Human germline gene editing. Recommendations of the European Society of Human Genetics and the European Society of Human Reproduction and Embryology.*

Abstract

Technological developments in gene editing raise high expectations for clinical applications, first of all somatic gene editing but in theory also germline gene editing. The latter is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if germline gene editing would become safe and effective. What were the arguments behind this legislation, and are they still convincing? If a technique can help to avoid serious genetic disorders, in a safe and effective way, would this be a reason to reconsider earlier standpoints? The European Society of Human Reproduction and Embryology (ESHRE) and European Society of Human Genetics (ESHG) together developed a Background Document and Recommendations to inform and stimulate ongoing societal debates. After consulting its membership and experts, this final version of the Recommendations was endorsed by the Board and Executive Committee of the Societies in April/May 2017. Taking account of ethical arguments, it is argued that both basic and preclinical research regarding human germline gene editing can be justified on conditions. Furthermore, while clinical germline gene editing would be totally premature, it might become a responsible intervention in the future, but only after adequate preclinical research. Safety of the child and future generations is a major concern. Future discussions must also address priorities among reproductive and potential non-reproductive alternatives, such as preimplantation genetic diagnosis and somatic editing if that would be safe and successful. The prohibition of human germline modification, however, needs renewed discussion among relevant stakeholders, including the general public and legislators.