Health law and the European Union

Cover......Page 1
Half-title......Page 3
Series-title......Page 4
Dedication......Page 6
Title......Page 7
Copyright......Page 8
Contents......Page 9
Acknowledgements......Page 13
Table of abbreviations......Page 15
Table of conventions and treaties......Page 17
Regulations......Page 24
Soft law......Page 49
Denmark......Page 52
Greece......Page 53
Netherlands......Page 54
United Kingdom......Page 55
STATUTORY INSTRUMENTS......Page 56
B......Page 57
C......Page 58
E......Page 59
F......Page 61
G......Page 62
K......Page 63
M......Page 64
O......Page 65
P......Page 66
S......Page 68
T......Page 69
V......Page 70
X......Page 71
Part One......Page 73
I. Health law and the European Union......Page 75
II. What is health law?......Page 78
What is health?......Page 79
The evolution of law’s engagement with health......Page 83
In the beginning, there was “medical law”?......Page 85
The movement to “health law”......Page 87
“Health law” and “health care law”......Page 88
Public health law......Page 91
Administration of health services: financing and resources......Page 93
Health and human rights......Page 95
III. Conclusion......Page 99
I. Introduction: what is the European Union?......Page 103
II. What does the European Union do?......Page 109
III. What methods of governance does the European Union employ?......Page 115
Deregulation......Page 116
“Old style” harmonisation......Page 120
“New approach” harmonisation......Page 125
Regulatory coordination......Page 131
“Soft” coordination......Page 133
Financial incentives......Page 134
IV. Courts and fundamental rights......Page 135
V. Conclusions......Page 139
I. Introduction......Page 141
Historical context......Page 144
The elements of Article 152 EC......Page 148
Secondary legislation adopted on the basis of Article 152 EC......Page 153
Common policies as legal basis: “mainstreaming” of health protection......Page 156
Article 308 EC: health protection as a Community objective......Page 159
Health and the internal market......Page 162
The Tobacco Advertising ruling......Page 168
Community competence in health after Tobacco Advertising......Page 172
IV. Conclusions......Page 177
Part Two......Page 179
I. Introduction......Page 181
Migrant patients as migrant workers......Page 184
Migrant patients as recipients of services......Page 191
Freedom to receive health care services......Page 196
Impact on access to health services and wider implications......Page 210
III. “Reproductive tourism”......Page 216
IV. Conclusions......Page 228
I. Introduction......Page 231
Why safeguard health information privacy?......Page 232
II. Rights to health information privacy in international and EU law......Page 235
Introduction......Page 238
Processing of personal data......Page 240
Ordinary personal data......Page 241
Special data......Page 242
Anonymisation......Page 244
Consent and special data......Page 247
Clinical research and public health monitoring......Page 251
Control rights for data subjects......Page 254
Implementation and compliance with the Directive......Page 256
IV. Conclusions......Page 257
I. Introduction......Page 261
II. The impact of EU law on health care professional practice......Page 265
EU employment law......Page 266
EU law on provision of services......Page 269
Freedom of establishment: Treaty provisions......Page 271
The sectoral (professional) directives......Page 275
Doctors......Page 278
Impact on medical training......Page 279
Advisory Committee on Medical Training......Page 280
General practice and reform of the Doctors Directive......Page 281
Pharmacists......Page 283
Interactions with free movement of pharmaceuticals......Page 285
The general directives on mutual recognition of qualifications......Page 287
Assessment of the sectoral and general directives......Page 290
Quality in health care and professional training......Page 294
Difficulties with the general directives......Page 299
Non-EU citizens and qualifications from non-EU states......Page 302
IV. Conclusions......Page 305
I. Introduction......Page 309
II. Co-ordinating and funding clinical research activities......Page 311
III. The Clinical Trials Directive......Page 320
IV. The regulation of medical research using genetic technology......Page 331
Cloning......Page 343
Stem cell research......Page 346
V. Conclusions......Page 352
I. Introduction......Page 354
Introduction......Page 360
Marketing authorisations......Page 361
The EMEA......Page 362
The decentralised procedure......Page 363
The centralised procedure......Page 364
The centralised procedure: assessment......Page 367
The decentralised procedure: assessment......Page 368
Authorisation of manufacture......Page 370
Pharmacovigilance......Page 372
Labelling and packaging......Page 374
Advertisement......Page 376
Product liability......Page 379
Reform proposals......Page 384
Wider implications and assessment......Page 389
IV. Internal market law......Page 391
The Transparency of Pharmaceuticals Pricing Directive......Page 395
V. Conclusions......Page 399
I. Introduction......Page 402
Introduction......Page 407
The EU public health programmes......Page 408
HIV/AIDS and free movement of persons......Page 412
Blood safety and HIV......Page 415
The Blood Safety Directive......Page 418
Introduction......Page 420
BSE/nvCJD: historical context......Page 423
Regulation 178/2002/EC: the Food Law Regulation......Page 429
European Food Safety Authority......Page 436
III. Health promotion......Page 438
Cancer and tobacco......Page 440
“Europe Against Cancer”......Page 441
Composition of tobacco products......Page 446
Advertising of tobacco products......Page 451
IV. Conclusion......Page 456
Part Three......Page 459
I. Introduction: the roles of the EU in health law......Page 461
Four themes of “European health law”?......Page 462
II. The “spectrum”: how does EU law affect health law and policy in the member states?......Page 466
Areas of health law affected most strongly......Page 467
Areas of health law affected by general measures of EU law......Page 468
Marginal effect......Page 471
No prospect of convergence or consensus?......Page 472
The Draft Constitutional Treaty......Page 476
Fundamental rights within the DCT......Page 477
Competence within the DCT......Page 482
Enlargement......Page 486
Regulating the use of human material......Page 493
“e-Health”......Page 498
Further future developments?......Page 505
IV. Conclusions: health law and the European Union......Page 508
Bibliography......Page 509
Index......Page 539