2007 discharge: European Medicines Agency EMEA

2008/2262(DEC)

The European Parliament adopted by 582 votes to 13, with 40 abstentions, a decision concerning the discharge to be granted to the Executive Director of the European Medicines Agency in respect of the implementation of its budget for the financial year 2007. The decision to grant discharge is also an approval of the closure of the accounts of this EU agency.

In parallel, the European Parliament adopted a resolution with observations which are an integral part of the decision to grant discharge.

Parliament notes that 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. It encourages 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, Parliament calls on the Agency to implement the ECA's recommendation to use differentiated appropriations for the Telematics programme promptly and calls on the Agency to report on the action taken in its annual activity report for 2008.

In relation to procurement procedures, Parliament notes 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, Parliament notes that the ECA, in its 2006 annual report, found that the Agency's practice was in breach of its fee regulation for the following reasons: the Agency's customers were billed an amount which was divided into two parts, the Agency's costs and an amount which was repaid to the Member States' rapporteurs to cover their own costs; and the Member States' rapporteurs however never provided full evidence of their actual costs. It calls on the Agency to resolve this issue and report on the follow-up action taken in its annual activity report for 2008.

Lastly, noting that the Agency’s annual accounts for the financial year 2007 are reliable, and the underlying transactions are legal and regular, the Parliament approves the closure of its accounts and refers, for other observations accompanying its decision on discharge, to its resolution on financial management and control of EU agencies - see 2008/2207(INI) - adopted in parallel.