The Regulation of Assisted Reproduction

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Experts discuss the role of regulation in standardizing fertility treatment.

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As scientific developments progress, the use of assisted reproductive technology has become increasingly commonplace. Such developments have increased calls for improving the regulation of fertility treatments.

The Centers for Disease Control and Prevention (CDC) defines assisted reproductive technology as any fertility treatment in which medical professionals handle or manipulate eggs or embryos. Traditional in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) are the most common assisted reproductive technology procedures provided by fertility clinics, with IVF targeting female infertility while ICSI addresses male infertility.

The first infant conceived in the United States using assisted reproductive technology was born in 1981, but the use of advanced infertility treatments has since increased dramatically. In 2019, approximately 2 percent of all infants born in the United States were conceived through the use of assisted reproductive technology. This translates to over 80,000 infants born in that year.

Despite the surging popularity of assisted reproductive technology and the associated rise in the number of fertility clinics, the industry remains largely unregulated. Sometimes referred to as the “Wild West” of fertility treatments, the United States’ regulatory scheme is one in which, as one commentary has provocatively put it, “cash is king and informed consent is optional.”

Due to the federal government’s reluctance to fund research on reproductive treatments, the U.S. Department of Health and Human Services exerts only limited oversight over fertility clinics. The U.S. Food and Drug Administration (FDA) limits its oversight of assisted reproductive technology to its general regulation of drugs, devices, and donor tissue, while the CDC tracks laboratory certifications and successful birth rates but shirks many more direct regulatory opportunities.

Although a dearth of federal regulatory oversight does leave the states with room to regulate assisted reproductive technology, most states have failed to do so to any substantial degree, relying instead on industry standards and self-regulation to protect patients.

In this week’s Saturday Seminar, scholars explore the possibility of reforming and standardizing the regulation of assisted reproductive technology in the United States.

  • The need to balance long-term health and social risks against significant benefits to individuals and health care systems requires robust regulatory oversight, contends Walter G. Johnson of the Australian National University and Diana M. Bowman of Arizona State University’s Sandra Day O’Connor College of Law in an article in the Journal of Law and the Biosciences. Bowman and Johnson anticipate that the presence of “inherited regulation” will frustrate most jurisdictions’ efforts to establish new regulatory regimes specifically tailored to address assisted reproductive technology. Novel technologies frequently pose policy challenges to pre-existing systems of governance, with regulatory bodies struggling to keep pace with such innovation, explain Bowman and Johnson. Because existing regulatory frameworks can be applied to emerging technologies, however, this “legal lag” does not necessarily create significant regulatory gaps, according to Bowman and Johnson. Thus, they argue that the primary question is whether the current regime, in which FDA’s product regulations are applied to assisted reproductive technology, can effectively address emergent concerns in this novel landscape.
  • In an article published in the Global Journal of Transformation in Law, Human Rights and Social Justice, Aryadeep Roychoudhury of Xavier’s College, Kolkata explains how sperm donation as a component of assisted reproductive technology raises particular ethical issues that must be considered in crafting relevant regulations. Roychoudhury argues that the most prominent ethical issues are those related to the physical and psychological health of the donors, recipients, and future children. He notes, however, that because “unofficial policy” largely determines the ways in which sperm banks operate, one of the most significant supervisory influences is the threat of revoked accreditation or licensing. Roychoudhury argues in favor of replacing this system with a set of regulations for sperm donation that aim to maximize the overall welfare of all parties involved in or impacted by the process of artificial reproduction.
  • In a Harvard Public Law Working Paper, Glenn Cohen of Harvard Law School argues that reproductive technologies are more widely permitted in the United States due to the fragmented and indirect system of regulating their development and use. Although a few federal laws govern fertility clinic reporting and acceptable therapies, individual states maintain primary control over the regulatory landscape, Cohen notes. In addition to state control, Cohen outlines how market forces and abortion politics influence regulation of reproductive technologies in the United States unlike in other countries, such as Canada, Germany, and Australia. Cohen concludes that the variety of legal regimes regulating reproductive technologies in the United States create issues of “fertility tourism” and will persist until a single national approach takes hold.
  • New regulatory models are needed to respond to developments in assisted reproductive technology, contend Naomi Cahn of the University of Virginia School of Law and Sonia M. Suter of The George Washington University Law School in an article published in the Chicago-Kent Law Review. Current law does not directly govern whether and under what circumstances a patient can undergo IVF, despite the existence of some federal and state regulations, note Cahn and Suter. They advocate a novel system that would oversee all forms of assisted reproductive technology writ large, either by creating a special section within FDA or establishing a new entity comparable to England’s Human Fertilization and Embryology Authority. Such a regulatory reform, they argue, would mitigate medical risks, facilitate democratic deliberation, and equalize access.
  • In an article published in the Georgetown Journal of Gender and the Law, Jenna Casolo of Georgetown University Law Center and several coeditors use the example of pre-implantation genetics (PGD) to show the difficulty regulators confront in catching up with assisted reproductive technology innovation. With PGD, medical professionals test an embryonic cell for potential genetic defects with the intention of preventing hereditary diseases. Most significantly, PGD informs parents of the embryo’s sex, which creates a legal concern about potential sex discrimination, argue Casolo and her coeditors. The uncertainties assisted reproductive technology generates, coupled with its increasing popularity, necessitate a more rapid and dynamic legal response.
  • The fast-paced science of assisted reproductive technology requires comprehensive legal reform that can embed social and ethical concerns in the technology’s development, argues Elizabeth Chloe Romanis of Durham University in an article published in the Journal of Medical Ethics. Romanis suggests adopting a conceptual framework separating the gestation period from pregnancy as a means of protecting pregnant people from overregulation. She notes concerns about inequitable access since assisted reproductive technologies generally do not receive public funds. Romanis further explores narrow constructions of legal parentage and how parents who use assisted reproductive technology may be vulnerable under strict interpretations of what it means to have a child. Investigating and re-imagining these conceptual concerns is crucial to addressing the growing legal concerns about assisted reproductive technology, Romanis asserts.

The Saturday Seminar is a weekly feature that aims to put into written form the kind of content that would be conveyed in a live seminar involving regulatory experts. Each week, The Regulatory Review publishes a brief overview of a selected regulatory topic and then distills recent research and scholarly writing on that topic.