The Ethical, Legal and Social Issues of Pandemics : An Analysis From the EU Perspective

This book proposes an ethical and legal framework to improve the responses to social issues related not only to the current SARS-CoV-2 pandemic, but also to future pandemics. Its contents cover the issues that are likely to be most controversial in any public health crisis. It starts by discussing non-pharmacological measures, such as the appropriateness of confinement, how to control compliance with public health measures and the ethical, legal and social acceptability of health certificates. Then it turns to issues related to the production, distribution and administration of vaccines, with a particular focus on the design and implementation of vaccination policies. Finally, it analyses the most appropriate criteria to develop a triage, when the situation brings us to this terrible scenario. The analyses presented in this book are based on the ethical and legal frameworks, as well as the social context, of the European Union, and aims to address the main dilemmas faced by any liberal democracy dealing with a pandemic: how to reconcile the defense against a public health crisis together with a respect for fundamental rights and freedoms. The European legal systems have developed a number of conceptual tools designed to ensure that there is no room for arbitrariness in the restrictions introduced by the political power in emergency situations, and this book builds upon these tools. The Ethical, Legal and Social Issues of Pandemics: An Analysis from the EU Perspective is a predominantly practice-oriented book, which will help policy makers to adopt policies that effectively combine public health needs with individual rights and freedoms. It will also help health care givers to understand better the ethical and legal issues involved in their work and citizens, in general, to participate in public decision making in an informed manner. Finally, it will help to design tools that faithfully comply with existing fundamental rights standards. Foreword 6 This Time Is Different? A New Book on the Ethical, Legal and Social Issues of Pandemics 6 Preface 9 Acknowledgements 13 Contents 15 Chapter 1: Confinement, Isolation and Tracking 19 1.1 Introduction 19 1.2 Mitigation and Eradication: The Facts 21 1.2.1 Introduction 21 1.2.2 The Economic Cost 21 1.2.3 Health Costs 22 1.2.4 Costs for Minors 24 1.3 Ethical, Legal, Political Analysis 24 1.4 Test, Isolation and Adherence 28 1.5 Technology to Our Aid: Geospatial Data as a Response Tool 31 1.5.1 Introduction 31 1.5.2 The Use of Location Data and in the EU Context 32 1.5.3 Proximity Data 34 1.5.4 Tagging Venues 37 References 39 Chapter 2: Immunity Certificates: The New Frontier 42 2.1 Introduction 42 2.1.1 Definition and Typologies of Health Certificates 43 2.2 Certificates of Immunity in the Absence of Vaccinations or Diagnostic Tests 45 2.2.1 The Question of Scientific Certainty 46 2.2.2 The Privilege 47 2.2.3 The Promotion of Inappropriate Behaviour (Voluntary Contagion) 49 2.2.4 Public Order Problems 51 2.2.5 Concluding Remarks 51 2.3 Health Certificates When Vaccines and/or Screening Tests Are Already Available to the General Population 52 2.3.1 Introduction 52 2.3.2 The Discrimination Argument 54 2.3.3 The Equity Problem 55 2.3.4 The Proportionality of the Measure 58 2.3.5 Other Considerations: The Possibility of Counterfeiting and Fraud 60 2.4 The Issue of Personal Data 61 2.5 Organic Disability: Privileges for the Vulnerable? 63 References 65 Chapter 3: Vaccines (I): Creation and Distribution 67 3.1 Introduction 67 3.2 Clinical Trials and Their Alternatives 68 3.2.1 Introduction: Clinical Trials in Times of Pandemic 68 3.2.2 Placebo Groups and Approved Vaccines 69 3.2.3 Challenge Studies or Exposure Studies 71 3.3 Patents and Other Intellectual Property Rights (Data Rights/Industrial Secrecy) 73 3.3.1 Introduction 73 3.3.2 The Legal Regime of Intellectual Property: An Overview 74 3.3.3 Other Forms of Industrial Property Protection: Data and the 8 + 2 + 1 Rule 76 3.3.4 The Introduction of Waivers on Intellectual Property-Related Rights 77 3.3.5 Licences and Suspensions: The Arguments 78 3.3.6 Concluding Remarks: Pros and Cons of the Different Options and Difficulties Underlying Any of Them 80 3.4 The Question of Distribution: Vulnerability and Imminence of the Risk 81 3.4.1 The Distribution of Vaccines Between Countries: Equity and Utility 82 3.4.2 The Distribution of Vaccines Between Countries: Where Are They Most Needed First? 84 References 84 Chapter 4: Vaccination (II): Vaccination Policies 88 4.1 Introduction 88 4.2 Compulsory (or Not) Nature of Vaccines: Questions of Morality 89 4.2.1 Compulsory Nature “For Your Own Good”: The Seat Belt Analogy 90 4.2.2 Compulsory Nature as a Way of Breaking the Chains of Contagion 94 4.2.3 Mandatory Nature as a Way to Save Public Resources 97 4.2.4 Moral Consideration of the Obligatory Nature of Vaccines: Concluding Remarks 98 4.3 The Obligatory (or Not) Nature of Vaccines: Legal Issues 98 4.4 Health Policies: An Analysis of the Different Options Available 103 4.4.1 Proactive Measures to Increase Vaccination: Persuasion, Manipulation and Incentives 104 4.4.2 Classical Compulsory Measures: Vaccination Policies Based on Sanctions (Mandatory Vaccination) 106 4.4.3 Reimbursement of Health-Care Costs: The Singapore Proposal 108 4.4.4 Coercive Systems or Forced Vaccination Systems 112 4.4.5 Different Systems for Different Collectives? 112 4.5 Concluding Remarks: What Vaccination Policies Are Relevant in a Public Health Crisis? 114 4.6 Addenda: Vaccination as a Factor to be Included in Triage Protocols 115 References 117 Chapter 5: Triage: When the Tsunami Hits 121 5.1 Introduction 121 5.2 Emergency Triage: Description 122 5.3 Distinguishing Triage from Not Triage 124 5.3.1 Patients Do Not Need the Resource 124 5.3.2 Patients Do Not Wish to Be Administered the Remedy or Are Willing to Forgo It for Altruistic Reasons 125 5.3.3 Available Resources Can Be Increased to Meet Demand 126 5.4 Different Possible Objectives 127 5.5 The Objectives 128 5.6 Equity Criteria 130 5.6.1 Preference for Socially Vulnerable People 131 5.6.2 Preference for Risky Professions 133 5.6.3 The Fair Innings 134 5.6.4 The Child’s Best Interests 135 5.7 Rules for the Implementation of the Criteria 136 5.7.1 Preference for Those Who Show the Best Ratio Between the Probability of Salvation and the Time of Use of the Resource 136 5.7.2 “First Come, First Served” 137 5.7.3 The Draw 138 5.7.4 The Compensation System: The “Weighed Lotteries” 139 5.8 Should the Reservation or Reallocation of Resources Be Accepted or Even Promoted? 141 5.8.1 The Reservation of Resources Is Unacceptable 141 5.8.2 To Reassign Is to Kill? 142 5.8.3 Other Arguments 146 5.8.4 Reallocating Resources: Final Considerations 147 5.9 A Combined Resource Allocation Model: Mixing Equity and Efficiency 149 5.10 Operational Standards: Who Is to Control the Allocation of Resources? How to Decide Which Criteria Are to Be Applied? 150 5.10.1 Response Planning in General 150 5.10.2 Decision-Making on the Individual Patient 151 References 153 Index 159