Abstract:

The enabling capabilities of synthetic biology (SynBio) are advancing at a rapid pace, with its applications increasingly integrated into daily life and generating significant social and economic impacts. Around the world, countries are intensifying policy efforts and resource investments to gain a strategic advantage in SynBio, aiming to harness its potential for biotechnology innovation and bioeconomy development. However, the development and application of SynBio are accompanied by emerging biorisks that may pose threats to human health and ecological security. These biorisks can be broadly categorized into two types: first, subjective biorisk arising from the intentional misuse of technology, such as illegal germline gene editing, bioterrorism, and the development of biological weapons; and second, objective biorisk resulting from non-intentional factors, including technical errors, negligence, or the inherent uncertainty of the technology itself, such as pathogenic leaks, gene escape, and biological invasions. Striking a balance between fostering innovation and ensuring safety has become a critical challenge for policymakers. In China, both hard law and soft law mechanisms respond to SynBio-related biorisks through different pathways. However, hard law-based governance faces structural difficulties, including gaps or delays in existing legislation and the practical challenges of enacting timely amendments or developing specialized laws. These obstacles reflect a fundamental tension between the stability and conservatism of law and the rapid evolution of SynBio. In this context, soft law has emerged as a promising alternative. Its flexibility, inclusiveness, and non-binding nature make it particularly well-suited to the dynamic and complex nature of SynBio and its associated risk governance needs. This paper analyzes the nature of biorisks in SynBio, and the regulatory challenges posed by current hard law frameworks. It then proposes a soft law-based approach to address these gaps. Through a comparative analysis of extraterritorial practices—primarily those of the United States—in the soft law governance of biorisks in SynBio, this paper identifies three strategic pathways for advancing soft law governance in SynBio: (1) developing soft law instruments that align with existing legal and ethical principles; (2) fostering a collaborative governance model centered on scientist self-governance + government guidance for the R&D phase; and (3) promoting a co-governance structure of industry self- discipline + government oversight for the application phase. The overarching goal is to enable innovation in SynBio while effectively protecting the public interest.

Key words: synthetic biology, biorisks, soft law governance, scientist self-governance, industry self- discipline

摘要：

合成生物学赋能边界迅速拓展，赋能产品逐渐进入大众生活，产生了广泛的社会和经济影响。全球纷纷布局加大政策资源投入布局抢占合成生物学发展先机，以发挥合成生物学赋能生物产业和生物经济的潜力。与此同时，合成生物学研究开发与应用伴生潜在生物风险，可能引发对人类生命健康与生态系统的危害。如何平衡创新与安全，在促进合成生物学发展的同时防范其可能引发的生物风险，是摆在治理主体面前的难题。本文基于对合成生物学生物风险的分析，讨论现行硬法的规制困局，提出软法治理策略。通过对域外（以美国为主）合成生物学生物风险软法治理实践的考察，基于我国现状提出生物风险软法治理的未来进路：一是基于现有上位法及治理准则，制定与二者衔接相适配的软法；二是围绕具体技术的研究开发，构建“科学家自治+政府机构引导”协同机制；三是，围绕具体技术的应用，推动“行业自律+政府机构监督”共治模式，从而促进合成生物学的创新与发展，实现对社会公共利益的拓展与维护。

关键词: 合成生物学, 生物风险, 软法治理, 科学家自治, 行业自律