European Commission publishes options for a new EMA Fee Structure

Earlier this month, the European Commission published the outcome of an evaluation of the fee system of the European Medicines Agency (EMA) together with an Inception Impact Assessment (which can be downloaded here). The latter outlines three different options on how the EMA fee system could be changed.

The assessment particularly considered the question whether the fee system is coherent with other EU policies, including strengthening small and medium-sized enterprises (SMEs) and incentivising the development of OMPs and paediatric use medicinal products. The report comes to the conclusion that the provision of incentives for SMEs could be seen as a strength of the EMA fee system, offering more incentives and exemptions than any other EU agencies do.

Against this background, the Commission proposes three Policy Options:

• Option 1: Limited changes to ensure financing the new/amended veterinary activities;
• Option 2: A cost-based fee system for human and veterinary activities with no changes to the fee system structure;
• Option 3: A cost-based fee system for human and veterinary activities, with a simpler and more efficient system structure.

All three options would maintain fee incentives as per applicable legislation, including the OMP Regulation and the Regulation on Paediatric Use Medicinal Products. However, it has to be seen whether the current fees incentives will be changed during a potential review process of these two Regulations. A first targeted public consultation on the review of the EMA Fee Regulation has been announced for Q4 2019.