1. This article draws on our research findings published as a more complete version in T K Hervey and J V McHale Health Law and the European Union (Cambridge: Cambridge University Press, 2004).

2. R v Human Fertilisation and Embryology Authority, ex p Blood [1997] 2 All ER 687; and see generally T Hervey ‘Buy Baby: The European Union and Regulation of Human Reproduction’ (1998) 18 OJLS 207; D Morgan and R Lee ‘In the Name of the Father? Ex parte Blood: Dealing with Novelty and Anomaly’ (1997) 60 MLR 84.

3. Articles 59 and 60 EC (now Arts 49 and 50 EC).

4. For details, see Hervey and McHale, above n 1, pp 150–154.

5. J Shaw Law of the European Union (Basingstoke: Palgrave, 2000) pp 424–428.

6. See, eg, J Harrington ‘Globalization, Health and the Law’,http://www.ghwatch.org.english.casestudies.globalisationhealthlaw.pdf; J Harrington ‘Editorial: Towards a Global Health Law’ (2004) (I) Law, Social Justice and Global Development, http://elj.warwick.ac.uk/global/issue/2004-1/editorial.html; R Freeman and M Moran ‘Reforming Health Care in Europe’ (2000) 23 West European Politics at 35–58.

7. See generally Fluss, S The Development of National Health Legislation in Europe: the Contribution of International Organisations’ (1995) 2 European Journal of Health Law 193 CrossRefGoogle Scholar.

8. ‘Health’ is not an objectively constructed scientific ‘fact’, but rather is constructed by reference to a social and political norm: see I Kennedy The Unmasking of Medicine (London: Allen and Unwin, 1981) pp 7–8. Notions of ‘health’ also vary according to temporal and geographical context. One need only look at global mortality rates, or mortality rates across time, to illustrate this. Health indicators are also closely linked to economic prosperity, both globally and within a particular state. However, our conceptions of health are subject to constant revision due to technological developments. That said, in the light of the developing globalisation of medicine and science, there may be prospects for the development of a more consistent standard: see D Morgan Issues in Medical Law and Ethics (London: Cavendish, 2001) pp 27–32; and (2002) 8(3) eurohealth, which devotes a major part of this issue to a discussion of globalisation.

9. Problems with such definitions, such as that promulgated by the WHO and UNICEF Declaration of Alma Ata, 1978, include significant problems with operationalising a ‘right to health’ in practical terms: see L O Gostin and Z Lazzarini Human Rights and Public Health in the AIDS Pandemic (Oxford: Oxford University Press, 1997); Fluss, above n 7.

10. J Montgomery ‘Recognising a Right to Health’ in R Beddard and D Hill (eds) Economic, Social and Culturul Rights: Progress and Achievement (Basingstoke: Macmillan, 1992); and see the further discussion in J Montgomery Health Care Law (Oxford: Oxford University Press, 2002) pp 2–4.

11. B Toebes The Right to Health as a Human Right in International Law (Antwerp: Intersentia/Hart, 1999);B Toebes ‘The Right to Health’ in A Eide, C Krause and A Rosas (eds) Economic, Cultural and Social Rights (The Hague: Kluwer, 2001) p 173; Gostin and Lazzarini, above n 9.

12. Public health provides one notable illustration: see generally L O Gostin Public Health Law: Powers: Duties arid Restraints (Berkeley and Los Angeles: University of California Press, 2000); L Johnson ‘Defining Public Health’ and ‘Issues of Public Health; Infectious Diseases’ in R Martyn and L Johnson LCIW and the Public Dimension of Health (London: Cavendish, 2001). A further area in which regulation is centuries old is that of health professional practice: see, eg, J Jacobs Doctors and Rules: A Sociology of Professional Values (New Jersey: Transaction Publishing, 1999).

13. See, seminally, D Giesen International Medical Malpractice Law (Tubingen: JCB Mohr (Paul Siebeck); Dordrecht, Boston, London: Martinus Nijhoff, 1988); see also I Kennedy and A Grubb in their introduction to Principles of Medical Law (Oxford: Oxford University Press 1998) p vii, who memorably commented that medical law ‘was once dominated by medical negligence actions and disciplinary cases arising out of the failure to adhere to the CMC's standards on the “three A's”: adultery, alcohol and advertising’; I Kennedy and A Grubb Medical Law: Text with Materials (London: Butterworths, 1991 and 2000); M Brazier Medicine, Patients and the Law (London: Penguin, 2003) ch 7 ‘Malpractice Litigation’; H Nys La Medicine et Le Droit (Diagem: Kluwer Edit Juridiques, Belgique, 1995); D Tomkin and P Hanafin Irish Medical Law (Dublin: Round Hall Press, 1995); D Madden Medicine Law and Ethics in Ireland (Dublin: Butterworths Law Ireland, 2002); L Westerhäll Medical Law: An Introduction (Stockholm: Fritzes, 1994); and A Laufs, W Uhlenbruck and H Genzel Handbuch des Artzrechts (Munich: CH Beck: 2002).

14. See, eg. Montgomery (2002), above n 10, J Montgomery ‘Time for a Paradigm Shift? Medical Law in Transition’ (2000) 53 CLP 363; S Sheldon and M Thompson Feminist Perspectives on Health Cure Law (London: Cavendish, 1998) Introduction: M Brazier and N Glover ‘Does Medical Law have a Future?’ in D Hayton (ed) Law's Futures (Oxford: Hart, 2000).

15. Whilst use of the term ‘health law’ may be regarded as a comparatively recent development, it is worth noting that the first national society of health law in Europe was founded in 1967: see Leenen, H J J The European Journal of Health Law: a New Publication (1994) 1 European Journal of Health Law 1 CrossRefGoogle Scholar.

16. This is either through tort or contract. In certain European countries, eg, Austria, Belgium, France. Germany, Greece and Italy, the regulation of the professional-patient relationship has been contractual, see Giesen, above n 13, p 9.

17. In particular in relation to decisions about treatment of infants, children and incompetent adults, through, where applicable, a member states' parens patriae jurisdiction.

18. For example, in the UK, the provision of modem reproductive technology is regulated by the Human Fertilisation and Embryology Act 1990. There are many pieces of legislation across Europe which regulate organ transplantation: see, eg, UK Human Tissue Act 1961, Human Organs (Transplants) Act 1989, Netherlands, Wet op de Orgaandonatie 1998; and see D Price and H Akeveld (eds) Living Donation in the Nineties: European Medico-Legal Perspectives (Leicester: Eurotold, 1994). Legislation has recently been enacted in The Netherlands and Belgium concerning end of life decision-making and the legalisation of euthanasia: see, eg, J De Haan ‘The New Dutch Law on Euthanasia’ (2002) 10 Medical Law Review 57. A number of European states (Netherlands, Norway, Lithuania, Denmark, France, Belgium and Austria) have adopted bills of patients' rights: see, eg, Danish Patients Rights Act 1998; Norwegian Patients Rights Act 1999. See further, Fallsberg, L Patients'; Rights in Europe: Where do we stand and where do we go? (2000) 7 European Journal of Health Law 1 CrossRefGoogle Scholar; Fallsberg, L Patients Rights in the Nordic Countries (2000) 7 European Journal of Health Law 123 CrossRefGoogle Scholar; Fallsberg, L Consequences of the Amsterdam Declaration — a Rights Revolution in Europe (2003) 10 European Journal of Health Law 5 Google Scholar.

19. See, in general, eg, Toebes, above n11; Toebes, in Eide, Krause and Rosas (eds), above n 11; Leary, V ‘The Right to Health in International Human Rights Law’ (1994) I Journal of Health and Human Rights 3–5 Google Scholar; Mann, J, Gostin, L et al ‘Health and Human Rights’ (1994) 1 Journal of Health and Human Rights 7 Google ScholarPubMed; M Brazier ‘Rights and Health Care’ in R Blackburn (ed) Rights of Citizenship (London: Mansell, 1993); J McHale ‘Enforcing Health Care Rights in the English Courts’ in R Burchill, D Harris and A Owers (eds) Economic, Social and Cultural Rights: Their Implementation in the United Kingdom (Nottingham: University of Nottingham Human Rights Law Centre, 1999); A Chapman Exploring a Human Rights Approach to Health Cure Reform (Washington DC: American Association for the Advancement of Science, 1993); L Westerhäll and C Phillips (eds) Patients' Rights: Informed Consent, Access and Equality (Stockholm: Nerenius and Santérus, 1994); J Montgomery ‘Recognising a Right to Health’ in R Beddard and D M Hill (eds) Economic, Social and Cultural Rights: Progress and Achievement (Basingstoke: Macmillan, 1992). On the ‘right to health’ in EU law, see T Hervey ‘The Right to Health in European Union Law’ in T Hervey and J Kenner (eds) Economic and Social Rights under the EU Charter of Fundamental Rights (Oxford: Hart, 2003).

20. Montgomery (2002), above n 10, p 4.

21. See, in general, S Callens E-health mid the law (Deventer: Kluwer, 2003). See also Mill, S Online Prescribing: Principles. Problems and Policing (2003) 9(1) Medico-Legal Journal of Ireland 36 Google Scholar; Roscam Abbing, H D C Editorial: Internet, the Patient and the Right to Care for Health (2000) 7 European Journal of Health Law 221 CrossRefGoogle Scholar.

22. Can a company manufacturing pharmaceuticals, or medical devices, be said to be providing ‘health care’ to a patient with whom it contracts as a consumer? Can the patient be said to be providing his or her own health care?.

23. See, eg, Bergkamp, L Internet, the Patient and the Right to Care for Health’ (2000) 7 European Journal of Health Law 221 Google Scholar.

24. P Freddolini ‘e-health for Europe: The possible and the practical’ (2002) eurohealth 5.

25. The boundaries between therapeutic and non-therapeutic care constitute a debate beyond the scope of this article, but they serve to illustrate the problematic nature of effective regulation.

26. Directive 95/46/EC OJ 1995 L 281/31.

27. Directive 2000/31/EC OJ 2000 L 178/1. See Callens, S Telemedicine and the E-Commerce Directive’ (2002) 9 European Journal of Health Law 93 CrossRefGoogle Scholar.

28. Montgomery (2002), above n 10.

29. Gostin, above n 12, p 327.

30. Y Arai-Takahashi ‘The role of international health law’ in R Martyn and L Johnson Law and Public Dimension of Health (London: Cavendish, 2001). For instance, Art 55 of the UN Charter makes reference to ‘higher standards of living’ and to ‘solutions of international …health. and related problems’. The World Health Organization plays a vitally important role in the resolution of health matters at a global level. The WHO drafts the international health regulations which have the aim of ‘ensuring maximum security against the international spread of disease with a minimum interference with world traffic’ (Foreword to the International Health Regulations) and which operate in international law. These impose legal obligations in international law upon states, regarding issues such as disease notification, border restrictions and specific provisions regarding cholera, plague and yellow fever.

31. See Gostin, above n 12, ch 6.

32. See, eg, Tobacco Products Consolidation Directive 2001/37/EC OJ 2001 L 194/26; the food labelling Directive 79/112/EEC OJ 1979 L 33/1, as amended and now consolidated in Directive 2000/13/EC OJ 2000 L 109/29; or Regulation 178/2002/EC OJ 2002 L 31/1 on the EU's food law, which is the result of a major reform following the BSE/nvCJD affair. Such provisions have been criticised, eg, in the context of the WTO, on the grounds that they constitute disguised protectionism.

33. For an introduction to the various theoretical approaches to the EU, see B Rosamund Theories of European Integration (Basingstoke: Macmillan, 2000).

34. Although more recent reform processes, notably that leading to the Treaty Establishing a Constitution for Europe 2004, have involved different actors, using a ‘Constitutional Convention’. See also the significant literature on the role of the European Court of Justice in ‘constitutionalising’ the Treaty, especially J H H Weiler ‘The Transformation of Europe’ (1991) 100 Yale LJ 2403; and A Stone Sweet Governing with Judges: Constitutional Politics in Europe (Oxford: Oxford University Press, 2000) especially pp 160–193.

35. For instance, the Ministers of State for Health, meeting within the Council of Ministers, included on their agenda matters concerning AIDS and HIV from the mid-1980s, long before the Community had any formal legal competence in the field. The fact of this common action may have been one important element in persuading the heads of state and government to agree the Treaty provisions that eventually gave the EU institutions some formal powers in the health field.

36. For proponents of a multilevel governance perspective, see L Hooghe and G Marks Multilevel Governance and European Integration (Lanham: Rowman & Littlefield, 2001): S Leibfried and P Pierson ‘European Social Policy’ in H Wallace and W Wallace (eds) Policy-Making in the European Union (Oxford: Oxford University Press, 2000): P Schmitter ‘Imagining the Future of the Euro-Polity with the Help of New Concepts’ in G Marks et al (eds) Governance in the Emerging European Union (London: Sage, 1996); S Leibfried and P Pierson ‘Semi-Sovereign Welfare States: Social Policy in a multitiered Europe’ in S Leibfried and P Pierson (eds) European Social Policy: Between Fragmentation rind Integration (Washington: Brookings, 1995); Scharpf, F Community and Autonomy: Multi-Level Policy-Making in the European Union (1994) 1 Journal of European Public Policy 219 Google Scholar; G Marks ‘Structural Policy in the European Community’ in A Sbragia (ed) Euro-Politics: 1nstitiitiori.s rind Policy-Making in the ‘New’ European Community (Washington: Brookings. 1992) p 191. As a starting point for a critique of such an approach, see Rosamund, above n 33; and see in particular the work of Moravcsik, eg, A Moravcsik ‘Preferences and Power in the European Community: A Liberal Intergovernmental Approach’ (1993) 31 JCMS 473.

37. See Hooghe and Marks, above n 36, pp 2–29.

38. For a starting point on ‘new institutionalism’ in EU studies, see Rosamund, above n 33; and P Craig ‘The Nature of the Community: Integration, Democracy and Legitimacy’ in P Craig and G De Búrca (eds) The Evolution of EU Law (Oxford: Oxford University Press, 1999); K Armstrong and S Bulmer The Governance of the Single European Market (Manchester: Manchester University Press, 1998); K Armstrong ‘Legal Integration: Theorizing the Legal Dimension of European Integration’ (1998) 36 JCMS 155; K Armstrong ‘The New Institutionalism’ in P Craig and C Harlow (eds) Lawmaking in the European Union (Deventer: Kluwer, 1998).

39. See, eg, A-M Burley and W Mattli ‘Europe before the Court: a Political Theory of Legal Integration’ (1993) 47 International Organization 1: K Alter and S Meunier-Aitsahalia ‘Judicial Politics in the European Community: European Integration and the Path-breaking Cassis de Dijon Decision’ (1994) 26 Comparative Political Studies 535; Stein, E Lawyers, Judges and the making of a Transnational Constitution (1971) 75 American Journal of International Law 1 CrossRefGoogle Scholar; A Stone Sweet ‘From free trade to supranational policy: the European Court and integration’ in W Sandholtz and A Stone Sweet (eds) European Integration mid Supranational Governance (Oxford: Oxford University Press, 1998).

40. See P Gray ‘The Scientific Committee for Food’ in M Van Schendelen EU Committees as Influential Policy-Makers (Aldershot: Dartmouth. 1998) pp 81, 83.

41. K Armstrong Regulation, Deregulation, Reregulation (London: Kogan Page, 2000) p 55: ‘Traditional hierarchical images of European governance tend to operate within simplified notions of that system of governance in the sense that decision-making is understood as taking place at “national” or “Community” level. In reality, governance takes place within linked networks of decision-making, drawing on human resources from national. European and international settings; harnessing public and private actors; and utilising different sources of knowledge’.

42. See N MacCormick Questioning Sovereignty (Oxford: Oxford University Press, 1999).

43. For discussion of the significance of this in the context of regulation of genetically modified foods, see T Hervey ‘Regulation of Genetically Modified Products in a Multi-Level System of Governance: Science or Citizens’? (2001) 10 Review of EC and International Environmental Law 321.

44. For a striking example of such a conceptualisation, see the work of Toth, eg, A Toth ‘A Legal Analysis of Subsidiarity’ in D O'Keeffe and P Twomey (eds) Legal Issues of the Maastricht Treaty (Chichester: Wiley, Chancery, 1994).

45. See Armstrong and Bulmer, above n 38: T Daintith (ed) Implementing EC Law in the UK: Structures for Indirect Rule (Chichester: Wiley, 1995).

46. For discussion of soft law, see, eg, L Senden Soft Law in European Community Law (Oxford: Hart, 2004); K C Wellens and G M Borchardt ‘Soft Law in European Community Law’ (1989) 14 ELRev 267; J Kenner ‘The EU Employment Title and the “Third Way”: Making Soft Law Work?’ (1999) 15 Int Jo Comp Labour Law and Ind Rels 33.

47. See, eg, E Szyszczak ‘The New Paradigm for Social Policy: A Virtuous Circle’ (2001) 38 CMLRev 1125; Kenner, above n 46; E Szyszczak ‘The Evolving European Employment Strategy’ in J Shaw (ed) Social Law and Policy in an Evolving EU (Oxford: Hart. 2000); C De La Porte ‘Is the Open Method of Coordination Appropriate for Organising Activities at European Level in Sensitive Policy Areas?’ (2002) 8 ELJ 38; K Armstrong ‘Tackling Social Exclusion through OMC: Reshaping the Boundaries of EU Governance’ in T Börzel and R Cichowski (eds) State of the Union: Law, Politics and Society vol 6 (Oxford: Oxford University Press, 2003) p 170; S Regent ‘The Open Method of Coordination: A New Supranational Form of Governance?’ (2003) 9 ELJ 190; F Scharpf ‘The European Social Model: Coping with the Challenges of Diversity’ (2002) 40 JCMS 645.

48. For discussion of the relationship between the role of law in ‘classic’ theories of integration, and under the open method of co-ordination, see Armstrong in Börzel and Cichowski, above n 47.

49. The EU budget represents only a fraction of levels of public spending in the member states. It is obvious from this that the EU, as currently constituted, cannot possibly replace health spending in the member states. The EU's redistributive interventions in the health field are small-scale, in the totality of health spending across the EU as a whole. However, they may nevertheless be significant, especially at the margins, eg, where EU funds are made available for activities for which there is little support among national administrations, such as in the case of research into ‘orphan medicines’, for the treatment of conditions affecting very small proportions of the populations of the member states. Financial support may promote integration through encouraging certain types of activities over others by granting them finance in addition to that available at national or sub-national level. Indirect pressures for change at national level may arise as a result, and these types of interactions are explored in our research findings.

50. The prohibition, through binding, directly applicable and directly effective norms, of all customs duties, quantitative restrictions on imports, exports and ‘measures having equivalent effect’ on goods moving between the member states (Art 28 EC); and of all (unjustified) restrictions on the freedom to provide services (Art 49 EC); and on the free movement of capital (Art 56 EC). Workers must be allowed to move freely within the EU in order to take up employment (Art 39 (I) and (3) EC); (unjustified) restrictions on the freedom of establishment of the self-employed (including professionals) and companies are prohibited (Art 43 EC).

51. The adoption of detailed, harmonised, ‘pre-emptive’ or ‘field occupying’ regulatory norms at EU level.

52. The adoption at EU level of a floor of minimum standards required to protect essential health and safety interests.

53. The mandatory co-ordination, at EU level, of separate national systems.

54. The persuasive co-ordination, at EU level, of separate national systems, eg, through the ‘open method of co-ordination’.

55. Under the procedures set out in Art 230 EC or Art 234 EC.

56. Cases 281, 283–5, 287/86 Germany v Commission [1987] ECR 3203.

57. On exclusive competence compare A Toth ‘A Legal Analysis of Subsidiarity’ and J Steiner ‘Subsidiarity under the Maastricht Treaty’ in D O'Keeffe and P Twomey (eds) Legal Issues of the Maastricht Treaty (London: Chancery, 1994); see also S Weatherill ‘Beyond Preemption? Shared Competence and Constitutional Change in the European Community’ O'Keeffe and Twomey (eds), above.

58. Article 5(2) EC; and see Protocol No 30 on Subsidiarity and Proportionality, annexed by the Treaty of Amsterdam to the EC Treaty, 1997.

59. Article 5(3) EC. For discussion of proportionality and subsidiarity, see G A Bermann ‘Proportionality and Subsidiarity’ in C Barnard and J Scott The Law of the Single European Marker: Unpacking the Premises (Oxford: Hart, 2002).

60. In particular, through judicial review litigation before the European Court of Justice: Art 230 EC.

61. The Treaty establishing a Constitution for Europe proposes some amendments to this provision: see Art 111–278 CT.

62. See, eg, P Craig and G de Búrca EU Law (Oxford: Oxford University Press, 2003); S Weatherill Cases and Materials on EU Law (Oxford: Oxford University Press, 2003); D Wyatt and A Dashwood European Union Law (London: Sweet & Maxwell, 2000); D Chalmers and E Szyszczak European Union Law Vol II: Towards a European Polity? (Aldershot: Ashgate, 1998).

63. The CAP has implications for food safety, a major determinant of public health and cause of illness.

64. Matters such as road safety contribute to public health.

65. Matters such as air and water quality are major determinants of public health, as may be the presence of substances hazardous to human health in the environment.

66. Food law is a major component of health-related consumer protection law, but other areas, such as cosmetics, could also be included.

67. The use of competition law to attack anti-competitive agreements such as those granting intellectual property rights to subsidiaries, or the enforcement of intellectual property rights by dominant firms, applied to the pharmaceuticals industry, may have implications for the pricing of pharmaceuticals and other medical goods within the member states, thus affecting health care provision.

68. The Community supports programmes of research and technological development, to encourage the competitiveness of European industry, in various fields, including health.

69. Measures aimed at health promotion, eg, HIV prevention and drug abuse control may form part of a contribution to economic and social development in ‘third countries’.

70. Legislation protecting workers from workplace hazards and occupational illness and accidents make a contribution to health protection.

71. As a matter of practical politics, Art 308 EC is limited by the fact that unanimity in Council is required for its successful use. Effectively, therefore, any one of the 25 member states exercises a veto under Art 308 EC.

72. See, eg, Case C-271/94 Parliament v Council (Edicom) [1996] ECR I-1689; Case 68/86 UK v Council (Hormones in Beef) [1988] ECR 855; Case C-131/87 Commission v Council (Animal glands and organs) [1989] ECR 3743: Case C-331/88 R v Minister of Agriculture, Fisheries und Food rind Secretary of State for Health, exp Fedesa [1990] ECR 1–4023; Case C-180/96 UK v Commission (BSE) [1998] ECR 1–2265; Case C-269/97 Commission v Council (Beef Labelling) [2000] ECR 1–2257.

73. Article 95 EC now provides for the ‘co-decision’ procedure, under which the European Parliament is ‘co-legislature’ with Council, and, ultimately, may veto a proposal.

74. Case C-376/98 Germany v Parliament and Council (Tobacco Advertising) [2000] ECR 1–8419. For further discussion, see K Lenaerts ‘Bricks for a Constitutional Treaty of the European Union: Values, Objectives and Means’ (2002) 27 ELRev 377 at 387; G de Búrca ‘Setting Constitutional Limits to EU Competence?’, Francisco Lucas Pires Working Papers Series on European Constitutionalism, Working Paper 2001/02; T Hervey ‘Community and National Competence in Health after %Tobacco Advertising’ (2001) 38 Common Market Law Review 1421; T Hervey ‘Up in Smoke: Community (anti) tobacco law and policy’ (2001) 26 ELRev 101; C Hillion ‘Tobacco Advertising: if you must, you may’ (2001) 60 CLJ 486; P Syrpis ‘Smoke without Fire: The Social Policy Agenda and the Internal Market’ (2001) 30 ILJ 271; J Usher ‘Annotation of Case C-376/98’ (2001) 38 CMLRev 1519; Editorial ‘Taking the limits of competences seriously’ (2000) 37 CMLRev 1301. For an interpretation of the TAD ruling, from the point of view of a solicitor acting for British American Tobacco, in the context of Directive 2001/37/EC on the manufacture, presentation and sale of tobacco products, see S Crosby ‘The New Tobacco Control Directive: An Illiberal and Illegal Disdain for the Law’ (2002) 27 ELRev 177. Crosby's implicit notion of the internal market is of a neo-liberal, deregulatory and permissive order, quite at odds with the notion of the internal market as inspired by ‘social market’ traditions, which we would argue are reflected in the Treaty and the jurisprudence of the European Court of Justice.

75. See further, T Hervey ‘The European Union and the governance of health care’ in G de Búrca and J Scott (eds) New Governance and constitutionalism in Europe and the US (Oxford: Hart, 2005, forthcoming).

76. See further, Black, H and Hervey, T The European Union and the governance of stem cell research’ (2005) 12 Maastricht Journal 3 Google Scholar.

77. See Directive 65/65/EEC OJ 1965 L 369/65; OJ Sp Ed p 20. Amended and consolidated by Directive 93/39/EC OJ 1993 L 214/22; and further consolidated by Directive 2001/83/EC OJ 2001 L 311/67. Enacted in response to the Thalidomide tragedies of the early 1960s, the Directive required member states to enact laws to ensure that new medicinal products may not be marketed on their territories without the approval of a competent regulatory body. More detailed harmonisation provisions for the criteria and procedures according to which approval may be given by national regulatory bodies for new medicinal products followed. A large number of detailed provisions of secondary legislation now cover all industrially produced medicines, including vaccines, toxins or serums and allergens (Directive 89/342/EEC OJ 1989 L 142/14); blood products (Directive 89/381/EEC OJ 1989 L 189/44); and radiopharmaceuticals (Directive 89/343/EEC OJ 1989 L 142/16). Provisions also cover medical devices (Directive 90/385/EC on active implantable medical devices OJ 1990 L 189/17; Directive 93/42/EC on medical devices OJ 1993 L 169/1). Technical requirements governing testing of new pharmaceuticals are regularly updated by the Commission, in accordance with power delegated for this purpose by the Council, see Council Recommendations 83/57 VEEC and 87/176/EEC concerning tests relating to the placing on the market of proprietary medicinal products OJ 1983 L 332/11 and OJ 1987 L 71/1. Amendments are made according to the ‘regulatory committee procedure’, under which the committee must support the Commission proposal by a qualified majority in order for the amendment to be adopted. In addition to criteria relating to quality, safety and efficacy, rules relating to procedures for marketing authorisation (time limits, giving of reasons, publication) (Directive 93/39/EC, amending Directive 65/65/EEC and Directives 75/318/EEC, 75/319/EEC OJ 1975 L 147/1); to manufacture (quality control, inspections) (Directives 75/318 and 75/319EEC; Directive 871] WEEC on harmonisation concerning the application of principles of good laboratory practice and the verification of their application for tests on chemical substances OJ 1987 L 15/29; Directive 88/320/EEC on inspection and verification of good laboratory practice OJ 1988 L 145/35); to labelling (packaging to include information relating to dose, ingredients, side effects) (Directive 92/27/EC OJ 1992 L 113) and to advertising of medicinal products (advertisement to the general public of prescription drugs is prohibited, although officially supported vaccination campaigns are exempted) (Directive 92/28/EC OJ 1992 L 113, see Art 3(5)); Directives 92/25/EC and 92/26/EC OJ 1992 L 113) have been harmonised. Many of these provisions were consolidated in Directive 2001/83/EC OJ 2001 L 311/67 on the Community code relating to medicinal products for human use. See further, J Gardner ‘The European Agency for the Evaluation of Medicines and European Regulation of Pharmaceuticals’ (1996) 2 ELJ 48; E Kaufer ‘The Regulation of New Product Development in the Drug Industry’ in G Majone (ed) Deregulation or Re-regulation? Regulatory Reform in Europe and the United Stares (London and New York: Pinter, 1990); W Sauer ‘The European Community's Pharmaceutical Policy’ in A F Casparie, H Hermans and J Paelinck (eds) Health Care in Europe After 1992 (Aldershot: Dartmouth, 1992).

78. Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use OJ 2001 L 121/34.

79. Directive 2002/98/EC setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components OJ 2002 L 33/30.

80. A number of member states have experienced major scandals with respect to HIV-infected blood transfusions, in particular to haemophiliacs. (See ‘Aids Scandals around the world’, BBC News Online, 9 August 2001; and D Giesen ‘Liability for Transfer of HIV Infected Blood in Comparative Perspective’ (1994) 10 Professional Negligence 2.) In France, about 4,000 people were given transfusions of HIV-infected blood in the mid-1980s. Many of these people died. (A subsequent trial led to the conviction of the former Health Minister Edmond Hervé; but former French Premier, Laurent Fabius, and Georgina Dufoix, former Social Affairs Minister, were acquitted of manslaughter.) Some 1,300 people have died in Italy from infected blood transfusions since 1985. More than 100 Portuguese haemophiliacs were infected after receiving transfusions of contaminated plasma. In 1993, it was reported that over 350 haemophiliacs in Germany had been infected with the HIV virus from blood products, as a result of the testing of the blood products by using pooled plasma from three donors, instead of testing each donation separately. See further J Abraham and G Lewis Regulating Medicines in Europe: Competition, expertise and public health (London and New York: Routledge, 2000). Blood and blood products are imported by member states of the EU, so blood safety cannot be considered simply within national borders.

81. Directive 2002/98/EC, Art 4(2).

82. Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells OJ 2004 L 102/48.

83. Article 3(b) ‘all constituent parts of the human body formed by cells’.

84. Article 3(a) ‘individual cells or a collection of cells of human origin when not bound by any form of connective tissue’.

85. Article 2.

86. This is defined as ‘cells or tissues removed from and applied in the same person’, Art 3(q).

87. Article 2(2)(a).

88. Article 2(2)(b).

89. Article 2(2)(c).

90. Article 12.

91. Recital 13.

92. Recital 14.

93. See R Watson ‘European Parliament tries to stamp out trafficking in human organs’ 327 (2003) BMJ 1003; S Wheeler ‘EU plans organ trade crackdown’, BBC news online, 22 October 2003.

94. OJ 1995 L 281/31. Replacement Art 31 from 20 November 2003. Regulation 1882/2003/ECOJL 284/1.

95. For an overview, see Commission First Report on the Implementation of the Data Protection Directive 95/4h/EC COM (2003) 265.

96. Dute, J Medical Malpractice Liability: No Easy Solutions’ (2003) 10 European Journal of Health Law 85 CrossRefGoogle Scholar.

97. OJ 1985 L 210/29; see A v National Blood Authority [2001] 3 All ER 289.

98. Case C-203/99 Henning Veedfald v Arhus Regional Authority [2001] ECR 1–3569.

99. Directive 93/104/EC, consolidated with Directive 2000 /33/EC, by Directive 2003/88/EC OJ 2003 L 299/9.

100. Case C-303/98 [2000] ECR 1–7963.

101. Case C-151/02 [2003] ECR 1–8389. A proposed amendment to the Directive would (partially) repeal this jurisprudence, see COM (2005) 236.

102. In the UK and Irish contexts, the Working Time Directive has been criticised by health care professionals and providers of health care as being insufficiently sensitive to the traditional practices of the British and Irish National Health Systems, and in particular to causing capacity problems as junior doctors may no longer work the long hours that have historically formed part of their training. Such criticisms led to an amendment of the Directive in 2000: Directive 2000/34/EC OJ 2000 L 195/41. Member states may now derogate from the Directive's provisions in respect of maximum weekly working time in the case of doctors in training, for a transitional period of five years from 1 August 2004, with a possible extension of three further years. This is ‘to take account of difficulties in meeting the working time provisions with respect to their responsibilities for the organisation and delivery of health services and medical care’ (Directive 93/104/EC, Art 17(2.4)(a)). None the less in the UK the controversy continues. Implementation of the Directive apparently means that by 2009. junior hospital doctors' hours will be cut by 25%. The British Medical Association chairman. James Johnson, stated that the consequence of the Directive would be to place general practitioners under pressure not to admit patients to hospital and may have the result that hospitals will close (see Z Kmietowicz ‘Emergency service under threat from working time directive’ (2003) 327 BMJ 184). See also ‘EU law “threatens NHS care”’, BBC News Online, 6 April 2004.

103. Directive 93/1W/EC, Art 17(2.1)(c)(i), where there is a need for continuity of service, in particular ‘services related to the reception. treatment and/or care provided by hospitals or similar establishments’. Now repealed and consolidated in Directive 2003/88/EC.

104. Directive 93/1W/EC, Art 18(1)(b)(i). which is effectively an ‘opt out’ from maximum weekly working time, although it is subject to the requirement to obtain ‘agreement’ from the employee, and to reporting and record-keeping duties on the part of the employer. Now repealed and consolidated in Directive 2003/88/EC. To date, only the UK has legislated to allow a general exception for individual employees who agree to waive their rights in Directive 93/104/EC, Art 6 to a maximum 48-hour working week: see Working Time Regulations 1999, SI 1999/3372, reg 4(1).

105. At first instance, R (on the application of Yvonne Watts) v Bedford Primary Cure Trust, Secretary, of State for Health [2003] EWHC 2228 (Admin). 1 October 2003: Court of Appeal. [2004] EWCA Civ 166; referred to the European Court of Justice, as Case C-372/04.

106. See, on the free movement of patients. Case C-158/96 Kohll [1998] ECR 1–1931; Case C-157/99 Geraets-Smits and Peerbooms [2001] ECR 1–5473; Case C-368/86 Vanbraekel [2001] ECR 1–5363: Case C-326/00 IKA v loannidis [2003] ECR 1–1703; Case C-385/99 Müller-Fauré and van Riet [2003] ECR 1–4509: Case C-156/01 ANOZ [2003] ECR 1–7045: Case C-8/02 Leichtle [2004] ECR 1–2641: and. most recently, Watts. above n 105. See also, on the free movement of pharmaceuticals and other health care products. eg, Case 181/82 Roussel [1983] ECR 3849: Case 56/87 Commission v Italy [1988] ECR 2919; Case 238/82 Duphar [1984] ECR 523; Case C-120/95 Decker v Caisse de Maladie des Employés [1998] ECR 1–1831; Case C-322/01 Deutcher Apothekerverband v 0800 DocMorris and Waterval [2003] ECR 1–4887.

107. The Treaty establishing a Constitution for Europe provides that ‘solidarity’ is one of the Union's ‘values’: see Art 1–2 CT.

108. See Nys, H Comparative health law and the harmonization of patients' rights in Europe’ (2001) 8 European Journal of Health Law 317 CrossRefGoogle Scholar; D Banta ‘Quality of healthcare in Europe ––– an introduction’ (2000/2001) 6(5) eurohealth 18; I Kalo ‘Development of quality of health systems in Europe’ (2000/2001) 6(5) eurohealth 20.

109. Whilst the notable recent illustrations concerning this practice relate to travel to Switzerland by UK citizens, there is potentially the prospect of more ‘death tourism’ in the future, given the policy shifts within certain EU member states, namely The Netherlands and Belgium. On the new legal developments on end of life decision-making, see De Haan, above n 18.

110. Of course, this phenomenon is global, rather than specific to the EU. See Harrington, above n 6.

111. Article 234 EC.

112. See, eg, A-G v X [1992] ILRM 401.

113. Doctors: Directive 75/362/EEC OJ 1975 L 167/1 and Directive 75/363 OJ 1975 L 167/14. Further minimum levels of training for general practitioners were introduced through Directive 86/457/EEC OJ 1986 L 267/26. The legislation is now consolidated in Directive 93/16/EEC OJ 1993 L 165/1, as amended. Dentists: Directive 78/686/EEC OJ 1978 L 233/1 and Directive 78/687/EEC OJ 1978 L 233/10, as amended by Directive 2001/19/EC OJ 2001 L 206/1. See also OJ 1978 C 202, Statement on the Directive concerning the coordination of provisions laid down by law, regulation, etc., on the activities of dental surgeons. Pharmacists: Directive 85/432/EEC OJ 1985 L 253/34 and Directive 85/433/EEC OJ 1985 L 253/37, as amended by Directive 2001/19/EC OJ 2001 L 206/1. Midwives: Directive 80/154/EEC OJ 1980 L 33/1 and Directive 80/155/EEC OJ 1980 L 33/8, as amended by Directive 2001/19/EC OJ 2001 L 206/1. Nurses: Directive 77/452/ EEC OJ 1977 L 176/1 and Council Directive 77/453/EEC OJ 1977 L 176/8, as amended by Directive 2001/19/EC OJ 2001 L 206/1.

114. Directive 89/48/ECOJ 1989L 19/16 and Directive 92/51/ECOJ 1989 L 19/16, as amended by Directive 2001 /19/EC OJ 2001 L 206/1.

115. J Lonbay ‘Free Movement of health care professionals’ in J Lonbay and R Goldberg Pharmaceutical Medicine, Biotechnology and European Law (Cambridge: Cambridge University Press, 2000) p 79; and see R v Secretary of Stare for Health, exp Goldstein [1993] 2 CMLR 589. See also Case C-202/99 Commission v Italy [2001] ECR 1–9319.

116. See S Thomson et al ISS Statistics: Health and Health Systems in the New Member States (London: LSE Health and Social Care and ECOHOST, London School of Hygiene and Tropical Medicine, 2004) pp 38–40, which predicts a possible ‘brain drain’ of skilled health care professionals from Central and Eastern European member states, but stresses that it is difficult to draw any firm conclusions given the paucity of evidence on migration of health care professionals within the EU.

117. OJ 1971 L 149/2; OJ Sp Ed 1971 II p 416. Regulation 1408/71/EEC is amended regularly. Readers are referred to EUR-LEX, http://europa.eu.int/eur-lex/lex/en/index.htm, the online source of EU legislation, for the latest text. Regulation 883/2004/EC OJ 2004 L 166/1, once implemented, will repeal Regulation 1408/71/EEC for most purposes: see Regulation 883/2004/EC, Art 90.

118. See Commission Communication on the framework for action in public health of 1993, COM(93) 559 final; the Biomed 2 strand of the Fourth Framework Programme Decision 1110/94/EC OJ 1994 L 126/1; Council Resolution on Orphan Drugs OJ 1995 C 350/3; and Regulation 141/2000/EC OJ 2000 L 18/1.

119. See, eg, Resolution of representatives of Governments of member states meeting within the Council of 29 May 1986 OJ 1986 C 184/21; Conclusions of Council and the representatives of the Governments of member states of 15 May 1987 OJ 1987 C 1781 1; and of 31 May 1988 OJ 1988C 197/8; Decision 91/317/EEC of Council and Ministers of Health of the member states adopting a plan of action in the framework of the first ‘Europe against AIDS’ programme 1991–1993 OJ 1991 L 175/26; Council Resolution OJ 1994 C 15/4 and Decision 1729/95/EC OJ 1995 L 168/1. A further ‘Europe against AIDS’ programme followed: see Decision 647/96/EC of the European Parliament and Council, based on old Art 129 EC, OJ 1996 L 95/16, repealed by Decision 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008) ––– Commission Statements, OJ 2002 L 271/1.

120. A catalyst for consideration of the regulation of stem cell research by the EU institutions was provided by the provision under the Sixth Framework Programme for the funding of research into human embryonic stem cells. In priority 1, ‘Life Sciences, Genomics and Biotechnology for human health’ in section I, ‘Application of knowledge and technologies in the fields of genomics and biotechnology for health’, it is provided that ‘research will focus on … development and testing of new preventive and therapeutic tools, such as somatic gene and cell therapies (in particular stem cell therapies)’ OJ 2002 L 294/10. The inclusion of this type of research led to controversy, as a result of which, in September 2002, the European Council of Science Ministers introduced a one-year moratorium on the use of EU funds to support embryonic stem cell research when they approved the Sixth Framework Programme's funding. However, this was followed by objections expressed by the European Parliament's Committee on Industry, External Trade, Research and Energy. The Committee questioned whether the Council's decision was legal. As a compromise, it was proposed that criteria regarding the research activities which involved embryos and stem cells would be established by the end of 2003. The governments of some member states are expressly opposed to the use of EU funds in this way. The European Parliament has also registered its opposition. See generally on the controversy around stem cell technology in member states of the EU, S Halliday ‘A Comparative Approach to the Regulation of Human Embryonic Cells in Europe’ (2004) 12(1) Medical Law Review 40.

121. When the Parliament and the Council adopted the Sixth Framework Programme.

122. OJ 2002 C 232/1; Proposal for a Council Decision amending Decision 2002/834/EC on the specific programme for research, technological development and demonstration; ‘Integrating and strengthening the European Research Area’ (2002-2006). 9 September 2003, COM(2003) 390, amended COM(2003) 749 final following a proposal from the European Parliament. The matter was discussed at Council meetings on 26 November and 3 December 2003. Following the former meeting, the Council Presidency put forward its own proposal. The Presidency text suggested that no Community funding may be provided for the procurement of new stem cells or stem cell lines from embryos. Nevertheless, research projects using embryonic stem cells would be eligible for Community funding, on condition that these stem cells come from existing stem cell lines that were created prior to the ‘cutoff’ date of 3 December 2003. However, no agreement was reached on any of the proposals on the table. See Halliday, above n 120. The moratorium apparently ended at the end of December 2003, after which point the Commission has stated that it will scrutinise each proposal for funds on a case-by-case basis.

123. Directive 2004/23/EC OJ 2004 L 102/48.

124. Nys, above n 108, at 325.

125. See also, Roscam Abbing, H D C Human Rights and Medicine; a Council of Europe Convention’ (1996) 3 European Journal of Health Law 201 CrossRefGoogle ScholarPubMed.

126. See, eg, the discussion in J K Mason, R A Mc Call Smith and G Laurie Law and Medical Ethics (London: Lexis Nexis UK, 6th edn, 2003) pp 151–158.

127. Irish Constitution, Art 40.3.3.

128. See discussion in AG v X [1992] 1 IR 1.

129. Treaty on German Unity (31 August 1990).

130. In Romania, induced abortions were legalised in 1990: see WHO and European Commission Health Status Overview for Countries of Central and Eastern Europe that are Candidates for Accession to the European Union (Copenhagen: WHO, 2002) p 20.

131. Polish Act on family planning, human embryo protection and conditions of permissibility of abortion 1993; Ruling of the Polish Constitutional Tribunal, 28 May 1997; see http://www.federa.org.pl/english/abortion.htmandhttp://www.federa.org.pl/english/constrib.htm.

132. This was probably because of the possibility that the association of a sensitive issue such as abortion with membership of the EU might have made more difficult the process of ratification of the Accession Treaty in Poland. Thanks to Christophe Hillion for elaborating this point.

133. See Maltese Criminal Code, ss 241–243A, http://www.docs.justice.gov.mt/lom/legislation/englishfeg/vol_1/chapt9.pdf.

134. This reads: ‘Nothing in the Treaty on European Union, or in the Treaties establishing the European Communities, or in the Treaties or Acts modifying or supplementing those Treaties, shall affect the application in Ireland of Art 40.3.3. of the Constitution of Ireland’.

135. The European Court of Justice has engaged indirectly with the issue of abortion, in litigation involving the advertisement of abortion services in an Irish student's union: see Case C-159/90 SPUC v Grogan [1984] ECR 377.

136. Article 1–9 CT appears to imply that the incorporation of the EUCFR would merely codify the existing position, according to which the institutions of the EU and the member states, when implementing EU law or derogating from Treaty obligations, must respect the rights contained in the EUCFR as ‘general principles’ of EU law. In fact, Art 1–9 CT may be read to exclude the application of the provisions to the member states, although Art 1–9 CT refers to the member states when implementing EU law.

137. See discussion in M Stauch ‘Pregnancy and the Human Rights Act 1998’ in J Tingle, A Garwood-Cowers and T Lewis (eds) Healthcare: the Impact of the Human Rights Act 1998 (London: Cavendish, 2002).

138. Paton v UK (1981) EHRR 408; H v Norway (1990) App No 170004/90; Open Door and Dublin Well Woman v Ireland (1992) 15 EHRR 244; Vo v France (Application 53924/00) [2004] ECHR 53924/00, ECtHR, 8 July 2004, in which the ECtHR held that the issue of when the right to life begins comes within the margin of appreciation enjoyed by Council of Europe states.

139. See, generally, M Otlowski Voluntary Euthanasia und the Common Law (Oxford: Clarendon Press. 1997); J Keown Euthanasia, Ethics and Public Policy: An Argument Against Legalisation (Cambridge: Cambridge University Press. 2002); J Keown (ed) Euthanasia Examined: Ethical, Legal arid Clinical Perspectives (Cambridge: Cambridge University Press, 1995); J McHale and M Fox Health Care Law: Text and Materials (London: Sweet & Maxwell, 1997) ch 14; I Kennedy and A Grubb Medical Law (London: Lexis Nexis UK, 2000) ch 14; R Dworkin Life's Dominion (London: Harper Collins, 1993); H Biggs Euthanasia: Death with Dignity und the Law (Oxford: Hart Publishing, 2001).

140. D Lamb Down the Slippenl Slope (London: Routledge, 1988) ch 2: ‘It started from small beginnings’.

141. H Nys ‘Physician involvement in a patient's death: a continental European perspective’ (1999) 7(2) Medical Law Review 208.

142. See Keown (2002). above n 139.

143. See De Haan, above n 18.

144. See M Adams and H Nys ‘Comparative Reflections on the Belgian Euthanasia Act 2002’ (2003) 1l(3) Medical Law Review 353.

145. R (on the application of pretty) v DPP [2001] 1 All ER 1; confirmed in the ECtHR in Pretty v UK (Application 2346/02) [2002] ECHR 2346/02, ECtHR.

146. See European Parliament report on the proposal for a European Parliament and Council directive on setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissue and cells AS-0103/2003; see also European Parliament legislative resolution on the proposal for a European Parliament and Council directive on setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissue and cells, 10 May 2002, COM(2003) 340, recital 6.

147. See further, Thomson et al, above n 116; M Flear and T Hervey ‘Bigger and better? The impacts of EU law on health law after enlargement’, paper presented to Socio-Legal Studies Association conference, Glasgow, March 2004.

148. Opinion of Advocate General Fennelly, Case C-70/95 Sodemare [1997] ECR 1–3395.

149. See Hervey and McHale, above n 1, ch 10.