New EU health package targets biotech, AI and medical device reform
The EU is seeking to close biotech investment gaps and speed access to medical innovation through a new health policy package.
The European Commission has proposed a new health policy package to strengthen innovation, competitiveness, and resilience across the EU health sector. Announced in Brussels, the measures focus on biotechnology, medical devices, and cardiovascular disease prevention.
At the centre of the package is a proposed European Biotech Act designed to address funding gaps, regulatory bottlenecks, and slow market access. The initiative seeks to accelerate clinical trials, support bio-manufacturing, and fast-track AI-enabled therapies through regulatory sandboxes.
The package also includes a Safe Hearts Plan, the first coordinated strategy by the EU to address cardiovascular disease, the bloc’s leading cause of premature death. It focuses on early detection, personalised prevention, and the use of data and AI to reduce health inequalities across member states.
Revised rules for medical devices form the third pillar of the proposal. The European Commission aims to simplify approval procedures, digitalise processes, and reduce delays, while maintaining high patient safety standards and ensuring consistent rules for AI-enabled devices.
Together, the measures are expected to modernise Europe’s health ecosystem, support domestic innovation, and reinforce the EU’s strategic autonomy in healthcare. Legislative proposals will now move to the European Parliament and the Council for consideration.
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