Law Commons^™

Segmented Innovation In The Legalization Of Mitochondrial Transfer: Lessons From Australia And The United Kingdom, Myrisha S. Lewis

Faculty Publications

The U.S. is often characterized as a leader in innovation—a home of Nobel Prize‐winning scientists, innovators, and abundant research funding. Yet, in the area of assisted reproduction combined with genetic modification or substitution, what I call “reproductive genetic innovation,” that characterization begins to wane. This Article focuses on the regulation of mitochondrial transfer, a subset of reproductive genetic innovation. While human clinical trials related to mitochondrial transfer go forward in the U.K., the clinical use of the technique remains illegal in the U.S. due to a system of subterranean regulation by the U.S. Food and Drug Administration and a now-recurring …

Normalizing Reproductive Genetic Innovation, Myrisha S. Lewis

Faculty Publications

Many societally accepted techniques were quite controversial at inception and for decades after. For example, historically, dialysis was “unnatural,” vaccination was “the poisoned quill,” and artificial insemination was akin to adultery. Despite social and cultural hurdles, the aforementioned medical techniques have today attained overall public acceptance, permissive legal treatment, and even health insurance coverage in some cases.

Unlike many now-routine treatments like in vitro fertilization (IVF), egg freezing, and organ transplantation, which flourished without significant governmental intervention, today’s controversial medical treatments, especially those involving reproductive genetic innovation, face intense regulatory barriers. Reproductive genetic innovation, which is the combination of IVF …