In Luxembourg on Tuesday 13 June, the EU health ministers reached a political agreement (‘general approach’) on the regulation on fees and charges payable to the European Medicines Agency (EMA).
The EU Council will now be able to begin negotiations with the European Parliament on this text.
The Council’s position maintains the key elements of the Commission’s proposal, including the move to a cost-based approach. Nevertheless, it refines the provisions relating to the adjustment of the EMA’s fees and remuneration, ensuring that the costs of the competent national authorities are covered.
The Council’s position also clarifies certain measures relating to flexibility, enabling other changes to be made to the charging system at a later date. In particular, the Council has extended the role of the EMA Management Board in updating fees.
For the European Commissioner for Health, Stella Kyriakides, the proposed fee increases “may need a closer look to ensure they remain proportionate”. The issue of delegation of powers, which is a tool for ensuring flexibility, may also need to be re-examined. “Let me stress that this is not about controlling the system, but about ensuring that adjustments can be made in an efficient, timely and objective manner, based on evidence from the cost monitoring mechanism”, stressed Ms Kyriakides. Consequently, at this stage of the institutional process, “the Commission formally reserves its position”.
Link to the Council’s general approach: https://aeur.eu/f/7h0 (Original version in French by Lionel Changeur)