Biosecurity Law in the Age of Synthetic DNA: Closing the Regulatory Gap

New ACHS research examines how existing international and national biosecurity laws apply to synthetic nucleic acids, identifies significant gaps in regulatory oversight, and proposes a roadmap for reform in the age of synthetic biology and AI.

For decades, governments have tightly regulated access to dangerous pathogens. Yet the genetic material needed to recreate some of these same pathogens can now be synthesised and obtained without triggering equivalent regulatory controls. This exposes a fundamental gap in modern biosecurity law.

A new report, Synthetic Nucleic Acids and Biosecurity Law: Mapping the Global Legal Landscape and a Roadmap for Reform, written by Honorary Visiting Assoc Prof Ayelet Berman and published by the Asia Centre for Health Security (ACHS), examines this regulatory challenge and sets out a roadmap for reform.

The problem

Synthetic nucleic acids (SNAs)—DNA and RNA produced directly from digital sequence information—are transforming biological research and biotechnology. But they can also be used to reconstruct dangerous pathogens without access to the original biological material.

As DNA synthesis becomes cheaper and more accessible, advances in AI-assisted biological design and benchtop synthesis devices are creating further challenges for biosecurity oversight. Yet, most existing laws were designed to regulate whole or naturally occurring pathogens, rather than the synthetic genetic material that can be used to recreate them.

What does the report find?

Drawing on an analysis of international legal instruments and national regulatory frameworks across Asia, Europe, North America, and Australia, the report identifies significant gaps in existing biosecurity laws.

At the international level, it finds that existing instruments, including the Biological Weapons Convention, UN Security Council Resolution 1540, and the International Health Regulations, provide a legal foundation for governing SNAs. Rather than negotiating a new treaty, the priority should be to clarify how existing obligations apply and strengthen their national implementation.

At the national level, the legal landscape is fragmented. Many countries lack legal biosecurity frameworks altogether. Among those that have them, most focus on whole or naturally occurring pathogens and do not cover SNAs. In others, the legal language is broad enough to encompass SNAs, but its application in practice remains ambiguous and uncertain. Even those that expressly regulate SNAs often fail to address novel sequences of concern, shorter genetic fragments, and benchtop devices.

The report also identifies inconsistencies between domestic biosecurity laws and export controls. Some synthetic genetic materials are regulated when exported but remain outside comparable domestic controls.

A roadmap for reform

The report proposes modernising existing biosecurity laws by amending their definitions and scope to expressly cover relevant SNAs and introducing tiered, risk-based controls.

Crucially, it argues that DNA synthesis screening alone is insufficient. Screening can help prevent the acquisition of dangerous genetic material, but does not govern its subsequent possession, storage, transfer, use, or disposal. Effective biosecurity oversight must extend across the lifecycle of SNAs.

Forthcoming second report

This is the first of two reports under the ACHS Biosecurity Law in the Age of Synthetic Nucleic Acids project. A forthcoming second report will focus specifically on the regulation of DNA synthesis screening, examining regulatory approaches to sequence and customer screening, the legal tools available to governments, and opportunities for international alignment.