On Tuesday (16 December), the Commission unveiled a three-part Health Package that tries to improve public health and sharpen Europe’s competitiveness. At its core is new legislation: the European Biotech Act and long-awaited fixes to medical-device rules. A cardiovascular “Safe Hearts” plan, meanwhile, targets Europe’s leading cause of death. The Commission’s direction of travel is clear: less friction, more speed.
Biotech to put Europe in the lead
The Biotech Act is the centrepiece. Europe’s health systems are under strain from ageing populations, chronic disease and rising costs, yet innovation has slowed. The EU’s share of global clinical trials has fallen from 22% to 12% in a decade, and only 7% of health-biotech venture capital is European. The diagnosis is: fragmented governance, slow approvals and limited late-stage funding.
Its prescription is acceleration. Clinical-trial authorisation timelines are to be cut to 47 days, down from more than 100. Complex products would follow single regulatory pathways. Harmonised templates, coordinated ethics reviews and broader use of real-world evidence aim to trim red tape. Electronic labelling and digital documentation would become standard, saving firms an estimated €2 billion a year.
Capital is the other bottleneck. A €10 billion public-private investment pilot with the EIB Group is meant to de-risk biotech finance. Faster permitting and targeted support should boost biomanufacturing. Companies developing and testing products in Europe would receive extra regulatory protection, nudging activity back onshore. Artificial intelligence is to be embedded throughout clinical trials, regulation and care.
Medical devices matter more than ever
Running alongside the Act is a targeted overhaul of the Medical Devices (MDR) and In Vitro Diagnostics Regulations (IVDR), whose complexity has caused delays and threatened supply. The Commission proposes fewer certificates for low-risk activities, lighter reporting obligations and longer deadlines for non-critical incident reports. Some devices would be reclassified into lower risk categories.
Certification should be more affordable and predictable. Remote and less frequent audits, rolling reviews for breakthrough and orphan devices, early scientific advice, and reduced fees for SMEs are all available options. Mandatory five-year recertification would disappear, replaced by risk-based periodic reviews. A stronger role for the EMA and expert panels is meant to bring coherence to a fragmented system. Full digitalisation rounds out the reform.
Targeting the top killer
The third pillar, the Safe Hearts plan, is softer but expansive. Cardiovascular disease remains Europe’s leading killer, claiming 1.7 million lives annually. The plan combines prevention and innovation: modernised tobacco rules, measures against unhealthy diets, personalised risk tools, AI-driven monitoring, and targeted support for vulnerable groups. By promoting early detection, timely treatment, and lifestyle interventions, the plan aims to cut premature deaths significantly. Member states will be encouraged to adopt national plans, with EU dashboards tracking progress and helping ensure measurable reductions in cardiovascular mortality.
