News

The long awaited proposals for revision of the Human Fertilisation and Embryology Act were published today in the form of a white paper which contains proposals to revise the existing Act. The white paper also establishes the statutory basis and chronology for a new regulatory body (the Regulatory Authority for Tissue and Embryos, or RATE) to be formed out of the existing Human Fertilisation and Embryology Authority (HFEA) and the recently formed Human Tissue Authority (HTA). The revised body is likely to be smaller than the combined HFEA and HTA, but will be able to draw on Expert Advisory Panels which will provide technical assistance. The individuals on these panels will have no executive powers.

Many of the proposals for legislative reform of the Human Fertilisation and Embryology Act take account of scientific and societal developments since the law was passed in 1990. Other changes include proposals to bring domestic law into line with European legislation such as the European Tissue and Cells directives. The wide ranging proposals for legislative change include:

• Changes to definitions:
  • Widening the definition of ‘embryo’ to include all embryos outside the human body regardless of how they are created
  • ‘gametes’ will include ‘artificial’ gametes capable of performing the same functions as naturally occurring eggs and sperm


• Changes to remit:
  • regulation of a couple’s own gametes in fertility treatments that do not include storage of gametes or creation of an embryo outside the body
  • internet-based businesses supplying sperm for private self-insemination


• Welfare of the child:
  • Proposals to remove the reference to the need for a father from the Act


• Procedural changes:
  • Allowing gametes from a person lacking capacity to be stored without consent where it is likely that the person may regain capacity
  • A cooling off period for up to one year for the withdrawal of consent to embryo storage


• Grounds for screening and selecting embryos:
  • The revised Act will provide explicit grounds for the testing of embryos including screening out of genetic or chromosomal abnormalities which may lead to serious medical conditions or disabilities or miscarriage. Deliberate selection of an embryo affected by a disease or disorder will be prohibited
  • To enable a tissue match to be identified to treat a sibling suffering from a life-threatening illness
  • Sex selection for non-medical reasons will be prohibited


• Genetic modification of gametes and embryos:
  • Revised legislation will ban reproductive use of genetically modified embryos and gametes but for research purposes only, the restriction on altering the genetic structure of a cell while it forms part of an embryo will be removed
  • Explicit provision to facilitate basic embryo research (rather than applied research) including replacing the nucleus of a cell of an embryo and research into serious injuries (as well as diseases)
  • Although the creation of hybrid and chimera embryos in vitro are likely to be prohibited, the legislation will preserve a power for future enabling regulations


• Information governance:
  • Limited rights of donors and offspring to access information and widening the status and legal parenthood provisions of the HFEA

The revised legislation is likely to be introduced in draft form as a Bill published for pre-legislative scrutiny in the Parliamentary session 2007-8 and the revised regulatory body, RATE is likely to be operational from 2009.