Procedure completed
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | CONT | MARTIN Hans-Peter (NI) | |
Opinion | ENVI | HAUG Jutta (PSE) |
Legal Basis RoP 094
Activites
- 2009/03/31 Final act published in Official Journal
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2008/04/22
Results of vote in Parliament
- Results of vote in Parliament
- Debate in Parliament
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T6-0152/2008
summary
The European Parliament adopted, by 622 votes in favour, 15 against and 38 abstentions, a Decision to grant the Executive Director of the European Medicines Agency discharge in respect of the implementation of its budget for the financial year 2006. The decision to grant discharge also constitutes closure of the accounts of this EU agency.At the same time, the Parliament adopted by 579 votes in favour, 22 against and 39 abstentions, a Resolution containing the comments which form part of the decision giving discharge. The report had been tabled for plenary by Hans-Peter MARTIN (NI, AT) on behalf of the Committee on Budgetary Control. As is the case for all EU agencies, Parliament's Resolution is divided into two parts: part one contains general comments on EU agencies, while part two focuses on the specific case of the Agency.1) General comments on the majority of EU agencies: the Parliament notes that the budgets of the 24 agencies and other satellite bodies audited by the Court of Auditors totalled more than EUR 1 billion and that the number of agencies is constantly increasing. The number of agencies subject to the discharge procedure evolved from 8 in 2000 to 20 in 2006. It concludes therefore that the auditing/discharge process has become cumbersome and disproportionate compared to the relative size of the agencies and that, in the future, this type of procedure should be simplified and rationalised for decentralised agencies.On the basis of the financial analysis, the Parliament is of the following opinion:Fundamental considerations: given the constantly increasing number of agencies, the Parliament requests that, before the creation of a new agency, the Commission provide clear explanations regarding agency type, objectives of the agency, internal governance structure, products, services, clients and stakeholders of the agency, formal relationship with external actors, budget responsibility, financial planning, and personnel and staffing policy. It also requests that each agency be governed by a yearly performance agreement which should contain the main objectives for the coming year and that the performance of the agencies be regularly audited by the Court of Auditors (and extend the financial analysis of expenditure to also cover administrative efficiency and effectiveness). More generally, the Parliament takes the view that, in the case of agencies, which are continually overestimating their respective budget needs, technical abatement should be made on the basis of vacant posts in order to reduce the assigned revenue for the agencies and therefore also lower administrative costs of the EU. It recalls that it is a serious problem that a number of agencies is criticised for not following rules on public procurement, the Financial Regulation, the Staff Regulations etc., and considers that the principal reason for this is that most regulations and the Financial Regulation are designed for bigger institutions rather than for small agencies. Therefore, it is necessary to seek a rapid solution in order to enhance the effectiveness of the legislation by grouping the administrative functions of various agencies together or by establishing implementing rules which are better adapted to the agencies. The Parliament also insists that the Commission, when drafting the Preliminary Draft Budget, take into consideration the results of budget implementation by the individual agencies in former years and revise the budget requested by the particular agency accordingly. If the Commission does not undertake this revision, the Parliament invites the competent committee to revise, itself, the budget in question to a realistic level. At the same time, the Parliament recalls that it expects the Commission to present every five years a study on the added value of every existing agency and to not hesitate to close an agency if it is deemed useless by the analysis. Such an assessment is expected as soon as possible given that this type of assessment has yet to be presented. Furthermore, the Parliament insists that recommendations of the Court of Auditors should be promptly implemented and the level of subsidies paid to the agencies should be aligned with their real cash requirements. Presentation of reporting data: noting that there is no standard approach among the agencies with regard to the presentation of information, the Parliament recalls that it already invited the directors of the agencies to accompany their annual activity report with a declaration of assurance concerning the legality and regularity of operations, similar to the declarations signed by the Directors General of the Commission. It therefore asks the Commission to amend its standing instructions to the agencies and to produce a harmonised model for presenting information, including: i) an annual report intended for a general readership on the body's operations, work and achievements; ii) financial statements and a report on implementation of the agency’s budget; iii) an activity report of the Directors of the agency (as requested by the Parliament since 2005); iv) a declaration of assurance signed by the body's director. General findings by the Court of Auditors: the Parliament refers to certain recurring findings by the Court, including the disbursement of subsidies paid by the Commission (not sufficiently justified estimates of the agencies' cash requirements), the non implementation of the ABAC accounting system by some agencies or the accrued charges for untaken leave which are accounted for by some agencies. It calls for rapid measures in these areas as well as improvements to the internal audit procedures of the agencies. The Parliament also calls on the agencies to consider an inter-agency disciplinary board, as some individual agencies have difficulty in setting up their own disciplinary boards due to their size. Draft inter-institutional agreement: the Parliament recalls the Commission's draft Interinstitutional agreement on the operating framework for the European regulatory agencies (see ACI/2005/2035), which was intended to create a framework for the creation, structure, operation, evaluation and control of the European regulatory agencies and awaits its adoption as soon as possible. It particularly welcomes the Commission's commitment to bring forward a Communication on the future of the regulatory agencies during the course of 2008.2. Specific points concerning the European Medicines Agency: while the Parliament recognises the efforts made by the Agency to accelerate the assessment of medicines that are of critical importance to public health, it criticises the fact that the utilisation rate for commitment appropriations was less than 60% in this Agency. Furthermore, a considerable amount of budget appropriations for 2006 was carried over to 2007 due to the nature of the projects dealt with by the Agency. In addition, the Agency would accumulate a large surplus since it receives a Community subsidy and fees and other revenue paid by undertakings for obtaining and maintaining Community marketing authorisations of medicines (revenue of EUR 119 million and a Community subsidy of EUR 31 million). The total surplus for 2006 therefore amounts to EUR 44 million, which, according to the Agency, is not a budgetary surplus but rather an economic outturn based on the application of accrual accounting principles. The Parliament does not understand why the board is concerned about the agency receiving new tasks that would not be met with adequate financing given that the financial situation of the Agency appears to be booming. The Parliament welcomes the conclusions of the first audit of the Agency in 2005, with the conclusion that the internal control system in place provides reasonable assurance regarding the achievement of the business objectives set up for the processes audited, with some exceptions.Lastly, the Parliament is aware that the preparation of the implementation of the Regulation on medicinal products for paediatric use had a considerable impact on the Agency's work in 2006 and welcomes the adoption of the joint Commission/Agency document on priorities for implementation of this Regulation.
- 2008/04/03 Committee report tabled for plenary, single reading
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2008/03/26
Vote in committee, 1st reading/single reading
- #2847
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2008/02/12
Council Meeting
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2007/10/25
Committee referral announced in Parliament, 1st reading/single reading
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2007/03/30
Non-legislative basic document published
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SEC(2007)1055
summary
PURPOSE: presentation of the final accounts of the European Medicines Agency for the financial year 2006.CONTENT: this document sets out a detailed account of the implementation of the 2006 budget, including the revenue and expenditure and the balance sheet for the year concerned. According to this document, the final budget amounted to EUR 138.7 million (in comparison to EUR 111.8 million in 2005) consisting of a 21.63% Community contribution (excluding subsidy for orphan medicines).As regards staffing, the Agency, whose head office is based in London (UK), set out a total of 424 posts in the establishment plan. 395 posts are currently occupied + 77 other posts (auxiliary contracts, seconded national experts and employment agency staff) totalling 472 posts assigned to operational and administrative tasks. Staff expenditure in 2006 accounted for EUR 42.941 million (final appropriations paid).Throughout 2006, the Agency concentrated on coordinating the scientific evaluation of medicinal products. Concerning medicinal products for human use, the Agency:replied to 79 applications for marketing authorisations and delivered 51 favourable opinions taking an average evaluation time of 171 days;delivered 1 380 opinions after authorisation;drafted 94 081 pharmacovigilance reports (64 186 in 2004) and 273 periodic reliability reports;delivered 193 scientific opinions and 9 241 procedures for mutual recognition.Concerning veterinary medicinal products, the Agency:replied to 5 new applications for marketing authorisations and 56 applications in respect of variants;carried out 128 inspections.As regards orphan medicinal products, the Agency replied to 104 applications and gave 81 favourable opinions.The complete version of the final accounts may be found at the following address: http://www.emea.europa.eu/index/indexg1.htm.
- DG {'url': 'http://ec.europa.eu/dgs/budget/', 'title': 'Budget'}, KALLAS Siim
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SEC(2007)1055
summary
Documents
- Non-legislative basic document published: SEC(2007)1055
- Committee report tabled for plenary, single reading: A6-0125/2008
- Results of vote in Parliament: Results of vote in Parliament
- Debate in Parliament: Debate in Parliament
- Decision by Parliament, 1st reading/single reading: T6-0152/2008
- : Budget 2009/217
- : OJ L 088 31.03.2009, p. 0175
Amendments | Dossier |
44 |
2007/2054(DEC)
2008/03/06
CONT
44 amendments...
Amendment 1 #
Motion for a resolution Paragraph 1 Amendment 10 #
Motion for a resolution Paragraph 14 Amendment 11 #
Motion for a resolution Paragraph 15 Amendment 12 #
Motion for a resolution Paragraph 16 Amendment 13 #
Motion for a resolution Paragraph 17 Amendment 14 #
Motion for a resolution Paragraph 18 Amendment 15 #
Motion for a resolution Paragraph 19 Amendment 16 #
Motion for a resolution Paragraph 20 Amendment 17 #
Motion for a resolution Paragraph 21 Amendment 18 #
Motion for a resolution Paragraph 22 Amendment 19 #
Motion for a resolution Paragraph 23 Amendment 2 #
Motion for a resolution Paragraph 2 Amendment 20 #
Motion for a resolution Paragraph 24 Amendment 21 #
Motion for a resolution Paragraph 25 Amendment 22 #
Motion for a resolution Paragraph 26 Amendment 23 #
Motion for a resolution Paragraph 27 Amendment 24 #
Motion for a resolution Paragraph 28 Amendment 25 #
Motion for a resolution Paragraph 29 Amendment 26 #
Motion for a resolution Paragraph 30 Amendment 27 #
Motion for a resolution Paragraph 31 Amendment 28 #
Motion for a resolution Paragraph 33 Amendment 29 #
Motion for a resolution Paragraph 34 Amendment 3 #
Motion for a resolution Paragraph 3 Amendment 30 #
Motion for a resolution Paragraph 36 36. Requests that the performance of the agencies be regularly (and on an ad hoc basis) audited by the Court of Auditors or another independent auditor; considers that this should not be limited to traditional elements of financial management and the proper use of public money, but should also cover administrative efficiency and effectiveness and should include a rating of the financial management of each agency;
Amendment 31 #
Motion for a resolution Paragraph 36 a (new) 36a. Takes the view that in the case of agencies which are continually overestimating their respective budget needs, technical abatement should be made on the basis of vacant posts; is of the opinion that this will lead in the long run to less assigned revenue for the agencies and therefore also to lower administrative costs;
Amendment 32 #
Motion for a resolution Paragraph 36 b (new) 36b. Notes that it is a serious problem that a number of agencies is criticised for not following rules on public procurement, the Financial Regulation, the Staff Regulations etc.; considers that the principal reason for this is that most regulations and the Financial Regulation are designed for bigger institutions and that most of the small agencies do not have the critical mass to be able to cope with these regulatory requirements; therefore asks the Commission to look for a rapid solution in order to enhance the effectiveness by grouping the administrative functions of various agencies together, in order to achieve this critical mass (taking into consideration the necessary changes in the basic regulations governing the agencies and their budgetary independence), or urgently to draft specific rules for the agencies (in particular implementing rules for the agencies) which allow them to be in full compliance;
Amendment 33 #
Motion for a resolution Paragraph 36 c (new) 36c. Insists that the Commission, when drafting the Preliminary Draft Budget, take into consideration the results of budget implementation by the individual agencies in former years, in particular in year n-1, and, revise the budget requested by the particular agency accordingly; invites its competent committee to respect this revision and, if not undertaken by the Commission, to revise itself the budget in question to a realistic level matching the absorption and implementation capacity of the agency in question;
Amendment 34 #
Motion for a resolution Paragraph 36 d (new) 36d. Recalls its decision on discharge in respect of the financial year 2005, in which it invited 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 to take the necessary steps by reformulating the mandate of that agency or by closing it; notes that there has not been one single evaluation undertaken by the Commission in 2007; insists that the Commission should present at least 5 such evaluations before the decision on discharge in respect of the financial year 2007, starting with the oldest agencies;
Amendment 35 #
Motion for a resolution Paragraph 36 e (new) 36e. Is of opinion that recommendations of the Court of Auditors should be promptly implemented and the level of subsidies paid to the agencies should be aligned with their real cash requirements; considers further that the amendments to the general Financial Regulation should be incorporated into the agencies' framework financial regulation and into their various specific financial regulations;
Amendment 36 #
Motion for a resolution Paragraph 36 f (new) 36f. Is concerned that a significant number of staff is employed on a temporary basis in a way that could undermine the quality of their work; therefore asks the Commission to improve its monitoring of the implementation of the Staff Regulations by the agencies;
Amendment 37 #
Motion for a resolution Paragraph 37 Amendment 38 #
Motion for a resolution Paragraph 38 Amendment 39 #
Amendment 4 #
Motion for a resolution Paragraph 4 Amendment 40 #
Motion for a resolution Paragraph 39 Amendment 41 #
Motion for a resolution Paragraph 39 39. Calls on the Commission to submit as quickly as possible a proposal to abolish or drastically cut back privileges
Amendment 42 #
Motion for a resolution Paragraph 40 Amendment 43 #
Motion for a resolution Paragraph 41 Amendment 44 #
Motion for a resolution Paragraph 61 Amendment 5 #
Motion for a resolution Paragraph 5 Amendment 6 #
Motion for a resolution Paragraph 6 Amendment 7 #
Motion for a resolution Paragraph 7 Amendment 8 #
Motion for a resolution Paragraph 8 Amendment 9 #
Motion for a resolution Paragraph 13 source: PE-402.809
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