Resolution of the European Parliament containing the comments accompanying the decision on the discharge to the Director of the European Agency for the Evaluation of Medicinal Products in respect of the implementation of its budget for the financial year 2002
Date: 2004-04-21
Institutions: European Parliament
Subjects: European Medicines Agency, budgetary discharge, financial year, implementation of the budget

4.11.2004

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Official Journal of the European Union

L 330/21

RESOLUTION

of the European Parliament containing the comments accompanying the decision on the
discharge to the Director of the European Agency for the Evaluation of Medicinal Products in
respect of the implementation of its budget for the financial year 2002

THE EUROPEAN PARLIAMENT,

— having regard to the Court of Auditors' report on the financial statements of the European Agency
for the Evaluation of Medicinal Products for the financial year 2002, together with the Agency's
replies (1) (C5‑0638/2003),

— having regard to the Council's recommendation of 9 March 2004 (C5-0143/2004),

— having regard to the EC Treaty, and in particular Article 276 thereof,

— having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial
Regulation applicable to the general budget of the European Communities (2), and in particular
Article 185 thereof, and to Council Regulation (EC) No 1647/2003 of 18 June 2003 amending
Regulation (EEC) No 2309/93 laying down Community procedures for the authorisation and
supervision of medicinal products for human and veterinary use and establishing a European Agency
for the Evaluation of Medicinal Products (3), and in particular Article 57a thereof,

— having regard to Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on
the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation
(EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the
European Communities (4), and in particular Article 94 thereof,

— having regard to Rule 93a of and Annex V to its Rules of Procedure,

— having regard to the Report of the Committee on Budgetary Control and the opinion of the

Committee on the Environment, Public Health and Consumer Policy (A5-0212/2004),

A. Whereas the European Court of Auditors (ECA) stated in its abovementioned report that it had
obtained reasonable assurances that the accounts for the financial year ended 31 December 2002 are
reliable and that the underlying transactions, taken as a whole, are legal and regular.

B. Whereas, in accordance with Article 185 of the new Financial Regulation, Parliament is exercising for
the

time its competence to give discharge to the Agency's Director in respect of

the first
implementation of the EMEA budget for the financial year 2002.

C. Whereas in inaugurating this new relationship with the Agency, Parliament's competent committee

received information from this Agency in reply to questions it had forwarded to it.

(1) OJ C 319, 30.12.2003, p. 22.
(2) OJ L 248, 16.9.2002, p. 1.
(3) OJ L 245, 29.9.2003, p. 19.
(4) OJ L 357, 31.12.2002, p. 72.

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1. Notes the following figures for the accounts of the European Agency for the Evaluation of Medicinal

Products for the financial years 2002 and 2001;

Revenue and expenditure account for the financial years 2002 and 2001

(1 000 euro)

2002

2001

Revenue received during the financial year (1)

Commission subsidy

Community subsidy for orphan medicines

Fees

EEE contribution

Sundry revenue

Total revenue (a)

Expenditure
Staff — Title I of the budget

Payments

Appropriations carried over
Administration — Title II of the budget

Payments

Appropriations carried over
Operating expenditure — Title III of the budget

Payments

Appropriations carried over

Total expenditure (b)

Outturn for the financial year (a − b) (2)

Balance carried over from the previous financial year

Reimbursement to the Commission

Sums carried over from the previous financial year and cancelled

Exchange rate differences

Other adjustments

Balance for the financial year

14 534

2 407

38 372

313

1 750

57 376

25 793

424

8 807

1 910

16 990

4 477

58 401

− 1 025

4 040
− 4 040

1 377
− 141
− 211

0

14 000

1 300

42 708

288

4 504

62 800

22 437

538

8 143

4 851

17 687

8 113

61 769

1 031

1 926

0

1 258

345
− 520

4 040

(1) This amount includes 5,2 million euro of revenue due in respect of the financial year 2002 (10,7 million

euro in 2001).

(2) Calculation based on the principles of Article 15 of Council Regulation (EC, Euratom) No 1150/2000 of

22 May 2000 (OJ L 130, 31.5.2000, p. 8).

NB: Discrepancies in totals are due to the effects of rounding.
Source: The Agency's data. These tables summarise the data provided by the Agency in its own financial
statements.

Implementation of the budget — Financial rules

2.

Expects the Agency in adopting its financial rules to take full account of the suggestions contained in
the Court of Auditors' opinion No 6/2003 of 17 July 2003;

3. Welcomes the agreement that was reached between the Agency and the Commission on the
payment of the Community subsidy in three instalments, intended to help reduce carry-overs; notes
furthermore the revised procedure put in place, in agreement with the Court of Auditors, for the
processing of commitments in the event that an inspection is decided upon, with a view to better
complying with the annuality principle; invites the Agency to further comment on whether the use
of differentiated appropriations might have a positive effect on the level of carry-overs;

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4.

Stresses however that, despite the agreement reached, the carry-overs situation resulting from the
procedure applied for inspections by a national agency would need to be improved;

5. Notes with interest the agreement reached between the Agency and the Commission allowing, in
compliance with the new Financial Regulation, for the positive balance of the outturn account of the
Agency to be available on the budget line of the Community subsidy should its income from fees
prove to be lower than forecast; points out that the responsibilities of the Agency, particularly in the
field of pharmaco-vigilance, exceed those attributable to fees paid by companies seeking
authorisation for medicinal products; takes the view that this solution, which allows for a different
treatment to be reserved to carry-overs relating to Community subsidy revenue and fee income, is
pragmatic and introduces the necessary flexibility, given the Agency's particular characteristics;

Financial statements

6. Notes the Agency's reply concerning the steps taken to improve the processing of advances paid for
inspections and fees actually due; expects the Agency to further clarify the information given on the
use of customers deposits;

Legality and regularity of the underlying transactions

7.

Notes the steps taken to improve internal control procedures; expects the Agency to adequately
comply with the requirement for providing systematically the necessary supporting documents
against which payments are to be made;

Other

8. Welcomes the Agency's decision to formalise the functioning of an internal audit service; expects the
Agency and the Commission to take further steps towards improving cooperation between that
service and the Commission's Internal Audit Service (IAS);

Horizontal points on the Agencies and the Commission

Implementing the new Financial Regulation — Internal audit and control

9.

Reiterates the position taken in its resolutions (1) accompanying the discharge given to the Agencies
for 2001 as regards the implementation of the new Financial Regulation; invites the Commission and
the Agencies to continue their cooperation, in particular in the areas of accounting, internal audit,
management and control procedures, so as to ensure that a coherent harmonised framework for the
functioning of the agencies is established;

10. Recalls that it expressed concern in the discharge resolution for 2001 concerning the lack of controls
on the agencies carried out by the internal audit service of the Commission (IAS); expresses grave
concern that such controls do not seem to have been carried out this year; asks the Commission and
the IAS to explain the reasons for this and to provide data about the number of staff available to the
Internal Auditor to carry out controls in the agencies; expects the Commission to indicate how it can
guarantee that sufficient and correct controls are carried out in the satellite bodies, in particular the
IAS.

(1) OJ L 148, 16.6.2003, p. 83 and OJ L 333, 20.12.2003, p. 53 (point 18).

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11. Stresses that it is essential that the agencies be required to submit to the investigative powers of
OLAF under the same conditions as the institutions (1); invites the ECA to provide information, in
time for adoption of the discharge resolution, on whether the Community bodies which acceded to
the Interinstitutional Agreement of 25 May 1999 (2) on internal investigations by OLAF did so in the
same terms as those laid down in the Annex to this Agreement;

Financial Management

12. Notes that in some of the agencies' replies to the questionnaire concerning the way in which the
recurrent problem of substantial carry-overs might be addressed, mention is made of the possibilities
offered by the new Financial Regulation, which provides for the use of ‘differentiated appropriations’;
invites the agencies to better explain their analysis and to indicate in particular which of their
activities of a multi-annual nature might be financed by such appropriations;

13.

Invites the Commission to present its position on such a solution and, should it consider that this
solution is not feasible, to outline alternatives allowing for a substantial reduction in carry-overs;

Review of the agencies

14. Stresses that, prior to any decision to set up an agency, the Commission must make a rigorous
analysis of the need for and added value of the functions that the agency will perform, with an eye to
the principles of subsidiarity, budgetary rigour and procedural simplification;

15. Calls on the Commission to make a general study of activities currently carried out by various
Community bodies that might overlap or serve the same goals, and to propose appropriate
solutions, including the possible mergers of agencies;

16.

Is concerned by the fact that there is an imbalance between administrative and operational
expenditure in many agencies, with administrative expenditure exceeding expenditure for operational
purposes; calls therefore on the Commission and the Agencies to set targets and a timetable to
reduce the level of administrative expenditure as a proportion of total expenditure; notes that many
agencies see opportunities in this regard, as listed in the questionnaire;

17. With reference to the replies to the questionnaire on interinstitutional cooperation, encourages the
agencies to improve cooperation between themselves in order to meet their needs in specific areas
(for example, software development) and reduce costs, rather than adopt solutions which were
initially designed for the purposes of the Commission but which often prove to be too cumbersome
and complicated for the Agencies' specific needs;

18. Encourages the agencies to organise and develop a close working relationship with the competent
parliamentary committees; invites its standing committees with competence in the areas of activity of
each of the agencies to coordinate their action with the Committees of Budgets and Budgetary
Control, with a view to ensuring efficient monitoring of the activity of the Agencies;

New sources of financing

19. Welcomes the responses and ideas that emerged from the questionnaire concerning the possibilities
of other sources of financing; notes that many current sources and proposals concern the letting of
buildings and facilities and the sale of publications and information; realises that for reasons of
independence, among other things, not all agencies are to accept additional financial sources; stresses
the economies of scale and financial benefits of the participation of non-EU countries in the

Texts adopted, 13.1.2004, P5_TA(2004) 0015.

(1)
(2) OJ L 136, 31.5.1999, p. 15.

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activities of certain agencies; calls on the Commission and the agencies to come forward with
constructive proposals with regard to further development of new sources of additional financing,
which would increase the level of self-financing;

20. Welcomes the financial contributions of some Member States and regions to the agencies located on
their area; considers it important for Council and the Commission to demand such contributions,
especially when new agencies are set up;

Harmonised operating framework

21. Recalls its position (1) that the multitude of different forms in the existing agencies' structures was
thought to be ‘neither transparent nor comprehensible, and, even bearing in mind the differences in
tasks, not justified’; invites the Commission to conduct a review of all the existing agencies with a
view to proposing, where appropriate, amendments to their basic instruments (2) so as to adapt
them to the models that the future regulatory framework should encompass; instructs its competent
committees to follow up this comprehensive review exercise, which should be conducted as soon as
possible, and to take into consideration the horizontal issues mentioned in this discharge resolution;

22.

Invites the Commission to present appropriate proposals, aimed at creating such a harmonised
framework for the agencies, prior to or at least in parallel with the presentation of the legislative
proposals for the new agencies; insists that an interinstitutional agreement spelling out common
guidelines is a pre-condition for creating the harmonised framework;

Staff policy

23. Notes that, as a result of the new Financial Regulation, the organigrams of the agencies are
established by the budgetary authority; stresses the importance of this change for the agency
discharge procedure in the years to come as regards checking application of the Staff Regulation in
matters of recruitment, promotion policy, vacancy rates and recruitment policy;

24. Notes that, in response to a questionnaire tabled in the course of the budgetary procedure for 2004,
it was established that, on average, it took considerably fewer years to obtain promotion at several
agencies than is the policy in the Commission, that vacancy rates were considerably higher compared
to other institutions and that several of the requested new posts were not proposed at the lowest
grade; considers that staff policy should form an important part of a review of the existing agencies;

25. Considers that the staff policy of the agencies should comply with the Financial Regulation, the Staff
Regulations and the best practice generally followed by the Institutions; considers that
the
Commission has been requested to give, before the 2005 budgetary procedure, guidelines
concerning staff policy, notably the rate of vacant posts, the rate of promotions, the level of
recruitment and the standard career profile;

26. Recalls the principle that the agencies should as far as possible employ staff on temporary contracts,

in order to maintain flexibility and efficiency;

27.

Is concerned about the serious anomalies detected in connection with the selection procedures of the
European Monitoring Centre for Drugs and Drug Addiction, including: imprecise notice, incomplete
selection committee minutes, criteria for assessing candidates not defined in advance (3); is very
concerned that this might not be an isolated case but that Agencies in general might have difficulty
in managing these rather complex procedures in a fair and transparent manner;

(1)
(2)
(3)

P5_TA(2004) 0015 (paragraphs 13 and 14).
P5_TA(2004) 0015 (paragraph 24).
See paragraph 13 of the Court of Auditors'specific report for 2002 (p. 64).

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28.

29.

Is of the opinion that selection procedures organised by agencies should meet the same standards as
those organised by the European Personnel Selection Office (EPSO) and that they should not be
perceived as a backdoor for easy entry into the European civil service;

Invites the Commission to make proposals in order to ensure that the agencies benefit from
appropriate support from the EPSO when organising selection procedures and that there is a
mechanism in place to validate the outcome of such procedures externally before recruitment takes
place.