The European group on ethics: Law, politics and the limits of moral integration in Europe

European Law Journal

Volumn 14, Issue 6, 2008, Pages 839-859

  Plomer, Aurora ^a  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

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[No Author keywords available]

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EID: 65249181668     PISSN: 13515993     EISSN: 14680386     Source Type: Journal    
DOI: 10.1111/j.1468-0386.2008.00447.x     Document Type: Article

References (136)

1. S. Jasanoff, Science & Democracy in Europe and the United States (Princeton, 2005).
2. See also B. Salter, Transnational Governance and Cultural Politics: The Case of Human Embryonic Stem Cells and the European Union's Sixth Framework Programme (2005), available at http://www.york.ac.uk/res/iht/ projects/l218252005/SalterTransnationalGovernance.pdf.
3. Evans v UK (App No 6339/05) ECrtHR, 7 March 2006.
4. Directive 98/44/EC of the European Parliament and the Council of 6 July 1998 on the legal protection of biotechnological inventions, [1998] OJ L213/13. Article 7 states that 'The Commission's European Group on Ethics in Science and New Technologies evaluates all ethical aspects of biotechnology'. Recital 44 of the Preamble reiterates the same point but adds that 'it should be pointed out in this connection that the Group may be consulted only where biotechnology is to be evaluated at the level of basic ethical principles, including where it is consulted on patent law'. The Legal Affairs Committee called for the insertion of an article in the directive providing for the creation of a new ethics committee to 'assess all ethical aspects of biotechnology and its utilisation, in particular with regard to patents' (Report of 18 June 1997, Art 9a).
5. For a detailed discussion see A. Plomer et al, Stem Cell Patents Report: European Law & Ethics (European Commission, 2006), available at http://www.nottingham.ac.uk/law/StemCellProject/project.report.pdf.
6. Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013). Paragraph 30 of the Preamble states that ' ... the Opinions of the European Group on Ethics on Science and New Technologies are and will be taken into account'.
7. See discussion below.
8. (2005) 6(1) The Scientist 1104-01.
9. EGE, Opinion 22: Recommendations on the ethical review of hESC FP7 research projects (20 June 2007).
10. Justice Noelle Lenoir, 'The Ethics of Biotechnology' (2001) 4(2) The Journal of Biolaw Business 111.
11. See also chapter 8 of Plomer et al, op cit n 4 supra on which this section is based.
12. See SEC (91)/629 Communication Paper to the European Parliament and Council in April 1991, Promoting the Competitive Environment for the Industrial Activities based on Biotechnology within the Community.
13. European Commission White Paper on Growth, Competitiveness and Employment: The Challenges and Ways forward into the 21st Century, COM (93)/700 final, stated in section 5g that the Commission would 'reinforce the role of the Group of Advisers on the Ethical Implications of Biotechnology' to 'further clarify ethical issues in relation to some applications of biotechnology'.
14. Commission Press Release IP/97/1196.
15. For a copy of the mandate 1998-2000 and rules of procedure, see the website available at http://ec.europa.eu/European_group_ethics/archive/ 1998_2000/mandat_en.htm.
16. Article 2 of the mandate: Commission Decision of 11 May 2005 on the renewal of the mandate of the EGE, [2005] OJ L127/12, available at http://ec.europa.eu/European_group_ethics/mandate/docs/ mandate2005_en.pdf.
17. On BEPA's mission and activities, see the website available at http://ec.europa.eu/dgs/policy_advisers/index_en.htm.
18. Commission Decision, n 14 supra, Art 2.
19. ibid.
20. This was the first time the MEPs had exercised their veto.
21. Resolution of the European Parliament EP B4-0484/97 of 13 June 1997.
22. ibid.
23. COM (2001) 428 final.
24. On 'comitology', see N. Bernard, Multilevel Governance in the European Union (Kluwer, 2002).
25. COM (2002) 713 final.
26. 'The core principles and guidelines apply whenever Commission departments collect and use advice of experts coming from outside the responsible department. The principles and guidelines thus cover the collection of advice though ad hoc and permanent expert groups; external consultants (individuals, groups or companies, possibly using study contracts); and instances when these mechanisms are used in conjunction with inhouse expertise (residing in Commission departments and in the Joint Research Centre)': Para 2 of COM (2002) 713.
27. ibid.
28. ibid.
29. ibid.
30. Bernard, op cit n 22 supra
31. quoting E. Vos, Institutional Frameworks of Community Health and Safety Regulation: Committees, Agencies and Private Bodies (Hart Publishing, 1999). For a critique of comitology
32. see C. Landfired, 'The European Regulation of Biotechnology by Polycratic Governance', in C. Joerges and E. Vos (eds), EU Committees: Social Regulation, Law and Politics (Hart, 1999), arguing that 'scientific' committees are an attempt to conceal covert political decisions by reference to technical experts.
33. ibid, at 147.
34. Article 3(2).
35. op cit n 28 supra.
36. M. B. Friele, 'Do Committees Ru(i)n the Bio-Political Culture? The Democratic Legitimacy of Bioethics Committees', (2003) 17(4) Bioethics 301.
37. K. Braun, Deliberation, Democracy, and Bioethics: How to Democratise the Politics of Biomedicine?, Paper presented at the European Consortium for Political Research, Joint Session of Workshops (Turin, 22-27 March 2002).
38. The list of members appointed in 2005 is published in the Official Journal: See the website available at http://ec.europa.eu/ European_group_ethics/mandate/docs/listmemberspubjo_fr.pdf.
39. See also op cit n 7 supra.
40. See Bioethics and Politics: The Future of Bioethics in a Divided Democracy, ASHB Conference Proceedings (Albany, USA, 13-14 July 2006). There is a fast growing body of critical literature on the conflicts engendered by bioethics committees, from the perspective of political science and philosophy.
41. See, for instance, U. Schuklenk and J. P. Lott 'Bioethics and (Public) Policy Advice', in F. Thiele et al (eds), Bioethics in a Small World (Springer, 2004)
42. and the special issue of the Kennedy Institute of Ethics Journal, Vol 15, No 3 (2005).
43. Where the government installed what appeared to be a committee which competed with the committee set up by the German Parliament (German Inquiry Commission) and was perceived as a tool to legitimise the liberal views of the German executive on biomedical research in contrast to the views of its elected counterpart in the parliament. This is Discussed in Braun, op cit n 33 supra.
44. For a trenchant critique of the politicisation of the President's Council, see A. Charo, 'Passing on the Right: Conservative Bioethics is Closer than it Appears', (2004) 32 Journal of Law, Medicine and Ethices 307.
45. M. Foster Riley and R. A. Merrill, 'Regulating Reproductive Genetics: A Review of American Bioethics Commissions and Comparison to the British Human Fertilisation and Embryology Authority', (2004-2005) 6 The Columbia Science and Technology Law Review 1.
46. Leon Kass has defended the group's work in 'Reflections on Public Bioethics: A View from the Trenches', (2005) 15(3) Kennedy Institute of Ethics Journal 221. On the other hand, in the view of some commentators, the President's selection of appointees from a wide spectrum of ethical perspectives was in any event bound to frustrate from the beginning the practical realisation of a consensus.
47. See Foster Riley and Merrill, op cit n 38 supra.
48. The European Group on Ethics to the European Commission, Rules of Procedure (2001), para B4.
49. ibid, para E19. See also para E18.
50. ibid, para E15.
51. Commission Decision of 11 May 2005 on the renewal of the mandate of the European Group on Ethics in Science and New Technologies (2005/383/EC), [2005] OJ L127/17.
52. Article 4(2).
53. Including ethical reviews suggested by the EGE under their right of self-initiative: Article 4(2).
54. Article 4(5) (emphasis added).
55. Recommendations on the Ethical Review of hESC FP7 Research Projects (July 2007), available at http://ec.europa.eu/European_group_ethics/ activities/docs/opinion_22_final_follow_p_en_en.pdf
56. Letter sent by EC President Barroso to the EGE on 22 November 2006. Under Article 2 of the 2005 Mandate, 'the Parliament and the Council may draw the Commission's attention to questions which they consider to be of major ethical importance. The Commission shall, when seeking the opinion of the EGE, set a time limit within which such an opinion shall be given'.
57. The principle of subsidiarity is a fundamental principle of EU law, enshrined in the Treaty on European Union.The principle acknowledges the competence of Member States in matters outside the competence of the EU. It applies to legislative measures and not to EU funding.
58. See the website available at http://www.epp-ed.org/Press/ showpr.asp?PRControlDocTypeID=1&PRControlID=4004&PRContentID= 7384&PRContentLG=en.
59. For instance Miroslav Mikolášik MEP (Poland) and Hiltrud Breyer MEP (Germany).
60. The resolution, asked the Commission, inter alia, to exclude human embryo cloning under the Seventh Research Framework Programme. See also Resolution of 24 October 2005, calling on the European Patent Office, the Commission and the competent authorities in theMember States to work together with Parliament to confirm that all kinds of human cloning are excluded from patenting under Directive 98/44/EC.
61. See Report on the Proposal for a Decision of the European Parliament and of the Council concerning the Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities (2007 to 2013).
62. Amendment 66 was adopted with 284 votes in favour, 249 against and 32 abstentions. See also ibid.
63. 'Germany seeks EU ban on Stem Cell Research Funding', Reuters, 20 July 2006.
64. COM (2005) 119-1, 2005/0043/COD Proposal for a Decision of the European Parliament and of the Council concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007 to 2013), available at http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId= 192725. The Common Position was adopted by the Council on 25 September 2006 (13149/O6 (Press 260)).
65. On 24 July 2006 (LifeSiteNews.com). The Polish Parliament issued a resolution against research using human embryos, in response to the EU's recent vote to provide funding for embryonic stem cell research with a strong majority of 341 votes in favour and only 47 against. Twenty votes were withheld. The resolution stated: 'Sejm of the Republic of Poland points out that those reprehensible practices (human embryo experimentation) are inconsistent with Polish law. [The destruction] of human embryos purposefully to receive stem cells is against the Polish Constitution, Chapter II, article 38, which states "The Republic of Poland shall ensure the legal protection of the life of every human being"'. The resolution goes on to state that human embryo experimentation would violate Art 157 of Poland's Penal Code, which enacts protection of human life from the moment of conception. Further, it would be inadmissible under the Medical Ethic Code. Poland's Catholic bishops issued a statement on 25 June 2006 condemning the EU decision to fund human embryonic research: 'Research into embryonic cells is carried out at the expense of human embryos who from their very beginning, that is from the moment of conception, have the right to that unconditional respect which is morally due to the human being'.
66. Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013), [2006] OJ L412/1 and. Regulation (EC) No 1906/2006 of the European Parliament and of the Council of 18 December 2006 laying down the rules for the participation of undertakings, research centres and universities in actions under the Seventh Framework Programme and for the dissemination of research results (2007-2013), [2006] OJ L391/1.
67. UK, Sweden, Belgium and Spain.
68. See EGE Opinion 22, table.
69. Germany and Itally. ibid.
70. Decision No 1982/2006/EC, n 58 supra, Preamble, para 30.
71. For an excellent analysis of examples of the 'framework' approach, see A. Farrell 'Is the Gift Still Good? Examining the Politics and Regulation of Blood Safety in the European Union', (2006) 14(2) Medical Law Human Origin 155
72. 'Governing the Body: Examining EU Regulatory Developments in Relation to Substances of Human Origin', (2005) 27(3-4) Journal of Social Welfare and Family Law 427
73. and more generally T. Hervey and J. McHale, Health Law and the European Union (Cambridge University Press, 2005).
74. infra.
75. 'The Community has the objective, set out in the Treaty, of strengthening the scientific and technological bases of Community industry, thereby ensuring a high level of competitiveness at international level': Decision No 1982/2006/EC, n 58 supra, Preamble, para 1. The objective is to meet the goals of the Lisbon European Council of 23-24 March 2000 which set the EU a new strategic goal for the next decade: To become the most competitive and dynamic knowledge- based economy in the world, capable of sustainable economic growth with more and better jobs and greater social cohesion by fostering trans-national cooperation and the creation of a European 'research-market'.
76. ibid, Art 2.
77. Article 152 EC, originally Article 129 EC, although the legal basis of Article 129 is considered 'dubious' by EU legal scholars.
78. See Hervey and McHale, op cit n 63 supra.
79. ibid.
80. ibid.
81. Although these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures; Art 152(4).
82. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC, [2003] OJ L33/30. Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components, [2004] OJ L91/25. Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments, [2005] OJ L256/41.
83. See Human Tissue Directives, infra.
84. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, [2004] OJ L102/48. Commission Directive 2006/ 17/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells, [2006] OJ L38/40. Commission Directive 2006/86/EC implementing Directive 2004/23/ EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells, [2006] OJ L294/32.
85. Medicinal products for human use: Advanced therapy medicinal products (amending Directive 2001/83/EC, n 71 supra, and Regulation 726/2004/ EC). The Directive was cleared by the European Parliament in April 2007, following concerted attempts by Christian Democrats to insert amendments excluding research on human embryos. Details of the the debates may be found in the European Parliament's Legislative Observatory, ref COD/2005/ 0227, available at http://www.europarl.europa.eu/oeil/ file.jsp?id=5291242.
86. ibid.
87. EC Treaty (1992), Arts 1, 2 and 3.
88. Article 6(2).
89. Article 6(3).
90. Article 6(1).
91. Article 5.
92. The judicial organ of the EU. Should not be confused with the ECrtHR.
93. The judicial organ of the Council of Europe.
94. Case C-377/98, Netherlands v European Parliament and Council [2001] ECR I-7079.
95. Case C-36/02, Omega Spielhallen-und Automatenaufstellungs-GmbH v Obergurgermeiterin der Bundesstdt Bonn [2004] ECR I-9609.
96. Case C-456/03, Commission v Italy [2005] ECR I-5335. On the principle of human dignity as a fundamental legal norm
97. see D. Feldman, 'Human Dignity as a Legal Value - Part 1', [1999] Public Law 682 and the collection of articles in R. Brownsword (ed), Human Dignity and Human Rights (Hart, 2004).
98. Netherlands v European Parliament and Council, n 82 supra.
99. Article 6(2).
100. Vo v France (App No 53924/00), GC 8 July 2004.
101. Evans v UK (App No 6339/05) ECrtHR 7 March 2006.
102. Evans v UK, ibid.
103. ibid. The court reiterated its approach in previous abortion cases for the need to respect the distinct constitutional traditions of European states in this morally sensitive field.
104. ibid.
105. Preamble 30: The Opinions of the European Group on Ethics in Science and New Technologies are and will be taken into account.
106. ibid.
107. Also, research activities should also take into account the Protocol on the Protection and Welfare of Animals and reduce the use of animals in research and testing, with a view ultimately to replacing animal use.
108. Directive 2004/23/EC, n 72 supra is mentioned in the main body of the Opinion , but only in relation to the provisions on altruistic donation (IV.2.2, IV.2.3.2 and IV.4).
109. See n 56 supra.
110. For the full text of the Declaration, see Unesco's Universal Declaration on Bioethics & Human Rights (adopted by UNESCO's General Conference on 19 October 2005), available at http://portal.unesco.org/shs/en/ ev.phpURL_ID1883&URL_DODO_TOPIC&URL_SECTION201.html.
111. UN Declaration on Cloning (2005). For details of the vote, see the UN press release available at http://www.un.org/News/Press/docs/2005/ ga10333.doc.htm.
112. See R. Isasi and G. Annas, 'Arbitrage, Bioethics, and Cloning: The ABCs of Gestating a United Nations Cloning Convention' (2004) 35(3) Case Western Reserve Journal of International Law 397
113. and the forthcoming article in Biosciences Law Review. Immediately following its adoption, the UK declared that it would not be bound.
114. See special issue of Developing World Bioethics , Vol 5, No 3 (2005). In particular, articles by the following authors: D. Benatar, 'The Trouble with Universal Declarations'
115. R. Macklin, 'Yet Another Guideline: Unesco's Draft Declaration'. For a trenchant critique
116. see R. Ashcroft, Nothing to Declare: Unesco on Ethics & Human Rights (9 September 2005), available at http://www.scidev.net/content/opinions/ eng/nothing-to-declare-unesco-on-ethics-human-rights.cfm
117. and D. Dickson, Sparks Fly over Unesco Bioethics' Pact (21 October 2005), available at http://www.scidev.net/content/news/eng/ sparks-fly-overunesco- bioethics-pact.cfm.
118. Opinion 22, at 3.
119. ibid.
120. Ibid, at 39.
121. See A. Plomer, Law and Ethics of Medical Research: International Bioethics & Human Rights (Cavendish, 2005).
122. ibid.
123. eg D. Beyleveld and R. Brownsword, Human Dignity in Bioethics and Biolaw (Oxford University Press, 2001)
124. and R. Brownsword, 'Bioethics Roday, Bioethics Tomorrow: Stem Cell Research and the "Dignitarian Alliance"', (2003) 17 Notre Dame Journal of Law, Ethics and Public Policy 15.
125. See controversy over UN Declaration on Cloning and more generally Plomer, op cit n 99 supra.
126. R. Macklin, 'Dignity is a Useless Concept', (2003) 327 British Medical Journal 1419.
127. For an overview of the bioethics literature on human dignity, see R. Ashcroft, 'Making Sense of Dignity', (2005) 31 Journal of Medical Ethics 679.
128. For alternative moral perspectives arguing the need to reduce animal suffering and calling for the ascription of equal rights to animals, see P. Singer, Practical Ethics (Cambridge University Press 1979)
129. and S. Wise, Rattling the Cage (Perseus, 2001).
130. [2006] OJ L412/1.
131. Paragraph 1.10.
132. n 72 supra.
133. eg Nuffield Council on Bioethics.
134. As with other comparable bioethics committees. See Plomer, op cit n 99 supra.
135. Friele, op cit n 32 supra.
136. More generally see the special issue of the Kennedy Institute of Ethics Jourrnal, Vol 15, No 3 (2005).