Abstract
Over 50,000 babies have been born by IVF in Britain alone since 1990. The issues arising are not simply ones of sience and medicine. People have quite rightly become very concerned about what the scientific possibilities are; they are more concerned today about ethicalissues than they were 10 years ago, and particularly so in the wake of the publicity surrounding the completion of the Human Genome Project and its potential. While recognising the benefits that scientific developments can bring to individuals, people are anxious about the effects on society as a whole, and fearful for the integrity of humanity. Uniquely in medicine, and almost uniquely in the world, social and legislative controls have been put in place by society over the way in which this field of medicine develops. The British Parliament recognised the mood of anxiety when in 1990 it passed the Human Fertilisation & Embryology Act which set up the Human Fertilisation & Embryology Authority (HFEA) to regulate certain assisted conception practices. In 1991 the HFEA took up its task of regulating research using human embryos, the storage of gametes and embryos and the use in treatment of donated eggs and sperm and of embryos produced outside the human body. As a regulatory body, much of the HFEA's work relates to the inspection and licensing of clinics carrying out IVF and research. The 21 members of the HFEA (and the 35 permanent staff) ensure that embryos are used responsibly and that infertile patients are not exploited at a vulnerable time. The HFEA grants research licences for certain purposes relating to infertility, but recently Parliament has permitted embryo research to extend to projects, including therapeutic cloning, intended to treat serious disease of all natures. The HFEA keeps a database of all treatments, successful or not, involving IVF, Dl and ICSI. It gives advice to government and to the patients. It regulates clinics through annual inspection and a Code of Practice. It monitors and licences new treatments, often after consultation with the public. It ensures that the legal requirement that the welfare of the potential child be considered before treatment is fulfilled. The HFEA meets 9 times a year, publishes an Annual Report and holds an annual open meeting. It applies ethical considerations in deciding whether a new treatment should be permitted. In 1998 the HFEA recommended that the permitted purposes of embryo search be extended to "ther-apeutic cloning", that is cloned embryos could be allowed to be kept for no more than 14 days outside the body with a view to procuring stem cells from them, which might one day yield new tissues for the body which would not be rejected by the patient because they would match him genetically. Reproductive cloning is and should remain banned. After a lively national and parliamentary debate, Britain legalised in January 2001 the use of embryos for research into serious disease. The research is to be licensed and monitored by the HFEA, adapting the processes already used for testing research proposals. The HFEA is concerned about controls being bypassed by scientists travelling abroad, and would welcome more international agreement about cloning, research and treatment regulation in the interests of safety and ethics.
