Health Law and the European Union

by Tamara K. Hervey , Jean V. McHale

• ISBN13: 9780521605243
• ISBN10: 0521605245
• Edition: 1st
• Format: Paperback
• Copyright: 2004-12-13
• Publisher: Cambridge University Press

Summary

How does the law of the European Union affect health law and policy? At first sight, it seems limited. However, despite its restricted formal competence, the EU has recently become increasingly involved in the health field. Litigation based on EU law has resulted in a 'right to receive health care services' across national boundaries which may have huge practical implications for national health systems. The EU has promulgated legislation regulating clinical research, and the marketing of pharmaceuticals; patients' rights are affected by EU legislation on data protection and product liability; the qualifications of health care professionals are legally recognised across the EU; and the EU has acted to promote public health. This book explores the various impacts of measures of EU law on national health law and policy. Through elaboration of selected examples, the authors show that, within the EU, health law cannot be regarded as a purely national affair.

Table of Contents

Acknowledgements	xi
Table of abbreviations	xiii
Table of conventions and treaties	xv
Table of EU legislation	xxii
Table of national provisions	1	(2)
Table of cases	lv
Part One
Introduction	3	(28)
Health law and the European Union	3	(3)
What is health law?	6	(21)
What is health?	7	(3)
The evolution of law's engagement with health	10	(3)
Definitions: delineating the boundaries of a discipline	13	(3)
The elements of ``health law''	16	(11)
Conclusion	27	(4)
Historical, legal and institutional contexts	31	(38)
Introduction: what is the European Union?	31	(6)
What does the European Union do?	37	(6)
What methods of governance does the European Union employ?	43	(20)
Deregulation	44	(4)
``Old style'' harmonisation	48	(5)
``New approach'' harmonisation	53	(6)
Regulatory coordination	59	(2)
``Soft'' coordination	61	(1)
Financial incentives	62	(1)
Courts and fundamental rights	63	(4)
Conclusions	67	(2)
Community competence in the field of health	69	(40)
Introduction	69	(3)
Article 152 EC	72	(12)
Historical context	72	(4)
The elements of Article 152 EC	76	(5)
Secondary legislation adopted on the basis of Article 152 EC	81	(3)
Other legal bases	84	(21)
Common policies as legal basis: ``mainstreaming'' of health protection	84	(3)
Article 308 EC: health protection as a Community objective	87	(3)
The internal market	90	(15)
Conclusions	105	(4)
Part Two
Access to health care services	109	(50)
Introduction	109	(3)
Access to health care services	112	(32)
Free movement of patients	112	(26)
Impact on access to health services and wider implications	138	(6)
``Reproductive tourism''	144	(12)
Conclusions	156	(3)
Data protection and health information privacy	159	(30)
Introduction	159	(4)
Why safeguard health information privacy?	160	(3)
Rights to health information privacy in international and EU law	163	(3)
The Data Protection Directive	166	(19)
Introduction	166	(2)
Processing of personal data	168	(1)
Ordinary personal data	169	(1)
Special data	170	(7)
Further exceptions allowing disclosure	177	(2)
Clinical research and public health monitoring	179	(3)
Control rights for data subjects	182	(2)
Implementation and compliance with the Directive	184	(1)
Transfer of data outside the EU	185	(1)
Conclusions	185	(4)
Regulation of health care professionals	189	(48)
Introduction	189	(4)
The impact of EU law on health care professional practice	193	(6)
EU employment law	191	(1)
EU law on provision of services	192	(7)
EU law and entry into professional practice in Member States	199	(34)
Freedom of establishment: Treaty provisions	199	(4)
The sectoral (professional) directives	203	(12)
The general directives on mutual recognition of qualifications	215	(3)
Assessment of the sectoral and general directives	218	(12)
Non-EU citizens and qualifications from non-EU states	230	(3)
Conclusions	233	(4)
The regulation of clinical research	237	(45)
Introduction	237	(2)
Co-ordinating and funding clinical research activities	239	(9)
The Clinical Trials Directive	248	(11)
The regulation of medical research using genetic technology	259	(21)
Cloning	271	(3)
Stem cell research	274	(6)
Conclusions	280	(2)
Regulating pharmaceuticals: risk, choice and compensation	282	(48)
Introduction	282	(6)
EU-level patient (consumer) protection measures	288	(24)
Introduction	288	(1)
Marketing authorisations	289	(11)
Pharmacovigilance	300	(2)
Labelling and packaging	302	(2)
Advertisement	304	(3)
Product liability	307	(5)
Proposed reform and wider implications	312	(7)
Reform proposals	312	(5)
Wider implications and assessment	317	(2)
Internal market law	319	(8)
The Transparency of Pharmaceuticals Pricing Directive	323	(4)
Conclusions	327	(3)
Public health law	330	(59)
Introduction	330	(4)
Communicable diseases	334	(32)
Introduction	334	(2)
HIV/AIDS	336	(12)
BSE/nvCJD	348	(18)
Health promotion	366	(18)
Cancer and tobacco	368	(16)
Conclusion	384	(5)
Part Three
Conclusions and future prospects	389	(48)
Introduction: the roles of the EU in health law	389	(5)
Four themes of ``European health law''?	390	(4)
The ``spectrum'': how does EU law affect health law and policy in the member states?	394	(10)
Areas of health law affected most strongly	395	(1)
Areas of health law affected by general measures of EU law	396	(3)
Marginal effect	399	(1)
``Slow convergence'' effect	400	(1)
No prospect of convergence or consensus?	400	(4)
Future directions	404	(32)
The Draft Constitutional Treaty	404	(8)
A ``health'' open method of coordination?	412	(2)
Enlargement	414	(7)
Regulating the use of human material	421	(5)
``e-Health''	426	(7)
Further future developments?	433	(3)
Conclusions: health law and the European Union	436	(1)
Bibliography	437	(30)
Index	467