Regulation (EU) 2024/568 on fees and charges payable to the European Medicines Agency

What it is

to ensure appropriate funding of the European Medicines Agency (EMA) activities carried out at Union level. PROPOSED ACT: Regulation of the European Union and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: the European Medicines Agency (EMA) plays a key role in ensuring that all medicinal products placed on the EU market are safe, effective and of high quality, thereby contributing to the proper functioning of the internal market while ensuring a high level of human and animal health protection. It is therefore necessary to ensure that it has sufficient resources to finance its activities, in particular from the fees it collects. The Committee on the Environment, Public Health and Food Safety adopted the report by Cristian-Silviu BUŞOI (EPP, RO) on the proposal for a regulation of the European Parliament and of the Council of the Council on fees and charges payable to the European Medicines Agency, amending Regulation (EU) 2017/745 of the European Parliament and of the Council and repealing Council Regulation (EC) No 297/95 and Regulation (EU) 658/2014 of the European Parliament and of the Council. The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows: Payment of remuneration to competent authorities of the Member States for the provision of services to the Agency Where the Agency grants a full waiver of fees, the remuneration of rapporteurs and co-rapporteurs appointed by the competent authorities of the Member States should be reduced by 50% or 100%, as set out in Annex V. The Commission should monitor the inflation rate, in relation to the amounts of fees, charges and remuneration set out in the Annexes to this Regulation. The relevant amounts should be updated to ensure that the fees, charges and remuneration payable are adjusted for such inflation before the date of application of this Regulation. The Commission should therefore adopt a delegated act to amend the relevant Annexes to this Regulation on the basis of the inflation rate published four months before the date of application of this regulation. It is proposed that, on a duly justified proposal from the Executive Director of the Agency, in particular for the protection of public or animal health or for the support of specific types of products or types of applicants, selected for duly justified reasons, the Management Board of the Agency may grant, following a favourable opinion from the Commission, a total or partial reduction of the applicable amount. The Agency should make information on such reductions publicly available on the Agency’s website, setting out the reasons for the reduction. The report stated that the Commission may take into account other factors that could have a substantive impact on the Agency’s budget, including but not limited to its workload and potential risks related to fluctuations in its fee revenues. The level of fees should be set at a level which ensures that the revenue…

Frequently asked