Source: European Parliament
The European Biotech Act I, proposed in December 2025, is the EU’s first standalone legislation regulating health biotechnology across its full lifecycle, from research to market placement. This briefing sets the Act’s scope and rationale against the sector’s economic weight and the widening global competitiveness gap. It maps the scope and regulatory landscape and places it in its competitiveness context. The briefing also profiles leading biotech hubs across Member States and identifies structural factors behind their success. This document was provided by the Policy Department for Transformation, Innovation and Health for the Industry, Research and Energy Committee (ITRE).
Adoption of Legislation by EP and Council