The UK model: Setting the standard for embryonic stem cell research?

• Author: Herder, Matthew

Introduction

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?

1. 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. 3(2) of the Act or one of the three purposes relating to therapeutic applications outlined in the new Regulations, the HFEA will grant a license for embryo research. Indeed, the new Regulations ensure that research involving both the derivation and use of ES cells is licensable in the U.K.

   In contrast, the distinction between derivation and use is allimportant in the U.S., in light of the extant Congressional ban on research with embryos which effectively precludes the derivation of ES cells. The NIH obtained a legal opinion in January 1999, taking the view that "by definition, ES cells are not embryos ... thus, ES cell research is not subject to the ban." (19) On this basis, the NIH moved to authorize the research use of ES cells but not their derivation, thereby avoiding, strictly speaking, a violation of the ban. (20)

   Under the Bush administration however, federal funding of all ES cell research within U.S. borders was put on hold. Then, on August 9, 2001, the President announced that only research with ES cell lines derived previously - that is, initiated prior to 9:00 p.m. E.D.T. on that date - would be eligible for federal funding. In his address, Bush asserted that roughly 60 viable ES cell lines currently exist in the world. The claim fell under immediate scrutiny, (21) but the NIH has subsequently released a list comprising 64 lines that were purportedly derived in accordance with the criteria outlined by the President. (22) Namely, ES cells "must have been derived from an embryo that was created for reproductive purposes and was no longer needed ... informed consent must have been obtained for the donation of the embryo and that donation must not have involved financial inducements." (23) In the realm of public funding then, the U.S. now seems to be the most conservative amongst the states that condone ES cell rese arch.

   Formerly, when Bush had not yet made his policy decision, Germany enjoyed this position. Under Germany's Embryo Protection Law, which confers full human status from the moment of fertilization, it is illegal to conduct research that is not in the best interest of the embryo. The "generation of human stem cells is permitted ... from fetal tissues only." (24) Nevertheless, this law supposedly does not preclude research with ES cells derived elsewhere, (25) creating an interest in the importation of these materials. (26) Insofar as German researchers can continue to use new sources of ES cells, while federally-funded American scientists can only use those created prior to the August 9 deadline, Germany is more permissive.

   (2) Origin of ES Cells

   ES cells can be derived from a number of sources: supernumerary embryos remaining from infertility treatment clinics; embryos created by in vitro fertilization (IVF) for research purposes ("research embryos"); and embryos created by somatic cell nuclear transfer (SCNT) for research ("SCNT embryos").

   In very general terms, the research use of spare embryos, destined for destruction, is treated as less morally problematic than the creation of research embryos by either IVF or SCNT. Annas, Caplan and Elias, for instance, argue that there is a "moral difference" behind the discardedcreated distinction:

   Although the destruction of a human embryo is lamentable, there is a considerable moral difference between creating and destroying embryos solely to obtain stem cells and destroying unwanted human embryos that will never be used for reproductive purposes, to achieve benefit for those with serious diseases and disorders. (27)

   On this reasoning, most jurisdictions that allow ES cell research limit the research to discarded infertility treatment embryos. (28)

   The U.K. scheme, however, goes further. More precisely, the U.K. legislation does not impose licensing restrictions in relation to the intention with which the embryo was created. Accordingly, research proposing to use embryos expressly created for research purposes, whether by IVF or SCNT (i.e. "therapeutic cloning"), falls within the ambit of licensable research. In sharp contrast, other jurisdictions including Canada, (29) prohibit the creation of embryos for ES cell research. (30) For example, the Embryos Bill in the Netherlands prima facie precludes the use of research embryos: "[t]he performance of scientific research with embryos created specifically for this purpose is prohibited." (31) Yet the Bill adds a caveat: "[a]dults ... can provide their gametes for the special production of embryos for ... the culturing of embryonic cells intended for transplantations in humans where this can only be achieved using specially created embryos." (32) Similar "nuances" (i.e. conditional constraints) can be found in the European Group on Ethics (EGE) and United Nations Educational, Scientific and Cultural Organization (UNESCO) documents. The EGE report states that deriving ES cells from research embryos is "ethically unacceptable" so long as "spare embryos represent a ready alternative source," while the creation of SCNT embryos "would be premature" at present. (33) UNESCO's statement largely focused upon therapeutic cloning, presenting arguments for and against. Notwithstanding the fact that the organization eventually took the latter position, it clearly emphasized the ongoing consideration of therapeutic cloning. (34) In France, although the CCNE has been openly divided, a majority of the members are in favour of giving therapeutic cloning the go-ahead. (35) Likewise, Australian states may follow suit if the Australian Academy of Science's (AAS) recommendation to allow research with SCNT embryos gains support. (36) Thus, the global perspective regarding the use of research embryos, particularly SCNT embryos, seems open to change.

   (3) (Informed) Consent

   A sine qua non of ethical research is the informed consent of the research subject. Research participants must be "respected as ends in themselves.. [and given] a fair opportunity to make an...