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Accelerated Access to Medicinal Products

open-access


Kaat Van Delm

DOI https://doi.org/10.21552/eplr/2020/4/4



Multiple procedures and projects  accelerating patient access to medicinal products have been rolled out in the EU. This paper provides an overview of the procedures currently in place at EU level aiming to accelerate the centralised marketing authorisation procedure for new medicinal products. Specifically, accelerated assessment, parallel consultations of EMA and HTA bodies, the PRIME scheme, SME support, conditional marketing authorisation, exceptional circumstances, CHMP opinions on compassionate use and adaptive pathways are discussed. The coherence of the procedures and implications on applicants' legal certainty is analysed, and the procedures are compared with their most similar US counterparts. Subsequently, the relevance of such procedures for the current Covid-19 crisis is highlighted. It is demonstrated that many of the existing EU procedures are intertwined and many of the EU procedures have a resembling counterpart in the US. Even though for access to most EU procedures the applicant should demonstrate the presence of an 'unmet need', this concept is not defined homogenously for all procedures, reducing legal certainty. In conclusion, the overview of the procedures in place at EU level demonstrates that the system is overly complicated. 

Kaat Van Delm, PhD researcher at KULeuven, Leuven Institute for Healthcare Policy (LIHP/LIGB). For Correspondence: <kaatjozefn.vandelm@kuleuven.be>

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