In the early 1980s the United Kingdom took a pioneering role in the area of new reproductive technologies (NRTs). Significant strides were made not only in terms of scientific and clinical development, but also in relation to relevant legal and ethical issues. In the latter category, attempts were made to address the debate concerning the moral status of human embryos by advocating a "14-day limit" for research: the Warnock Report, published in 1985, stipulated that research with human embryos only be allowed up to 14 days after fertilization, the point at which the three germ layers typically become distinct. (1) To many, the proposed moral dividing line was purely arbitrary, yet somehow a quasi-break in the ontogeny of a human being came to be used as a legitimate demarcation point. (2)
In 1990, the U.K. entrenched the 14-day limit in the Human Fertilisation and Embryology Act, (3) and since then most other industrialized nations that permit embryo research have followed suit. Draft legislation in Canada, (4) an opinion report issued by France's Comite Consultatif National d'Ethique (CCNE), (5) the Netherlands' Embryos Bill, (6) and Australia's National Health and Medical Research Council (NHMRC) (7) all expressly endorse the U.K. position. The United States' National Institutes of Health (NIH) has identified the formation of the mesoderm as the appropriate limit for embryo research, and notably this coincides with the 14-day limits. (8)
At present it is interesting to speculate about whether the U.K. will set the standard for embryonic stem cell research. In January of this year, after lengthy debates, the U.K. Parliament passed the Human Fertilisation and Embryology (Research Purposes) Regulations 2001, (9) permitting embryonic stem cell research using either in vitro fertilization (IVF) or somatic cell nuclear transfer (SCNT) technology, and thereby condoning therapeutic cloning. For the time being, this position is unique to the U.K. As policymakers around the world scramble to take a stance on this hotly debated issue, the question is: will the U.K. lead the way once again? Or, in the alternative, is the U.K. framework regulating embryonic stem cell research flawed, leaving other nation-states to formulate a different set of standards?
A. Reacting to the Science: A Comparative Analysis
In this article, the likelihood that the U.K. position will become the international position is assessed by way of comparison, examining guidelines and reports issued by governments and quasi-governmental bodies in Canada, (10) the United States, (11) the United Nations, (12) Europe, (13) France, (14) the Netherlands, (15) Germany, (16) and Australia. (17) The comparison, illustrative rather than comprehensive, focuses on key aspects of the U.K. scheme, namely: (1) the nature of the research; (2) the origin of the embryonic stem cells; (3) issues surrounding consent; (4) safeguards against commercialization; (5) directed donation; (6) animal/human hybrids and chimeras; (7) oversight mechanisms and the scope of the regulatory framework. It will examine these aspects in relation to policies developed by other jurisdictions. Points of agreement as well as inconsistencies will be highlighted, the goal being to critically evaluate the U.K.'s initiative as a likely or potential international consensus position.
(1) Nature of the Research
Stem cells can be derived from a variety of sources, including adult tissues, umbilical cords, aborted fetuses, and embryos. The present discussion focuses on stem cells of embryonic origin ("ES cells"). ES cells are derived from the isolated inner cell mass of early embryos, cultured to the blastocyst stage. (18)
The Human Fertilisation & Embryology Authority (HFEA), created under s. 5(1) of the HFE Act, is the licensing body for research involving embryos (according to s. 9(1) of the HFE Act). Assuming a particular research project satisfies one of the five purposes relating to reproduction described in Schedule 2, s. …