The European Union is taking decisive steps to secure its pharmaceutical supply chain through the proposed Critical Medicines Act, aimed at reducing the region's heavy dependence on Asian manufacturers and addressing growing medicine shortages.
European Commission President Ursula von der Leyen announced two significant legislative proposals on July 18, 2024, including the Critical Medicines Act, which seeks to strengthen the EU's pharmaceutical manufacturing capabilities and reduce reliance on external suppliers.
Current Supply Chain Vulnerabilities
The European Economic and Social Committee (EESC) has highlighted critical vulnerabilities in the EU's pharmaceutical supply chain. China currently stands as the world's largest supplier of active pharmaceutical ingredients (APIs), creating significant risks for Europe's medicine security. The situation has become increasingly concerning as medicine shortages continue to rise across the continent.
The challenge has been further complicated by reduced European good manufacturing practice (GMP) inspections of Chinese facilities. This reduction in oversight, partly due to China's new anti-espionage law enacted in July 2023, has led several German federal states to halt inspector visits to Chinese manufacturing sites. With many GMP certificates set to expire by the end of 2024, there are growing concerns about potential drug availability issues.
Five-Pillar Strategy for Supply Chain Security
Medicines for Europe (MfE) has proposed a comprehensive framework for the Critical Medicines Act, outlining five essential pillars:
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Manufacturing Investment The proposal calls for European Commission funding for critical medicines and API manufacturing through the Multi-Annual Financial Framework. This includes expanding the definition of "innovation" to encompass security of supply and supporting new production facilities for APIs and finished doses.
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Generic Pricing Reform Current price restrictions are deterring investment in older generic medications. The Act aims to evaluate how existing legislation affects manufacturing and marketing costs for critical medicines.
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Coordinated Stockpiling The framework proposes replacing fragmented national stockpiling requirements with a harmonized European Solidarity Mechanism, including more flexible packaging requirements to facilitate cross-border product movement.
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Supply Chain Diversification The strategy emphasizes building international partnerships, particularly with EU accession candidates like Ukraine and Moldova, to create new manufacturing opportunities and expand capacity.
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Workforce Development A dedicated focus on training and developing STEM professionals to address the current skills shortage in the pharmaceutical sector.
Immediate Actions and Implementation
The European Medicines Agency (EMA) has already initiated several measures to strengthen medicine supply chains. In January 2024, the Critical Medicines Alliance was established to combat shortages, while October 2023 saw the creation of a solidarity mechanism enabling EU countries to support each other during critical medicine shortages.
The European Commission is expected to prepare a draft version of the Critical Medicines Act within the next 12-18 months, following standard Commission timelines. This legislation represents a crucial step toward ensuring Europe's pharmaceutical independence and supply chain resilience in an increasingly complex global landscape.
