Wanted in the first 100 days of the new legislative mandate, doubts linger over whether the European Commission will unveil the Critical Medicines Act on time.
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.
Impact assessment needed
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 proposal.
Polish diplomats have also indicated that they remain uninformed about whether the act will be prioritised by the EU executive during the country’s EU Council presidency, which ends in June 2025—well beyond Várhelyi’s self-imposed deadline.
Theoretically the Commission could bypass the impact assessment, a rare move reserved for emergencies, with the condition that an analysis will be conducted within three months of the proposal’s publication. This approach was previously used during the COVID-19 crisis and for other initiatives during recent farmers’ protests.
During the last EU health council, Várhelyi emphasised the need for swift action to address what he called a “clear emergency”, noting: “It’s been four years since we had the COVID crisis, and we still face the same problems.”
Commission’s silver bullet
The Critical Medicines Alliance, a consultation body comprising 250 stakeholders, could play a pivotal role in advancing the act, according to EU sources.
Established under a broader initiative to address medicine shortages, the Alliance has been analysing supply chain weaknesses since its launch last April.
Their recommendations, expected on 12 February, could partially fulfil the Better Regulation requirements by providing evidence from the ground from a broad range of stakeholders.
Sources attending one of the latest behind-closed-doors meetings with the Commission indicated the EU executive is exploring whether the Alliance’s final strategic report, coupled with a separate legislative gap study due in early 2025, could suffice as an impact assessment.
This would help meet regulatory criteria while addressing the pressing need for action. An EU official said that internal discussions with the legal services on how to meet the Better Regulation criteria are ongoing.
Despite significant challenges, these developments offer a potential path forward for Várhelyi’s ambitious timeline, balancing urgency with procedural rigor.
