EU reaches preliminary agreement on Critical Medicines Act

The European Council, under the Cypriot Presidency, and the European Parliament have reached a preliminary agreement on the Critical Medicines Act. This legislation establishes a framework to address pharmaceutical shortages and improve supply chain security within the European Union. Key provisions include measures to diversify supply sources and reduce dependence on non-EU countries for essential medicines and active ingredients. Member states are encouraged to participate in joint procurement to increase collective bargaining power. The act also introduces the concept of 'Strategic Projects' to boost European production capacity, offering these projects faster administrative processes and improved access to financing. Additionally, the regulations simplify licensing for orphan drugs and require member states to mandate that companies maintain emergency pharmaceutical reserves. The policy aims to bolster the EU's strategic autonomy and strengthen the overall resilience of the health system.