Scholars of differing political affiliation and the President's Council on Bioethics have called for regulation of assisted reproductive technology (ART) that would emulate many aspects of the regulatory system of the United Kingdom, in particular that of the Human Fertilisation and Embryology Authority. Specifically, scholars and the Council have argued that research in the U.S. involving gametes and human embryos lacks consistent oversight.1 While the Centers for Disease Control and Prevention (CDC) produces an annual ART success rate report,2 submission of data is guaranteed only by the promise that non-responders will be noted as such in the appendix of CDC's report, and most ART clinics publish success rates on the Internet in a much more recognized forum: website advertising. Moreover, U.S. law does not require licensing or accreditation of infertility programs and few regulations govern embryo research.3 While the large majority of clinics report their success rate data, and many follow practice standards and apply for accreditation from private agencies, these practices are strictly voluntary.4 Clinics failing to report their success rates face no legal consequence.
In contrast, Great Britain's Human Fertilisation and Embryology Authority (HFEA) has complete authority over fertility clinics and human embryo research in the United Kingdom.5 All clinics and labs using gametes or human embryos must receive a license from the HFEA.6 British clinics and embryo laboratories follow clear guidelines for data reporting, advertising, confidentiality, and clinic practices, which the HFEA enforces through powers granted by the British Parliament. While some American clinicians would argue that the HFEA restricts the freedom of clinics and researchers, the HFEA has shown the ability to adapt its policies to reflect changing technology while maintaining its moral bedrock: protecting the welfare of the child.
In her benchmark comparison of British and American policy governing infertility, Gladys White7 argued quite explicitly that the British system is a good guide for U.S. policy. She based her argument on a review of U.K. policy and in particular on a visit to the HFEA in London. White's pro-HFEA position has become a staple argument in bioethics and legal scholarship. In this paper, we compare the two systems in greater detail, taking issue with the conclusions drawn by White and others. In Part II, we compare the role of the HFEA in the United Kingdom to the authority and limitations of several agencies and organizations in the United States. These are the Centers for Disease Control and Prevention (CDC), the American Society for Reproductive Medicine (ASRM), the Society for Assisted Reproductive Technology (SART), the American College of Obstetrics and Gynecology (ACOG), the Food and Drug Administration (FDA), and the Department of Health and Human Services (DHHS). Relying heavily on our review of the existing policies and on Dr. McGee's comparative analysis of the HFEA and American institutions-conducted for the Commonwealth Foundation during 2000-2002(8)-we address the roles of these organizations and the HFEA in legislation, data collection, licensing, and regulation of fertility clinics and embryo research. Our comparison reveals the patchwork and essentially unenforceable nature of the American regulatory system, and the centralized, effectual authority of the HFEA.
In Part III, we examine the effect that trans-Atlantic discourse has had on recent regulatory policy shifts and important ethical debates in reproductive medicine. Specifically, we analyze the feasibility of importing a U.K.-style system to the U.S. and the strengths and roots of the current U.S. system. We explore specific regulations regarding reproduction technology including embryonic stem cell research, in vitro fertilization (IVF), and novel infertility treatments (ooplasmic transplantation and egg freezing) involving the use of human cells, tissues, semen, and oocytes. …