Health Systems Governance in Europe: The Role of European Union Law and Policy

Half-title......Page 3
Series-title......Page 4
Title......Page 5
Copyright......Page 6
Contents......Page 7
Figure......Page 9
Tables......Page 10
Boxes......Page 11
Acknowledgments......Page 17
Abbreviations......Page 19
1. The scope and aims of this book......Page 25
2. EU health policy: contradictions and challenges......Page 28
A. Constraints and parameters: theoretical perspectives on EU health policy-making......Page 31
B. Taking EU Policy forward?......Page 35
3. EU Law and (the erosion/protection of) national social policies......Page 43
4. The role of the European Court of Justice in health care......Page 52
5. New forms of governance and the role of soft law......Page 58
A. The legal–policy patchwork......Page 66
B. Agencies and health (care) policy-making......Page 69
C. Health care and the EU: the hard politics of soft law......Page 73
D. Public health in the EU......Page 76
E. Fundamental rights and their applicability to health care......Page 78
F. EU competition law and public services, including health care......Page 81
G. Private health insurance......Page 86
H. Free movement of services......Page 88
I. Free movement of patients......Page 91
J. The status of e-health in the EU......Page 94
K. EU law and health professionals......Page 97
L. EU pharmaceutical policy and law......Page 99
7. Conclusions......Page 101
1. Introduction......Page 108
2. The EU’s public health policy......Page 111
3. Effects of EU law on national health care systems......Page 116
A. Internal market law:......Page 118
B. EU competition law and services of general interest......Page 125
C. EU social and employment law......Page 126
4. The ‘governance’ of health care in the EU......Page 129
A. The slow move of health care to the EU agenda......Page 130
B. After the Services Directive:......Page 145
5. Conclusions......Page 152
1. Introduction......Page 158
A. Delegating to European agencies......Page 161
B. Classification according to function......Page 163
3. Europeanization of health protection and the emergence of ‘health agencies’......Page 178
A. Health protection and the treaties......Page 179
B. The ‘European’ dimension to health protection in pharmaceuticals and foodstuffs......Page 181
C. Balancing single market priorities......Page 186
4. Health (care), the European Medicines Agency and the European Food Safety Authority......Page 188
A. Core functions and the politics of scientific advice......Page 189
Independence......Page 195
Accountability......Page 200
Transparency......Page 201
Participation......Page 203
The role of industry......Page 204
C. EMEA, EFSA and Member State health systems......Page 205
5. Conclusion......Page 206
1. Introduction......Page 210
2. New governance and soft law......Page 212
A. Why discuss ‘new governance’?......Page 213
B. Defining new governance in EU health policy......Page 215
C. New governance at work: the OMC......Page 217
3. The development of new governance in EU health policy......Page 222
A. Health care appears on the agenda......Page 223
B. New governance mechanisms in the developing EU health policy sector......Page 226
4. The ambiguity of new governance instruments......Page 236
A. The OMC as learning......Page 239
B. The OMC as soft law......Page 246
5. New governance in EU health policy: what future?......Page 248
A. Using scarce resources......Page 249
B. Commission … Council, Member States … Parliament......Page 250
C. Persistence and usefulness......Page 252
1. Introduction......Page 255
A. The Treaty......Page 259
B. The public health programmes......Page 264
3. The detection and control of communicable diseases......Page 271
A. Restrictions on movements of goods......Page 273
B. Restrictions on movements of people......Page 274
C. A European surveillance and response system......Page 275
D. Communicable diseases: a summary......Page 280
4. Tobacco control......Page 281
A. Advertising ban......Page 286
B. Product regulation and labelling......Page 289
C. Environmental tobacco smoke......Page 293
D. Price and taxation......Page 297
E. Industry lobbies, tobacco regulation and EU law......Page 299
5. Looking forward......Page 301
6. Conclusion......Page 304
1. Introduction......Page 306
2. Fundamental human rights and health care law......Page 307
A. The European Convention on Human Rights......Page 310
B. The European Social Charter......Page 314
C. Health, human rights and Member States......Page 316
3. Human rights, health law and the EU......Page 318
A. The impact of the Charter on health law......Page 322
B. Health rights and the EU Agency for Fundamental Rights......Page 332
4. Conclusions......Page 336
2. Markets and social solidarity......Page 339
3. The scope of European Union Competition Law......Page 343
4. Article 86(2) and services of general economic interest......Page 349
5. The European Commission and political reform......Page 354
6. Conclusions......Page 358
1. Introduction......Page 361
2. When does competition law apply?......Page 364
A. Cartels......Page 374
Exclusions......Page 379
B. Abuse of dominant position......Page 382
C. State regulation and services of general economic interest......Page 386
Efficient operator......Page 390
4. Enforcement of competition law......Page 391
5. Conclusions......Page 400
1. Introduction......Page 403
A. Logical links between state aid and public procurement......Page 405
B. Formal links between state aid and public procurement......Page 408
C. Procurement principles as a means of regulating 
the internal market......Page 413
3. Applying the EC rules to national health care......Page 417
A. Where is the service of general interest?......Page 418
Distinguishing capital costs from exploitation costs......Page 423
Calculating the cost of public service......Page 424
Funding the cost of services of general interest......Page 427
C. Who is a contracting entity and who is an undertaking?......Page 428
Contracting entities: some certainty?......Page 430
Undertakings everywhere?......Page 431
Undertakings subject to the procurement rules?......Page 435
No contractual relationship......Page 436
Closed awards......Page 437
Open awards......Page 438
Competitive awards......Page 439
4. Conclusion......Page 440
1. Introduction......Page 443
2. Private health insurance in the European Union......Page 444
3. Regulation and the Third Non-life Insurance Directive......Page 447
4. Implications for government intervention in health insurance markets......Page 453
A. When can governments intervene?......Page 454
Financial transfers (risk equalization schemes)......Page 461
The Netherlands......Page 463
Ireland......Page 464
Slovenia......Page 469
Benefits......Page 471
Minimum or standard benefits......Page 472
Benefits in kind......Page 473
Solvency requirements......Page 474
Tax treatment......Page 477
5. Conclusions......Page 479
1. Introduction......Page 485
A. The economic nature of health care......Page 489
B. Barriers to free movement of services......Page 492
A. From ‘non-discrimination’ to ‘justification’......Page 501
B. The Necessity Test: is regulatory intervention in the field of health care imperative for the protection of a higher public interest goal?......Page 503
C. The Proportionality Test: does the obstruction of free movement go beyond what is necessary?......Page 506
The Proportionality Test in the case of temporary provision of health care services......Page 507
The Proportionality Test in cases of permanent establishment of health service providers......Page 512
A. National actors and the call for more legal certainty......Page 517
The horizontal (internal market) approach......Page 521
The sectoral (health systems) approach......Page 523
The generic (social services of general interest) approach......Page 526
5. Conclusions......Page 529
1. Introduction......Page 533
A. The conceptual construct of patient mobility......Page 535
B. Social security coordination......Page 538
C. The case-law of the European Court of Justice......Page 540
D. The policy response to the ECJ rulings......Page 545
E. Cooperation initiatives and contractual arrangements in the field......Page 552
A. People seeking treatment abroad......Page 553
The remaining scope of prior authorization......Page 554
Adjustments to the coordination route......Page 559
Improving access to care for people living in border regions......Page 562
Contractual arrangements for planned care......Page 564
B. People in need of care while temporarily abroad......Page 568
Extending the right to occasional care abroad......Page 569
Taking into account the changing health care needs of people retiring to other countries......Page 574
4. Towards a community framework for safe, 
high-quality and efficient care?......Page 575
5. Conclusions......Page 580
1. Introduction......Page 585
A. The Data Protection Directive......Page 587
B. The E-commerce Directive......Page 590
C. Medical Device Directives......Page 592
D. Directive on Distance Contracting......Page 593
E. Directive on Electronic Signatures......Page 594
F. Competition law......Page 595
3. EU policy related to e-health and its impact on health care systems......Page 596
Electronic health records and e-health platforms......Page 599
Health grids......Page 603
Further use of genetic data and tissue......Page 604
B. Towards more guidelines on the reimbursement criteria for telemedicine......Page 606
C. Towards a European legal framework on liability and telemedicine......Page 609
5. Conclusion......Page 611
1. Introduction......Page 613
A. Introduction......Page 615
Sectoral and general directives......Page 617
Shortcomings......Page 622
Background......Page 627
Automatic recognition on the basis of the coordination of minimum training conditions......Page 628
The general system......Page 632
a. Establishment.......Page 634
b. Provision of services.......Page 635
Quality:......Page 637
Practices allowed......Page 642
Disciplinary matters......Page 643
D. Access to training: free movement of students......Page 644
E. Ethical recruitment guidelines......Page 646
3. The Working Time Directive......Page 647
A. The contents of the Directive......Page 649
B. Derogations and opt-outs......Page 651
C. Moving forward......Page 653
4. Conclusion......Page 656
1. Introduction......Page 659
A. Therapeutic competition......Page 664
B. Generic competition......Page 665
D. Consequences......Page 666
A. The centralized and decentralized licensing regime......Page 668
B. Patent protection and the supplementary patent certificate regime......Page 670
Clinical trials and pharmacovigilance – limited harmonization so far......Page 671
Remaining gaps......Page 672
4. Generic competition in the regulatory pathway......Page 673
A. Data exclusivity......Page 674
8+2+1 Year data and marketing exclusivity......Page 675
C. Bio-similar medicines or products......Page 677
D. Competition law and the regulatory pathway: the AstraZeneca Case......Page 679
E. The Commission Inquiry......Page 683
Anti-competitive agreements......Page 684
A. Pricing and marketing......Page 685
B. Intra-brand competition: the setting sun?......Page 686
C. The GlaxoSmithKline Case: dual pricing upheld......Page 687
The Greek Syfait Case......Page 690
The French Competition Council and the Paris Court of Appeal......Page 692
F. Implications......Page 693
Decentralization of competition law enforcement......Page 694
6. Further efforts at policy compromise: the role of the pharmaceutical forum......Page 696
A. Pricing......Page 698
B. Relative effectiveness......Page 700
C. Patient information......Page 701
7. Conclusion......Page 704
Bibliography......Page 707
Index......Page 769