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