Frontiers Article on NA synthesis screening

Innovation needs trust: Why Europe should see biosecurity screening as an enabler of biotechnology

Europe's biotechnology sector is entering a period of rapid transformation. Synthetic nucleic acid technologies are accelerating breakthroughs in healthcare, diagnostics and sustainable manufacturing, while AI is expanding the speed and scope of biological research. Together, these developments have the potential to deliver enormous benefits for society, but they also create new biosecurity risks that Europe must be prepared to manage.

So the question becomes, how can Europe support innovation while ensuring these powerful technologies are used responsibly?

A new peer-reviewed paper published in Frontiers by Sophie Peresson and Patrick Stadler offers one practical answer. The authors argue that nucleic acid synthesis screening should be seen not as a barrier to innovation, but as an enabler of it. The paper focuses on a key challenge facing policymakers: how to implement screening consistently across the European Union.

Peresson and Stadler propose a harmonised EU framework for nucleic acid synthesis screening to operationalise the proposed EU Biotech Act through two complementary mechanisms: Know Your Customer (KYC) verification and sequence screening against Sequences of Concern (SOC). Using existing international standards as a reference, the framework aims to create a consistent baseline for providers across Europe while remaining risk-based, proportionate and interoperable with international approaches.

A central finding of the paper is that today's largely voluntary screening arrangements leave important coverage gaps, particularly for smaller providers and the growing use of benchtop synthesis devices. Binding, harmonised EU obligations can help close these gaps while reducing regulatory fragmentation, lowering compliance uncertainty and providing researchers and biotechnology companies with a more predictable operating environment.

Rather than forcing a choice between competitiveness and security, the paper argues that effective implementation strengthens both. A trusted and consistent governance framework can support responsible research, encourage investment and reinforce Europe's biotechnology ecosystem.

As synthetic biology becomes increasingly accessible through commercial synthesis services, benchtop devices and AI-assisted design tools, Europe has a narrowing opportunity to establish practical governance approaches before fragmented regulatory systems become entrenched internationally. Decisions taken now could shape not only Europe's biosecurity resilience, but also global approaches to governing emerging biotechnologies.

Good governance is about more than setting ambitious objectives; it requires practical, evidence-based approaches that can be implemented effectively and adapt as technology evolves. This publication reflects Pour Demain's commitment to bridging policy and practice by exploring how Europe can operationalise nucleic acid synthesis screening in a way that is both effective and innovation-friendly.