2007 discharge: European Medicines Agency EMEA

The Committee on Budgetary Control adopted the report drawn up by Christofer FJELLNER (EPP-ED, SE) on discharge to be granted to the European Medicines Agency, calling on the European Parliament to grant the Executive Director of the Agency discharge in respect of the implementation of its budget for the financial year 2007.

Noting that the Agency’s annual accounts for the financial year 2007 are reliable, and the underlying transactions are legal and regular, MEPs approve the closure of the Agency’s accounts.

However, they make a number of recommendations as part of the decision on discharge. In addition to the general recommendations appearing in the draft resolution on financial management and control of EU agencies (see 2008/2207(INI)), MEPs make the following observations:

• the Agency's budget is financed both from the EU Budget and mainly by fees paid by pharmaceutical industry applicants for obtaining or maintaining a Community marketing authorisation;
• the Agency as a source of important scientific advice, science-based recommendations, best practice for medicines evaluation, which contributes towards the harmonisation of regulatory standards at international level.

MEPs encourage the Agency to continue its action in the Orphan Medicines field, while discouraging the decrease in the Orphan Medicines contribution which resulted in a 26.25% reduction in revenue in 2007 compared to 2006.

On the issue of weaknesses in budgetary management concerning the Telematics programme, MEPs call on the Agency to implement the ECA's recommendation to use differentiated appropriations for the Telematics programme promptly and call on the Agency to report on the action taken in its annual activity report for 2008.

In relation to procurement procedures, MEPs note the Court’s observations and the Agency’s replies and call on the Agency to address the weaknesses identified as soon as possible.

On the issue of fees, MEPs note that the ECA, in its 2006 annual report, found that the Agency's practice was in breach of its fee regulation. The ECA, in its 2007 annual report, followed up on these findings, stating that the Agency's Management Board set up a costing group which made a proposal for an alternative option for remunerating the rapporteurs at the end of 2007 .In this context, MEPs insist that the Agency make further progress to resolve this issue and report on the follow-up action taken in its annual activity report for 2008.