This topic was discussed at the Council's October
2002 meeting. This background paper was prepared by staff
solely to aid discussion, and does not represent the official views
of the Council or of the United States Government. |
Staff Background Paper
On the British Regulatory System
1. The structure of the British system
The United Kingdom has a large and complex system of regulatory and advisory bodies that deal with issues of biotechnology, biomedical research and human genetics. These include the Human Genetics Commission, the Gene Therapy Advisory Committee, the Genetics and Insurance Committee, the Agriculture and Environment Biotechnology Commission, National Institute for Clinical Excellence, The Committee on Safety of Medicines, the Xenotransplantation Interim Regulatory Authority, and the Human Fertilisation and Embryology Authority. These agencies act, together and separately, to advise the government on policy regarding medicine and biotechnology and to regulate these fields, where authorized by law. The attached document ("The UK Regulatory and Advisory Framework for Human Genetics") contains further details on the system and its parts.
On questions of human genetics and reproductive medicine and research, the two key bodies are the Human Genetics Commission (an advisory body) and the Human Fertilisation and Embryology Authority (a regulatory body.)
2. The Human Genetics Commission (HGC)
The HGC was established following a comprehensive government review of the regulatory and advisory framework for biotechnology, conducted in 1999. The review concluded that while the regulatory system operated well, the advisory system needed to be redesigned. The Human Genetics Commission was a product of this redesign.
Part of the mission of the HGC is to help form links between the assorted regulatory and advisory bodies that have some say over human genetic research and technology. The HGC does not have any power over these other agencies, and none of them report to the HGC, but it attempts to act as a clearinghouse for information, to identify problems and gaps in the overall regulatory and advisory system, and to serve as the government's chief advisory body on the "big picture" issues involved, and on new developments.
The Commission assesses new developments to advise the government on their impact on health care as well as their social, ethical, legal and economic implications. It also offers recommendations for the utilization of technologies by the UK National Health Service, and attempts to suggest priorities for scientific research. It therefore addresses itself not only to the government, but also to the medical and scientific communities.
The Commission generally has approximately 20 members, as well as several "co-opted" members, who serve on sub-groups but not the main Commission. The chair of the HFEA has an automatic seat on the HGC, as do representatives of the Chief Medical Officers of England, Scotland, Wales and Northern Ireland. All other members are appointed by the government, and are selected for their own expertise and not (officially) as representatives of any group.
Much of the Commission's work to this point has focused on the collection, handling and availability of genetic information, and its impact on privacy, employment, insurance and forensics. They have also begun a project assessing the use of preimplantation genetic diagnosis, which has so far resulted in several interim reports, mostly presenting arguments pro and con and discussing public attitudes and comments. They have recommended that PGD be limited to "specific and serious conditions," and should not be used for positive trait selection or for purposes that could be understood as eugenic in nature.
The HGC may be of special interest to our Council because of its role and experience as an advisory body, and because it has been asked to provide advice to the government on the structure and functioning of the regulatory system in place to oversee genetic research and medicine.
3. The Human Fertilisation and Embryology Authority (HFEA)
The HFEA was established by the Human Fertilisation and Embryology Act of 1990, following the recommendation of the Warnock Committee that 6 years earlier had called for establishing a statutory agency to regulate IVF and embryo research. The HFEA was charged with licensing and monitoring clinics and labs that conduct assisted reproduction and embryo research. It also regulates the storage of gametes and embryos; produces and updates a code of conduct for licensed labs and clinics; and maintains a database of donors, treatments and births in the assisted reproduction industry.
The Authority consists of 21 members, appointed by the government, and selected for their personal expertise and not as representatives of any groups. The law requires that more than half of the members must come from disciplines other than medicine or human embryology. A staff of inspectors and researchers carries out the decisions of the 21-member authority and enforces its rules and regulations.
(a) Assisted Reproduction
The regulation of assisted reproduction clinics is among the Authority's chief purposes. Its rules and regulations are made public in the form of a "Code of Practice" which includes rules and instructions on the selection and screening of sperm donors; payment of expenses to donors; legal requirements for consent; handling and use of gametes and embryos; required staff and facilities; the availability of information and counseling; and the welfare of the child-to-be. This last category, the welfare of the child, has been especially controversial. The law requires clinics to provide assisted reproduction treatments only after "account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for a father), and of any other child who may be affected by the birth." In interpreting this statute, the HFEA has required clinics to consider "the prospective parents' ages and their likely future ability to look after, or provide for, a child's needs, and any risk of harm to the child or children who may be born. Where the child will have no legal father, clinics must pay particular attention to the prospective mother's ability to meet the child's needs throughout its childhood." The HFEA does not usually become involved in individual cases and decisions, but it ensures that the necessary process is correctly followed by each clinic. A clinic that fails to follow the Code of Practice can have its license revoked. The code of practice is now in its fifth edition, and a sixth is expected in the spring of 2003. Each amended edition must be approved by the Ministry of Health.
License applications for assisted reproduction clinics are considered by a licensing committee made up of five members of the HFEA. In granting licenses, these committees may attach specific conditions and requirements, which can differ for each clinic. New clinics are licensed for one year, but after two years without violations, a clinic can be granted a three-year license. The Authority regularly inspects licensed clinics to assure compliance with the code of practice and license conditions. When violations of HFEA rules are found, the Authority can revoke the clinic's license and in certain cases even refer the case for criminal prosecution.
(b) Embryo Research
The regulation of embryo research is an additional important purpose of the Authority. Any research project involving the creation, keeping or using of human embryos outside the body must be licensed by the HFEA. Before 2001 the HFEA could grant licenses for research projects only for five specified purposes: promoting advances in the treatment of infertility; increasing knowledge about the causes of congenital disease; increasing knowledge about the causes of miscarriages; developing more effective techniques of contraception; or developing methods for detecting the presence of abnormalities in embryos before implantation. In January 2001 Parliament passed regulations extending the purposes for which research licenses may be authorized to include increasing knowledge about the development of embryos; increasing knowledge about serious disease; and enabling any such knowledge to be applied in developing treatments for serious disease. The range of permitted human embryo research is therefore quite broad, though the HFEA does require proof that the use of human embryos is essential to the project in question before permitting it.
Applications for research licenses are considered by a peer-review committee that considers whether the proposed research falls under the permitted purposes; the potential importance of the research to the particular field; whether the research has previously been undertaken elsewhere; whether the use of human embryos is justified in furthering knowledge in the field; the suitability of the methods to be used for achieving the stated aims of the research; the suitability of the proposed length of the study; and the suitability of the applicant's qualifications and professional background to undertaking research on
human embryos. Researchers in approved projects are required to keep the HFEA regularly informed of their work, and may be subject to inspections. As of the summer of 2001, the HFEA had received 135 applications for research licenses since 1991. Of these, 115 were granted.
As of 2001, British law and HFEA rules prohibited five specific research practices: keeping or using an embryo after the appearance of the primitive streak or after 14 days, whichever is the earlier; placing a human embryo in an animal; replacing the nucleus of a cell of an embryo with a nucleus taken from the cell of another person, another embryo, or a subsequent development of an embryo; altering the genetic structure of any cell while it forms part of an embryo; and using embryos for any other purposes not explicitly licensed by the HFEA.
Most recently, the HFEA has begun to take up questions of preimplantation genetic diagnosis (which it permits on a limited scale); human cloning-to-produce-children (which it prohibits, since Parliament passed a specific prohibition in 2001 after the applicability of the 1990 law was challenged); human cloning-for-biomedical-research (which it permits, in accordance with an act of Parliament); the number of eggs or embryos that may be transferred in IVF procedures; and the provision of free or subsidized IVF treatments for women willing to donate surplus eggs created by such procedures.
The HFEA remains nearly unique as a regulatory agency whose work is centered on the human embryo. With a decade of experience, it may have a great deal to teach us about the ways in which assisted reproduction and embryo research may or may not be monitored and regulated.