On 16 December 2025, the European Commission proposed a package of measures to improve resilience, competitiveness, and safety of the EU health sector. One of these measures is the proposal for the new EU Biotech Act. Despite the European Union's strong scientific foundations, barriers like limited access to capital and regulatory complexity have left the EU lagging in biotech innovation, reflected in low venture capital investment, a decline in clinical trial activity, and a growing trend of start-ups relocating outside the EU. With the Biotech Act, the EU aims to dismantle these barriers and establish Europe as a global leader in biotechnology innovation.

The Biotech Act is designed in the legal form of an EU Regulation, and will amend existing EU health, food, and biotech legislation, such as the Clinical Trials Regulation and the Food Safety Regulation. To enhance the EU's attractiveness for biotech investments and innovation, the proposal includes:

• mechanisms to improve access to funding, particularly for Small- and Medium-sized Enterprises (SMEs) and start-ups, including an EU health biotechnology investment pilot in cooperation with the European Investment Bank Group, designed to support scale-up stages of biotech development;
• biosecurity measures aimed at preventing the misuse of biotechnology and protecting public health, including requirements to verify that purchasers of high-risk biotech products have a legitimate need, and measures to enhance biodefense capabilities, such as early detection of emerging biological threats;
• rewards for innovation, such as an additional 12-month extension to supplementary protection certificates (extending patent protection) for eligible biotech medicinal products developed and manufactured (at least partially) in the EU;
• measures to simplify and accelerate regulatory procedures and market access processes, such as introducing dedicated regulatory sandboxes for novel health biotechnology products, and shortening timelines of certain clinical trials; and
• measures that require the European Medicines Agency (EMA) to develop and update guidance on a tailored regulatory approach for the development of biosimilars, in which the EMA shall consider a potential reduction of the clinical data required for the development and approval of biosimilars

The proposal for the Biotech Act will be submitted to the European Parliament and the Council for amendments and adoption. The final text of the Biotech Act is likely to be adopted towards the end of 2026 or later.