The European Commission faces mounting challenges in meeting its ambitious goal of unveiling the Critical Medicines Act within the first 100 days of EU Health Commissioner Olivér Várhelyi’s tenure.
The proposed act aims to address critical shortages of essential medicines, such as antibiotics, insulin, and painkillers, particularly those that are difficult to source or rely on limited manufacturers or countries for supply. While Commission President Ursula von der Leyen confirmed the initiative in her July political guidelines, she did not provide a specific timeline. Várhelyi’s promise to introduce the act within 100 days surprised many and was reiterated during a recent meeting with EU health ministers.
“I want to cut my deadlines so that I can deliver earlier for the people,” Várhelyi emphasized, underscoring the urgency of the proposal. However, doubts have emerged as the Critical Medicines Act is notably absent from the European Commission’s list of planned initiatives up until March 5, with the schedule still subject to change.
This raises concerns about whether the act can realistically be unveiled by mid-March. Key preliminary work, such as mandatory assessments and consultations, remains incomplete. A major obstacle is ensuring compliance with the EU’s Better Regulation principles, which require an impact assessment for all new legislative proposals. These assessments, introduced in 2002, evaluate the environmental, social, and economic impacts of proposals to ensure that policymaking is based on evidence.
