The European Union (EU) is moving forward with its Critical Medicines Act, but many in the pharmaceutical industry are concerned about the fast pace. The Act aims to address shortages of essential medicines in the EU. However, industry leaders believe the proposal is rushing through without enough review, which could cause problems.
Health Commissioner Oliver Várhelyi promised to introduce the Critical Medicines Act within his first 100 days in office. The Commission plans to present the Act on March 11 in Strasbourg, hoping to meet this pledge. Despite the urgency, many in the pharmaceutical sector argue the proposal is developing too quickly. They believe the Commission is not fully considering the impact before it publishes the proposal.
Industry Raises Concerns Over Rushed Process
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), which represents small and medium-sized pharmaceutical companies, has raised concerns. EUCOPE urges the Commission to slow down. The organization believes the Act is being drafted too quickly and needs more time for a full review.
In their response to the Commission’s request for feedback, EUCOPE stressed the importance of understanding how the proposal will affect the broader industry. They fear that a rushed timeline will overlook critical impacts on supply chains and the market.
The Critical Medicines Act targets shortages of vital medicines, such as antibiotics, insulin, and painkillers. These drugs are difficult to source and rely on limited manufacturers. The proposal aims to ensure the availability of these medicines. Yet, many feel that the plan is moving forward too fast without considering its full implications.
Calls for Thorough Impact Assessments
One of the main concerns is the lack of an impact assessment. Under the EU’s Better Regulation principles, the Commission should conduct assessments for policies with significant consequences. These assessments examine the potential environmental, social, and economic effects of the proposal.
However, Swiss pharmaceutical company Roche has criticized the lack of an impact assessment for the Critical Medicines Act. Roche called it “a serious omission,” arguing that the proposal could lead to unintended effects. Without a thorough analysis, the Commission might overlook potential disruptions to the pharmaceutical supply chain, environmental impacts, or unfair competition.
“We believe that a full impact assessment is essential,” said Roche in a statement. The company also emphasized that the proposal should not rely solely on pilot projects or ad-hoc reports. Instead, the Commission must base the proposal on a comprehensive review that accounts for all potential outcomes.
EUCOPE shares Roche’s concerns. The organization agrees that it cannot support the Act without a proper evaluation. They argue that the Commission should take more time to evaluate the proposal’s potential risks and benefits before proceeding.
The Industry Remains Divided
The pharmaceutical industry is divided over the proposal. While EUCOPE and Roche push for a more careful approach, the Critical Medicines Alliance—a group of over 250 stakeholders—is also calling for a slower process. The Alliance includes major companies like Bayer, who have echoed EUCOPE’s concerns about the fast pace of drafting.
The Critical Medicines Alliance formed in April 2024 to assess vulnerabilities in the EU’s pharmaceutical supply chains. Bayer and other members of the Alliance worry that rushing the Act could ignore problems in manufacturing and distribution. They argue that taking more time will allow the Commission to understand the risks better.
The Need for a Balanced Approach
While the pharmaceutical industry pushes for a slower process, the Commission justifies its fast pace by highlighting the urgency of addressing medicine shortages. The shortage of critical drugs has been a longstanding issue in the EU. The Commission believes that quick action is needed to avoid worsening the situation.
However, critics argue that the Commission should not sacrifice careful planning for speed. The pharmaceutical industry warns that a rushed process could have negative consequences. For example, the proposal might not address the underlying issues in the pharmaceutical supply chain or the market.
The European Federation for Pharmaceutical Industries and Associations (EFPIA) has also called for a full review of the proposal. EFPIA believes that a rushed process could cause unintended consequences, and more data is needed to ensure the proposal is effective.
Moving Forward with Caution
As the EU prepares to present the Critical Medicines Act on March 11, the debate over the proposal’s timeline is intensifying. The Commission faces pressure to address medicine shortages quickly. However, industry leaders warn that rushing the proposal could create more problems than it solves.
The Commission will need to consider the concerns raised by the pharmaceutical industry. It must balance the urgency of addressing shortages with the need for careful planning. Ultimately, the future of the EU’s pharmaceutical landscape depends on the Commission’s ability to make the right decision.
This article is published in New York Mirror.