The European Union (EU) is preparing to introduce the Critical Medicines Act, a law aimed at solving medicine shortages. The Act will be presented on 11 March in Strasbourg. However, the pharmaceutical industry is urging the EU to slow down and reconsider the plan.
Health Commissioner Oliver Várhelyi promised to present the proposal in his first 100 days. But industry leaders believe rushing the process could cause problems. They say there is not enough time for proper review and input from experts. These leaders argue that quick decisions might lead to mistakes that could hurt patients.
Industry Leaders Call for More Time
The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) represents smaller pharmaceutical companies. It has asked the EU to delay the proposal. The group says the Act should go through a full review. It argues that rushing this law could lead to supply chain issues. These problems could make medicines harder to get or more expensive for patients.
The deadline for feedback on the Act passed last Thursday. Many groups say this was not enough time for people to give proper feedback. The pharmaceutical industry wants more time to carefully study the law’s possible effects. The goal is to avoid unintended problems in the future.
The Critical Medicines Act is designed to solve shortages of important drugs in the EU. These include antibiotics, insulin, and painkillers. The law will strengthen supply chains. It will also make sure that medicines are available even when there are only a few manufacturers.
Why the Act Needs More Time
The EU argues that the Act must be passed quickly to solve the medicine shortage crisis. But many experts believe that the law’s quick timeline does not allow for enough discussion. They argue that rushing this Act might cause new problems.
Bayer, a large pharmaceutical company in Germany, is also concerned. Bayer is a member of the Critical Medicines Alliance. This group of 250 companies believes the law needs more time for careful review. They also want a full impact assessment. Bayer has said that the law should not move forward without a better understanding of its effects.
Roche, a Swiss pharmaceutical company, shares these concerns. It says the EU has skipped a key step by not doing a full impact assessment. Roche says the EU is relying too much on pilot projects and quick reports, which could overlook important details. The company insists that a proper assessment is necessary before moving forward.
The Need for a Thorough Review
In 2022, the EU introduced rules for better regulation. These rules require a full impact assessment for big laws. These assessments help policymakers understand the effects of new laws. They can identify risks and challenges before laws are passed. However, many believe the EU is ignoring this step with the Critical Medicines Act.
Roche has called this decision a “big mistake.” It says the law should not move forward without a thorough review. The impact assessment should look at the effects of the law on the environment, society, and the economy. It should also consider the potential impact on competition.
EUCOPE agrees. The group argues that the Act will have a big impact on patients and supply chains. A full review is needed to understand the long-term consequences. Without it, the law might hurt patients who rely on important medicines.
Why the Law Is Important, but Needs Careful Consideration
There is no doubt that medicine shortages are a growing problem in the EU. Many critical drugs are in short supply, and this affects patients across the region. The Critical Medicines Act is meant to address these shortages. But industry leaders argue that solving this problem should not come at the cost of rushing a law that could have unintended negative effects.
A full, careful review of the Act will help ensure that it works as intended. It will also allow for better planning and preparation. Industry groups such as the European Federation for Pharmaceutical Industries and Associations (EFPIA) and Takeda, a Japanese pharmaceutical company, are also calling for more time to assess the proposal.
As the Commission moves closer to presenting the Act, the pressure from the pharmaceutical industry continues to grow. Industry leaders are pushing for a more thoughtful approach to avoid any unnecessary risks. The growing demand for a careful, data-driven review of the Critical Medicines Act will likely shape the future of the EU’s approach to addressing medicine shortages.
The Commission’s decision on this matter will have long-term consequences for patients and the pharmaceutical sector. As more stakeholders weigh in, the EU faces the challenge of balancing the urgent need for action with the need for careful consideration. Only time will tell how the Critical Medicines Act will shape the future of medicine availability in the EU.
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