Xenotransplantation - Nuffield Council on Bioethics

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Animal-to-Human Transplants : the ethics of xenotransplantation Convention and patents are granted by the European Patent Office. In 1992, the European Patent Office granted a patent for the Harvard Oncomouse, a transgenic mouse strain that has been genetically modified so that it has a predisposition to cancer. The decision provoked widespread protests from animal welfare and environmentalist groups and the European Patent Office has heard evidence relating to 17 different appeals against the patent. 41 The verdict on the appeals is still awaited. At the same time, the European Commission is trying to clarify the situation with a directive that would allow patents on genetically altered animals and plants. 42 The directive has been submitted to the <strong>Council</strong> of Ministers and the European Parliament for their approval, but a similar directive has previously been rejected by the Parliament. 4.54 A detailed discussion of the ethics of patenting transgenic animals lies outside the scope of this report. The issues have been examined in some detail in a previous report of the <strong>Nuffield</strong> <strong>Council</strong> on Bioethics, and elsewhere. 43,44 Proposals to patent transgenic pigs produced for xenotransplantation would increase the debate about the morality and legality of patenting transgenic animals. This adds force to the recommendation of the <strong>Nuffield</strong> <strong>Council</strong> in their previous report “that the Government joins with other member states of the European Patent Convention (EPC) in adopting a protocol to the EPC which would set out in some detail the criteria to be used by national courts when applying the immorality exclusion to patents in the area of human and animal tissue.” 43 41 Oncomouse hearing ends up in confusion (1995) Nature, 378:427. 42 European proposal reopens debate over patenting of human genes (1995) Nature, 378:765. 43 <strong>Nuffield</strong> <strong>Council</strong> on Bioethics (1995) Patent Issues, Chapter 11 in Human Tissue : Ethical and Legal Issues. 44 National Academies Policy Advisory Group (1995) Intellectual Property & the Academic Community. 56
Animal concerns : practice Chapter 5 Animal concerns : practice 5.1 In Chapter 4 the principles underlying the use of animals for medical purposes in general, and for xenografting in particular, were discussed. The Working Party concluded that the use of transgenic pigs as a source of organs for xenotransplantation was ethically acceptable, provided animal welfare was a high priority. Much stronger ethical concerns are raised by the proposed use of primates to supply organs. The Working Party concluded that non-primate species should be regarded as the source animals of choice for xenotransplantation, but it considered the use of small numbers of primates for research purposes during the development of xenografts was ethically acceptable. In all cases, great attention should be paid to the welfare of any animals used. This chapter looks at the practical implications of these conclusions. The relevant areas of concern are: the care of primates used in xenotransplantation research; the production and care of transgenic pigs; the production of transgenic pigs free from infectious organisms; and the removal from transgenic pigs of tissues and organs for xenotransplantation. In the UK, the use of animals for experimental or other scientific purposes is regulated by the Animals (Scientific Procedures) Act 1986. This chapter describes the protection given to animals by the 1986 Act, and assesses how far it would cover the use of animals for xenotransplantation. The need for any changes is discussed. Animals (Scientific Procedures) Act 1986 5.2 The Animals (Scientific Procedures) Act 1986 (hereafter called the 1986 Act) and its associated Guidance and Codes of Practice controls the use of animals for scientific purposes in the UK. 1 An animal is defined as any living vertebrate (including fetuses more than 50 per cent of the way through gestation) and one invertebrate - 1 Home Office Guidance on the Operation of the Animals (Scientific Procedures) Act 1986. London: HMSO 182 (1990). Home Office Code of Practice for the Housing and Care of Animals in Designated Breeding and Supplying Establishments. London: HMSO (1995). Home Office Code of Practice for the Housing and Care of Animals Used in Scientific Procedures. London: HMSO 107 (1989). 57
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NUFFIELD COUNCIL ON BIOETHICS Anima
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Preface Preface Since the N
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Table of contents Table of contents
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Working Party on Xenografts Working
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Summary of recommendations Summary
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Summary of recommendations Effects
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The promise and the problems Chapte
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Xenotransplantation - Nuffield Council on Bioethics

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