1. What led to your interest in the moral, political and social issues that influence the federal regulation of assisted reproductive technology (ART)?

 

This topic combines my interests in assisted reproduction and my practice experience (and interest) in federal administrative agency regulation.  I became interested in assisted reproduction during an intensive summer Family Law course in law school.   I found it interesting that individuals would often use traditional assisted reproduction to build their families, and the law would respond to these uses afterwards.  Reproductive genetic innovation interests me because the regulatory regime has attempted to regulate these techniques before they are used.  Additionally, that regulation has come from the federal government instead of the individual states, which usually regulate the practice of medicine through medical licensing, criminal law (in particularly extreme cases), and civil malpractice regimes. 

 

 

2. Who is this book written for? What chapter should non-lawyers read first?

 

The book is written for anyone interested in reproductive rights, scientific innovation, or medical innovation including regulators, legislators, attorneys, academics, and the public.  This book largely focuses on assisted reproduction, but it also examines the regulatory and popular treatment of in vitro fertilization, recombinant DNA technology, cloning, stem cell research, germline gene editing, and other innovations.  Everyone should start with the Introduction Chapter.  Lawyers can likely skip over Chapter 1, A Range of Regulatory Options, but depending on one’s field of practice, it can be a useful reminder of the many ways we regulate, and a reminder that the way we regulate one issue is not how we regulate all of them, nor how we have to do so.   Chapter 1, A Range of Regulatory Options, will be especially useful to non-lawyers and those early in their legal studies, as it provides an overview of important concepts like federalism, administrative agency regulation, the regimes that allow for self-regulation, funding restrictions, and other important legal concepts.

 

3. What are some misconceptions about advances in human reproduction and reproductive genetic innovation, and how have these led to over-regulation? 

 

Sensationalism often impacts regulation, and individuals regulate based on fear or views on morality often without an actual understanding of the science involved.   Recurring terms include “test tube babies,” “designer babies,” “three-parent in vitro fertilization” along with references to Aldous Huxley’s A Brave New World.  Additionally, as the book details, reproductive genetic innovation is often subject to hidden regulation, as indicated by agency responses to Freedom of Information Act (FOIA) requests related to the ways in which reproductive genetic innovation has been targeted for federal agency action. 

 

4. Although the prevalence of fertility treatments in the U.S. in recent years has increased and led to more babies being born, what has not been addressed in the regulatory framework to keep pace?

 

Assisted reproduction continues to be viewed as a supplemental, elective procedure as opposed to a medical necessity.  Fertility preservation techniques like “egg freezing,” especially for unmarried people, are often not covered by health insurance plans.  Even in states where statutes seem to require coverage of assisted reproduction, extensive exceptions exist. 

 

5. How have regulations contributed to disparities in access to assisted reproduction, and how might lifting even a few specific regulations help increase access?  

 

In Vitro Fertilization (IVF) and other (sometimes) controversial reproductive and innovative techniques have been subject to deliberate failures of research funding.  As a result, access to them tends to be limited to those who have (1) disposable income (or the ability to obtain loans) to afford access to fertility treatment or (2) those with access to particularly expansive health insurance plans, which is rare even when state statutory mandates exist. 

 

6. What do you hope readers take away from the book?

First, there are many regulatory options—the way we regulate a field or a technique is not the way we have to do so.  Second, reproductive rights face opposition on all sides, even sides that are considered “friendly.”  Third, significant disparities exist in healthcare and reproductive exceptionalism, which treats issues related to reproduction differently than other forms of health care, contributes to the increasing costs of assisted reproduction and the continued disparities in access to fertility treatments.  Ultimately, Regulating Conception urges the minimal regulation of assisted reproduction and reproductive genetic innovation in place of clandestine regulation, to increase transparency and safeguard reproductive rights.