Study for the Evaluation of the EMA Fee System

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:

• Assess the extent to which the fee and remuneration levels under the current financial model correspond to the costs of the European Medicines Agency (EMA) and the National Competent Authorities' (NCAs') contribution to EMA activities.
• Test the impact of theoretical cost-based fee systems on the EMA financial model, including the EU/EEA budget contributions, NCA remuneration and industry fees.

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.