The regulation of reproductive technologies in the United Kingdom falls under the Human Fertilization and Embryology Act (HFE Act) (1990), which covers, among other techniques, in vitro fertilization and donor insemination, but does not address PGD or PND specifically. Under the HFE Act, consent from egg donors is required for the creation of embryos and for any purpose for which oocytes might be used. Under U.K. laws, access to reproductive genetic testing is available to couples (heterosexual or homosexual) as well as to single women. Any infringements of the HFE Act constitute a criminal act resulting in imprisonment, the imposition of fines, or the revocation of licenses.
Regarding PGD and PND, the U.K. has adopted a mixed public-private approach that implicitly permits the two procedures. The HFE Act created the HFE Authority (HFEA), a national regulatory agency with the power to issue licenses and monitor clinics that carry out reproductive genetic testing. Under its Code of Practice (2003), all research projects must seek approval from a “properly constituted ethics committee” before applying to the HFEA for a license. The HFEA Code of Practice also sets out minimum standards for centers performing genetic testing and requires that they limit their determination of carrier status to inherited recessive disorders.
The HFEA explicitly prohibits sex selection of embryos for social or cultural reasons as well as the use of sperm-sorting techniques for sex selection. In 2003 the HFEA published recommendations proposing that current legislation permitting sex selection to avoid sex-linked disorders should continue. It further recommended that gender selection through sperm sorting should be regulated in the U.K.
According to the Consultation Document of PGD (2000) of the HFEA and the Advisory Committee on Genetic Testing (ACGT), PGD is not acceptable for testing “social or psychological characteristics, normal physical variations, or any other conditions which are not associated with disability or a serious medical condition.” PGD should, however, be accessible to individuals who have a known family history of serious genetic disorders. Neither the HFEA nor the ACGT have adopted a list enumerating which conditions constitute “serious genetic disorders,” leaving clinical teams and patients to decide. Concerning fetal abnormalities, centers applying the Royal College of Obstetricians and Gynaecologists (RCOG)’s criteria for termination of pregnancy limit the use of PND to cases where there is precise diagnosis and “substantial risk” of “serious handicap.”
The Department of Health enacted the “Guiding Principles for Commissioners of NHS” which state the reasons for requesting PGD, including “patients with chromosomal disorders” and “couples at risk of transmitting serious genetic disorders to their offspring.” The principles recommend that priority be on cases where the risk of the offspring being affected by a disorder is greater than 10 percent.
The use of PGD to diagnose of late-onset disorders is permitted but should only be done after full genetic counseling, according to the ACGT and the Human Genetics Commission (HGC) (“Report on Genetic Testing for Late Onset Disorders,” 1998). The HGC also recently released recommendations encouraging additional research in order to make PGD safer and more effective while promoting long-term follow-up of children born after HLA matching (“Making Babies: Reproductive Decisions and Genetic Technologies,” 2006).
The House of Commons Science and Technology Committee on the HFEA Act recently released a controversial report (“House Report,” 2005) suggesting moving away from the current regulatory model. Recommendations included reducing state intervention in reproductive testing and changing legislation to allow sex selection for non-medical reasons.
In 2004 the HFEA conducted a review of its policy on pre-implantation tissue typing, concluding that PGD tissue typing should continue to be available, subject to appropriate safeguards and approval on a case-by-case basis in circumstances where there is a need for potentially life-saving tissue of therapeutic benefit for an affected child.
Finally, the aforementioned HGC in its 2006 report “Making Babies: Reproductive Decisions and Genetic Technologies” issued a series of recommendations for the improvement of the practice of PND and PGD in the U.K. The HGC recommends that efforts be made to develop screening techniques that do not reveal carrier status (unless it would compromise the reliability of the test or unless the information about the status is clinically important to the child’s health). The HGC also recommends that the HFEA Act be amended to permit more satisfactory and systematic follow-up of all children born following PGD, especially those children born after HLA matching, and that the Medical Research Council should support appropriate research.
- United Kingdom Parliament, The Human Fertilisation and Embryology Act 1990 (Chapter 37), 42: 1 Int. Dig. Hlth. Leg. 69 (1991).
- Advisory Committee on Genetic Testing - Human Genetics Commission, Code of Practice and Guidance on Human Genetic Testing Services Supplied Direct to the Public, (September 1997).
- Advisory Committee on Genetic Testing - Human Genetics Commission, Report on Genetic Testing for Late Onset Disorders, (July 1998).
- Human Fertilisation and Embryology Authority and Advisory Committee on Genetic Testing, Consultation Document on PGD, (2000).
- Nuffield Trust Genetics Scenario Project, Genetics and Health: Policy Issues for Genetic Science and their Implications for Health and Health Services, (May 2000).
- Advisory Committee on Genetic Testing - Human Genetics Commission, Prenatal Genetic Testing – Report for Consultation, (February 2000).
- Human Fertilisation and Embryology Authority, HFEA Code of Practice (6th edition), (2003).
- Human Fertilisation and Embryology Authority, Ethical Issues in the Creation and Selection of Preimplantation Embryos to Produce Tissue Donors, (December 2001).
- Human Genetics Commission, Response to the Human Fertilisation and Embryology Authority on the Consultation on Preimplantation Genetic Diagnosis, (March 2001).
- Human Genetics Commission, Human Fertilisation and Embryology Authority - Outcome of the Public Consultation on PGD, (November 2001).
- Department of Health, Prenatal Genetic Diagnosis, Guiding Principles for Commissioners of NHS, (September 2002).
- House of Commons, Developments in Human Genetics and Embryology, Fourth Report of Session 2001-02, (July 2002).
- Advisory Committee on Genetic Testing - Human Genetics Commission, Inside Information: Balancing Interest in the Use of Personal Genetic Data, (May 2002).
- Royal College of Obstetricians and Gynaecologists, Report of the RCOG Working Party on Biochemical Markers and the Detection of Down's Syndrome, (2003).
- Human Fertilisation and Embryology Authority, Sex Selection: Options for Regulation, (2003).
- Human Fertilisation and Embryology Authority, Preimplantation Tissue Typing, (2004).
- House of Commons Science and Technology Committee, Inquiry into Human Reproductive Technologies and the Law, Eighth Spec. Rep. Sess. 2004-2005. London: The Stationary Office Limited (2005).
- Human Genetics Commission, Making Babies: Reproductive Decisions & Genetic Technologies, (2006).
- Human Fertilisation and Embryology Authority, Statement on use of Preimplantation Genetic Diagnosis (PGD) for inherited cancer susceptibility, (May 2006).
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