In response to persistent drug shortages within the European Union (EU), the European Commission and Belgian Presidency have joined forces to launch the Critical Medicines Alliance. This initiative seeks to bolster the resilience and diversification of the EU’s medicine supply chain, addressing vulnerabilities exposed by recent shortages of critical drugs such as paracetamol and antibiotics.
Acknowledging that medicine shortages are not a novel issue, Health Commissioner Stella Kyriakides emphasized the exacerbating effects of the COVID-19 pandemic and geopolitical challenges. The Critical Medicines Alliance forms part of a broader strategy outlined in a Communication published in October 2023, which also proposes extending the mandate of the European Centre for Disease Prevention and Control and reforming current pharmaceutical legislation.
With a mandate spanning five years, the Alliance will prioritize industrial policy, leaving regulatory matters to the forthcoming pharmaceutical legislation. Its efforts will focus on bolstering manufacturing capacities through leveraging EU and national funding, implementing market incentives like capacity reservation contracts or joint procurement, and issuing recommendations outlined in a Strategic Plan slated for release by year’s end.
The Alliance comprises 250 members, including representatives from the European Commission, member states, the pharmaceutical industry, patient groups, and healthcare professionals. Belgian Health Minister Frank Vandenbroucke highlighted the risks associated with the shift in medicine production away from Europe towards countries like China and India, emphasizing the need for diversified supply chains.
The Alliance will collaborate on diversifying the international supply chain for identified critical medicines, fostering joint projects, and forging strategic partnerships with third countries. Additionally, it will engage with the Union List of Critical Medicines published by the Commission and the European Medicines Agency in December 2023. This list includes over 200 essential human medicines whose shortages pose a threat to public health. The Commission has initiated a pilot exercise to analyze vulnerabilities in the supply chains of 11 substances from this list, serving as the foundation for the Alliance’s work.
Drawing inspiration from similar industrial initiatives, such as the European Alliances on critical raw materials and semiconductors, the Critical Medicines Alliance is anticipated to pave the way for potential future legislation, akin to the European Raw Materials Act and European Chips Act. Minister Vandenbroucke emphasized the need for a comprehensive legal framework, including a Critical Medicines Act. In 2023, 23 member states issued a non-paper advocating for such an act as a foundational step towards a more structured, long-term approach.
The Alliance envisions its work contributing to the potential development of a Critical Medicines Act in the future, recognizing the necessity for thorough preparation, including economic impact assessments. In October 2023, the Commission initiated a study to assess the feasibility of such an act, though no concrete timeline has been established for future actions.
