人类生殖系基因编辑的法律规制研究

A Study on the Legal Regulation of Human Germline Gene Editing

人类生殖系基因编辑存在脱靶效应、嵌合体效应的安全风险和损害人类尊严、侵害后代自由选择权、加剧社会不平等的伦理风险,有法律规制必要性。现有法律规制存在民法、行政法、刑法界限模糊,损害结果与路径高度不确定、结果难以归责等规范适用困境。应结合法益侵害与行为模式对责任边界加以明确,宜主张报应到预防理念转变重塑归责进路。据此,存在重大安全风险的基因编辑才可构成刑事犯罪;具有较低程度安全风险的基因编辑属于行政违法的范畴;仅侵犯胚胎人格权的行为属于民事违法。在归责层面,可建立客观归责论和规范责任论。

Human germline gene editing has safety risks of off-target effects,chimera effects,and ethical risks that undermine human dignity,infringe on the right of future generations to freely choose,and exacerbate social inequality,and there is a need for legal regulation.Existing laws and regulations have difficulties in the application of norms,such as blurring the boundaries between civil,administrative and criminal law,highly uncertain damage results and paths,and difficult attribution of results.The boundary of responsibility should be clarified in combination with the infringement of legal interests and the mode of behavior,and it is appropriate to advocate the transformation of the concept of retribution to the concept of prevention to reshape the path of attribution.According to this,gene editing that presents a significant safety risk can constitute a criminal offence;gene editing with a low degree of security risk falls under the category of administrative offences;infringement of embryonic personality rights alone is a civil offense.At the level of attribution,the theory of objective attribution and the theory of normative responsibility can be established.