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August 11, 2010

U.K. Government to Dissolve Stem Cell Research Regulators and Transfer Functions to New Agency

by Ubaka Ogbogu

The U.K. Government has announced plans to dissolve the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) – two independent regulators primarily responsible for stem cell research oversight in the U.K. – and to transfer their functions to a new yet-to-be-named research regulator. The HFEA was created under the 1990 Human Fertilisation and Embryology Act to independently regulatte and monitor the use of gametes and embryos in fertility treatment and in research. Its role therefore includes oversight of stem cell research activities involving the use of gametes and embryos. The HTA provides guidance on the implementation of U.K. and European Union (EU) legislation designed to ensure the safe and ethical use of human tissues (other than gametes and embryos), and is primarily responsible for licensing and inspecting institutions that store and use human tissue for research, treatment, teaching and other purposes. The changes are expected to take effect on or before June 2015, and are part of an extensive review of “arm’s length bodies” (ALBs) – independent national organizations undertaking executive functions under the auspices of the Department of Health (DH) – that began in 2004. The HFEA and HTA are both ALBs. For details of the review of ALBs, see here and here.

According to the DH report announcing the changes, the rationales for the reforms are to establish a resilient and coherent regulatory system by “placing responsibility for…different aspects of medical research regulation within one arm’s-length body” and to “streamline the process of gaining permission to undertake medical research, making it more attractive to universities and health institutions.” Both rationales suggest that the era of heightened or special regulatory focus on gamete, embryo and tissue research may be coming to an end. However, it is important to note that the U.K. oversight system for stem cell research has been an exemplary model of science governance; one that has adapted well to the social and scientific twists and turns in the regulatory lifecycle of stem cell research. In 2008, the U.K. Parliament revised and updated the legislation governing the regulation and licensing of the use of embryos in research, thus bringing it into conformity with improved research knowledge. A variety of legislation, directives and codes of practice have been established for effective regulation of tissues, cells, gametes and embryos, and to ensure harmonization with EU-wide regulatory initiatives. The HFEA is by far the greatest success story of the U.K. regulatory system – the institution has been very responsive to regulatory tasks and demands, and has responsibly managed the various contesting interests jostling for recognition in the world of stem cell research regulation. By contrast, Canada’s gamete and embryo research legislation has not been updated since its enactment in 2004 (a stipulated Parliamentary review expired in 2009), there have been few significant updates to our stem cell research oversight policies, and the national agency charged with licensing and monitoring research has been largely stagnant and ineffective.

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