Report on the annual accounts of the European Medicines Agency for the financial year 2004 together with the Agency's replies
Date: 2005-10-05
Institutions: European Court of Auditors
Subjects: European Court of Auditors, European Medicines Agency, administration of the Institutions, financial control, interinstitutional relations (EU), operating result, report

C 332/8

EN

Official Journal of the European Union

28.12.2005

on the annual accounts of the European Medicines Agency for the financial year 2004
together with the Agency’s replies

REPORT

(2005/C 332/02)

CONTENTS

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

THE COURT’S OPINION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

OBSERVATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1-2

3-6

7-9

Tables 1 to 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Agency’s replies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9

9

9

10

14

Paragraph

Page

28.12.2005

EN

Official Journal of the European Union

C 332/9

INTRODUCTION

1.
The European Medicines Agency (hereinafter referred to as
the Agency) was created by Council Regulation (EEC) No 2309/93
of 22 July 1993 which was replaced by Regulation (EC)
No 726/2004 of the European Parliament and of the Council of
31 March 2004 (1). The Agency operates through a network
and coordinates the scientific resources made available by the
national authorities in order to ensure the evaluation and super-
vision of medicinal products for human or veterinary use. Table 1
summarises the powers and activities of the Agency on the basis
of the information supplied by it.

2.
For information, the annual accounts drawn up by the
Agency for the financial year 2004 are summarised in Tables 2, 3
and 4.

The Court has obtained a reasonable basis for the opinion

6.
expressed below.

Reliability of the accounts

The Agency’s accounts for the financial year ended 31 Decem-
ber 2004 are, in all material respects, reliable.

Legality and regularity of the underlying transactions

The transactions underlying the Agency’s annual accounts,
taken as a whole, are legal and regular.

The observations which follow do not call the Court’s opin-
ion into question.

THE COURT’S OPINION

OBSERVATIONS

3.
The Court’s opinion is addressed to the European Parlia-
ment and the Council in accordance with Article 185(2) of Coun-
cil Regulation (EC, Euratom) No 1605/2002 (2); it was drawn up
following an examination of the Agency’s accounts, as required
by Article 248 of
the Treaty establishing the European
Community.

The Agency’s accounts for the financial year ended
4.
31 December 2004 (3) were drawn up by its Executive Director,
pursuant to Article 68 of Regulation (EC) No 726/2004, and sent
to the Court, which is required to give its opinion on their reli-
ability and on the legality and regularity of the underlying
transactions.

5.
The Court conducted an audit in accordance with its poli-
cies and standards, which are based on international auditing
standards that have been adapted to the Community context. The
audit was planned and performed to obtain reasonable assurance
that the accounts are reliable and the underlying transactions are
legal and regular.

7.
The Agency’s Management Board has set up an Audit
Advisory Committee to advise the Executive Director on matters
regarding quality assurance and risk-mitigating strategies. The
existence of such a body and its operating procedures, including
the recruitment procedure for its members, must be provided for,
on account of its permanent nature, in the rules which govern the
Agency’s internal organisation.

8.
The contracts concluded with the banks have been in force
for over five years even though the detailed rules for the imple-
mentation of the Agency’s financial regulation lay down that
there should be a new invitation to tender at least once every five
years (4).

9.
The Court notes that the Agency’s new financial regula-
tion, as finally adopted after receipt of the Commission’s opin-
ion, takes account of the observations which the Court made in
its previous report (5). Similarly, the system for managing the
Agency’s fixed assets has been considerably improved (6).

This Report was adopted by the Court of Auditors in Luxembourg at its meeting of 5 October
2005.

For the Court of Auditors
Hubert WEBER
President

(1) OJ L 214, 24.8.1993, p. 1 and OJ L 136, 30.4.2004, p. 1. Pursuant to
the latter Regulation the Agency’s original name, European Agency for
the Evaluation of Medicinal Products, was changed to European Medi-
cines Agency.

(2) OJ L 248, 16.9.2002, p. 1.
(3) These accounts were drawn up on 29 September 2005 and received

(4) Article 53(3).
(5) See paragraph 7 of the Report for the financial year 2003 (OJ C 324,

30.12.2004, p. 31).

by the Court on 29 September 2005.

(6) See paragraph 10 of the Report for the financial year 2003.

C 332/10

EN

Official Journal of the European Union

28.12.2005

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EN

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C 332/12

EN

Official Journal of the European Union

28.12.2005

European Medicines Agency — Revenue and expenditure account for the financial years 2004 and 2003

Table 3

2004

2003 (1)

(1 000 euro)

Revenue

Fees relating to marketing authorisations

Commission subsidy including contributions received from the EEA

Community subsidy for orphan medicines

Contributions for Community programmes

Administrative revenue

Sundry revenue

Expenditure

Staff expenditure

Administrative expenditure

Operating expenditure

Depreciation

Other expenses

68 412

20 529

4 026

0

1 973

1 473

Total (a)

96 413

34 333

11 224

38 573

3 650

280

88 060

8 353

1 160

9 513

Total (b)

Operating result (c = a – b)

Financial result (e)

Economic outturn (f = c + e)

58 657

19 786

2 814

1 208

1 703

1 788

85 956

29 663

10 835

32 838

2 364

0

75 700

10 256

676

10 932

(1) The data for the financial year 2003 have been reprocessed to make them comparable to those of 2004.
Source: The Agency’s data — This table summarises the data provided by the Agency in its annual accounts.

28.12.2005

EN

Official Journal of the European Union

C 332/13

European Medicines Agency — Balance sheet at 31 December 2004 and 31 December 2003

Table 4

Assets

Intangible assets

Fixed assets

Plant, machinery and tools

Furniture and vehicle fleet

Computer equipment

2004

5 109

2 480

1 375

3 151

7 006

Subtotal

2003

Liabilities

2004

2003

3 401

Own capital

(1 000 euro)

Outturn carried over from previous financial
years

Economic outturn

13 767

9 513

Subtotal

23 280

6 872

10 932

17 804

1 635

1 011

2 548

Current liabilities

5 194

Amounts owed in social security charges

320

0

Current assets

Current liabilities

VAT paid and to be recovered

1 888

1 105

Other accounts payable

Amounts owed to Community institutions and
bodies

4 910

479

13 151

11 936

106

127

107

Advances from customers

11 250

8 845

Amounts owed by Community institutions and
bodies

Sundry accounts receivable

Sundry receivables and advances

Subtotal

148

1 795

2 061

5 892

1 034

64

2 310

Available assets

35 010

28 286

Total

53 017

39 191

Source: The Agency’s data — This table summarises the data provided by the Agency in its annual accounts.

Subtotal

29 737

21 387

Total

53 017

39 191

C 332/14

EN

Official Journal of the European Union

28.12.2005

THE AGENCY’S REPLIES

The Audit Advisory Committee is a consultative body and
7.
has no operational role in the internal organisation of the Agency.
On 4 February 2005 the Management Board of the agency
adopted the Terms of Reference of the Audit Advisory Commit-
tee which include the mission statement of this committee as well
as the rules of proceedings.

8.
The Agency has had to implement a wide-ranging reform
of the Financial Regulation and Accounting procedures over the
last few years. It was considered prudent not to seek a change in
the main bank at the same time due to the integration of our sys-
tems with this bank’s electronic payment system. Now that the

Agency is in the final stage of implementing the new Financial
Regulation, a call for tender will be launched in the last quarter of
this year. However it should be noted that substantial reductions
in bank transfer costs have been achieved through direct negotia-
tions with the bank and automation of payments. Also place-
ments of funds are subject to individual bids from up to three
banks based on the market rates on a particular day.

9.
The Agency notes with satisfaction that these points, men-
tioned in the Court’s report on the 2003 accounts, have been
resolved.