The Critical Medicines Act (CMA) reflects growing political momentum to address medicine shortages and access across Europe. Its core objectives of strengthening supply chain resilience and ensuring timely, equitable patient access are fully supported by the European research-based pharmaceutical industry.

In this position paper and feedback to the Commission, EFPIA sets out recommendations to ensure the successful implementation of the Act. In a rapidly evolving global environment, investment is increasingly drawn to regions offering greater predictability and stronger support for innovation. At the same time, Europe’s policy landscape is becoming more fragmented, and this is contributing to the EU’s declining share of global biopharmaceutical research and development (R&D) spending. To address these challenges, it is important to align the Act with existing EU and national legislation and avoiding duplicative or conflicting administrative requirements. By embedding flexibility, coordination, and proportionate regulation into its implementation, the Act can support a future-ready pharmaceutical ecosystem that ensures patients across Europe get the medicinal products they need when they need them.

EFPIA stands ready to work with the EU institutions and all stakeholders to ensure that the Act delivers on its objectives, while maintaining Europe’s leadership in pharmaceutical innovation and manufacturing.