Securing Europe's Biotech Future: Our Joint Contribution to the EU Biotech Act
- Laurent Bächler
- Jun 11
- 4 min read
Updated: Jun 18
Pour Demain submitted a joint contribution with 14 co-signees to the European Commission’s Call for Evidence on the EU Biotech Act, alongside colleagues from academia, industry, and civil society.
Our recommendations show how embedding biosecurity into EU biotech governance can strengthen innovation, bolster strategic autonomy, and build a high-trust bioeconomy.
Submission to the EU Biotech Act Call for Evidence
To realise Europe's potential as a global leader in biotech, we recommend fortifying this ambition through an integrated approach to innovation and security.
The strategic imperative of an innovative European biotechnology sector is undeniable; as demonstrated during the COVID-19 pandemic, sovereign production capacity is a direct determinant of crisis recovery and economic resilience.
The stakes are high, as NATO states, “the next revolutionary technology cycle will be driven by synthetic biology. While the potential benefits from increased biotechnology use are substantial, especially for healthcare, the risks of harmful uses are also enormous”.
Concurrently, the convergence of AI with biotech and increased access to powerful AI and biological tools create novel dual-use risks that existing oversight cannot adequately address. Current regulatory frameworks remain fragmented and ill-adapted to this new reality.
Pillar 1: Building a Harmonised EU Biorisk Governance Framework
The threat of misuse is not theoretical. Both European security bodies and global health coalitions stress the urgency of updating oversight. The pan-European assessment of synthetic biology explicitly warns that "the accelerated technological developments... raise concerns about the potential for misuse".
Similarly, the Coalition for Epidemic Preparedness Innovations (CEPI, 5) stresses the need to “ensure that biosafety and biosecurity risk identification and mitigation approaches keep pace with the evolution of the ways in which biological tools could accidentally or deliberately be misused”.
Experts from the Community for European Research and Innovation for Security (CERIS) have identified the possibility of bioterrorism attacks among the top ten security priorities.
Recommendation: Codify Nucleic Acid Synthesis Screening
We recommend that screening orders for dangerous sequences and know-your-customer procedures be made a binding legal requirement for all nucleic acid synthesis providers operating within the EU. To ensure verifiable compliance, we propose a system of annual third-party conformity assessment. This approach establishes a more robust assurance mechanism than alternative models, such as public self-attestation, and aligns with ongoing international efforts by industry and government partners.
The primary objective is to create a harmonised system that establishes a level playing field for industry and ensures high standards of biosecurity across the single market, which could be achieved through a new legislative act or by amending an existing legal framework.
Mandated screening for biosecurity risks answers industrial stakeholders’ call for to ensure a secure, trustworthy and thus strong bioeconomy. The IGSC, representing over 40 synthesis companies, is itself calling for harmonization and safeguards. This is reinforced by the scientific community, with over 175 leading researchers pledging to obtain DNA synthesis services only from providers that screen orders, as part of a series of commitments for responsible AI development in protein design.
Modern DNA/RNA synthesis screening processes integrate seamlessly with scientific workflows, and cost-effective solutions are offered by independent nonprofits, venture-backed startups, and established defence contractors.
This measure addresses critical security gaps in global health security, aligning with findings from the WHO on the limitations of current voluntary approaches and building on a broad consensus from key stakeholders.
Although nucleic acid synthesis screening is a cost-effective and high-impact measure, it should be integrated into a broader, multi-layered EU biorisk governance framework.
Establish a European Biosecurity Expert Group
We recommend the creation of an expert group to monitor emerging threats, foster preparedness, and continuously adapt risk management frameworks, an action consistent with proposals from the Joint Action TERROR assessment.
Pillar 2: Aligning EU Funding with Biosecurity and Synthesis Capacity
Effective governance requires financial instruments to ensure its implementation. Currently, Europe's biotechnology sector relies heavily on non-EU suppliers for critical synthetic biology components, creating vulnerabilities in both supply chains and security oversight. These financial instruments must therefore be directed towards addressing this core strategic vulnerability.
Recommendation: Introduce Biosecurity Conditionality in Research Funding
We recommend making biosecurity compliance a prerequisite for biotechnology research grants like Horizon Europe and its successor, FP10. Specifically, funded biological research projects should procure synthesized nucleic acid synthesis from credible synthesis providers that conduct screening according to established industry standards and undergo regular third-party conformity assessment.
This hardwires a "Preparedness-by-Design" approach consistent with the EU's security and preparedness strategies and requires updating EU guidance on dual-use research of concern, particularly at the AI-biology interface, while streamlining compliance through clear, unified standards that reduce administrative burden.
Recommendation: Dedicate Funding to Secure Industrial Capacity and Accelerate Research
We recommend establishing dedicated EU funding to (a) strengthen the EU’s sovereign capacity for nucleic acid synthesis; and (b) consolidate and accelerate research in biotechnology.
The EU faces strategic dependencies in biotech supply chains, particularly in nucleic acid synthesis capacity, causing week-long delays for critical applications like vaccine development.
By embedding these recommendations within the EU Biotech Act, the EU can create the secure foundation necessary for a thriving, competitive, and resilient European bioeconomy. The Biotech Act has to go hand in hand with the new CBRN Action Plan.
Signatories
Dr. Carlos Acevedo-Rocha, Senior Researcher, Technical University of Denmark
Laurent Bächler, Program Lead Biosecurity, Pour Demain, Belgium
Jens Berlips, SecureDNA Foundation, Switzerland
James Diggans, Chair, International Gene Synthesis Consortium, USA
Prof. Dr. Dr. Adrian Egli, Institute of Medical Microbiology University of Zurich, Switzerland
Prof. David Gisselsson Nord, Division of Clinical Genetics, Faculty of Medicine, Lund University, principal investigor of Greyzone Genomics, Sweden
John Halstead, Research Fellow, Centre for the Governance of AI, UK
Prof. Dr. Thomas V. Inglesby, MD, Director, Johns Hopkins Center for Health Security, Professor, Environmental Health and Engineering, Johns Hopkins Bloomberg School of Public Health, Joint Appointment, Medicine, Johns Hopkins School of Medicine, USA
James Mulhall, Research Associate, Alliance to Feed the Earth in Disasters (ALLFED), UK
Dr. Wladimir Labeikovsky, Co-Founder & Head of Data Operations, Ribbon Bio, Vienna, Austria
Prof. Dr. Panagiotis L. Kastritis, Institute of Biochemistry and Biotechnology, Martin-Luther University Halle-Wittenberg; ERA Chair for cryo-EM, Institute of Chemical Biology, National Hellenic, Research Foundation, Athens, Greece
Sophie Peresson, International Biosecurity & Biosafety Initiative for Science, Switzerland
Luisa Prisecaru, LL.M., Legal Affairs Specialist, Ribbon Bio, Vienna, Austria
Dr. Erwan Sallard, Nuffield Departement of Medicine, University of Oxford, UK
Eloise Todd, Executive Director & Co-Founder, Pandemic Action Network, Belgium
