The European Commission is under intense pressure to introduce the Critical Medicines Act. EU Health Commissioner Olivér Várhelyi has vowed to deliver the proposal within his first 100 days in office. However, tight timelines and complex procedures cast doubt on whether the deadline can be met.
The legislation aims to prevent severe shortages of vital medicines like antibiotics, insulin, and painkillers. It prioritizes drugs that are hard to source or rely on limited manufacturers and fragile supply chains.
Procedural Roadblocks: Balancing Speed and Compliance
The EU’s strict regulatory requirements present a key challenge. Every legislative proposal must undergo an impact assessment to evaluate its economic, social, and environmental effects. Skipping this step risks delays during the Commission’s internal approval process.
Poland and other member states have raised concerns about whether the act will be prioritized during their EU Council presidency, which ends in June 2025. To expedite matters, the Commission could use a streamlined process, similar to the COVID-19 crisis response. In that scenario, the impact assessment would follow the publication of the proposal.
Moving Forward: Input from Stakeholders as a Solution
The Critical Medicines Alliance, a group representing 250 stakeholders, is central to finding solutions. Since April, it has been identifying weaknesses in Europe’s medicine supply chains. The Alliance is set to deliver its recommendations on February 12, which could provide a strong foundation for the proposal.
EU sources indicate that the Commission is considering whether the Alliance’s report, combined with an upcoming legislative study planned for 2025, could satisfy the regulatory requirements. This approach could accelerate the process without sacrificing procedural standards.
Várhelyi remains resolute in his mission: “The time to act is now. Europe cannot afford further delays as the current shortages present a clear emergency.” The European Commission continues to work toward a swift and effective solution to stabilize Europe’s critical medicine supply.