Paradoxes and Political Problems: The U.S. Approach to ART as Seen from the U.K.

Abstract

Viewed from a country where the development and application of new assisted reproductive technoloies (ART) are primarily regulated by a single statutory body, the U.S. approach seems some thing of a patchwork. A complex mix of federal, state, indirect governmental, and non-governmental regulation govern research and practice in ART. The President's Council on Bioethics' recent report, Reproduction and responsibility, acknowledges and explains the complexity in the context of the U.S. legal landscape. In doing so, it concludes that the U.S. regulatory framework lacks coherence and that much within it is unenforceable. It argues that more needs to be done to protect consumers, particularly women who receive ART and children born with its help. The report takes as its starting point the confluence of developments in reproductive biology developmental biology; and human genetics, against a background of the growing use of genetic screening and embryo selection. Since technologies that deal with human reproduction are closely linked to the debate on abortion, their use is fraught with ethical and political difficulties. In addition, the deep disagreement in the United States about the degree of respect owed to in vitro embryos has created a strong disincentive for regulation, and is one of the main reasons for what is described as the United States' laissez-faire approach. The council's report unpacks the regulatory framework, starting with federal legislation. In clinical practice, there is only one federal statute relating to ART, which primarily provides consumers with data about success rates of fertility clinics. Failing to report does not, however, attract penalties. With regard to state legislation, few state laws appear to bear directly on the use of ART. Rather, the report concludes, state oversight of ART is achieved indirectly, primarily by the licensure and certification of practitioners. The FDA is described as having broadly abstained from regulating ART, but some notable exceptions are highlighted, including a requirement for an IND (investigational new drug) for the transfer of ooplasm and an assertion that the same would be required for the transplantation of cloned embryos. Finally, the importance of professional guidance, such as the standards propounded by the American Society for Reproductive Medicine (ASRM) published in conjunction with the Society for Assisted Reproductive Technology (SART), is acknowledged, but with the caveat that enforceability is weak. The report adds some welcome insights into the context that has formed the backdrop for regulation of one of the most contentious technologies--the derivation and use of embryonic stem cells. …