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How bans on germline editing deprive patients with mitochondrial disease

Nature Biotechnology volume 37, pages 589–592 (2019)Cite this article

To the Editor — In 2015, the UK parliament voted to empower its Human Fertilization and Embryo Authority (HFEA) to approve the use of mitochondrial replacement therapy (MRT)1 in some circumstances. The decision followed a multiyear process of searching scientific reviews, at times heated parliamentary debates, and a widespread attempt to get “public views on emerging techniques designed to prevent mitochondrial DNA disease” (including 1,836 questionnaire responses, two public meetings, and three public workshops). Those who are carriers of pathogenic mitochondrial DNA in the United States and Canada also hoped that they would be able to access the same technologies. Unfortunately, in the United States, MRT was outlawed the same year as it was legitimized in the United Kingdom. The reason: another germline engineering technology—human gene editing. Rightly or wrongly, human germline gene editing struck fear in the hearts of many US legislators in 2015—and legislation aimed at banning it swept MRT into its eddy. The relevant Canadian law, by contrast, predates both developments in MRT and gene editing. And so, despite well thought out analyses by entities like the US National Academies of Sciences, Engineering, and Medicine recommending a distinct regulatory pathway to enable MRT, legislators in Canada and the United States have instead put in place a much blunter, restrictive, and omnibus approach2,3.

Here we discuss the US and Canadian policies and what opportunities may be available for changes that would enable MRT to go forward under a careful and well delineated regulatory pathway. We describe current human germline engineering legislation, its impact on research, how it sweeps MRT into its current prohibitions, and possible ways to move forward in coming years. We also speak to the need for regulatory harmonization across jurisdictions and briefly discuss the problem of medical tourism for germline gene editing in the absence of such harmonization.

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Authors and Affiliations

  1. Harvard Law School, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Harvard University, Cambridge, MA, USA

    I. Glenn Cohen

  2. The Warren Alpert Medical School, Brown University, Providence, RI, USA

    Eli Y. Adashi

  3. Bioethics Program, Department of Social and Preventive Medicine, School of Public Health, University of Montreal, Montreal, Quebec, Canada

    Vardit Ravitsky

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  1. I. Glenn Cohen
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  3. Vardit Ravitsky
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Correspondence to I. Glenn Cohen.

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Cohen, I.G., Adashi, E.Y. & Ravitsky, V. How bans on germline editing deprive patients with mitochondrial disease. Nat Biotechnol 37, 589–592 (2019). https://doi.org/10.1038/s41587-019-0145-8

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