1. Summer Course on European Health Law & Ethics June 17 - 28, 2013 Riga, Latvia

2. European Health Law Course introduction Structure Objectives Events

3. 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

4. Programme Week II Human Rights in Health Care: Introduction (Saturday) Human Rights and Health Ethics Medical Research Human Genetics Organ Donation

5. Objectives 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.

6. Outline Basics of EU Law I. History of the European Integration II. Institutional System of the EU III.Sources of the EU Legal order IV.Legal Protection V.Left over

7. I. History of the European Integration Plurality of International Organizations in Europe – A series of International Organizations active in Europe: 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

8. 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?

10. Source: www.eur-charts.eu

11. 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) – …….

12. III. Sources of EU Law: Overview I. Primary sources - Founding treaties (ECT, EUROTOM, TEU) - Agreements in International Law II.Secondary sources: - Regulations - Directives: no direct effect - Decisions - Recommendations and opinions - Caselaw EUCJ III. General Principles of law deriving from the common traditions and constitutional rules shared by MS

13. 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 effect

14. III.Sources: Substantive law Single Market Free movement Goods Workers Services/Establishment Capital Competition law

15. 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

16. 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

17. 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 II: Elimination of all ((non)financial) obstacles to free movement

18. Free Movement of Goods Exceptions to the prohibition of art 28 Two different concepts: – Art 36 TFEU – Cassis de Dijon case : Rule of Reason

19. 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

20. Exception to the prohibition of Art. 28 TFEU Cassis de Dijon (ECJ C-120/78): "Rule of Reason" - 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

21. 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"

22. 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 nationals

23. Free movement of Workers Workers' right of movement and residence: - right to remain in the host country after working there - rights of family members

24. Exceptions to Free Movement of Workers -Art 52 TFEU: -public policy, public security or public health requirement of proportionality - "Rule of Reason doctrine

25. 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

26. 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 MS Objectives: - 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 Exceptions

27. Rules on Competition Underlying the Internal market and European integration Objective: free competition Treaty provisions: 101 – 109 TFEU To be continued….

28. EU law & Human Rights Art 6 TEU: – (1): The Union is founded on the principles of … respect for human rights and fundamental freedoms – (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

29. 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

30. IV.The System of Legal Protection The EU Court of Justice

31. 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)

32. The system of Legal Protection Legal Remedies: Overview – Damages Actions/liability Non-contractual liability of the Community (art 268 TFEU) Member States liability

33. 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

34. V.Left over: EU Citizenship: right to movement & residence. Introduced in Maastricht and further developed in Lisbon, extended movement and residence, election, citizens' initiative

35. What's the relevance to Health?