Abstract

In the UK, following many years of consultation and debate, Parliament passed the Human Fertilisation and Embryology Act in 1990. This introduced a system of detailed regulation of banks and clinics undertaking the storage and use of gametes and embryos in the UK. The law established the framework for the system and set up the Human Fertilisation and Embryology Authority (HFEA) to implement it from 1991. The HFEA is required to license and monitor centres which store or use donated gametes, and to provide them with guidelines in a Code of Practice. The Code of Practice contains guidance on practical clinical matters and also the HFEA's policy on a number of social and ethical issues. The regulatory system was set up to reassure the public, to protect the interests of potential children, patients and donors, and to promote good practice in fertility research and treatment. It works by consultation and cooperation between the HFEA and the scientists and clinicians being regulated, although sanctions do exist for use where needed. The HFEA is notable in regulating an area of medical practice in such a detailed way. It has established itself as an effective regulator and adviser, and has provided a basis for the development of policy in the field of fertility treatment.

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