The European Commission is under growing pressure to present the Critical Medicines Act quickly. EU Health Commissioner Olivér Várhelyi promised to deliver the proposal within his first 100 days. However, tight schedules and bureaucratic challenges cast doubt on this goal.

The proposed legislation aims to resolve severe shortages of essential medicines like antibiotics, insulin, and painkillers. It focuses on reducing vulnerabilities caused by limited suppliers and fragile supply chains.

Regulatory Hurdles Threaten Progress

Under EU rules, all new legislation requires an impact assessment. This step ensures thorough evaluation of the social, economic, and environmental effects. Skipping it risks delays during the Commission’s internal approval process.

Poland and other member states have questioned whether the proposal will remain a priority during their EU Council presidency, which runs until June 2025. To speed things up, the Commission may use an emergency procedure similar to the one implemented during the COVID-19 pandemic. In that case, the impact assessment would follow the proposal’s release.

Stakeholders Drive Potential Solutions

The Critical Medicines Alliance, a group of 250 stakeholders, plays a key role in addressing the issue. Since April, the Alliance has been examining weaknesses in Europe’s medical supply chains. Its final recommendations, expected on February 12, could serve as the foundation for the new legislation.

Sources close to the Commission suggest that combining the Alliance’s findings with a planned legislative gap study for 2025 might satisfy regulatory requirements. This strategy could allow progress without bypassing necessary legal procedures.

Várhelyi emphasizes the urgency: “We cannot wait any longer. The shortages are a crisis that demands immediate action.” The Commission continues to search for solutions that balance speed with procedural rigor, ensuring reliable access to essential medicines across Europe.