On 13 June, EU health ministers are expected to reach a ‘general approach’ to the proposed regulation on fees and charges payable to the European Medicines Agency (EMA).
The European Commission’s proposal dates from 13 December 2022. The European Parliament’s Environment Committee plans to adopt a position on this issue at its meeting on 26 and 27 June.
The work and debates in the EU Council have shown broad support for both a targeted approach to adapting charges and remuneration and for flexibility (see EUROPE 13185/37).
Horizontal adjustments. For the human element of the proposal, an inflation adjustment of around 13% has been applied to the amounts in Annexes I, III and IV for the annual inflation rates for the calendar years 2021 and 2022. However, on the veterinary side of the proposal, in recognition of the need expressed by some Ministers to balance the sustainability of the network with the viability of the industry when setting fees and remuneration, the inflation adjustment applied to the amounts in Annex II only reflects fifty per cent of the annual inflation rates for the calendar years 2021 and 2022.
Given the importance attached by Ministers to the sustainability of the EU regulatory network, approximately 7% has been added to the remuneration paid to national competent authorities as a sustainability factor, resulting in a total horizontal adjustment of 20%. Fees have been adjusted accordingly.
Once these horizontal adjustments had been made, other adjustments, this time targeted, were made to the following seven procedures supported by the ministers (including scientific opinions, generics, inspections, the risk assessment committee, etc.).
Link to the EU Council’s draft general approach: https://aeur.eu/f/785 (Original version in French by Lionel Changeur)