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Consenting to bio-risk: xenotransplantation and the law

Published online by Cambridge University Press:  02 January 2018

Sara Fovargue
Sara Fovargue*
Affiliation:
Law School, Lancaster University
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Abstract

Research into alternative sources of organs for transplantation, including the use of organs from non-human genetically engineered animals, has occurred since the introduction of allotransplantation in the 1960s. Xenotransplantation is different from other developing genetic technologies because whilst the potential benefit is to the individual, the possible risks are to society as a whole. The risks include the transmission of unknown and currently indeterminable infectious diseases. This article explores whether the current regulator framework is able to address this issue and, in particular, whether ‘first-party’ consent to involvement in a clinical trial is a sufficient to protect third parties from harm. The competence of a xeno-recipient to consent is also considered, and it is suggested that, at the very least, public debate and participation in deciding whether clinical trials should be permitted must occur, because by allowing xenotransplant trials to help an individual, the risks will be borne by all.

Type
Research Article
Information
Legal Studies , Volume 25 , Issue 3 , September 2005 , pp. 404 - 430
Copyright
Copyright © Society of Legal Scholars 2005

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References

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34. UKXIRA Draft Report of the Infection Surveillance Steering Group of the UKXIRA (London: DH, 1999).

35. Above n 15.

36. Re MB [1997] 8 Med LR 217 at 224, CA, per Butler-Sloss LJ: (a) the patient must be able to comprehend and retain the information which is material to the decision, especially as to the likely consequences of having or not having the treatment in question; and (b) the patient must be able to use the information and weigh it in the balance as part of the process of arriving at the decision.

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39. [1993] 2 All ER 75 at 103, HL, per Lord Mustill; Law Commission Consent in the Criminal Law (Consultation Paper no 139, 1995) para 8.51.

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41. For arguments that xenotransplants are unlawful because of the personal risks involved see, for example, J K Mason ‘Organ Donation and Transplantation’ in C Dyer (ed) Doctors, Parients and the Law (Oxford: Blackwell, 1992) pp 121–122; M Fox and J McHale ‘Regulating Xenotransplantation’ (1997) New Law Journal 139 at 140.

42. See, for example, Editorial ‘Xenotransplantation: Time to Leave the Laboratory’ (1999) 354 The Lancet 1657; R E Michler ‘Xenotransplantation: Risks, Clinical Potential, and Future Prospects’ (1996) 2 Emerging Infectious Diseases 64.

43. Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO) International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) General Ethical Principles, available at http://www.cioms.ch/guidelines_nov_2002_blurb.htm.

44. World Medical Association (WMA) Declaration of Helsinki (2004) para 16, emphasis added, available at http://www.wma.net/e/policy/b3.htm; CIOMS and WHO, above n 43, Guideline 8; the Clinical Trials Regulations, above n 15, Sch 1, Pt 2, para 2; The European Agency for the Evaluation of Medicinal Products ICH Topic E6 Guideline for Good Clinical Practice-Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95)(1996) para 2.2, available at http://www.emea.eu.int/pdfs/human/ich/013595en.pdf. In contrast, the General Medical Council's (GMC) guidelines emphasise the risks and benefits to the patients: GMC Research: The Role and Responsibilities of Docrors (2002) para 5, available at http://www.gmc-uk.org/standards/research.htm.

45. WMA, above n 44, Article 32.

46. WMA, above n 44, Article 28.

47. See also J Hughes ‘Xenografting: Ethical Issues’ (1998) 24 Journal of Medical Ethics 18 at 20.

48. Hughes, above n 47, p 21, emphasis in original.

49. J Herring ‘Caesarean Sections and the Right of Autonomy’ [1998] 57 Cambridge Law Journal 438 at 440.

50. Council of Europe Report on the State of the Art in the Field of Xenotransplantation CDBI/CDSP_XENO (2003) 1 (Strasbourg: CDBI/CDSP) para 7.5.3. See also T L Beauchamp and J F Childress Principles of Biomedical Ethics (Oxford: Oxford University Press, 5th edn, 2001) p 65.

51. For example, it requires that the patient is competent to consent, that the consent is obtained voluntarily and in the presence of a third party, that patients are aware that they are free to withdraw from the trial at any time and that their consent is obtained before personal information is passed to close relatives or friends: UKXIRA, above n 12, paras 7.13-7.14.

52. Above n 47, p 20.

53. Above n 41, p 20.

54. British Medical Association (BMA) The Medical Profession and Human Rights - Handbook for a Changing Agenda (London: Zed Books, 2001) p 213.

55. A Hastillo and M L Hess ‘Heart Xenografting: A Route Not Yet to Trod’ (1993) 12 Journal of Heart and Lung Transplantation 3 at 4.

56. CIOMS and WHO, above n 43, Guidelines 4–6, 9; WMA, above n 44, Articles 20, 22–26; GMC, above n 44, paras 5, 8, 15–22.

57. Above n 54, pp 206–201.

58. J Katz ‘Human Experimentation and Human Rights’ (1993) 38 Saint Louis University Law Journal 7.

59. I Kennedy ‘Consent to Treatment: The Capable Person’ in C Dyer (ed) Doctors, Patients and the Law (Oxford: Blackwell, 1992) p 61.

60. BMA Report of the Consent Working Party: incorporating Consent Toolkit (2001) p 7, available at http://www.bma.org.uk/ap.nsf/Content/Reportofitheconsentworkingparty.

61. S Hewlett ‘Consent to Clinical Research - Adequately Voluntary or Substantially Influenced?’ (1996) 22 Journal of Medical Ethics 232 at 236.

62. GMC Seeking Patients’ Consent: The Ethical Considerations (1998) para 36, available at http://www.gmc-uk.org/standards/default.htm.

63. N E Kass et al ‘The Fragile Foundation of Contemporary Biomedical Research’ (1996) 26 Hastings Center Report 25 at 27. 64. Kass et al, above n 58, p 20.

64. Kass et al, above n 58, p 20.

65. The Nuffield Report, above n 10, para 7.18; the Kennedy Report, above n 10, para 7.13; US Department of Health and Human Services (US DHHS) PHS Guideline on Infectious Disease Issues in Xenotransplantation (2001) para 2.5, available at http://www.fda.gov/cber/gdlns/xenophs0101.pdf; Health Canada Proposed Canadian Standard for Xenotransplantation (1999a) p 6, available at http://www.hc-sc.gc.ca/hpfb-dgpsa/bgtd-dpbtg/xeno_std_e.pdf; UKXIRA, above n 12, para 7.13.

66. CIOMS and WHO, above n 43, Guideline 5; WMA, above n 44. paras 22, 31; GMC, above n 44, paras 19–21.

67. ‘A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art’: Bolam v Friern Hospital Management Committee [1957] 2 All ER 118 at 121, per McNair J. Endorsed in Sidaway v Bethlem Royal Hospital Governors [1985] 1 All ER 643, HL.

68. Blyth v Bloomsbury [1993] 4 Med LR 151. The applicability of the professional standard test to information disclosure has been questioned in, for example, Smith v Tunbridge Wells Health Authority [1994] 5 Med LR 334.

69. Bolitho v City and Hackney Health Authority [1997] 4 All ER 771 at 778, HL, per Lord Browne-Wilkinson.

70. Pearce v United Bristol Healthcare NHS Trust [1999] PIQR 53 at 59, CA, per Lord Woolf MR.

71. See, for example, Kennedy and Grubb, above n 14, pp 1710–1717; J K Mason, R A McCall Smith and G T Laurie Law and Medical Ethics (Edinburgh: Butterworths, 6th edn, 2002) pp 586–588.

72. The Kennedy Report, above n 10, para 7.11.

73. The Nuffield Report, above n 10, para 7.18.

74. The Nuffield Report, above n 10, para 7.19; the Kennedy Report, above n 10, para 7.11.

75. The Kennedy Report, above n 10, para 7.11.

76. UKXIRA, above n 12, para 7.13, emphasis added.

77. UKXIRA, above n 12, para 7.16.

78. UKXIRA, above n 12, para.7.16.

79. UKXIRA, above n 12, para 7.17.

80. UKXIRA, above n 34, para A5.4, emphasis added.

81. A L Caplan ‘Ethical Issues Raised by Research Involving Xenografts’ (1985) 254 Journal of the American Medical Association 3339 at 3343, emphasis in original.

82. F H Bach et al ‘Ethical and Legal Issues in Technology: Xenotransplantation’ (2001) 27 American Journal of Law and Medicine 283 at 290.

83. Above n 10, paras 7.16-7.17.

84. Above n 10, para 7.16.

85. M Fox ‘Clinical Research and Patients: The Legal Perspective’ in J Tingle and A Cribb (eds) Nursing Law and Ethics (Oxford: Blackwell Science, 2nd edn, 2002) p 270.

86. See, for example, Institute of Medicine Xenotransplantation: Science, Ethics and Public Policy (Washington, DC: National Academy Press, 1996) p 62. For examples of overoptimistic claims about when xenotransplant clinical trials will begin see above n 9.

87. The Nuffield Report, above n 10, para 7.17.

88. The Nuffield Report, above n 10, para 7.17.

89. Swedish Committee on Xenotransplantation From One Species to Another - Transplantation Fromhimals to Humans Swedish Government Official Report no 1999:120 (1999), available at http://www.oecd.org/dataoecd/28/36/2397231.doc; Health Canada (1999a), above n 65; J W Ebert, L E Chapman and A P Paterson ‘Xenotransplantation and Public Health’ (1996) 2 Current Issues in Public Health 215 at 218.

90. UKXIRA, above n 34; UKXIRA Draft Guidance Notes on Biosecurity Considerations in Relation to Xenotransplantation (London: DH, 1999).

91. T A Caulfield and G B Robertson ‘Xenotransplantation: Consent, Public Health and Charter Issues’ (2001) 5 Medical Law International 81; D K C Cooper and R P Lanza Xeno - The Promise of Transplanting Animal Organs into Humans (New York: Oxford University Press, 2000) p 218. For an argument against a contract of consent see P S Florencio and E D Ramanathan ‘Are Xenotransplantation Safeguards Legally Viable?’ (2001) 16 Berkeley Technology Law Journal 937.

92. ‘TB Carrier Sparks Quarantine Review’Mail on Sunday, 8 May 2005, available at http://www.mailonsunday.co.uk; J Meikle ‘Law Lets TB Patient Infect 12 Others’Guardian, 9 May 2005, available at http://www.guardian.co.uk; ‘TB Human Timebomb Infects 12′Mail on Sunday, 8 May 2005, available at http://www.mailonsunday.co.uk; ‘TB Sufferer ‘Putting Lives at Risk’Mail on Sunday, 8 May 2005, available at http://www.mailonsunday.co.uk; J Meikle ‘TB Case Sparks Alarm at Hospital’Guardian, 21 October 2002, available at http://www.guardian.co.uk.

93. Meikle (2005), above n 92; Mail on Sunday (2005), above n 92.

94. UKXIRA, above n 34, para A5.3.

95. For discussion of the effectiveness and role of the 1984 Act see, for example, M Brazier and J Harris ‘Public Health and Private Lives’ (1996) 4 Medical Law Review 171.

96. Section 36 concerns the medical examination of one of a group of people who may be carrying an organism capable of causing a notifiable disease, where it is in their interest, or that of their family's or the public for an examination to occur.

97. Section 37.

98. Section 38.

99. Above n 34, para A5.3, emphasis added.

100. Above n 34, para A5.3.

101. Above, n 34, para A5.3.

102. Above nn 34 and 90. The UKXIRA's website publications page still lists the reports as draft six years after they were first published: see http://www.advisorybodoies.doh.dov.uk/ukxira/publications.htm.

103. Above n 34, para A5.2.

104. See, for example, F H Bach and A J Ivinson ‘A Shrewd and Ethical Approach to Xenotransplantation’ (2002) 20 Trends in Biotechnology 129; M Tallacchini ‘Council of Europe Working Party on Xenotransplantation: State-of-the-Art Report on Xenotransplantation (2000)’ (2001) 8 Xenotransplantation 154; Council on Ethical and Judicial Affairs 113. The Ethical Implications of Xenotransplantation (2001) p 3, available at http://www.ama-assn.org/ama/upload/mm/369/ceja_report_113.pdf.

105. A Fano ‘If Pigs Could Fly, They Would: The Problems with Xenotransplantation’ in B Tokar (ed) Redesigning Life? The Worldwide Challenge to Genetic Engineering (New York: Zed Books, 2001) p 189.

106. A S Daar ‘Xenotransplantation: Informed Consent/Contract and Patient Surveillance’ (1999) 4 Biomedical Ethics 87.

107. For a list of the current members of the UKXIRA see http://www.advisorybodies.doh.gov.uk/ukxira/members.htm.

108. Public debate/‘consent’ was recommended in the Agriculture and Environment Biotechnology Commission (AEBC) Crops on Trial - A Report by the AEBC (2001), available at http://www.aebc.gov.uk/aebc/pdf/crops.pdf.

109. Department for Environment, Food and Rural Affairs (DEFRA) The GM Public Debate: Lessons Learned from the Process (2004) paras 6, 9, 10 and 14, available at http://www.defra.gov.uk/environment/gm/debate/pdf/gmdebate-lessons.pdf.

110. Above n 109, paras 16, 22 and 23.

111. Above n 109, para 30.

112. GeneWatch UK ‘How to Get Involved in the “GM Nation?” Debate’ (2003), available at http://www.genewatch.org/Debate/Debate_howtogetinvolved.htm.

113. Above n 109, para 2.

114. ‘GM Nation? About the Debate’, available at http://www.gmnation.org.uk/ut_09/index.htm.

115. R Heller ‘GM Nation? The Findings of the Public Debate’ (2003) p 6, available at http://www.gmnation.org.uk/docs/gmnation_finalreport.pdf.

116. Above n 115, p 7.

117. Above n 115, p 8.

118. DH Donor Information Consultation - Providing Information About Gamete or Embryo Donors (2002), available at http://www.dh.gov.uk/assetRoot/04/01/87/74/04018774.pdf; Advisory Committee on Genetic Testing and Human Fertilisation and Embryology Authority (HFEA) Consultation Document on Preimplantation Genetic Diagnosis (1999), available at http://www.dh.gov.uk/assetRoot/O4/04/28/96/04042896.pdf.

119. For a discussion of who ‘the public[s]’ are see, for example, J Edwards ‘Taking “public understanding” seriously’ (2002) 21 New Genetics and Society 315.

120. The Nuffield Report, above n 10, Annex A.

121. The Nuffield Report, above n 10, Annex D.

122. The Kennedy Report, above n 10, Annex B, Appendix C.

123. Canadian Public Health Association (CPHA) ‘A Consultation on Xenotransplantation’ (2000), available at http://www.xeno.cpha.ca/english/about/pagel.htm.

124. Health Canada Report of the National Forum on Xenotransplantation - Clinical, Ethical and Regulatory Issues (1998), available at http://www.hc-sc.gc.ca/hpfb-dgpsa/bgtd-dpbtg/frmptx_e.pdf.

125. Health Canada (1999a), n 65 above; Health Canada Viewpoint - A Summary of Recommendations from the National Forum on Xenotransplantation (1999b), available at http://www.hc-sc.gc.ca/hpfb-dgpsa/bgtd-dpbtg/forumsummary_e.pdf.

126. Health Canada ‘Proposal for a Public Involvement Plan for Xenotransplantation’ in Report from the Planning Workshop: Public Involvement on Xenotransplantation (2000), available at http://www.hc-sc.gc.ca/hpfb-dgpsa/bgtd-dpbtg/awsreport_e.html.

127. Above n 126, p 3.

128. CPHA Executive Summary - Animal-to-Human Transplantation: Should Canada Proceed? A Public Consultation on Xenotransplantation (2001). available at http://www.xeno.cpha.ca/english/execsumm/execsume.pdf; Health Canada (1999b), above n 125.

129. Health Canada Report from the Planning Workshop: Public Involvement on Xenotransplantation (2000) p 3, available at http://www.hc-sc.gc.ca/hpfb-dgpsa/bgtd-dpbtg/awsreport_e.html.

130. For information on the affect of the public debate on GM food and crops on policy decision-making see DEFRA, Scottish Executive Environment and Rural Affairs Department, Welsh Assembly Government and Department of the Environment in Northern Ireland The GM Dialogue: Government Response (2004), available at http://www.defra.gov.uk/environment/gm/debate/pdf/gmdialogue-response.pdf.

131. The extent of the tragedy remains uncertain: see J Meikle ‘Child Tonsil Tests Set to Predict vCJD Fatalities’Guardian, 21 May 2004, available at http://www.guardian.co.uk.

132. I Welsh and R Evans ‘Xenotransplantation, Risk, Regulation and Surveillance: Social and Technological Dimensions of Change’ (1999) 18 New Genetics and Society 197 at 202.

133. Above n 132, at 206.

134. Above, n 132, at 202; U Beck Risk Society: Towards a New Modemity (London: Sage, 1992).

135. Above n 132, at 212.

136. Swedish Committee, above n 89, p 14.

137. R Brownsword et al ‘Human Genetics and the Law: Regulating a Revolution’ in R Brownsword et al (eds) Human Genetics and the Law: Regulating a Revolution (Oxford: Hart, 1998) p 5.

138. See, for example, US DHHS, FDA, Center for Biologics Evaluation and Research Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans -Final Guidance (2003) p 3, available at http://www.fda.gov/CBER/gdlns/clinxeno.pdf; WHO Report of WHO Consultation on Xenotransplantation - Geneva, Switzerland, 28–30 October 1997 WHO/EMC/ZOO/98.2 (1998) para 8.1.9, available at http://www.who.int/eme-documents/zoonoses/whoemczoo982c.html. The importance of public debate and participation is not, however, universally accepted and it has been argued that since public opinion was not taken into account for allotransplantation or in vitro fertilisation, discussion on xenotransplantation is also unnecessary: Editorial, above n 42.

139. A Coote and J Franklin ‘Negotiating Risks to Public Health - Models for Participation’ in P Bennett and K Calman (eds) Risk Communication and Public Health (Oxford: Oxford University Press, 2001) p 188.

140. Coote and Franklin, above n 139, p 189.

141. Bach and Ivinson, above n 104.

142. Bach et al, above n 82, at 289.

143. Coote and Franklin, above n 139, p 193.

144. For information on how public participation in the genetically modified crops debate occurred and the results of the consultation, see above n 109, 115 and 130.

145. For recent criticism of the UKXIRA's decision not to publish a commissioned report on the legal and ethical implications of xenotransplantation because of the findings, see M Townsend ‘Doubts on Pig Organ Transplants Ignored’Observer, 29 June 2003, available at http://observer.guardian.co.uk. The UKXIRA website lists The Law and Ethics of Xenotransplantation - Bibliography and Abstracts of Key Articles as a publication but the collection of material ceased in September 2002, available at http://www.advisorybodies.doh.gov.uk/ukxira/publications.htm.

146. The Annual Report for the period December 2000-November 2001 was originally due to be published in October 2002 but was not published until December 2002. The latest annual report for January 2002-September 2003, covering a 21-month period, was only published in February 2004.

147. UKXIRA, above n 34; UKXIRA, above n 90. The former was advertised on the UKXIRA website on 4 August 1999 and required comments by 15 October 1999, and the latter was sent to those requesting a copy of the consultation paper with an undated letter that requested comments by 10 December 1999.

148. See, for example, S Boseley ‘Gender Machine Put to the Test’Guardian, 23 October 2002, available at http://www.guardian.co.uk, concerning the HFEA consultation Sex Selection: Choice and Responsibility in Human Reproduction (2002), available at http://www.hfea.gov.uk/AboutHFEA/Consultations/Sex%20Selection.pdf. T Radford ‘Warningon Linking Genes and Human Behaviour’Guardian, 2 October 2002, available at http://www.guardian.co.uk, detailing the findings of the Nuffield Council public consultation exercise outlined in Genetics and Human Behaviour: The Ethical Context (London: Nuffield Council on Bioethics, 2002).

149. J A Fishman ‘Infection in Xenotransplantation: A Clinical Approach’ (1999) 31 Transplantation Proceedings 2225 at 2227.

150. Bach and Ivinson, above n 104, at 130.

151. Bach and Ivinson, above n 104, at 130.

152. For a discussion of alternatives see, for example, Mason et al, above n 71, ch 14; D Price Legal and Ethical Aspects of Organ Transplantation (New York: Cambridge University Press, 2000) ch 2, Pt II and Conclusion; I Kennedy et al ‘The Case for “Presumed Consent” in Organ Donation’ (1998) 351 The Lancet 1650.

153. J M Kress ‘Xenotransplantation: Ethics and Economics’ (1998) 53 Food and Drug Law Journal 353.

154. Brownsword et al, above n 137, p 1.

155. H Auchincloss, reported in Carlton Television Organ Farm (Birmingham: Carlton Television, 2001) p 10.