According to a document from 16 December 2025, the European Commission’s proposed European Biotech Act is designed to make it easier for Europe to turn strong biotech science into real products and scaled manufacturing, while keeping high standards for health, safety, ethics, the environment, and biosecurity. It comes as the Commission notes the EU biotech industry’s rapid growth, including major economic and jobs impact driven largely by health biotech.
The big Picture European Biotech Act
Europe’s biotech challenge is not discovery, it’s follow through. The proposal argues that fragmentation across Member States and barriers in clinical development, regulation, and manufacturing make it harder to scale in the EU, so too many startups grow and commercialize elsewhere. It also flags skills gaps in areas like R&D, regulatory affairs, AI, and data analytics as a competitiveness bottleneck.
Seven pillars that act like a policy blueprint
The proposal organizes the plan into seven connected pillars that cover the full path from lab to market to security.
Strategic projects with EU level backing
A core move is creating a framework to recognize and support strategic health biotechnology projects and high impact strategic projects to accelerate translation from research to real market applications.
Capital and an EU investment pilot
The Commission proposes an EU health biotechnology investment pilot aimed at closing the funding gap that can prevent biotech innovation from reaching late stage development and commercialization. It also highlights blended finance and coordination support to help project promoters connect with investors.
A biosimilars manufacturing push
A standout manufacturing priority is biosimilars. The proposal points to advances in analytics that can support comparability and encourages EMA work on guidance that could reduce clinical data requirements in some cases based on strong analytical and nonclinical evidence. It also calls for Member States to recognize and support qualifying biosimilars manufacturing strategic projects, plus encourage cooperation with international biotech clusters.
AI first for biotech and biomanufacturing
The Act promotes an AI first policy approach for biotech and biomanufacturing, emphasizing responsible use aligned with EU rules and the sharing of standards and best practices.
Rules that keep up with science
The proposal aims to ensure a legislative framework that encourages innovation and adapts to scientific and technological change, including specific provisions for health biotech products and updates to relevant EU laws.
Biodefense and preventing misuse
The proposal treats biosecurity as central, with measures to prevent misuse of biotechnology and strengthen biodefense capabilities. It includes the concept of projects contributing to an EU Biothreat Radar and other biodefense capability projects receiving high impact status and potential priority handling.
Making the rest of EU law work better for biotech
To make these changes stick, the proposal amends multiple EU frameworks, including rules touching clinical trials, advanced therapies, substances of human origin, veterinary medicines, and general food law.
A faster lane for breakthrough products
Regulatory sandboxes are one of the most concrete innovation tools in the proposal. The Commission would be able to establish sandboxes for early stage health biotech products that don’t fit neatly under existing EU health legislation, creating a controlled environment with a defined plan, duration, risk mitigation, and supervision. The intended output is a Commission recommendation on the best existing regulatory pathway, and the lessons learned can shape future EU action.
The draft text also includes strong safety brakes: sandboxes do not weaken supervisors’ corrective powers, and authorities can suspend or restrict use if public health risks appear. It also says evidence gathered in a sandbox should be considered when a product later seeks authorization.
Data quality becomes infrastructure not an afterthought
The proposal repeatedly connects biotech competitiveness to high quality interoperable well annotated datasets, especially for trustworthy AI. It introduces biotechnology data quality accelerators as a type of high impact project, meant to improve data quality at the source, standardize it, and support the creation and use of shared datasets for developing and refining AI models in health biotech. It also ties this work to EU health data infrastructure and privacy governance.
Skills and talent get treated like a strategic input
Beyond money and regulation, the Act also targets workforce capacity. It calls out actions like attracting and retaining talent, upskilling and reskilling across technical and digital areas including AI and data science, and building public private partnerships between universities, training providers, SMEs, startups, and applied research institutes.
Written By Aren Karapetyan, MD