Chapter
F. EU competition law and public services, including health care
G. Private health insurance
H. Free movement of services
I. Free movement of patients
J. The status of e-health in the EU
K. EU law and health professionals
L. EU pharmaceutical policy and law
2 Health care and the EU:
2. The EU’s public health policy
3. Effects of EU law on national health care systems
B. EU competition law and services of general interest
C. EU social and employment law
4. The ‘governance’ of health care in the EU
A. The slow move of health care to the EU agenda
B. After the Services Directive:
3 EU regulatory agencies and health protection
2. European agencies as a new mode of governance
A. Delegating to European agencies
B. Classification according to function
3. Europeanization of health protection and the emergence of ‘health agencies’
A. Health protection and the treaties
B. The ‘European’ dimension to health protection in pharmaceuticals and foodstuffs
C. Balancing single market priorities
4. Health (care), the European Medicines Agency and the European Food Safety Authority
A. Core functions and the politics of scientific advice
C. EMEA, EFSA and Member State health systems
4 The hard politics of soft law:
2. New governance and soft law
A. Why discuss ‘new governance’?
B. Defining new governance in EU health policy
C. New governance at work: the OMC
3. The development of new governance in EU health policy
A. Health care appears on the agenda
B. New governance mechanisms in the developing EU health policy sector
4. The ambiguity of new governance instruments
5. New governance in EU health policy: what future?
A. Using scarce resources
B. Commission … Council, Member States … Parliament
C. Persistence and usefulness
2. The EU’s competence in public health
B. The public health programmes
3. The detection and control of communicable diseases
A. Restrictions on movements of goods
B. Restrictions on movements of people
C. A European surveillance and response system
D. Communicable diseases: a summary
B. Product regulation and labelling
C. Environmental tobacco smoke
E. Industry lobbies, tobacco regulation and EU law
6 Fundamental rights and health care
2. Fundamental human rights and health care law
A. The European Convention on Human Rights
B. The European Social Charter
C. Health, human rights and Member States
3. Human rights, health law and the EU
A. The impact of the Charter on health law
B. Health rights and the EU Agency for Fundamental Rights
7 EU competition law and public services
2. Markets and social solidarity
3. The scope of European Union Competition Law
4. Article 86(2) and services of general economic interest
5. The European Commission and political reform
8 EU competition law and
health policy
2. When does competition law apply?
3. Prohibited conduct under competition law
B. Abuse of dominant position
C. State regulation and services of general economic interest
4. Enforcement of competition law
9 Public procurement and state aid
in national health care systems
2. Public procurement and state aid
A. Logical links between state aid and public procurement
B. Formal links between state aid and public procurement
C. Procurement principles as a means of regulating
the internal market
3. Applying the EC rules to national health care
A. Where is the service of general interest?
Distinguishing capital costs from exploitation costs
Calculating the cost of public service
Funding the cost of services of general interest
C. Who is a contracting entity and who is an undertaking?
Contracting entities: some certainty?
Undertakings subject to the procurement rules?
D. What kind of award procedures should be followed?
No contractual relationship
10 Private health insurance and the internal market
2. Private health insurance in the European Union
3. Regulation and the Third Non-life Insurance Directive
4. Implications for government intervention in health insurance markets
A. When can governments intervene?
B. How can governments intervene?
Financial transfers (risk equalization schemes)
Minimum or standard benefits
Differential treatment of insurers
11 Free movement of services in the EU and health care
2. Health care as an economic activity and its consequence
A. The economic nature of health care
B. Barriers to free movement of services
3. Justified and unjustified restrictions to free movement in health care
A. From ‘non-discrimination’ to ‘justification’
B. The Necessity Test: is regulatory intervention in the field of health care imperative for the protection of a higher public interest goal?
C. The Proportionality Test: does the obstruction of free movement go beyond what is necessary?
The Proportionality Test in the case of temporary provision of health care services
The Proportionality Test in cases of permanent establishment of health service providers
4. Health care and free movement: the policy challenge
A. National actors and the call for more legal certainty
B. Searching for policy responses at the EU level
The horizontal (internal market) approach
The sectoral (health systems) approach
The generic (social services of general interest) approach
12 Enabling patient mobility in the EU:
2. The governance of patient mobility in the European Union
A. The conceptual construct of patient mobility
B. Social security coordination
C. The case-law of the European Court of Justice
D. The policy response to the ECJ rulings
E. Cooperation initiatives and contractual arrangements in the field
3. Types of patient mobility and related arrangements for access
A. People seeking treatment abroad
The remaining scope of prior authorization
Adjustments to the coordination route
Improving access to care for people living in border regions
Contractual arrangements for planned care
B. People in need of care while temporarily abroad
Extending the right to occasional care abroad
Taking into account the changing health care needs of people retiring to other countries
4. Towards a community framework for safe,
high-quality and efficient care?
13 The EU legal framework on e-health
2. European legal instruments related to e-health
A. The Data Protection Directive
B. The E-commerce Directive
C. Medical Device Directives
D. Directive on Distance Contracting
E. Directive on Electronic Signatures
3. EU policy related to e-health and its impact on health care systems
4. Legal challenges to promote e-health
A. New challenges due to new e-health applications
Electronic health records and e-health platforms
Further use of genetic data and tissue
B. Towards more guidelines on the reimbursement criteria for telemedicine
C. Towards a European legal framework on liability and telemedicine
14 EU law and health professionals
2. Mobility of health professionals
B. Before Directive 2005/36/EC: sectoral and general directives
Sectoral and general directives
Automatic recognition on the basis of the coordination of minimum training conditions
Pursuit of the profession
Establishment versus provision of services
b. Provision of services.
D. Access to training: free movement of students
E. Ethical recruitment guidelines
3. The Working Time Directive
A. The contents of the Directive
B. Derogations and opt-outs
15 The EU pharmaceuticals market:
2. The parameters for competition in the European pharmaceutical market
A. Therapeutic competition
C. Intra-brand competition
3. Recent developments in the ‘regulatory’ pathway
A. The centralized and decentralized licensing regime
B. Patent protection and the supplementary patent certificate regime
Clinical trials and pharmacovigilance – limited harmonization so far
4. Generic competition in the regulatory pathway
B. From data exclusivity to marketing exclusivity
8+2+1 Year data and marketing exclusivity
C. Bio-similar medicines or products
D. Competition law and the regulatory pathway: the AstraZeneca Case
E. The Commission Inquiry
Anti-competitive agreements
5. Developments in the marketing pathway
B. Intra-brand competition: the setting sun?
C. The GlaxoSmithKline Case: dual pricing upheld
D. Abuse of a dominant position
E. Supply quotas and refusals to supply
The French Competition Council and the Paris Court of Appeal
The Spanish Tribunal for Fair Trading
Decentralization of competition law enforcement
6. Further efforts at policy compromise: the role of the pharmaceutical forum
B. Relative effectiveness
Health Systems Governance in Europe
：The Role of European Union Law and Policy
( Health Economics, Policy and Management )
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