A Law-Policy Proposal to Know Where Babies Come From During the Reproductive Revolution

I. INTRODUCTIONThe awesome capability to intervene at the beginning of human life through medicine-to actually enable the creation of life and choices about human characteristics-has burgeoned in recent years and continues to expand at an ever-quickening pace.1 Assisted reproduction technology (ART) has become an increasingly accessible means for prospective parents to realize parenthood when confronting human health impediments-overcoming infertility, or avoiding an identifiable genetic risk or health impairment. Assisted reproduction (AR), which is carried out in the United States predominantly in hundreds of private, independent clinics, has become a vibrant, highly competitive business that markets itself aggressively and generates billions of dollars annually.2The revolution in human reproduction through AR (reproduction revolution) is broadening parental choice about whether to have children and what genetic characteristics those children will or will not have.3 This reproduction revolution and the genomics revolution, both ongoing and raging, are becoming intertwined through the use of AR technologies.4 Colleagues have termed the nexus "reprogenetics."5 Professor John Robertson, a visionary immersed in me law and policy aspects of AR and genomics, has predicted our society's destiny in reprogenetics. As observed by Professor Robertson, "Ultimately, decisions about how to use or not use genomics in human reproduction will be determined, not by biologic necessity or evolutionary theory, but by how those uses fit into the fabric of rights and interests of individual and social choice and responsibility that particular societies recognize."6The objective of this Article is to question the role of regulation in the field of AR at the present time and over the next several years as the genomics and AR revolutions continue to intensify and integrate. Part II discusses the extent to which AR is a distinguishable field of medicine, and does so from the often conflicting perspectives of patient, provider, and payer. Part III probes the United States' unique level of acceptance of AR among industrialized countries, attributable largely to a trilogy of deferences: to human reproduction, to the physician's discretion to practice medicine, and to physician-patient decision making. The Article concludes that assurance of good medical practices and public accountability through regulation are at least as desirable in AR as in most other areas of medicine. Proposals for regulatory reform include a comprehensive, national licensing requirement for all AR services and the establishment of a federal overseeing authority.II. DISTINGUISHING FEATURES OF AR AS A FIELD OF MEDICINEAR is generally performed as a medical clinical service,7 and the Food and Drug Administration's jurisdiction historically has been checked not to interfere with physician discretion to practice medicine.8 In fact, the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA)9 expressly provides: "In developing the certification program, the secretary [of the Department of Health and Human Services] may not establish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in assisted reproductive technology programs."10 Consequently, the United States' federal regulation consists almost entirely of self-regulation through a program of voluntary reporting and certification.11 The federal system rests largely upon the FCSRCA, pursuant to which the Centers for Disease Control and Prevention (CDC) developed a model certification program for AR laboratories.12 The CDC has contractually outsourced implementation of its responsibilities under the FCSRCA to the Society for Assisted Reproductive Technology (SART) and the American Society for Reproductive Medicine (ASRM).13 Most AR providers belong to these organizations and report data to them voluntarily. SART-ASRM then collects, processes, and submits the data to the CDC, which in turn processes that data in a standard format and issues reports annually for public dissemination. …