Finland supports proposal for new regulation on fees payable to European Medicines Agency — proposal requires clarifications
The European Commission has issued a proposal for a regulation on fees and charges payable to the European Medicines Agency (EMA). The goal is to move from a flat-rate system to a cost-based system for EMA fees. In principle, the Government is in favour of the proposal but considers that the views of the Member States should be better taken into account.
The European Medicines Agency (EMA) collects fees from marketing authorisation holders and applicants for medicinal products in the EU. The Agency pays remuneration to national pharmaceutical authorities for the services they provide to the Agency. The fee system plays a key part in funding the collective regulatory system for medicines at the EU and national levels.
According to the Commission’s proposal, the fees collected by the Agency would in the future be based on the underlying costs of the Agency and the costs of the tasks performed by competent authorities in the Member States for the Agency. Among other things, increased flexibility is sought for the regulation. The aim is to ensure the sustainability of the European regulatory network formed by the Agency and national competent authorities to prepare for changes in costs and structures.
In principle, the Government is in favour of the Commission’s proposal and its objectives. However, better account should be taken of the actual costs of the work done by national authorities and the scientific advice provided by them in order to safeguard European innovation activities and ensure a favourable operating environment for the national competent authorities that conduct assessment work. In addition, the Government has reservations about the wide use of regulations that delegate powers to the Commission. The opportunities of the Member States to exert influence must be ensured when applying the regulation. The Presidency of the Council of the EU is expected propose amendments that take into account the views of the Member States.
The Government submitted a Union communication to Parliament on the matter on Thursday 16 March. A Union communication is used in EU affairs whenever there is a matter concerning an EU legislative proposal or other proposal that falls within Parliament’s competence. The communication is published under Government proposals and decisions.
Mari Laurén-Häussler, Senior Specialist, [email protected]