17 Dec 2025
Commission proposes Biotech Act
On 16 December 2025, the European Commission unveiled a package of measures to improve the health of EU citizens, while ensuring the long-term resilience and competitiveness of the health sector. The package is designed to boost biotechnology, medical innovation and cardiovascular research across the EU.
At its core is a proposed Biotech Act, aimed at moving breakthroughs faster from lab to market. The Act foresees new funding instruments, including a health biotech investment pilot with the EIB Group, and targeted support for bio-manufacturing. It aims at streamlining and accelerating cross-border clinical trial authorisations, and at creating single regulatory pathways for complex, innovative products. Regulatory sandboxes are planned to support AI- and data-driven therapies, reducing compliance burdens while maintaining safety.
The Safe Hearts Plan establishes the first EU-wide research and innovation framework against cardiovascular disease. It prioritises integrated data infrastructures, AI-based risk prediction, and personalised prevention and treatment tools. Dedicated initiatives will address research gaps between Member States, support national cardiovascular research strategies, and promote uptake of digital solutions in clinical practice.
Reforms to EU medical device rules will further shape the research environment. Digitalised, simplified conformity procedures and a stronger scientific role for the EMA aim to shorten time-to-market for innovative devices, including those with embedded AI. A new monitoring system for shortages and a list of critical devices will guide R&D priorities and investment.
The proposals now move to the European Parliament and Council for negotiation and adoption.