The Regulation of Mitochondrial Replacement Techniques Around the World

Abstract

Mitochondrial replacement techniques (MRTs, also referred to as mitochondrial replacement therapies) have given hope to many women who wish to have genetically related children but have mitochondrial DNA mutations in their eggs. MRTs have also spurred deep ethical disagreemensts and led to different regulatory approaches worldwide. In this review, we discuss the current regulation of MRTs across several countries. After discussing the basics of the science, we describe the current law and policy directions in seven countries: the United Kingdom, the United States, Canada, Australia, Germany, Israel, and Singapore. We also discuss the emerging phenomenon of medical tourism (also called medical travel) for MRTs to places like Greece, Spain, Mexico, and Ukraine. We then pull out some key findings regarding similarities and differences in regulatory approaches around the world. Expected final online publication date for the Annual Review of Genomics and Human Genetics, Volume 21 is August 31, 2020. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

Disruptive Synergy: Melding of Human Genetics and Clinical Assisted Reproduction

“…No such clinical trials are anticipated in the United States, where a statutory moratorium on “heritable genetic modification” remains in force. 28 …”

“…As of the time of this writing, no live birth following an MRT has been reported in the United Kingdom. 28 …”

“….in research in which a human embryo is intentionally created or modified to include a heritable genetic modification.” 30 The rider was reintroduced and passed by every successive Congress, although in 2019, there was an unsuccessful attempt to alter the legislation during the appropriations process and some discussion of exempting MRTs from the prohibition. 28 Although MRTs remain unlawful to perform in the United States, some have tried to skirt the prohibition by moving some parts of the MRT process offshore. Possibly for the first time, MRTs may have prevented heritable transmission of a fatal mtDNA disease (Leigh syndrome).…”

“…Beyond the United States and United Kingdom, Australia, Canada, Germany, Israel, and Singapore have developed their own policies regarding MRTs, with some taking more and some less permissive approaches. 28 …”

Therapeutic gene editing is here, can regulations keep up?

“…However, the growing popularity of genome editing technologies has challenged the existing frameworks that regulate them [7]. Some countries have updated their regulatory systems in an attempt to assure the translation of research to a clinical setting, while others are lagging behind [8,9]. While international coordination is usually not sought for biomedical breakthroughs and their applications, the case of gene editing is an exception, as these technologies having the potential to alter the human species in ways that transcend borders.…”