Representatives of the Council of the European Union, the European Parliament and the European Commission hope to conclude their negotiations on Monday 25 September on the proposal concerning fees and charges payable to the European Medicines Agency (EMA).
This is the second, and possibly the last, trilogue on this issue.
The main points to be discussed are the level of fees and remuneration due to the EMA to ensure the sustainability of the network made up of the EMA and the national competent authorities, transparency requirements and the exemptions granted to universities and the not-for-profit sector.
The European Parliament adopted its position on 12 July (https://aeur.eu/f/8ps ). MEPs want a 100% fee reduction for protocol assistance and scientific advice requests on medicinal products to be granted for applicants from the academic sector that are not financed or managed by private profit organisations in the pharmaceutical sector.
EU health ministers reached a political agreement (‘general approach’) on the regulation in question (see EUROPE 13200/19) on 13 June. (Original version in French by Lionel Changeur)