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Access to Medicine Index 2018 Access to Medicine Foundation Access to Medicine Index 2018 Access to Medicine Foundation Access to Medicine Index 2018 ACCESS TO MEDICINE FOUNDATION November 2018 1 Access to Medicine Index 2018 ACKNOWLEDGEMENTS The Access to Medicine Foundation would like to thank the following people and organisations for their contributions to this report. FUNDERS UK Department for International Development The Dutch Ministry of Foreign Aff airs Bill & Melinda Gates Foundation EXPERT REVIEW COMMITTEE RESEARCH TEAM Hans Hogerzeil – Chair Danny Edwards Sanne Frost Helt Beth Boyer Fumie Griego Clarke Cole Suzanne Hill Myriam Diallo Frasia Karua Karrar Karrar Dennis Ross-Degnan Alex Kong Dilip Shah Nestor Papanikolaou Yo Takatsuki Stine Trolle Joshua Wamboga Margo Warren Prashant Yadav Mariska van der Zee REVIEWERS EDITORIAL TEAM Hans Hogerzeil Anna Massey Gabrielle Breugelmans Deirdre Cogan Esteban Burrone Emma Ross Jennifer Dent Michele Forzley ADDITIONAL CONTRIBUTORS Frasia Karua We would like to thank the many other experts Niranjan Konduri who contributed their views to the development of this report (see Appendix XVI). ACCESS TO MEDICINE FOUNDATION The Access to Medicine Foundation is an independent non-profi t organisation based in the Netherlands. It aims to advance access to medicine in low- and middle-income countries by stimulating and guiding the pharmaceutical industry to play a greater role in improving access. Naritaweg 227-A 1043 CB, Amsterdam The Netherlands For questions about this report, please contact Danny Edwards, Research Programme Manager [email protected] +31 (0) 20 215 35 35 www.accesstomedicineindex.org 2 Access to Medicine Foundation How to radically ramp up access to healthcare How can we radically ramp up access to healthcare worldwide? This 6th Access to Medicine Index shows where pharmaceutical companies are currently focusing their efforts to improve access. The Index is a guide to what is working, and a tool for inspiring further action. Public health has seen massive gains in the past The risk of a retreat decades. Yet, millions of people still face uncer- In 2018, we find that every single company evalu- tainty when it comes to the supply and affordabil- ated is taking greater steps than before, albeit at ity of health products. This is not only a problem different paces. The current range of practices and for people in resource-limited settings, but it is initiatives includes many good examples and ones today a global issue. The challenges are complex, that are being successfully expanded to cover going beyond the persistent challenges posed by more people. Most activity we see is being taken infectious killers and the rise of lifestyle diseases. by just a few companies, where any retreat could Climate change is already affecting the supply of have a catastrophic impact on access and yet many medicines to island nations and isolated communi- countries and communities have yet to be reached. ties. With 70% of the world in close contact with To close the gaps that remain, a greater diversity animals, zoonotic diseases are sadly part of every- of companies must get involved and stay engaged day life for many people. for the long haul. The power of priority setting The question I am asked most often in our work is When there are competing global issues, we know ‘how can the best pharmaceutical innovations that priority-setting works. It is 40 years since reach the most people?’ The 106 countries cov- world leaders agreed that primary healthcare is ered by the Index are home to 77% of all people key to improving health for all people. This com- alive today. The global reach of the pharmaceutical mitment has been renewed this year in Kazakhstan industry means that much more can be done. This to ensure no one is left behind. More people are new Index sets out which steps still need to be signing up to these priorities, with the SDGs pro- taken, and highlights the urgency of greater viding a framework for organisations working to collaborative action. improve all health. Governments are advancing uni- versal health coverage (UHC) and implementing national action plans to address areas such as com- prehensive cancer care. At the Access to Medicine Foundation, we clarify the priorities for pharma- ceutical companies, as innovators and top produc- ers, to improve access to medicine. Each Index reports in detail how companies are performing against these priorities. Jayasree K. Iyer Executive Director Access to Medicine Foundation 3 Access to Medicine Index 2018 Table of contents TECHNICAL AREAS 6 EXECUTIVE SUMMARY 30 GENERAL ACCESS TO MEDICINE MANAGEMENT 10 INTRODUCTION 31 How companies compare: Roche joins leading group in high-scoring area 14 KEY FINDINGS 33 Industry activity per topic: Pro-access governance 14 R&D: Five companies are carrying out 63% of the becoming standard practice most urgently needed R&D projects 38 Best practices 16 Cancer: Access initiatives for cancer products focus 40 Innovative practices on pricing, mainly for small populations 42 Innovative business models: Business models that 18 On-patent products: Majority of key on-patent aim to include the poor are expanding products have access initiatives, but these are lim- ited in reach 48 MARKET INFLUENCE & COMPLIANCE 49 How companies compare: Leaders demonstrate 20 THE 2018 ACCESS TO MEDICINE RANKING strong, transparent approaches to compliance 20 2018 ranking: Progress led by handful of compa- 51 Industry activity per topic: Most companies extend nies, including in pricing and R&D compliance standards to cover third parties 21 Overall ranking 55 Best practices 24 PIPELINE & PORTFOLIO ANALYSIS 56 RESEARCH & DEVELOPMENT 24 Leading graphic: Products for non-communicable 57 How companies compare: Top four extend lead diseases dominate the pipeline and portfolio by performing well in access planning and priority 25 Leading graphic: which diseases have treatments R&D on the market or promise in the pipeline? 59 Industry activity per topic: Almost one quarter of 26 Leading graphic: a closer look at company pipelines R&D projects target a priority product gap and portfolios 64 Leading graphic: Are pharmaceutical companies 27 Leading graphic: which diseases account for most responding to calls for urgently needed R&D? new treatments? 65 Leading graphic: Priority R&D focuses on five diseases 66 Leading graphic: Multiple priority R&D gaps are going unaddressed 68 Leading graphic: Are pharmaceutical companies planning to make new products quickly accessible? 69 Leading graphic: Which companies plan ahead for access? 70 Best practices 73 Innovative practices IN THIS REPORT 3 KEY FINDINGS 2018 RANKING 7 TECHNICAL AREAS 4 Access to Medicine Foundation 76 PRICING, MANUFACTURING & DISTRIBUTION 131 COMPANY REPORT CARDS 77 How companies compare: Gilead and Novartis new 132 GSK in leading group; use of equitable pricing improves 136 Novartis 79 Industry activity per topic: While registration per- 140 Johnson & Johnson formances lag, prices within countries become 144 Merck KGaA more tailored according to need 148 Takeda 84 Leading graphic: Which countries benefit from 152 Novo Nordisk rapid registration filings? 156 Sanofi 86 Leading graphic: How many products are linked to 160 Eisai fairer pricing strategies? 164 AstraZeneca 88 Leading graphic: How do companies use pricing, 168 Roche licensing and donations to improve access to key 172 Pfizer products? 176 Merck & Co., Inc. 90 Best practices 180 Gilead 184 Boehringer Ingelheim 92 PATENTS & LICENSING 188 Bristol-Myers Squibb 93 How companies compare: Top four companies lead 192 Bayer through broad licensing approaches 196 AbbVie 95 Industry activity per topic: Licensing plateaus, while 200 Daiichi Sankyo patent transparency leaps forward 204 Astellas 98 Best practices 208 Eli Lilly 100 CAPACITY BUILDING 213 APPENDICES 101 How companies compare: Leaders build diverse 214 I – Company scope capacities, with more initiatives in line with 215 II – Disease scope expected standards 217 III – Cancers in scope 103 Industry activity per topic: Around one third of ini- 219 IV – R&D priorities tiatives evaluated meet all standards for good 221 V – Countries in scope practice 222 VI – Priority countries 110 Best practices 225 VII –Product types in scope 117 Innovative practices 226 VIII – Stakeholder engagement 2017 227 IX – Ranking, scoring and review process 122 PRODUCT DONATIONS 231 X – Identifying best & innovative practices 123 How companies compare: A focus on coverage 232 XI – Indicators and scoring guidelines and sustainability brings newcomers to the leading 249 XII – Report card analysis: further explanation group 250 XIII – Capacity building practice framework 125 Industry activity per topic: Companies take a range 251 XIV – Definitions of approaches to sustainability planning for dona- 253 XV – Figures in this report tion programmes for non-communicable diseases 254 XVI – Acknowledgments 130 Best practices LEADING GRAPHICS 45 BEST & INNOVATIVE PRACTICES 20 REPORT CARDS 5 Access to Medicine Index 2018 Executive Summary INTRODUCTION Globally, two billion people cannot access the med- products. Also for the first time, the Index zeroes icines they need, with millions in low- and mid- in on 53 products on the market that it considers dle-income countries dying each year from dis- particularly critical candidates for company access eases because the vaccines, medicines and diag- initiatives and evaluates what companies are doing nostic tests that they need are either unavailable to facilitate their affordability and
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