从基因编辑看欧美对新型基因修饰生物技术的监管及挑战  

The Regulation and Challenges of New Biotechnology in EU and US from the Perspective of Gene Editing

作　　者：唐伟华[1] TANG Wei-hua(Faculty of LAW,QingdaoUniversity)

机构地区：[1]青岛大学法学院

出　　处：《科学与社会》2023年第3期85-104,共20页Science and Society

摘　　要：近年来,为适应基因编辑技术的发展,欧美对各自监管GMO的法律框架做出了修正。其中,对于基因编辑植物和食品,欧美延续了宽严有别的监管取向。双方的分歧源于彼此对GMO生物风险的界定存在差异,这使得双方在风险评估取向上持不同立场,突出体现在对基因改造植物及食品的监管中。但是,双方对其它种类及用途的基因编辑生物尤其是非植物GMO的监管均表现出谨慎态度,并付之以程度不同的强化监管举措。更重要的是,随着新技术、新用途及应用场景的不断涌现,GMO生物风险的类型及作用方式也日趋多样化和复杂化。对此,现行的监管模式、经验及通行的风险评估方法已经难以满足监管需求。面对该挑战,场景化施策或具有合理性,但欧美针对基因驱动的“分阶段”治理中展现的利已导向值得我们关注和警惕。In recent years,in order to adapt to the development of genome editing technology,Europe and the United States have amended their respective legal frameworks for regulating GMO.Among them,for genome editing plants and food,Europe and the United States have continued the different regulatory orientation of leniency and strictness.The differences between the two sides stem from differences in their definitions of GMO biological risk,which leads to different positions on risk assessment,particularly in the regulation of genetically modified plants and food.However,both parties have shown a cautious attitude towards the supervision of other types and uses of genome editing Organisms(especially non plant GMO),and have taken various measures to strengthen supervision.More importantly,with the continuous emergence of new technologies,new uses,and application scenarios,the types and ways of action of GMO biological risks are becoming increasingly diverse and complex.In this regard,the current regulatory model,experience,and commonly used risk assessment methods are no longer sufficient to meet regulatory needs.In the face of this challenge,scenario based strategies may be reasonable,but the self-interest orientation demonstrated in gene driven"phased"governance in Europe and America is worth paying attention to and being vigilant.

关 键 词：欧美 基因修饰生物 基因编辑 生物安全 立法 

分 类 号：C936[经济管理—管理学]