistance only. out the permission of the patent owner. property regimes are deemed of concern to US companies. Technology Transfer United Nations Global Compact (UNGC) The process by which any party gains access to A UN administered agreement that encour- Spurious, falsely-labelled, falsified, counter- another party’s technical information or know- ages businesses to align with ten principles feit products how and successfully learns and absorbs it into of responsible behaviour, including fighting The term counterfeit medical product de- its research, development or manufacturing corruption. However, it is not a performance- scribes a product with a false representation processes. assessment tool, and is not enforceable. of its identity and/or source. This applies to the product, its container or other packaging Tiered pricing Voluntary licence or labelling information. Counterfeiting can A pricing scheme where a company adapts A contract through which the patent holder apply to both branded and generic products. product prices based on the purchasing power allows permits the contracting party to use the Substandard batches of or quality defects of consumers in different geographic or socio- patent. or noncompliance with Good Manufacturing economic segments. Tiered pricing that takes Practices/Good Distribution Practices (GMP/ into account affordability of medicines and Whistleblower GDP) in legitimate medical products must other products for low-income segments is a An informant who exposes wrongdoing by a not be confused with counterfeiting. Medical form of equitable pricing. company that threatens public interest, such as products (whether generic or branded) that are neglect or abuse, within an organisation, either not authorised for marketing in a given country Tracer product internally or publicly, in the hope of stopping it. but authorised elsewhere are not considered [Working definition, used for analysis] counterfeit. Products that account for highest sales WHO Prequalification revenue in relevant countries covered by the A service provided by WHO to assess the Stringent approval Index for which equitable pricing strategies are quality, safety and efficacy of certain medicinal Positive opinions or tentative approval for med- available. products (mainly for HIV/AIDS, TB, malaria and icines used exclusively outside the ICH region, reproductive health). under any of the following special regulatory Trade association schemes are recognized as stringent approval: An organisation founded and funded by compa- • Article 58 of European Union Regulation (EC) nies from a particular industry, through which No. 726/2004 companies can collaborate with each other on • United States FDA tentative approval (for an- activities such as standardisation, lobbying, tiretrovirals under the PEPFAR programme) education, and other areas.

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Acronyms

ABPI Association of the British Pharmaceutical Industry ACHAP African Comprehensive HIV/AIDS Partnership AIDS Acquired Immuno Deficiency Syndrome AMPATH Academic Model Providing Access to Healthcare API Active Pharmaceutical Ingredient ARV Antiretroviral drug COPD Chronic Obstructive Pulmonary Disease CROs Clinical Research Organisations DNDi Drugs for Neglected Diseases initiative EFPIA European Federation of Pharmaceutical Industries and Associations EMA European Medicines Agency EML WHO Model Essential Medicines List FDA Food and Drug Administration (US) GHIT Global Health Innovative Technology Fund GAVI Global Alliance for Vaccine Immunization GCP Good Clinical Practices GDP Gross Domestic Product GMP Good Manufacturing Practices GNI Gross National Income HIC High-income country [World Bank] HIV Human Immunodeficiency Virus ICH-GCP International Conference on Harmonisation guideline for Good Clinical Practice IFPMA International Federation of Pharmaceutical Manufacturers & Associations IP Intellectual Property IPASA Innovative Pharmaceutical Association of South Africa KPI Key Performance Indicator LDC Least Developed Country [United Nations] LIC Low-income country [World Bank] LMIC Lower-middle income country [World Bank] MDG Millennium Development Goals MDR-TB Multidrug-resistant Tuberculosis MPP Medicines Patent Pool MSF Médecins Sans Frontières NEVLS Non-Exclusive Voluntary Licences NGO Non-governmental organisation NCDs Non-communicable Diseases NTDs Neglected Tropical Diseases NTD-SCF Neglected Tropical Diseases Supply Chain Forum PAHO Pan American Health Organization PACI Partnering Against Corruption Initiative PEPFAR President’s Emergency Plan for AIDS Relief PhRMA Pharmaceutical Research and Manufacturers of America PDP Product Development Partnership PPP Public-Private Partnership R&D Research and Development TRIPS Trade Related Aspects of Intellectual Property Rights UMIC Upper-middle income country [world bank] UN United Nations UNGC United Nations Global Compact WHO World Health Organisation WIPO World Intellectual Property Organisation WTO World Trade Organisation UNAIDS Joint United Nations Programme on HIV/AIDS TB Tuberculosis

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