BAKGRUNN (fra kommisjonsforslaget)

Reasons for and objectives of the proposal

Article 67(3) of the founding Regulation of the European Medicines Agency (EMA, the Agency) stipulates that fees and charges are part of the revenues of the Agency. Article 86a of that regulation, as amended by Regulation (EU) 2019/5, provides that the Commission is to put forward, as appropriate, legislative proposals with a view to update the regulatory framework for fees payable to the Agency in relation to medicinal products for human use and veterinary medicinal products (VMP).

Over the years, the legal framework governing EMA fees has become rather complex, requiring some legislative simplification. EMA fees are currently laid down in two separate regulations: Council Regulation (EC) No 297/95 and Regulation (EU) No 658/2014. Both regulations convey the will of the co-legislators that revisions of fees levied by the Agency should be based on an evaluation of the costs of the Agency and the costs of the tasks carried out by competent authorities in Member States.

Following changes introduced recently to the EMA Founding Regulation (the EMA Regulation) and to the rules applicable to the authorisation of veterinary medicinal products, the provisions applicable to the fee system need to be adapted. In particular, the current legislation does not envisage fees in support of new or changed activities introduced by Regulation (EU) 2019/6 (VMP Regulation), which became applicable in January 2022. In addition, Regulation (EU) 2022/123 introduced new activities for the Agency that require further adjustments of the costs that the EMA fees should take into account. The structure of the EMA’s revenue sources should also be aligned with the provisions in Article 67 of the EMA Regulation. In particular, the EMA is able to levy not only fees, but also charges for services and activities of the Agency for which a fee is not levied.

When establishing a new fee system for veterinary medicinal products, the characteristics and specificities of the veterinary sector should be taken into account.

This revision also aims to address the following problems identified by the recent evaluation of the EMA fee system:

1) complexity of the fee system due to the many different categories and types of fees it currently establishes;

2) misalignment of some fees with underlying costs;

3 )lack of any fees or national competent authority remuneration for some procedural activities;

4) misalignment with the underlying costs of certain remuneration paid to national competent authorities in Member States; and

5) discrepancy between the main EMA Fee Regulation (Council Regulation (EC) No 297/95) and the Pharmacovigilance Fee Regulation (Regulation (EU) No 658/2014), which differ in their approach to determining the amount of national competent authority remuneration and in the approach to national competent authority remuneration in the case of reduced fees.

By addressing these specific problems, the general objective of this proposal is to contribute to providing a sound financial basis to support the EMA’s operations, including remuneration for services to the EMA rendered by national competent authorities, in line with the applicable legislation. This translates into the objective of providing for fee and remuneration amounts that are cost-based, following a thorough evaluation of the costs of the Agency and its various statutory tasks and the cost of the contributions of competent authorities of the Member States to its work.

In addition, the proposal aims to streamline the system by simplifying the fee structure to the extent possible and by addressing the unnecessary complexity of the corresponding legal framework through bringing together in a single legal instrument fee rules that are currently governed by the two EMA Fees Regulations.

Finally, a key objective pursued by this proposal is to make the fee system future-proof by introducing regulatory flexibility in the way it is adjusted, on an objective basis.

This initiative is part of the Regulatory Fitness Programme (REFIT).