On 16 June 2026, EU Health Commissioner Olivér Várhelyi praised the Cyprus Presidency of the Council for its work on the Critical Medicines Act and the Biotech Act during the EPSCO Health Council. Várhelyi noted that the Presidency reached an agreement on the Critical Medicines Act in May, which he described as a remarkable achievement, and that Member States agreed on the first part of the Biotech Act, a directive, at record speed. He also highlighted progress on medical devices legislation and discussions on health security preparedness.
Várhelyi made a personal commitment to present the Critical Medicines Act proposal within the first 100 days of his mandate, and the Cyprus Presidency matched and even outperformed that ambition. The Act aims to strengthen EU resilience and security of supply of critical medicines, addressing shortages that became evident during the COVID-19 crisis. The Commissioner stressed that the objective is to ensure patients in Europe have better access to medicines when they need them.
The Biotech Act, part of last year's health package, is seen as key to the EU's competitiveness agenda. Várhelyi noted that Europe remains a leader in biotechnology but must accelerate to maintain its position. The Act is expected to bring more precise diagnostics, new treatments, and personalised medicine. He expressed hope that the incoming Irish Presidency will build on the Cyprus Presidency's work.
On medical devices legislation, the Presidency updated ministers on progress, aiming to support innovation, simplify rules, and maintain patient safety while ensuring faster access to new treatments. Várhelyi framed these initiatives—pharmaceutical reform, the Critical Medicines Act, the Biotech Act, and medtech proposals—as redefining European healthcare and providing a long-term vision for the sector.
Ministers also discussed health security preparedness, with the Presidency updating on Ebola outbreaks. Várhelyi confirmed the Commission is closely following the situation, supporting the ECDC and international partners to contain the outbreak.
Stakeholder impact: The Critical Medicines Act and Biotech Act are expected to positively impact EU patients by improving access to medicines and innovative therapies. EU pharmaceutical and biotech companies may face new compliance requirements but also benefit from a more predictable regulatory framework and incentives for innovation. National health authorities will need to adapt to new rules, potentially increasing administrative burdens. EU taxpayers may see long-term benefits from reduced shortages and more efficient healthcare systems, though short-term costs for implementation could arise.