人体基因编辑活动的协同规制——以《民法典》第1009条为切入点

Title:Collaborative Regulation of Human Gene Editing Activities——Taking Article 1009 of the Civil Code as the Starting Point

从《民法典》第1009条来看,对于与人体基因有关的医学和科研活动,立法者选择的是一种协同规制的路径。从人体基因编辑活动的损害对象、潜在风险、法律影响以及人体基因编辑技术的发展趋势等方面来看,协同规制都是必然选择。面对人体基因编辑活动,宪法应重点回答基本原则、行为边界和国家补偿等问题,民法应重点关注人格尊严原则的有效适用、基因编辑人本人及其父母的损害救济、基因编辑人的隐私与个人信息(私密信息)保护等问题。尽管《刑法》(2020年修正)解决了专门罪名缺失的问题,但后续立法仍需适当加重法定刑并考虑给基因编辑人增加特别义务。为强化对人体基因编辑活动的行政法规制,应设定行政许可、完善行政监管、强化行政处罚、重视行政指导并落实后续跟踪。尽管人体基因编辑活动的潜在风险很大,但只要找到理想的协同规制方案,就可以将风险控制在合理限度内。

According to Article 1009 of the Civil Code,legislators choose a collaborative regulation approach for medical and scientific research activities related to human genes.In terms of the damage objects,potential risks,legal impact and the development trend of human gene editing technology,collaborative regulation is an inevitable choice.In the face of human gene editing activities,the Constitution should focus on answering questions of basic principles,boundaries of conduct,state compensation and other issues,while the Civil Law should focus on the effective application of the principle of human dignity,the remedies for damages to the genetically edited people themselves and their parents,and the protection of privacy and personal information(private information)of the genetically edited people.Although the lack of specific provisions on gene editing has been resolved by Criminal Law(Amended in 2020),subsequent legislation will need to aggravate the statutory penalties and consider adding special obligations for gene editors.In order to strengthen the administrative regulation of human gene editing activities,administrative permits should be established,administrative supervision should be improved,administrative penalties should be strengthened,administrative guidance should be emphasized and follow-up should be implemented.Despite the high potential risks of human gene editing activities,the risks can be reasonably controlled if an ideal synergistic regulatory solution is found.