Norms Reborn: Controversies and Challenges for the Future of Reproductive Technologies

Despite its role as an international leader in technological and scientific advancement, the United States is notoriously underregulated in the field of reproductive research and the advancement of reproductive technologies. This notable lack of oversight has led these fields to be characterized as the “wild west” of medicine.^[1] Despite this dearth of regulation, United States clinics earn billions of dollars every year for providing infertility services.^[2] Assisted reproductive technologies have been used since 1981 to help would-be parents achieve pregnancies. Currently available assisted reproductive technologies include in vitro fertilization (IVF), gamete intrafallopian transfer, pronuclear stage tubal transfer, tubal embryo transfer, zygote intrafallopian transfer, egg-freezing, and preimplantation genetic diagnosis.^[3] These technologies are increasingly relied upon to achieve or defer pregnancy. Between 2000 and 2009, the number of infants born resulting from procedures involving assisted reproductive technologies nearly doubled, and the use of assisted reproductive technologies more than doubled in the decade before 2019. That year, there were almost 84,000 babies born in the United States using assisted reproductive technologies.^[4]

While technologies such as IVF have become somewhat ubiquitous, new discoveries and innovations are introduced on a semi-regular basis. Most recently, mitochondrial transfer,^[5] uterine transplants, and DNA-modifying technologies like CRISPR-Cas9 are transforming our understandings of reproduction, embryo development, and disease prevention.

In the wake of the introduction of new technologies and the evolution of already existing scientific knowledge, 2021 witnessed many changes in law and policy related to reproductive technologies and research. For example, in March, a group of scientists revealed that they had successfully grown mouse embryos inside an artificial uterus.^[6] In the same month, the International Society for Stem Cell Research (ISSCR) announced its proposal to eliminate the prohibition on embryonic research after the existing 14-day limit. For approximately four decades, early embryo research has been subject to this rule, which prohibits research after the first two weeks of development, or at the time of the appearance of the primitive streak (the point at which cell differentiation begins to occur). However, recent research has demonstrated that it is technologically feasible to culture embryos longer than 14 days,^[7] which may present extended opportunities to investigate embryo development.

At the same time that reproductive technologies and research seemingly underregulated, pregnancies are becoming increasingly regulated. Government control of access to legal abortions is intensifying. States are now banning abortions sought because of sex, race, or genetic anomaly,^[8] eliminating exceptions for rape and incest, and banning abortions before the point of viability. In August 2021, the state of Texas passed Senate Bill 8, effectively banning abortion as early as six weeks after a woman’s last menstrual period – a time when most women do not even know they are pregnant yet. The law, which is subject to a Supreme Court challenge, delegates enforcement responsibility to private citizens, effectively creating a private right of action against abortion providers where none previously existed. S.B. 8 is currently the most restrictive law in the United States, and will serve as a model for other states that would restrict a person’s ability to access a legal abortion.

Against this backdrop, the Health Law and Policy Institute at the University of Houston Law Center sponsored the ninth annual Health Law Symposium Workshop on October 22, 2021. The event, entitled “Norms Reborn: Controversies and Challenges for the Future of Reproductive Technologies,” explored the legal and ethical controversies and challenges arising from evolving reproductive technologies and changing cultural and societal norms. This symposium issue of the Houston Journal of Health Law & Policy represents the insights of four scholars with expertise at the intersection of law, technology, and reproduction. Read together and apart, the four authors’ pieces are important scholarly contributions as the courts and legislators grapple with complicated questions in research, reproductive technologies, and abortion.

Hank Greely, the Deane F. and Kate Edelman Johnson Professor of Law and Director of the Center for Law and the Biosciences at Stanford Law School, brings his unique authorial voice to the question of the 14-day rule in embryo research. In his piece entitled The 14-Day Embryo Rule: A Modest Proposal, he interrogates the decision by ISSCR to eliminate the 14-day rule without proposing an alternative. Recognizing that drawing a line that reflects societal consensus can be difficult (if not impossible), he nonetheless offers what he personally believes is a reasonable alternative.

Sonia Suter, the Kahan Family Research Professor of Law and Founding Director of the Health Law Initiative at the George Washington University Law School, takes a step back and looks at the state of reproductive technologies in the context of broader societal shifts. In Eroding Lines in Embryo Research and Abortion—Contradictory Slippery Slopes, she observes that the ISSCR’s new position comes at a unique point in history when long-standing legal precedents on abortion are being challenged all the way up to the Supreme Court of the United States. She notes that, with Roe v. Wade on the chopping block, technological advancements allowing scientists to keep embryos alive longer in a lab may mean little if the state’s interest in fetal life could begin as early as fertilization.

Myrisha S. Lewis, associate professor of law at William & Mary Law School, turned to the issue of advanced assistive reproductive technologies like mitochondrial transfer. Instead of looking within, like Professor Greely, she looked abroad. In her essay, Segmented Innovation in the Legalization of Mitochondrial Transfer: Lessons from Australia and the United Kingdom, she uses a comparative analysis of international approaches to help identify potential avenues for a gradual approach to legalizing mitochondrial transfer in the United States. The article interrogates the role of public deliberation or engagement in aiding the United States in reaching consensus on advanced assisted reproductive technologies.

Radhika Rao, professor of law at the University of California Hastings Law School, pushed back on the idea that all advances in reproductive technologies can be disruptive or groundbreaking. In Egg-Freezing, Uterine Transplants, and In Vitro Gametogenesis: Disruptive or Normalizing Reproductive Technologies, she asks the provocative question: do these technologies live up to the hype? She concludes that, despite claims that technologies such as egg-freezing, uterine transplants, and in vitro gametogenesis may revolutionize reproduction and liberate individuals from the limits of biology, they instead double down on the status quo.

Taken together, these articles raise important questions about how we shape policy around evolving technologies and decision making at the beginning of life. They examine how and why we draw lines around reproduction and reproductive technologies, and they recognize that lines may be vulnerable to erosion or extension. Further, these four papers underscore the sometimes contradictory goals and reasoning underlying various rules relating to the creation and destruction of embryos, as well as the legalization or proscription of new technologies. Our approach to these policies can either hinder or encourage innovation.

Each author explores line drawing in their own unique way. For example, Professor Rao’s recognition that once-experimental but regulated techniques can become unregulated prevailing practices elucidates the rapid and seemingly-constant moving lines. Professor Greely’s and Professor Suter’s pieces provide complementary perspectives on the 14-day rule. Although the rule does not enjoy absolute unanimity on the ethical and scientific permissibility of research on human embryos, the bright line rule reflects scientific understanding of embryogenesis, respects general consensus that embryos are entitled to special respect, and has provided relatively consistency in application. As a matter of public policy, the rule has allowed scientists and policy makers to avoid the complex and obviously contentious arguments involved in drawing lines based on the features of human embryos that confer upon them special moral status. These two articles demonstrate the nuance and complexity of adapting once-defined lines to reflect changing political winds, technological advancements, and societal values.

However, seemingly consensus-driven rules – like the 14-day rule – can actually be, in practice, driven more by intuition and emotion than by scientific data and ethical principles. And even when rules seem to reflect the views of the majority of the population, like in the case of the right to seek a legal abortion,^[9] new state laws (like Texas’ S.B. 8) can undermine existing rules. Professor Lewis’ call for public deliberation calls into question whether rules should be set by technological limits and political appetite, or by strong ethical deliberation. Her proposal seeks to achieve consensus via deliberative democracy; public consultation could extend beyond decision-making around the legalization of mitochondrial transfer and inform line-drawing on embryos research and pregnancy. The pieces in this symposium are important and timely scholarly contributions to the discussion of reproduction and reproductive technologies against a backdrop of increasing complexity and politicization.