The American Democratic Deficit in Assisted Reproductive Technology Innovation

By Lewis, Myrisha S. | American Journal of Law & Medicine, May 2019 | Go to article overview

The American Democratic Deficit in Assisted Reproductive Technology Innovation


Lewis, Myrisha S., American Journal of Law & Medicine


I. INTRODUCTION

The 2010 Nobel Prize in Physiology or Medicine was awarded to Robert G. Edwards “for the development of in vitro fertilization.”1 In awarding the prize, the Nobel Committee noted that Dr. Edwards' “achievements have made it possible to treat infertility, a medical condition afflicting a large proportion of humanity including more than 10 percent of all couples worldwide.”2 Since the birth of the first child using in vitro fertilization (a form of assisted reproductive technology) in 19783 in the United Kingdom, various strides have been made in assisted reproductive technology. Yet while the United States has been a leader in many domains of technological innovation and regulation, the same characterization does not apply to the United States' place in assisted reproductive technology (“ART”).4 Most recently, forms of ART involving genetic modifications have been developed in both the United Kingdom and the United States.5 A number of media and scientific publications have noted that the United States will lag behind the United Kingdom in ART development due to regulatory barriers that prevent the approval of a new form of ART, mitochondrial transfer, which combines in vitro fertilization with genetic modification in order to prevent the transmission of genetic disease.6

Newer forms of ART, such as mitochondrial transfer and cytoplasmic transfer, another form of ART used in the late 1990s that also combined traditional ART with genetic modification (also referred to as “advanced assisted reproductive technologies”), raise interesting federalism issues: the U.S. Food and Drug Administration (“FDA”) has asserted jurisdiction over these forms of ART, meanwhile state law governs the practice of medicine and family formation.7 This article will examine the regulation of mitochondrial transfer in the United States and the United Kingdom, as well as the regulation of an earlier, similar technique of ART, cytoplasmic transfer.8 Research on that technique in the United States has been suspended since at least 2001, when the FDA sent letters threatening legal action to physicians researching the technique.9 The FDA's assertion of jurisdiction over in vitro fertilization (“IVF”) practice in 2001, which is usually the subject of state regulation, had a negative impact on research and clinical use of other IVF techniques, including mitochondrial transfer.10 Also, by not addressing the safety and ethical issues related to cytoplasmic transfer in 2002, the United States fell further behind in the race towards the clinical use of mitochondrial transfer as a number of safety and ethical issues overlap between cytoplasmic transfer and mitochondrial transfer.11 Instead, U.S.-based physicians and patients have been driven to reproductive tourism where they provide these techniques in countries with less restrictive regulation.12 Thus, those opposed to the type of work involving mitochondrial transfer have succeeded in halting the use of the technique in the United States, whereas institutional structures in the United Kingdom have thoroughly considered the ethical and legal issues surrounding the use of the technique before ultimately approving it.13

This article applies a comparative analysis to ART innovation before concluding that the United States should undertake a public consultation related to ART innovation similar to the United Kingdom. The political science subfield of comparative politics has often focused on the European Union's purported “democratic deficit,” which some have blamed for the U.K.'s vote to leave the E.U.14 While there is no standard definition of the “democratic deficit,” generally, when a national or supranational body suffers from a “democratic deficit,” that body lacks public accountability, transparency, and public engagement. …

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