Xenotransplantation - Nuffield Council on Bioethics

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Summary of recommendations Summary of recommendations <strong>Xenotransplantation</strong> raises a particularly wide range of concerns about which people have differing and strongly held views. The Working Party has concluded that the development of xenotransplantation should continue subject to rigorous regulation to ensure protection for potential human recipients and care for animal welfare. The recommendations of the Working Party are as follows: Animal concerns: principles 1 The Working Party endorses the special protection afforded to primates used for medical and scientific purposes (paragraph 10.9). Non-primate species should be regarded as the source animals of choice for xenotransplantation (paragraph 10.12). 2 The use of pigs for the routine supply of organs for xenotransplantation is ethically acceptable (paragraph 10.14). The use of transgenic pigs that have been genetically modified to reduce the human immune response to pig organs is also ethically acceptable (paragraph 10.15). Animal concerns: practice 3 The Home Office should require that all animals used for xenotransplantation are protected under the Animals (Scientific Procedures) Act 1986 (paragraph 10.23). Thus, the standards set by the 1986 Act should become the minimum for the industry (paragraph 10.23). The convention by which the Animal Procedures Committee advises on project licences in difficult areas should extend to applications for the use of animals for xenotransplantation (paragraph 10.18). 4 When decisions are made about the acceptability of using animals for xenotransplantation, particular attention should be paid to reducing the adverse effects associated with the need to produce animals free from infectious organisms (paragraph 10.21). The Animals (Scientific Procedures) Act should continue to be interpreted as prohibiting sequential removal from animals of tissues or organs for transplantation (paragraph 10.22). Transmission of infectious diseases 5 The risks associated with possible transmission of infectious diseases as a consequence of xenotransplantation have not been adequately dealt with. It would not be ethical therefore to begin clinical trials of xenotransplantation involving human beings (paragraph 10.25). viii
Summary of recommendations 6 A code of practice should be drawn up specifying which organisms should be excluded from specified-pathogen free animals. <strong>Xenotransplantation</strong> teams should be required to exclude from source animals all the pathogens listed in the code of practice (paragraph 10.27). A regulatory framework should be devised to control the safety and quality of animal organs and tissue for xenotransplantation (paragraph 10.27). 7 Standards and mechanisms for monitoring xenograft recipients and for the action to be taken in case of disease transmission should be in place before human trials begin. It should be a requirement of clinical trials that the need for monitoring is explained to the patient and that it is made clear that consent to the operation also implies consent to subsequent monitoring (paragraph 10.28). <strong>Xenotransplantation</strong> teams should be required to record all information concerning individual xenograft recipients in a xenotransplantation register maintained by an independent body (paragraph 10.29). 8 The Working Party recommends that the Department of Health should establish an Advisory Committee on <strong>Xenotransplantation</strong> (paragraph 10.31). Early patients 9 No xenotransplantation trials involving human recipients should proceed until the proposed Advisory Committee on <strong>Xenotransplantation</strong> is in place and has approved the trials (paragraph 10.32). Consent of patients to participation in xenotransplantation trials should be sought by appropriately trained professionals who are independent of the xenotransplantation team. The information given to prospective recipients should include an estimation of likely success, attendant risks and subsequent quality of life (paragraph 10.34). No protocol to conduct a trial should be accepted unless it contains a commitment to a robust description and assessment of the patient’s pre-operative and post-operative quality of life (paragraph 10.35). 10 The first xenotransplantation trials should involve adults rather than children (paragraph 10.36). The first xenotransplantation trials should not involve adults incapable of consenting to participation on their own behalf (paragraph 10.38). 11 At any stage in the development of xenotransplantation, patients who, for whatever reasons, refuse xenografts should remain entitled to consideration for human organs on the same basis as before their refusal (paragraph 10.40). Xenograft recipients should remain entitled to consideration for human organ transplantation on the same basis of clinical need as before xenotransplantation (paragraph 10.41). ix
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Xenotransplantation - Nuffield Council on Bioethics

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