Legal Regulation and Xenotransplantation

In 2011, Human tissue on November 11, 2011 at 6:08 pm

The Nuffield Council on Bioethics report on Human Bodies: donation for medicine and research suggested that the initial promise of xenotransplantation has yet been realised, partly because of concerns over the risk of gene transmission (para 3.43) but that its future use should not be discounted. The regulation of Xenotransplantation has become less visible since the UK Xenotransplantation Interim Regulatory Authority (UKXIRA) was disbanded in 2006. Guidance on Xenotransplantation was issued by the Department of Health that expects Research Ethics Committees to oversee such activity. The latest guidance on research governance procedures came into effect on 1 September 2011. The Gene Therapy Advisory Committee had been responsible for licensing decisions on xenotransplantation of animal cells (but not solid organs) until June 2011, when this role transferred to the National research Ethics Service (NRES). In due course, the NRES will become part of the body established under the Health Research Authority (Establishment and Constitution) Order 2011 and  Health Research Agency Regulations 2011, as recommended by a  report of the Academy of Medical Sciences.These regulations come into force on 1 December 2011. The Academy has also recently published a report on issues raised by animals containing human material. According to the MRC, trials of xenogenic cell therapy must comply with the Advanced Therapy Medicinal Product Regulations (EC) No 1394/2007. Hazel Biggs has also drawn attention to the conundrum of consent in this area of uncertainty, see Healthcare Research Ethics and Law at page 90. Perhaps it is time to revisit this area of legal regulation.

  1. […] 199os when both the Department of Health and the Nuffield Council on Bioethics undertook work on Xenotransplantation. Advertisement GA_googleAddAttr("AdOpt", "1"); GA_googleAddAttr("Origin", "other"); […]

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