Race against time for EU’s Critical Medicines Act

A combination of time constraints and procedural hurdles looks set to complicate new EU Health Commissioner, Olivér Várhelyi's desire to present the Critical Medicines Act, one of the key health legislations of the term, within the first 100 days of his tenure.

The Critical Medicines Act is intended to tackle severe shortages of essential medicines such as antibiotics, insulin and painkillers in the EU, with a focus on those trickiest to source or which rely on few manufacturers or countries for supply.

While Commission President Ursula von der Leyen confirmed the initiative in her July political guidelines, she did not specify a timeline. Várhelyi’s promise to deliver the act within 100 days came as a surprise and was reiterated during his first meeting with EU health ministers earlier this month.

“I want to cut my deadlines so that I can deliver earlier for the people,” he said at that time, stressing the urgency of the initiative.

However, the act is absent from the European Commission's list of potential initiatives scheduled until March 5 – which is still subject to changes.

This has led stakeholders and lawmakers to question whether it can realistically be presented by the mid-March deadline. Internal preliminary work such as compulsory assessments and consultations remain unfinished.

A key hurdle is adherence to the EU's Better Regulation principles, which mandate an impact assessment for all new legislative proposals. Introduced since 2002, these assessments evaluate a proposal's environmental, social, and economic implications to ensure evidence-based policymaking.

Insufficient time to complete an impact assessment could delay a so-called inter-service consultation process, where all Commission departments review the