Legal constraints with regard to MAPPs (D2.08)
Executive summary
The conceptual framework of Medicines Adaptive Pathways to Patients (MAPPs) has its basis in fostering access to novel beneficial treatments for the right patient groups at the earliest appropriate time in the product lifespan in a sustainable fashion. Embedded in the MAPPs concept are key facets of products getting to the market earlier and in initially small defined (sub) population, with an emerging evidence base supporting a positive benefit-risk and indication expansion. This creates uncertainty for medicine developers and authorities as to whether there are any legal constraints or even blocks. Activities of the D2.08 working group as part of Work Package 2, have been to map the general regulatory landscape with regard to both the centralised approval and the market access, in particular pricing and reimbursement, of medicinal products applicable for the intended MAPPs concept.
A broad review of the main legal areas governing medicinal product development, approval and market access, in the context of MAPPs, was undertaken – except any potential impact of MAPPs on Intellectual Property and Regulatory Exclusivity Rights that will be analysed by D3.06 working group, within Work Package 3. The two documents should be read and understood together.
The result of the conducted review is that the current legal framework does not include any legal constraints in implementing MAPPs at both European and national level or prevent the implementation of an adaptive approach to medicines development. MAPPs can work well within the existing legal framework.