Adding value? EU governance of organ donation and transplantation

European Journal of Health Law

Volumn 17, Issue 1, 2010, Pages 51-79

  Farrell, Anne Maree ^a  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

Author keywords

European Union (EU); governance; organ donation; organ procurement; organ shortage; organ transplantation; organs; risk regulation

Indexed keywords

ARTICLE; ETHICS; EUROPEAN UNION; GOVERNMENT REGULATION; HEALTH CARE POLICY; HEALTH EDUCATION; HUMAN; INTERNATIONAL COOPERATION; LEGAL ASPECT; MEDICAL ETHICS; ORGAN TRANSPLANTATION; PATIENT CARE; PATIENT RIGHT; SAFETY; TRANSPLANTATION;

CODES OF ETHICS; EUROPEAN UNION; GOVERNMENT REGULATION; HEALTH EDUCATION; HEALTH POLICY; HUMANS; INTERNATIONAL COOPERATION; ORGAN TRANSPLANTATION; PATIENT CARE; PATIENT RIGHTS; SAFETY; TISSUE AND ORGAN PROCUREMENT;

EID: 77957131906     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/157180909X12604572349683     Document Type: Article

References (127)

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23. T. Hervey, "The European Union's Governance of Health Care and the Welfare Modernization Agenda", Regulation & Governance 2(1) (2008), 103.
24. Notwithstanding its growing institutional popularity at EU level, there has been much academic debate about the eff ectiveness of OMC processes. There is little published empirical research to substantiate its eff ectiveness in either engendering consensus in a given policy area at EU level, or in facilitating horizontal or vertical policy transfer or organisational learning. Concerns have also been raised about the extent to which OMC actually facilitates greater participation in EU decision-making processes in practice. Participation requires being able to access and respond to Commission working documents, background knowledge in relation to issues under discussion, and being able to be physically present at meetings which are regularly held in Brussels. Th is limits the fi eld of potential participants in a given policy area, and the evidence available to date is that the promise of OMC as an instrument for enhancing participatory governance at EU level has not been realised (see J. Zeitlin, "Social Europe and Experimentalist Governance: Towards a New Constitutional Compromise" in G. de Búrca, (ed.), EU Law and the Welfare State: In Search of Solidarity (Oxford: Oxford University Press, 2005), pp. 218, 227-228;
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27. Commission of the European Communities. Communication. 8.12.2008, supra, n. 2, 2-3.
28. Priority Action 5 focuses on the need to take action to identify potential organs donors, as well as the potential for cross-border donation, within the EU. The Commission provides little in the way of detail, however, regarding what specifi c work will be done to realise this action. It is for this reason that it is not examined further in this paper (see Commission of the European Communities. Communication. 8.12.2008, supra, n. Ibid., 5, 10).
29. Commission of the European Communities. Communication. 8.12.2008, supra, n. 2, 3.
30. R. Matesanz, and B. Dominguez-Gil, "Strategies to Optimize Deceased Organ Donation", Transplantation Reviews 21 (2007), 182.
31. Department of Health, Organs for Transplant: A Report from the Organ Donation Taskforce (London: Department of Health, 2008), 13-15.
32. Council of Europe. Recommendation Rec (2006) 16 of the Committee of Ministers to Member States on the Quality Improvement Programmes for Organ Donation (adopted 8 November 2006).
33. Commission of the European Communities. Communication. 8.12.2008, supra, n. 2, 4, 9.
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35. Commission of the European Communities. Communication. 8.12.2008, supra, n. 2, 4, 9-10.
36. L. Wright, "Ethical Controversies in Public Solicitations for Organs", Transplantation Reviews, 22 (2008), 184-186.
37. The Human Tissue Authority is the regulatory authority empowered to oversee living organ donation and transplantation in England under sections 33 and 34 of the Human Tissue Act 2004, c. 30. Its responsibilities in this regard are further elaborated upon in its Code of Practice 2: Donation of Solid Organs for Transplantation, paragraphs 26-92.
38. H.D.C., Roscam Abbing, "A Council of Europe Protocol on Transplantation of Organs and Tissue of Human Origin" European Journal of Health Law 9 (2002), 67. It is important to note that Article 10 of the Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Transplantation of Organs and Tissues of Human Origin, Strasbourg, 24.I.2002, states that 'organ removal from a living donor may be carried out for the benefit of a recipient with whom the donor has a close personal relationship as defi ned by law, or, in the absence of such relationship, only under the conditions defi ned by law and with the approval of an appropriate independent body'.
39. The risk of serious, but not life-threatening complications, for living organ donors, has been estimated to be 1-2%. The mortality risk has been calculated at 1:3000 (see Commission of the European Communities. Impact Assessment. 30.5.2007, supra, n. 11, 31).
40. R. Truog, "The Ethics of Organ Donation by Living Donors", New England Journal of Medicine, 353(5) (2005), 444-446.
41. R. Truog, "The Ethics of Organ Donation by Living Donors", New England Journal of Medicine, 353(5) (2005), 444-446 Ibid., 5, 10.
42. Europeans and Organ Donation Report. Special Eurobarometer 272D/Wave 66.2 - TNS Opinion and Social (May 2007), 5, 9.
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44. M. Sque, T. Long, S. Payne and D. Allardyce, "Why Relatives Do Not Donate Organs for Transplants: 'Sacrifi ce' or 'Gift of Life'?", Journal of Advanced Nursing, 61(2) (2008), 134-144.
45. M. Levitt, "Educating the Public to Encourage Organ Donation?" in A.M. Farrell, D. Price, M. Quigley, (eds.), Organ Shortage: Ethics Law and Pragmatism (Cambridge: Cambridge University Press, 2010), forthcoming.
46. Commission of the European Communities. Communication. 8.12.2008, supra, n. 2, 5.
47. Commission of the European Communities. Communication. 8.12.2008, supra, n. Ibid., 5, 11.
48. The Committee of Experts on the Organisational Aspects of Co-operation in Organ Transplantation (SP-CTO) was established following the 3rd Conference of European Health Ministers in Paris in 1987 and it has an ongoing work programme. Retrieved 10 November, 2009 www.edqm.eu/en/Organisation- Work-Programme-72. html.
49. Recommendations adopted by the Council of Europe have covered a wide range of aspects of organ donation and transplantation including xenotransplantation, the role and training of professionals working in the fi eld, and organ traffi cking. Retrieved 11 November, 2009 www.edqm.eu/en/ Recommendations- 74.html. Recent Resolutions have focused in particular on aspects of living organ donation and transplantation. Retrieved 11 November, 2009 www.edqm.eu/en/Background-amp-Missions-67.html.
50. Council of Europe. Guide to the safety and quality assurance for organs, tissues and cells. 3rd edition, and Addendum 2009, Strasbourg: Council of Europe Publications, 2009.
51. The most up-to-date published data on organ donation and transplantation in the Council of Europe's Member States can be accessed via the Transplant Newsletter International Figures on Organ Donation and Transplantation - 2008. 14 (1), September 2009. Retrieved 11 November, 2009 www.edqm.eu/en/ Background-Missions-67.html.
52. Council of Europe. Organ shortage: current status and strategies for improvement of organ donation - A European consensus document. Retrieved 11 November, 2009 www.edqm.eu/medias/fi chiers/Organ- shortagecurrent-status-and
53. R. Matesanz, and B. Dominguez-Gil, supra, n. 26, 181;
54. see also R. Matesanz, and B. Miranda, "A Decade of Continuous Improvement in Cadaveric Organ Donation: The Spanish Model", Journal of Nephrology 15(1) (2002), 22-28.
55. R. Matesanz, and B. Dominguez-Gil, supra, n. 26, 185-186.
56. Department of Health, Organs for Transplant: A Report from the Organ Donation Taskforce. London: Department of Health, 2008, pp. 42-45.
57. Commission of the European Communities, Impact Assessment Accompanying Communication. 30.5.2007, supra, n. 11, 38.
58. Commission of the European Communities. Communication, 8.12.2008, supra n. 2, 6,11-12.
59. Roscam Abbing, supra n. 34, 66-67;
60. S. Gevers, "Editorial: A Fair Distribution of Organs for Transplantation Purposes: Looking to the Past and the Future", European Journal of Health Law 14 (2007), 216-217;
61. see also Article 3, Additional Protocol to the Convention on Human Rights and Biomedicine Concerning the Transplantation of Organs and Tissues of Human Origin (Strasbourg 24.I.2002), which states that 'in the case of international organ exchange agreements, the procedures must also ensure justifi ed, eff ective distribution across the participating countries in a manner that takes into account the solidarity principle within each country'.
62. Commission of the European Communities. Communication (8.12.2008), supra n. 2, 6, 11.
63. R.-G. Vermot-Mangold (Rapporteur). Traffi cking in Organs in Europe. Report to the Social, Health and Family Affairs Committee. Doc 9822. 3 June 2003. Retrieved 18 November, 2009 http://assembly. coe.int//Main.asp?link=http:/ /assembly.coe.int/Documents/WorkingDocs/doc03/EDOC9822.htm- Council of Europe. Recommendation 1611(2003) Traffi cking in Organs in Europe. Retrieved 18 November, 2009 http://assembly.coe.int/Main.asp?link =/Documents/AdoptedText/ ta03/EREC1611.htm.
64. The Declaration of Istanbul on Organ Traffi cking and Transplant Tourism (2008) Retrieved 11 November 2009 www.edqm.eu/medias/fi chiers/The-Declaration- of-Istanbul.pdf;
65. Steering Committee of the Istanbul Summit "Organ Traffi cking and Transplant Tourism and Commercialism: the Declaration of Istanbul", The Lancet 372 (2008), 5-6.
66. Commission of the European Communities. Experts Meeting on Organ Donation and Transplantation Action Plan: Summary Report. 11-12 March 2009, 5. Retrieved 20 November 2009 http://ec. europa.eu/health/phthreats/human-substance/keydo- organs-en.htm.
67. The current members of the European Transplant Network are Italy, Austria, Cyprus, Czech Republic, Estonia, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, the Netherlands, Poland and Slovakia.
68. Original members of the EOEO include national transplant organisations in France, Hungary, Italy, Poland, Portugal, Spain, Switzerland, the UK, as well as regional organisations Eurotransplant and Scandiatransplant. The relevant national organisation in the Czech Republic became a member in 2006.
69. For further details, see http://www.ceapir.org/wb/pages/ceapir/ activities/epat.php.
70. Commission of the European Communities. Communication, 8.12.2008, supra, n. 2, 8, 12-13.
71. Commission of the European Communities. Communication, 8.12.2008, supra, n. 12-13.Ibid., 7, 12.
72. The other term that is commonly used to describe this category is donation after cardiac death.
73. It has been suggested that the use of ECD organs should only be contemplated in exceptional cases, in the context of the individual doctor and patient relationship, see Roscam Abbing, supra, n. 34, 65-66.
74. Commission of the European Communities (DG Sanco). 2nd National Expert Meeting on Organ Donation and Transplantation, supra, n. 20, 3-4.
75. J. Pascual, J. Zamora and J.D. Pirsch, "A Systematic Review of Kidney Transplantation From Expanded Criteria Donors", American Journal of Kidney Disease 52(3) (2008), 553-558.
76. For a detailed overview, see A. Cronin, "Making the Margins Mainstream: Strategies to Maximise the Donor Pool" in A.M. Farrell, D. Price and M. Quigley (eds.), Organ Shortage: Ethics Law and Pragmatism (Cambridge: Cambridge University Press, 2010), forthcoming.
77. V. Audard, M. Matignon, K. Dahan, P. Lang, and P. Grimbert, "Renal Transplantation from Extended Criteria Cadaveric Donors: Problems and Perspectives Overview", Transplant International 21 (2008), 11-17.
78. R.D. Truog, and F.G. Miller, "The Dead Donor Rule and Organ Transplantation", New England Journal of Medicine, 359(7) (2008), 674.
79. Commission of the European Communities. Impact Assessment accompanying Communication. 30.5.2007, supra, n. 11, 26.
80. G. Koff mann and G. Gambaro, "Renal Transplantation from Non-Heart-Beating Donors: A Review of the European Experience", Journal of Nephrology, 16(3) (2003), 334-341.
81. Commission of the European Communities. Impact Assessment accompanying Communication. 30.5.2007, supra, n. 11, 26.
82. M.G.J. Snoeijs, E.L.W. van Heurn, W.N.K.A. van Mook, M.H. Christiaans and J.P. van Hooff , "Controlled Donation after Cardiac Death: A European Perspective", Transplantation Reviews, 21(4) (2007), 219.
83. It has been claimed that such ethical concerns 'have largely been resolved over the past decade' (Ibid., 225). However, for a contrary view, see D. Price, "Promoting Organ Donation: Challenges for the Future" in A.M. Farrell, D. Price and M. Quigley (eds.), Organ Shortage: Ethics Law and Pragmatism (Cambridge: Cambridge University Press, 2010), forthcoming.
84. Commission of the European Communities. Communication. 30.5.2007, supra, n. 14, 9-10.
85. Commission of the European Communities. 1st National Expert Meeting on Organ Donation and Transplantation at Community Level: Summary Report. Brussels, 13 July 2007. SANCO C6 EFZ/ges D (2007) 360346), 3. Retrieved 17 November 2009 http://ec.europa.eu/health/phthreats/human- substance/events-organs-en.htm.
86. House of Lords European Union Committee, Increasing the Supply of Donor Organs within the European Union, Volume 1: 17th Report of Session 2007-08. HL Paper 123-I. London: The Stationery Offi ce, 2008, 25-28.
87. EUROPA. Press Release, supra, n. 1.
88. Article 152(4)(a) EC, now Article 168(4)(a) TFEU.
89. In relation to the Blood Directive, quality and safety standards cover the collection, testing, processing, storage and distribution of human blood and its components. In relation to the Tissues and Cells Directive, such standards cover donation, procurement, testing, processing, preservation, storage and distribution.
90. Article 2(1), proposed Organs Directive, supra, n. 3.
91. Paragraph 17, Explanatory Memorandum, proposed Organs Directive, 4.
92. 'Standard operating procedures' mean 'written instructions describing the steps in a specifi c process, including the materials and methods to be used and the expected end product' (Article 3(o), proposed Organs Directive).
93. Blood Directive, Annex 1, Part B (description of quality system); Tissues and Cells Directive: Article 16 (quality management); Article 20 (tissue and cell processing); Article 21 (tissue and cell storage).
94. Article 4, proposed Organs Directive, supra, n. 3.
95. Article 7 and Annex, proposed Organs Directive.
96. Arts. 5-6, proposed Organs Directive.
97. For further details of the work to be done by the designated competent authorities in Member States, see Arts. 18-20, proposed Organs Directive.
98. Article 15, proposed Organs Directive.
99. Article 16; in particular, there should be compliance with 'Data Protection Directive' (see Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal of data and on the free movement of such data. OJ L 281/31. 23.11.1995).
100. Article 17, proposed Organs Directive, supra, n. 3.
101. Article 23, proposed Organs Directive.
102. Article 13, proposed Organs Directive.
103. As a result of the Lisbon Treaty coming into force on 1 December 2009, the Charter of Fundamental Rights now has legal force within the EU.
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105. Additional Protocol to the Convention on Human Rights and Biomedicine Concerning the Transplantation of Organs and Tissues of Human Origin, supra, n. 34.
106. For example, A.S. Daar, "Paid Organ Donation - the Grey Basket Concept", Journal of Medical Ethics, 24 (1998), 365-368;
107. J. Radcliff e-Richards, A.S. Daar, R.D. Guttmann, R. Hoff enberg, I. Kennedy, M. Lock, R.A. Sells and N. Tilney, (for the International Forum for Transplant Ethics), "The Case for Allowing Kidney Sales", The Lancet, 351 (1998), 1950-1952.
108. For example, see, L.A. Cohen, "A Futures Market in Cadaveric Organs: Would It Work?", Transplantation Proceedings, 1 (1993), 60- 61; C.A. Erin, and J. Harris, "An Ethical Market in Human Organs", Journal of Medical Ethics, 29(3) (2003), 137-138.
109. For an interesting recent examination of the ethical issues raised by off ering a range of fi nancial measures to incentivise organ donation, particularly from living donors, see G. Van Dijk and M.T. Hilhorst, Financial Incentives for Organ Donation: An Investigation of the Ethical Issues. Ethics and Health Monitoring Report 2007/3. Centre for Ethics and Health. The Hague, Council for Public Health and Health Care, 2007.
110. The Commission has acknowledged that 'there are many complex and sensitive ethical issues in this area . . . It is generally accepted that the donation should be voluntary and altruistic with legal and ethical contexts clearly defi ned, the data from donors and recipients should be protected, provided that traceability is ensured, except in the case of a living donor with a close relationship to the recipient', see Commission of the European Communities. Impact Assessment Accompanying Communication, 8.12.2008, supra, n. 30, 20.
111. Article 14, proposed Organs Directive, supra, n. 3.
112. Commission of the European Communities. Impact Assessment accompanying Communication, 30.5.2007, supra, n. 11, 24-27.
113. S., Gevers, A. Janssen, and R. Friele, "Consent Systems for Post Mortem Organ Donation in Europe", European Journal of Health Law, 11 (2004), 176-177.
114. R.W., Gimbel, M.A. Strosberg, S.E. Lehrman, E. Gefenas, and F. Taft, "Presumed Consent and Other Predictors of Cadaveric Organ Donation in Europe", Progress in Transplantation, 13 (2003), 17-23;
115. A., Abadie, and S. Gay, "The Impact of Presumed Consent Legislation on Cadaveric Organ Donation: A Cross-Country Study", Journal of HealTheconomics, 25 (2006), 599-620.
116. M. Quigley, M. Brazier, M. Navarro Michel and D. Paredes, "The Organs Crisis and the Spanish Model: Theoretical versus Pragmatic Considerations", Journal of Medical Ethics, 34 (2008), 223-224.
117. The initial call was made by the Chief Medical Offi cer for England: see Chapter 4, Chief Medical Offi cer, 2006 Annual Report of the Chief Medical Offi cer: On the State of Public Health (London: Department of Health, 2007). Th is was followed by the publication in a national newspaper of a letter from the UK Prime Minister, Mr. Gordon Brown which off ered support for the change to a presumed consent regime in the UK: see Gordon Brown, "Organ Donations Help Us Make A Diff erence", The Daily Telegraph, (14 January 2008).
118. Organ Donation Taskforce, The Potential Impact of An Opt Out System for Organ Donation in the UK: An Independent Report from the Organ Donation Taskforce. 17 November 2008, 34. Retrieved 20 November, 2009 www.dh.gov.uk/en/Publicationsandstatistics/Publications/ PublicationsPolicyAndGuidance/DH 090312.
119. Article 21, proposed Organs Directive, supra, n. 3.
120. Article 22, proposed Organs Directive.
121. Commission of the European Communities (DG Sanco). Experts Meeting on Organ Donation and Transplantation, supra, n. 57.
122. P. Haas, "Introduction: Epistemic Communities and International Policy Coordination", International Organization, 46 (1) (1992), 1-33.
123. A.M. Farrell, "The Politics of Risk and EU Governance of Human Material", Maastricht Journal of European and Comparative Law", 16(1) (2009), 51-54.
124. A.M. Farrell, "The Politics of Risk and EU Governance of Human Material", Maastricht Journal of European and Comparative Law", 16(1) (2009), Ibid., 63-64.
125. A.M. Farrell, "Is the Gift Still Good? Examining the Politics and Regulation of Blood Safety in the European Union", Medical Law Review 14(2) (2006), 168.
126. A.M. Farrell, supra, n. 111, 60-61.
127. A.M. Farrell, supra, n. 111, Ibid., 62.