According to a document obtained by EUROPE, the Swedish Presidency of the Council of the European Union sent, to the Member States delegations on Tuesday 28March,an updated version of its draft compromise on the European Commission’s proposal for a regulation on fees and charges payable to the European Medicines Agency (EMA). The previous version of the compromise was discussed in a working group on Monday 27 March.
The initial proposal aims to simplify and align the remuneration received by the EMA with the cost of its activities and new tasks (see EUROPE 13084/26).
The Presidency wanted to clarify that EMA remuneration should be provided in the form of a single remuneration amount per type of fee concerned, irrespective of the home Member State of the national competent authority.
In order to provide flexibility in adapting the regulation to scientific advances and to facilitate the application of the regulation, the Commission’s proposal included the possibility for the EMA Management Board to specify operating procedures on the basis of a justified proposal from the EMA Executive Directorate and following a favourable opinion from the Commission. These operating procedures will include the definition of due dates, payment deadlines and methods, timetables, lists of additional fee reductions.
The Presidency proposed that the operating procedures mentioned in the Commission’s proposal be supplemented by “a common but flexible format” allowing national competent authorities to transmit the relevant financial information to the EMA.
In Article 8 on these operating modes, the Presidency also wished to clarify that the EMA Management Board could add an additional operating mode concerning the partial or total reduction of fees.
Furthermore, the Presidency suggested that the definition of “public health emergency” should now be aligned with Article 23(1) of the new Cross-Border Threats Regulation EU/2022/2371 (see EUROPE 13049/19) rather than the older Cross-Border Threats Decision of 2013 (Decision No 1082/2013).
In Article 6, which concerns the reduction of fees, the Presidency suggested that where an EMA assessment, opinion or service is requested by a Member State or an EU institution, rather than waiving the full fee or the applicable charge (which was the Commission’s proposal), the EMA should simply not collect the fee from that State or institution.
Also on the sensitive subject of the adjustment of charges, the Presidency proposed that the Commission’s inflation monitoring exercise should start on the first January following the application of the regulation and thereafter be conducted on an annual basis.
Finally, the Presidency requested that the special report provided to the Commission by the EMA Directorate (see EUROPE 13139/15) be adopted by its Management Board. These revisions are expected to take into account the sustainability of the EMA’s regulatory activities, as requested by several delegations (see EUROPE 13139/15).
Link to the document: https://aeur.eu/f/65q (Original version in French by Émilie Vanderhulst)