14 - The Regulation of Human Germline Genome Modification in France

Summary

In France, civil law provisions on research involving human subjects, on donation and use of human body parts, and on medically assisted reproduction – originally developed between 1988 and 1994 and generally referred to as loi de bioéthique (law on bioethics) – specify whether and under which statutory conditions activities potentially leading to human germline genome modification can be undertaken. International law, including European law, poses further conditions. This chapter explores legislative and regulatory constraints on this type of research in France, analyzing how they developed over time to reach their present state. We will show that, in France, it is prohibited to create a human embryo solely for research purposes; that, however, research activities on supernumerary embryos and human embryonic stem cells are possible upon authorization by the national agency on biomedicine; but that, nevertheless, alterations to the genome of an embryo under circumstances that allow the modifications to pass on to future generations (i.e. through a successful pregnancy) are strictly prohibited. A peculiar feature of French legislation in this domain is that the law on bioethics is regularly updated in light of new technological or scientific developments, and as a result of a national public consultation held at least every five years. In 2018 one such rounds of public consultation took place, and a report summarizing its outcome is now being considered as the basis for possible legislative reform – including in the domain of genetic engineering. While it is not possible to anticipate future legislative developments, the report signals some degree of openness in the French civil society regarding the use of genetic engineering and genome editing, at least in the context of research.