Access to novel cancer medicines in Europe: inequities across countries and their drivers

Hofmarcher T, Charalambous A, Normanno N, Szmytke E, Wilking N

What do we mean by “access” to new cancer medicines, how does it differ across countries in Europe, and why does it differ? This study reviews inequities in access to novel cancer medicines across EU, EEA, and neighboring countries at the stages of regulatory approval, reimbursement, and clinical use. While EMA’s centralized approval eliminates regulatory disparities within the EU/EEA, access outside the region is slower. Reimbursement rates and timelines vary widely, and clinical use shows up to a 10-fold difference, with Central and Eastern Europe consistently lagging. Contributing factors include country-specific prioritization of pharmaceutical companies for regulatory and reimbursement applications, HTA processes and criteria, constraints in financial resources for medicines and testing infrastructure, suboptimal care processes, organization, and continuing medical education. Policy harmonization may narrow gaps but cannot overcome underlying economic and system limitations. Achieving equity requires balancing innovation, affordability, and sustainability.

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ESMO Open, 2025, 10(10):105810
DOI: https://doi.org/10.1016/j.esmoop.2025.105810