Vaccines, Medicines and COVID-19

How Can WHO Be Given a Stronger Voice?
1. Auflage 2022
ISBN: 978-3-030-89124-4
Verlag: Springer

Buch, Englisch, 117 Seiten, Format (B × H): 155 mm x 235 mm, Gewicht: 219 g

Reihe: 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.

Zielgruppe

Professional/practitioner

Autoren/Hrsg.

Velásquez, Germán

Fachgebiete

• Technische Wissenschaften Maschinenbau | Werkstoffkunde Technische Mechanik | Werkstoffkunde Materialwissenschaft: Biomaterialien, Nanomaterialien, Kohlenstoff
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Public Health, Gesundheitsmanagement, Gesundheitsökonomie, Gesundheitspolitik
• Naturwissenschaften Chemie Chemie Allgemein
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Präventivmedizin, Gesundheitsförderung, Medizinisches Screening

Inhaltsverzeichnis

Chapter 1 COVID-19 Vaccines: Between Ethics, Health and Economics 11.1 Introduction 11.2 Development of the COVID-19 Vaccine 11.3 Two Key Issues: Immunity and Contagion 21.4 Vaccine Nationalism 21.5 The COVAX Mechanism 31.6 Compulsory Licensing 31.7 Access to Medicines and Vaccines: A New Player 3
References…………………………………………………………………………………………….#Chapter 2 Medicines and Intellectual Property: 10 Years of the WHO Global Strategy 72.1 Introduction 72.2 The Background of the IGWG Negotiations 92.3 The IGWG Stakeholders 112.4 The IGWG Process 122.4.1 The First Meeting in Geneva: 4–8 December 2006 122.4.2 Regional Consultations 132.4.3 Second Meeting, 5–10 November 2007 152.4.4 Continuation of the Second Meeting of the IGWG: 28 April to 3 May 2008 152.4.5 Sixty-First World Health Assembly, 24 May 2008 152.5 The Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property 172.5.1 Main Elements of the 2008 Global Strategy 172.5.2 Additional Mandates of the 2008 Global Strategy 172.5.3 Progress in the Implementation of the GSPOA 182.5.4 The Collaboration of the WHO with other International Organisations 192.6 The WHO Consultative Expert Working Group 202.6.1 A Binding International Convention 202.6.2 The Framework Convention on Tobacco Control 212.7 The Evaluation of the GSPOA 222.8 The Report of the United Nations Secretary-General's High-Level Panel on Access to Medicines 232.9 The Roadmap on Access to Medicines 252.9.1 Background 252.9.2 Regulatory Systems Strengthening 262.9.3 Health Research and Development 262.9.4 Intellectual Property 272.10 Resolution on “Improving the Transparency of Markets for Medicines, Vaccines and other Health-Related Technologies” 272.11 Access to Biotherapeutic Products Including Similar Biotherapeutic Products 292.12 Conclusions 30References 31Chapter 3 Re-thinking Global and Local Manufacturing of                                                      Medical Products After COVID-19 333.1 Introduction 333.2 Background: The View of UN Agencies on Pharmaceutical Production in Developing Countries 343.3 COVID-19 “Vaccine Nationalism” 373.4 COVID-19 Global Vaccine Access Facility (COVAX Facility) 423.5 Global Preparedness Monitoring Board 443.6 A COVID-19 Technology Sharing Platform: A Recent UN Initiative 463.7 Concluding Remarks 46References 47Chapter 4 Rethinking R&D for Pharmaceutical Products After                                          the Novel Coronavirus COVID-19 Shock 534.1 Introduction 534.2 Background of the Debate on the R&D Model 544.3 Problems of the R&D Model for Pharmaceutical Products 564.3.1 Lack of Transparency of R&D Costs 564.3.2 Pharmaceutical Innovation Has Significantly Decreased 574.3.3 High Prices Restrict Access 574.3.4 Fragmentation and Lack of Coordination 584.3.5 Waste and Overlap 594.4 A Binding International Convention 594.4.1 Objective and Scope 604.4.2 Possible Main Components 604.5 The Need to Act Fast 614.6 Conclusions and Recommendations 62
References…………………………………………………………………………………………….#Chapter 5 Intellectual Property and Access to Medicines and Vaccines 675.1 Introduction 675.2 The WTO TRIPS Agreement 675.3 What Is a Patent? 675.3.1 There Is no Global or International Patent 685.3.2 The Patent Cooperation Treaty 685.3.3 Validity of Patents 695.3.4 Minimum Standards of Patent Protection 705.3.5 Patents on Pharmaceutical Products 715.3.6 Patents and Access to Essential Medicines 725.4 The Doha Declaration on the TRIPS Agreement and Public Health 735.5 What Are the TRIPS Flexibilities? 745.5.1 Criteria for Patentability 755.5.2 Compulsory Licences 755.5.3 Government Use 765.5.4 Parallel Imports 765.5.5 Exceptions to Patent Rights 765.5.6 Flexibility in Test Data Protection 775.5.7 Avoidance of TRIPS-plus Provisions and Policies, Including Extension of Patent Term, Data Exclusivity, Second-Use Patents, Border Measures 775.5.8 Mitigating Implementation or Effects of TRIPS-plus Provisions 775.5.9 Exemption for LDCs 775.5.10 Pre- and Post-Patent Grant Opposition 775.5.11 Use of Competition Law to Address the Misuse of Patents 785.5.12 Disclosure Requirement, Particularly for Biologics 785.5.13 Flexibilities in Enforcement of IP 785.6 The Paragraph 6 Problem and its Solution 785.7 Impact of "TRIPS-plus" and "TRIPS Extra" Provisions 795.7.1 Extension of Patent Protection Beyond the TRIPS Minimum 795.7.2 Restrictions on the Use of Compulsory Licences 805.7.3 Data Exclusivity 805.7.4 Marketing Approval and Patent Term Linkage 805.8 Conclusions 80References 81Chapter 6 The World Health Organization Reforms in the Time of COVID-19 836.1 Introduction 836.2 Background 846.3 COVID-19 and the WHO Reform 856.3.1 Problem 1: The Public-Private Sector Dilemma 866.3.2 Problem 2: The Dilemma Between Voluntary Recommendations and Binding Instruments in the Health Field 886.3.4 Problem 3: The Dilemma Between Regulations and Humanitarian Aid 906.4 The International Health Regulations (IHR) 916.4.1 Taking a Straightforward Approach: Modifying the IHR 916.5 Non-Paper Proposals of Action 926.6 The Special Meeting of the Executive Board on 5–6 October 2020 926.7 Concluding Remarks 93
References…………………………………………………………………………………………….#
Epilogue 97

Über Autor(innen)

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.