here - Erasmus Observatory on Health Law

Summer Course on European
Health Law & Ethics
June 17 - 28, 2013
Riga, Latvia
European Health Law
Course introduction
Programme Week I
EU and Health: General introduction
Public Health
Professional Mobility and Pharmaceuticals
Patient Mobility in the EU
EU Competition law and Health Care
Programme Week II
• Human Rights in Health Care: Introduction
• Human Rights and Health Ethics
• Medical Research
• Human Genetics
• Organ Donation
• Establishing a 3-years course ‘European health
law’ in Latvia accessible for European students
interested in European health law.
• Identifying and analyzing major health
challenges that require a common approach
• Explaining the concept of EU and CoE Law and
its relevance to health care
• Understanding the concept of ‘European
health law’, including its rationale,
instruments and effectiveness.
Outline Basics of EU Law
History of the European Integration
II. Institutional System of the EU
III. Sources of the EU Legal order
IV. Legal Protection
V. Left over
I. History of the European
• Plurality of International Organizations in
– A series of International Organizations active in
• European Union; Council of Europe; Org. Security and
Cooperation in Europe (OSCE); OECD; NATO
– Different Channels of Integration:
• European law in a wide sense
• In a narrow sense: EU law
EU Law: The Beginnings
• The First Community: Treaty Establishing the
European Coal and Steel (1951)
• The Second and Third Communities: Treaty
Establishing the European Economic Community (EEC)
& Treaty Establishing the European Atomic Energy
Community (Euratom) = Treaties of Rome (1957)
• Treaty of Maastricht (1992)
• Treaty of Amsterdam (1997)
• Treaty of Nice & Charter of Fundamental Rights of the
EU (2000)
• Treaty of Lisbon (2007)
• What's next?
II. The Institutional System of the EU
The EU Institutions:
– European Council (art. 15 TEU)
– Council (of Ministers) (art. 16(1) TEU)
– European Commission (art. 17(2) TEU)
– European Parliament (EP, art. 14 TEU)
– EU Court of Justice (art. 18 TEU)
– …….
III. Sources of EU Law: Overview
Primary sources
- Founding treaties (ECT, EUROTOM, TEU)
- Agreements in International Law
Secondary sources:
- Regulations
- Directives: no direct effect
- Decisions
- Recommendations and opinions
- Caselaw EUCJ
General Principles of law deriving from the common traditions and
constitutional rules shared by MS
EC/EU Competence
• Legislation must be properly based upon a
Treaty article, that is, must have a proper legal
basis in the Treaty in order to produce legal
III. Sources: Substantive law
Single Market
Free movement Goods
• Competition law
Single Market
• Main objective
– Establishing a Single Market (art 3 a-c Art 4 ECT)
• Terminology
– Single/Internal/Common market
• Stages of Integration
Free trade area
Customs area
Common market
Economic and Monetary Union
Complete Economic Integration
Single Market
• Definition: 14(2) ECT states:
– “The internal market shall comprise an area
without internal frontiers in which the free
movement of goods, persons, services and capital
is ensured in accordance with the provisions of
this Treaty”
– Essential elements: the Four Freedoms
Free Movement of Goods
I. Main provisions
• Treaty Articles
Art. 28 -37 TFEU
• Secondary legislation
• Case law
Goods : “products which can be valued in money and which are capable, as
such, of forming the subject of commercial transaction”
Elimination of all ((non)financial) obstacles to free movement
Free Movement of Goods
• Exceptions to the prohibition of art 28
• Two different concepts:
– Art 36 TFEU
– Cassis de Dijon case : “Rule of Reason”
Art 36
• Can justify measures which are qualified as
measures in the sense of art 28
• Only on the grounds of the Article (Public
Morality, Public Security, The Protection of the
Health of the Humans and animals…)
• Requirement of proportionality: the national
measure must be the least restrictive possible
to attain the end in view
• EUCJ interprets art 36 very strictly
Exception to the prohibition of Art. 28
• Cassis de Dijon (ECJ C-120/78): "Rule of
- when there is no EU law in force MS can
regulate all matters regulating of goods
- necessary to fulfill mandatory requirements (in
pursuit of reasonable special interest)
- proportionality
Free movement of Workers
I. Provisions
Treaty Article: art 45-48 TFEU
Secondary Legislation: eg Directive 2005/34
> right to take up an activity as a 'worker'
concept of "worker": wide notion,
including job seekers
.. “a person which performs services for another
during a certain period of time under the
direction of another in return for remuneration"
Free movement of Workers
• Objectives free movement of workers:
– increasing Union's workers' chances of finding work
– encouraging mobility of workers
• Rights provided under art 45 ECT:
– Rights concerning the Work immediately
– Free access of workers from one MS to employment
market in another MS
– (in)direct discriminatory and nondiscriminatory
obstacles are prohibited
– equal treatment at work as to nationals and non
Free movement of Workers
Workers' right of movement and residence:
- right to remain in the host country after working
- rights of family members
Exceptions to Free Movement of
- Art 52 TFEU:
-public policy, public security or public health
requirement of proportionality
- "Rule of Reason” doctrine
Freedom of Establishment and the
Freedom of Services
I. Provisions
- Treaty Articles
- freedom of establishment art 49
- freedom of services art 56
- Secondary legislation: eg Directive 2004/36
Cover only the self-employed, in contrast with
employed workers under art 45 TFEU
Freedom of Establishment and the
Freedom of Services
II Distinction
Freedom of Establishment: Right to Participate on a “stable and continuous basis”, in
economic life of any MS other than the state of origin
Freedom of Services: right to move to another MS to pursue an activity o a temporary
basis: crucial features: periodicity, continuity and regularity of the activity in the host
- to ensure that self-employed are free to exercise their profession throughout the EU
- to ensure the possibility of EU citizens to provide and receive services without any
obstacle throughout the EU
Rules on Competition
• Underlying the Internal market and European
• Objective: free competition
• Treaty provisions: 101 – 109 TFEU
• To be continued….
EU law & Human Rights
• Art 6 TEU:
– (1): The Union is founded on the principles of …
respect for human rights and fundamental
– (2): The Union shall respect fundamental rights, as
guaranteed (by the ECHR) and as they result from
the constitutional traditions common to the MS,
as general principles of Community law”
Fundamental Rights: the Charter
• Charter of Fundamental Rights of the EU (2007)
• “…the rights as they result from the constitutional
traditions and international pobligations common to the
MS … (ECHR), the Social Charters adopted by the
Community and by the CoE and the case law of the EUCJ
and ECrtHR
• “art 7 TEU: sanction mechanism in case of a clear risk of a
serious breach” of principles mentioned in art 6(1) TEU
• next step: Accession ECHR
IV. The System of Legal Protection
• The EU Court of Justice
The system of legal protection:
Legal Remedies
• Overview
– Direct Jurisdiction of the EUCJ
• Actions against Community Acts
Actions to annual Community acts (Art 263 TFEU)
Actions for failure to act ( 265 TFEU)
Petition to EP (21(1), 227 TFEU)
Complaint to Ombudsman (228 TFEU)
– Actions against MS
– Enforcement actions (258, 259 TFEU)
– Complaints to Commission
– Preliminary References/Rulings (art 267 TFEU)
The system of Legal Protection
• Legal Remedies: Overview
– Damages Actions/liability
• Non-contractual liability of the Community (art 268
• Member States liability
Preliminary Ruling
• Preliminary Rulings Procedure: 267 TFEU
• Most important mechanism of legal review: developed
legal principles and remedies in EU law (Van Gent en
Loos, Costa/Enel, Simmenthal, Francovich)
• Based on judicial cooperation (refering crt; discretion
or obligation)
• Function: interpretation EU law
• Effect of ruling: mandatory judgment, fully binding
V. Left over:
• EU Citizenship: right to movement &
• Introduced in Maastricht and further
developed in Lisbon, extended movement and
residence, election, citizens' initiative
What's the relevance to Health?