On December 15, 2025, the European Commission (EC) announced a legislative package that includes a proposal for a regulation to establish measures to strengthen the European Union’s (EU) biotechnology and biomanufacturing sectors (Biotech Act). The questions and answers (Q&A) on the Biotech Act note that the proposal is focused on health biotech, “although it also includes provisions on food and feed.” According to the Q&A, the Biotech Act would amend specific parts of EU health and food regulations “to adapt the whole ecosystem to the needs of modern society and this fast-growing sector.” The proposal would revise EU rules on clinical trials, advanced therapy medicinal products, substances of human origin, veterinary medicinal products, general food law, human organs, and genetically modified organisms.
The Q&A states that the Biotech Act focuses on industrial policy measures and simplification. In particular, it will:
- Boost access to funding to help EU biotech companies grow and scale up, with economic incentives to facilitate the biotech sector’s access to capital in the EU. Already in 2026 and 2027, in cooperation with the European Investment Bank (EIB) Group, the EC will run a health biotech pilot to complement the EIB’s BiotechEU initiative that will mobilize up to €10 billion of investment in the sector.
- Reinforce EU industrial capabilities and support for innovation to deliver high-impact biotechnology developments, including centers of excellence for advance therapy medicinal products, testing and training environments for biomanufacturing, data quality accelerators, and biodefense capability projects.
- Reward key EU innovations in health and veterinary biotech with a targeted extension of patent rights, along with support for strategic areas such as biosimilar development and production.
- Harness the use of artificial intelligence (AI), data, and digital solutions in the biotech sector by implementing the European Health Data Space, creating trusted AI testing environments, facilitating data sharing, and supporting small and medium enterprises, start-ups, and scale-ups in using high-performance technologies.
- Simplify and accelerate regulatory procedures to reduce time to market for biotech products, for example, with harmonized requirements and the use of regulatory sandboxes as controlled environments for companies to experiment and try innovative solutions and regulatory procedures and technologies.
- Provide biosecurity safeguards to protect against the misuse of biotechnologies and boost the EU’s biodefense capabilities.
The legislative proposal for a Biotech Act will be submitted to the European Parliament and the Council of the EU for adoption.
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