European Medicines Agency Fee System Evaluation
Oct 7, 2019
Published in: Publications Office of the European Union (September 2019). doi: 10.2875/226858
Posted on RAND.org on October 04, 2019
This methodology note to support the 'Study for the Evaluation of the Fee System' for the Directorate General for Health and Food Safety (DG SANTE) is provided as a formal deliverable alongside the final report. The note explains the methodology used for the quantitative modelling undertaken as part of the evaluation of the current fee system. The model was designed to:
A single model was developed that enabled both of these analytical activities to be conducted. The model first determined the cost to EMA and NCAs of undertaking EMA-related activities. Fees and remuneration levels under the current fee system were then calculated. These were compared to EMA and NCA costs (i.e. the extent to which the current fee system is cost-based). Then, by changing the model parameters, different theoretical cost-based scenarios were tested. The model facilitated the analysis of the current and theoretical fee systems.
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