Biotech Act adopted: stronger incentives and faster trials to boost EU biotech

The European Union has formally adopted the Biotech Act, marking a significant step in its efforts to strengthen Europe’s position in global biotechnology. The legislation introduces speedier clinical trial approvals, financial support for industry, and an extra year of patent protection for biotech therapies via a supplementary protection certificate (SPC), with the condition that they are “distinctly different” from drugs already on the market and which were tested and partially made in Europe.

Earlier drafts of the Act had already signalled this direction, with proposals focused on reducing regulatory delays for clinical trials and improving conditions for advanced and high-risk innovations. Those earlier discussions framed the Act as a response to Europe’s persistent challenge: strong scientific output, but weaker translation into commercial and clinical impact compared with the US and China.

The adopted version confirms a more explicit use of industrial incentives. By linking extended monopolies to EU-based development and production, the Act aims to attract investment, retain companies, and encourage scale-up within Europe. Faster trial timelines are intended to make the EU a more attractive setting for early- and mid-stage clinical research, particularly in complex therapeutic areas.

The Biotech Act also aligns with broader EU efforts to integrate regulatory reform with competitiveness policy, complementing changes under the revised pharmaceutical legislation and upcoming initiatives such as the European Competitiveness Fund. Together, these measures reflect a more assertive approach to using regulation as a tool to shape industrial outcomes.

While the Act has been welcomed by parts of the biotech sector, its impact will depend on implementation — including how eligibility criteria are defined, how trial acceleration is delivered in practice, and how incentives interact with access and affordability considerations. For health innovation, the Biotech Act signals a clear shift: Europe is now actively using regulatory incentives to try to keep biotech development, trials, and manufacturing at home.