Abstract

Technological developments in gene editing raise high expectations for clinical applications, first of all for somatic gene editing but in theory also for germline gene editing (GLGE). GLGE is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if GLGE 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 the 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 Executive Committee and the Board of the respective Societies in May 2017. Taking account of ethical arguments, we argue that both basic and pre-clinical research regarding GLGE can be justified, with conditions. Furthermore, while clinical GLGE would be totally premature, it might become a responsible intervention in the future, but only after adequate pre-clinical 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 PGD 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.

Highlights

  • Recent research and expected further studies in gene editing raise high expectations, especially regarding possible therapeutic applications in humans

  • What were the arguments behind this legislation, do they still apply 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? Discussion with relevant stakeholders is needed, including professional health care workers, patients and different groups of lay public, plus legal, and ethical experts

  • The European Society of Human Genetics (ESHG) and the European Society of Human Reproduction and Embryology (ESHRE) consider it to be their professional responsibility to contribute to further discussion by means of a set of Recommendations, based on a Background document, focusing on human germline gene editing (GLGE)

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Summary

Introduction

Recent research and expected further studies in gene editing raise high expectations, especially regarding possible therapeutic applications in humans. The European Society of Human Genetics (ESHG) and the European Society of Human Reproduction and Embryology (ESHRE) consider it to be their professional responsibility to contribute to further discussion by means of a set of Recommendations, based on a Background document, focusing on human germline gene editing (GLGE).

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