Strengthening Europe’s Medicine Supply Chain: A New Era for Health Security
The European Commission has unveiled a groundbreaking proposal to fortify the supply chain for critical medicines, marking a significant step toward ensuring the health and well-being of EU citizens. The proposal, introduced as part of the Critical Medicines Act, aims to enhance the security and availability of essential drugs, particularly those deemed critical to public health. At the heart of this initiative is a "Buy Europe" mechanism, which prioritizes EU-based suppliers in public procurement processes. This measure is designed to reduce the bloc’s dependence on foreign manufacturers and mitigate the risks of supply chain disruptions. The proposal was fast-tracked, with Health Commissioner Olivér Várhelyi emphasizing the urgency of addressing persistent medicine shortages across the EU. Despite the accelerated timeline, which has drawn criticism for lacking a comprehensive impact assessment and stakeholder input, the Commission argues that the current geopolitical climate and ongoing shortages justify swift action.
Tackling Medicine Shortages in the EU
The Critical Medicines Act seeks to address a pressing issue: the frequent shortages of essential medicines in the EU. Drugs such as antibiotics, insulin, and painkillers have become increasingly difficult to obtain, primarily due to the EU’s heavy reliance on a limited number of manufacturers or countries. This vulnerability was starkly exposed during the COVID-19 pandemic, which highlighted the fragility of global supply chains. The Commission acknowledges that pharmaceutical companies bear responsibility for ensuring adequate supply, but the fragmented nature of oversight—where distribution is managed at the national level—has left the EU ill-equipped to respond to shortages effectively. To combat this, the Act establishes the security of supply and availability of critical medicines as a strategic EU objective, requiring a coordinated approach at both European and national levels.
"Buy European": A Strategic Shift in Public Procurement
Central to the proposal is the "Buy Europe" principle, a mechanism that introduces new public procurement rules to prioritize the security of supply over price alone. Under this system, when vulnerabilities in the supply chain are identified—particularly when there is heavy dependence on a single third country—EU contracting authorities will favor suppliers that manufacture a significant portion of critical medicines within the EU. This shift aims to boost investment in local manufacturing and reduce external dependencies, thereby making supply chains more resilient. The Commission emphasizes that these measures will comply with the EU’s international commitments, ensuring that the initiative does not violate trade agreements or harm global partnerships. An EU official explained that the goal is to "increase EU production capacity and diversify supply chains to make them more resilient, while also leveraging demand."
Joint Procurement and Strategic Projects
The proposal also introduces a novel concept: "medicines of common interest." These include drugs with limited availability in at least three EU member states, such as those used to treat rare diseases. For these medicines, the Commission suggests coordinated procurement mechanisms, involving member states, to prevent inequalities and supply gaps. This approach could pave the way for joint procurement of medicines at the EU level, a long-awaited initiative. Additionally, the proposal promotes "strategic projects" aimed at enhancing the EU’s capacity to manufacture and develop critical medicines. These projects will benefit from incentives such as fast-tracked permitting, streamlined environmental assessments, and potential EU funding. By fostering collaboration and investment, the Commission hopes to create a more robust and self-sufficient pharmaceutical ecosystem within the EU.
Criticism and Calls for Greater Ambition
While the proposal has been welcomed as a step in the right direction, it has also drawn criticism for its perceived lack of ambition and funding. Luxembourgish Green MEP Tilly Metz argued that the measures do not go far enough, calling for bolder initiatives to reshore medicine production in Europe. "Joint procurement and just accelerating the processes is not enough," she said. Others have raised concerns about the proposal’s indicative budget of €83 million for 2026-2027, which they fear will be insufficient to address the scale of the problem. Romanian liberal MEP Vlad Voiculescu, however, struck a more optimistic tone, describing the proposal as a positive step toward greater access to affordable medicines. "It’s a beginning," he said. "We hope to see it backed by funding, budgets, and national legislation as soon as possible."
The Path Forward: Integration and Investment
As the proposal moves forward, there are growing calls for it to be integrated into Europe’s broader security and defense framework. Belgian Health Minister Frank Vandenbroucke, among 11 EU health ministers who advocated for expanding the scope of the EU defense funding scheme to include critical medicines, emphasized that "medicine security is just as important as defense or energy security. Our collective safety depends on it." The Commission faces a challenging road ahead, balancing the need for urgent action with the demands of stakeholders who argue for more ambitious measures and greater financial investment. Nonetheless, the Critical Medicines Act represents a pivotal moment in the EU’s efforts to safeguard the health and well-being of its citizens, signaling a commitment to building a more resilient and self-reliant pharmaceutical industry.
