Deal on streamlining the European Medicines Agency’s fees system

Simplified, transparent, flexible and future-proof fee system

Sufficient resources for the agency to fulfil its tasks

On Monday, Parliament and Council reached a provisional agreement to the fees and charges payable to the European Medicines Agency (EMA) in order to secure its appropriate funding.

Negotiators agreed that the fees payable to the agency should be proportionate with the work carried out and based on a transparent evaluation of EMAs estimations and forecasts as regards workload and related costs.

MEPs succeeded in strengthening the transparency requirements linked to decisions taken by the EMA. The agency must make information on reductions granted to the fees publicly available and provide detailed data in its annual activity report, including a breakdown of remunerated amounts paid to national authorities. It must also make regular recommendations to the Commission on adapting fees’ amounts, in special reports made available on the agency’s website.

Parliament managed to ensure that the current fees level for scientific advice provided by the agency is maintained, in order to ensure the availability of scientific advice to the pharmaceutical industry and avoid delays in the authorisation process. The deal foresees that entities not engaged in an economic activity, such as not-for-profit organisations and the academic sector, may benefit from a full waiver of the fees for scientific advice.

Negotiators also agreed to adapt the fees related to the marketing authorisation application for generic medicines and the application fees for major type II variations.

Quote

Rapporteur Cristian-Silviu Buşoi said: “I welcome the constructive work that has been brought forward and the agreement that we reached today, only three weeks after the first trialogue. I believe we sent out an important message that this piece of legislation is a key priority for the Parliament and that with today’s deal we will ensure EMA’s financial sustainability and agility. We made sure that the agency can continue to fulfil 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. 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.”

Next steps

Parliament and Council need to formally approve the agreement before it can come into force.

Background

The EMA plays a key role in ensuring that all medicinal products placed on the EU market are safe, effective and of high quality. The legal framework governing the agency’s financing has become rather complex over the years with the agency’s fees currently laid down in two separate regulations. The overall objective of the proposal is to provide a simplified, flexible and sound financial basis to support EMA’s operations, including remuneration for services to the EMA rendered by National Competent Authorities, in line with the applicable legislation.