Commission aims to present three legislative initiatives before the end of the year.

The run-up to Christmas will not be very quiet in Brussels this year, as there is still a considerable amount of work ahead. The European Commission and the Directorate-General for Health and Food Safety are currently under significant pressure. On 16 December, EU Health Commissioner Olivér Várhelyi will present his health package, which is expected to contain three initiatives. With these early legislative proposals, the winter break is likely to be correspondingly shorter.

Cardiovascular Health Plan

The new EU Cardiovascular Health Plan is intended to become the first comprehensive EU strategy against cardiovascular diseases and respond to the sharply rising case numbers and costs across the European Union. The structure and logic of the plan are expected to follow the EU Cancer Plan and include three pillars: prevention, early detection and screening, as well as treatment and care. In addition, three horizontal priorities are envisaged: digitalisation, research and social inequalities. Similar to the Cancer Plan, the Cardiovascular Health Plan is expected to set concrete targets and address structural shortcomings, including low investment in prevention, missing standards for early detection, fragmented care, data gaps, weak research and large social and gender-related disparities.

Even though the initiative will start as a plan, it is expected to lead to political initiatives, including binding legislation, non-binding recommendations and additional financial support. A leaked draft already provides initial insights. According to this draft, the Commission intends to introduce a Food Processing Assessment System that will evaluate highly processed foods and foods high in sugar, fat or salt based on scientific criteria. On this basis, the Commission aims to introduce EU-wide charges on such products and on alcopops in 2026.

Biotech I

Commissioner Várhelyi is planning two Biotech Acts. The first Act will focus specifically on the health sector and aim to promote biotechnological innovation and simplification, particularly in clinical trials, but also in the food and feed sectors. The second Act will address the broader European biotech ecosystem. The Biotech Act I, expected in December, aims to strengthen European biotechnology and is guided by the principles of simplification and reducing administrative burden. Planned measures include amendments to the Clinical Trials Regulation. The Act is also expected to provide targeted EU funding to support smaller companies developing therapies for rare diseases or advanced biotechnological procedures. Proposals for faster market authorisation of biotechnological products are also anticipated. Despite the extensive changes, the Commission does not plan to carry out an impact assessment. The effects and scope of the proposed measures therefore lack analytical and scientific underpinning.

Targeted revision for medical devices and in vitro diagnostics

Under the theme of simplification and reducing bureaucracy, the European Commission is also planning a targeted revision to the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation. A simplification package is envisaged that would revise key procedures, streamline certification, reduce administrative hurdles and costs, and improve the regulatory framework for healthcare institutions. The package is expected to include exemptions from certification requirements for legacy devices and a fast-track procedure for niche products, known as orphan devices, aimed at small patient populations. No impact assessment will be carried out. Commissioner Várhelyi has emphasised the goals of these adjustments: “We must significantly reduce bureaucracy, decrease complexity, shorten time to market for new products and lower costs.”

With these three initiatives, the Commission is setting strong health policy signals at the end of the year, which are likely to shape the political framework for 2026.