European Medicines Agency Fee System Evaluation
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The EMA established a fee system to ensure a sound financial basis for its assessments of medicines and other pharmacovigilance activities at the EU level.
Researchers found the system is generally efficient and effective, but it is not cost-based at a granular level and not always flexible, and over time it has become increasingly complex. Additionally the EMA relies on both industry fees and EU and EEA budget contributions to meet the costs of all its activities.
The European Medicines Agency (EMA) is a decentralised EU Agency responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The EMA carries out scientific assessments to support the authorisation of new medicines, meaning they can be sold on the EU market and used across Europe.
The EMA fee system was established to help ensure a sound financial basis for assessments related to the granting, maintaining and monitoring of EU market authorisations. It also supports other services related to medicinal products including pharmacovigilance activities at EU level.
RAND Europe was commissioned to conduct a study to support the evaluation of the EMA fee system on behalf of the Directorate-General for Health and Food Safety of the European Commission (DG SANTÉ). Researchers examined the fees paid by pharmaceutical companies to the EMA, and the fees paid by the EMA to National Competent Authorities (NCAs) to remunerate them for the work they undertake for the EMA. In particular, the researchers examined the relationship between the fees and the costs of the services delivered. In assessing the strengths and weaknesses of the EMA fee system, the study determined the extent to which:
- fees are founded on a sound economic basis
- they are fair and proportionate, and
- the system avoids unnecessary administrative burden on fee-payers.
The researchers addressed these questions with reference to the system’s relevance, effectiveness, efficiency, coherence and sustainability. This analysis helped the European Commission to consider the need for reform of the fee system.
The study involved:
- data gathering through desk research and stakeholder consultation,
- developing a costing methodology and a financial model of the EMA,
- assessing the current fees and remuneration levels against costs and
- identifying gaps between a more cost based model and the current system.
- The current EMA fee system enables the EMA to meet its costs after remunerating NCAs, and there is no evidence that the EMA is hindered in its activities by the existing charging and remuneration arrangements. EMA does however rely on both industry fees and EU and EEA budget contributions to meet the costs of all its activities.
- The fee system is generally efficient and effective but it is not cost-based at a granular level. There are many different procedural activities, for some of which full fees are charged, some have reductions applied, some have the fees waived, and some are exempted from fees.
- The fee and remuneration system provides for a certain degree of flexibility, which is beneficial to its current operation. In other respects, the system is less flexible, which creates challenges for its current operation.
- The EMA fee system has become more complex over time, which has created challenges for its effective operation, and this complexity is expected to increase in the future. While the fee system has elements that contribute to its sustainability, there are challenges in the long-term here as well.