On March 12, 2025, the European Commission took an important step in strengthening the European Union’s strategic autonomy with regard to the availability of essential medicines. It presented the Critical Medicines Act, a new initiative aimed at guaranteeing continuous access to essential medicines, preventing shortages and improving the resilience of supply chains in the pharmaceutical industry.
Check out the main points of this proposal:
1.Central Objective of the Law
The main objective of the Critical Medicines Law is to mitigate vulnerabilities in manufacturing and supply chains, ensuring the production of essential medicines and raw materials. The idea is to strengthen the European Union’s strategic autonomy, ensuring that critical medicines are always available to European citizens.
2. Causes of Medicines Shortages
The proposal recognizes that medicine shortages are mainly caused by problems related to production and the complexity of global supply chains. The COVID-19 pandemic, for example, has revealed the fragility of many supply systems.
3. Critical Medicines Alliance report
In February 2025, the Critical Medicines Alliance released a report with important recommendations for a more coordinated approach in the European Union. The document advocates the creation of a European list of critical medicines, the security of supply chains and the implementation of investment mechanisms in strategic industrial projects. The proposals aim to improve security of supply and stock management in the pharmaceutical sector.
4. European coordination
Rui Santos Ivo, president of Infarmed’s Board of Directors, highlights the importance of the new law in promoting a coordinated approach at European level, ensuring that essential medicines are always available. He emphasizes that the issue of shortages is a strategic topic of great relevance to the regulatory authorities, which have been working to develop instruments and policies to mitigate these problems.
5. Next Steps and Implementation
The European Commission continues to work to implement the proposals of the Critical Medicines Alliance, with a focus on strengthening the safety and resilience of medicines supply chains. The new legislation should be accompanied by practical procurement measures and production support programs.
The Critical Medicines Act represents an important step forward for public health and safety in Europe by ensuring that shortages of essential medicines are prevented in a coordinated and strategic manner.
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This measure promises to be a milestone in European pharmaceutical regulation, with a direct impact on the management of essential medicines for all citizens.
