Discussion paper on Engagement Criteria for MAPPs (D2.03)

An issue of divergent views became apparent early in the course of the ADAPT SMART project,
namely; to what kind of novel medicines and clinical scenarios/conditions should a MAPPs approach
be applied? Should MAPPs become the default pathway for most or all-new and promising
products? Or should it be reserved for a small and well-defined number of exceptional medicines in

Against this background, the ADAPT SMART consortium convened discussion fora with relevant
stakeholders to elaborate MAPPs engagement criteria that may be broadly acceptable to all
concerned within the existing legislation. In this paper, we summarize viewpoints from these
discussions.  The paper is intended to inform and drive future discussions on MAPPs, both within the
ADAPT SMART consortium and in the wider scientific and healthcare communities.

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