First independent assessment of pharmaceutical company action on AMR Antimicrobial Resistance Benchmark 2018 Access to Medicine Foundation Antimicrobial Resistance Benchmark 2018 ACCESS TO MEDICINE FOUNDATION January 2018 1 Antimicrobial Resistance Benchmark 2018 ACCESS TO MEDICINE FOUNDATION The Access to Medicine Foundation is an independent non-profit 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 to medicine. For 10 years, the Foundation has been building consensus on the role for the pharmaceutical industry in improving access to medicine and vaccines. It publishes the Access to Medicine Index every two years, with the next Index due in late 2018. In 2017, the Foundation published the first Access to Vaccines Index. This is the first Antimicrobial Resistance Benchmark. ACKNOWLEDGEMENTS The 2018 Antimicrobial Resistance Benchmark has been made possible through collaboration with experts and specialists working across the spectrum of organisations working to curb antimicrobial resistance.1 The Foundation is grateful for their time and expertise, and would like to thank them for providing valuable insights throughout the development of this research and its methodology. Expert Review Committee Research Team Reviewers Hans Hogerzeil (Chair) Gowri Gopalakrishna Niranjan Konduri Greg Frank Adrián Alonso Ruiz Joakim Larsson Nina Grundmann Dulce Calçada Marc Mendelson Magdalena Kettis Karrar Karrar Jean-Pierre Paccaud Joakim Larsson Josefien Knoeff Marie Petit Marc Mendelson Marijn Verhoef Andrew Singer Katarina Nedog Evelina Tacconelli Editorial Team Evelyn Wesangula Anna Massey Deirdre Cogan Rachel Jones Emma Ross FUNDERS The Antimicrobial Resistance Benchmark research programme is made possible with financial support from UK AID and the Dutch Ministry of Health, Welfare and Sport. Address Contact Naritaweg 227 A For questions about this report, please contact NL-1043 CB Amsterdam Jayasree K. Iyer, Executive Director 1 This acknowledgement is not intended to imply that the individuals and institutions referred to above endorse The Netherlands [email protected] the Antimicrobial Resistance Benchmark methodology, +31 (0) 20 215 35 35 analyses or results. Decisions regarding the final anal- ysis were ultimately made by the Access to Medicine www.amrbenchmark.org Foundation. 2 Access to Medicine Foundation The superbugs can be stopped – if we put good ideas into action At the Access to Medicine Foundation, we have been analys- ing how pharmaceutical companies tackle access to medicine for more than a decade. This first Antimicrobial Resistance Benchmark is the first independent, detailed evaluation of how pharmaceutical companies are halting the rise of drug resistance. new antimicrobials. Nevertheless, a core group of compa- nies remain committed to providing these critical medicines, Drug resistance – also called antimicrobial resistance or AMR with some continuing to develop innovative new products to – is on the increase and it can spread fast. But if action is replace the ones that don’t work anymore. Without antibi- taken now, it can be contained. Global AMR strategies focus otics, common infections will become harder to treat. Many on improving how we all use antimicrobials, so that bacteria other areas of modern medicine will become riskier, such as and other pathogens have less chance to develop resistance. cancer therapy, surgery and even childbirth. These strategies must also ensure people can still get hold of these lifesaving medicines when they need them: many mil- In this first AMR Benchmark, we found that almost all compa- lions of people around the world lack reliable access to anti- nies we looked at are taking some action to limit AMR. There microbials or to good information on how to use them. are good practices in most areas we examined, although there is also much more to be done. The ‘superbug’ threat cannot be removed by one single per- son, organisation or sector working alone. Coordination, com- I invite you to use this first Benchmark as you review AMR mitment and collaboration are key, from political leaders and strategies – use it as a book showing the good ideas now policymakers to doctors, farmers and pharmaceutical execu- being implemented, and as a map of the opportunities to tives. In recent years, the international community and the pri- amplify current efforts to contain AMR. The power of busi- vate sector have swung their collective weight behind efforts ness, the public sector and individuals to radically transform to contain AMR – these commitments now need to lead to society is immense. real action, with progress toward set targets being publicly monitored. New ideas and new opportunities are also needed to limit AMR, including new ways of incentivising further action. Importantly, good practices must be shared, so that companies and other stakeholders can seize more opportuni- ties to make change. As a global community, we look to pharmaceutical com- panies to bring us safe and effective antimicrobials. It is Jayasree K. Iyer widely acknowledged to be a challenging and commer- Executive Director cially unattractive market, with little incentive to develop Access to Medicine Foundation 3 Antimicrobial Resistance Benchmark 2018 Table of contents 6 EXECUTIVE SUMMARY 83 COMPANY REPORT CARDS 84 Achaogen, Inc. 10 INTRODUCTION 86 Aspen Pharmacare Holdings Limited 88 Aurobindo Pharma Limited 16 BENCHMARK PERFORMANCE 90 Cempra, Inc. 16 AMR: what are the priorities and where are pharmaceuti- 92 Cipla Limited cal companies focussing? 96 Dr. Reddy’s Laboratories Ltd. 18 The Antimicrobial Resistance Benchmark – 98 Entasis Therapeutics Inc. which companies lead? 100 Fresenius Kabi AG 102 GlaxoSmithKline plc 24 KEY FINDINGS 106 Johnson & Johnson 24 Out of 28 antibiotics in late stages of clinical develop- 110 Lupin Limited ment, only two have both access and stewardship 112 Macleods Pharmaceuticals Ltd. provisions in place 115 Melinta Therapeutics, Inc. 25 Nearly half of companies with products on the market 117 Merck & Co., Inc. are involved in AMR surveillance 120 MGB Biopharma 26 Eight companies are setting limits on antibiotic 122 Motif Bio plc wastewater discharge 124 Mylan NV 27 Four companies move to decouple antibiotic sales vol- 127 Nabriva Therapeutics plc umes from sales agents’ bonuses 129 Novartis AG 132 Pfizer Inc. 28 PORTFOLIO ANALYSIS 135 Polyphor Ltd. 28 Antimicrobial portfolios: what medicines are 137 Roche Holding AG on the market? 140 Sanofi 30 Case studies: how three companies are addressing 143 Shionogi & Co., Ltd. access and stewardship in tandem 146 Summit Therapeutics plc 34 Vaccines in the push to limit antimicrobial resistance 148 Sun Pharmaceutical Industries Ltd. 150 Tetraphase Pharmaceuticals, Inc. 39 RESEARCH AREAS 152 Teva Pharmaceutical Industries Ltd. 40 Research & Development: What is in companies’ antimi- 154 The Medicines Company* crobial pipelines? 156 Wockhardt Limited 58 Manufacturing & Production: How pharmaceutical companies ensure the production of antibiotics does 159 APPENDICES s not contribute to resistance 160 I - Methodology scopes 66 Access & Stewardship: How pharmaceutical companies 163 II - Priority pathogens for R&D approach access and stewardship for antibiotics 164 III - Products for access 169 IV - Countries for access 170 V - Analysis, scoring and review 173 VI - Limitations 174 VII - Scoring guidelines 179 VIII - Guide to report cards 180 IX - List of figures 181 X - Definitions 183 XI - Acronyms 4 Access to Medicine Foundation About this report The Antimicrobial Resistance Bench- Framework of analysis gathered from public sources was veri- mark provides the first independent The analytical framework is structured fied, cross-checked and supplemented assessment of how pharmamaceutical across three Research Areas: Research by the Foundation’s research team using companies are responding to AMR. The & Development; Manufacturing & public databases, sources and support- 30 companies in scope include those Production; and Appropriate Access & ing documentation. with the largest R&D divisions, the Stewardship. The Benchmark assesses largest market presence, and specific company behaviour regarding infec- The first baseline for companies expertise in developing critically needed tious diseases and product types and AMR is increasingly recognised as medicines and vaccines. The goal of the in a specific geographic scope, depend- a growing public health problem. Antimicrobial Resistance Benchmark is ing on the Research Area in question. Governments, policy-makers, farmers, to guide and incentivise such compa- Its metrics correspond to areas where doctors and pharmaceutical executives nies to adopt and implement effective experts and stakeholders agree that have a role to play. The Antimicrobial actions for tackling AMR. It highlights pharmaceutical companies can and Resistance Benchmark provides an ini- where good ideas for limiting AMR are should be taking action to limit AMR. tial baseline measure of how pharma- being implemented and where action ceutical companies are limiting AMR. is still required. The AMR Benchmark What the Benchmark analyses Companies and stakeholders can use is independently funded by UK AID and The Benchmark evaluated data gath- this analysis to inform priorities and the Dutch Ministry of Health, Welfare ered via a detailed survey of company strategies,