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C 309/34 EN Official Journal of the European Union 19.12.

2007

REPORT
on the annual accounts of the European Medicines Agency for the
financial year 2006 together with the Agency’s replies
(2007/C 309/07)

CONTENTS
Paragraph Page

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 35
STATEMENT OF ASSURANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6 35
OBSERVATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8 35
Tables 1 to 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
The Agency’s replies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
19.12.2007 EN Official Journal of the European Union C 309/35

INTRODUCTION 6. The Court has thus obtained a reasonable basis for the
Statement set out below.

1. The European Medicines Agency (hereinafter ‘the Agency’)


was created by Council Regulation (EEC) No 2309/93 of
22 July 1993, which was replaced by Regulation (EC)
Reliability of the accounts
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 The Agency’s accounts for the financial year ended 31 Decem-
authorities in order to ensure the evaluation and supervision of ber 2006 are, in all material respects, reliable.
medicinal products for human or veterinary use.

Legality and regularity of the underlying transactions

The transactions underlying the Agency’s annual accounts,


2. Table 1 summarises the Agency’s competences and activi- taken as a whole, are legal and regular.
ties. Key data summarised from the financial statements drawn up
by the Agency for the financial year 2006 is presented inTables 2,
3 and 4 for information purposes. The observations which follow do not call the Court’s State-
ment into question.

STATEMENT OF ASSURANCE

3. This Statement is addressed to the European Parliament OBSERVATIONS


and the Council in accordance with Article 185(2) of Council
Regulation (EC, Euratom) No 1605/2002 (2); it was drawn up fol-
lowing an examination of the Agency’s accounts, as required by
Article 248 of the Treaty establishing the European Community.

7. As regards the implementation of the budget for adminis-


4. The Agency’s accounts for the financial year ended
trative expenditure (Title II), the utilisation rate for commitment
31 December 2006 (3) were drawn up by its Executive Director,
appropriations was less than 60 %. More than 40 % of the com-
pursuant to Article 68 of Regulation (EC) No 726/2004, and sent
mitments, in particular in the area of Information Technology,
to the Court, which is required to give a Statement of Assurance
were carried over to the financial year 2007. Thus, the budgetary
on their reliability and on the legality and regularity of the under-
principle of annuality was not strictly observed.
lying transactions.

5. The Court conducted its audit in accordance with the IFAC


and INTOSAI International Auditing Standards and Codes of Eth-
ics, insofar as these are applicable in the European Community
context. The audit was planned and performed to obtain reason- 8. Article 12(4) of the Fee Regulation (4) states ‘Any review of
able assurance that the accounts are reliable and that the under- the fees shall be based on an evaluation of the Agency’s costs and
lying transactions are legal and regular. on the basis of the related costs of the services provided for by the
Member States. Those costs shall be calculated in accordance with
generally accepted international costing methods, which shall
(1) OJ L 214, 24.8.1993, p. 18 and OJ L 136, 30.4.2004, p. 1. Pursuant be adopted in accordance with Article 11(2).’ Up to now,
to the latter Regulation the Agency’s original name, the European
Agency for the Evaluation of Medicinal Products, was changed to the
European Medicines Agency.
(2) OJ L 248, 16.9.2002, p. 1.
(3) These accounts were drawn up on 21 June 2007 and received by the (4) As amended by Council Regulation (EC) No 1905/2005 amending
Court on 17 July 2007. Council Regulation (EC) No 297/95 (OJ L 304, 23.11.2005, p. 1).
C 309/36 EN Official Journal of the European Union 19.12.2007

the Agency’s customers are billed an amount which is divided the Fee Regulation. The Agency has not been in a position to
into two parts: one part covers the Agency’s costs and the other make a comprehensive analysis of the costs incurred by Member
is repaid to the Member States’ rapporteurs to cover their own. As States’ rapporteurs in order to obtain an objective and docu-
the Member States’ rapporteurs did never provide full evidence or mented basis on which to adapt its payments to them and, con-
documentation of their real costs, this situation was in breach of sequently, the fees charged to its customers.

This report was adopted by the Court of Auditors in Luxembourg at its meeting of
27 September 2007.

For the Court of Auditors


Hubert WEBER
President
19.12.2007
Table 1
European Medicines Agency (London)

Areas of Community Resources made available


Competences of the Agency as defined in Regulation (EC) Products and Services in 2006
competence deriving from Governance to the Agency in 2006
No 726/2004 and Regulation (EC) No 141/2000 (2005)

EN
the Treaty (2005)

A high level of human health Objectives Tasks 1. The Committee for Medicinal Products Final budget for 2006: Medicinal Products for
protection shall be ensured in for Human Use, consisting of one member and Human Use
— To coordinate the scien- — To coordinate the scien- 138,7 (111,8) million euro
the definition and implemen- one alternate from each Member State, advises on
tific resources that the tific evaluation of — Applications for market-
tation of all Community poli- any question relating to the evaluation of medici- Community contribution
Member States’ authori- medicinal products ing authorisations: 79 (43)
cies and activities. nal products for human use. (excluding subsidy for orphan
ties make available to the which are subject to
medicines): 21,63 % (22,7 %) — Favourable opinions: 51
Community action, which Agency for the authori- Community marketing 2. The Committee for Medicinal Products
(24)
shall complement national sation and supervision of authorisation proce- for Veterinary Use, consisting of one member Staff numbers at 31 Decem-
policies, shall be directed medicinal products for dures; and one alternate from each Member State, advises ber 2006: — Average evaluation time:
towards improving public human and veterinary on any question relating to the evaluation of vet- 171 days (203 days)

Official Journal of the European Union


— To coordinate the super- 424 (379) posts provided for
health, preventing human ill- use; erinary medicinal products.
vision of medicinal prod- in the establishment plan — Opinions after authorisa-
ness and diseases and obviat-
— To provide the Member ucts which have been 3. The Committee for Orphan Medicinal tion: 1 380 (1 148)
ing sources of danger to Posts occupied: 395 (337,5)
States and the institu- authorised within the Products, consisting of one member and one
human health. (…) — Pharmacovigilance:
tions of the European Community (pharma- alternate from each Member State, advises on any + 77 (34) other staff (auxiliary
(Article 152 of the Treaty) Union with scientific covigilance); question relating to the evaluation of orphan 94 081 reports (91 565
staff, contract staff, seconded
advice on medicinal medicinal products. reports)
— To advise on the maxi- national experts,
products for human or employment-agency staff) — Periodic safety update
veterinary use. mum limits for residues 4. The Committee on Herbal Medicinal
of veterinary medicinal Products, consisting of one member and one reports: 273 (279)
Total staff: 472 (371,5)
products which may be alternate from each Member State, advises on any — Scientific opinions: 193
accepted in foodstuffs of question relating to the evaluation of herbal Assigned to the following
(135)
animal origin; medicinal products. duties:
— Procedures for mutual rec-
— To coordinate verifica- 5. The Management Board consists of one — Operational: 406 (302,5) ognition: 9 241 (8 451)
tion of compliance with member and one alternate from each Member — Administrative: 66 (69)
the principles of good State, two representatives of the Commission, two Medicinal Products for Vet-
manufacturing practice, representatives appointed by the European Parlia- erinary Use
good laboratory practice ment, two representatives from patients’ organi- — New applications: 5 (11)
and good clinical prac- sations, one representative from doctors’
tice; organisations and one representative from veteri- — Applications in respect of
narians’ organisations. The Board adopts the work variants: 56 (40)
— To record the status of
programme and the annual report. — Inspections: 128 (114)
marketing authorisations
granted for medicinal 6. The Executive Director is appointed by the Orphan Medicinal Products
products. Management Board on a proposal from the Com-
mission. — Applications: 104 (118)
7. External audit: European Court of Auditors — Favourable opinions: 81
(88)
8. Discharge authority: Parliament on a rec-
ommendation from the Council.

C 309/37
Source: Information supplied by the Agency.
Table 2

C 309/38
European Medicines Agency (London) — Implementation of the budget for the financial year 2006
(1 000 euro)

Revenue Expenditure
Appropriations carried over from
Revenue entered Final budget appropriations
previous year(s)
Source of revenue in the final budget Revenue collected Allocation of expenditure

EN
for the financial year carried
entered committed paid cancelled entered paid cancelled
over

Own revenue 92 580 94 556 Title I


Community subsidies 30 650 32 551 Staff 44 921 43 709 42 941 768 1 212 700 563 136
Title II
Other subsidies 8 160 7 374 Administration 34 454 34 007 18 946 15 061 447 10 041 8 535 1 505
Title III
Other revenue 7 286 6 820 Operating activities 59 301 58 431 44 846 13 585 870 8 092 7 603 490

Official Journal of the European Union


Total 138 676 141 301 Total 138 676 136 147 106 733 29 414 2 529 18 833 16 701 2 131
NB: Any discrepancies in totals are due to the effects of rounding.
Source: Data supplied by the Agency. This table summarises the data provided by the Agency in its annual accounts. Revenue collected and payments are estimated on a cash basis.

Table 3 Table 4
European Medicines Agency (London) — Economic outturn account for the financial European Medicines Agency (London) — Balance sheet at 31 December 2006
years 2006 and 2005 and 2005
(1 000 euro) (1 000 euro)
2006 2005 ( )
1 2006 2005 (1)
Operating revenue Non-current assets
Fees and other revenue 119 039 72 979 Intangible fixed assets 14 889 10 492
Tangible fixed assets 6 695 6 945
Community subsidies 31 503 28 957
Current assets
Total (a) 150 542 101 936
Short-term receivables 26 045 14 490
Operating expenses Cash and cash equivalents 37 508 29 934
Staff expenses 45 150 40 057 Total assets 85 138 61 861
Other administrative expenses 26 607 22 459 Current liabilities
Operational expenses 63 437 37 849 Provisions for risks and charges 2 699 1 214
Total (b) 135 194 100 365 Accounts payable 38 550 33 539
Total liabilities 41 249 34 753
Surplus/(deficit) from operating activities (c = a – b) 15 348 1 571
Net assets
Financial operations revenue (e) 1 433 2 257 Accumulated surplus/deficit 27 108 23 280
Surplus/(deficit) from non-operating activities (f = e) 1 433 2 257 Economic result for the year 16 781 3 828
Economic result for the year (g = c + f) 16 781 3 828 Total net assets 43 889 27 108
(1) For the 2005 published accounts, the accrual accounting had not been fully implemented. Total liabilities and net assets 85 138 61 861

19.12.2007
(1) For the 2005 published accounts, the accrual accounting had not been fully implemented.

Source: Data supplied by the Agency . This table summarises the data provided by the Agency in its annual accounts: these accounts are drawn up on an accrual basis.
19.12.2007 EN Official Journal of the European Union C 309/39

THE AGENCY’S REPLIES

7. The total automatic carry over to 2007 on Title 2 8. The Agency has together with the national competent
amounted to 15 million euro, of which 8 million euro was for authorities made long efforts to assess the costs incurred by the
Information Technology (Chapter 21). The Agency is in the pro- Member States’ rapporteurs. At its December 2006 meeting the
cess to develop and implement a multi-annual programme of EU Management Board of the agency ‘took the decision in principle
Telematics for the regulation of medicinal products. The gover- to revise the scale of fees system’ and decided to establish a cost-
nance process and the nature of the projects makes it dificult to ing group in order to ‘… to prepare and agree on generally
strictly observe the annuality principle, especially as many gover- accepted international costing methods referred to in Article 12
nance steps are outside the control of the EMEA. Every effort is of the fee Regulation … Representatives from all national com-
made to bring down the level of automatic carry overs in the petent authorities will be invited to participate in this work.’
future.