Disagreements over ethical issues what ought individuals and societies do with regard to certain practices often evolve into political and legal disputes what should individuals and societies be allowed to do. Such has been the case in the debate over stem cell research. Governments around the world are now trying to decide how, if at all, they should attempt to monitor and control research on stem cells.
GREAT BRITAIN
Probably the earliest attempt to deal with bioethical issues that would later arise in the stem cell debate took place in Great Britain in the early 1980s. Questions as to the status of the human embryo and how it should be treated in scientific research came about shortly after and as a result of the birth of the first baby born as a result of in vitro fertilization, Louise Brown, in 1978. Parliament appointed a committee in July 1982 Уto examine the social, ethical, and legal implication of recent, and potential developments in the field of human assisted reproduction.Ф The committee was chaired by Dame Warnock and is, therefore, generally known as the Warnock Committee, and its final report as the Warnock Report.
The major recommendation of the committeeТs 103-page report, issued in July 1984, was that research should be permitted on human embryos during a period up to 14 days after fertilization, provided a number of conditions were observed. The committee also recommended the establishment of a supervisory body to monitor all such research in the country. Parliament was somewhat slow in acting on the Warnock CommitteeТs recommendation, but eventually passed the Human Fertilisation and Embryology Act in 1990, essentially adopting the committeeТs major recommendations. The act also created the Human Fertilisation and Embryology Authority (HFEA) to regulate in vitro fertilization and experimentation on human embryos. HFEAТs charter restricted it to the approval of activities that fall into one of six categories:
1. promoting advances in the treatment of infertility;
2. increasing knowledge about the causes of congenital disease;
3. increasing knowledge about the causes of miscarriages;
4. developing more effective techniques for contraception; and
5. developing methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation; or
6. for such other purposes as may be specified in regulations.
The Human Fertilisation and Embryology Act had been in force for only a relatively short period of time before scientific developments began to raise new issues regarding the cloning of human embryos. One of the most significant of those developments was the cloning of a sheep, named Dolly, in 1996, by scientists at the Roslin Institute in Scotland under the direction of Ian Wilmut. Dolly was conceived by somatic cell nuclear transfer (SCNT), a form of reproduction not envisioned by the Warnock committee, not mentioned in its report, and hence not specifically covered by the Human Fertilisation and Embryology Act.
The birth of Dolly prompted the British government to take two additional actions to handle new issues raised by SCNT. First, the HFEA and the governmentТs Human Genetics Advisory Commission (HGAC) undertook a review of the governmentТs position on human cloning, requesting input from the scientific community and the general public. As a result of this review, the HFEA and HGAC recommended, among other things, that the Secretary of State for Health should add two new fields of research for which the HFEA might issue licenses: the development of treatments for mitochondrial disease and the development of treatments for diseased or damaged tissues or organs.
The government also created a new advisory committee in September 1999 under the chairmanship of Sir Liam Donaldson, the nationТs Chief Medical Officer. The committee was charged with reviewing developments in the field of in vitro fertilization and other kinds of assisted reproduction, determining potential benefits and risks of these developments, and recommending changes in the Human Fertilisation and Embryology Act of 1990 to meet these new findings. The report of the Donaldson committee, issued in June 2000, is important, among other reasons, because of its specific and detailed consideration of the growing significance of stem cell research, a topic that earlier committees had largely not had to deal with.
The Donaldson report agreed in principle with the governmentТs existing position on embryonic research, as expressed in the Human Fertilisation and Embryology Act of 1990 and the policies adopted by the HFEA. It did make nine recommendations for changes in these policies, most notably the addition of three new fields in which embryonic research should be permitted and a firm restatement of the prohibition of cloning for the purposes of human reproduction. In response to the Donaldson report, the British Parliament enacted the Human Fertilisation and Embryology (Research Purposes) Regulations (HFER) of 2001 that added three categories of research for which the HFEA was responsible: 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 new regulations went into effect on January 31, 2001.
The deliberations within Parliament on the status of the human embryo were, of course, of considerable interest to a number of groups whose position was that human life begins at conception. For such groups, the Human Fertilisation and Embryology Act and related legislation and regulations were incorrect because they authorized the destruction of human life. Passage of the HFER of 2001 prompted one of those groups, the ProLife Alliance, to ask for a judicial review of the governmentТs position on embryonic research. On November 15, 2001, the British High Court ruled that embryos created by SCNT were not regulated by the new HFER because they were not created by fertilization of an egg by a sperm.
The courtТs ruling raised a host of new questions about the governmentТs system of regulating human embryo research. It meant that a possibility existed that the cloning of humans for reproductive purposes using SCNT might be permitted and beyond the reach of existing regulations. As a spokesperson for ProLife said, The Human Fertilisation and Embryology Act 1990 is now in tatters . . . the Human Fertilisation and Embryology Authority, which has become the mouthpiece of vested biotechnology interests, has been seriously undermined, and the GovernmentТs gross incompetence has been exposed.
The government responded immediately. It announced that legislation designed specifically to prohibit human cloning would be introduced and that the High CourtТs decision would be appealed to the Appeals Court. The promised legislation was rushed through Parliament, introduced on November 21, 2001, and passed into law on December 4, 2001. Only a month later, the Appeals Court overturned the High CourtТs decision and restored the original intent of the Human Fertilisation and Embryology acts.
Still, the story was not complete. At this point, ProLife appealed its case to the House of Lords, asking that it rule against existing policies. In response, the House of Lords appointed yet another committee to investigate the social, ethical, and legal implications of embryonic research. That committee issued its report on February 13, 2002, once more essentially upholding government policies and practices on cloning, in vitro fertilization, and embryonic stem cell research developed over the previous two decades. Among its 27 recommendations, perhaps the most important were:
- To ensure maximum medical benefit it is necessary to keep both routes to therapy [using adult and embryonic stem cells] open at present since neither alone is likely to meet all therapeutic needs.
- For the full therapeutic potential of stem cells, both adult and ES, to be realised, fundamental research on ES cells is necessary, particularly to understand the processes of cell differentiation and dedifferentiation.
- Whilst respecting the deeply held views of those who regard any research involving the destruction of a human embryo as wrong and having weighed the ethical arguments carefully, the Committee is not persuaded, especially in the context of the current law and social attitudes, that all research on early human embryos should be prohibited
- Fourteen days should remain the limit for research on early embryos
- Embryos should not be created specifically for research purposes unless there is a demonstrable and exceptional need which cannot be met by the use of surplus embryos
- Although there is a clear distinction between an IVF embryo and an embryo produced by CNR [SCNT] (or other methods) in their method of production, the Committee does not see any ethical difference in their use for research purposes up to the 14 days limit
- УThe Committee unreservedly endorses the legislative prohibition on reproductive cloning now contained in the Human Reproductive Cloning Act 2001
As is apparent from the preceding summary, British policies regarding in vitro fertilization, cloning, and stem cell research have remained consistent over the past two decades. They encourage and support, both financially and in terms of policy, the use of human embryos developed by a variety of methods in research up to about the 14th day following gestation, and they strongly and unequivocally oppose the cloning of embryos for the purpose of human reproduction.
