It is not possible to review all legislation and policy recommendations throughout the world, but two early initiatives are of particular interest. They come from countries that share a common law tradition with the United States, Australia (Victoria), and the United Kingdom.
AUSTRALIA (VICTORIA). The earliest comprehensive legislation on reproductive technologies was enacted in the State of Victoria, Australia in 1984. The Infertility (Medical Procedures) Act addressed embryo research by prohibiting research that might damage the embryo or make it unfit for implantation. This prohibition appeared to outlaw any IVF or embryo research that was not directed toward benefiting each individual embryo.
In 1986 the review committee established by the act received a proposal for research on the microinjection of a single sperm into an egg. In their application the investigators suggested a novel approach for circumventing the prohibition on embryo research. They proposed to examine the egg after the sperm had penetrated it, but before the genetic contributions of the sperm and egg had fused at the stage known as syngamy. Arguing that fertilization was not completed until syngamy had occurred, researchers claimed that the law did not apply until the time of syngamy, thus giving them approximately twenty-two hours after sperm penetration for conducting their studies.
Since the review committee was uncertain as to whether the 1984 act allowed this interpretation, it recommended that the act be amended to clarify that research was permissible if it ended by the time of syngamy, even if the research destroyed the embryo's potential for implantation. The act was amended according to this recommendation in 1987.
UNITED KINGDOM. The issue of the regulation of reproductive technologies and embryo research was particularly pressing in the United Kingdom because of the publicity given to the birth of Louise Brown in England in 1978. The Warnock Committee was appointed to study the matter, and its 1984 report recommended national regulation of assisted reproduction. It also recommended that research on embryos resulting from IVF be permitted up to the fourteenth day after fertilization, under the jurisdiction of a licensing body.
Based on the Warnock Report, the Human Fertilisation and Embryology Act (HFE Act) of 1990 commissioned a standing body, the Human Fertilisation and Embryology Authority (HFEA), to develop standards for licensing clinical facilities and research protocols, and mechanisms for auditing and oversight. Initially research protocols were restricted to the study of infertility, the causes of congenital diseases, and the detection of gene or chromosome abnormalities in embryos.
Since its establishment in 1991 the HFEA has addressed new types of procedures and research through public consultation processes as well as the advice of experts. If a matter was beyond the scope of authority of the HFEA, it was referred to Parliament. In January 2001 Parliament extended the HFE Act to permit embryo research directed at increasing knowledge about treatments for serious diseases. This provision would allow the HFEA to issue licenses for research on embryonic stem cells, including stem cells derived from blastocysts resulting from somatic cell nuclear replacement (SCNR). However, the Pro-Life Alliance brought a challenge to this provision, arguing that the HFE Act applied only to embryos resulting from the fertilization of eggs by sperm. Despite a Court of Appeal ruling against the Pro-Life Alliance, in June 2002 the House of Lords agreed to hear a final appeal of the case. In March 2003 the House of Lords ruled that the HFE Act applied to all types ofembryos, and hence the HFEA had authority over research with embryos created by nuclear transfer as well as embryos resulting from fertilization by sperm.
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