Vaccines, Medicines and COVID-19. How Can WHO Be Given a Stronger Voice?

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