Key laws and policies
- Human Reproductive Cloning Act (2001)
- Human Embryology & Fertilization Act (1990)
- Surrogacy Arrangement Act (1985)
The UK’s HFE Act delegated most policy decisions to the Human Fertility and Embryology Authority (HFEA), and contained only a few statutory prohibitions itself. They are:
- Placing a non-human embryo, or non-human gametes, in a woman
- Placing a human embryo in a non-human animal
- Keeping or using in vitro embryos after 14 days.
The original Act also banned "replacing a nucleus of a cell of an embryo with a nucleus taken from a cell of any person, embryo or subsequent development of an embryo," i.e., somatic cell nuclear transfer. However, in 2001 scientists voiced a desire to do this, and the Act was amended and the prohibition removed.
In 2003 the HFEA adopted an additional rule prohibiting: "altering the genetic structure of any cell, while it forms part of an embryo." This clause would prohibit human inheritable genetic modification as presently conducted in animals. But it would not prohibit inheritable genetic modification using the approach proposed by Ian Wilmut, in which stem cell nuclei are genetically modified and then used to create an embryo via somatic cell nuclear transfer.
HFEA also prohibits cash payment for egg donation (above expenses, including loss of earnings), however "benefits-in-kind such as reduced treatment costs" are permitted.
Permitted and regulated practices
Assisted reproductive practices explicitly permitted by the HFEA, and subject to licensing and regulation, are:
- Donor insemination
- Assisted fertilisation (IVF; GIFT; ICSI; ZIFT )
- Preimplantation genetic diagnosis & screening
- Assisted hatching (chemical, mechanical, laser; zona drilling & dissection)
- Storage of sperm, eggs, embryos, testicular tissue, ovarian tissue
- Egg sharing
- Sex selection
The HFEA also overseas research using human embryos. It allows embryonic stem cell research using surplus embryos, and explicitly allows embryos created via SCNT. Licenses can only be granted for embryo research:
- Promoting advances in infertility treatment
- Increasing knowledge about the causes of congenital disease
- Increasing knowledge about causes of miscarriage
- Developing more effective techniques of conception
- Developing methods for detecting the presence of gene or chromosome abnormalities in embryo before implantation
Surrogacy is allowed as long as commercial payments are not made to a third party.
The HFEA is responsible for these activities:
- Licensing and monitoring clinics that carry out in vitro fertilisation (IVF) and donor insemination
- Licensing and monitoring centres undertaking human embryo research
- Licensing and monitoring the storage of gametes and embryos
- Producing a Code of Practice which gives guidelines to clinics about the proper conduct of HFEA licensed activities
- Maintaining a formal register of information about donors, treatments and children born as a result of those treatments
- Providing relevant advice and information to patients, donors and clinics
- Reviewing information about human embryos, the provision of treatment services and activities governed by the HFEA Act.
- Monitoring any subsequent developments in this area and where appropriate, advising the Secretary of State for Health on developments in these field.
The UK has also established a Stem Cell Steering Committee (SCSC) that has the following responsibilities:
- Oversees the national stem cell bank and research involving stem cell lines
- Develops a Code of Practice for the bank and the use of stem cell lines
- Reports to the UK Medical Research Council and briefs Minister
Accountability and governance
The HFEA currently has 18 members, appointed by the UK Health Ministers (i.e. , the Ministers of Health for England, Scotland, Wales and No. Ireland). The HFE Act doesn’t set an upper limit on the size of the HFEA.
The HFE Act requires that “the Chair, Deputy Chair and at least half of the HFEA Members are neither doctors nor scientists involved in human embryo research or providing infertility treatment.”
The UK Stem Cell Steering Committee has 11 members, including ethicists, theologians, scientists, clinicians, lay members. The members are appointed by the UK Health Ministers. It meets 3 times a year. Researchers who want to conduct embryonic stem cell research must first apply to the HFEA for a license. Once licensed, they must be approved by the SCSC to get access to the stem cell lines themselves.
In January 2002 the UK Court of Appeals overturned the High Court decision of November 15, 2001 ruling that clones produced by cell nuclear replacement can be classified as embryos, thus coming under the regulations of the Human Fertilization and Embbryology Act of 1990 which allows creation of and research on embryos before the appearance of the primitive steark. Pursuant to the Act, a Code of Practice was produced by the HFEA, which permits embryo research for the following purposes:
- To promote advances in the treatment of infertility;
- To increase knowledge about the causes of congenital disease;
- To develop more effective techniques of contraception;
- To develop methods for detecting the presence of gene or chromosome abnormalitites.
In 2001, new regulations were made to allow creation of embryos for the following purposes:
- To increase knowledge about the development of embryos;
- To increase knowledge about serious disease;
- To enable any such knowledge to be applied in developing treatment for serious diseases.
- HFEA, "FAQs about donating eggs for research," accessed June 6, 2008