On Tuesday 16 December, the European Commission is due to adopt a package of proposals in the field of health, comprising in particular legislation on biotechnology, an updated regulation on medical devices and an action plan to combat cardiovascular disease.
The Biotech Act is an ambitious legislative proposal designed to boost the competitiveness of biotechnology in Europe, from research to production, while ensuring high standards of health, food safety, ethics and biosafety.
The text applies to the entire life cycle of health biotechnology products and services, from research to marketing.
In particular, the Biotech Act introduces the concept of strategic health biotechnology projects, as well as high-impact projects designed to strengthen the EU’s industrial capacity and value chains. Projects will be able to benefit from public and private support, accelerated authorisations and strategic mapping of the European ecosystem.
To facilitate financing, the text provides for the creation of a biotechnology investment facility, in partnership with the European Investment Bank Group, including financial instruments tailored to the risks of the sector. Medical products developed through biotechnology or advanced therapies will also benefit from a 12-month extension to the Supplementary Protection Certificate (SPC) to encourage their development and production in Europe.
The text includes specific measures to support competitiveness in biosimilars, encourage the adoption of artificial intelligence in biotechnology and put in place flexible regulatory tools for innovative products, including a regulatory testing environment (sandbox) for products under development. Security and the prevention of malicious use are also at the heart of the text, with biodefence and transaction monitoring systems for sensitive products.
Finally, the Biotech Act proposes major changes to a number of existing regulations, notably on food and medicines (human and veterinary), clinical trials and substances of human origin (SoHO), in order to simplify procedures, speed up time-to-market and encourage innovation.
Medical devices. The European Commission is to propose simplifying the European regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR).
With regard to the person responsible for regulatory compliance (PRRC), it is planned to remove the detailed qualification requirements. SMEs will be able to use an external PRRC, with no obligation of permanent and continuous availability.
With regard to the validity of certificates and recertification, the Commission is planning to remove the maximum period of validity of certificates (five years), which would be replaced by periodic reviews proportionate to the risk of the device.
With regard to clinical data, the acceptable sources will be widened (published studies, post-marketing data, etc.), as will the possibility of demonstrating safety and performance using non-clinical data (in silico testing) and the flexibility of equivalence criteria for similar devices.
The Commission also plans to introduce a specific definition and apply proportional requirements or exemptions for devices with well-established technology (low-risk devices with no known safety problems). For repackaging and relabelling, the proposal provides for the removal of the requirement for a notified body certificate for these activities. Finally, with regard to the classification of devices, the Commission is considering a reduction in the level of risk for certain devices, such as reusable surgical instruments and accessories for active implantable devices.
Link to the draft regulation: https://aeur.eu/f/jzy ; and the annex: https://aeur.eu/f/jzz
Cardiovascular diseases. The Commission will adopt an EU Safe Hearts Plan (EU action plan for cardiovascular health), which aims to reduce premature mortality from cardiovascular diseases by 25% by 2035 (compared to 2022) and to improve the detection and control of hypertension, diabetes and obesity.
The Commission will help EU countries to develop national cardiovascular health plans by 2027.
It confirms its wish to propose a revision of the Tobacco Taxation Directive (scheduled for July 2025), aimed at increasing excise duties on traditional products and harmonising the taxation of new products (electronic cigarettes, tobacco-free nicotine). The aim is to reduce the number of smokers in the EU to less than 5% by 2040. The regulation of tobacco and alcohol advertising will be strengthened, notably through a planned revision of the Audiovisual Media Services Directive (2026).
Ultra-processed foods (high in sugar, salt and fat) are linked to obesity, diabetes and cardiovascular disease. Thirteen Member States have already introduced taxes on sugar-sweetened beverages or foods high in sugar, salt or fat. The Commission is considering the introduction of a European tax on ultra-processed products, primarily sugar-sweetened non-alcoholic beverages. This tax would be proportional, inflation-neutral and its revenues would be reinvested in health. It would complement national systems, without replacing them.
Another priority of the action plan is early screening and diagnosis (hypertension, cholesterol, diabetes, obesity, genetic diseases such as familial hypercholesterolaemia). The Commission is counting on artificial intelligence and digital twins to predict risks and personalise care. A budget of €20 million (EU4Health 2025) is earmarked for deploying these AI tools in early detection, personalised prevention and care.
Link to the draft action plan: https://aeur.eu/f/jzw (Original version in French by Lionel Changeur, with Anne Damiani)