AUTHOR=Maksimova Mariia V. , van Thiel Ghislaine J. M. W. , Tromp Yke , Lechner Rosan , van Delden Johannes J. M. , Bloem Lourens T. 

TITLE=Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda

JOURNAL=Frontiers in Medicine

VOLUME=Volume 11 - 2024

YEAR=2024

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1408553

DOI=10.3389/fmed.2024.1408553

ISSN=2296-858X

ABSTRACT=The European Medicines Agency's conditional marketing authorization (CMA) aims to expedite access to medicines for unmet medical needs by shifting part of the drug development process post-authorization. We highlight ethical issues surrounding CMA: i) complexity of defining unmet medical need; ii) poor understanding of CMA and its impact on informed consent; iii) hope versus unrealistic optimism; iv) implications of prolonged post-authorization studies and potential patient harm; v) rights and duties of patients surrounding participation in post-authorization studies; vi) access to previously authorized CMA medicines; vii) the 'benefit slippage' phenomenon, defined as the gradual shift of strict criteria to less strict criteria. We propose a comprehensive research agenda to address these ethical issues, and stress the need for multi-stakeholder engagement to ensure patient-centered use of CMA.