基因编辑的类型化分析与法律规制进路

Typological Analysis of Genome Editing and Its Legal Regulation Approach

人体基因编辑的正当性边界为基因治疗还是基因增强颇具争议。在伦理与法哲学视域下,基于福克斯的自由主义正义观,出于对人自主发展权、人格尊严等基本人权的维护和对当前人类社会伦理道德观与自然演进秩序的保护,应当允许基因治疗而禁止基因增强。明确基因编辑应用类型的边界后,法律规制基因编辑的进路为,在分析其带来的加剧社会不平等的风险、生物安全与致害风险、隐私与个人信息泄露风险的基础上,采取社会许可理论下基因编辑的普遍获得、包容审慎的分级监管思路,进而构建事前的人权影响评估与公共承运人制度、事中的多元化风险评估与包容审慎分级监管框架,确立事后的基因编辑归责原则,动态闭环地规范基因编辑应用的秩序。

Many controversies exist surrounding the legitimate boundary of human genome editing-whether it is gene therapy or genetic enhancement.From the perspectives of ethics and philosophy of right,based on Keith Faulks's liberal conception of justice,gene therapy should be allowed while genetic enhancement should be prohibited,in order to safeguard basic human rights such as the right to independent development and human dignity,and to protect the existing ethics ideology and natural evolution order of human society.Upon clarifying the boundaries for the types of genome editing applications,the approach to legal regulation of genome editing is as follows:based on the analysis of the risk of increasing social inequality,risk of biosecurity and damage,as well as the risk of privacy or personal information leakage brought about by genome editing,adopt an inclusive,prudential hierarchical supervision approach featuring universal access of genome editing under the social license theory,and then construct an ex ante human rights impact assessment and common carrier system,an in-process framework of diversified risk assessment and inclusive and prudential hierarchical supervision,as well as an expost principle of attribution regarding genome editing,thus forming a dynamic closed loop for regulating the order of genome editing applications.