Study for the Evaluation of the EMA Fee System

The European Union (EU) provides for a centralised procedure that enables medicinal products for human and veterinary use to undergo a single EU-wide assessment and marketing authorisation that is valid throughout the European Economic Area (EEA) (28 EU Member States and Iceland, Liechtenstein and Norway) (Regulation (EC) No 726/2004). The European Medicines Agency (EMA) was established under Council Regulation (EEC) No 2309/93 as a decentralised EU Agency with a role in the evaluation and supervision of centrally authorised medicines and pharmacovigilance of all medicinal products in the EU (Regulation (EU) No 1235/2010, Commission Implementing Regulation (EU) No 520/2012). National Competent Authorities (NCAs) in the Member States work together with the EMA to carry out assessments aimed at granting, maintaining and monitoring EU marketing authorisations and other services related to medicinal products for human and veterinary use including pharmacovigilance activities for medicines for human use at EU level. The EMA fee and NCA remuneration system was established to provide a sound financial basis for these activities under Council Regulation (EC) No 297/95 on general fees payable to the EMA, and Regulation (EU) No 658/2014 on fees payable for the conduct of pharmacovigilance activities.

This is a study of the EMA fee and NCA remuneration system and its relationship to the underlying costs associated with the services provided. The study assesses the strengths and weaknesses of the fee system to show the extent to which fees and remuneration are founded on a sound economic basis, whether they are fair and proportionate, and whether the fee system avoids unnecessary administrative burden on fee-payers. It addresses these questions with reference to the fee system's relevance, effectiveness, efficiency, coherence and sustainability. This analysis provides a basis from which to consider the need for reform of the EMA fee and NCA remuneration system, and to consider which elements of the fee system might be specifically targeted for reform.

This is the final report for the 'Study for the evaluation of the European Medicines Agency fee system'. The study was commissioned by the Directorate General for Health and Food Safety (DG SANTE) and is being delivered by RAND Europe.