The European pharmaceutical industry is urging the European Commission to slow down the rollout of the Critical Medicines Act, warning that the rushed timeline could lead to unintended consequences. The act, set for release on March 11 in Strasbourg, aims to tackle essential medicine shortages across the EU, but industry leaders are calling for a comprehensive impact assessment before finalization.
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), representing small and medium-sized pharma firms, has formally requested that the Commission reconsider its rapid drafting process. This appeal was part of a stakeholder feedback initiative, which closed on Thursday—drawing criticism for limiting industry input.
The Critical Medicines Act is designed to address shortages of vital drugs such as antibiotics, insulin, and painkillers. However, major pharmaceutical companies, including Bayer and Roche, argue that the proposal lacks a proper impact assessment. Bayer, a member of the Critical Medicines Alliance—a coalition of 250 stakeholders established in April 2024 to analyze supply chain vulnerabilities—stressed the need for a data-driven approach. Roche echoed this concern, calling the absence of a formal evaluation a “serious omission” and emphasizing that regulatory decisions should not rely solely on pilot programs or ad hoc reports.
Other major industry players, including the European Federation for Pharmaceutical Industries and Associations (EFPIA) and Japanese pharma giant Takeda, have also voiced concerns. They argue that a structured evaluation is crucial to assess the environmental, social, economic, and competitiveness impacts of the proposed legislation.
Despite these objections, the European Commission maintains that the urgency of addressing medicine shortages justifies bypassing a formal impact study. Health Commissioner Oliver Várhelyi remains committed to delivering the act within his first 100 days in office.
As the debate continues, pharmaceutical leaders stress that a well-structured, thoroughly assessed policy will better safeguard long-term medicine security across the EU. Industry stakeholders are pushing for a more measured approach to ensure the legislation effectively addresses supply chain challenges without unintended negative effects.