Chapter 1 COVID-19 Vaccines: Between Ethics, Health and Economics 1
1.1 Introduction 1
1.2 Development of the COVID-19 Vaccine 1
1.3 Two Key Issues: Immunity and Contagion 2
1.4 Vaccine Nationalism 2
1.5 The COVAX Mechanism 3
1.6 Compulsory Licensing 3
1.7 Access to Medicines and Vaccines: A New Player 3
References…………………………………………………………………………………………….#
Chapter 2 Medicines and Intellectual Property: 10 Years of the WHO Global Strategy 7
2.1 Introduction 7
2.2 The Background of the IGWG Negotiations 9
2.3 The IGWG Stakeholders 11
2.4 The IGWG Process 12
2.4.1 The First Meeting in Geneva: 4–8 December 2006 12
2.4.2 Regional Consultations 13
2.4.3 Second Meeting, 5–10 November 2007 15
2.4.4 Continuation of the Second Meeting of the IGWG: 28 April to 3 May 2008 15
2.4.5 Sixty-First World Health Assembly, 24 May 2008 15
2.5 The Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property 17
2.5.1 Main Elements of the 2008 Global Strategy 17
2.5.2 Additional Mandates of the 2008 Global Strategy 17
2.5.3 Progress in the Implementation of the GSPOA 18
2.5.4 The Collaboration of the WHO with other International Organisations 19
2.6 The WHO Consultative Expert Working Group 20
2.6.1 A Binding International Convention 20
2.6.2 The Framework Convention on Tobacco Control 21
2.7 The Evaluation of the GSPOA 22
2.8 The Report of the United Nations Secretary-General's High-Level Panel on Access to Medicines 23
2.9 The Roadmap on Access to Medicines 25
2.9.1 Background 25
2.9.2 Regulatory Systems Strengthening 26
2.9.3 Health Research and Development 26
2.9.4 Intellectual Property 27
2.10 Resolution on “Improving the Transparency of Markets for Medicines, Vaccines and other Health-Related Technologies” 27
2.11 Access to Biotherapeutic Products Including Similar Biotherapeutic Products 29
2.12 Conclusions 30
References 31
Chapter 3 Re-thinking Global and Local Manufacturing of Medical Products After COVID-19 33
3.1 Introduction 33
3.2 Background: The View of UN Agencies on Pharmaceutical Production in Developing Countries 34
3.3 COVID-19 “Vaccine Nationalism” 37
3.4 COVID-19 Global Vaccine Access Facility (COVAX Facility) 42
3.5 Global Preparedness Monitoring Board 44
3.6 A COVID-19 Technology Sharing Platform: A Recent UN Initiative 46
3.7 Concluding Remarks 46
References 47
Chapter 4 Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock 53
4.1 Introduction 53
4.2 Background of the Debate on the R&D Model 54
4.3 Problems of the R&D Model for Pharmaceutical Products 56
4.3.1 Lack of Transparency of R&D Costs 56
4.3.2 Pharmaceutical Innovation Has Significantly Decreased 57
4.3.3 High Prices Restrict Access 57
4.3.4 Fragmentation and Lack of Coordination 58
4.3.5 Waste and Overlap 59
4.4 A Binding International Convention 59
4.4.1 Objective and Scope 60
4.4.2 Possible Main Components 60
4.5 The Need to Act Fast 61
4.6 Conclusions and Recommendations 62
References…………………………………………………………………………………………….#
Chapter 5 Intellectual Property and Access to Medicines and Vaccines 67
5.1 Introduction 67
5.2 The WTO TRIPS Agreement 67
5.3 What Is a Patent? 67
5.3.1 There Is no Global or International Patent 68
5.3.2 The Patent Cooperation Treaty 68
5.3.3 Validity of Patents 69
5.3.4 Minimum Standards of Patent Protection 70
5.3.5 Patents on Pharmaceutical Products 71
5.3.6 Patents and Access to Essential Medicines 72
5.4 The Doha Declaration on the TRIPS Agreement and Public Health 73
5.5 What Are the TRIPS Flexibilities? 74
5.5.1 Criteria for Patentability 75
5.5.2 Compulsory Licences 75
5.5.3 Government Use 76
5.5.4 Parallel Imports 76
5.5.5 Exceptions to Patent Rights 76
5.5.6 Flexibility in Test Data Protection 77
5.5.7 Avoidance of TRIPS-plus Provisions and Policies, Including Extension of Patent Term, Data Exclusivity, Second-Use Patents, Border Measures 77
5.5.8 Mitigating Implementation or Effects of TRIPS-plus Provisions 77
5.5.9 Exemption for LDCs 77
5.5.10 Pre- and Post-Patent Grant Opposition 77
5.5.11 Use of Competition Law to Address the Misuse of Patents 78
5.5.12 Disclosure Requirement, Particularly for Biologics 78
5.5.13 Flexibilities in Enforcement of IP 78
5.6 The Paragraph 6 Problem and its Solution 78
5.7 Impact of "TRIPS-plus" and "TRIPS Extra" Provisions 79
5.7.1 Extension of Patent Protection Beyond the TRIPS Minimum 79
5.7.2 Restrictions on the Use of Compulsory Licences 80
5.7.3 Data Exclusivity 80
5.7.4 Marketing Approval and Patent Term Linkage 80
5.8 Conclusions 80
References 81
Chapter 6 The World Health Organization Reforms in the Time of COVID-19 83
6.1 Introduction 83
6.2 Background 84
6.3 COVID-19 and the WHO Reform 85
6.3.1 Problem 1: The Public-Private Sector Dilemma 86
6.3.2 Problem 2: The Dilemma Between Voluntary Recommendations and Binding Instruments in the Health Field 88
6.3.4 Problem 3: The Dilemma Between Regulations and Humanitarian Aid 90
6.4 The International Health Regulations (IHR) 91
6.4.1 Taking a Straightforward Approach: Modifying the IHR 91
6.5 Non-Paper Proposals of Action 92
6.6 The Special Meeting of the Executive Board on 5–6 October 2020 92
6.7 Concluding Remarks 93
References…………………………………………………………………………………………….#
Epilogue 97