European Medicines Agency: Council agrees approach on a more modern and simplified fee structure

EU health ministers have set out the Council’s position on a regulation to modernise and simplify the structure of the fees payable to the European Medicines Agency (EMA) to better reflect the evolving demands and challenges it faces. The general approach approved today will enable the Council to start negotiations with the European Parliament.

The European Medicines Agency and national competent authorities play vital roles in protecting and promoting public and animal health. Today EU health ministers endorsed an approach that will enable this work to continue, supported by a fee system that is modern, straightforward and sufficiently flexible to adapt to future developments.

Jakob Forssmed, Swedish Minister for Social Affairs and Public Health

Aims of the new rules

The proposed regulation aims to update the existing legislation governing fees charged by EMA. It will ensure that fees and remuneration are cost-based, flexible, and ensure adequate funding to guarantee the future sustainability of operations of the EMA while also providing sufficient support to member states’ national competent authorities (NCAs). The proposal also seeks to reduce the complexity of the current legal framework.

Why does EMA’s fee structure need updating?

EMA plays a crucial role in evaluating and supervising medicines, with the wider goal of benefitting human and animal health.

In order to deliver on its mission, the agency needs a sound financial basis to support its operations, yet the existing fee structure is increasingly complex and no longer reflects the nature of the work and challenges involved. It is also necessary to remunerate the fundamental contribution of NCAs in a sustainable way.

The position of the Council

The Council’s general approach maintains the key elements of the Commission’s proposal, including the transition to a cost-based approach. Nevertheless, it fine-tunes the provisions for adjusting EMA’s fees and remuneration, ensuring that NCAs’ costs will be covered.

The general approach also clarifies some of the measures relating to flexibility, which allow for further changes to be made to the fee system at a later date. Specifically, the Council has expanded the role of EMA’s management board updating the fees.

Next steps

Today’s general approach provides the upcoming Spanish presidency of the Council with a mandate to begin negotiations with the European Parliament, with a view to reaching a provisional agreement.

Background

EMA’s existing fee system has been in place for almost two decades, during which time it has become increasingly complex. A recent evaluation of the system identified five key issues, including misalignment of some of the fees with the underlying costs, a lack of remuneration for certain procedural activities, and discrepancies between relevant legal provisions.

On 13 December 2022, the Commission published a proposal for a regulation revising the existing EMA fees system. The proposal has three objectives:

• to move from a flat-rate system to a cost-based system for EMA fees
• to ensure the sustainability of the European regulatory network formed by the EMA and National Competent Authorities (NCAs)
• to simplify existing legislation by merging the content of the two current EMA fee regulations for pharmacovigilance and non-pharmacovigilance fees into one single legal instrument

Health ministers discussed the proposal and the Council’s position at the EPSCO Council on 14 March 2023.