Proposal for the European Biotechnology Act (Biotech Act I)

European biotechnology has seen a major milestone. In line with the priorities of the European Commission President Ursula von der Leyen, the long-awaited proposal for the European Biotechnology Act was presented at the end of 2025. This legislative package targets the sector’s biggest pain points: it promises to simplify complex regulations, remove bureaucratic barriers, and finally introduce a “fast-track” for innovations entering the European market. The goal is nothing less than to create a modern regulatory environment that will allow European research and development to fully realize its potential.

The explanatory memorandum to the proposal cites the problem of translating research results into practice as the main motivation for the proposed changes. Although the EU has a world-class scientific base (accounting for 21% of the most cited publications in the biological sciences, which is comparable to the US and China), it lags significantly behind when it comes to transforming research into commercial products and ensuring their large-scale production.

Due to fragmented administration, lengthy approval processes, and a lack of venture capital during growth phases, companies and experts often relocate outside the territory of the EU.

To overcome these barriers, the proposal outlines seven key pillars:

1.      Strengthening research and production capacities: Creating a framework to support strategic biotechnology projects in healthcare with the aim of strengthening European self-sufficiency.

2.      Facilitating access to capital and investment support: Facilitating financing for biotechnology companies, including the establishment of a pilot EU investment program to bridge the innovation gap.

3.      Developing capacity for biosimilar medicines: Increasing European manufacturing capacity and expertise in biosimilars, including through international cooperation.

4.      Integrating artificial intelligence (AI): Facilitating the application of AI tools in biotechnology and manufacturing ecosystems in accordance with the EU Artificial Intelligence Act (AI Act).

5.      Adapting legislation for innovation: Ensuring flexible rules capable of responding to rapid scientific and technological progress in modern health products.

6.      Preventing misuse and biological defence: Preventing the misuse of biotechnology and strengthening the EU’s overall capabilities in the field of biosecurity and defence.

7.      Revising legislation to streamline practices: Removing bureaucratic barriers by amending regulations, particularly in the areas of clinical trials, veterinary medicine, and food safety.

The current proposal, known as Biotech Act I, is the first part of a broader initiative and targets primarily on healthcare. It is currently in the early stages of the EU legislative process.

The second part, Biotech Act II, is expected to be introduced in the third quarter of this year and is slated to concentrate on industrial biotechnology and biomanufacturing.