In November 2025, the Biosecurity Policy Unit at the Centre for Long-Term Resilience submitted written evidence to the European Union (EU)’s Public Consultation informing the European Biotech Act.
This was in addition to our written submission in July 2025 to the European Commission’s call for evidence on the European Biotech Act and ongoing engagement efforts.
For this Public Consultation in November 2025, we focused on the following five recommendations.
1. Mandate Screening for Synthetic Nucleic Acids
The current voluntary approach to synthetic nucleic acid screening creates an uneven playing field that disadvantages responsible providers. We urged the EU to implement mandatory, harmonised screening for synthetic nucleic acids over 50 basepairs in length. We cited data from our now-published cost-benefit analysis in the UK, which demonstrated a high return on investment for mandatory screening of customers and sequences for safety and security.Research explicitly designed to close these gaps can lower the barriers to creation. Therefore, we need a rigorous method to decide which experiments, if any, should be conducted, given the extreme risks.
2. Establish Governance for Biological AI Models
As AI capabilities in the life sciences expand, governance is failing to keep pace for the subset of developments that pose misuse risks. We recommended a Biotech Act Scientific Advisory Panel be established to assess and provide advice on biological AI models, similar in form to the EU AI Act Scientific Panel. This Panel could help establish a systematic framework for assessing biological AI models and collaborate with the European AI Office.
3. Strengthen Strategic Manufacturing and Supply Chains
Current supply chains are opaque and fragile. For example, 93 active pharmaceutical ingredients (APIs) required in Europe currently have no European manufacturers. To address these single points of failure, we recommended developing strategic, distributed manufacturing clusters focused on critical capabilities like API production and vaccine platforms. In addition, we recommended establishing cross-border resilience partnerships, including manufacturing surge capacity agreements and shared stockpiling. Mandatory supply chain transparency requirements will be essential and must include real-time visibility and the mandatory disclosure of single points of failure.
4. Close the Financing Gap for Defensive Biotechnology
Europe faces a “critical financing gap” in late-stage (Series B/C/D) funding, driving talent flight to other jurisdictions. To secure European strategic autonomy, we proposed the EU public sector de-risk investment through coordinated procurement commitments. We recommended adopting models similar to the UK’s Defence and Security Accelerator (DASA) to use challenge competitions to rapidly place contracts for R&D. A centralised biotechnology funding hub could be created to consolidate fragmented funding opportunities, making it easier for SMEs to navigate the landscape.
5. Upskill the Workforce in Biosecurity
The workforce must be equipped to handle the convergence of AI and biology responsibly. We recommended fostering a workforce capable of developing commercially viable defensive biotechnologies while managing emerging security risks. We emphasised that the most effective way to retain talent is to fix the financing gap that currently forces startups and skilled teams to move overseas.
Draft Regulation
In December 2025, the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) published its proposal for the European Biotech Act and we were please to see many of our recommendations included in the draft regulation. In particular, we were pleased to see:
- A Landmark Mandate for Nucleic Acid Screening
We urged the EU to implement mandatory, harmonised screening for synthetic nucleic acids to close a critical security gap and level the playing field for responsible providers. The draft Act delivers decisively on this. Chapter VIII, Section 2 introduces a mandatory framework for ‘Biotechnology products of concern’. Crucially, Article 44 mandates that economic operators must verify the identity of customers and assess their ‘legitimate need’ prior to transactions. Article 43(1) applies the restrictions to making products available to “any natural or legal person outside the Union.” This is a crucial detail: it prevents EU companies from exporting unscreened materials to jurisdictions with weaker regulations, effectively exporting EU biosecurity standards globally.
The draft regulation specifically defines sequences of concern as “at least 50 nucleotides in length” (Annex I, Point 2), as we recommended. Synthetic sequences of concern also include function‑based criteria (pathogenicity, toxicity contributions) and combinatorial assembly logic. Furthermore, Article 45 specifically requires that benchtop nucleic acid synthesis equipment must contain automatic mechanisms to screen for sequences of concern. This prevents users from bypassing screening protocols, a critical security feature for decentralised manufacturing. Penalties for non-compliance are included (Article 51) with the Act giving Member States the power to impose fines of “not exceeding 5% of their annual total worldwide turnover” for economic operators who fail to verify legitimate need. This is a significant deterrent that underscores the EU’s seriousness about biosecurity.
This shift from voluntary to mandatory screening creates the harmonised security baseline we advocated for, protecting both the European bioeconomy and the public.
- Dedicated Governance for AI-Bio Risks
We recommended the creation of a Scientific Advisory Panel to assess biological AI models and collaborate with the European AI Office. The Commission has adopted this approach through the establishment of an Advisory Group on Biosecurity (Article 52). This independent body of experts is explicitly tasked with monitoring biosecurity risks arising from AI models in biological applications and contributing to guidance for responsible innovation. Additionally, Article 53 mandates the monitoring of ‘biological systemic risk’ from AI models, ensuring that governance mechanisms keep pace with rapid technological convergence.
- Strategic Focus on Biodefence and Resilience
We called for dedicated support for defensive biotechnology and the strengthening of strategic manufacturing to reduce dependencies. The draft Act introduces ‘High impact health biotechnology strategic projects’ (Article 4), which includes a specific category for Biodefence Capability (Article 42). These projects are defined by their contribution to preventing misuse, providing rapid surge capacity for testing and sequencing, and developing robust pathogen-agnostic defences. For example, Article 41 establishes the “EU Biothreat Radar” projects as a specific category of high-impact strategic project. This aligns with our June 2025 recommendations on pathogen surveillance and early warning systems. This explicit recognition of biodefence as a pillar of industrial strategy directly addresses the financing gap we identified for technologies that serve national and regional security.
- Centralised Support to Navigate Funding
We proposed a centralised funding hub to help SMEs and start-ups navigate the fragmented European funding landscape. In response, the draft Act establishes the EU Health Biotechnology Support Network (Article 19). This network is designed to assist project promoters in identifying relevant funding, scaling-up, and networking opportunities at both Union and national levels. By reducing information asymmetries, this measure will help retain European talent and ensure that innovative companies can access the capital required to scale within the EU.
- Supply Chain Transparency and Strategic Mapping
We recommended mandatory transparency regarding single points of failure and dependencies. While the Act approaches this through a strategic lens, Article 17 mandates a comprehensive Strategic Mapping of the Union’s biotechnology ecosystem. This mapping is required to assess industrial capacities, detect gaps, and identify dependencies and systemic challenges across value chains. This evidence base is essential for the proactive management of supply chain resilience and directly supports our recommendation for greater visibility into the vulnerabilities of the bioeconomy.
Next Steps
The inclusion of these provisions represents a significant step forward for European biosecurity, with regional and global reach. However, the effectiveness of the European Biotech Act will ultimately depend entirely on its implementation.
As the regulation moves through the legislative process, the Centre for Long-Term Resilience will continue to engage with European policymakers to ensure that the technical standards for screening are robust and the Advisory Group on Biosecurity is resourced with appropriate expertise and a prioritised mandate. We look forward to supporting the Commission and Member States in refining these critical measures to build a bioeconomy that is as secure for the future as it is innovative.
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To read the November 2025 written evidence submission, please click ‘DOWNLOAD’ below.
Citation: Nelson, Cassidy. 2026. “Informing the European Biotech Act and Inclusions of our Recommendations”. The Centre for Long-Term Resilience. https://doi.org/10.71172/8z55-25gh
