EXPLORING THE EXPANSIONEXPLORING THE OF THE MEDICINES PATENT POOLEXPANSION OF THE ’S MANDATE TO PATENTED MEDICINES PATENT POOL’S ESSENTIAL MEDICINESMANDATE TO PATENTED ESSENTIAL MEDICINES A feasibility study of the public health needs A study of the and potential impactpublic health needs, feasibility and potential impact Exploring the expansion of the Medicines Patent Pool’s mandate to patented essential medicines 1 Table of contents Acknowledgments ......................................................................................................................... 3 Acronyms .......................................................................................................................................... 6 Executive summary ....................................................................................................................... 8 1 Introduction ...................................................................................................................... 22 2 Methodology ..................................................................................................................... 33 3 Patented medicines included in the EML: Case study on medicines for chronic myeloid leukaemia ........................................................................................................ 38 4 Patented medicines that the WHO Expert Committee considered as having relevant clinical benefits but needing additional data: Case study on novel medicines for type 2 diabetes .................................................................................................... 48 5 Patented medicines that have clinical benefits but did not meet the EML Expert Review committee’s comparative cost-effectiveness criterion: Case study on novel oral anticoagulants .................................................................................................... 64 6 Patented medicines for which the WHO Expert Committee recommended a therapeutic area review by a separate working group: Case studies on lung cancer, prostate cancer, multiple myeloma and breast cancer ..................................................... 80 7 New antibiotics to combat antimicrobial resistance ....................................... 104 8 Other products in the WHO EML, highlighted by EML Committee or mentioned in discussions with stakeholders .................................................................. 114 9 Discussion and conclusions ...................................................................................... 124 Exploring the expansion of the Medicines Patent Pool’s mandate to patented essential medicines 2 Acknowledgments Esteban Burrone (Head of Policy at the Medicines Patent Pool (MPP)) coordinated the study under the overall direction of Greg Perry (in 2017) and Marie-Paule Kieny (in 2018). Dzintars Gotham (MPP Consultant) and Esteban Burrone drafted the study, with contributions from Chan Park (General Counsel, MPP). Katie Moore (Head of Communications, MPP) contributed to editing the study. Sandeep Juneja and Asma Rehan supported the interviews with several stakeholders and Alnaaze Nathoo contributed to managing the project. We are grateful for the thoughtful comments and discussion provided by other members of the MPP team: Yao Cheng (Scientific Manager), Erika Dueñas (Policy and Advocacy Manager), Aastha Gupta (Business Development Manager), Sandeep Juneja (former Senior Business Development Director), Marie-Paule Kieny (Chair of the Board), Liudmyla Maistat (Policy and Advocacy Manager), Hannah Moak (Business Development Manager), Alnaaze Nathoo (former Head of Strategy and Operations), Greg Perry (former Executive Director of the MPP), Asma Rehan (Grants and Operations Manager) and Maica Trabanco (Associate Counsel). We are grateful to the members of the Steering Group that oversaw the conduct of this study and provided technical peer reviews for draft chapters: Andy Gray (University of KwaZulu-Natal), Kees de Joncheere (formerly Essential Medicines and Health Products Department, WHO), Nicola Magrini (Expert Committee on the Selection and Use of Essential Medicines, WHO) and Yehoda Martei (University of Pennsylvania). We thank the experts who provided national background papers: Nicholas Anthony Othieno Abinya (University of Nairobi, Kenya), Zeba Aziz (Hameed Latif Hospital, Pakistan), Dilshod Egamberdiev (National Cancer Center of Uzbekistan), Temidayo Fadelu (Dana-Farber Cancer Institute, USA), Yehoda Martei (University of Pennsylvania, USA), Orlando Benito Martínez-Granera, (Fundación Movicancer Nicaragua, Nicaragua) and Tuan Anh Pham (National Cancer Hospital, Vietnam) provided the national reports on chronic myeloid leukaemia and other cancers. Abdul Basit (Baqai Medical University, Pakistan), Margo Hudson and Andrea Haas (Brigham and Women’s Hospital, USA), German Malaga (Hospital Cayetano Heredia, Peru), Viswanathan Mohan (Dr. Mohan’s Diabetes Specialities Centre, India), and Kaushik Ramaiya (Shree Hindu Mandal Hospital, Tanzania) provided the national reports on medicines for type 2 diabetes. Marc Blockman (University of Cape Town/Groote Schuur Hospital, South Africa), Prabhakar Dorairaj (Public Health Foundation India, India), German Malaga (Hospital Cayetano Heredia, Peru) and Anthony Oyekunle (University of Botswana, Botswana) provided the national reports on novel oral anticoagulants. We thank the experts who provided technical peer reviews for draft chapters: for the case studies on chronic myeloid leukaemia and other cancers, Gilberto de Lima Lopes Junior (University of Miami, USA) and Yehoda Martei (University of Pennsylvania); for the case study on medicines for type 2 diabetes, Sylvia Kehlenbrink Oh (Brigham and Women’s Hospital, Boston, Massachusetts, USA); and for the case study on novel oral anticoagulants, Gualtiero Palareti (University of Bologna). Exploring the expansion of the Medicines Patent Pool’s mandate to patented essential medicines 3 We thank Jane Robertson and Kotoji Iwamoto (Health Technologies and Pharmaceuticals, WHO) for discussions on National Essential Medicines Lists (NEMLs) and for sharing data on NEMLs. We thank Padmaja Surapureddy and Pascale Boulet for support in collecting patent information on many of the medicines considered in the case studies of this analysis. We thank the representatives of civil society and intergovernmental organisations that provided written comments, were interviewed or shared their thoughts to inform this study: Helle Aargard, Maarten van der Heijden, and Anna Zorzet (ReAct), Manica Balasegaram (Global Antibiotic Research & Development Partnership), Thirukumaran Balasubramaniam, Andrew Goldman, Jamie Love and Diane Singhroy (Knowledge Ecology International), Peter Beyer (Public Health, Innovation and Intellectual Property, Essential Medicines and Health Products Department, WHO), Eduardo Cazap (Latin- American & Caribbean Society of Medical Oncology), Danny Edwards, Gabrielle Breugelmans and Adrian Alonso Ruiz (Access to Medicines Foundation), Jean-Luc Eisele, Jeremiah Mwangi, and Pablo Perel (World Heart Federation), Marg Ewen and Tim Reed (Health Action International), Akthem Fourati (UNICEF Supply Division), Sanne Fournier-Wendes (Unitaid), Andre Ilbawi (WHO Department for Management of Noncommunicable Diseases, Disability, Violence and Injury Prevention), Jordan Jacobson and Richard Wilder (Bill & Melinda Gates Foundation), Jordan Jarvis (Young Professionals Chronic Disease Network), Timothy Jinks and Jeremy Knox (The Wellcome Trust), Mohga Kamal-Yanni (Oxfam), Marieke Korsten (IDA Foundation), Lorenzo Moja (Essential Medicines and Health Products Department, WHO), Kevin Outterson (CARB-X), Manon Ress (Union for Affordable Cancer Treatment), Gojka Roglic (Department for Management of NCDs, Disability, Violence and Injury Prevention, WHO), Catherine Tomlinson (Cancer Alliance), Julie Torode (Union for International Cancer Control) and David Wilson (World Bank). We are grateful to the pharmaceutical companies that provided written comments and/or were interviewed to inform this study: Bristol-Myers Squibb, Celltrion, Eli Lilly and Company, Emcure Pharmaceuticals, F. Hoffmann-La Roche, Gilead Sciences, GlaxoSmithKline, Janssen, Merck KGaA, Mylan, Novo Nordisk and Sun Pharmaceuticals. We thank representatives of the Ministries of Health of Belarus, Colombia, Ecuador, Guatemala, India, South Africa, Tanzania, Thailand, Ukraine and Vietnam for helpful discussions. We thank the numerous other experts who provided useful insights, discussed with us specific parts of the feasibility study or responded to specific questions that helped to inform the study: Amitava Banerjee (Senior Lecturer in Clinical Data Science and Honorary Consultant in Cardiology, Farr Institute of Health Informatics), David Beran (Geneva University Hospitals and the University of Geneva, Switzerland), Richard Bergström (formerly European Federation of Pharmaceutical Industries and Associations), Lori Buswell (Dana-Farber Cancer Institute, USA), Franco Cavalli (Ente Ospedaliero Cantonale, Swizerland), Pamela Donggo (Makerere University, Uganda), Ellen ‘t Hoen (Medicines Law & Policy, Netherlands), Hans Hogerzeil (former Director for Essential Medicines and Pharmaceutical Policies, WHO), Andrew Hill (University of Liverpool, UK), Andrew Jenner (independent consultant, formerly International Federation of Pharmaceutical Manufacturers and Associations), Warren Kaplan (Boston Exploring the expansion of the Medicines Patent Pool’s mandate to patented essential medicines