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OXFORD STUDIES IN EUROPEAN LAW

Professor of English Law at St John’s College, Oxford

Professor of Law at New York University School of Law

EU Health Law & Policy

The Expansion of EU Power in Public Health and Health Care

OXFORD STUDIES IN EUROPEAN LAW

Series Editors

Paul Craig, Professor of English Law at St John’s College, Oxford and Gráinne de Búrca, Professor of Law at New York University School of Law

The aim of this series is to publish important and original research on EU law. The focus is on scholarly monographs, with a particular emphasis on those which are interdisciplinary in nature. Edited collections of essays will also be included where they are appropriate. The series is wide in scope and aims to cover studies of particular areas of substantive and of institutional law, historical works, theoretical studies, and analyses of current debates, as well as questions of perennial interest such as the relationship between national and EU law and the novel forms of governance emerging in and beyond Europe. The fact that many of the works are interdisciplinary will make the series of interest to all those concerned with the governance and operation of the EU.

other titles in this series

EU Powers Under External Pressure

How the EU’s External Actions Alter its Internal Structures

Christina Eckes

Frontex and Human Rights

Responsibility in ‘Multi-Actor Situations’ under the ECHR and EU Public

Liability Law

Melanie Fink

EU Equality Law

The First Fundamental Rights Policy of the EU

Elise Muir

Subnational Authorities in EU Law

Michèle Finck

Accessing Asylum in Europe

Extraterritorial Border Controls and Refugee Rights under EU Law

Violeta Moreno-Lax

National Parliaments after the Lisbon Treaty and the Euro Crisis Resilience or Resignation?

Davor Jancic

Environmental Integration in Competition and Free-Movement Laws

Julian Nowag

EU Agencies

Legal and Political Limits to the Transformation of the EU Administration

Merijn Chamon

Coherence in EU Competition Law

Wolf Sauter

Foreign Policy Objectives in European Constitutional Law

Joris Larik

Economic Governance in Europe

Comparative Paradoxes and Constitutional Challenges

Federico Fabbrini

EU Health Law & Policy

The Expansion of EU Power in Public Health and Health Care

Great Clarendon Street, Oxford, OX2 6DP, United Kingdom

Oxford University Press is a department of the University of Oxford. It furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide. Oxford is a registered trade mark of Oxford University Press in the UK and in certain other countries © Anniek de Ruijter 2019

The moral rights of the author have been asserted First Edition published in 2019

Impression: 1

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, without the prior permission in writing of Oxford University Press, or as expressly permitted by law, by licence or under terms agreed with the appropriate reprographics rights organization. Enquiries concerning reproduction outside the scope of the above should be sent to the Rights Department, Oxford University Press, at the address above

You must not circulate this work in any other form and you must impose this same condition on any acquirer

Crown copyright material is reproduced under Class Licence Number C01P0000148 with the permission of OPSI and the Queen’s Printer for Scotland

Published in the United States of America by Oxford University Press 198 Madison Avenue, New York, NY 10016, United States of America

British Library Cataloguing in Publication Data

Data available

Library of Congress Control Number: 2018957187

ISBN 978–0–19–878809–6

Printed and bound by CPI Group (UK) Ltd, Croydon, CR0 4YY

Links to third party websites are provided by Oxford in good faith and for information only. Oxford disclaims any responsibility for the materials contained in any third party website referenced in this work.

Series Editors’ Preface

Like several of the European Union’s supplementary or coordinating competences, EU health law and policy is both uncertain in its scope and boundaries while at the same time constituting a field of major social and political importance for the EU. The EU can intervene in the field of public health in a variety of ways, and not only through its explicit health policy powers, but its role in this field is shaped in part by other EU objectives and in particular by those of the internal market.

In this book, Anniek de Ruijter approaches the field of EU health law and policy from various perspectives, with a view to shedding greater light on this important area, and to appraising its impact. She uses the framework of fundamental rights as a lens through which to assess the impact and significance of EU health policy in various respects. Thus the book considers the range of positive as well as negative rights that underpin and inform aspects of health law and policy, as well as the effect of EU law and policy in this field on rights such as human dignity and personal integrity, and on the ways in which member states regulate and protect health.

The aim of the book is to describe the growth and extent of EU powers in the field, as well as analyzing their impact on fundamental rights and other values in the area of human health. And while it is primarily a book about law rather than policy, it goes beyond a doctrinal approach to describing and appraising the field and integrates information derived from interviews carried out with civil servants working on health policy within the EU as well as material drawn from the legislative archives. The author describes the expansion of EU activity in the field of public health as a stealthy one, or a ‘silent revolution’, given that it is achieved not just by the use of explicit regulatory powers but by a range of other EU policy actions and initiatives too.

The book includes two detailed and interesting case studies as part of its analysis, one on the EU’s response to the outbreak of swine flu and the declaration of a global pandemic, and the other on cross-border health care in the EU and the adoption of a directive on patients’ rights in that context. Each of these case studies reflects the broader themes of the book by illustrating the growth and scope of EU powers in the field of health law and policy, the role of various institutional actors at national and EU level in that field, and the implications they have for fundamental rights and other values.

The book raises important questions about the EU’s role and interventions in the field of health law and policy, and its impact not just on the rights of individuals and communities but also on the policy powers and competences of the member states. It should be of interest to students and teachers of EU law and policy, as well as all of those interested in health law and policy and fundamental rights in Europe.

Acknowledgements

This book is the result of the support of many of my great colleagues at the Amsterdam Centre for European Law and Governance. I am indebted to Professor Christina Eckes, who has encouraged me to write this book. I am grateful to Dr Madalina Busuioc and Professor Deirdre Curtin who have been a great support and given me indispensable advice. I also thank my dear colleagues for shared interests and wonderful conversations. The great people at OUP, Natalie Patey and Elinor Shields, thank you so much for your patience and helpful guidance through the process of getting the book out. Hannah van Kolfschooten, we care about in the same things, which makes it a true inspiration to work together. Thank you for your help with this book. And of course, to Professor Tammy Hervey, Dr Scott Greer, Dr Mark Flear, Professor Johan Legemaate, and many other colleagues who have been an inspiration through their writing and advice over the years, thank you very much. I am also thankful to the students at the Faculty of Law in Amsterdam, for their questions and their shared enthusiasm for EU (health) law and policy. Last, and most importantly, I want to express the utmost gratitude to my friends and family, for their patience and support. And to my parents: Pap, Mam, dank voor alles. Sean, Maya†, Wendel, and Benjamin, together we are strong.

Anniek de Ruijter

Amsterdam July 2018

4.2.2

3. EU ‘Public Health’ and ‘Health-care’ Law and Policy

1. Human ‘Health’ in the EU

1.1 Legal sources defining health in the EU

1.2 Beyond a biomedical concept

1.3 Differentiating EU ‘public health’ and ‘individual health (care)’

2. EU Power: Policy and Law in Human Health

2.1 Human health as part of the EU regulatory state

2.2 Authority: policymaking and power

2.3 Differentiating EU ‘health-care’ and ‘public health’ policy

3. EU Public Health Policy and Law

3.1 Public health in the Common Agricultural Policy

3.2 EU public health to promote the free movement of goods

3.3 Mutual recognition

3.4 Tensions between internal market and public health objectives

3.4.1

3.4.2 Constitutional tensions over tobacco advertising

3.5 Treaty bases for public health: reconciling different objectives

3.6 Redistributing through public health programmes

3.7 The Treaty gives and the Treaty takes: legislative basis

4.1.4

2.1

2.1.1

2.1.2

2.2

2.3

2.2.1

3.

3.1

3.2

3.3

4. Health Policy in the Council of the European Union

4.1 At the level of ministers: the EPSCO Council

4.2 Lower-level Member State representatives for health in the Council

4.2.1 The Council Working Party on Public Health

4.2.2 The Working Party on Public Health at senior level

4.3 The role of the Council

5. Health Policy in Committees, Expert Groups, and Fora

5.1 Independent scientific committees

5.2 Committees and groups with a political role, and private interests lobby

5.3 Lower-level legislation through committees in health

5.4 The role of committees and experts in EU health policy

6. Health Policy in European Agencies

6.1 Agencies for health policy

6.2 The role of EU agencies

7. Growing Institutional Capacity to Make EU Health Policy and Law

5. EU Public Health: Countermeasures to Swine Flu

1. The 2009 Outbreak of Swine Flu and the EU Response

1.1 The role of EU institutional actors

1.2 Commission services’ role in early warning and response

1.3 The network committee for communicable diseases

1.3.1 Other instruments for response: surveillance and Rapid Response Systems (RAS)

1.4 The Health Security Committee

1.5 Ad hoc policy coordination in the Council: friends of the presidency

1.6 The agencies: the ECDC and the EMA

2. EU Countermeasures to Swine Flu

2.1 Market authorization of vaccines and antivirals, and defining priority groups for vaccination

2.1.1 Defining priority groups for vaccination

2.2 Information exchange, contact tracing, and passenger screening

2.3 School closures, delaying strategies, and information to the public

2.4 The role of the EU in taking countermeasures to the swine flu outbreak

3. Expanding EU Health Policymaking: Linking Practices to Law

3.1 Linking the Health Security Committee with the EWRS Committee

3.2 Ad hoc policymaking as bedrock for law

4. The Impact of EU Public Health Policy on Fundamental Rights and Values

4.1 Individual rights

4.1.1 Market authorization of vaccines and defining priority groups for vaccination

4.1.2 Information exchange, contact tracing, and passenger screening

4.2 The right to health

4.2.1 Market authorization of vaccines and defining priority groups for vaccination

4.2.2 Information exchange, contact tracing, and passenger screening

4.2.3 School closures, delaying strategies, and information to the public

5. The Impact of Intertwining Informal Coordination and Formal Law

6. EU Health Care: Access to Medical Care

1. Access to Cross-border Health Care before and after the Directive

1.1 Access to health care before the adoption of the Directive

1.1.1 Planned care: prior authorization

1.2 Access to cross-border health care on the basis of the free movement principles

1.3 Access to health care after the adoption of the Directive

1.3.1 Two schemes for access to cross-border health care: what difference?

1.3.2 Implementation and delegation: possibilities for expanding the EU’s role in health care

1.4 Cross-border health care: a hot-button issue

2. The Adoption of the Directive: Creating a Policy Discourse on Values and Rights

2.1 The first evolutionary stage: DG MARKT

2.2 The second evolutionary stage: DG SANTE—taking a ‘health values and rights’ approach 162

2.3 The third evolutionary stage: the ‘Council proposal’—bringing in the Member States 164

2.4 Opposing values: market versus health

2.5 The paradoxical expansion of power through limits and circumscriptions

3. A Thousand Stones and You Have a Wall: Health Policy and Law beyond the Market

3.1 Institutionalizing the policy discourse

3.2 From a policy debate on health values to law

4. Access to Medical Care in the EU: Impact on Values and Rights

4.1 The right to health: the quality and safety of health care in the Directive

4.2 The right to health: prior authorization in the Directive

4.3 The impact of EU health policy on individual rights

4.4 Individual rights: informed consent in the Directive

4.5 Individual rights: the right to privacy and data protection

5. The Impact of the Struggle over Policy Frames: The Market, Health, Values, and Rights

7. The EU Constitutional Constraints on the Intrinsic Relationship of Values, Rights, and Human Health

1. The Juxtaposition: Health Law and the EU Internal Market

2. Silent Revolution: Implicit Fundamental Rights and Value Implications

2.1 Vertical implications: between the EU and the Member States

2.1.1 Health care

2.1.2 Public health

2.2 Horizontal implications: between (institutionally defined) policy domains

2.2.1 Health

2.2.2 Public

3. Depoliticization as a Constitutional Constraint on Human Health Regulation 183

3.1 Limiting values, rights, and welfare perspectives 183

3.2 The legitimating function of human health considerations, without constitutional protection 185

4. Common Values and Rights in EU Human Health Policy and Law? 186

4.1 The relationship between values and fundamental rights in health 187

4.2 EU health values 188

5. EU Powers in Public Health and Health Care into the Future 189

Bibliography

Table of Cases EU

Case C-9/56 and 10/56 Meroni v. High Authority [1957/1958] ECR 133 ............. 116, 118

Case 25/62 Plaumann & Co v. Commission [1963] ECR 95 ............................ 144

Case 6/64 Flaminio Costa v. ENEL [1964] ECR 584 .................................. 65

Case 29/69 Erich Stauder v. City of Ulm Sozialamt [1969] ECR 00419 .................... 27

Case 11/70 Internationale Handelsgesellschaft mbH v. Einfuhr- und Vorratsstelle fur getreide und Futtermiddel [1970] ECR 1125 27

Case 8/74 Procureur du Roi v. Dassonville [1974] ECR 837 67

Case 35/76 Amministrazione delle Finanze dello Stato v. Simmenthal [1976] ECR 1871 67

Case 182/78 Bestuur van het Algemeen Ziekenfonds Drenthe-Platteland v. G. Pierik (Pierik II) [1978] ECR 825 81

Case 100/78 Claudino Rossi v. Caisse de Compensation pour Allocations Familiales des Regions de Charleroi et Namur [1979] ECR 831 .................................. 79

Case 120/78 Rewe-Zentrale AG v. Bundesmonopoverwaltung fur Branntwein [1979] ECR 649 ............................................................ 67, 177

Case 177/77 Bestuur van het Algemeen Ziekenfonds Drente-Platteland v. G. Pierik (Pierik I) [1979] ECR 77 .................................................... 81

Case 272/80 Frans-Nederlandse Maatschappij voor Biologische Producten [1981] ECR 3277 56

Case 174/82 Officier van Justitie v. Sandoz BV [1982] ECR 2445 57

Joined cases C-283/82 and C-26/83 Luisi and Carbone v. Ministero del Tesoro [1984] ECR-377 81, 154

Case 178/84 Commission v. Germany [1987] ECR 1227 57

Case 5/88 Hubert Wachauf v. Federal Republic of Germany [1989] ECR 2609 32

Case C-159/90 Society for the Protection of Unborn Children (Ireland) Ltd v. Stephen Grogan [1991] ECR I-4685 ............................ 32, 81, 82, 154

Case C-62/90 Commission v. Germany [1992] ECR I-2575 ...................... 49–50, 141

Case C-204/90 Hanns-Martin Bachmann v. Belgium [1992] ECR I-149 .................. 154

Case  C260/89  Elliniki  Radiophonia  Tileorassi Anonymi Etairia v. Dimotiki Etairia Pliroforisis and Kouvelas (ERT) [1993]  ECR  I-2925 .............................. 32

Case C-404/92 P, X v. Commission, October 5, 1994, [1994] ECR I-4737 ................. 143

Case C-404/92 X v. Commission of the European Communities [1994]

ECR I-04737 49–50, 141

Case C-120/95 Nicolas Decker v. Caisse de maladie de employes prives [1998]

ECR I-1831 82, 154, 161–62

Case C-158/96 Raymond Kohll v. Union des caisses de maladie [1998]

ECR I-1931 1, 82, 154, 155–56

Case C-303/98 Sindicato de Medicos de Asistencia Publica v. Conselleria de Sanidad y Consumo de la Generalidad Valenciana (SIMAP v. CSCGV) [2000] ECR I-7963 ......... 83

Case C-369/98 (Fisher) The Queen v. Minister of Agriculture, Fisheries and Food, ex parte Trevor Robert Fisher and Penny Fisher [2000] ECR I-06751 ........................ 143

Case C-376/98 Germany v. Parliament and Council (Tobacco Advertising) [2000] ECR I-8419 .......................................................... 73, 177

Case C-157/99 B.S.M. Geraets-Smits v. Stichting Ziekenfonds VGZ and H.T.M. Peerbooms v. Stichting CZ Groep Zorgverzekeringen [2001] ECR I-5473 56, 82, 155

Case C-270/99 Z. v. EP Opinion of A.G. Jacobs of 22 March 2001 [2001] ECR I-9197 30

Case 368/98 Abdon Vanbraekel and Others v. Alliance nationale des mutualités chrétiennes [2001] ECR I-5363 82, 155–56, 162

Case C-377/98 Kingdom of the Netherlands v. European Parliament and Council of the European Union [2001] ECR I-7149 46, 47, 141

Case T-13/99 Pfizer Animal Health SA v. Council of the European Union [2002] ECR II-3318 .............................................................

Case C-491/01 BAT and Imperial Tobacco v. Secretary State of Health [2002] ECR I-11453

42

74

Case C-112/00 Eugen Schmidberger, Internationale Transporte und Planzüge v. Republik Österreich [2003] ECR I-5659 30, 32, 35

Case C-151/02 Landeshauptstadt Kiel v. Jaegar [2003] ECR I-08389

Case C-385/99 Joint case V.G. Muller-Faure and E.E.M. van Riet v. Onderlinge Waarborg

Maatschappij ZAO Zorgverzekeringen [2003] ECR I-4509

83

155

Case C-36/02 Omega Spielhallen- und Automatenaufstellungs-GmbH v. Oberbürgermeisterin der Bundesstadt Bonn [2004] ECR I-9609 ................ 30, 35, 46

Case C-466/04 Yvonne Watts v. Bedford Primary Care Trust, Secretary of State for Health [2005] ECR I-4325 ......................................... 155, 158, 172

Case C-540/03 European Parliament v. Council of the European Union (Family Reunification) [2006] ECR I-5769 ...................................... 27, 30, 38

Case C-303/05 Advocaten voor de Wereld VZW v. Leden van de Ministerraad [2007] ECR I-3633 30

Case C-438/05 International Transport Workers’ Federation and Finnish Seamen’s Union v. Viking Line ABP and OÜ Viking Line Eesti [2007] ECR I-10779 30

Case C-444/05 Aikaterini Stamatelaki v. NPDD Organismos Asfaliseos Eleftheron Epangelmation (OAEE), AG Opinion, [2007] ECR I-3185 45

Case C-427/06 B. Bartsch v. Bosch und Siemens Hausgerate (BSH) Altersfursorge GmbHage [2008] ECR I-07245

34

C-208/07 Petra von Chamier-Glisczinski v. Deutsche Angestellten-Krankenkasse [2009] ECR I-6095 ....................................................... 167

Case C-64/09 European Commission v. French Republic [2010] ECR I-03283. .

166

Joined Cases C-317/08 Rosalba Alassini v. Telecom Italia SpA, C-318/08 Filomena Califano v. Wind SpA, C-319/08 Lucia Anna Giorgia Iacono v. Telecom Italia SpA, and C-320/08 Multiservice Srl v.Telecom Italia SpA [2010] ECR I-2213 142

Case C-555/07 Seda Kücükdeveci v. Swedex GmbH & Co. KG[2010] ECR I-00365 144

Case T-18/10 Inuit Tapiriit Kanatami and Others v. Commission [2011] ECR 39-46 32, 144

Case F-46/09 V & EDPS v. European Parliament [2011] ECR-SC 31–32, 144

Case C-256/11 Murat Dereci and Others v. Bundesministerium für Inneres [2011] ECR I-11315 31

Case T-262/10 Microban International and Microban (Europe) v. Commission [2011] ECR II-07697 31–32, 144

Case C-370/12 Thomas Pringle v. Government of Ireland, Ireland, The Attorney General [2012] ECLI:EU:C:2012:756 .......................................... 34

Case C-467/10 Baris Akyüz v. Germany, Judgment of the Court (Second Chamber) [2012] ECLI:EU:C:2012:112 ...................................................... 44

Case C-617/10 Åklagaren v. Hans Åkerberg Fransson [2013] ECLI:EU:C:2013:105 ....... 32, 170

Case C-176/12 Association de médiation sociale v. Union locale des syndicats CGT, Hichem Laboubi, Union départementale CGT des Bouches-du-Rhône, Confédération générale du travail (CGT) [2014] ECLI:EU:C:2014:2 33, 41, 43, 144

EC t HR

ECtHR, Airey v. Ireland, Application No. 6289/73, 9 October 1979 .......................

24

ECtHR, X and Y v. the Netherlands, Application No. 8978/80, 26 March 1985 48

ECtHR, Soering v. the United Kingdom, Application No. 14038/88, 7 July 1987 23

ECtHR, Z v. Finland, Application No. 22009/93, 25 February 1997 174

ECtHR, L.C.B. v. the United Kingdom, Application No. 23413/94, 9 June 1998

ECtHR, Osman v. the United Kingdom, Application No. 23452/94, 28 October 1998

43

43

ECtHR, Powell v. the United Kingdom, Application No. 45305/99, 4 May 2000 44

ECtHR, Cyprus v. Turkey, Application No. 25781/94, 10 May 2001

44

ECtHR, Calvelli and Ciglio v. Italy, Application No. 32967/96, 17 January 2002 ....... 24, 43, 44

ECtHR, Nitecki v. Poland, Application No.65653/01, 21 March 2002 ............... 24, 40, 45

ECtHR, Pretty v. the United Kingdom, Application No.2346/02, 29 April 2002 .

48, 49

ECtHR, Nikky Sentges v. the Netherlands, Application No. 27677/02, 8 July 2003 .......... 179

ECtHR, Glass v. the United Kingdom, Application No. 61827/00, 9 March 2004 ...... 23–24, 36

ECtHR, Vo v. France, Application No. 53924/00, 8 July 2004 36

ECtHR, Oneryildiz v. Turkey, Application No. 48939/99, 30 November 2004 43, 149

ECtHR, Tysiąc v. Poland, Application No. 5410/03, 20 March 2007 47

ECtHR, K.H.and others v. Slovakia, Application No. 32881/04, 28 April 2009 47

ECtHR, Opuz v. Turkey, Application No. 33401/02, 9 June 2009 38–39

ECtHR, R.R. v. Poland, Application No. 27617/04, 26 May 2011 47

Table of Legislation

EU TREATIES

The Treaty on European Union (TEU) (OJ C 191/1, 1992) 74

The Treaty on European Union (TEU) (OJ 115/15, 09-05-2008)............ 4

Treaty on the Functioning of the EU (OJ 115/49) .

1, 5

Charter of Fundamental Rights of the European Union (OJ C 364/01, 18-12-2000) 27, 63, 188

EU REGULATIONS

Regulation No. 3 of the Council on Social Security for Migrant Workers (OJ 3025-1954) ........... 79–80, 153

Provisional Rules of Procedure of the Council of the European Economic Community (EEC) 18 March 1958, in Communauté économique européenne (1958) 107

Council Regulation (EEC) No. 1408/72 on the Application of Social Security Schemes to Employed Persons, to Self-Employed Persons and to Members of their Families Moving within the Community (OJ L149, 05-07-1971) ..................... 79

Council Directive 83/189/EEC Laying down a Procedure for the Provision of Information in the Field of Technical Standards and Regulations (OJ L 109, 26-04-1983) 113–14

Directive 89/656/EEC—use of personal protective equipment of 30 November 1989 on the equipment at the workplace (third individual directive within the meaning of Article 16(1) minimum health and safety requirements for the use by workers of personal protective of Directive 89/ 391/EEC) (OJ L 393, 30-12-1989) .... 88

Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 28, 23-11-1995) 141, 174

Decision No. 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331/1,07-12-1998) .... 72, 99, 122, 125, 127, 130, 135, 140, 141, 148–49, 182

Directive 98/44 on the legal protection of biotechnological inventions (OJ L213/13 1999) 47

Directive 99/92/EC—risks from explosive atmospheres of 16 December 1999 on the minimum requirements for improving the safety and health protection of workers potentially at risk from explosive atmospheres (15th individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 23, 28-01-2000) ..................... 88

Commission Decision 2000/96/EC on the communicable diseases to be progressively covered by the Community network under Decision 2119/98/EC of the European Parliament and of the Council (OJ L28/50, 03-02-2000) 125, 130 Decision No. 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003–2008) (OJ 271/1, 09-10-2002) 104

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 08-02-2003) .... 72

Directive 2003/88/EC of the European Parliament and of the Council of 4 November 2003 concerning certain aspects of the organisation of working time (OJ L 299, 18-11-2003) ........ 83

Decision No. 190 of the Administrative Commission on Social Security for Migrant Workers Regulation (EC) No.851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for Disease Prevention and Control (OJ L 142/1, 30-04-2004) 72, 130

Regulation (EC) No 883/2004 of the European Parliament and of the Council on the Coordination of Social Security Systems (OJ L166, 03-04-2004) ....... 1, 79–80, 153, 155

Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 136/85, 31-03-2005) 57

Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (L 255/22, 30-09-2005) ............ 83

Commisson Regulation (EC) No.507/ 2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No.726/2004 of the European Parliament and of the Council (OJ L92/6, 30-03-2006) 132

Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (OJ L376/36) ... 86, 108

Regulation (EC) 1338/2008 of the European Parliament and of the Council on Community statistics on public health and health and safety at work (OJ L 354/70, 31-12-2008) 55

Regulation (EC) No.596/2009 of the European Parliament and of the Council of 18 June 2009 (OJ L 188, 18-07-2009) 88

Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55/13, 28-02-2011) 114

Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88/45, 04-04-2011) 104, 151, 152, 156, 169, 181

Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/ 83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products (OJ L 174/74, 01-07-2011) 66

Regulation (EU) No 1257/2012 of the European Parliament and of the Council of 17 December 2012 implementing enhanced cooperation in the area of the creation of unitary patent protection (OJ L 361/1, 31-12-2012) 104

Decision No. 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No. 2119/98/EC (OJ L 293/1 05-11-2013) 49, 99, 117, 127, 129, 140, 141, 148–49, 182

Council Regulation (EEC) No. 1365/ 75 of 26 May 1975 on the creation of a European Foundation for the Improvement of Living and Working Conditions (OJ L 139, 30-05-1975) ................ 115, 116

Council Decision of 16 June 1975 setting up a Committee of Senior Officials on Public Health (75/365/EEC) (OJ 167/19, 30-06-1975).......... 113

Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29-06-1989) 88

Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/ 319/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products and laying down special provisions for medicinal products

derived from human blood or human plasma (OJ L 181, 28-06-1989) ...... 71

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189/17, 20-07-1990) 69

Council Directive 93/16/EEC of 5 April 1993 to facilitate the free movement of doctors and the mutual recognition of their diplomas, certificates and other evidence of formal qualifications (OJ L 165, 07-07-1993) ............ 83

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169,12-07-1993) 69

Commission Decision 97/404/EC of 10 June 1997 setting up Scientific Committees in the field of consumer health and food safety (OJ L 169, 27-06-97) 111

Decision No 2119/98/EC, ‘Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 Setting up a Network for the Epidemiological Surveillance and Control of Communicable Diseases in the Community (O.J. L 268/1, 03-10-1998) 49, 72, 99, 122, 125, 127, 130, 135, 140, 141, 148–49, 182

Commission Decision 2000/57/EC of 22 December 1999 on the early warning and response system for the prevention and control of communicable diseases under Decision No. 2119/98/EC of the European Parliament and of the Council (OJ L 21, 26-01-2000) ..... 122, 125, 126, 135, 144

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121/34, 01-05-2001) ............... 39, 88, 89

Council Decision 2002/834/EC of 30 September 2002 adopting a specific programme for research,

technological development and demonstration: ‘Integrating and strengthening the European Research Area’ (2002–2006) (OJ L294/1, 29-10-2002) 88

2003/751/EC: Decision No 189 of 18 June 2003 aimed at introducing a European health insurance card to replace the forms necessary for the application of Council Regulations (EEC) No 1408/71 and (EEC) No 574/72 as regards access to health care during a temporary stay in a Member State other than the competent State or the State of residence (Text with relevance for the EEA and for the EU/Switzerland Agreement.) (OJ L 276, 27-10-2003)

79–80

Decision No. 191 of 18 June 2003 concerning the replacement of forms E 111 and E 111 B by the European health insurance card (OJ L 276, 27-10-2003) . . . . .

79–80

Directive 2004/18/EC of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts (OJ L 134, 30-04-2004) 84

Commission Decision of 15 December 2004 setting up an executive agency, the ‘Executive Agency for the Public Health Programme’ for the management of Community action in the field of public health— pursuant to Council Regulation (EC) No.58/2003 (2004/858/EC) (OJ L 369/73, 16-12-2004) ......... 76

Commission Directive 2005/28/ EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91/13, 09-04-2005) 41

Commission Decision 2008/351/ EC of 28 April 2008 amending Decision 2000/57/EC as regards events to be reported within the early warning and response system for the prevention and control of communicable diseases (OJ L 117, 01-05-2008) 125, 126

Commission Decision 2008/544/EC of 20 June 2008 amending Decision 2004/858/EC in order to transform the ‘Executive Agency for the Public Health Programme’ into the ‘Executive Agency for Health and Consumers’ (OJ L 173/27, 03-07-2008)

76, 117

Commission Decision of 20 June 2008 amending Decision 2004/858/EC in order to transform the ‘Executive Agency for the Public Health Programme’ into the ‘Executive Agency for Health and Consumers’ (2008/544/EC) (OJ L 172/27, 03-07-2008)

76, 117

Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC (OJ L 241/21, 10-09-2008) .................... 111

Commission Decision 2009/312/ EC of 2 April 2009 amending Decision 2000/96/EC as regards dedicated surveillance networks for communable diseases (OJ L 91/27, 03-04-2009) 130

Commission Decision 2009/547/EC of 10 July 2009 amending Decision 2000/ 57/EC on early warning and response system for the prevention and control of communicable diseases under Decision No. 2119/98/EC of the European Parliament and of the Council (OJ L 181/57, 11-07-2009) .................... 144

Commission Decision of 10 July 2009 amending Decision 2002/253/ EC as regards case definitions for reporting Influenza A (H1N1) to the Community network (2009/540/EC) (OJ L 180/25, 11-07-2009) 122, 134, 144

Commission Decision 2009/872/EC of 30 November 2009 establishing a European Union Committee of Experts on Rare Diseases (OJ L 315, 02-12-2009) ........... 122

Council Decision 2009/937/EU of 1 December 2009 adopting the Council’s Rules of Procedure (OJ L 325/35, 11-12-2009) ........ 112

Council Regulation (EC) No.2062/94 of 18 July 1994 establishing a European

Agency for Safety and Health at Work (OJ L 21, 20-08-1994) ....... 117

Commission Decision 2005/842/EC of 28 November 2005 on the application of Article 86(2) of the EC Treaty on State Aid in the form of public service compensation granted to certain undertakings entrusted with the operation of services of general economic interest (notified under document number C (2005) 2673) (OJ L 312, 29-11-2005) ............ 85

European Commission, Commission Regulation (EU) No 185/2010 of 4 March 2010 laying down detailed measures for the implementation of the common basic standards on aviation security (OJ L 55 05-03-2010) 48

European Commission, Commission implementing Regulation (EU) No 711/2012 amending Regulation (EU) No 185/2010 laying down detailed measures for the implementation of the common basic standards on aviation security as regards the methods used for screening persons other than passengers and items carried, 3 August 2012 (OJ L 209/04-08-2012) 48

EU REPORTS, COMMUNICATIONS, AND RESOLUTIONS

Commission de la Securite, de hygiene du travail et de la protection sanitaire (Commission Permanente) Resolution (OJ 1, 20-04-1958) .......... 101, 113 Europees Parlement, resolutie nopens de samenstelling en de bevoegdheden van de commissies nodig voor de goede verloop van de werkzaamheden der vergadering (OJ 4/58 20-04-1958) 101 De Commissie van de Europese Gemeenschap voor Atoomenergie, Eerste Algemeen Verslag over de werkzaamheden van de gemeenschap (Januari 1958 – September 1958) ........... 94

Communication from Giuseppe Petrilli, 24 November 1958 (COM (58) 257).. 95

EEC Bulletin February 1961 no. 2, Fourth year, Brussels (1958) Europees Parlement, Commissie voor de bedrijfsveiligheid, voor de arbeids

hygiene en voor de bescherming van de gezondheid, Notulen van de constitutieve vergadering van vrijdag

9 januari 1959 (PE/CSH/PV59-1) 95

Rapport général sur les activités de la Communauté (La structure interne des sept directions générales ellemême a été adoptée le 1er juillet)

CECA: Luxembourg,1960, point 1 94

Bulletin of the European Economic Community (Third Year), No. 3, 1960, (Brussels, March–April) ....... 96

Europees Parlement, Zittingdocumenten 1961–1962, Verslag namens de Commissie voor Juridische aangelegenheden, voor het Reglement en Immuniteiten, nopens de benaming van de Commissies van het Europese Parlement, 24 Februari 1961, Document No. 2 101

Commission Administrative pour la Securite Sociale des Travailleurs Migrants, Assurance maladiematernite des membres de la famille residant au Luxembourg alors que le travailleur est occupe dans un autre pays de la Communauté. Guide No. 5 (1961) .................... 79

Voorstel van de Commissie aan de Raad, ingediend op 23 Juni 1962, Ontwerp richtlijn van de Raad tot regeling van sanitaire vraagstukken op het gebied van handelsverkeer in vers vlees binnen de gemeenschap, Supplement van het Bulletin van de Europese Economische Gemeenschap (No. 11, 1962) ................... 95

Draft Council Directive on the harmonization of laws and regulation governing pharmaceutical products, proposal submitted to the Council by the Commission on 5 November 1962, in Supplement to Bulletin of the European Economic Community (No. 12 1962) at p. 2 95

Europees Parlement, Commissie voor de bescherming van de Gezondheid, Nota betreffende het programma van werkzaamheden van de commissie voor de bescherming van de gezondheid tijdens het dienstjaar september 1964 – juli 1965 (PE12.467 - B) .................. 101

EEC Commission (1964) ‘Veterinary matters: harmonisation of legislation, and other activities’ Newsletter on the Common Agricultural Policy no. 24 65

European Commission, Medical expenses incurred during temporary residence in another country of the European Economic Community Information Memo P-39/64 1964 65

Europees Parlement, Commissie voor de bescherming van de gezondheid, notulen van de constitutieve vergadering, gehouden op 23 maart 1964, (PE 11.549) ............... 101

European Community Information Service (1966) Social Policy in the ECSC 1953–1965, Community Topics 20 ....................... 64

Europees Parlement, Commissie voor de bescherming van de gezondheid, Nota inzake het Programma van werkzaamheden van de Commissie voor de bescherming van de gezondheid in het jaar september 1965 – juni 1966 (PE 14462) 101

Hoge Authoriteit EGKS, Reeks arbeidshygiëne en arbeidsgeneeskunde nr. 5 Symposium Bronchitis-Emfyseem (Stresa, 21–22 april 1966) Luxemburg .

95–96

Minutes of the Meeting on the High level Reflection process on Patient Mobility and Hoge Authoriteit 15 de Algemeen verslag van de EGKS (1967) 161

Europees Parlement, Notulen van de Vergadering van 2 Februari 1967 Resolutie nopens de samenstelling van commissies van het Europees parlement (EEC OJ 449/67, 17-02-1967) .................... 101

Commissie van de Europese Gemeenschappen, Het Eerste Algemeen Verslag over de werkzaamheden van de Gemeenschappen in 1967 (E.G. Pub. bl. 1/68) 95–96

Europees Parlement, commissie voor de bescherming van de gezondheid, notulen van de vergadering gehouden op dinsdag 7 maart 1967, (PE67-4 - PE17.198) 101

Committee on Animal Feed, Food stuffs and Veterinary measures, Establishment of permanent committees for the approximation of agricultural legislation (Information Memo P-38/67, June 1967) ........ 113

Hoge Authoriteit, 15de Algemeen verslag van de EGKS (1967) 95–96

Commission of the European Communities, Information Memo: New proposals by the Commission to eliminate obstacles to intraCommunity merchandise trade resulting from technical regulations, Brussels, July 1968 (P-47/68) 67

Vierde algemeen verslag over de werkzaamheden van de gemeenschappen 1970 (Februari 1971) .................. 96

Commission Des Communautes Europeennes, Note d’Information: Le Conseil des Ministres adopte 12 directives concernant l’ élimination des entraves techniques, Bruxelles, décembre 1972 (P-54/72) 67

Resolution of the European Parliament on the number of Committees of the European Parliament and their membership (OJ C19/14, 12-041973), including annex (OJ C19/14, 12-04-1973) 102

Zevende Algemeen verslag over de werkzaamheden van de Europeesche gemeenschappen in 1973, Februari 1974.................... 96

Minutes of the constituent meeting held on 9 March 1976 (OJ C 28, 09-02-1976) 102

Secretariaat Generaal van de Raad der Europeesche gemeenschappen, Vijfentwintigse Overzicht der Werkzaamheden van de Raad (1 januari – 31 december 1977) 105

Secretariaat Generaal van de Raad der Europeesche gemeenschappen, zesentwintigste overzicht der werkzaamheden van de Raad, (1 januari – 31 december 1978) ..... 106

Exchange of letters between the European Communities and the World Health Organization laying down the procedure for cooperation between the two organizations— Memorandum defining the arrangements for cooperation between the World Health Organization and the European Communities (72/725/ECSC, EEC, Euratom) (OJ L 300, 28-10-1982) ........ 70, 138

Minutes of the constituent meeting held on 13 March 1973 (PE/VIII/PV/731) (OJ C 19, 12-04-1973) ......... 102

Conclusions of the Fontainebleau

European Council (25 and 26 June

1984) (Bulletin of the European Communities June 1984, no. 6 Luxembourg) 106

Resolution of Representatives of the Governments of Member States meeting within the Council of 29 May 1986 on AIDS (OJ C 184/21, 23-07-1986) 70–71

Council resolution on the preliminary programme of the EEC for a consumer protection and information policy (OJ 92/1, 25-04-1975) ....... 70

Commission of the European Communities, Biology and Health Protection Programme, Research Programme 1976-1980 (COM (75) 351 final) 76, 113, 184 Commission of the European Communities, Cooperation at Community level on Health Related Problems (COM (1984) 502 final) 106

General Secretariat of the Council of the European Communities, thirty-second review of the Councils work (1 January – 31 December 1984) ..... 70

General Secretariat of the Council of the European Communities, thirty-third review of the Councils work (1 January – 31 December 1985) 106

Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards (OJ C136/01, 04-06-1985) 68

European Commission, White paper from the Commission to the European Council, Completing the Internal Market (COM (1985) 310 final) ..... 68

European Council Conclusion Milan 28 and 29 June 1985 (2740/1/85) ...... 106

A People’s Europe Reports from the Ad Hoc Committee, Chairman Pietro Adonnino, Bulletin of the European Communities (Supplement 7/85) 106

A Programme of Action of the European Community Against Cancer (OJ C184, 23-07-1986) 72

Secretariat of the Council of the European Communities, thirty-fourth review of the Councils work, (1 January – 31 December 1986) ................ 106

Proposal for a Council Directive on the Authorized Advertising of Tobacco Products in the Press and by Means of Bills and Posters (OJ C 124, 19-05-1989)

73

Commission Proposal for a Decision of the Council and the Ministers for Health of the Member States meeting within the Council adopting a plan of action in the framework of the 1991–1993 ‘Europe against Aids’ programme (COM (90) 601 final) (1990) 70–71

The Europe Against Aids Programme, Decision 91/317/EEC of the Council of Ministers of Heath of the Member States (OJ L 175/26,04-07-1991). . . . . 73

The European Council in Edinburgh, 11–12 December 1992 (DOC/92/8, 13-12-1992) .

80

Communication from the Commission to the Council, the European Parliament and the Economic and Social Committee, Blood self-sufficiency in the European Community (COM (93) 198 final) 80

Communication from the Commission to the Council, the European Parliament and the Economic and Social Committee on the framework for action in the field of public health in the European Community (COM (93) 559) 75–76

Resolution of the Council and the Ministers for Health, meeting within the Council of 27 May 1993 on future action in the field of public health (OJ C 174, 25-06-1993) 75

Commission Proposal for a European Parliament and Council Decision adopting a programme of Community action on the prevention of AIDS and certain other communicable diseases within the framework for action in the field of public health (COM (94) 413 final)

70–71

Report of the Temporary Committee of Inquiry into BSE, set up by the Parliament in July 1996, on the alleged contraventions or maladministration in the implementation of Community law in relation to BSE, without prejudice to the jurisdiction of the Community and the national courts of 7 February 1997 (A4-0020/97/A, PE 220.544/fin/A) ................ 97

Communication from the Commission, An action plan for free movement of workers (COM (1997) 586 final) 80

Commission Communication on Consumer health and food safety (COM(1997) 183 final) 111

European Parliament, ENVI Committee, Activity Report of the Committee on the Environment, Public Health and Consumer Policy 1999–2004 Parliament (DT\537810EN.doc) 102 Exchange of letters between the World Health Organization and the Commission of the European Communities concerning the consolidation and intensification of cooperation (2001/C1/04) (OJ C1/7 2001) . . . . . . . . . . . . . . . 107–8

European Commission, Programme of Cooperation on Preparedness and Response to Biological and Chemical Agent Attacks (Health Security) Luxembourg, 17 December 2001 (G/FS D(2001) GG) 126 European Commission, The Internal Market and Health Services, Report of the High Level Commitee on Health, Brussels, 17 September 2001 .......... 108, 161 General Guidelines for cooperation between the Commission of the European Communities (CEC) the European Free Trade Association (EFTA) and the European Standards institutions the European Committee for Standardization (CEN) the European Committee for Electrotechnical Standardization (CENELEC) (CEN/ CELENEC Guide 4 2001/01) 89 European Health Management Asscociation, The European Union and Health Services,The Impact of the Single European Market on Member States, Summary of a Report to the European Commission Directorate General for Research (BIOMED2), Dublin (2001) 161 Presidency Conclusions, Goteborg European Council, 15 and 16 June, 2001 (ECOFIN) Council conclusions, Report on budgetary challenges posed by ageing populations, Brussels 6 November 2001 (SN 4406/1/01 REV 1) ........ 107 Conclusions of the Council and the Representatives of the Member States Meeting in the Council of 19 July 2002 on Patient Mobility and Health Care Developments in the European Union (OJ C 183/01) 161

Presidency Conclusions, Barcelona European Council 15 and 16 March 2002 (SN 100/1/02 REV 1) 80

European Commission, Proposal for a Joint Report: Health Care and Care for the Elderly: Supporting National Strategies for Ensuring a High Level of Social Protection (COM (2002)774 final) 108

Health care Developments in the European Union, 3 February 2003 (HLPR/2003/2 REV1)............ 161

EU Health Security Committee (HSC)/ Early Warning and Response System (EWRS)HSC 25 August 2009, avaliable at Conference of the Representatives of the Governments of the Member States, Naples Ministerial Conclave: Presidency proposal CIG 52/03 addendum to the Presidency Note, Brussels, 25 November 2003 77

Communication from the Commission concerning the introduction of a European health Insurance card (COM(2003)73 final) ............ 153

European Commission, High level process on Patient Mobility and Healthcare Developments in the EU, outcome of the reflection process (HLPR/ 200316, December 2003) 99

Commission Staff Working Paper, Report on the Application of Internal Market Rules to Health Services, Implementation by the Member States of the Courts Jurisprudence, (SEC(2003) 900) ................ 156

Working Document on the Proposal for a Directive of the European Parliament and of the Council on the Application of Patients’ Rights in Cross-Border Healthcare from the General Secretariat of the Council to the Working Party on Public Health (11307/08 SAN 136 SOC389 MI 234 CODEC 904) (2008/0142 (COD)15655/08) May 2003 165

European Parliament (2004) ‘European Parliament, Delegations to the Conciliation Committee, Activity Report, 1 May 1999 to 30 April 2004 (5th Parliamentary term) (DV\530227EN.doc, PE 287.644) .. 103

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EU Health Strategy’, European Communities (2004) . . . . . . . . . . 160–61

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Commission Communication on patient mobility and health care developments in the EU (COM (2004) 301 final) 161

European Commission, Proposal for a Directive of the European Parliament and of the Council on services in the internal market (COM(2004) 2 final) ............. 156

European Commission, Interim Document, Technical guidance on preparedness planning for public health emergencies, April 2005 121

European Parliament resolution on the Commission’s 21st and 22nd Annual reports on monitoring the application of Community law (2003 and 2004) (2005/2150(INI)) ............... 103

European Council, 22 and 23 March 2005 (7619/1/05, REV 1) ........................ 104

EU Platform on Diet, Charter, Physical Activity and Health, Diet, Physical Activity and Health—a European Platform for Action, 15 March 2005, avaliable at: <http://www.ec.europa. eu/health/archive/ph_determinants/ life_style/nutrition/platform/docs/ platform_charter.pdf> (last accessed March 2014) 112

Communication from the Commission to the Council on transitional prolongation and extension of the mandate of the Health Security Committee in view of a future general revision of the structures dealing with health threats at the EU Level (COM (2006) 699 final) 127

European Commission HLG, Work of the high level group in 2006 (HLG/2006/08, 2006) 99, 163

Council Conclusions on Common values and principles in European Union Health Systems (OJ C146/1 2006) 3, 40, 60, 78, 145, 163, 170, 179, 188

Communication from the Commission, Consultation regarding Community action on health services (SEC(2006)1195/4) .............. 163

European Parliament resolution of 23 May 2007 on the impact and consequences of the exclusion of health services from the Directive on services in the internal market (2006/2275(INI)) 103, 162, 163

EU Platform on diet, Physical Activity and Health (2006) Monitoring Framework, available at: < http:// www.ec.europa.eu/health/archive/ ph_determinants/life_style/nutrition/ platform/docs/eu_platform_monframework_en.pdf> (last accessed: March 2014) ................... 112

European Commission, Amended proposal for a Directive of the European Parliament and of the Council on services in the internal market (COM/2006/0160 final) 162

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European Parliament, Resolution of 23 May 2007 on the impact and consequences of the exclusion of health services from the Directive on

services in the internal market (P6_TA(2007) 0201) ..... 103, 162, 163 European Medicines Agency, Mandate, Objectives and Rules of Procedure for the GCP inspectors Working Group, London, 27 July 2007 (EMEA/INS/ GCP/239486/2007) 89 Council of the European Union, 2786th Council Meeting Employment, Social Policy, Health and Consumer Affairs, Brussels, 22 February 2007 (6226/07, Presse 23).............. 127 European Commission, DG SANCO, The Commission Health Emergency Operations Facility: for a coordinated management of public health emergency at EU level, 2007, available at: < http://www.ec.europa. eu/health/archive/ph_threats/com/ preparedness/docs/heof_en.pdf> (last accessed March 2014) 124 European Commission, White paper: Together for Health, A Strategic Approach for the EU 2008-2013 (COM (2007) 630 final) ........... 75

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Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committeee and the Committee of Regions on rare diseases: Europe’s challenges (COM(2008) 679 final) ........... 112

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on telemedicine for the benefit of patients, health care systems and society (COM/2008/689 final) 84

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