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Thesis

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The promotion of public health in EU external relations

RUIZ CAIRO, Elisabet

Abstract

This research examines how the European Union promotes public health in its external relations and evaluates the effectiveness of such action. The study aims at two sub-objectives: an examination of the constitutional framework governing EU public health, with a particular emphasis on its external dimension, and an assessment of the factors influencing the effectiveness of the promotion of EU public health at the global level. While the research attempts to undertake a horizontal study of EU public health, it is illustrated by numerous case studies. These include the Union's external promotion of tobacco-control legislation, its role in the fight against cross-border health threats, the balance of trade interests and public health in bilateral trade and investment agreements, and the position of the Union towards intellectual property rights and public health at the WTO.

RUIZ CAIRO, Elisabet. The promotion of public health in EU external relations. Thèse de doctorat : Univ. Genève, 2020, no. D. 1001

DOI : 10.13097/archive-ouverte/unige:148612 URN : urn:nbn:ch:unige-1486120

Available at:

http://archive-ouverte.unige.ch/unige:148612

Disclaimer: layout of this document may differ from the published version.

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The promotion of public health in EU external relations

PhD Thesis

Thesis submitted for assessment in view to obtaining the degree of Doctor of Laws of the University of Geneva

ElisabetRUIZ CAIRÓ

Under the supervision of Professor Christine KADDOUS

Imprimatur No1001

UNIVERSITY OF GENEVA

2020

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Acknowledgements

This work is first and foremost dedicated to the two women that have inspired and encouraged me during my time researching at the University of Geneva. I would first like to thank Professor Christine KADDOUS, my thesis supervisor, for her insight, her patience and her contribution to this work. She has supported me throughout the process and has given me the opportunity to grow in the department and to participate in several activities that have contributed to the final result of this thesis. I would then like to dedicate this work to my mother, whose strength and determination have inspired me through my whole life. She has supported me in all my academic achievements and has encouraged me to pursue this thesis.

I am truly grateful to my examining board, composed by Professors Estelle BROSSET, Luis Miguel HINOJOSA MARTINEZ and Nicolas LEVRAT, for taking the time to read my thesis and to participate in the defense despite the difficult circumstances. I enjoyed our lively discussion and their comments have had a significant influence in the final version of this thesis. I would also like to thank Professor Maya HERTIG for presidig the session.

I would finally want to thank all the people that have supported me at different stages of this experience. I would like to thank those who were my first inspiration for writing a PhD thesis, the academic team at the College of Europe. I am also grateful to all the people that have supported me with the practical aspects of writing a PhD thesis: the Faculty of Law of the University of Geneva for creating a stimulating working environment for PhD researchers, Megumi MOSCA for helping with the administrative formalities and for being always there to help, and Anouchka OFFENSTEIN for her help with bibliographic matters. I have also been very fortunate to work with a wonderful team at the Centre d’études juridiques européennes. I would especially like to thank Margaux BIERMÉ for all our brainstorming sessions, for making sure that I persevered in difficult times and for her collaboration in all tasks unrelated with the thesis.

She has been a friend rather than a colleague. I have had the chance to work next to many other PhD students who have taught me that there is law beyond EU law and have introduced me to Swiss law. In particular, I would like to thank Margaux TERRADAS and Camille VALLIER, for the coffee breaks, the ski breaks, and the wonderful years spent together. I lastly wish to express my gratitude to all the people in Geneva who have made my years here so pleasant and who have taught me to love this city and the opportunities it offers.

The thesis is updated by the end of December 2020.

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Table of contents

ACKNOWLEDGEMENTS ... iii

TABLE OF CONTENTS ... v

SUMMARY ... xiii

LIST OF ABBREVIATIONS ... xv

INTRODUCTION. The definition of public health and its position in the European Union ... 1

SECTION I. CONCEPTUAL AND HISTORICAL BACKGROUND TO THE RESEARCH ... 4

I. KEY CONCEPTS OF THE RESEARCH ... 4

A. Health ... 4

B. Public health ... 6

C. Global health ... 8

II. EVOLUTION OF EU PUBLIC HEALTH: POLITICAL AND LEGAL ASPECTS ... 9

A. Early concerns regarding public health ... 10

B. Public health as a justification to barriers to the internal market ... 11

C. Public health as an autonomous field ... 13

SECTION II. RESEARCH QUESTION... 17

SECTION III. RELEVANCE OF THE TOPIC ... 19

SECTION IV. METHODOLOGY AND STRUCTURE ... 21

PART I. Fragmentation in the EU public health constitutional framework ... 25

SECTION I. LEGAL BASES IN EU PUBLIC HEALTH ... 27

I. ASYMMETRY BETWEEN EU PUBLIC HEALTH OBJECTIVES AND COMPETENCES ... 27

A. EU public health objectives ... 28

B. EU public health competences under Article 168 TFEU ... 30

1. EU internal public health competence ... 30

2. EU external public health competence ... 32

II. FROM COMPETENCE GAP TO COMPETENCE CREEP?ALTERNATIVE LEGAL BASES TO LEGISLATE IN EU PUBLIC HEALTH ... 33

A. The unsuitability of the flexibility clause as a legal basis ... 34

1. Evolution of the conditions in the flexibility clause ... 34

2. Interpretation of the flexibility clause by the CJEU... 35

B. The appropriateness of Article 114 TFEU as a legal basis ... 37

1. Article 114 TFEU and public health protection ... 37

2. Limits to the use of Article 114 TFEU for public health reasons ... 38

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3. The mainstreaming of Article 114 TFEU as an alternative legal basis for public health measures ... 40

a. Article 114 TFEU in the early case law on tobacco control ... 40

b. Recent case law on tobacco control ... 41

c. Article 114 TFEU as a legal basis for the conclusion of international agreements... 43

C. Other legal bases for the adoption of public health measures ... 45

1. Common Agricultural Policy ... 45

2. EU environmental policy ... 46

CONCLUSIONS ON SECTION I... 47

SECTION II. INSTITUTIONAL FRAGMENTATION IN EU PUBLIC HEALTH... 49

I. INTERNAL FRAGMENTATION IN EU PUBLIC HEALTH ... 49

A. Inter-institutional and intra-institutional fragmentation... 50

1. Inter-institutional fragmentation ... 50

a. The BSE crisis as a turning point in the institutional structure of EU public health ... 50

b. Role of EU institutions in public health ... 52

2. Intra-institutional fragmentation ... 55

B. EU agencies in the public health institutional framework ... 56

1. EU agencies as an additional layer of fragmentation in EU public health ... 56

a. The increasing number of EU agencies ... 57

b. The contested role of EU agencies ... 58

i. Nature of EU agencies scientific opinions: from advisory opinions to binding acts ... 58

ii. Challenges against EU agencies’ scientific opinions ... 59

2. EU agencies as an opportunity for the global promotion of public health ... 61

a. Participation-cooperation: agencies’ activities beyond the borders of the European Union ... 61

i. Cooperation instruments between EU agencies and third parties ... 61

ii. Legal nature of cooperation instruments between EU agencies and third parties ... 63

b. Participation-integration: the integration of third countries in EU agencies ... 65

II. HETEROGENEOUS PARTICIPATION OF THE EUROPEAN UNION IN INTERNATIONAL ORGANISATIONS AND AGREEMENTS ... 67

A. Participation in international organisations ... 67

1. The European Union as a full member in international organisations and its implications ... 68

a. The European Union as a full member: the examples of the FAO, the Codex Alimentarius Commission and the WTO ... 68

i. Food and Agriculture Organization ... 68

ii. Codex Alimentarius Commission... 69

iii. World Trade Organization ... 70

b. Implications of the full-membership status ... 70

i. The complex exercise of voting rights at the FAO ... 71

ii. The smooth exercise of voting rights at the WTO ... 73

2. The European Union as an observer: the example of the World Health Organization ... 74

a. Rights and obligations of the European Union at the World Health Organization ... 74

b. Can the European Union become a full member to the WHO? ... 76

B. Negotiation and conclusion of international agreements ... 79

1. The European Union as a contracting party to international agreements ... 79

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2. Member States as contracting parties to international agreements ... 81

CONCLUSIONS ON SECTION II ... 82

SECTION III. IMPACT OF FRAGMENTATION ON THE CONSISTENCY PRINCIPLE ... 84

I. THE PRINCIPLE OF CONSISTENCY IN EU LAW ... 84

A. Evolution of the principle of consistency in EU law ... 84

B. Obligations under the principle of consistency ... 85

1. Vertical and horizontal consistency ... 86

2. Positive and negative consistency... 87

II. THE PRINCIPLE OF CONSISTENCY IN EU PUBLIC HEALTH ... 88

A. Horizontal and vertical consistency in EU public health ... 89

1. Horizontal consistency in EU public health ... 89

2. Vertical consistency in EU public health ... 90

B. Positive and negative consistency in EU public health ... 92

III.ADDING ONE MORE PIECE TO THE PUZZLE: CONSISTENCY AT THE GLOBAL LEVEL ... 93

A. Potential conflicts between the WHO, the WTO and the Codex Alimentarius Commission ... 94

1. Conflicts between WHO agreements and WTO agreements ... 94

2. Conflicts between WTO agreements and international public health standards ... 95

B. Potential solutions to the conflicts of norms at the global level ... 96

1. Balancing the different interests at stake ... 96

2. Private international law rules of interpretation ... 97

3. The ‘Bosphorus’ solution ... 97

4. Other international agreements as international standards ... 98

5. Rule of harmonious interpretation ... 98

6. Cooperation mechanisms between international organisations ... 98

CONCLUSIONS ON SECTION III ... 99

GENERAL CONCLUSION ON PART I ... 100

PART II. The promotion of EU public health in the convergence scenario ... 103

SECTION I. THE PROMOTION OF PUBLIC HEALTH AS A RESPONSE TO SECURITY CHALLENGES: THE CASE OF CROSS-BORDER HEALTH THREATS ... 106

I. CONVERGENCE AT THE EU AND AT THE GLOBAL LEVELS REGARDING THE PROTECTION OF PUBLIC HEALTH FOR SECURITY REASONS ... 108

A. Foundations of the regulation of communicable diseases in Europe ... 108

B. Internationalisation and securitisation of cross-border health threats control ... 110

C. Regulation of cross-border health threats in the European Union ... 112

1. Notion of cross-border health threats ... 113

2. EU policy on cross-border health threats: from a securitarian to a ‘one-health’ approach ... 115

a. A securitarian approach towards cross-border health-threats ... 115

i. The Health Security Committee as the first attempt to link health and security ... 116

ii. The European Centre on Disease Prevention and Control: a more formalised approach to health security ... 117

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iii. The contribution of EU institutions to the promotion of the health-security linkage ... 118

b. A ‘one health’ approach towards cross-border health threats ... 120

3. Surveillance and response system to cross-border health threats ... 123

a. Surveillance system to cross-border health threats ... 124

b. Response mechanism to cross-border health threats ... 125

II. THE PROMOTION OF PUBLIC HEALTH THROUGH THE LENS OF SECURITY IN BILATERAL AGREEMENTS: THE EXAMPLE OF THE EUROPEAN NEIGHBOURHOOD POLICY ... 128

A. Goals of the European Neighbourhood Policy: security as a pillar ... 129

B. EU public health actions in the neighbourhood ... 130

1. The security-oriented discourse towards cross-border health threats in the European Neighbourhood Policy . 132 2. Surveillance systems for cross-border health threats in the European region ... 133

C. Is there room for improvement? ... 134

III.THE PROMOTION OF PUBLIC HEALTH SECURITY STANDARDS AT THE MULTILATERAL LEVEL: THE NEGOTIATION OF THE INTERNATIONAL HEALTH REGULATIONS ... 136

A. The International Health Regulations as a multilateral response to cross-border health threats ... 137

B. EU participation in the negotiation and implementation of the IHR ... 139

1. EU participation in the negotiation of the IHR ... 140

2. EU role in the implementation of the IHR ... 142

C. Prospective role of the European Union at the multilateral level ... 144

IV.THE SUCCESSFUL PROMOTION OF EU STANDARDS ON CROSS-BORDER HEALTH THREATS: THE CASE OF ANTIMICROBIAL RESISTANCE ... 145

A. Convergence at the EU and at the global levels in the field of antimicrobial resistance... 146

1. EU actions on antimicrobial resistance: multiple standards for a coherent action plan ... 147

a. EU standards in antimicrobial resistance ... 147

i. Antimicrobial resistance and the health-security linkage ... 147

ii. A variety of concerns on antimicrobial resistance ... 148

b. A comprehensive approach towards antimicrobial resistance ... 149

i. EU competence in the field of antimicrobial resistance ... 149

ii. Development of a holistic approach towards antimicrobial resistance ... 151

2. Global approach on antimicrobial resistance: a strong interest and a patchwork of actions ... 153

a. Priorities on AMR at the World Health Organization ... 153

b. Difficulties to a coherent action on AMR at the global level ... 155

B. Role of the European Union at shaping international standards ... 157

1. The role of the European Union at the global level as an opportunity and a requirement ... 157

2. AMR clauses in bilateral agreements ... 158

3. The European Union as a key actor at the multilateral level ... 160

CONCLUSIONS ON SECTION I... 162

SECTION II. THE PROMOTION OF PUBLIC HEALTH BEYOND SECURITY: THE CASE OF NON- COMMUNICABLE DISEASES ... 165

I. THE EUROPEAN UNION AND THE FIGHT AGAINST TOBACCO CONSUMPTION ... 166

A. Convergence at the EU and at the global levels in tobacco control ... 166

1. EU expertise in tobacco control ... 166

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a. Shadows in the EU tobacco-control system ... 167

b. EU tobacco-control legislation ... 169

2. The international momentum for tobacco-control measures ... 173

B. EU role in the negotiation and implementation of the Framework Convention on Tobacco Control .. 175

1. Difficulties in the participation of the European Union in the negotiation of the FCTC ... 176

a. EU competence in the field of tobacco control ... 176

b. Status of Regional Economic Integration Organisations in the negotiation and conclusion of the FCTC .. 177

2. EU leadership during the negotiation of the FCTC ... 178

a. Obstacles to an EU common approach in the FCTC negotiations ... 178

b. Overcoming the challenges: the European Union as a positive force during the negotiations ... 180

3. EU commitment in the implementation of the FCTC ... 182

a. Implementation of the FCTC at the global level ... 182

b. Implementation of the FCTC at the EU level ... 184

II. THE PROMOTION OF HEALTHY DIETS AT THE INTERNATIONAL LEVEL:WHAT ROLE FOR THE EUROPEAN UNION? ... 187

A. Convergence at the EU and at the global levels towards the promotion of healthy diets ... 187

1. EU actions in the fight against obesity ... 187

a. The promotion of the internal market and the fight against obesity ... 188

b. Examining the validity of ‘sugar taxes’ under EU law ... 189

c. Soft law instruments to fight against obesity ... 191

2. Global actions in the fight against obesity ... 192

a. Existing measures in the fight against obesity ... 193

b. The need for a legally binding multilateral convention ... 194

B. Implications for the promotion of EU standards at the global level in the fight against obesity ... 196

CONCLUSIONS ON SECTION II ... 197

GENERAL CONCLUSION ON PART II ... 199

PART III. The promotion of EU public health in the divergence scenario ... 201

SECTION I. THE PROMOTION OF EU PUBLIC HEALTH STANDARDS IN THE TRADE OF GOODS ... 204

I. DIVERGENCE BETWEEN THE EUROPEAN UNION AND THIRD PARTIES IN THE BALANCE BETWEEN THE TRADE OF GOODS AND PUBLIC HEALTH ... 205

A. The precautionary principle in EU law... 206

1. Genesis of the precautionary principle in the European Union... 206

2. Interpretation of the precautionary principle by the CJEU ... 207

a. Recognition and definition of the precautionary principle ... 207

b. Conditions for the application of the precautionary principle ... 209

B. The contested nature of the precautionary principle at the global level ... 211

1. The precautionary principle in international agreements ... 211

a. Development of the precautionary principle in multilateral environmental agreements ... 211

b. Limits to the precautionary principle in WTO agreements ... 213

i. SPS Agreement ... 213

ii. GATT 1994 ... 215

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iii. TBT Agreement ... 216

2. The precautionary principle in a comparative perspective ... 217

C. Implications of the divergent approaches for trade negotiations... 220

1. Risks to public health protection in the procedural features of the EU trade policy ... 220

2. The limited promotion of non-trade interests at the World Trade Organization ... 221

a. The failed incorporation of non-trade interests during the Doha Round negotiations ... 221

b. Litigation resulting from divergent regulatory approaches ... 222

3. Risks to public health protection in EU bilateral trade and investment agreements ... 223

a. Regulatory convergence and its impact on the precautionary principle ... 223

i. TBT and SPS chapters: the crystallization of WTO rules ... 223

ii. TSD chapters: a weak attempt to preserve non-trade interests ... 224

iii. Equivalence of legislation: the circumvention of the obligation to respect regulatory standards . 227 iv. Regulatory cooperation: the development of a unique regulatory approach... 227

b. Risks to public health in bilateral investment agreements ... 229

i. Status of the right to regulate in investment agreements ... 229

ii. The investor-State arbitration system and its risk to the preservation of public interests ... 230

iii. Lack of participation of third parties to the proceedings ... 231

c. Litigation resulting from the risks of bilateral trade agreements to public health ... 232

II. TRADE AS A TOOL TO PROMOTE PUBLIC HEALTH ... 234

A. EU influence in multilateral negotiations ... 235

1. EU influence in the negotiation of trade-related multilateral environmental agreements ... 235

2. The right to regulate in the negotiation of a multilateral investment court ... 237

B. Protecting public health in bilateral trade and investment agreements ... 238

1. Public health protection through the procedural features of the Common Commercial Policy ... 239

a. General principles and the Common Commercial Policy ... 239

b. Role of the European Parliament at protecting public health in trade negotiations ... 242

c. Participation of other actors in the debate on bilateral trade agreements ... 244

2. Public health protection in the substantive provisions of EU trade agreements ... 245

a. The significance of TSD chapters in EU trade agreements ... 245

b. ‘Conditional equivalence’ as a mechanism to protect public interests ... 246

c. The right to regulate in a context of regulatory cooperation ... 248

3. Public health protection in the substantive provisions of EU investment agreements ... 249

a. The ‘loser pays’ principle as an incentive to regulate in the public interest ... 249

b. The ‘judicialisation’ of arbitration ... 250

C. The European Union as a regulatory hegemon and its influence in public health promotion ... 251

1. The European Union as a regulatory hegemon ... 252

2. The European Union as a global regulator of cosmetic products and its impact on public health protection ... 254

a. Foreign legislation based on EU rules on cosmetic products ... 254

b. Role of civil society in the adoption of voluntary rules by private undertakings ... 256

CONCLUSIONS ON SECTION I... 257

SECTION II. THE PROMOTION OF EU STANDARDS IN THE BALANCE BETWEEN INTELLECTUAL PROPERTY RIGHTS AND ACCESS TO MEDICINES ... 260

I. DIVERGENCE IN THE DEBATE ON INTELLECTUAL PROPERTY RIGHTS AND ACCESS TO MEDICINES ... 261

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A. Debate on the trade-related aspects of intellectual property rights at the global level ... 262

1. International regulation of intellectual property rights: from WIPO to the WTO ... 262

2. Debate on public health and intellectual property rights at the WTO ... 264

a. Divergent views in the negotiating process of the TRIPS Agreement ... 264

b. Arrangements to accommodate public health concerns in the TRIPS Agreement... 265

i. Impact of the TRIPS Agreement on public health ... 265

ii. The Doha Declaration on the TRIPS Agreement and Public Health ... 266

B. The evolutionary approach of the European Union towards intellectual property rights and public health ... 268

1. Evolution of the EU external capacity to act in the field of intellectual property ... 268

a. The European Union in intellectual property international organisations ... 269

b. EU external competence in the field of intellectual property rights ... 269

2. Evolution of the EU position on the balance between intellectual property rights and public health ... 271

a. The European Union in the road to Doha: from a strict application of intellectual property rules to the embracement of flexibilities ... 271

i. EU position in the pre-Doha period... 271

ii. The Doha Declaration: a turning point in the EU position on intellectual property rights and public health ... 274

b. Inconsistencies following the Doha Declaration ... 275

i. The 2005 Strategy for the enforcement of intellectual property rights in third countries ... 275

ii. EU legislation facilitating access to essential medicines ... 276

iii. The 2014 Strategy for the protection of intellectual property rights in third countries ... 279

II. THE PROMOTION OF EU STANDARDS IN THE BALANCE BETWEEN INTELLECTUAL PROPERTY RIGHTS AND PUBLIC HEALTH ... 280

A. Role of the European Union in the negotiation of the Doha Declaration ... 280

B. Negotiation and conclusion of bilateral trade agreements and their impact on access to medicines ... 283

1. Bilateral trade agreements with developing countries: the example of the EC-CARIFORUM Agreement... 284

2. Bilateral trade agreements with developed countries: the EU-Korea Agreement ... 286

3. Recent trends in the negotiation of bilateral trade agreements ... 286

CONCLUSIONS ON SECTION II ... 289

GENERAL CONCLUSION ON PART III... 291

PART IV. Conclusions ... 295

SECTION I. SUMMARY OF THE MAIN FINDINGS ... 297

SECTION II. IS THE EUROPEAN UNION SUCCESSFUL AT PROMOTING PUBLIC HEALTH AT THE GLOBAL LEVEL? ... 302

I. FACTORS CONTRIBUTING TO PUBLIC HEALTH PROMOTION IN EU EXTERNAL RELATIONS ... 302

II. ROLE OF THE EUROPEAN UNION IN THE GLOBAL PROMOTION OF TOBACCO-CONTROL LEGISLATION ... 305

SECTION III. RECOMMENDATIONS AND FURTHER RESEARCH ... 309

I. A HORIZONTAL APPROACH TOWARDS PUBLIC HEALTH ... 309

A. Redrafting public health provisions in the Treaties ... 310

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1. Expansion of EU public health powers under Article 168 TFEU ... 310

2. Beyond economic health concerns: a human rights approach to public health ... 312

3. Addressing current public health challenges ... 313

B. Effective use of the principle of sincere cooperation ... 313

II. WHAT RELATIONSHIP BETWEEN PUBLIC HEALTH AND EU PRINCIPLES AND OBJECTIVES? ... 315

A. Public health protection as a general objective of the European Union ... 315

B. Further research: principles applicable to EU public health ... 316

Bibliography ... 319

TABLE OF LEGISLATION ... 319

PRIMARY EUROPEAN UNION LAW ... 319

INTERNATIONAL AGREEMENTS ... 319

INTERNATIONAL AGREEMENTS NOT YET IN FORCE ... 321

SECONDARY EUROPEAN UNION LAW ... 322

NATIONAL LEGISLATION ... 329

SOFT LAW ... 330

TABLE OF CASES ... 334

COURT OF JUSTICE OF THE EUROPEAN UNION ... 334

INTERNATIONAL DECISIONS AND AWARDS ... 339

NATIONAL DECISIONS... 341

DOCTRINE ... 342

BOOKS ... 342

CONTRIBUTIONS TO EDITED BOOKS ... 345

ARTICLES ... 354

PHDTHESES ... 363

REPORTS,DOCUMENTS AND ARTICLES FROM THINK TANKS ... 364

INSTITUTIONAL SOURCES ... 368

DOCUMENTS FROM EUINSTITUTIONS ... 368

DOCUMENTS FROM INTERNATIONAL ORGANISATIONS ... 375

PRESS RELEASES ... 378

SCIENTIFIC OPINIONS FROM EU INSTITUTIONS AND INTERNATIONAL ORGANISATIONS ... 382

OTHER DOCUMENTS ... 383

INSTITUTIONAL WEBSITES ... 384

INTERVIEWS ... 388

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Summary

This research examines how the European Union promotes public health in its external relations and evaluates the effectiveness of such action. The study aims at two sub-objectives: an examination of the constitutional framework governing EU public health, with a particular emphasis on its external dimension, and an assessment of the factors influencing the effectiveness of the promotion of EU public health at the global level. While the research attempts to undertake a horizontal study of EU public health, it is illustrated by numerous case studies. These include the Union’s external promotion of tobacco-control legislation, its role in the fight against cross-border health threats, the balance of trade interests and public health in bilateral trade and investment agreements, and the position of the Union towards intellectual property rights and public health at the WTO.

EU public health is characterised by a fragmented constitutional framework. The European Union adopts public health legislation on the basis of several provisions in addition to Article 168 TFEU, notably the internal market and the environmental policy. EU public health actions are undertaken under a complex institutional framework characterized by the difficulties to coordinate national and EU measures and the varying role of EU institutions. In its global health action, the EU status in health-related international organisations and agreements varies on a case-by-case basis.

Several factors influence the successful promotion of EU public health at the global level. The alignment between EU interests and those of its negotiating partners is crucial in the outcome of the negotiations. The Union’s competence in a certain area, its status in the international organisation or agreement concerned, the existence of an attractive bargaining tool in the negotiation or the expertise previously developed by the Union in a certain area will also be determinant in the effective promotion of public health by the European Union.

Considering these findings, this work proposes a number of measures that could enhance the EU external public health action and points at several aspects of this area that should be further researched. A clarification of EU public health competences and of the relationship between public health and EU principles should be the main priorities in this area.

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List of abbreviations

ACP countries African, Caribbean and Pacific countries ACTA Anti-Counterfeiting Trade Agreement AIDS Acquired Immune Deficiency Syndrome AMR Antimicrobial resistance

BSE Bovine Spongiform Encephalopathy CAP Common Agricultural Policy

CBD Convention on Biological Diversity CBRN Chemical, biological and nuclear agents CCP Common Commercial Policy

CDN Communicable Diseases Network

CEDEFOP Centre for the Development of Vocational Training

CESE Council of European State Epidemiologists for Communicable Disease CETA Comprehensive Economic and Trade Agreement

CFI Court of First Instance

CHAFEA Consumers, Health, Agriculture and Food Executive Agency CJEU Court of Justice of the European Union

Coreper Permanent representatives Committee COVID-19 Coronavirus disease 2019

DG Directorate General

DPAS Global Strategy on Diet, Physical Activity and Health EAR European Agency for Reconstruction

EASHW European Agency for Safety and Health at Work

EC European Community

EC Treaty establishing the European Community

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xvi ECDC European Centre for Disease Prevention and Control

ECHA European Chemicals Agency ECHR European Court of Human Rights ECSC European Coal and Steel Community EEA European Environment Agency EEA European Economic Area

EEAS European External Action Service

EEC Treaty establishing the European Economic Community EFSA European Food Safety Agency

EFTA European Free Trade Association EMA European Medicines Agency

EMCDDA European Monitoring Centre of Drugs and Drug Addiction EMCF European Monetary Cooperation Fund

EMEA European Agency for the Evaluation of Medicinal Products ENP European Neighbourhood Policy

ERCC Emergency Response Coordination Centre

EUROFUND European Foundation for the Improvement of Living and Working Conditions

ed editor

EU European Union

EUPHIN European Union Public Health Information Network EWRS Early Warning and Response System

FAO Food and Agriculture Organization

FCTC Framework Convention on Tobacco Control FDA United States Food and Drug Administration

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xvii FDHA Swiss Federal Department of Home Affairs

FRA Fundamental Rights Agency FTA Free Trade Agreement

HERA Health Emergency Response Authority

GATT 1994 General Agreement on Tariffs and Trade 1994 GHSA Global Health Security Agenda

GMOs Genetically Modified Organisms GMP Good Manufacturing Practices

G7 Group of seven

G8 Group of eight

G20 Group of twenty

HIV Human Immunodeficiency Virus Ibid. Ibidem

ICS Investment Court System

ICSID International Centre for Settlement of Investment Disputes IHR International Health Regulations

ILO International Labour Organization INB Intergovernmental Negotiating Body IPCR Integrated Political Crisis Response

ISDS Investor-State Dispute Settlement mechanism

JPIAMR Joint Programming Initiative on Antimicrobial Resistance LMOs Living Modified Organisms

NGOs Non-Governmental Organisations

OECD Organization for Economic Cooperation and Development

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xviii OIE World Organization for Animal Health

OJ Official Journal

OLAF European Anti-Fraud Office op. cit. opere citato

PAHO Pan-American Health Organization

p. page

pp. pages

para. Paragraph

PCA Permanent Court of Arbitration PFOS Perfluorooctane sulfonic acid

PHEIC Public Health Emergency of International Concern PMI Philip Morris International

REACH Regulation No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals

REFIT European Commission Regulatory Fitness and Performance Programme REIO Regional Economic Integration Organisation

SARS Severe acute respiratory syndrome

SCCP Scientific Committee on Consumer Products SDGs Sustainable Development Goals

SPS Sanitary and Phytosanitary

Swissmedic Swiss Agency for Therapeutic Products

TATFAR Transatlantic Taskforce on Antimicrobial Resistance TBT Technical Barriers to Trade

TEU Treaty on European Union

TFEU Treaty on the Functioning of the European Union

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xix TRIPS Agreement on Trade-Related Aspects of Intellectual Property Rights

TSD Trade and Sustainable Development

TTIP Transatlantic Trade and Investment Partnership

UN United Nations

UNCITRAL United Nations Commission on International Trade Law UNDP United Nations Development Programme

UNICEF United Nations Children’s Fund UNSC United Nations Security Council UNTS United Nations Treaty Series

US United States

v versus

WHA World Health Assembly WHO World Health Organization

WIPO World Intellectual Property Organization WTO World Trade Organization

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1

INTRODUCTION. T

HE DEFINITION OF PUBLIC HEALTH AND ITS POSITION IN THE

E

UROPEAN

U

NION

The role of the European Union (EU) as a global actor has gradually strengthened. The increased powers of the Union in international relations have been driven by political commitments, Treaty modifications and the contribution of the case law of the Court of Justice of the European Union (CJEU).

The political message of EU institutions has evolved over time. In the Council conclusions of 2001, EU Member States, in a rather shy manner, suggested that the Union should play a more prominent role at the global level: ‘Does Europe not, now that is finally unified, have a leading role to play in a new world order, that of a power able both to play a stabilising role worldwide and to point the way ahead for many countries and peoples?’1 The message of President Ursula VON DER LEYEN when presenting the new European Commission portfolios in 2019 was more assertive. She claimed a strong role for the European Union in multilateralism:

‘We will take bold action against climate change, build our partnerships with the United States, define our relations with a more self-assertive China and be a reliable neighbour, for example to Africa. […] And I want the European Union to be the guardian of multilateralism’.2

The political evolution has been followed by legal modifications. The Lisbon Treaty constitutes a major contribution towards a more effective EU role in international relations.3 Several values and principles currently guide the Union’s external action.4 A new institutional setting has been defined through the establishment of the High Representative of the Union for Foreign Affairs and Security Policy,5 which is responsible for EU delegations in third countries

1 European Council, Conclusions of the Presidency, Annex I, Laeken Declaration on the Future of the European Union, 14-15 December 2001, SN 300/1/01 REV 1, p. 20.

2 European Commission, The von der Leyen Commission: for a Union that strives for more, 10 September 2019, IP/19/5542.

3 See, for example, Articles 3(5), 18, 21, 22, 27 and 47 TEU; Articles 216-221 TFEU; see Christine KADDOUS,

‘External Action under the Lisbon Treaty’ in Ingolf PERNICE and Eugeni TANCHEV (eds), Ceci n’est pas une Constitution – Constitutionalisation without a Constitution? (Baden-Baden, Nomos, 2007), pp. 177-178; Ricardo GOSALBO BONO, ‘The Organization of the External Relations of the European Union in the Treaty of Lisbon’ in Panos KOUTRAKOS (ed), The European Union’s External Relations a Year after Lisbon (The Hague, TMC Asser Press, CLEER Working Papers, 2011), pp. 13-37; Guest Editorial, ‘The EU’s External Action: Moving to the Frontline’ (2014) 19(3) European Foreign Affairs Review 329; Panos KOUTRAKOS, EU International Relations Law (Oxford/Portland, Hart Publishing, 2nd edition, 2015), pp. 7-8; Marise CREMONA, ‘External Relations and External Competence of the European Union: The Emergence of an Integrated Policy’ in Paul CRAIG and Gráinne DE BÚRCA (eds), The Evolution of EU Law (Oxford, Oxford University Press, 2nd edition, 2011), pp. 261-262.

4 Articles 3 (5) and 21 TEU.

5 Article 18 TEU.

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2 and international organisations.6 The establishment of the European External Action Service should lead to a more coherent approach of the EU as a global actor.7 The Union has been explicitly granted the international legal personality to conclude international agreements8 and to act in the global scene more generally.9 The European Union can consequently be qualified as a global legal actor.10

The current situation favours an increased role of the European Union at the global level, but the effectiveness of such role is to be assessed. This thesis examines the position of the European Union as a global actor in public health. It is argued that the European Union should seek a leadership role in this field. Two reasons justify this argument. On the one hand, public health has a strong global component. Diseases, both communicable and non-communicable, do not know about borders. This has always been the case, but globalisation has intensified this trend and public health concerns are increasingly in the headlines of current world affairs.11 This feature is undisputed in 2020, as the COVID-19 pandemic is the major topic of discussion around the globe.12 As President Ursula VON DER LEYEN affirmed in her State of the Union address of 2020, ‘none of us will be safe until all of us are safe’ and, in this context, she wants the European Union to lead the global response to the pandemic.13 However, public health events have been crucial in previous years as well. Should States ban vaping, the use of e- cigarettes, given the number of deaths reported in the United States in the past months?14 What should the attitude of States towards vaccination be, following the strengthening of the anti-

6 Article 221 TFEU.

7 Steven BLOCKMANS and Marja-Liisa LAATSIT, ‘The European External Action Service: Enhancing Coherence in EU External Action?’ in Paul James CARDWELL (ed), EU External Relations Law and Policy in the Post-Lisbon Era (The Hague, TMC Asser Press, CLEER Working Papers, 2012), pp. 135-159; Mauro GATTI, European External Action Service: Promoting Coherence through Autonomy and Coordination (Leiden, Brill, 2016); Simon DUKE, ‘The European External Action Service: Antidote Against Incoherence?’ (2012) 17(1) European Foreign Affairs Review 45.

8 Article 47 TEU.

9 Articles 216-220 TFEU.

10 Bart VAN VOOREN and Ramses WESSEL, EU External Relations Law: Text, Cases and Materials (Cambridge, Cambridge University Press, 2014), p. 2. The authors characterise the Union as an international legal actor because it is ‘an entity which interacts with third countries and international organizations in ways which are legally and politically distinguishable from its constitutive Member States’.

11 See infra, Introduction, Section I, I, C.

12 COVID-19 stands for Coronavirus disease 2019, an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

13 European Commission, State of the Union Address by Prsident von der Leyen at the European Parliament Plenary, 16 September 2020, SPEECH/20/1655.

14 Centers for Disease Control and Prevention, Outbreak of Lung Illness Associated with Using E-cigarette Products, 11 September 2019, available at https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe- lung-disease.html (last accessed 30 January 2020).

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3 vaccination movement?15 Has the international community provided an adequate response to the 2019 Ebola outbreak?16 These are a few of the topics of worldwide concern, and providing an appropriate response to these questions is key to becoming a global health leader. On the other hand, the goals and competences of the European Union in public health have increased over time.17 The Union has specific public health powers under Article 168 TFEU. Public health is to be taken into account in all policies and activities in accordance with Article 9 TFEU.

There is a fundamental right to health under Article 35 of the Charter of Fundamental Rights of the European Union (the Charter), and public health is mentioned in several Treaty provisions under other EU policies.18 Most importantly, the Treaties contain an express requirement to foster cooperation with third countries and international organisations in the sphere of public health.19 The European Union has the opportunity to shape global health rules, and this work attempts to examine whether and how this objective has been reached.

The goal of this thesis is therefore to analyse the promotion of public health in EU external relations and to determine whether the Union has emerged as a global health leader. In undertaking this research, the thesis seeks to establish the factors influencing the effectiveness of EU actions in public health. This preliminary chapter will introduce the topic. The conceptual and historical background of the research will first be presented (Section I). Before turning to the main parts of the work, it is useful to define the notion of public health that will be considered in this thesis. It is also relevant to briefly recall the major events in the development of the Union’s public health field to understand how the Union has emerged as a public health actor in the global scene. After presenting the background information, we will establish the research question of the thesis (Section II), the relevance of the topic (Section III) and the methodology that will be followed throughout the work (Section IV). The introduction will thus present the essential elements to understand the object, the tools and the content of the thesis before turning to the substantive parts of this work.

15 See for instance American Academy of Family Physicians, Confirmed US Measles Cases Now Highest in 25 Years, 25 April 2019, available at https://www.aafp.org/news/health-of-the-public/20190425measlesupdt.html (last accessed 30 January 2020); WHO Europe, European Region loses ground in effort to eliminate measles, 29 August 2019, available at http://www.euro.who.int/en/media-centre/sections/press-releases/2019/european- region-loses-ground-in-effort-to-eliminate-measles (last accessed 30 January 2020).

16 World Health Organization, Ebola virus disease – Democratic Republic of Congo, 6 September 2019, available at https://www.who.int/csr/don/06-september-2019-ebola-drc/en/ (last accessed 30 January 2020).

17 See infra, Part I, Section I.

18 See, for example, Article 114 (4) TFEU on the internal market, Article 153 TFEU on the social policy, Article 169 (1) TFEU on consumer protection or Article 191 (1) TFEU on the environmental policy.

19 Article 168 (3) TFEU.

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4

S

ECTION

I. Conceptual and historical background to the research

This work deals with the promotion of EU public health standards at the global level. In order to address this topic, it is essential to define the conceptual and historical background that leads to our research question. From a conceptual perspective, it is indispensable to define public health and to differentiate this area from the more general field of health (I). These definitions will limit the scope of our research, which will exclusively address public health concerns. From a historical perspective, a brief review of the evolution of public health considerations in the European Union underlines the increased relevance of this field in the European project (II). This analysis reveals an increasingly global dimension in public health matters. The concept of global health is becoming an autonomous notion in international law and the need for the Union to cooperate in public health matters beyond its borders is explicitly required by the Treaties.

I. Key concepts of the research

Several authors have attempted to define public health and to differentiate this field from other related areas.20 In order to establish the material scope of the thesis, it is first necessary to look at the several concepts of health that have been adopted (A), before defining public health itself (B). Our analysis lastly reveals that public health is increasingly globalised. This evolution implies that actors need to be relevant at the global level in order to preserve their own public health standards (C).

A. Health

While a general definition of health is manageable, reaching a precise, comprehensive and legally certain definition of this concept is challenging. A distinction can be found in international instruments between those that require a higher level of health protection and those that provide lower standards. The World Health Organization (WHO) Constitution provides that ‘health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity’.21 This definition includes not only physical but also mental and even social well-being. It contains both a negative and a positive approach to health, as

20 See Charles-Edward A. WINSLOW, ‘The Untilled Fields of Public Health’ (1920) 51 Sciences 23, p. 23; Tamara K. HERVEY and Jean V. MCHALE, Health Law and the European Union (Cambridge, Cambridge University Press, 2004), pp. 19-21; Lawrence O. GOSTIN, ‘A Theory and Definition of Public Health Law’ (2008) 8 O’Neill Institute for National Global Health Law Scholarship Research Paper 1, p. 3; Lawrence O. GOSTIN and Lindsay F. WILEY, Public Health Law: Power, Duty and Restraint (Berkeley/Los Angeles, University of California Press, 3rd edition, 2016); Tamara K. HERVEY and Jean V. MCHALE, European Union Health Law: Themes and Implications (Cambridge, Cambridge University Press, 2015), pp. 25-28.

21 Preamble, Constitution of the World Health Organization, New York, 22 July 1946, 14 UNTS 185 (WHO Constitution).

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5 health requires the absence of disease but also well-being as such.22 This notion embraces a broad meaning of health, which can be problematic. First, defining health in terms of well-being implies having recourse to a philosophical concept that can be hard to define. Second, requiring States to guarantee a ‘complete state of physical, mental and social well-being’ might be too ambitious in some countries.23 Third, a complete state of well-being might also be over- ambitious for high-income countries, where the increase of chronic diseases implies that some people are definitely ill.24

A narrower definition of health is contained in the International Covenant on Economic, Social and Cultural Rights, which recognises ‘the right of everyone to the enjoyment of the highest attainable standard of physical and mental health’.25 This definition restricts the quality of a healthcare system to the ‘highest attainable standard’, which will vary in accordance with the wealth of a State. The International Covenant on Economic, Social and Cultural Rights also contains an illustrative list of objectives that a State should reach, thus adopting a more limited approach that might be more realistic.26

Another distinction has been made between an ‘engineering model’ and a ‘social model’ of health protection.27 While the former requires ‘the provision of health care to repair the defective human machine’, the latter seeks ‘to control the causes of the initial break down’.28 The difference between both models is whether we include prevention or not, which involves taking into account external factors such as social or environmental concerns.29 For the purposes

22 A third aspect, the egalitarian one, has also been highlighted by Michael BOTHE, ‘Les concepts fondamentaux à la santé: le point de vue juridique’ in René-Jean DUPUY (ed), The Right to Health as a Human Right (Leiden/Boston, Brill Nijhoff Publishers, 1979), pp. 14-34.

23 Sev S. FLUSS, ‘The Development of National Health Legislation in Europe: The Contribution of International Organisations’ (1995) 2(3) European Journal of Health Law 193, p. 208 cited in Tamara K. HERVEY and Jean V.

MCHALE, Health Law and the European Union, op. cit., p. 8.

24 Machteld HUBER, J. André KNOTTERUS, Lawrence GREEN et al., ‘How Should we Define Health?’ (2011) 343 The British Medical Journal 4163.

25 Article 12 (1) International Covenant on Economic, Social and Cultural Rights, New York, 16 December 1966, 993 UNTS 3; Part I, para. 11, European Social Charter (Revised), Strasbourg, 3 May 1996, European Treaty Series No 163: ‘Everyone has the right to benefit from any measures enabling him to enjoy the highest possible standard of health attainable’; Para. I Declaration of Alma-Ata, International Conference on Primary Health Care, Alma- Ata, 6-12 September 1978: ‘…health, which is a state of complete physical, mental and social wellbeing, and not merely the absence of disease or infirmity, is a fundamental human right and that the attainment of the highest possible level of health is a most important world-wide social goal…’.

26 Article 12 (2) International Covenant on Economic, Social and Cultural Rights.

27 Jonathan MONTGOMERY, ‘Recognising a Right to Health’ in Ralph BEDDARD and Dilys M. HILL (eds), Economic, Social and Cultural Rights: Progress and Achievement (New York, Palgrave Macmillan, 1992), pp.

186-187.

28 Idem.

29 For instance, MONTGOMERY follows the social model, whereas HERVEY and MCHALE follow the engineering model; see Jonathan MONTGOMERY, ‘Recognising a Right to Health’, op. cit., p. 187; Tamara K. HERVEY and Jean V. MCHALE, European Union Health Law, op. cit., p. 12.

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6 of the thesis, the social model will be adopted. This approach is more consistent with the WHO definition. In order to attain well-being, it is not enough to cure people when they have fallen ill; instead, prevention will play a crucial role. Moreover, if health does not only seek physical and mental well-being but also social well-being, then it is necessary to take into account external factors such as poverty, education, or the environment. The social model additionally allows for an interpretation of health that goes beyond the professional-patient relationship to include public health. Since the focus of the work will be in this particular area, it seems logical to adopt a broad definition that considers it as part of the same field. Interestingly, even authors that adopt the engineering model tend to expand the scope of health beyond the purely private relationship.30 Under this broad definition, public health constitutes a sub-category within the field of health. It is characterised by several features that will be defined below.

B. Public health

There is no unanimous definition of public health. One of the first definitions was established in 1920 and considered public health as ‘the science and art of preventing disease, prolonging life and promoting physical and efficiency through organised community efforts for the sanitation of the environment, the control of community infections, the educations of the individual in principles of personal hygiene, the organisation of medical and nursing service for the early diagnosis and preventive treatment of disease, and the development of social machinery which will ensure to every individual in the community a standard of living adequate for the maintenance of health’.31 From a legal perspective, public health has been defined as

‘the study of the legal powers and duties of the state to assure the conditions for people to be healthy (to identify, prevent, and ameliorate risks to health in the population) and the limitations on the power of the state to constrain the autonomy, privacy, liberty, proprietary, or other legally protected interests of individuals for the common good’.32 It results from this definition that four elements are essential in order to consider that an action belongs to the public health field.

First, there has to be a State action, since public health activities are a special responsibility of the government. It is for the government to ensure the conditions for the population’s health because it ‘possesses the authority and responsibility to persuade, create incentives, and even

30 Tamara K. HERVEY and Jean V. MCHALE, Health Law and the European Union, op. cit., p. 10.

31 Charles-Edward A. WINSLOW, ‘The Untilled Fields of Public Health’, op. cit., p. 30.

32 Lawrence O. GOSTIN and Lindsay F. WILEY, Public Health Law, op. cit., p. 4.

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