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6 The Governance of Reprogenetic Technology: International Models
- Johns Hopkins University Press
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The Governance of Reprogenetic Technology International Models C H A P T E R S I X Recently, American bioethics committees have begun to examine foreign models of biotechnology governance in order to develop their own domestic policy advice. President Clinton’s National Bioethics Advisory Committee (NBAC, 1999) and President Bush’s Council on Bioethics (2002, 2004) invited presentations from experts on international regulation of assisted reproductive technology (ART), stem cell, and embryo research policy. In large part, the interest in other countries’ approaches to biotechnology governance stems from recent developments in reprogenetics, primarily the possibility of human reproductive cloning raised by the cloning of Dolly, and the continued intense interest in human embryonic stem (ES) cell research. These developments have reinforced the international nature of biotechnology initiatives, both in development and in implementation. This is certainly the case for reprogenetic technologies. A vast body of political, scientific, and public opinion data and analysis informs the policy and regulatory decisions of foreign governments concerning new biotechnological developments. Understanding and building on that body of work makes sense in striving to develop domestic policy. The strengths and weaknesses of foreign systems offer lessons for future policy initiatives . Keeping in mind that reprogenetic technologies are defined as technologies involving the use, manipulation, and storage of gametes and embryos, in this chapter I examine how selected foreign models of technology governance address the use of human embryos in research and treatment. L O R I P. K N O W L E S These models suggest how such policy might be created in the United States, backed by trends that inform that endeavor. Although the range of policy responses to reprogenetic technologies is wide, a distinction can be made between those countries in which all research involving human embryos is prohibited and those in which it is not. For example , through legislation passed over the last twenty-five years, Ireland, Austria, Norway, Italy, Poland, and Germany prohibit all embryo research, and consequently reprogenetic research and treatment are practically nonexistent in those countries.1 In countries that permit such research, regulation of reprogenetic technologies falls primarily within the scope of embryo research regulation . Embryo research regulation is often part of a comprehensive ART regulatory scheme, as in the United Kingdom (Human Fertilisation and Embryology Act 1990), Canada (Assisted Human Reproduction Act 2004), and France (Loi Relative à la Bioethique 2004); however, it may also be covered in part by human subjects research regulation or by specific legislative initiatives, as has happened in Australia and Germany (Research Involving Human Embryos Act 2002; Prohibition of Human Cloning Act 2002).2 Several countries have recently enacted reprogenetic regulation, as the therapeutic possibilities that may flow from human ES cell research have helped galvanize or reshape efforts to create reprogenetic policy. This is the case in France, Australia, and Canada. Because most reprogenetic interventions with people happen in infertility clinics, how those clinics are regulated affects the success of human research protections as a means to govern the use of reprogenetic technologies. In the field of reproductive medicine, there is a historical and ongoing overlap between infertility treatment involving clinical innovation and experimentation on human subjects. Many of the newest techniques that offer hope to infertile couples, such as ooplasm transplantation, have clearly involved human experimentation at the initial stages but have not always been regulated as such (Barritt et al. 2001; U.S. FDA 2002). Consequently, how regulations define what activities constitute research determines whether women are research subjects or patients or both. Absent a comprehensive scheme that oversees appropriate uses of human embryos, the enforcement of human subjects research protections and of important safeguards such as informed consent depends on the individual clinician-researcher’s perceptions of the nature of the intervention as mere treatment, as innovative treatment, or as research. Although many clinician-researchers are motivated by deep concern for the well-being of their patient clients, their knowledge may not always lead to clarity on where the line between innovation and experimentation lies. 1 2 8 L O R I P. K N O W L E S [54.197.64.207] Project MUSE (2024-03-28 19:54 GMT) In many countries, legislators have attempted to create a broader regulatory structure that recognizes cloning and human ES cell research as embryo research and encompasses the larger reprogenetic enterprise. This is a daunting task, however, especially in the United States, which remains so divided by the abortion issue that all human embryo research...