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The European Union is preparing to introduce the Critical Medicines Act, a proposal aimed at addressing severe drug shortages. However, the pharmaceutical industry is urging the Commission to slow down, arguing that rushing the process could lead to problems. The EU Commission plans to present the Act on March 11 in Strasbourg, but industry leaders warn that the legislation needs careful review before being finalized.

Industry Concerns Over Speedy Legislation

Health Commissioner Oliver Várhelyi had committed to launching the proposal within his first 100 days in office. While the initiative aims to secure the availability of essential medicines, pharmaceutical companies across Europe believe the approach is too rushed. They argue that meaningful consultation and analysis are necessary to prevent unexpected consequences.

The Act focuses on strengthening supply chains, particularly for medicines such as antibiotics, insulin, and painkillers. It is designed to address shortages by increasing production and reducing reliance on a small number of suppliers. However, industry representatives believe the short deadline for feedback has not allowed for thorough evaluation.

Calls for a More Comprehensive Review

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), which represents small and medium-sized pharmaceutical firms, has asked the Commission to reconsider its timeline. The organization warns that if the Act is passed too quickly, it could lead to disruptions in medicine supply and regulatory confusion.

“We urge the Commission to carefully reassess the timeline and conduct a full impact assessment before finalizing the proposal,” stated German pharmaceutical giant Bayer. The company is part of the Critical Medicines Alliance, a coalition of 250 stakeholders formed in April 2024 to analyze weaknesses in drug supply chains.

Other major pharmaceutical firms have echoed similar concerns. The European Federation for Pharmaceutical Industries and Associations (EFPIA) and Japanese drugmaker Takeda are among those pushing for a more methodical approach. They argue that policymakers must ensure the Act effectively strengthens medicine supply without creating unintended regulatory obstacles.

Demand for an Impact Assessment

An impact assessment is a critical part of EU policymaking, introduced in 2022 under the Better Regulation framework. These assessments evaluate the potential economic, social, environmental, and competitive effects of a proposal before it becomes law. However, the Commission has decided to move forward with the Act without conducting a full impact study.

Swiss pharmaceutical company Roche criticized this decision, calling it “a significant oversight.” The company insists that a full impact assessment is necessary to examine how the Act will affect medicine availability, pricing, and competition in the pharmaceutical industry.

“These considerations should be examined through a proper impact assessment rather than relying solely on pilot projects, ad hoc reports, and strategic reviews by the Critical Medicines Alliance,” Roche stated in response to the proposal.

Despite these concerns, the Commission maintains that urgent action is necessary to address growing medicine shortages. It argues that the Act will provide a framework to strengthen the EU’s medicine supply chain and reduce dependence on foreign manufacturers. However, industry leaders remain skeptical, saying the current approach lacks sufficient data to justify its rapid implementation.

Balancing Speed with Effective Policy

The debate over the Critical Medicines Act highlights a broader issue: how to balance urgency with responsible policymaking. Addressing medicine shortages is a pressing concern, but industry experts caution that rushed legislation could create more problems than it solves.

Pharmaceutical companies emphasize the need for collaboration between policymakers and industry stakeholders. They argue that a well-designed law, developed with proper input, will be more effective in securing long-term medicine supplies.

As the March 11 deadline approaches, discussions continue over whether the Commission will reconsider its approach. Companies and industry groups continue to advocate for a full impact assessment, stressing that careful planning is essential for the Act’s success.

For further updates on the Critical Medicines Act, visit Financial Mirror.