A report prepared by the EU parliamentary rapporteur, Romanian MEP Cristian Silviu Bușoi, passed with 595 votes in favour, and only 25 against, with 25 abstentions. The rapporteur is the MEP who is responsible for handling a legislative proposal.
The affirmative vote at this first stage of the legislative process saw the President of the EU Parliament, Roberta Metsola, an MEP from Malta, refer the proposals back to European Parliament’s Health Committee under its procedural rule 59.4. This allows for any interinstitutional negotiations that may be required to take place.
The vote follows the European Parliament’s Health Committee’s vote in favour of the report on 27 June. The existing fee system for the EMA has been criticised as being too complex and outdated, and the changes being sought are to make the agency’s work more streamlined but also better funded.
After the committee’s vote, rapporteur Cristian Silviu Bușoi, a Romanian MEP from the Christian Democrats, said the objective is not only to make the current framework less complex but also to secure proper funding for both the EMA and the National Competent Authorities.
“We also aim to ensure the fee system is adaptable for the future by safeguarding regulatory flexibility,” he said.
The European Council had previously agreed on 13 June to back a modernised and simplified fee structure. It recognised that the existing fee structure – which has been in place for nearly 20 years – is overly complicated and does not reflect the current (and future) nature of the agency’s work.
MEPs agreed in the Parliament the need for fees paid to the agency to be proportionate to its work. For that to happen they further approved measures to bring about a transparent evaluation of the agency’s costs.
Report on the proposal for a regulation of the European Parliament and of the Council of the Council on fees and charges payable to the EMA:
Proposals for revision for EMA fee structure:
Council of EU:
EU Parliament – Rules of Procedure: