基因编辑技术应用风险的法律规制

The Legal Regulation of Risk in the Application of Gene Editing Technique

新一代基因编辑技术使基因定位和精准修改成为现实,在农业、医疗、环保等领域应用前景广阔,但随之而来的是风险不确定性问题。这种风险不确定性源于技术上的脱靶效应和应用中的伦理争议,尤其集中于临床应用领域和农业育种领域,并呈现多元利益诉求。通过对欧美有关法律规制比较分析,发现立法模式、监管手段与法律体系等关系着基因编辑技术应用风险治理的实践效果。着眼我国实践情况,现有的法律规定和传统的法学理论尚不足以调控基因编辑技术及其风险,为此应立足基因编辑技术自身特质及其产品治理需求,以产品导向的立法模式指导并制定生物技术专门法,重点完善科学的风险预防制度体系和伦理审查制度体系,健全现有生物技术监管体系并强化程序性权利,从而系统性地回应基因编辑技术应用风险治理的法律问题。

Gene editing technique,a kind of gene engineering technique making gene positioning and accurate modifying come true,has been widely used in fields of agriculture,medicine and environmental protection.However,the risk and uncertainty come with the advent of gene editing technology,which originates from the off-target effects and ethical dispute in applications,especially for clinical practice and agricultural breeding and presents in a manner of diverse interests.After a comparative study of laws and regulations of gene editing technique in US and Europe,this paper finds that there is a close relationship between the practice effect of risk management and legislation pattern,administrative means and legal system.As for China,current laws and regulations,together with the traditional legal theory,are far from adequate to regulate the technology and its potential risk.Therefore,there is a necessity to compile specialized laws on biotechnology based on its personal traits and the governance needs of products,improve the risk-preventing system and ethic censorship,better the on-going biotechnology supervision system and reinforce the procedural right so as to systematically respond to the risk management issues in the application of gene editing technique.