Academic journal article Harvard Law Review

Guiding Regulatory Reform in Reproduction and Genetics

Academic journal article Harvard Law Review

Guiding Regulatory Reform in Reproduction and Genetics

Article excerpt

Only a few decades ago, doctors and scientists began to understand how to manipulate the fundamental elements of human genetics and human reproduction, raising new hopes but also strong concerns. New reproductive techniques such as in vitro fertilization (IVF) were denounced as heralding a "new holy war against human nature," (1) and as representing "morally forbidden" techniques that constituted "a disastrous further step toward the evil design of manufacturing our posterity." (2) Likewise, the prospect of mixing together DNA from different sources was viewed as "an additional fearful load on generations that are not yet born." (3) Many believed that the specter of drastic consequences arising from such unfettered research necessitated scrutiny and tight regulation.

Despite the similarity of early concerns regarding reproductive medicine and genetic research, the two fields have spawned very different regulatory regimes. Assisted reproduction is now dominated by private firms that provide reproductive services, including fertility treatments, to parents willing to pay, operating under only a minimal set of guidelines with little formal oversight. (4) In contrast, most genetic research remains tightly regulated by overlapping federal agencies, with funding subject to the approval and oversight of review boards that scrutinize the ethical, safety, and policy concerns of new research. (5)

Some of the most contentious new research and development--from embryonic stem cells (ES cells) to cloning to genetic chimeras--occurs at the intersection of these fields. Largely unregulated fertility clinics, for example, are seeking to offer advanced genetic tests at increasingly early stages of embryonic development that can help parents shape the traits of their future children by screening embryos. (6) At the same time, a growing amount of genetic research utilizes the techniques pioneered in reproductive medicine, with the study and use of ES cells being a prime example. The regulatory disparity creates a number of dilemmas, perhaps most prominently the increasing difficulty of determining which regulatory regime to apply when the underlying technologies and procedures span both fields.

It is tempting to dismiss the jumbled state of regulation as an accident of history, and many policy proposals indeed devote little attention to the origins of the divergence. (7) However, a closer examination of the social, political, and economic forces that produced the modern-day regulatory divergence suggests policy principles relevant to regulatory reform efforts. This Note seeks to draw out some of these lessons. Part I examines the growing technological convergence between reproductive medicine and genetic research, the current state of regulation and its shortcomings, and the challenges to formulating comprehensive and coherent policy principles. Part II traces the development of regulation in these fields, identifying factors that shaped present-day institutions and laws. Part III extracts from this history lessons that current policymakers may wish to heed, focusing on the potential role of expanded governmental funding of ethically problematic research. It also suggests that the willingness of American society to accept new technologies once introduced should motivate policymakers to permit some degree of new development even in the face of initially negative public opinion, but that policymakers should take care that public enthusiasm for new technology does not result in underprotective safety regulations.

I. REGULATORY CHALLENGES OF CONVERGENCE

A. Convergence of Reproduction and Genetics

The convergence of the fields of reproduction and genetics presents new challenges not easily answered by a simple choice between more and less regulation. (8) Practitioners of reproductive medicine have traditionally focused on problems related to infertility, using genetic material from existing sperm or eggs to replicate the ordinary process of conception. …

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