2005 discharge: European Agency for the Evaluation of Medicinal Products

 The committee adopted the report by Edit HERCZOG (PES, HU) granting discharge to the the European Medicines Agency for 2005. In its accompanying resolution, it made a number of general points concerning the majority of the EU agencies:

- the ever-growing number of Community Agencies and the activities of some of them do not seem to form part of an overall policy framework, and "the remits of some Agencies do not always reflect the real needs of the Union or the expectations of its citizens”;

- the Commission should therefore define an overall policy framework and should present a cost-benefit study before the setting up of any new Agency, and the Court of Auditors should give its opinion on this study before Parliament takes its decision;

- every 5 years, the Commission should present a study on the added value of every existing Agency; where the evaluation is negative in the case of a particular Agency the latter’s mandate should be reformulated or the Agency should be closed;

- the Commission should improve administrative and technical support to the Agencies, given the growing complexity of the Community’s administrative rules and technical problems;

- the Agencies should improve their cooperation and benchmarking with actors in the field;

- the Commission should harmonise the format of the annual reporting by the Agencies to develop performance indicators which would allow a comparison of their efficiency.

In its specific remarks concerning the EMA, the committee welcomed the increased appropriations for and full implementation of the Orphan Drugs budget line. It pointed out that the new pharmaceuticals legislation adopted in 2004 had had a considerable impact on the Agency's work, management structures and staff, and it welcomed the Agency's efforts to provide more scientific advice at early stages of the development of new medicines. It also noted the Agency's work in facilitating a quick assessment of vaccines in the event of an influenza pandemic. Lastly, the committee asked the Agency, before 1 January 2010 and every 5 years thereafter, to commission an independent external evaluation of its achievements on the basis of its founding Regulation and the work programmes decided by the Management Board. In the light of this evaluation, the Board should draft "such recommendations to the Commission and Parliament as may be necessary regarding changes in the Agency, its working practices and programmes".