主要国家生物技术安全管理体制简析

Brief Analysis of Major National Biosafety Regulatory Regimes

生物技术作为两用技术,既有积极的一面,同时也存在因为误用和滥用,给人口健康、生态环境、国家安全造成威胁的可能。发达国家高度重视生物技术的两用性问题,利用生物安全的理念和手段保障生物技术的健康发展,建立了相应的法律法规体系和管理制度,形成了相应的管理体系。本文首先重点介绍了美国、俄罗斯和英国生物技术安全管理的立法体系及管理体制,研究发现,美国采取分头管理机制,通过立法明确了各部门的职责,针对生物技术还颁布了专门的规章,建立了专门的咨询机构;俄罗斯和英国则采取集中管理的机制,成立了专门的管理机构。随后,本文结合我国生物安全法律制度体系、生物技术安全管理方面存在的问题,包括生物安全立法方面相对滞后,生物安全管理体系存在重利用、轻监管,各部门管理职责分散,缺乏统一有效领导等,提出建立健全我国生物技术安全管理体制的针对性建议,包括加强生物技术研究和应用的风险评估、完善政策和管理体系以及加强国际合作3条建议。

As a dual-use technology,biotechnology has both a positive side and the possibility of threatening the health of the population,the ecological environment,and national security due to misuse and abuse.Most developed countries attach great importance to the dual-use of biotechnology,they established corresponding laws and management system,using the concept and means of biosecurity to ensure the healthy development of biotechnology.This article first focuses on the legislative system and management system of biotechnology safety in the United States,Russia and the United Kingdom.It is found that the United States adopted a separate management mechanism,clarified the responsibilities of various departments through legislation,promulgated special regulations for biotechnology,and established specialized consulting agencies.Russia and the United Kingdom have adopted a centralized management mechanism and established special management agencies.Subsequently,taking into account the problems in China’s biosafety legal system and biosafety management,including the relative lag in biosafety legislation,the emphasis on utilization rather than supervision in the biosafety management system,the dispersion of management responsibilities among departments,and the lack of unified and effective leadership,the paper puts forward targeted recommendations for establishing and improving China’s biosafety management system,including strengthening risk assessment in biotechnology research and application,improving policies and management systems,and strengthening international cooperation.