Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda
Mariia V. Maksimova,
Ghislaine J. M. W. van Thiel,
Yke Tromp
et al.
Abstract:The European Medicines Agency’s conditional marketing authorization (CMA) aims to expedite patient access to medicines for unmet medical needs by shifting a part of the drug development process post-authorization. We highlight ethical issues surrounding CMA, comprising (i) the 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; (… Show more
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