Is the gift still good? Examining the politics and regulation of blood safety in the European union

Medical Law Review

Volumn 14, Issue 2, 2006, Pages 155-179

  Farrell, Anne Maree ^a  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BLOOD; BLOOD BANK; BLOOD DONOR; BLOOD STORAGE; BLOOD TRANSFUSION; BLOODBORNE BACTERIUM; COMMODIFICATION; EUROPE; EUROPEAN UNION; GIFT GIVING; GOVERNMENT REGULATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LEGAL ASPECT; POLICY; POLITICS; QUALITY CONTROL; RISK ASSESSMENT; SAFETY; STANDARD;

BLOOD BANKS; BLOOD DONORS; BLOOD PRESERVATION; BLOOD TRANSFUSION; BLOOD-BORNE PATHOGENS; COMMODIFICATION; EUROPE; EUROPEAN UNION; GIFT GIVING; GOVERNMENT REGULATION; HIV INFECTIONS; HUMANS; POLITICS; PUBLIC POLICY; QUALITY CONTROL; RISK ASSESSMENT; SAFETY;

EID: 33746136473     PISSN: 09670742     EISSN: 14643790     Source Type: Journal    
DOI: 10.1093/medlaw/fwl001     Document Type: Article

References (84)

1. D. Nelkin, 'Cultural Perspectives on Blood' in E. Feldman and R. Bayer (eds), Blood Feuds: AIDS, Blood and the Politics of Medical Disaster (Oxford University Press 1999) at 275.
2. In this article, I employ the commonly used term 'voluntary, unpaid donation'. Donation by this method is more formally referred to as 'voluntary, non-remunerated blood donation'. A donation is considered voluntary and non-remunerated 'if the person gives blood, plasma or cellular components of his/her own free will and receives no payment for it, either in the form of cash or in kind, which could be considered a substitute for money. This would include time off work other than that reasonably needed for the donation and travel. Small tokens, refreshments and reimbursements of direct travel costs are compatible with voluntary, non-remunerated donations' [see paragraph 9 (d) of 98/ 463/EC Council Recommendation of 29 June 1998 on the Suitability of Blood and Plasma Donors and the Screening of Donated Blood in the European Community (OJ L 203, 21.7.1998, p. 14)].
3. Different meanings have been ascribed to 'self-sufficiency' in relation to the blood supply. An internationally recognised definition of the term is 'the provision of blood and blood products from within a population to satisfy the clinical needs of that population' [see P. Hagen, Blood Transfusion in Europe: A "White Paper" (Council of Europe 1993) at 190].
4. 'Plasma' is the straw-coloured fluid in which the blood cells are suspended. It contains a high concentration of various proteins. Through a treatment process known as 'fractionation', plasma proteins are separated into fractions of more or less purified proteins with different properties. Following on from research and technological developments, industrial production of plasma-derived products expanded exponentially from the mid-1960s onwards (Ibid. at 188-190).
5. P. Hagen, Blood: Gift or Merchandise? Towards an International Blood Policy (Alan R. Liss 1982) at 18, 114, 134.
6. D. Starr, Blood: An Epic History of Medicine and Commerce (Alfred R. Knopf 1998) at 220-224.
7. 'Haemophilia' is a genetic disorder, which is carried by females, but affects - with rare exceptions - male offspring. The disorder results in a (severe, moderate, or mild) deficiency of clotting Factors VIII or IX. 'Factor concentrates' are plasma-derived products that have been sourced from thousands of donors in order to extract a concentrated form of the clotting factors, which are lacking in people with haemophilia. Factor concentrates can be administered at home to stop internal bleeding episodes (depending on their severity), thus avoiding the need for regular hospital attendance [see H. Krever, Commission of Inquiry on the Blood System in Canada (Canadian Government Publishing 1997) at 26-27].
8. Hagen, supra n. 5.
9. Hagen, supra n. 3 at 15. Prior to the creation of a Community competence to act in the field of blood quality and safety, the Council of Europe had long been active in developing blood policy at national, as well as European, level. In the absence of a regulatory mandate, the Council has regularly published guidelines and recommendations in the field. It has consistently recognised the importance achieving self-sufficiency through voluntary, unpaid blood donation on ethical, as well as safety, grounds.
10. R.M. Titmuss, The Gift Relationship: From Human Blood to Social Policy (George Allen and Unwin 1970) at 88-89, 157, 224-226.
11. The Human Immunodeficiency Virus (HIV) is the virus that causes the Acquired Immune Deficiency Syndrome (AIDS). A person may be infected with the virus, but will only be considered to have AIDS once there is severe immune deficiency, or s/he is diagnosed with illnesses associated with such deficiency. For the purposes of this article, I use the term HIV/AIDS to describe the disease, except where it is necessary to just use the term HIV to describe testing or prevalence of the virus in a particular population.
12. Prior to the 1990s, Council Directive 89/381/EC was adopted. It was designed to approximate laws in relation to proprietary medicinal products derived from human blood and plasma as part of the completion of the internal market project. It has since been repealed (see fn.70 infra). It was only in the 1990s, however, that a more strategic approach was taken to developing blood policy and regulation in the wake of national HIV/AIDS blood contamination episodes. For further details of communications, resolutions and recommendations adopted by EU institutions in the 1990s in relation to blood quality, safety and self-sufficiency,
13. Article 152(4)(a) EC.
14. 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, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC, OJ L 33, 8.2.2003, p. 30.
15. An examination of civil and criminal legal action arising out of HIV/ AIDS blood contamination episodes in the UK and France is outside the scope of this article. Instead, this article focuses on the deeper, underlying problems involved in the assessment and management of the risk posed by HIV/AIDS to the blood supply, which precipitated such legal action.
16. T. Murray, 'Gifts of the Body and the Needs of Strangers' (1987) 17 Hastings Center Report at 36.
17. J. Keown, 'The Gift of Blood in Europe: An Ethical Defence of EC Directive 89/381' (1997) 23 Journal of Medical Ethics at 99.
18. M. Radin, Contested Commodities: The Trouble with Trade in Sex, Children, Body Parts and Other Things (Harvard University Press 1996) at 93-94.
19. Titmuss, supra n. 10 at 71, 224-225. In making such an argument, Titmuss drew in part on the earlier work of French anthropologist, Marcel Mauss, on the role of gift-giving in regulating social relationships in pre-industrial societies. Mauss saw gift-giving in this context as a form of reciprocal altruism creating a cycle of 'exchange relationships' that regulated such societies. Mary Douglas has pointed out that Mauss would have disagreed with Titmuss's interpretation of gift-giving in the context of blood donation, as it represents a form of non-reciprocal altruism
20. [see M. Douglas'Foreword: No Free Gifts' in M. Mauss, 'Essai sur le don' in Sociologie et Anthropologie (Presses Universitaires de France 1950) translated by W.D. Halls as The Gift: The Form and Reason for Exchange in Archaic Societies (Routledge 1990) at vii-ix].
21. Ibid. at 195-208. Besides supporting voluntary, unpaid donation on ethical and safety grounds, Titmuss also argued that a blood system sourced from such donors was likely to be much more economically efficient than one that was sourced from paid donors. His conclusion in this regard was based on empirical research conducted in the mid to late 1960s, drawing a comparison between the blood collection system in the UK (voluntary, unpaid donation) and that of the United States (paid donation). An examination of this issue is outside the scope of this article, although it should be noted that Titmuss's arguments in this regard promoted a lively debate on both sides of the Atlantic, eliciting a particularly strong response from American academics who disputed his research methods and findings
22. [see for example, K. Arrow, 'Gifts and Exchanges' (1972) 4 Philosophy and Public Affairs at 343
23. H.M. Sapolsky and S.N. Finkelstein, 'Blood Policy Revisited - A New Look at "The Gift Relationship"' (1977) 46 The Public Interest at 15
24. cf P. Singer, 'Altruism and Commerce: A Defence of Titmuss against Arrow' (1973) 2 Philosophy and Public Affairs 3 at 312].
25. R. Beal and W. van Aken, 'Gift or Good? A Contemporary Examination of the Voluntary and Commercial Aspects of Blood Donation' (1992) 63 Vox Sanguinis at 3.
26. A.M. Farrell, Contaminated Blood: A Comparative Study of Policy-Making Arising out of HIV Contamination of the Blood Supply in France, the United Kingdom and Ireland (PhD thesis) (University of Manchester 2004, unpublished) at 49.
27. By the late 1990s, a senior blood banker was even prepared to concede that 'today the plasma industry in the United States is at least as safe as the voluntary system, if not safer' [see R. Beal, 'Titmuss Revisited' in E.A. Robinson (ed.), 'Altruism: Is It Alive and Well? (1999) 9 Transfusion Medicine at 355].
28. S. Lewis, 'Europe: Blood Donation' (18.4.1992) 339 The Lancet 8799 at 981.
29. These would include appropriate donor-screening measures and testing; limiting the number and frequency of donations; regular medical follow-up of donors; and instituting sufficient regulatory controls to ensure non-exploitative conditions for donors, as well as overall quality and safety [see P.R. del Pozo, 'Paying Donors and the Ethics of Blood Supply' (1994) 20 Journal of Medical Ethics at 33-34;
30. H. von Schubert, 'Donated Blood: Gift or Commodity? Some Economic and Ethical Considerations on Voluntary vs Commercial Donation of Blood' (1994) 39 Social Science and Medicine at 204].
31. Beal and van Aken, supra n. 21 at 1.
32. R. Bayer and E. Feldman, 'Understanding the Blood Feuds' in E. Feldman and R. Bayer (eds) Blood Feuds: AIDS, Blood and the Politics of Medical Disaster (Oxford University Press 1999) at 7, 9.
33. Hagen, supra n. 5 at 5, 149.
34. J. Cash, 'The Blood Transfusion Service and the National Health Service' (12.9.87) British Medical Journal at 617.
35. Ibid. at 618.
36. Farrell, supra n. 22 at 119-120.
37. Ibid. at 125-126. Although the national regulator for medicines in the UK was responsible for the licensing of such products, a combination of chronic under-staffing and lack of administrative resources made it difficult to meet the demands placed upon it. As such, it was essentially reliant on the American regulator, the Food and Drug Administration (FDA), as well as commercial fractionators, to vouch for the safety of factor concentrates sourced from American paid donors, which were imported into the UK for use by British haemophiliacs.
38. V. Berridge, AIDS in the UK: The Making of Policy 1981-1994 (Oxford University Press 1996) at 38.
39. It is debatable whether self-sufficiency in blood and blood products has ever been achieved in the UK, or indeed whether it is appropriate in the light of new risks to the safety of the national blood supply, such as the one posed by vCJD (see Farrell, supra n. 22 at 223, and fn. 55 infra).
40. R. Cheingsong-Popov, R. Weiss, R.A. Dalgleish et al., 'Prevalence of Antibody to Human T-Lymphotropic Virus Type III in AIDS and AIDS-Risk Patients in Britain' (1.9.84) The Lancet ii at 477-480.
41. C.R. Rizza, R.J.D. Spooner, and P. Giangrande (on behalf of the UK Haemophilia Centre Directors' Association) 'Treatment of Haemophilia in the UK: 1981-1986' (2001) 7 Haemophilia at 349-359.
42. It is instructive to compare the epidemiological profile of the British volunteer donor population in relation to HIV/AIDS with another more recent transmissible disease, vCJD. In relation to vCJD, the British donor population has a high-risk epidemiological profile, necessitating the ongoing importation of American-sourced plasma for use in the manufacture of blood products by BPL. This is despite the commitment in national blood policy to achieving self-sufficiency through voluntary, unpaid donation (see fn. 55 infra).
43. European Centre for the Surveillance of HIV/AIDS (WHO-EC Collaborating Centre on AIDS) 'Prevalence of HIV Infection Among Haemophiliacs at 31st December 1992' (31.12.1992) 36 AIDS Surveillance in Europe Quarterly Report at 33. HIV prevalence among national haemophilia populations in Europe is relatively easy to ascertain given that they are subject to regular monitoring of their condition.
44. European Centre for the Surveillance of HIV/AIDS (WHO-EC Collaborating Centre on AIDS), 'Cumulative AIDS cases by Country and Transmission Group Reported by 31st December 1992' (31.12.1992) 36 AIDS Surveillance in Europe Quarterly Report at 19. Because of the difficulties in ascertaining the group of individuals who may have been infected with HIV through blood transfusion (as they are often not under regular treatment), only end-stage AIDS cases are reported in this category.
45. M. Setbon, Pouvoirs contre sida: De la transfusion sanguine an dépistage: Décisions et pratiques en France, Grande Bretagne et Suède (Éditions du Seuil 1993) at 78-83.
46. Subsequent investigations by journalists revealed that importations of commercially-sourced blood products in fact continued on a 'clandestine' basis throughout the 1980s [see A.M. Casteret, L'Affaire du sang contaminé (Éditions La Decouverte 1992) at 64;
47. J.Y. Nau and F. Nouchi, 'Des produits sanguins ont été importés illégalement' (13.2.1992) Le Monde].
48. M. Steffen 'The Nation's Blood: Medicine Justice and the State' in E. Feldman and R. Bayer (eds), Blood Feuds: AIDS Blood and the Politics of Medical Disaster (Oxford University Press 1999) at 99.
49. Farrell, supra n. 22 at 90.
50. Ibid. at 72-73. During the period when HIV/AIDS emerged as a risk to the blood supply, Direction-Générale de la santé (DGS), which was part of the larger Ministry of Health and Social Affairs, was the state department that had overall institutional responsibility for national blood policy and regulation. Despite having considerable regulatory powers in this regard, DGS suffered from a chronic lack of financial, personnel and administrative resources, which severely hampered its ability to exercise such powers effectively. DGS adopted a consensual, reactive approach to managing risks to the blood supply, essentially 'rubber-stamping' advice received from blood bankers who dominated its blood advisory committee.
51. Casteret, supra n. 40 at 71-72.
52. Ibid. at 85.
53. J.P. Geronimi, F. Henry-Bonnot, A. Feltz, A. Morelle, A. Roquel, and M. Vernerey, M. Les Collectes de sang en milieu pénitentiare Paris: Inspection Générale des services judiciares ISGJ RMT 1392 IGAS Code Mission SA07 No. 92 119 (November 1992) at 55-68.
54. Ibid.
55. Casteret, supra n. 40 at 63.
56. Farrell, supra n. 22 at 108-109.
57. Nelkin, supra n. 1 at 275.
58. An analysis of the reasons why an enduring political scandal arising out of the HIV/AIDS blood contamination episode developed in France, but not in the UK, is outside the scope of this article. For a detailed examination of the issue, see A.M. Farrell, AIDS, Blood and Politics: Interests, Institutions and the Management of Public Health Risks (Ashgate 2007; forthcoming).
59. Farrell, supra n. 12 at 142-144.
60. This has been described as an example of 'new approach' harmonisation that sets 'minimum standards required to protect essential health and safety interests' and 'gives significant discretion to national authorities at the level of detail' [see T.K. Hervey and J.V. McHale, 'Law, Health and the European Union' (2005) 25 Legal Studies 2 at 239, fn. 52, and 246].
61. Hagen, supra n. 3 at 63-84.
62. S. Boseley, 'NHS imports all plasma to avoid risk of CJD' (14.5.1998) The Guardian at p. 4. Since 1998, only American-sourced plasma has been used in the manufacture of blood products by BPL (Bio Products Laboratory, formerly known as the Blood Products Laboratory) due to the risk of vCJD. At the beginning of 2003, the Department of Health purchased Life Resources Inc, an independent plasma supplier based in the United States, which operates 24 FDA-licensed plasma collection centres in order to ensure the long-term supply of plasma for the UK at http://www.bpl.co.uk/public/therapy_areas/coagulation/ latest_news_details.asp (accessed 8.12.2005).
63. Article 2 (1).
64. Hospital blood banks are excluded from this definition of blood establishments under Article 3(e) and Article 6 states that only Articles 7, 10, 11(l), 14, 15, 22 and 24 of the Directive apply to hospital blood banks.
65. Article 4(1). In the UK, for example, the 'competent authority' is the Secretary of State for Health. The Medicines and Healthcare Products Regulatory Agency (MHRA) has been designated on an interim basis to discharge the enforcement obligations of the Secretary of State for Health under the Blood Directive. Such obligations have now been set out in the Blood Safety and Quality Regulations 2005, which came into force on 8 November 2005 (SI 2005/50), together with amendments to such regulations set out in the Blood Safety and Quality (Amendment) (No.2) Regulations (SI 2005/2898). It is envisaged that the MHRA's obligations in this regard will eventually be transferred to the Regulatory Authority for Tissue and Embryos, which is to be established by 2008.
66. Article 9.
67. Articles 11 and 12.
68. Article 24.
69. Articles 14, 15. The Commission has subsequently adopted two Directives that set out in more detail technical requirements, specifications and standards to be met pursuant to the Blood Directive in relation to traceability requirements and notification of serious adverse events and reactions (see Commission Directive 2005/61/EC, OJ L 256, 1. 10.2005, p. 32), and in relation to a quality system for blood establishments
70. Article 22.
71. Article 21.
72. Articles 16-19.
73. The Commission has subsequently adopted a Directive that sets out in more detail the technical requirements to be met in relation to donor information, donor eligibility, storage, transport and distribution, quality safety requirements and autologous transfusions
74. This was an estimate that was provided in the early 1990s [see S. Lewis, 'EC Commission and Blood Self-Sufficiency' (13.1.1993) 342 The Lancet at 1228]. Accurate, up-to-date data on current levels relating to the shortfall in plasma is difficult to obtain, as is the extent of Member State dependency on commercially-sourced blood products.
75. Indeed, the last time the Commission published any data on the issue was over ten years ago [see CEC (Commission of the European Communities) Commission Communication on Blood Safety and Self-Sufficiency in the Community COM (94) 652 (final) (21.12.1994)].
76. Farrell, supra n. 12 at 140-141.
77. It is Useful to compare the approach taken in the Blood Directive on the issues of donation, procurement and third-party sourcing/traceability with that taken in the later Tissues/Cells Directive 2004/23/EC (OJ L 102, 7.4.2004, p. 48), which was required to be implemented by Member States by 7 April 2006. Both Directives deal with quality and safety standard-setting involving substances of human origin, and both were adopted pursuant to Article 152(4)(a) EC. The Tissues/Cells Directive refers directly and in detail to third-country sourcing/traceability (Article 9), provides information on what compensation is permitted in the context of voluntary, unpaid donation [Article 12(1)], and makes specific reference to the fact that Member States 'shall endeavour to ensure' that procurement is carried out on a non-profit basis [Article 12(2)].
78. For a more detailed examination of the reasons for such differences in approach between the two Directives, see A.M. Farrell, 'Governing the Body: Examining EU Regulatory Developments in Relation to Substances of Human Origin' (2005) 27 Journal of Social Welfare and Family Law 427-437.
79. Council Directive 89/381/EEC of 14 June 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action, relating to medicinal products and laying down special provisions for proprietary medicinal products derived from human blood or human plasma (repealed).
80. Directive 2001/83/EC, OJ L 311, 28.11.2001, p. 67.
81. Commission Directive 2003/63/EC, OJ L 149, 27.6.2003, p. 46.
82. In addition, a further Commission Directive 2003/94/EC (OJ L 262, 14.10.2003, p. 22) has been adopted, which sets out principles and guidelines for good manufacturing practice in respect of medicinal and investigative medicinal products for human use, where the manufacture of such products requires authorisation under Articles 40 and 13, respectively, of Directive 2001/83/EC. Although it has wider application, Directive 2003/94/EC applies to medicinal products derived from human blood or plasma. Under Article 3(2) of the Directive, it states that the interpretation of principles and guidelines of good manufacturing practice, manufacturers and competent authorities shall take into account the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/EC. It also requires, inter alia, that where medicinal products for human use are imported from third countries, the importer shall ensure that the products have been manufactured in accordance with standards that are at least equivalent to the good manufacturing practice standards laid down by the Community (Article 4); that the manufacturer shall establish and maintain a quality control system (Article 11), and that the manufacturer shall implement a system for recording and reviewing complaints together with an effective system for recalling promptly and at, any time, the medicinal products in the distribution network (Article 13).
83. Committee for Proprietary Medicinal Products (CPMP) 'Guideline on the Scientific Data Requirements for a Plasma Master File (PMF)' (26.2.2004) European Agency for the Evaluation of Medicinal Products EMEA/CPMP/BWP/ 3704/03 at http://www.emea.eu.int/index/indexh1.htm (accessed 22.6.2005).
84. INRA (Europe), Eurobarometer 41.0, Europeans and Blood (1995). Report prepared for the European Commission, at europa.eu.int/comm./ public_opinion/archives/ebs_083_en.pdf (accessed 28.7.2004); European Opinion Research Group, EEIG, Le don de sang (2003) Eurobaromètre special 1883-4/Vague 58.2, Report prepared for the European Commission at europa.eu.int/comm./health/ph_threats/human_substance/documents/ ebs_183.4_fr. pdf (accessed15.6.2005).