美国生物技术产业发展的法律保障及其启示  

Legal Protection of Biotechnology Industry in the United States and Its Implications

作　　者：秦天宝[1] 刘安翠 

机构地区：[1]武汉大学环境法研究所 [2]荷兰马斯特里赫特大学法学院

出　　处：《学术研究》2017年第3期53-61,70,共10页Academic Research

基　　金：国家社科基金重点项目"生物技术及其产业发展的法律保障机制研究"(11AZD105);教育部人文社会科学重点研究基地重大课题"国外环境法理论与实践的最新发展--兼论新时期中国环境法律的发展"的阶段性成果

摘　　要：美国鼓励和支持生物技术产业的发展,同时鼓励科技创新和技术转让、确保充足的技术研发投入、保护知识产权,促进了生物技术产业发展。根据《生物技术管理协调框架》,美国在既有法律体系之下建立了以产品为基础的生物安全管理法律体系,以防范生物技术产业可能产生的风险。农业部动植物检疫局、环境保护局、食品与药品管理局是主要的安全管理机关。美国生物技术产业发展法律保障的理念是平衡安全和效率,其监管方式灵活开放。加强生物技术产业管理机关的协调性、生物技术产业的发展要以安全性为基础、科学全面地进行生物安全评价、加强批后监管,这是美国生物技术产业发展法律保障的启示。The United States encourages and supports the development of biotechnology industry.The paper analyzes the legal framework in this regard from the perspective of industry promotion and risk management.By means of legislation,the US encourages scientifi c innovation and technology transfer,gives incentives to biotechnology research and development,and protects intellectual property.As a result,biotechnology industry in US develops rapidly.According to the Coordinated Framework for Regulation of Biotechnology,the US has constructed a unique legal framework on the basis of pre-existing legislation which may prevent potential risks associated with biotechnological products.Key agencies regarding the risk management of biotechnology are composed of the Animal and Plant Health Inspection Service(APHIS)within the United States Department of Agriculture,the Environmental Protection Agency,and the Food and Drug Administration.Its primary goal is to balance safety and effi ciency.Moreover,the legal measures taken by the United States are fl exible and welcome public involvement.The implications are to increase coordination of competent authorities,to take safety as the basis of developing the biotechnology industry,to conduct safety assessment thoroughly and to enhance post approval supervision.

关 键 词：生物技术产业 产业促进 风险方法 

分 类 号：D912.1[政治法律—宪法学与行政法学]