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Accelerating Access to Hepatitis C Diagnostics and Treatment Accelerating access to hepatitis C diagnostics and treatment Overcoming barriers in low- and middle-income countries Global progress report 2020 Accelerating access to hepatitis C diagnostics and treatment Overcoming barriers in low- and middle-income countries Global progress report 2020 Accelerating access to hepatitis C diagnostics and treatment: overcoming barriers in low- and middle-income countries. Global progress report 2020 ISBN 978-92-4-001900-3 (electronic version) ISBN 978-92-4-001901-0 (print version) © World Health Organization 2021 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non- commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules/). Suggested citation. Accelerating access to hepatitis C diagnostics and treatment: overcoming barriers in low- and middle-income countries. Global progress report 2020. Geneva: World Health Organization; 2021. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Layout by 400 Communications. iii Contents Acknowledgements iv Abbreviations and acronyms v Executive summary vii I Introduction 1 II Overview of the global hepatitis C epidemic and response 5 III Progress in 12 selected countries 11 IV Key enablers for accelerating towards universal access to hepatitis C diagnostics and treatment 19 IV.1 Availability: Simplified norms and standards, more and improved product options 20 IV.2 Quality: Meeting quality assurance and product regulation standards 21 IV.3 Affordability: Lowering prices and patent-related barriers 25 IV.4 Equity: Addressing the needs of key and vulnerable populations 34 IV.5 Efficiency: Leveraging opportunities for procurement, financing and service delivery 36 V Future priorities 39 Annexes 42 Annex 1: Drug profiles 43 Annex 2: Summary of the DAA procurement situation in selected low- and middle-income countries with a high burden of hepatitis C, 2019 52 Annex 3: Low- and middle-income countries and areas not included in at least one voluntary licensing agreement, 2020 55 References 58 iv Accelerating access to hepatitis C diagnostics and treatment: overcoming barriers in low- and middle-income countries. Global progress report 2020 Acknowledgements This publication was developed jointly by the Global HIV, Hepatitis and STIs Programmes (HHS) and the Division on Access to Medicines and Health Products (MHP) of the World Health Organization (WHO). The process was led by Françoise Renaud and Erika Dueñas Loayza, and coordinated by Daniel Low-Beer and Clive Ondari. The contributions of Fernando Pascual Martinez, who managed the data collection and conducted the interviews, Emmanuel Fajardo who conducted research on diagnostics, and Parijat Baijal, who was the lead writer, are gratefully acknowledged. We particularly thank colleagues in ministries of health and in WHO regional and country offices for their contributions, as well as Fuqiang Cui, Boniface Dongmo Nguimfack, Philippa Easterbrook, Olufunmilayo Lesi, Niklas Luhmann, Gilles Forte, Kiu Siang Tay, Adriana Velazquez Berumen, Deusdedit Mubangizi, Maria Mercedes Perez Gonzalez, Irena Prat, Anita Sands, Dzintars Gotham and Nicole Homb from WHO headquarters. Bandana Malhotra edited the report. We are grateful to Meg Doherty, Minghui Ren and Mariângela Simão for their overall support and leadership. The following persons were interviewed for the report: François Bompart (Drugs for Neglected Diseases initiative, Switzerland), Esteban Burrone (Medicines Patent Pool, Switzerland), Jessica Burry (Médecins Sans Frontières, Switzerland), Jean Michel Caudron (United Nations Development Programme, Switzerland), Lorena Di Giano (Redla Red Latinoamericana por el Acceso a Medicamentos), Khalil Elouardighi (Coalition PLUS, Paris, France), Gamal Esmat (Cairo University, Egypt), Charles Gore (Medicines Patent Pool, Switzerland), Andrew Hill (University of Liverpool, United Kingdom), Priti Krishtel (I-Mak, United States of America), Vidhi Lohia (Clinton Health Access Initiative), Pauline Londeix (Observatoire pour la Transparence, France), Cécile Macé (United Nations Development Programme, Switzerland), Amina Maillard (Medicines Patent Pool), Mila Maistat (Medicines Patent Pool), Craig McClure (Clinton Health Access Initiative), Leena Menghaney (Médecins Sans Frontières, India), Othoman Mellouk (International Treatment Preparedness Coalition, Morocco), Sonjelle Shilton (Foundation for Innovative New Diagnostics), Ellen ‘t Hoen (Medicines Law & Policy, The Netherlands), Karin Timmermans (Unitaid, Switzerland), Pedro Villardi (Grupo de Trabalho sobre Propriedade Intelectual, Brazil), Marcela Vieira (Graduate Institute, Switzerland) and Ernst Wisse (Médecins du Monde, France). We are also grateful to colleagues in the Clinton Health Access Initiative, the Foundation for Innovative New Diagnostics, the Medicines Patent Pool and Unitaid for their comments during the finalization of the report. Financial acknowledgments Funding support for the development of the report was kindly provided by Unitaid. WHO also thanks the other institutions that provided staff time and made other contributions to the production of the report. v Abbreviations and acronyms APH Alliance for Public HIV human Health Ukraine immunodeficiency virus API active pharmaceutical ingredient IVD in vitro diagnostics APRI aspartate LDV ledipasvir aminotransferase-to- MDM Médecins du Monde platelet ratio index MSF Médecins Sans BMS Bristol-Myers Squibb Frontières Clinton Health Access CHAI MoH Ministry of Health Initiative MPP Medicines Patent Pool COVID-19 coronavirus disease 2019 MSM men who have sex with men DAA direct-acting antiviral (medicine) NAT nucleic acid testing DCV daclatasvir PCR polymerase chain reaction DNDi Drugs for Neglected Diseases initiative POC point of care EASL European Association PWID people who inject drugs for the Study of the RDT rapid diagnostic test Liver RNA ribonucleic acid EMA European Medicines Agency SDGs Sustainable Development Goals EPO European Patent Office STI sexually transmitted ERP Expert Review Panel infection FAS Federal Antimonopoly TB tuberculosis Service (Russian Federation) TRIPS Agreement on Trade- Related Aspects of FIND Foundation for Intellectual Property Innovative New Rights Diagnostics UNDP United Nations Global Fund the Global Fund Development to Fight AIDS, Programme Tuberculosis and Malaria USA United States of America GNI gross national income US FDA United States Food and Drug Administration G/P glecaprevir/pibrentasvir WHO World Health HBV hepatitis B virus Organization HCV hepatitis C virus vi © WHO/NOOR/Sebastian Liste Executive summary vii Executive summary The 2020 global report on access to hepatitis C Some champion countries are leading the way and have
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