英文_EFPIA_对_关键药物法_的立场_13页_7mb

报告摘要

EFPIA Analysis and Recommendations on the Critical Medicines Act

Introduction: The Critical Medicines Act (CMA) aims to address medicine shortages and ensure equitable access across Europe. The European Federation of Pharmaceutical Industries and Associations (EFPIA) supports the core objectives but emphasizes that the CMA must avoid compounding existing pressures on the sector. The pharmaceutical industry is essential for public health and economic development, but faces challenges related to innovation investment and regulatory fragmentation. The CMA should promote streamlined, risk-based measures aligned with existing EU legislation and international commitments.
Risk Evaluation: EFPIA supports proactive risk assessment but cautions against overly simplistic vulnerability criteria that rely on broad indicators like geographic sourcing or supplier concentration. These criteria do not capture product-specific factors essential for complex medicines. The industry recommends amending the definition of 'vulnerability evaluation' to include recent shortage history, product complexity, and real-world evidence, and ensure measures remain proportionate and targeted.
Collaborative Procurement: While joint procurement is proposed to address access issues, EFPIA argues that barriers lie more in national pricing/reimbursement systems than procurement. Collaborative mechanisms should only be used as a last resort where national efforts fail, to avoid unintended consequences like reduced national autonomy or administrative burdens.
Contingency Stocks: Proportionate and risk-based contingency stock obligations are recommended, with measures replacing national fragmentation. Industry involvement is crucial to ensure feasibility and avoid disproportionate impacts, while reinforcing solidarity mechanisms and stock redistribution.
Public Procurement: EFPIA strongly advocates for moving beyond lowest-price tendering, recommending a value-based, multi-criteria approach that considers supply chain resilience and quality. Preferential treatment should apply to confirmed vulnerabilities, but exclude medicines of common interest (MPCIs) to avoid trade conflicts and misallocation of resources.
Data Reporting: New data requirements should align with existing systems like the European Shortages Monitoring Platform to avoid redundancy and minimize administrative burdens.
Strategic Investment: CMA should support EU manufacturing capacity via strategic projects and international cooperation, focusing on green technology and intrinsically risky products for localization incentives.
Global Collaboration: Phasing out reliance on national stockpiles is prioritized over increased unilateral investment, with a focus on diversification, innovative supply chains, and structured partnerships with trusted third countries.