Parltrack

Activites

• 2008/07/15 Final act published in Official Journal
  • Budget 2008/521
  • OJ L 187 15.07.2008, p. 0128
• 2007/04/24 Text adopted by Parliament, single reading
  • T6-0120/2007 summary

    The European Parliament adopted a resolution drafted by Edit HERCZOG (PSE, HU), and granted the executive director of the European Medicines Agency discharge for the implementation of the Agency's budget for the financial year 2005. It then approved the closing of the accounts of the Centre for the financial year 2005. The Parliamentary resolution is divided into two parts. The first contained general points, and concerned the majority of EU Agencies requiring individual discharge. The second part contained specific points relating to the Agency. General points: Parliament considers that the ever-growing number of Community Agencies and the activities of certain of them do not seem to form part of an overall policy framework, and that the remits of some Agencies do not always reflect the real needs of the Union.  Accordingly, it invites the Commission to define an overall policy framework for the setting up of new Community Agencies and to present a cost-benefit study before the setting up of any new agency, while being careful to avoid any overlap of activities between Agencies or with the remits of other European organisations. Parliament calls on the Court of Auditors to give its opinion on this cost-benefit study before Parliament takes its decision, and it asks the Commission to present every five years a study on the added value of every existing Agency. ; invites all relevant institutions In the case of a negative evaluation of the added value of an Agency, all relevant institutions are asked to take the necessary steps by reformulating the mandate of that Agency or by closing it. In view of the constantly increasing number of Agencies, Parliament feels that the Directorates-General of the Commission charged with the setting up and monitoring of Agencies must develop a common approach to the Agencies. It also asks the Commission to improve administrative and technical support to the Agencies. Parliament regretted that the negotiations on the draft interinstitutional agreement on the operating framework for the European regulatory agencies have not yet been concluded, and calls on the Commission, in consultation with the Court of Auditors, to do their utmost to ensure that the agreement is brought to a rapid conclusion. Noting that the Commission's budgetary responsibility calls for closer linking of the Agencies to the Commission, Parliament calls on the Commission and the Council to take all necessary steps to give the Commission a blocking minority in the supervisory bodies of the regulatory Agencies by 31 December 2007 and to provide for such a minority from the outset when new Agencies are set up. It invites the Court of Auditors to create an additional chapter in its Annual Report, devoted to all Agencies to be discharged under the Commission's accounts in order to have a much clearer picture of the use of EU funds by Agencies. Parliament goes on to ask the Commission to come up with a proposal to harmonise the format of the annual reporting by the Agencies and to develop performance indicators which would allow a comparison of their efficiency. The Commission is urged to monitor and direct the management of the Agencies, especially in relation to the proper application of tender procedures, transparency of recruitment procedures, sound financial management and, most importantly, the proper application of the rules concerning the internal control framework. Specific points concerning the European Medicines Agency: Parliament noted that for administrative expenditure (Title II) the utilisation rate for commitment appropriations was less than 90 %, with more than 40 % of the commitments made being carried over to the following financial year. It also noted that the budget of the Agency has grown considerably between 2003 and 2005 due to the enlargement of the EU and new tasks, and pronounced itself very pleased with the increased appropriations for, and the full implementation of, the Orphan Drugs budget line. Parliament invited the Agency to make sure that only staff members with delegation rights have access to the corresponding computer system. It demanded that contract award procedures should be transparent and follow the guiding rules including in the IT area, and it asked the Agency to inform Parliament about the new call for tender concerning bank contracts according to standard rules as soon as possible. Parliament went on to point out that the new pharmaceuticals legislation, adopted in 2004, has had a considerable impact on the Agency's work, management structures and staff, congratulating the Agency on successfully adapting to the new regulatory framework. It welcomed the Agency's efforts to provide more scientific advice at early stages of the development of new medicines as well as the introduction of measures to accelerate the assessment of medicines that are of critical importance to public health, noting the work done by the Agency to facilitate a quick assessment of vaccines in the event of an influenza pandemic. Lastly, Parliament wanted the Agency to commission an independent external evaluation of its achievements before 1 January 2010 and every five years thereafter. The Agency should draft such recommendations to the Commission and Parliament as may be necessary regarding changes in the Agency. The evaluation and the recommendations must be made public.

  • Results of vote in Parliament
• 2007/04/24 Commission response to text adopted in plenary
  • SP(2007)2625/2
  • DG Budget, KALLAS Siim
• 2007/03/30 Committee report tabled for plenary, single reading
  • A6-0099/2007
• 2007/03/30 Committee report tabled for plenary, single reading
  • A6-0099/2007
• 2007/03/26 Vote in committee, 1st reading/single reading
  • CONT CONT/6/42413 HERCZOG Edit PSE
  • ENVI HAUG Jutta PSE
• #2787
• 2007/02/27 Council Meeting
• 2007/02/09 Committee draft report
  • PE384.440
• 2006/11/29 Committee referral announced in Parliament, 1st reading/single reading
  • CONT CONT/6/42413 HERCZOG Edit PSE
  • ENVI HAUG Jutta PSE
• 2006/10/31 Non-legislative basic document published
  • N6-0029/2006 summary

    PURPOSE: presentation of the final accounts of the European Medicines Agency for the financial year 2005. CONTENT: this document published in the Official Journal of the EU sets out a detailed account of the implementation of the 2005 budget, including the revenue and expenditure and the balance sheet for the year concerned. According to this document, the final budget amounted to EUR 111.8 million (in comparison to EUR 99.4 million in 2004) consisting of a 22.7% Community contribution. As regards staffing, the Agency, whose headquarters are based in London (UK), set out a total of 379 posts in the establishment plan. 337.5 posts are currently occupied + 34 other posts (auxiliary contracts, seconded national experts, local staff, employment agency staff) totalling 317.5 posts (340 in 2004) assigned to operational, administrative and mixed tasks. Staff expenditure accounted for EUR 41.356 million. Throughout 2005, the Agency concentrated on coordinating the scientific evaluation of medicinal products which are subject to Community marketing authorisation procedures. Concerning medicinal products for human use, the Agency: - replied to 43 applications for marketing authorisations and delivered 24 favourable opinions taking an average evaluation time of 203 days as opposed to 187 days in 2004; - delivered 1 148 opinions after authorisation; - drafted 91 565 pharmacovigilance reports (64 186 in 2004) and 279 periodic reliability reports; - delivered 135 scientific opinions and 8 451 procedures for mutual recognition. Concerning veterinary medicinal products, the Agency: - replied to 11 new applications for marketing authorisations and 70 applications in respect of variants; - carried out 114 inspections. As regards orphan medicinal products, the Agency: - replied to 118 applications and gave 88 favourable opinions. The complete version of the final accounts may be found at the following address: www.emea.eu.int

Documents

• Non-legislative basic document published: N6-0029/2006
• Committee draft report: PE384.440
• Committee report tabled for plenary, single reading: A6-0099/2007
• Committee report tabled for plenary, single reading: A6-0099/2007
• Decision by Parliament, 1st reading/single reading: T6-0120/2007
• Results of vote in Parliament: Results of vote in Parliament
• Commission response to text adopted in plenary: SP(2007)2625/2
• : Budget 2008/521
• : OJ L 187 15.07.2008, p. 0128

History

(these mark the time of scraping, not the official date of the change)