Department of Health, Ethics and Society, Research Institutes GROW and CAPHRI, Fac. of Health, Medicine and the Life Sciences, Maastricht University, Maastricht, The Netherlands.
Bioethics Institute Ghent, Department of Philosophy and Moral Science, Ghent University, Ghent, Belgium.
Eur J Hum Genet. 2018 Apr;26(4):445-449. doi: 10.1038/s41431-017-0076-0. Epub 2018 Jan 12.
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.
基因编辑技术的发展为临床应用带来了很高的期望,首先是体细胞基因编辑,但理论上也包括种系基因编辑(GLGE)。目前,许多国家都不允许进行 GLGE。这使得这些国家现在无法进行临床应用,即使 GLGE 变得安全有效。这项立法背后的论据是什么,它们仍然有说服力吗?如果一种技术能够以安全有效的方式帮助避免严重的遗传疾病,这是否是重新考虑早期观点的一个理由?欧洲人类生殖与胚胎学会(ESHRE)和欧洲人类遗传学学会(ESHG)共同制定了一份背景文件和建议,以告知和推动正在进行的社会辩论。在咨询其成员和专家后,这一建议的最终版本于 2017 年 5 月得到了两个学会的执行委员会和理事会的认可。考虑到伦理论点,我们认为,只要有条件,GLGE 的基础研究和临床前研究都可以得到证明。此外,虽然临床 GLGE 还为时过早,但在进行充分的临床前研究后,它可能成为未来负责任的干预措施。儿童和后代的安全是一个主要关注点。未来的讨论还必须解决生殖和潜在非生殖替代方案之间的优先事项,如 PGD 和体细胞编辑,如果这些方案是安全和成功的。然而,禁止人类种系修饰需要包括公众和立法者在内的相关利益攸关方重新讨论。