European Biotech Act and accompanying Directive on genetically modified micro-organisms

The European Biotech Act, adopted on 16 December and announced in the Political Guidelines for the European Commission 2024–2029, aims to create an enabling environment that facilitates the transition of biotechnology products from the laboratory to industrial production and ultimately to the market, while maintaining high safety and ethical standards.

While biomanufacturing of biological medicines generates high economic value, highly skilled jobs, and additional investment in R&D, the EU’s strong global position in fundamental biotech research has not yet translated into sufficient marketable products or scalable industrial processes.

The Act seeks to strengthen Europe’s competitiveness in biotechnology – particularly health biotechnology – by accelerating clinical trials, simplifying fragmented regulatory frameworks, improving access to scale-up funding, and boosting EU-based biomanufacturing. Its core objective is to ensure that biotech innovation, investment, and production remain in Europe, rather than EU discoveries being commercialised abroad.

This opinion will build on previous CCMI opinions, including CCMI/221 – Communication on the Availability of Medicines, CCMI/235 – Industrial Changes in the Health Sector in the Face of Multiplying Crises, CCMI/240 – Critical Medicines Act, and CCMI/251 – EU Medical Countermeasures and Stockpiling Strategies.