《生物安全法》实施背景下对合成生物学的监管

Regulation of synthetic biology under background of implementing Biosafety Law

2020年10月17日,全国人大常委会通过了《中华人民共和国生物安全法》(简称《生物安全法》)并自2021年4月15日起施行。《生物安全法》是我国第一部生物安全领域的带有基础性、全局性的框架法,只规定基本的原则和要求。生物技术的研究与应用安全、病原微生物实验室生物安全、防范生物恐怖及生物武器威胁是《生物安全法》所涉及的8个方面生物安全风险中的3个主要内容,而合成生物学又与这3个方面紧密相关。合成生物学作为近几年全球的研究热点和颠覆性的前沿生物技术,可以应用于人工合成病毒或细菌,存在制造生物恐怖和生物武器的风险及威胁,其监管也备受关注。本文首先阐述了《生物安全法》的实施对生物技术安全发展的意义,然后介绍了合成生物学的定义和发展现状,并分析了合成生物学面临的生态安全、生物防御和生物伦理三大风险,综述了合成生物学在各国的监管现状,指出《生物安全法》的出台为我国合成生物学的管理制定了框架,最后,提出在法律层面和技术层面如何更好地加强合成生物学风险的预防及管控。

The Standing Committee of the National People’s Congress passed the Biosafety Law of the People’s Republic of China(referred to as the Biosafety Law)and came into force since April 15,2021.The Biosafety Law is the first framework law of biosafety with a fundamental and overall nature in China,which only stipulates basic principles and requirements.The security of research and application of biotechnology,the biosafety of pathogenic microorganism laboratories,and the prevention of bioterrorism and biological weapons threats are the three main contents of the eight aspects of biosafety risks involved in the Biosafety Law,and synthetic biology is closely related to these three aspects.Synthetic biology,as a hotspot of global research and disruptive cutting-edge biotechnology in recent years,can be applied to artificially synthesized viruses or bacteria.There are risks and threats of creating bioterrorism and biological weapons,and its regulation is of great concern as well.This article first expounds the significance of implementing the Biosafety Law to the development of biotechnology safety,then introduces the definition and development of synthetic biology,analyzes the risks faced by synthetic biology,reviews the regulation of synthetic biology among different countries,and points out that the introduction of the Biosafety Law has established a framework for the management of synthetic biology in China.Finally,it proposes how to better strengthen the prevention and control of synthetic biology risks at the legal and technical levels.