Vaccines, Medicines And Covid-19: How Can Who Be Given A Stronger Voice? (springerbriefs In Public Health)

This open access book is a collection of research papers on COVID-19 by Germán Velásquez from 2020 and early 2021 that help to answer the question: How can an agency like the World Health Organization (WHO) be given a stronger voice to exercise authority and leadership? The considerable health, economic and social challenges that the world faced at the beginning of 2020 with COVID-19 continued and worsened in many parts of the world in the second-half of 2020 and into 2021. Many of these countries and nations wanted to explore COVID-19 on their own, sometimes without listening to the main international health bodies such as WHO, an agency of the United Nations system with long-standing experience and vast knowledge at the global level and of which all countries in the world are members. In this single volume, the chapters present the progress of thinking and debate — particularly in relation to drugs and vaccines — that would enable a response to the COVID-19 pandemic or to subsequent crises that may arise. Among the topics covered: COVID-19 Vaccines: Between Ethics, Health and Economics Medicines and Intellectual Property: 10 Years of the WHO Global Strategy Re-thinking Global and Local Manufacturing of Medical Products After COVID-19 Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock Intellectual Property and Access to Medicines and Vaccines The World Health Organization Reforms in the Time of COVID-19 Vaccines, Medicines and COVID-19: How Can WHO Be Given a Stronger Voice? is essential reading for negotiators from the 194 member countries of the World Health Organization (WHO); World Trade Organization (WTO) and World Intellectual Property Organization (WIPO) staff participating in these negotiations; academics and students of public health, medicine, health sciences, law, sociology and political science; and intergovernmental organizations and non-governmental organizations that follow the issue of access to treatments and vaccines for COVID-19. Preface Acknowledgements Contents About the Author List of Abbreviations and Acronyms Chapter 1: COVID-19 Vaccines: Between Ethics, Health and Economics 1.1 Introduction 1.2 Development of the COVID-19 Vaccine 1.3 Two Key Issues: Immunity and Contagion 1.4 Vaccine Nationalism 1.5 The COVAX Mechanism 1.6 Compulsory Licensing 1.7 Access to Medicines and Vaccines: A New Player References Chapter 2: Medicines and Intellectual Property: 10 Years of the WHO Global Strategy 2.1 Introduction 2.2 The Background of the IGWG Negotiations 2.3 The IGWG Stakeholders 2.4 The IGWG Process 2.4.1 The First Meeting in Geneva: 4–8 December 2006 2.4.2 Regional Consultations 2.4.3 Second Meeting, 5–10 November 2007 2.4.4 Continuation of the Second Meeting of the IGWG: 28 April to 3 May 2008 2.4.5 Sixty-First World Health Assembly, 24 May 2008 2.5 The Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property 2.5.1 Main Elements of the 2008 Global Strategy 2.5.2 Additional Mandates of the 2008 Global Strategy 2.5.3 Progress in the Implementation of the GSPOA 2.5.4 The Collaboration of the WHO with Other International Organisations 2.6 The WHO Consultative Expert Working Group 2.6.1 A Binding International Convention 2.6.2 The Framework Convention on Tobacco Control 2.7 The Evaluation of the GSPOA 2.8 The Report of the United Nations Secretary-General’s High-Level Panel on Access to Medicines 2.9 The Roadmap on Access to Medicines 2.9.1 Background 2.9.2 Regulatory Systems Strengthening 2.9.3 Health Research and Development 2.9.4 Intellectual Property 2.10 Resolution on ‘Improving the Transparency of Markets for Medicines, Vaccines and Other Health-Related Technologies’ 2.11 Access to Biotherapeutic Products Including Similar Biotherapeutic Products 2.12 Conclusions References Chapter 3: Rethinking Global and Local Manufacturing of Medical Products After COVID-19 3.1 Introduction 3.2 Background: The View of UN Agencies on Pharmaceutical Production in Developing Countries 3.3 COVID-19 ‘Vaccine Nationalism’ 3.4 COVID-19 Global Vaccine Access Facility (COVAX Facility) 3.5 Global Preparedness Monitoring Board 3.6 A COVID-19 Technology Sharing Platform: A Recent UN Initiative 3.7 Concluding Remarks References Chapter 4: Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock 4.1 Introduction 4.2 Background of the Debate on the R&D Model 4.3 Problems of the R&D Model for Pharmaceutical Products 4.3.1 Lack of Transparency of R&D Costs 4.3.2 Pharmaceutical Innovation Has Significantly Decreased 4.3.3 High Prices Restrict Access 4.3.4 Fragmentation and Lack of Coordination 4.3.5 Waste and Overlap 4.4 A Binding International Convention 4.4.1 Objective and Scope 4.4.2 Possible Main Components 4.5 The Need to Act Fast 4.6 Conclusions and Recommendations References Chapter 5: Intellectual Property and Access to Medicines and Vaccines 5.1 Introduction 5.2 The WTO TRIPS Agreement 5.3 What Is a Patent? 5.3.1 There Is No Global or International Patent 5.3.2 The Patent Cooperation Treaty 5.3.3 Validity of Patents 5.3.4 Minimum Standards of Patent Protection 5.3.5 Patents on Pharmaceutical Products 5.3.6 Patents and Access to Essential Medicines 5.4 The Doha Declaration on the TRIPS Agreement and Public Health 5.5 What Are the TRIPS Flexibilities? 5.5.1 Criteria for Patentability 5.5.2 Compulsory Licences 5.5.3 Government Use 5.5.4 Parallel Imports 5.5.5 Exceptions to Patent Rights 5.5.6 Flexibility in Test Data Protection 5.5.7 Avoidance of TRIPS-Plus Provisions and Policies, Including Extension of Patent Term, Data Exclusivity, Second-Use Patents, Border Measures 5.5.8 Mitigating Implementation or Effects of TRIPS-Plus Provisions 5.5.9 Exemption for LDCs 5.5.10 Pre- and Post-patent Grant Opposition 5.5.11 Use of Competition Law to Address the Misuse of Patents 5.5.12 Disclosure Requirement, Particularly for Biologics 5.5.13 Flexibilities in Enforcement of IP 5.6 The Paragraph 6 Problem and Its Solution 5.7 Impact of ‘TRIPS-Plus’ and ‘TRIPS Extra’ Provisions 5.7.1 Extension of Patent Protection Beyond the TRIPS Minimum 5.7.2 Restrictions on the Use of Compulsory Licences 5.7.3 Data Exclusivity 5.7.4 Marketing Approval and Patent Term Linkage 5.8 Conclusions References Chapter 6: The World Health Organization Reforms in the Time of COVID-19 6.1 Introduction 6.2 Background 6.3 COVID-19 and the WHO Reform 6.3.1 Problem 1: The Public-Private Sector Dilemma 6.3.2 Problem 2: The Dilemma Between Voluntary Recommendations and Binding Instruments in the Health Field 6.3.3 Article 19 of the WHO Constitution 6.3.4 Problem 3: The Dilemma Between Regulations and Humanitarian Aid 6.4 The International Health Regulations (IHR) 6.4.1 Taking a Straightforward Approach: Modifying the IHR 6.5 Non-paper Proposals of Action 6.6 The Special Meeting of the Executive Board on 5–6 October 2020 6.7 Concluding Remarks References Epilogue Index This book is a collection of research papers on COVID-19 by Germán Velásquez from 2020 and early 2021 that help to answer the question: How can an agency like the World Health Organization (WHO) be given a stronger voice to exercise authority and leadership? The considerable health, economic and social challenges that the world faced at the beginning of 2020 with COVID-19 continued and worsened in many parts of the world in the second-half of 2020 and into 2021. https://directory.doabooks.org/handle/20.500.12854/77329