Legal issues regarding gene editing at the beginning of life: an EU perspective

Abstract

The development of clustered regularly interspaced short palindromic repeats (CRISPR)–Cas gene-modification technologies has opened impressive possibilities for the biomedical sciences. However, their application to human embryos and early fetuses has raised huge ethical and legal discussions because it affects the human germline. This paper provides a critical and in-depth analysis of the current legal framework on this topic in the EU context and at the national level in the member states. It also offers an alternative interpretation of the regulation, so as to help researchers, practitioners, policy makers and society as a whole to find efficient responses to challenges that cannot wait for a legally updated answer. As a final result, this paper will show that eugenic uses of CRISP–Cas and any kind of modification intended to alter the human germ line are generally banned in the EU context, while basic research on human embryos is mostly permitted. The legal status of therapeutic applications of CRISPR–Cas on early fetuses, however, has not been adequately addressed by the EU zone regulation.