The European Union is preparing to introduce the Critical Medicines Act. This legislation aims to address severe shortages of medicines like antibiotics, insulin, and painkillers. However, as the Commission moves forward, pharmaceutical leaders have raised concerns. They argue that speeding up the process might lead to mistakes and unintended consequences.
The Commission plans to present the Act on 11 March in Strasbourg. This date is important as Health Commissioner Oliver Várhelyi promised to launch the proposal within his first 100 days. However, many pharmaceutical companies across Europe believe the process has moved too fast. They think more time is needed to properly assess the impact of the proposal.
Industry Pushes for More Time
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), representing small and medium-sized pharmaceutical companies, has called for more time. EUCOPE warns that rushing the proposal could disrupt the supply chain and create regulatory issues.
The deadline for stakeholders to provide feedback was tight. It ended on Thursday, leaving industry representatives with limited time to offer meaningful input. Many leaders in the pharmaceutical industry fear that the Commission is ignoring key factors that could impact the availability and affordability of essential medicines.
The Critical Medicines Act is designed to solve the shortages of essential medicines in the EU. These shortages often involve drugs that depend on just a few manufacturers or suppliers. By improving the supply chain for these medicines, the Commission hopes to stabilize availability.
“We urge the Commission to reassess the timeline and conduct a full impact assessment before finalizing the proposal,” said a Bayer spokesperson. Bayer, a large German pharmaceutical company, is part of the Critical Medicines Alliance. This group of 250 stakeholders, formed in April 2024, focuses on identifying weaknesses in the medicine supply chain.
Need for a Full Impact Assessment
The Commission’s Better Regulation framework, introduced in 2022, stresses the need for impact assessments. These assessments ensure policies are based on thorough analysis of their potential effects. Yet, many pharmaceutical leaders feel the Commission has skipped this important step with the Critical Medicines Act.
Swiss pharmaceutical company Roche has criticized the lack of a full impact assessment. Roche believes this is a serious oversight that could have long-term consequences. The company argues that the Act should be evaluated for its environmental, social, and economic impacts, rather than relying solely on pilot projects and strategic reports.
“These factors should be examined through a full impact assessment,” Roche stated. “It should not depend only on ad hoc reports and strategic reviews.”
The Commission argues that addressing medicine shortages justifies the urgency of speeding up the process. However, industry leaders argue that the existing evidence is not enough to fully understand the potential consequences. They stress that a more thorough analysis is needed.
“We cannot support the publication of the Act without a full impact assessment,” EUCOPE added. The group believes that rushing the process could lead to serious risks.
Calls for More Caution
Other organizations have joined the call for a careful review of the proposal. The European Federation for Pharmaceutical Industries and Associations (EFPIA) and Takeda, a Japanese pharmaceutical company, have both asked the Commission to slow down. These groups believe that a hasty decision could harm the pharmaceutical industry and the patients who rely on these medicines.
These organizations argue that the supply chain is already under strain. Rushed regulations could worsen these problems. They call for a detailed, methodical review to ensure the legislation works as intended.
The debate over the Critical Medicines Act highlights the need for careful consideration. Industry leaders believe that the Commission should slow down and take more time to assess the proposal’s effects. Rushed decisions could lead to costly mistakes.
A Critical Moment for the Commission
As the March deadline approaches, the pressure on the European Commission is mounting. Many in the pharmaceutical industry believe that the Commission should take a step back and re-evaluate the proposal. A careful review could help avoid potential risks and ensure the Act achieves its goal of improving the availability of critical medicines.
The growing number of voices urging caution reflects the importance of this issue. If the Commission ignores these concerns, it risks creating unnecessary complications. A more careful, data-driven approach could ensure that the Critical Medicines Act delivers its intended benefits without causing harm.
For more updates on the Critical Medicines Act and other EU policies, visit Euro News 24.