A soft law perspective on the governance of biorisks in synthetic biology

LI Yujuan

doi:10.12211/2096-8280.2025-058

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A soft law perspective on the governance of biorisks in synthetic biology

Invited Review | 更新时间：2026-01-15

- A soft law perspective on the governance of biorisks in synthetic biology
- Synthetic Biology Journal Vol. 6, Issue 6, Pages: 1384-1397(2025)
- 作者机构：
  
  1.澳门大学法学院，澳门 999078
  2.中国科学院深圳先进技术研究院，定量合成生物学全国重点实验室，深圳合成生物学创新研究院，广东深圳 518055
- 作者简介：
- 基金信息：
- DOI：10.12211/2096-8280.2025-058
  CLC： D920.4;Q1
- Received：09 June 2025，
  
  Revised：2025-10-15，
  
  Published：31 December 2025
- 稿件说明：
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李玉娟. 合成生物学生物风险的软法治理［J］. 合成生物学， 2025， 6（6）： 1384-1397

LI Yujuan. A soft law perspective on the governance of biorisks in synthetic biology［J］. Synthetic Biology Journal， 2025， 6（6）： 1384-1397
李玉娟. 合成生物学生物风险的软法治理［J］. 合成生物学， 2025， 6（6）： 1384-1397 DOI： 10.12211/2096-8280.2025-058.

LI Yujuan. A soft law perspective on the governance of biorisks in synthetic biology［J］. Synthetic Biology Journal， 2025， 6（6）： 1384-1397 DOI： 10.12211/2096-8280.2025-058.

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。

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. Globally

nations are intensifying policy initiatives and resource allocations to secure strategic advantages in SynBio

seeking to harness its potential for biotechnological innovation and bioeconomic 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 i

ntentional 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 effe

ctively protecting the public interest.

关键词

Keywords

references

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