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Lawmakers reach speedy provisional deal on European Medicines Agency fees

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The EU Council and the European Parliament struck an agreement on Monday evening (25 September) on the fee structure for the European Medicines Agency (EMA), just three weeks after the first round of inter-institutional negotiations.

The fees in question, charged by the EMA to companies who want to launch a new medicine on the market, account for 89% of the EMA’s budget. The agency then produces a scientific assessment of the quality, safety and efficacy of the medicine before it can be authorised in the EU.

“Streamlining” the rules of the EMA’s fee structure will better reflect all its costs as well as make payments to the national authorities more transparent, according to the European Commission. The new rules will also include a “cost-monitoring mechanism” and flexibility to adjust fees in the event that there are changes in the underlying costs.

For the Parliament, the main successes were increased transparency requirements for the EMA. This includes how the agency has to make information about reductions to the fees publicly available and make regular recommendations to the Commission about the adaptation of fee amounts available online.

They also highlighted that the fees for scientific advice by the agency are maintained and the deal ensures that entities such as not-for-profit organisations and the academic sector will not have to pay for scientific advice.

“We made sure that the agency can continue to fulfill its responsibilities effectively and we also understood that the EMA is to a large extent assisted by National Competent Authorities (NCAs) in carrying out its mandated tasks,” said the parliament’s rapporteur on the file, Cristian-Silviu Bu?oi (EPP), in a statement following the agreement.

“Moreover, by establishing an appropriate fee structure, the regulation can promote innovation in the pharmaceutical sector while ensuring fair access to safe and effective medicines for patients,” he added.

The Council’s focus was rather on “simplification of the current legal framework by establishing a single legal instrument for all fees”.

The approach promotes a more sustainable and flexible fee system, meaning that the fees can soon be adjusted to reflect inflation rates, scientific advice and procedures regarding generic medicines, and payments can be increased for national authorities to cover the full costs of their work.

“In order to ensure safety and high-quality medicines in the Union market, it is of paramount importance to ensure adequate funding for the agency and national competent authorities to deliver a top-class regulatory system,” said Jos? Manuel Mi?ones Conde, Spain’s acting Minister of Health, on behalf of the Spanish EU Council presidency.

The new regulation for the EMA’s fees was proposed by the Commission in December 2022 to “ensure that these fees better reflect the underlying costs of the work done and coordinated by EMA”. It was also estimated that the existing fee structure, in place since 1995, was increasingly complex and needed simplifying.

The fee revision follows the extension of the agency’s mandate in March 2022. Six months later, EMA’s Executive Director Emer Cooke warned that “we need more resources to deal with the increase in workload” at an ENVI hearing in Parliament on 25 October 2022.

In 2019 the fee system was evaluated, which indicated the need for more flexibility for adopting future developments and more sustainability in the long term.

The EMA has a total budget of EUR458 million for 2023, and fees and charges account for 89% of that, totalling over EUR407 million.

The EMA also pays compensation to the national medicines regulatory authorities for their part of the work related to the scientific evaluation of applications as well as the authorities’ staff involved in the EMA’s scientific committees, working groups and more.

It is estimated that the EMA will pay EUR163 million to national medicines regulatory authorities during 2023.

The agreement reached by the co-legislators now moves on to get formally adopted by both institutions. After this, the regulation will enter into force on the day after it is published in the official journal.

[Edited by Giedr? Peseckyt?/Nathalie Weatherald]

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