EU Proposes Critical Medicines Act to Address Supply Chain Vulnerabilities and Reduce Import Dependency
核心洞察
The European Commission has proposed the Critical Medicines Act (搜索) (CMA) to safeguard supply of essential medicines by boosting EU manufacturing and reducing dependency on overseas suppliers amid rising shortages since 2013.
The legislation includes collaborative procurement decisions, investment incentives for companies increasing EU manufacturing, and strategic projects qualifying for fast-tracked regulatory support and easier access to EU funding.
Industry groups support the CMA's principles but raise concerns about potential disruption to existing pricing pathways and call for comprehensive impact assessments and better consultation processes.
The European Commission has unveiled the Critical Medicines Act (搜索) (CMA), comprehensive legislation designed to strengthen the EU's pharmaceutical supply chain by boosting domestic manufacturing and reducing reliance on overseas suppliers. The proposal comes as medicine shortages (搜索) have been rising since 2013 and peaked during the COVID-19 pandemic, creating substantial risks to public health and patient safety.
Addressing Critical Supply Chain Vulnerabilities
The CMA represents a strategic response to the EU's increased dependency on overseas manufacturers for generic medicines (搜索) and pharmaceutical ingredients (搜索), particularly as geopolitical tensions continue to rise. According to the European Commission, shortages "pose a substantial risk to public health and patient safety and undermine the functioning of healthcare systems," while also highlighting variable access to drugs between EU member states that has led to accusations of stockpiling.
Olivér Várhelyi, EU Commissioner for Health and Animal Welfare, emphasized that the act "is a key initiative to improve access and availability to medicines for everyone in the EU, and to strengthen our health security." He noted that the legislation will positively impact EU competitiveness by creating a more stable and predictable operating environment.
Comprehensive Policy Framework
The CMA includes a toolkit of measures designed to incentivize domestic pharmaceutical production. Key provisions include collaborative procurement decisions and investment support for companies that increase manufacturing of critical medicines within the EU, potentially including state aid. The legislation also establishes strategic projects that could qualify for easier access to EU funding and fast-tracked administrative, regulatory, and scientific support.
Medicines for Europe (搜索) has called for the reform to be united with determined progress on the CMA, emphasizing that "Europe must plan to restructure its capacity to produce essential off-patent medicines, via securing funds for critical medicines in the upcoming EU budget and deliver bold state aid reforms for critical medicines and API production."
Industry Response and Concerns
While industry groups support the CMA's principles, they have raised significant concerns about implementation. The European Federation of Pharmaceutical Industries and Associations (搜索) (EFPIA) expressed support for introducing criteria beyond price for public procurement of critical medicines but warned that "while these options may be appropriate under very specific circumstances where they accelerate patient access to critical medicines, a systematic application could create more harm than offering a more permanent solution to access related issues."
Industry stakeholders have voiced alarm about the lack of clarity regarding which medicines will fall under the CMA's scope, fearing that an overly broad application could disrupt existing national pricing and reimbursement pathways. They have also criticized the limited comprehensive impact assessment and restricted consultation opportunities, urging lawmakers to utilize existing data systems like the European Medicines Verification System (EMVS) to avoid duplicating reporting requirements.
Regulatory Reform Proposals
Medicines for Europe (搜索) has proposed significant changes to regulatory exclusivity periods, advocating for a reduction from 11 to 9 years that could save €10 billion annually. The organization stated this reduction "would increase access to medicines in Eastern European countries" and emphasized that "there is no reason to extend exclusivity periods in Europe, there is actually a strong case to reduce."
The organization's broader reform agenda includes eliminating inequalities for patients through fair medicine access, supporting affordable treatment by boosting market competition on Day 1 following patent expiry, and preventing medicine shortages (搜索) via improved EU coordination and digital tools.
Patient Advocacy Perspective
The European Patients' Forum (搜索) (EPF) welcomed the CMA but identified serious gaps that must be addressed for effectiveness. The organization questioned how initiatives will be financed long-term, given that current plans involve diverting money from the EU4Health and Horizon Europe programmes in fiscal 2026-27.
"From our standpoint, there is insufficient focus on structured cooperation and involvement of civil society, particularly patient organisations, in the decision-making processes at the national and European level," according to the EPF.
Geopolitical Considerations
Medicines for Europe (搜索) has urged EU member states to "resist pressure to stall negotiations on the pharmaceutical legislation over transatlantic trade tensions." The organization referenced the Draghi Report evidence showing that "competition stimulates productivity, investment and innovation," noting that some companies are shifting production to the US, which should not delay reforms serving European patients.
The industry group called for the EU to advocate for a US-EU deal ensuring free passage of pharmaceuticals between markets while supporting the Critical Medicines Act (搜索) and ensuring timely entry of generic medicines (搜索).