Resolution of the European Parliament with comments forming an integral part of the decision on the discharge for the implementation of the budget of the European Medicines Agency for the financial year 2004
Date: 2006-04-27
Institutions: European Parliament
Subjects: European Medicines Agency, budgetary discharge, financial year, implementation of the budget

L 340/110

EN

Official Journal of the European Union

6.12.2006

RESOLUTION OF THE EUROPEAN PARLIAMENT

with comments forming an integral part of the decision on the discharge for the implementation
of the budget of the European Medicines Agency for the financial year 2004

THE EUROPEAN PARLIAMENT,

— having regard to the final annual accounts of the European Medicines Agency for the financial year

2004 (1),

— having regard to the Court of Auditors' report on the annual accounts of the European Medicines

Agency for the financial year 2004, together with the Agency's replies (2),

— having regard to the Council's recommendation of 14 March 2006 (5972/2006 — C6-0093/2006),

— 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
the European Communities (3), and in particular

Regulation applicable to the general budget of
Article 185 thereof,

— having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of
31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal
products for human and veterinary use and establishing a European Medicines Agency (4), and in par-
ticular Article 68 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 (5), and in particular Article 94 thereof,

— having regard to Rule 71 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 Food Safety (A6-0101/2006),

A.

B.

1.

whereas the Court of Auditors stated that it had obtained reasonable assurance that the annual
accounts for the financial year ended 31 December 2004 were reliable and that the underlying
transactions, taken as a whole, were legal and regular,

whereas the Court of Auditors states that it has obtained reasonable assurance from all the agencies,
excepting the express reservations in respect of the 2004 financial year concerning the European
Agency for Reconstruction, the European Centre for the Development of Vocational Training, the
European Training Foundation, the European Monitoring Centre on Racism and Xenophobia and
the European Food Safety Authority,

Recalls that, under Article 185 of the Financial Regulation, Parliament shall give discharge for the
implementation of the budgets of the bodies set up by the Communities and having legal personality
which actually receive grants charged to the budget; points out, however, that not all of these bodies
are fully, or even partially, funded via grants charged to the budget; emphasises that the discharge
decision therefore covers both the budget and the non-budget funding of these bodies; considers it
unacceptable that some of the bodies set up by the Union are accountable for the expenditure of
income received from sources other than the budget whilst others, which do not receive a subsidy
from the budget, are not; affirms the principle that all Community agencies, whether or not they are
subsidised, are subject to discharge by Parliament, even when another discharge authority intervenes
in accordance with their basic texts; takes the view that there is a need to review all texts that go
against this principle;

(1) OJ C 269, 28.10.2005, p. 17.
(2) OJ C 332, 28.12.2005, p. 8.
(3) OJ L 248, 16.9.2002, p. 1.
(4) OJ L 136, 30.4.2004, p. 1.
(5) OJ L 357, 31.12.2002, p. 72. Regulation as amended by Regulation (EC, Euratom) No 1261/2005 (OJ L 201,

2.8.2005, p. 3).

6.12.2006

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Official Journal of the European Union

L 340/111

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

Finds table 1 of the Court of Auditors' report,
introduced for the first time during the 2003
discharge exercise, which summarises the Agency's powers and responsibilities, governance,
resources, activities and services provided, of great value; notes that the information contained in
table 1 is supplied by the Agency; asks the Court of Auditors to verify the contents of table 1;

Insists that as well as spending money properly, agencies should also strive to spend money as effi-
ciently and effectively as possible;
invites the Court of Auditors to consider the possibility of
extending its specific annual reports on the agencies to include an examination of performance and
achievement of objectives; in this context and in line with its resolutions on the 2003 discharge,
insists that the following aspects be taken into account: that duplication of work among the agencies
must be avoided as much as possible and that 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;

Notes that Community agencies do not always have a good image or good press and that many of
them do not deserve such a negative image; points out that EU citizens should be made aware of
this, with the appropriate means being used to explain as often as is necessary the raisons d'être and
achievements of the agencies; calls on the Commission to act accordingly, using whatever means it
considers necessary;

Notes that the enlargement of the European Union in 2004 has affected the structures and operating
arrangements of the Community agencies in many ways, and that several of the agencies draw atten-
tion to these effects in their activity reports, focusing in particular on the increase in the number of
administrators; calls on the Commission to assess the real or supposed problems encountered and to
recommend the regulatory changes required;

Notes that the Commission has made a commitment to harmonising the way in which activity
reports concerning its directorates-general are presented; calls for a similar approach to be taken in
respect of the activity reports of the Communities' agencies, which differ significantly in terms of
content; calls on the Commission to point out to the Communities' agencies the information and
activity indicators that they must provide;

Notes the Court of Auditors' finding that contracts concluded with banks have 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; notes the Agency's reply explaining the
reasons for the delay in launching a call for tender and setting out the benefits achieved through
direct negotiation with the bank and will bear this in mind when considering revisions to the Finan-
cial Regulation;

Notes that the implementation of both the operating and the administrative budget was lower in
2004 than in 2003; is very pleased with the full implementation of the orphan drugs budget line;

Points out that the new pharmaceuticals legislation, which was adopted in 2004, had a considerable
impact on the Agency's work and management structures; congratulates the Agency on its successful
adaptation to the new regulatory environment;

Notes that the implementation by Member States of the Europe-wide pharmacovigilance reporting
system (the EudraVigilance database) was slower than expected; is, however, satisfied with the recent
announcement by the Executive Director that the situation has substantially improved during 2005;

Invites the Agency to improve contacts with consumer protection organisations in order to improve
awareness concerning toxic and potentially harmful products in medicinal products; underlines the
Agency's duty to act in the public interest;

Calls on the Commission to help the agencies follow as closely as possible the work plan agreed for
the year ahead, allowing activities to be properly planned and implemented, and particularly to
avoid major, last-minute changes to the work load;

Asks 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.