2004 discharge: European Agency for the Evaluation of Medicinal Products

The European Parliament adopted a resolution drafted by Umberto GUIDONI (GUE/NGL, IT) and granted discharge to the Executive Director of the European Medicines Agency for the implementation of the Centre’s budget for the financial year 2004. In its accompanying comments, Parliament noted the Court of Auditors' finding that contracts concluded with banks had been in force for over five years, in contravention of the Agency's financial regulation implementing rules, which require a new invitation to tender at least every five years. It also noted the Agency's reply explaining the reasons for the delay and setting out the benefits achieved through direct negotiation with the bank and will bear this in mind when considering revisions to the Financial Regulation. 

Parliament also noted that the implementation of both the operating and the administrative budget was lower in 2004 than in 2003, and stated that it was very pleased with the full implementation of the orphan drugs budget line. It pointed out that the new pharmaceuticals legislation, which was adopted in 2004, had a considerable impact on the Agency's work and management structures, and congratulated the Agency on its successful adaptation to the new regulatory environment. The implementation by Member States of the Europe-wide pharmacovigilance reporting system (the EudraVigilance database) was slower than expected, but Parliament was satisfied with the recent announcement by the Executive Director that the situation has substantially improved during 2005.

It invited the Agency to improve contacts with consumer protection organisations in order to improve awareness concerning toxic and potentially harmful products in medicinal products and underlined the Agency's duty to act in the public interest.

Parliament also made a series of general remarks on the agencies. As well as spending money properly, agencies should also strive to spend money as efficiently and effectively as possible. The Court of Auditors was asked to consider the possibility of extending its specific annual reports on the agencies to include an examination of performance and achievement of objectives. The following aspects should be taken into account: duplication of work among the agencies must be avoided as much as possible and measures designed to improve transparency and communication with the public must be clarified, along with Community affirmative action measures at all levels of recruitment, training and the assignment of responsibilities.

Parliament noted that Community agencies did not always have a good image or good press and that many of them did not deserve such a negative image. EU citizens should be made aware of this, and Parliament called on the Commission to act accordingly, using whatever means it considers necessary.

Furthermore, the enlargement of the European Union in 2004 had affected the structures and operating arrangements of the Community agencies in many ways, and several of the agencies draw attention to these effects in their activity reports, focusing in particular on the increase in the number of administrators. The Commission needed to assess the problems encountered and recommend the regulatory changes required.

The Commission had made a commitment to harmonising the way in which activity reports concerning its directorates-general were presented. Parliament called for a similar approach to be taken in respect of the activity reports of the Communities" agencies, which differed significantly in terms of content. The Commission should point out to the agencies the information and activity indicators that they must provide.

Finally, Parliament asked the Commission to improve synergies between agencies by making cooperation more effective, avoiding duplication of work and addressing shortcomings, in particular as regards common areas such as training, the implementation of Community policies across the board, the use of the latest management systems and solving problems relating to sound management of the budget.