The European Commission has proposed new rules to enhance the security of supply and access to critical medicines within the EU, with a focus on prioritizing EU-based suppliers in public procurement. The proposal, part of the Critical Medicines Act, aims to address ongoing medicine shortages and ensure a stable and reliable supply chain. The Act primarily targets critical medicines included in the EU’s list of essential medicinal products, focusing on drugs used to treat serious conditions or with limited alternatives. The proposal comes as a response to the heavy dependence on foreign suppliers for active pharmaceutical ingredients and the vulnerabilities exposed by the COVID-19 pandemic.
The new ‘Buy Europe’ mechanism introduced in the proposal seeks to increase investment in essential medicine manufacturing and key ingredients within the EU, reducing external dependencies. This mechanism includes public procurement award criteria that prioritize the security of supply over price alone. EU contracting authorities will be encouraged to favor suppliers that manufacture a significant portion of critical medicines within the EU to address vulnerabilities in supply chains and dependence on a single third country. The aim is to increase EU production capacity, diversify supply chains, and make them more resilient, while complying with international commitments.
The proposal also introduces a category of medicines of common interest, such as those with little availability in at least three EU member states, to be subject to coordinated procurement mechanisms. This could lead to joint procurement of medicines at the EU level, with the involvement of the European Commission supporting member states in collaborative procurement efforts. Strategic projects within the EU aimed at bolstering the capacity to manufacture and develop critical medicines will benefit from incentives like fast-tracked permitting and potential EU funding. While the proposal has been generally welcomed as a positive step toward greater access to affordable medicines, concerns remain over its lack of ambition and financing.
Green MEP Tilly Metz has called for bolder initiatives to reshore medicine production in Europe, emphasizing that joint procurement and accelerated processes may not be enough. Others, like Romanian liberal MEP Vlad Voiculescu, see the proposal as a beginning and hope that it will be supported by funding, budgets, and national legislation. Despite concerns over the proposal’s indicative budget of €83 million for 2026-2027 through the EU4Health program, 11 EU health ministers have advocated expanding the scope of EU defence funding to include critical medicines. Belgian Health Minister Frank Vandenbroucke highlighted the importance of medicine security, stating that collective safety depends on it and urging the integration of the Act into Europe’s security and defence framework.
