The European Commission has unveiled a broad set of health measures. It brings together the Biotech Act, a major overhaul of medical device rules, and the EU’s first-ever cardiovascular strategy. The Union’s executive arm says the initiative is essential to secure Europe’s medical future.
The package comprising the Biotech Act, a device rules update, and the Safe Hearts Plan seeks to make Europe’s health sector more innovative, competitive and resilient. The Commission also wants European patients to benefit first from breakthroughs developed on the continent.
Urgency drives the scale of the proposal. “There is no time to lose,” Mr Várhelyi said. “This legislation will be done in one or two years, which means that this legislation we are proposing today will start to have an impact only after that.”
A system under pressure
Europe’s various healthcare models have delivered decades of universal access, high quality and affordability. But demographic change and chronic disease now strain those systems.
An ageing population, rising cardiovascular disease and slow uptake of innovation threaten public health and industrial competitiveness. At the same time, Europe continues to lose ground globally in biotech investment and clinical trials.
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“This is the moment to redefine what to expect from the European healthcare system in the next five, 10, 15 years,” the Commissioner said. “Otherwise, we will be just following the global trends and we are not going to be able to set them.”
Keep innovation in Europe
The proposed Biotech Act sits at the core of the package. The Commission sees biotechnology as the foundation of future medicine, and a sector where Europe risks falling behind.
Biotech employs more than 900,000 people in the EU, three-quarters of them in health. Yet Europe attracts only seven per cent of global health biotech venture capital. Its share of global clinical trials has fallen from 22 to 12 per cent in a decade. None of the top-selling advanced therapy medicinal products originate in Europe.
The Biotech Act aims to reverse that trend. It targets faster clinical trial approvals, with timelines cut to around 47 days. The Act promotes systematic use of artificial intelligence in trial design, patient selection and data analysis. It also introduces regulatory sandboxes and single regulatory pathways for complex innovative products.
Predicting threats
The act also introduces new incentives for high-impact biotechnology projects. These include projects that create research and development infrastructure, help startups scale up manufacturing, or strengthen Europe’s ability to predict biosecurity threats. These projects can benefit from EU financial support and much faster permitting procedures.
“This is an incentive in the form of an extra year of patent protection by extending the supplementary protection certificates for those products that are invented in Europe, that are biotechnological products and that are tested in Europe and manufactured in Europe,” said the Commissioner. “This is a big incentive for the companies to develop these products here, but also to make sure that it is going to be our patients who will enjoy the benefit of these products first globally.”
This is the moment to redefine what to expect from the European healthcare system in the next five, 10, 15 years. — Health Commissioner Olivér Várhelyi
The Commission will also mobilise capital. Together with the European Investment Bank Group, it has already activated €10bn to support biotech scale-up. The goal is to attract private investors and reduce risk in early-stage development.
Cutting delays, costs
The second pillar focuses on medical devices, a sector that employs close to one million people and relies heavily on small and medium-sized firms. Current rules create unnecessary costs, delays and uncertainty, the Commission argues. These barriers slow market access and push companies to move development elsewhere.
The proposed reform simplifies procedures, digitalises reporting and sets clear timelines for conformity assessments. It cuts fees and aligns processes more closely with international competitors, including the US. The reform also adapts the framework to new technologies. Devices that combine AI, software and active substances will follow single authorisation pathways instead of multiple parallel procedures.
The European Medicines Agency will take on a stronger coordination role. It will monitor device shortages and help define a list of critical medical devices to secure supply. The Commission estimates annual cost savings of €3.3bn, including €2.4bn in reduced administrative burden.
Europe’s leading killer
The third pillar tackles public health directly. Cardiovascular disease remains the leading cause of death in the EU. It claims 1.7 million lives each year and costs the economy €282bn annually. Without action, the number of Europeans living with cardiovascular disease could double by 2050.
The Safe Hearts Plan marks the EU’s first comprehensive strategy on cardiovascular health. It focuses on prevention, early detection, treatment and care. Measures include coordinated screening programmes, a Europe-wide “Know Your Numbers” campaign, and a mobile screening pilot to boost participation. The plan also targets risk factors such as tobacco use, unhealthy diets and ultra-processed foods. Further tobacco control reforms are planned for 2026.
The benefits will only be felt once the process concludes. — Valdis Dombrovskis, EU Economy Commissioner
The strategy places strong emphasis on data, digital tools and AI to personalise prevention and treatment. It also seeks to reduce health inequalities by supporting national cardiovascular plans and monitoring outcomes through EU dashboards. “This is the last moment to act,” Commissioner Várhelyi warned. “To avoid the trouble that we see already now.”
One package, one logic
The Commissioner rejected claims that the package bundles unrelated measures. Instead, they argue that each element reinforces the others. The Biotech Act generates new therapies. Medical devices translate those therapies to patients. The Safe Hearts Plan provides the pathway to deploy them at scale.
The Biotech Act and the medical devices reform now move to the European Parliament and Council. Work on implementing the Safe Hearts Plan with member states is to begin immediately.
The Commission stressed that legislative speed will determine impact. “The benefits will only be felt once the process concludes,” said Valdis Dombrovskis, the Economy Commissioner. Maintaining ambition is essential. The message from Brussels is clear: Europe’s health future will not wait.
