Securing the Supply of Medicines in the EU through the Critical Medicines Act

The COVID-19 pandemic and geopolitical tensions have exposed the vulnerability of global supply chains for medicines. To avoid future shortages and increase security of supply, the European Commission proposed the Critical Medicines Act on March 11, 2025, incorporating the findings and recommendations of the Critical Medicines Alliance strategy report. This step aims to strengthen the resilience of the European healthcare system and reduce dependence on non-European suppliers.

Background and necessity

In recent years, there have been increasing supply bottlenecks for essential medicines, which have impaired patient treatment and shaken confidence in the healthcare system. Causes have included production shortfalls, quality issues and geopolitical conflicts disrupting global supply chains. This situation highlighted the need for the EU to take action to secure the supply of medicines.

Key points of the regulation on critical medicinal products

• Definition of critical medicinal products: A list of medicinal products that are considered essential for public health is drawn up. This list serves as the basis for targeted measures to ensure their availability.
• Promotion of supply chain diversification: Manufacturers are encouraged to diversify their supply chains in order to reduce dependencies on individual suppliers or regions. This is to be achieved through financial incentives and regulatory relief.
• Strengthening production within the EU: The production of critical medicines in the EU is to be expanded through investments and support programs. The aim is to increase production capacities and thus improve security of supply.
• Improving transparency: A reporting system will be introduced to provide early warning of potential bottlenecks. Manufacturers and wholesalers are obliged to provide information on stocks and production capacities to enable proactive planning.
• Rapid response mechanisms: Mechanisms will be established that take effect quickly in the event of supply bottlenecks. These include coordinated measures between the Member States and the Commission as well as the possibility of activating emergency plans.

Expected effects

The Commission expects the implementation of the regulation to increase the resilience of the healthcare system. Patients should have continuous access to necessary medicines, regardless of global crises or disruptions. In addition, the European pharmaceutical industry will be strengthened, which will secure jobs and promote innovation in the long term

Role of the member states and stakeholders

The successful implementation of the regulation requires close cooperation between the EU, the member states, the pharmaceutical industry and other relevant stakeholders. National authorities are called upon to support the measures and implement them in their countries. The industry should be enabled to react flexibly to changes and adapt its production capacities accordingly.

The proposed regulation is a decisive step towards securing the supply of medicinal products in the EU. By promoting supply chain diversification, strengthening production within the EU and improving transparency, future bottlenecks are to be avoided. This serves to protect public health and strengthens citizens' trust in the European healthcare system. The proposal will now be submitted to the European Parliament and the Council for examination. Numerous amendments and voting procedures are expected there. It therefore remains to be interesting to see when and in what form the proposed regulation will come into force. Read the full report on the Critical Medicines Act on the European Commission's website.