Gene drives and biosecurity
A living literature review by the ICGEB Regulatory Science Group examines the potential dual-use implications of gene drive technologies and identifies priorities for responsible oversight, environmental monitoring and international cooperation.
Developed within the ICGEB Regulatory Science Group, Monitoring Gene Drives is an open, continuously updated resource that analyses and contextualises scientific evidence to support regulators, policymakers, researchers and other stakeholders addressing the opportunities and risks of gene drive technologies.
Gene drives are genetic systems designed to increase the likelihood that a particular trait will be inherited, allowing it to spread through sexually reproducing populations over successive generations. They are being investigated for applications such as controlling disease-carrying mosquitoes, managing agricultural pests and reducing populations of invasive species. However, the same ability to spread beyond an individual organism or breeding line raises questions about containment, cross-border movement, accountability and response.
Engineered gene drive organisms are relevant to biosecurity due to potential unanticipated consequences of a release in nature, which may have adverse ecological effects in the release site or in neighbouring countries, raising questions concerning responsibility, liability and international notification. While catastrophic events caused by gene drives are still speculative, they provide a reference for biosecurity analysis, which can identify where emerging capabilities and technologies might intersect with weak oversight, limited surveillance or unclear institutional responsibility.
In this respect, the ICGEB literature review confirms the widely recognised fragmentation of existing governance landscapes. Many biosecurity frameworks were developed around pathogens, toxins or specifically listed biological agents, which do not comprehensively capture potential negative side effects of emerging biotechnology products, such as engineered gene drive organisms. International agreements such as the Biological Weapons Convention could apply where engineered gene drive organisms are developed or used for hostile purposes but are less easily applied to ambiguous situations involving negligence, accidental release, poorly governed private research or cross-border spread from an ostensibly peaceful project. Biosafety regulation, environmental law, export controls, institutional review and DNA-synthesis screening each address parts of the issue, but no single framework provides comprehensive coverage.
The review proposes a layered approach to risk reduction that combines technical safeguards, institutional oversight and responsible information governance by bringing together physical containment with molecular, reproductive and ecological safeguards, while embedding dual-use considerations into institutional and funding reviews. It also emphasises responsible management of access to sensitive materials, sequences and protocols.
Read the full living literature review: Gene drives and biosecurity: Dual-use risks, governance gaps and monitoring needs
