EU Biotech Act: EU Proposes First Set of Rules to Facilitate Biopharmaceutical Competitiveness

The proposed Biotech Act I combines industrial‑policy measures with targeted amendments to existing EU life sciences legislation. Key aspects of the proposed Biotech Act I:

1. Clinical trials: a major overhaul of the Clinical Trials Regulation (CTR). 
   Although the CTR harmonized the EU rules for clinical trials, it has not delivered the speed and predictability initially expected. Sponsors continue to face long and variable timelines, parallel ethics committee reviews and limited flexibility to adapt trials during their lifecycle.
   
   To address these issues, Biotech Act I proposes the following:
   
   Shorter and more predictable timelines.
   (i) Multinational clinical trials: Overall authorization timelines would be reduced from ~106 to 75 days, and from 75 to 47 days where no request for information is issued. (ii) Advanced therapy medicinal product (ATMP) trials: The additional 50‑day extension currently applicable to ATMPs would be abolished, reflecting the increased regulatory experience. (iii) Substantial modifications: Timelines would be more than halved (from 96 to 47 days), and parallel substantial modifications would be possible where they concern independent aspects of the dossier.
   
   Enhanced role for reporting Member State (rMS) and coordinated ethics committee review.
   The rMS’ role would be strengthened and become the central lead for scientific, ethical, and regulatory assessment of Part I of the dossier. Other Member States concerned (MSc) would be able to raise objections only on limited and clearly defined grounds. Another novel aspect would be stronger coordination among national ethics committees, including the involvement of the rMS’ ethics committee in the Part I assessment.
   
   New risk-proportionate trial categories. 
   In addition to the existing concept of low‑intervention trials, the proposal would introduce “minimal‑intervention clinical trials.” The approval of these trials, which use authorized medicines in accordance with the marketing authorisation, would be limited to an ethical review.
   
   Lifecycle flexibility. 
   The proposal introduces the novel concept of an EU‑level investigational medicinal product core dossier, aiming to reduce duplication for clinical trials using the same investigational medicine. An MSc would assume the role of the core dossier’s depositary and be responsible for verifying completeness and suitability and managing requests for updates. A core dossier would help streamline data collection, improve oversight and support efficient assessment.
   
   Digitalization, AI, and data protection.
   The proposal provides an explicit legal basis for General Data Protection Regulation–compliant processing of clinical trial data. It also anticipates that the European Medicines Agency (EMA) issues guidance on the use of AI in trial design, conduct, and analysis in coordination with the EU AI Office.
   Overall, if adopted, these changes would represent the most significant recalibration of the EU clinical trials framework since 2014, with the potential to materially improve the EU’s attractiveness for multinational and ATMP trials.
   
   
2. ATMPs, GMOs, and SoHO: targeted but impactful simplifications.
   Developers of ATMPs often face overlapping and duplicative requirements under pharmaceutical, genetically modified organism (GMO), and substances‑of‑human‑origin (SoHO) legislation, leading to delays without commensurate safety benefits.
   
   Biotech Act I introduces targeted, risk‑proportionate adjustments to address these frictions.
   
   ATMP-GMO interface.
   The proposal would introduce a risk‑proportionate exemption from the GMO environmental risk assessment for clearly defined categories of investigational ATMPs that present no or negligible risk, for example, replication‑deficient viral vectors without resistance genes. The corresponding GMO related requirements for manufacturing and import would be lifted during the trial. This would be a significant simplification for gene and cell therapy developers conducting multinational trials.
   
   Future-proofing the ATMP framework.
   The Commission would be empowered to update ATMP definitions by delegated acts to reflect scientific advances, without expanding the scope of the framework.Biotech Act I proposes a more integrated approach by introducing a single‑application pathway for combined studies in which a clinical trial is combined with a performance study of an in vitro diagnostic or clinical investigation of a medical device. In response to current challenges, the proposal anticipates that there can be multiple sponsors for combination studies. 
   
   
3. Medicines–devices combinations: from coordination to integration.
   Combination products frequently face parallel and poorly aligned assessment pathways under medicines and medical‑device legislation.
   
   Biotech Act I proposes a more integrated approach by introducing a single‑application pathway for combined studies in which a clinical trial is combined with a performance study of an in vitro diagnostic or clinical investigation of a medical device. In response to current challenges, the proposal anticipates that there can be multiple sponsors for combination studies.
   
   
4. Novel biotechnology: support and increased coordination.
   The proposal also establishes a number of support and coordinating tools. These include establishment of an EU Health Biotechnology Support Network, which shall support biotechnology developers, in particular small and medium-size enterprises (SMEs), startups, and scale-ups, in identifying, for example, applicable rules, regulatory pathways, and funding opportunities. The Commission shall also create a Union‑wide “regulatory status repository,” that is, a central database of regulatory classification and borderline decisions for medicines, medical devices, and combination products, to improve transparency, predictability, and consistency across the Member States. Moreover, the proposal would establish a Foresight Panel for Emerging Health Innovations, formalizing cross‑framework consultation among EMA, the Medical Device Coordination Group, the SoHO Coordination Board, and the Coordination Group on Health Technology Assessment.
   
   
5. Strategic projects, funding, and industrial scale-up.
   EU biotech SMEs and scale‑ups often struggle to secure late‑stage financing and to navigate slow authorization processes for manufacturing and infrastructure projects. To address this, Biotech Act I introduces the concepts of (a) health biotechnology strategic projects and (b) high-impact health biotechnology strategic projects. The goal is to support projects aimed at strengthening the EU’s industrial biomanufacturing capacity by, for example, providing access to funding, priority access to administrative support, and fast-tracked procedures at Member State level.
   
   To improve such access to funding, the Biotech Act I proposal envisages an investment pilot to be established by the European Commission and the European Investment Bank Group (EIBG) for an initial two-year period. The pilot will make a variety of financial products available to biotech firms and projects across the business lifecycle, including by mobilizing private investment, and providing advisory support.
   
   In advance of that pilot and emphasising the EU’s commitment to the industry, the European Commission and EIBG have announced a joint project “BioTechEU”, by which they aim to mobilize €10 billion in investment in 2026-27 into the biotech and life sciences sector, building on the EIBG’s existing €3.5 billion life sciences debt portfolio. The Commission and EIBG indicate that this project may lay the foundation for the Biotech Act I investment pilot.
   
   
6. New Supplementary Protection Certificate (SPC) incentive.
   A targeted but powerful incentive would be the introduction of a 12‑month SPC extension for certain best‑in‑class biotechnology medicines and ATMPs, subject to genuine therapeutic innovation, multinational EU clinical trials, and at least one manufacturing step in the EU.

Next Steps and Outlook

Biotech Act I now enters the ordinary legislative procedure in the European Parliament and Council. Stakeholders have an early opportunity to engage with policymakers as the text is debated and amended. According to the Commission, a Biotech Act II is expected in 2026, which will shift the focus to the “wider biotech ecosystem beyond health to ensure a competitive internal market for all areas of biotechnology.”

By tackling clinical trials, ATMPs, digital tools, ethics, SME support, and supply resilience in one package, it looks like Biotech Act I may facilitate a more coherent and supportive framework for biopharmaceutical innovation in the EU. Coupled with strategic support, funding opportunities and scale-up backing, European health biotechnology has a real opportunity towards a pro-innovation framework that accelerates transformation. Together with the upcoming Biotech Act II, the Pharma Package, the proposed Critical Medicines Act, and the Life Sciences Strategy, the EU is taking steps to move toward a clearer, long-term approach to strengthening its biopharmaceutical ecosystem.

Sidley’s Global Life Sciences and Global Finance teams continue to closely monitor the Biotech Act, and we are available to assist companies in anticipating and managing related opportunities and challenges.