Legal and Regulatory Issues

A draft United Nations (UN) convention to prohibit human reproductive cloning seeks to augment the advisory regulatory approach enshrined in the Universal Declaration on the Human Genome and Human Rights. The latter was developed by the United Nations Educational, Scientific and Cultural Organization (UNESCO), adopted unanimously by its 186 states on November 11, 1997, and adopted by the UN General Assembly on March 10, 1999 (via Resolution 53/152). Article 11 of the UNESCO Declaration states (in part): "Practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted." The limitations of this provision were revealed in a report by the director-general of UNESCO. The report concluded that "this prohibition concerns the reproductive cloning of human beings and should not be interpreted as prohibiting other applications of cloning" (UNESCO, 1999, p. 13).

The Council of Europe's Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (1997; known as the Convention on Human Rights and Biomedicine), to which the United Kingdom is not a signatory, does provide some form of protection for the human embryo. Thus, Article 18(1) provides the following: "Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo," and Article 18(2) states, "The creation of human embryos for research purposes is prohibited." Under Article 36, countries—such as the United Kingdom—that have a preexisting law may make a reservation to the convention based on that existing law. Those countries that have no preexisting law on the embryo and that sign the convention will be hindered or prohibited from sanctioning embryo research, unless they formally withdraw from the convention, pass the new permissive law, and then re-sign (as has happened with Finland and Greece).

In the United Kingdom, the appending of the Human Rights Act of 1998, which brought U.K. domestic law closer to the provisions of the Convention on Human Rights and Biomedicine, has provoked some commentators to focus on the provisions of Article 2 as having potentially significant effect on domestic abortion law and hence the status of the embryo in law. Article 2 stipulates the following: "Everyone's right to life shall be protected by law." Whether this will afford any greater degree of recognition to the fetus, let alone to the embryo, is unlikely.

No European consensus exists on abortion, (or, as Table 1 shows, on embryo research), and the European Commission and the European Court of Human Rights have been reluctant to pronounce substantively on whether the protection in Article 2 of the convention extends to the fetus. In the light of these differing laws, a state will have what is called under European human rights legislation a wide "margin of appreciation" with regard to the convention on the issue of abortion, and hence, it is thought, on the status of the embryo (Decision Reports of the European Commission of Human Rights, Application 17004/90 H v Norway 73 DR 155 (1992) E Com HR.).

The European Court of Human Rights has yet to rule on whether the term everyone includes a fetus. In Open Door

Counselling & Dublin Well Woman v. Ireland, the European Commission had recognized the possibility that Article 2 might in certain circumstances offer protection to a fetus, but they took the point no further.

THE UNITED KINGDOM POSITION. Important distinctions must be drawn in the law's treatment of human cloning. The first distinction is between reproductive cloning, which is designed to result in the birth of a live human being genetically identical to another, and therapeutic cloning, in which an embryo is cloned for research purposes and will not be permitted to develop into a fetus or a live birth. The second essential distinction is that between two different cloning techniques: The first of these (when applied to human cloning) involves replacing the nucleus of an embryonic cell with a nucleus taken from another human embryonic or adult cell, and it is known as cell nuclear replacement (CNR).

The HFE Act of 1990. The Human Fertilisation and Embryology Act of 1990 (HFE Act) contains a clear prohibition on the first technique. Section 3(3)(d) states that a license granted under the act "cannot authorise ... replacing a nucleus of a cell of an embryo with a nucleus taken from a cell of any person, embryo or subsequent development of an embryo." CNR, on the other hand, is not expressly prohibited by the act, nor is "embryo splitting," a process that can occur naturally at a very early stage of embryonic development, forming identical twins, but which can also be done in vitro to produce identical, cloned embryos. The form of CNR whereby the nucleus of an oocyte is replaced with a nucleus from an adult cell was beyond the bounds of scientific credibility when the 1990 legislation was being debated and drafted.

The legal status of CNR in the United Kingdom is, therefore, unclear. The regulatory framework of the HFE Act rests on a definition in section 1(1)(a), in which an embryo is defined as "a live human embryo where fertilisation is complete." This definition's emphasis on the process of fertilization (an emphasis repeated throughout the act) raises the possibility that embryos created by CNR fall outside the scope of the act and that accordingly their creation and use is unregulated. In their 1998 report, Cloning Issues in Human Reproduction, the Human Genetics Advisory Commission (HGAC) and the Human Fertilisation and Embryology Authority (HFEA) argued for a purposive rather than a literal interpretation of the definition. Through such an approach, organisms created by CNR would fall within the statutory definition of embryo on the basis that Parliament clearly intended to regulate the creation and use of embryos outside the human body, and that excluding organisms created by

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