Title: European Biotech Act – establishing a framework of measures for strengthening the Union’s biotechnology and biomanufacturing sectors, particularly in the area of health, and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938
Document: COM/2025/1022 final/2 Date: Strasbourg, 16 December 2025
EXPLANATORY MEMORANDUM
1. Context of the proposal
- Objectives: Strengthen the EU’s competitiveness, strategic autonomy and economic security through a robust biotechnology and biomanufacturing sector, with a focus on health.
- Economic significance: In 2022 the EU biotechnology industry contributed €38.1 billion to EU GDP and created 913 160 jobs (≈75 % in health biotechnology). The sector has grown more than twice as fast as the overall EU economy over the last decade.
- Challenges: The EU lags behind other regions in translating scientific excellence into commercially viable products and large‑scale manufacturing. Structural barriers include fragmented governance, limited access to risk‑capital, skill shortages, and complex regulatory frameworks.
- Opportunities: Harness AI for biotechnology, improve biosecurity, and align with the EU’s AI Act (Regulation (EU) 2024/1689). The EU aims to simplify clinical‑trial procedures, boost investment, and create strategic projects to accelerate time‑to‑market.
2. Legal basis, subsidiarity and proportionality
- Legal basis: Article 114 TFEU (harmonisation), Article 168(4) TFEU (high level of human health protection), and Article 173(3) TFEU (competitiveness of industry).
- Subsidiarity: The cross‑border nature of biotechnology, the need for coordinated financing, shared infrastructure and data, and the impossibility for Member States to act alone justify EU‑level action.
- Proportionality: Measures are targeted to specific barriers (e.g., streamlined clinical‑trial timelines, regulatory sandboxes, AI‑enabled biotech testing) and are limited to what is necessary to achieve the objectives.
3. Results of ex‑post evaluations, stakeholder consultations and impact assessments
- Extensive consultations (call for evidence, public consultation) gathered over 500 contributions from industry, NGOs, academia and public authorities.
- Stakeholders highlighted financing gaps, regulatory fragmentation, skill shortages and biosecurity risks.
- The proposal integrates findings from the European Biotech Act announced in the 2024‑2029 Political Guidelines, the Draghi and Letta reports, and the EU’s Competitiveness Compass.
4. Budgetary implications
- The proposal foresees a contribution from the “Health, Biotech, Agriculture and Bioeconomy” window of the European Competitiveness Fund (~€20.4 billion for 2028‑2034) and reinforcement of EMA and EFSA staff.
- Additional funding may come from the Investment Plan, InvestEU and public‑private partnerships.
MAIN PROVISIONAL CHAPTERS
Chapter I – Subject‑matter, scope and definitions
- Defines “health biotechnology” as the application of biotechnology in human medical, veterinary, pharmaceutical and phytosanitary areas throughout the product lifecycle.
Chapter II – Union health biotechnology and biomanufacturing
- Establishes Health Biotechnology Strategic Projects and High‑Impact Health Biotechnology Strategic Projects with EU‑wide recognition, support, and accelerated permitting.
- Creates the EU Health Biotechnology Support Network and the European Health Biotechnology Steering Group to coordinate funding, regulatory pathways and networking.
Chapter III – Access to funding
- Introduces an EU Health Biotechnology Investment Pilot (in partnership with the European Investment Bank Group) to mobilise private and public capital, targeting a financing gap of €40 billion per year.
- Allows a Union‑wide Late‑Stage Capital Booster Pilot for high‑impact projects.
Chapter IV – Extension of the Supplementary Protection Certificate (SPC)
- Grants an additional 12 months of SPC protection for medicinal products developed by biotechnological processes and for ATMPs.
Chapter V – Enhancing competitiveness in biosimilars
- Promotes EMA guidelines to facilitate biosimilar authorisation and supports EU‑based biosimilar manufacturing capacity.
Chapter VI – Artificial intelligence and data as biotechnology enablers
- Aligns with the AI‑First policy (Apply AI Strategy) and mandates the development of AI‑enabled testing environments, data‑quality accelerators and regulatory sandboxes for AI‑driven biotech.
Chapter VII – Regulatory tools for novel health biotechnology products
- Creates a Regulatory Status Repository to compile opinions, recommendations and decisions across Union frameworks.
- Establishes Regulatory sandboxes for early‑stage biotech products that fall outside existing legislation, ensuring safety and proportional oversight.
Chapter VIII – Biodefence and preventing biotechnology misuse
- Defines Biotechnology products of concern (e.g., high‑risk nucleic‑acid sequences, benchtop synthesis equipment) and requires legitimate‑need screening, reporting of suspicious transactions and coordinated EU‑wide monitoring.
- Sets up an Advisory Group on Biosecurity to monitor emerging threats and advise the Commission.
Chapter IX – Amendments to existing Union legislation
- General Food Law (Regulation EC 178/2002): Broadens pre‑submission scientific advice, shortens non‑compliance procedural delays (6 → 3 months) and introduces regulatory sandboxes for food‑related biotech.
- Advanced Therapy Medicinal Products Regulation (Regulation EC 1394/2007): Provides risk‑proportionate exemptions for ATMPs containing GMOs with negligible risk, and streamlines environmental risk assessment.
- Clinical Trials Regulation (Regulation EU 536/2014): Reduces multinational trial timelines (106 → 75 days), eliminates the additional 50‑day assessment for ATMPs, introduces minimal‑intervention trials, harmonised templates and AI‑enabled trial processes.
- Veterinary Medicinal Products Regulation (Regulation EU 2019/6): Aligns GMO assessment with veterinary law, adds a one‑year SPC extension for biotech veterinary products, and permits regulatory sandboxes for animal‑health innovations.
- STEP Regulation (Regulation EU 2024/795): Recognises health‑biotech strategic projects as contributing to STEP objectives.
- Substances of Human Origin Regulation (Regulation EU 2024/1938): Allows regulatory sandboxes for innovative SoHO products under strict supervision.
Chapter X – Final provisions
- Sets monitoring, evaluation and reporting obligations (five‑year reviews, regular Commission reports to Parliament and Council).
- Provides powers for delegation, committee procedures and entry‑into‑force provisions.
Contact: European Commission, Directorate‑General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW), Brussels.
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