Present LegislationStem Cell Research

The Human Fertilisation and Embryology (HFE) Act 1990 established the first official legislation regarding embryo research.

In their consideration of the initial laws governing the area, the Human Fertilisation and Embryology Authority (HFEA) centred its rulings on two key principles:

  1. That respect is due to embryos from fertilisation but up until the development of the primitive streak (at approximately Day 14) the potential benefits that can be derived from embryo research outweigh the interests of the embryo. From Day 14 however, full rights of protection are granted to the embryo.

  2. The need to relieve public fears of a future of scientists being given free reign to create clones, hybrids and other such creatures.

Subsequently, the 1990 Act ruled that it was an offence punishable by up to two year imprisonment for any embryo to be kept and/or experimented upon beyond the appearance of its primitive streak or beyond 14 days after the gametes were mixed, depending on which occurs first. The ‘14 days’ are deemed to begin upon the day which the process of creating the embryo first occurs and not any time during which the embryo is stored.

Other practices expressly forbidden include:

  • The implantation of human embryos or gametes in to animals (or visa versa)

  • Trans-species fertilisation (the creation of human-animal hybrids). (The only exception to this being the ‘hamster test’ used to establish more effective techniques for determining the fertility or normality of sperm. All hybrids formed in this process however, must be destroyed when the research is complete and not allowed to develop beyond the two cell stage).

Subsequent revisions to the Act have upheld these rulings, including the most recent 2008 Act, due to become law as of October 1st 2009.

However, the original act expressly forbade the creation of human admixed embryos due to fears regarding their use to enable cloning. With the development of CNR and creation of Dolly in 1997 however, the HFEA in conjunction with the Human Genetic Advisory Commission (HEAC) reviewed this ruling upon the consideration that the 1990 Act covered the creation of such embryos via the removal of a cell taken from a person or embryo. The advent of CNR, however, enabled the removal of a nucleus from an egg cell and therefore did not require any involvement of cells from pre-existing embryos. The parties also considered the perceived potential benefits that therapeutic cloning/stem cell therapy could offer.

Following approval by the Chief Medical Officer in 2000, regulations to permit stem cell therapy were approved by parliament in January 2001 in the form of the Human Reproductive Cloning Act 2001. The 2008 HFE Act therefore permits the creation, storage and use of human admixed embryos in vitro “for the purposes of a project of research specified in the licence.” Reproductive cloning, including any attempt to transfer such an embryo to the womb of a woman, remains expressly forbidden.

The 1990 Act specifies that research licences may be issued for one of five specific reasons:

  1. Promoting advances in the treatment of infertility

  2. Increasing knowledge about the causes of any congenital disease or congenital medical condition (with certain specific exceptions)

  3. Increasing knowledge about the causes of miscarriage

  4. Developing more effective techniques of contraception

  5. Developing methods for detecting the presence of gene, chromosome or mitochondrion abnormalities in embryos before implantation

The 2001 regulations to enable stem cell therapy also added the following reasons as suitable for the issue of a research licence:

  1. Increasing knowledge about the development of embryos

  2. Increasing knowledge about serious disease or other serious medical conditions

  3. Developing treatments for serious disease or other serious medical conditions

All eight conditions have been upheld in the most recent Act (2008)