European Parliament seeks control over EMA fees for pharma firms
A suggested reform package seeks to clarify how EMA is funded and operates
The European Parliament has voted for the structure and level of fees charged by the European Medicines Agency (EMA) to be set by MEPs and European Union (EU) ministers, not the European Commission, as at present.
The amendment to proposed reforms to EMA’s founding regulation (No 726/2004) has to be accepted by the EU Council of Ministers to go forward.
The reform package seeks to clarify how EMA is funded and operates. MEPs backed amendments that laid down the financial sources that the agency can tap, namely: the EU; any non-EU country striking EU agreements over pharma regulation; company fees for market authorisations; charges for other services; and ad hoc grants.
Also, a reserve fund should help EMA cope with fluctuations in demand for services, said the revised legislation.
With EMA’s financial accounts having received criticism in the past, MEPs backed a rule saying its draft annual books should be screened by the EU’s financial watchdog the European Court of Auditors and the Commission’s accounting officer.
Meanwhile, amendments passed by MEPs said that EMA should develop a system for accepting alternative models for testing medicines and related chemicals other than using animals – 'and take into consideration the opportunities presented by new concepts which aim at providing for more predictive medicines.' These tests could use computer or cellular models, it noted.
