As the European Commission rushes to meet its March 11 deadline for presenting the Critical Medicines Act, the EU’s pharmaceutical industry is raising alarms about the rushed timeline and lack of proper evaluation. Originally promised by Health Commissioner Oliver Várhelyi within the first 100 days of his mandate, the proposal aims to address critical shortages of essential medicines, including antibiotics, insulin, and painkillers. However, the speed at which the legislation is being drafted has led to growing concerns among stakeholders about the adequacy of the process.
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), representing small and medium-sized pharmaceutical companies, voiced its concerns in a recent submission to the Commission, urging a more deliberate approach to ensure comprehensive evaluation. The feedback process itself, which closed on Thursday, has been criticized for its timing, adding to the sense of urgency that some industry leaders believe is compromising the quality of policymaking.
The Critical Medicines Act aims to tackle the increasing shortages of life-saving medicines in the EU, particularly those reliant on limited suppliers or manufacturers. While the Commission argues that the urgency of the situation justifies bypassing a full impact assessment, critics assert that rushing the legislation could have significant unintended consequences, including economic, social, and environmental impacts that have yet to be properly analyzed.
Notably, global pharma players like Bayer and Roche have expressed their concerns. Bayer, a member of the Critical Medicines Alliance, emphasized the importance of conducting a thorough impact assessment before moving forward. Roche also voiced its objection, describing the lack of such an assessment as a “serious omission,” stressing that reliance on ad-hoc reports and pilot programs alone is insufficient for a policy of this scale.
The European Federation for Pharmaceutical Industries and Associations (EFPIA) and Japanese pharmaceutical company Takeda also echoed these concerns, underscoring the need for a full evaluation to guide the drafting of the act. According to EUCOPE, the absence of a comprehensive impact assessment could undermine the long-term effectiveness of the legislation in solving medicine shortages across the EU.
As the Commission faces mounting pressure to meet its deadline, the pharma industry is calling for a more measured approach that ensures evidence-based policymaking. With critical medicines in short supply and rising concerns about the broader implications of the proposed legislation, it remains to be seen whether the Commission will heed these calls or move forward with its aggressive timeline.
Sources: EUCOPE, Bayer, Roche, EFPIA, Takeda
