American Journal of Law & Medicine

Lessons across the pond: assisted reproductive technology in the United Kingdom and the United States.

I. INTRODUCTION

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 White (7) 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. We then examine the role of ethical discourse in the regulation of ART by studying the ways in which the U.K. and U.S. seek to prevent multiple births.

In part IV, we conclude that the basis for differences in policy between the U.S. and the U.K. is rooted in each nation's history of dealing with reproduction, and that a system of the sort advocated by White, the HFEA, and most recently by Leon Kass and the U.S. President's Council on Bioethics would be extremely difficult to implement in the U.S.

II. COMPARATIVE ANALYSIS: AN OCEAN BETWEEN US

A. LEGISLATION

1. United Kingdom

The Human Fertilisation and Embryology Act of 1990 (HFE Act) forms the basis for all U.K. legislation regarding fertility clinics and embryo research. (9) It describes the functions and procedure of the Human Fertilisation and Embryology Authority (HFEA), the conditions requiring licensing for fertility clinics and related research, and specific regulations governing the creation, storage or use of human gametes and embryos. (10) Significantly, the HFE Act authorized the formation of the HFEA, the first statutory body of its kind in the world. It grants the HFEA several general functions, outlined in the 2004 HFEA annual report. (11) The HFEA is primarily responsible for the licensing and monitoring of clinics that perform IVF, donor insemination and/or human embryo research, and the regulation of gamete and embryo storage. (12) In addition, the HFEA produced a Code of Practice with guidelines on licensed activities (13) and keeps a register of information on donors, treatments, and children born through ART. (14) It also publicizes its role, gives advice and information, and reviews new developments in the field. (15)

2. United States

Those scholars advocating a U.S. shift to a U.K. model offer only a brief, disparaging account of U.S. legislation regarding fertility clinics and embryo research. (16) This reflects the fact that no comprehensive policy governs ART in the U.S. The law that most closely parallels the HFE Act is the U.S. Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA). (17) The FCSRCA mandates that infertility clinics submit ART success rate data and describes the responsibilities of the CDC in regard to data reporting and licensing. (18) Specifically, the CDC must (1) publish annual success rates for pregnancies achieved via ART technology, and (2) develop a model program for the licensing of embryo laboratories for adoption by the states. (19) The FCSRCA legislation, however, does not go nearly as far as the HFE Act. It fails to give the CDC the authority to enforce the data-reporting requirement, and simply outlines a voluntary system of licensing that has not been implemented or enforced. (20)

The States have been more active than the federal government in using legislation to regulate the use of human embryos. State activity appears minimal, however, when contrasted with HFEA's oversight. Some states have regulated the use of human embryos for research purposes; others have banned human cloning. (21) No state has created an agency with powers like the HFEA or regulated ART in any other significant manner. (22)

B. DATA REPORTING

1. United Kingdom

The HFEA began collecting data in a register of information on August 1, 1991. (23) Its registry is now the largest of its type in the world. (24) The HFEA maintains data on everyone who receives ART treatment, donates embryos, or is born through ART in licensed British fertility clinics. (25) The HFEA updated its register in 1998, and now provides non-confidential ART success rate data on its website. (26) In order to ensure data reliability, the HFEA implemented a five-year auditing program. (27) Over the course of the program, which ran from October 1996 until January 2002, the HFEA audited data from 106 licensed clinics. (28) The HFEA is presently engaged in a large strategic project to improve the Register, (29) which holds data on cycles of licensed treatments, following a review that identified technical problems and challenged the rigor of the data. (30) Specifically, as the HFEA Chief Executive, Dr. Maureen Dalziel, noted in the 2002 Annual Report:

 
   The HFEA's information technology shortcomings are being addressed 
   and comprehensive information management systems are being put in 
   place to ensure that meaningful information can be extracted from 
   data entered into the Register. It is frustrating that we are again 
   unable to publish detailed information on treatment cycles in this 
   Annual Report. (31) 

By 2004, the HFEA reported progress in developing a comprehensive Data Register and had undertaken an Historic Audit Project to guarantee the accuracy of treatment information. (32)

In addition to using data to monitor treatments and provide information, the HFEA maintains a confidential registry of information for the sake of children born from ART treatment. (33) Its registry includes patient and partner names, patient reference numbers, treatment dates, and details of sperm and egg donors. (34) This personal information is kept confidential except for children over the age of 18 (or over 16 if they are going to marry), who may be told whether or not they were born via ART. (35) In this way, the HFEA aims to ward off a situation where two people marry without knowing that they are genetically related.

2. United States

In the U.S., the process of data collection demands a thorough review. U.S. law (36) requires clinics to submit ART success rate data for publication by the CDC, but the process is essentially voluntary and non-reporting clinics suffer little or no consequences.

From 1992 to 2004, the responsibility for data collection rested largely on the Society for Assisted Reproductive Technology (SART), (37) a private organization of ART clinical programs and an affiliate of the American Society for Reproductive Medicine (ASRM). (38) SART has been keeping an ART success rate database since 1986. (39) Although the CDC took over publishing ART success rate reports in 1995, (40) SART remained the driving force behind the CDC's publications.

SART is individually incorporated for tax purposes, but SART members are meant to be ASRM members also. (41) Clinics that join SART pay a $300 yearly membership fee, a $500 registry fee for data collection services, and additional $4.00 per cycle. (42) SART requires its members to submit and verify annual ART success rate data and their other membership requirements. (43) SART members must receive inspection and accreditation by an outside agency every two years, and must meet all SART/ASRM ethical practice, laboratory and advertising guidelines. (44)

In 2004, the CDC announced a change in its data collection contractor and in approved data reporting systems for 2004-2008. It contracted with Westat to perform the services previously performed by SART under Westat's web-based National ART Surveillance System (NASS). (45) Even under the CDC's contract with Westat, SART members may continue to enter their data into the SART system. (46) SART then transfers its data into the Westat system so that clinics maintain compliance with the federal mandate. (47) The CDC has not yet published a report based on the Westat data.

Regardless of whether they are SART members or not, federal law requires all ART clinics to report and verify ART success rate data annually. (48)

Unlike the U.K., where data collection is simply a part of the licensing process, data collection in the U.S. is its own entity. To complete the process, clinics must submit verified data about every ART cycle performed and maintain medical records in their own files for validation purposes. (49) Until 2004, SART collected all submitted data and compiled a database that the CDC used to publish its annual report. The CDC oversaw SART, in part by selecting a percentage of clinics for random verification inspections which SART conducted with CDC supervision. In 1999, validation site visits took place at 29 of 370 reporting clinics. (50) Based on its review of the 2000 data, SART conducted 40 validation visits in 2003, 20 visits in 2004, and 39 visits in 2005. (51) The CDC will presumably continue its inspection of clinics under its new contract with Westat.

The CDC has sought to make clear that it maintains "ultimate authority" over the validation process and the annual report. (52) It explained its decision to contract with SART for data collection and validation as follows:

 
   CDC's authority to publish and disseminate the annual report is not 
   being ceded to SART, but rather SART is serving as a valuable 
   resource from which CDC can obtain the necessary information to 
   fulfill its statutory obligation.... Prior to the decision to 
   partner with SART, CDC reviewed the SART reporting database and 
   system and found that it provided the necessary information to 
   publish an annual report as required by FCSRCA. Rather than 
   duplicate SART's reporting system and thereby burden ART clinics, 
   CDC has contracted with SART to annually obtain a copy of their 
   clinic specific database. (53) 

The CDC offered no explanation when it awarded the data collection contract to Westat in 2004. (54) Our discussion will focus on data collected by SART since the agency has not yet published a report based on data collected by Westat.

Every clinic that reported data for the first CDC report (1995) was a SART member. (55) Over time, however, the percentage of non-SART members reporting data to SART has increased. Six percent (6%) of clinics that reported data in the CDC's 2000 data report (56) were not SART members. This likely reflects efforts by both the CDC and SART to include all existing clinics in the report. In the CDC's recent CDC 2002 data report, 8.7% of clinics were not SART members. (57)

Since the start of the CDC/SART joint reporting effort in 1995, a high percentage of all programs in the U.S. providing ART services have submitted data on procedures performed in their practices. (58) In 1999, 370 of the 399 listed clinics, or 92.7%, reported verified data. (59,60) The number of non-reporting clinics documented by the CDC has decreased from 30 of 390 in 1998, to 29 of 399 in 1999, and 25 of 408 in 2000. (61,62,63) While many consider it a successful reporting trend, a significant cohort of programs continues to defy the law by not reporting verified ART success rates. For instance, eight of the non-reporting clinics in 1999 were also listed as non-reporting in 1998, and four of the eight were listed as non-reporting in 1997 as well. (64,65,66) Nearly half of the 25 non-reporting clinics in 2000 also did not report data in 1999. (67,68) One clinic, The Genetics & IVF Institute (GIVF) of Fairfax, VA, was listed as non-reporting in 1996, 1997, 1998, 1999, and 2000. (69,70,71,72,73) This is especially disturbing because GIVF is a particularly large and well-known clinic. They have received national attention for pioneering the "Micro sort," sperm-sorting technology (74) and advertise nationally on the Google search engine and in the New York Times Magazine. (75)

The long list of non-reporting clinics (and an increasing number of repeat non-reporters) in the CDC's annual report illustrates the essentially voluntary nature of data-reporting, even when it is mandated by federal law. According to Richard J. Sherins, M.D., director of the GIVF Division of Andrology (Male Infertility), a number of factors may lead a clinic to not report ART success rates. These include the lack of solid criteria to correctly identify the etiology of infertility, an imprecise separation of clinical indications, and the inherent bias in the reporting structure toward pregnancy rates as the sole arbiter of a clinic's success (even though other criteria may be useful to the public as they choose an ART clinic). …

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