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
- 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.
- Commercial surrogacy is prohibited.
- It is unlawful for intending parents to advertise for a surrogate, or for a woman to advertise a willingness to become a surrogate.
- The Surrogacy Arrangements Act 1985 s.2(1) prevents a third party (though not a surrogate or intending parents) from initiating or taking part in negotiations, offering or agreeing to negotiate, or compiling any information with a view to its use in making, or negotiating the making of, surrogacy arrangements.
Permitted and regulated practices
Assisted reproductive practices explicitly permitted by the HFEA, and subject to licensing and regulation, are:
- Donor insemination
- Assisted fertilization (IVF, GIFT, ICSI, ZIFT)
- Preimplantation genetic diagnosis and screening
- Assisted hatching (chemical, mechanical, laser, zona drilling and dissection)
- Storage of sperm, eggs, embryos, testicular tissue, and 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 embryos 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 fertilization (IVF) and donor insemination
- Licensing and monitoring centers 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 and 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 fields
The UK has also established a Stem Cell Steering Committee (SCSC) that has the following responsibilities:
- Oversee the national stem cell bank and research involving stem cell lines
- Develop a Code of Practice for the bank and the use of stem cell lines
- Report to the UK Medical Research Council and brief 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, and lay members. The members are appointed by the UK Health Ministers. The SCSC 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 Embryology Act of 1990 which allows creation of and research on embryos before the appearance of the primitive streak. 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 abnormalities.
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