European Parliament Looks to Take Over EMA Fee Process

Regulatory NewsRegulatory News | 11 April 2016 | By

The European Parliament has voted to lessen the European Commission’s control of the structure and level of fees charged by the European Medicines Agency (EMA), which may instead be set by members of Parliament and European Union (EU) ministers.

The amendment, which was proposed alongside a host of other amendments on fees and EMA-related structures linked to EMA’s founding regulation (No 726/2004), though any changes must be accepted by the EU Council of Ministers.

“Members felt that matters relating to the structure and level of [EMA] fees should be decided through the co-decision procedure rather than through implementing acts. Accordingly, they deleted the relevant parts of the text that empowered the Commission to adopt implementing acts relating to fees,” according to text adopted by Parliament on 10 March.

The amendment package also seeks to clarify how EMA is funded and operates. Members clarified and separated EMA’s sources of revenue, stating that revenue will consist of:

  • A contribution from the EU;
  • A contribution from any European third country with which the EU has agreements;
  • The fees paid by undertakings for obtaining and maintaining EU marketing authorisations for human and veterinary medicinal products and for other services provided by the agency;
  • Charges for any other services provided by EMA; and
  • Other sources of income, including ad-hoc grants.

The European Parliament and the Council will re-examine the level of the EU contributions on the basis of need and by taking into account the current level of fees. And in order to avoid fluctuations in fee revenue, “any positive budget outturn of a financial year will be set aside as assigned revenue and serve as a reserve in the event that actual fee revenue be below budgeted appropriations.”

Meanwhile, other amendments called on EMA to develop a system for accepting alternative models for testing medicines that can be “more predictive” and “may be based on human-relevant computer or cellular models, pathways of toxicity, or adverse outcome pathways.”

And a report on the experience acquired through the amending of this regulation will be published every five years (rather than every 10 years), according to the adopted text.

2014/0256(COD) - 10/03/2016 Text adopted by Parliament, partial vote at 1st reading/single reading


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy