Segmented Innovation In The Legalization Of Mitochondrial Transfer: Lessons From Australia And The United Kingdom

Abstract

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 federal budget rider.

In the U.K., the government structured and carried out a public consultation as part of the legalization of mitochondrial transfer. Recently, Australia announced a plan to consider the potential legalization of mitochondrial transfer. In August 2021, the Australian federal government completed a public‐facing step in implementing a gradual approach to considering the legalization of mitochondrial transfer, and in March 2022, Maeve’s Bill passed in the Australian Parliament.

This Article draws on the experiences of two common‐law countries, the United Kingdom and Australia, to identify potential avenues for a gradual approach to legalizing mitochondrial transfer in the United States. Progress on mitochondrial transfer could start a broader American discourse that could facilitate access to mitochondrial transfer and the other techniques in the area of reproductive genetic innovation.

Keywords: mitochondrial transfer, comparative law, health law, assisted reproduction, food and drug, funding