对《关键药物法》的立场

Position on theCritical Medicines Act June 2025 CONTENTS Contents..................................................................................................................................................................................1 Introduction.........................................................................................................................................................................2 Detailed recommendations Effective supply resilience starts with betterrisk evaluation........................................................................................................................................................................3 Collaborative/joint procurement is no panaceato tackle persistent access issues..............................................................................................................................4 Contingency stock obligations must beproportionate and risk based....................................................................................................................................5 Rewarding supply chain resilience througha new approach to public procurement.............................................................................................................7 Data requirements must be proportionate,streamlined and aligned with existing systems..............................................................................................9 Resilient supply requires both strategic EUinvestment and global collaboration..................................................................................................................10 INTRODUCTION The Critical Medicines Act (CMA) reflects growing political momentum to address medicine shortages andunequal 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. Our sector is a cornerstone of public health and economic development. It drives high-value employment,scientific excellence and strategic investment across Europe. However, 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’sdeclining share of global biopharmaceutical research and development (R&D). The CMA must avoid compounding these pressures. As it introduces new regulatory obligations and channelspublic investment, its implementation must be carefully calibrated to align with existing EU and nationallegislation, avoid duplication and prevent administrative burdens that could deter investment or delay accessto medicines. This includes ensuring coherence with environmental and chemical legislation to preventunintended barriers to manufacturing. Rather than adding complexity, the CMA should promote streamlined, risk-based measures that enhanceEurope’s competitiveness and reinforce long-term supply security, including via strengthened collaboration withtrusted international partners. EFPIA stands ready to work with the EU institutions and all stakeholders to ensure that the CMA deliverson its objectives, while maintaining Europe’s leadership in pharmaceutical innovation and manufacturing. DETAILED RECOMMENDATIONS Effective supply resilience starts with better risk evaluation Commission’s proposal The Commission’s proposal links the Critical Medicines Act to the vulnerability evaluation set out in the GeneralPharmaceutical Legislation. The evaluation identifies medicines at risk of supply disruption, and especially thosereliant on a single country, a limited number of manufacturers or highly concentrated supply chains. Medicinesclassified as vulnerable could face a wide range of follow-up measures. These include procurement conditionsand eligibility for Strategic Projects under Articles 15-27. In addition,further actionsmay be recommendedby EMA’s Executive Steering Group on Shortages (MSSG) and enforced by the Commission under Article134 of the proposed EU Pharmaceutical Regulation. Such measures could include obligations to increasemanufacturing capacity, diversify sources of supply, hold safety stocks or participate in EU joint procurement. Our assessment EFPIA supports proactive risk assessment, but cautions that the current vulnerability assessment criteria, asdeveloped by the Commission as part of their pilot exercise, rely too heavily on broad indicators like geographicsourcing or supplier concentration. These do not capture key product-specific factors such as manufacturingcomplexity, reliance on rare inputs (e.g., plasma, radioisotopes), shelf life or actual shortage history. This isespecially problematic for biologics, vaccines and advanced therapies, where diversification is often not feasible.Under the current approach, such