Synthetic nucleic acids (custom DNA and RNA sequences) are routinely ordered from commercial providers and are essential inputs to vaccines, diagnostics, therapeutics, agriculture and industrial biotechnology. At the same time, the systems that enable rapid ordering and delivery of genetic material, may also allow access to sequences associated with hazardous biological functions. Screening, which involves checking both ordered sequences and customer legitimacy, has therefore been identified internationally as a key biosecurity safeguard.
However, across the European Economic Area (EEA), screening remains largely voluntary and unevenly implemented, raising concerns about regulatory arbitrage, market fragmentation and the distribution of security responsibilities between private actors and society.
Against this background of expanding technological capability, increasing accessibility and growing policy attention, RAND Europe sponsored by Sentinel Bio, developed a European-level cost–benefit assessment of alternative policy pathways for expanding synthetic nucleic acid synthesis screening. Rather than advocating a single regulatory outcome, it evaluates trade-offs between policy options and clarifies their expected societal implications. The analysis models three policy approaches over a ten-year horizon: voluntary guidance, conditionality linked to EU funding and procurement, and mandatory EU-wide regulation. It incorporates uncertainty surrounding rare, high-consequence biological incidents and accounts for compliance costs, research disruption, and expected reductions in accidental or deliberate misuse, including attempted evasion through non-EU providers.
The overall aim of the study was to provide a transparent, comparable basis for evaluating costs, implementation implications and societal impacts under different regulatory designs, thereby supporting evidence-informed and proportionate decision making.
All policy pathways deliver net societal benefit, with non-linear gains as coverage expands
All policy pathways generate positive societal benefits. Benefits rise disproportionately as screening coverage expands because higher coverage improves direct detection, increases deterrence of misuse attempts, and reduces the availability of non-compliant suppliers that enable evasion. Under conservative assumptions, these risk-reduction benefits exceed compliance and research-related costs.
Policy strength strongly affects outcomes
Voluntary measures deliver modest gains (€193 million annually), conditionality linked to EU funding yields substantially larger benefits (€1.1 billion annually), and mandatory EU-wide screening provides the largest and most comprehensive impact (€4.6 billion annually), generating roughly €6 in avoided losses per €1 spent.
Internal market harmonisation matters
EU-level alignment protects responsible providers from competitive disadvantage, reduces market fragmentation and limits displacement of orders to weaker screening regimes within the EEA.
Implementation design determines policy performance
Cost estimates in the model are highly conservative and policy performance depends on clear requirements, phased rollout and alignment with existing screening practices to minimise administrative burden, particularly for small- and medium-sized enterprises (SMEs).
Regulatory precedent adds international value
Behavioural spillovers from internationally active suppliers may create additional risk reduction beyond the EU’s jurisdiction, increasing estimated benefits by roughly 50% without proportionate increases in EU enforcement costs.
Policy choice affects security and innovation together
More comprehensive coverage strengthens biosecurity while maintaining an open research ecosystem, provided regulatory design minimises friction in legitimate research activity.
The research described in this report was sponsored by Sentinel Bio and conducted by RAND Europe.
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