Vaccines, Medicines and Covid-19: How Can Who Be Given a Stronger Voice?

ISBN-13: 9783030891244 / Angielski / Miękka / 2021 / 136 str.

Germán Velásquez

Opis

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.

Spis treści

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

O autorze

Germán Velásquez is, since 2010, the Special Adviser for Policy and Health of the South Centre in Geneva, Switzerland, which is an intergovernmental think tank of and for developing countries.  

Until May 2010, he was Director of the World Health Organization (WHO) Secretariat on Public Health, Innovation and Intellectual Property, at the Director-General’s Office, in Geneva. He is a pioneer in the new area on health, intellectual property and access to medicines, and he represented WHO at the World Trade Organization (WTO) Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) from 2001 to 2010.

Germán Velásquez graduated from Javeriana University, Bogotá, Colombia, with a degree in Philosophy and Humanities that was further complemented by a Master’s in Economics and a PhD in Health Economics from the Sorbonne University in Paris, France. In 2010, he received a PhD Honoris Causa on Public Health from the University of Caldas, Colombia. In October 2015, he received a Honoris Causa Doctorate from the Faculty of Medicine of the Complutense University of Madrid, Spain.

Germán Velásquez is author or co-author of numerous publications on subjects such as health economics and medicines, health insurance schemes, globalisation, international trade agreements, intellectual property and access to medicines.