The EU legal framework on clinical trials directed to therapeutic germline gene alteration: A critical and systematic analysis

Abstract

Interventions in the human germline, whether for purposes of therapy for a hereditary disease or for purposes of enhancement, are controversial. While enhancement is almost unanimously rejected, therapy-oriented intervention is not a priori regarded as unacceptable. The legal discussion so far has focused primarily on the questions of whether manipulation of the embryo’s germline is permissible or whether the genetic manipulation of germ cells and the use of these germ cells for embryo generation is permissible. Up to now, the upstream questions regarding the systematic germline therapy development in clinical trials have been ignored, including questions as to whether the development of germline therapy would be legally permissible within the European Union framework of clinical studies. This article highlights the legal issues connected with the clinical development of germline intervention, provides an overview of the various answers to these legal questions, and indicates where further research and discussion are needed.