The U.K. Human Fertilisation and Embryology Authority. How it has contributed to the evaluation of assisted reproduction technology

Int J Technol Assess Health Care. Winter 1999;15(1):3-10. doi: 10.1017/s0266462399015123.


The Human Fertilisation and Embryology Act of the United Kingdom was passed in 1990, leading to the formation of the Human Fertilisation and Embryology Authority (HFEA), the first statutory body to regulate and control assisted conception anywhere in the world. The principal function of the HFEA is to license and monitor clinics that carry out in vitro fertilization (IVF), donor insemination (DI), and embryo research. Information on over 135,000 treatment cycles, 20,000 pregnancies, and 25,000 babies following IVF has now been collected as part of the regulatory process, and these data have permitted unbiased and accurate evaluation of treatment efficacy using pregnancy and live-birth rates. The treating clinics are required by law to provide information on the outcome of all births, including neonatal mortality and congenital malformations, but there is no systematic validation of these data using medical records or any follow-up of treated women, or babies, over time. In addition, the strict confidentiality of data supplied to the HFEA means that outside researchers have been unable to access the database for research projects. Thus, at the present time, it is not possible to evaluate the long-term safety of assisted conception procedures using HFEA data. There is reasonable scientific evidence to justify full investigation of the health of both treated women and resulting children. Particular health outcomes requiring evaluation include obstetric complications, preterm births, cerebral palsy, and cancer. The HFEA has recognized the need for follow-up studies and is currently investigating ways of enabling research projects using HFEA data to be undertaken.

MeSH terms

  • Congenital Abnormalities / epidemiology
  • Female
  • Government Regulation
  • Humans
  • Infant Mortality
  • Infant, Newborn
  • Male
  • Pregnancy
  • Pregnancy Outcome
  • Reproductive Techniques / legislation & jurisprudence*
  • Reproductive Techniques / statistics & numerical data
  • Risk Assessment
  • Technology Assessment, Biomedical* / statistics & numerical data
  • United Kingdom / epidemiology