DH consultation on regulations to implement HFEA Act 2008

15 January 2009

Following Royal Assent of the Human Embryology and Fertilisation Act 2008 in November, the Department of Health (DH) is currently conducting a three month consultation on draft regulations to implement the Act. Regulations and proposals have been made which fall into four broad categories:

  • The statutory storage period for embryos and gametes: regulations set out the circumstances in which embryos and gametes can be stored beyond the statutory period of 10 years. Amendments include providing for a maximum storage period (of 55 years) rather than imposing a limit of 55 years on the age of patients eligible for treatment.
  • The procedure for revocation, variation or refusal of licences: regulations set out the process for considering licence applications when the HFEA is minded to refuse, impose a variation to, or revoke a licence.
  • Appeals regulation: regulations set out the membership of, and procedures for, the Appeals Committee to reconsider licensing decisions made by the HFEA.
  • The disclosure of information for research purposes: regulations set out the procedure for applying for authorisation for the disclosure by the HFEA of identifying information to researchers. This includes creating an authorisation process by which identifying information can be accessed (and appropriate fee levied by the HFEA) where consent cannot be obtained from donors for the release of that information.

The consultation is aimed at gathering views on key principles of each set of regulations and the draft regulations themselves. The DH is aiming to bring most of the provisions of the Act into force by October 2009 following consideration of the any relevant regulations by Parliament in the summer. However, the provisions of the Act relating to parenthood will come into force earlier, in April whilst those relating to parental orders will commence in April 2010.

The British Fertility Society (BFS), along with a multidisciplinary working group, has also released new UK guidelines relating to laboratory procedure in the screening of sperm, egg and embryo donors in the UK (see press release). The recommendations update and combine in a single document guidelines that had previously been published by the British Andrology Society for sperm donors and the BFS for egg and embryo donors. They are aimed at protecting recipients of donor material as well as any donor conceived people from acquiring infections or serious heritable disorders from the donor. Along with the recommendation that donors should be assessed/screened for infectious diseases and inherited conditions, a new recommendation is the requirement to assess risk of prion-related diseases and the recommendation to screen for human lymphotropic viruses (HTLV) 1 and 2.

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