Blurred lines: law, science, and the regulation of dual-use biological research

Akhila Anand
Zerodha, Bangalore
akhilaanand9@gmail.com

Introduction

Covid-19 has shown the world how catastrophic biological threats can be, although it was not a byproduct of scientific research. Portions of scientific research have always straddled the line between science that can be weaponised or used for genuine progress. This is the core of dual-use research of concern (DURC). How much should law regulate life sciences research, and where is the line drawn for what should be made publicly available?

With artificial intelligence (AI) accelerating research across domains, the law governing DURC and biodefence globally needs to keep pace. For instance, in 2022, an open-source AI model generated 40,000 potential bioweapon molecules in a matter of hours. Even for those of us not in academia or scientific research, that is easily indicative of why robust regulation is required.

This article explores the blurred lines between research for biodefence that can easily become DURC or bio-offence, examines Covid-related actions and AI-related threats, and proposes an adaptive legal framework to balance innovation and national security.

Origins and evolution of DURC

Dual-use research of concern is defined as research that, while intended for benefit, could be misused to pose a significant threat to public health, agriculture, or national security. The United States, for example, lists 15 high-consequence pathogens and toxins, including ‘Pathogens with Enhanced Pandemic Potential’ that require institutional and federal review with mandatory risk mitigation plans.

Dual-use research has been a concern since the early 20th century: it started with the Haber-Bosch process, which helped enable creation of both fertilisers and munitions for World War I. In life sciences, this began at the 1975 Asilomar Conference on Recombinant DNA. Scientists voluntarily paused their work and established guidelines for self-regulation to ensure biosafety. However, as biotechnology advanced, state and non-state actors recognised the potential of biological research for both defence and offence. Once they began acting on this, the need for binding legal frameworks grew.

The US and Soviet Union both ran biological weapon programmes. By the 1960s, the European idea to stop such programmes had gained popularity, leading to the Biological Weapons Convention (BWC) in 1972; the first multilateral treaty to prohibit development, production and stockpiling of biological weapons. However, it lacked stringent verification and enforcement mechanisms.

Despite being a BWC signatory, the Soviet Union covertly ran its infamous Biopreparat programme – one of the world’s largest biological weapons programmes, employing tens of thousands under the guise of civilian research. Despite US and UK scientists visiting for inspections, the Soviet Union managed to keep the extent hidden for decades. The programme weaponised anthrax, smallpox and other pathogens, often genetically modifying them for increased virulence: a clear BWC violation. This shows the loopholes of verification and enforcement, gaps that must be addressed in any future biosecurity legislative framework.

A landmark example of proactive executive initiative is the 2011 H5N1 avian flu controversy. Two research teams engineered the virus to be transmissible between mammals. The US National Science Advisory Board for Biosecurity intervened, recommending redaction of key methods before publication: a rare instance of pre-publication censorship in science.

The Covid-19 era

The Covid-19 pandemic, while not a byproduct of DURC, exposed the extent and intensity of biological risk for the first time in decades. Legal responses to Covid can be used to draw parallels to how intentional national biosecurity threats may be dealt with.

In Australia, the Federal Court upheld international travel restrictions under the Biosecurity Act 2015 in LibertyWorks Inc v Commonwealth (2021), prioritising public health over individual rights. This established judicial deference to executive authority during biosecurity emergencies, raising fundamental questions about constitutional proportionality. Similarly, the EU invoked various laws to restrict vaccine raw material exports, citing biosecurity and resource allocation. In the US, executive action has continued to restrict gain-of-function research funding, citing Covid-19 concerns.

Such actions have set precedent for governments to invoke extraordinary legal powers to manage biosecurity risks, even at the expense of civil liberties or international cooperation.

Global comparision

In national legislation and policy, three themes around biosecurity stand out: scope of regulation, enforcement, and adaptability.

Scope of regulation

The US and European Union both base their regulation on lists of high-risk agents or technology. The US focuses on a defined set of pathogens requiring institutional and federal-level review. The EU has a broader approach, also covering technology including gene synthesis tools that require export licences. The World Health Organization’s (WHO) guidance provides best practices globally, as informal law that is not binding on WHO members.

In Asia, China has a state oversight model. The Export Control Law (2020) mandates government approval for all high-risk biotechnology research and criminalises unauthorised possession or transfer of engineered pathogens. India’s approach leans towards biodiversity protection through its Biodiversity Act 2002, following a post facto enforcement approach. Several South American countries like Brazil lack DURC regulation despite being BWC parties, while Southeast Asian countries have adopted WHO-style biosafety protocols but rely on non-binding guidelines.

Enforcement

Global North jurisdictions differ significantly in enforcement. The US adopts a layered approach – funding restrictions, administrative penalties and criminal liability. The EU primarily uses administrative enforcement through denial of export licences and financial penalties, such as Germany’s decision to block CRISPR technology exports to Iran. However, criminal sanctions are rarely imposed.

In much of the Global South, enforcement remains minimal, relying on soft mechanisms like biosecurity training and lab audits, often funded by international organisations.

With enforcement, a key factor is proportionality: does intent matter, or is national security always paramount? This needs to be balanced with effective ability to enforce. Additionally, these laws usually place liability on individuals, raising questions about whether institutional accountability should extend to universities and laboratories, given that ideas, resources and mentorship for such research arise from institutional support.

Adaptability

The Covid-19 pandemic exposed the limits and strengths of legal adaptability. The EU used flexibility in its Dual-Use Regulation to add pandemic-relevant goods such as sequencing tools to its export control list. China rapidly expanded its Biosecurity Law in 2020, mandating centralised approval and reporting for pathogen-related research. India used legacy legislation to enforce lockdowns but made no structural change to its DURC regulation in response to Covid-19.

The intersection of AI with synthetic biology has introduced new oversight challenges. In the US, agencies issued updated guidance for projects using AI in sequence prediction and gene synthesis, and executive action has required federal review of AI projects with biological sequence generation capability. The EU’s AI Act contains provisions for high-risk AI applications in biotech, and the 2024 amendment to its Dual-Use Regulation includes AI-driven gene synthesis platforms as controlled items. India has not yet introduced AI-specific governance in biotech research, leaving a gap in oversight as AI tools become more accessible.

Recommendations and conclusion

The key takeaway is that regulatory alignment is required across countries to ensure risks do not pass from nation to nation. Ideally, global treaties should have better verification and enforcement mechanisms to keep all signatory countries on an equal playing field.

No jurisdiction has developed a comprehensive regulatory framework that adequately addresses all DURC challenges. The US and EU emphasise pre-publication and export controls; China uses centralised punitive enforcement; India is building capacity but remains reactive; and several other countries do not have specific DURC frameworks.

An ideal international framework should be enforceable, have verification and a complaints mechanism independent of a separate body like the UN Security Council, and allow AI and synthetic biology work only within regulated, auditable environments.

There should not be blanket bans or restrictions without the opportunity to review, and actions should follow the proportionality principle. This will help ensure that restrictions on research are commensurate with the potential risks. Legal frameworks should incorporate mechanisms for case-by-case assessments, allowing for subject matter inputs and nuanced judgements. An overly broad or restrictive approach could stifle innovation and drive research underground, making oversight more difficult or easier for bad actors to access.

Furthermore, legislation must have adaptable facets, evolving in response to new scientific developments and emerging threats. This adaptability necessitates ongoing dialogue between scientists, policymakers, and legal experts, to ensure that regulations remain relevant and effective without unduly hindering beneficial research.