European Union: European Commission opened consultation on European Biotech Act

On 4 August 2025, the European Commission opened a consultation, until 10 November 2025, as part of the development of the European Biotech Act. The Act aims to support the development of the EU biotech sector by addressing regulatory delays, funding gaps, fragmented infrastructure, workforce shortages, and limited access to computing and data resources. According to the call for evidence for an impact assessment, the Act will address growing dependencies in biotech on data, storage, computing power, and artificial intelligence (AI). AI is increasingly used to accelerate drug development and reduce the risk of biotechnology misuse. In health biotech, access to anonymised real-world health data, enabled by frameworks like the European Health Data Space, is seen as critical. Supercomputing and AI testing facilities (AI Factories) are also considered essential to help biotech companies make full use of available data. The Act is expected to establish targeted EU programmes to speed up the adoption of digital and AI solutions across biotech, while ensuring their safe and ethical use.