On Monday 25 September, the Presidency of the Council of the European Union and negotiators from the European Parliament reached a provisional agreement on a proposal for a regulation to modernise and simplify the structure of fees payable to the European Medicines Agency (EMA). The agreement still has to be confirmed by the two institutions before going through the formal adoption procedure.
“The agreement reached marks the transition to a sustainable, simpler and more flexible fee system for the EMA”, commented José Manuel Miñones Conde, Spain’s acting Health Minister.
The compromise text stipulates that the fees charged by the EMA must be based on costs. It simplifies the current legal framework by establishing a single legal instrument for all fees (pharmacovigilance and market authorisations). It also provides for a more sustainable and flexible fee system, which will ensure both adequate funding for the EMA and sufficient support for the national competent authorities in their tasks.
To this end, three changes have been made to the initial proposal:
- the adjustment of certain royalties to reflect inflation rates, including for human medicines, and a lower increase for veterinary products;
- an increase in fees for scientific advice and procedures relating to generic medicines in order to provide the EMA with a sustainable financial basis;
- an increase in the remuneration allocated to the national competent authorities in order to cover the full costs of the work they carry out for the EMA and to ensure that they have the necessary qualified staff to do so.
The text also contains amendments concerning the monitoring and review of fees, in particular to extend the role of the EMA Management Board to cover areas such as updating fees or adapting them to changing circumstances.
Transparency. MEPs succeeded in strengthening the transparency requirements for decisions made by the EMA. The agency must make public information on reductions in fees and provide detailed data in its annual activity report, including a breakdown of the remunerated amounts paid to national authorities. It must also make regular recommendations to the Commission on adjusting the amounts of the fees, in special reports available on the agency's website.
Parliament succeeded in ensuring that the current level of fees for scientific advice provided by the Agency was maintained in order to guarantee the availability of scientific advice to the pharmaceutical industry and to avoid delays in the authorisation process. The agreement stipulates that entities that are not engaged in economic activity, such as non-profit organisations and the university sector, can benefit from a total exemption from fees for scientific advice.
Link to the EU Council’s last mandate: https://aeur.eu/f/8qp (Original version in French by Lionel Changeur)