15.12.2011   

EN

Official Journal of the European Union

C 366/27

1.

The European Medicines Agency (hereinafter ‘the Agency’), which is located in London, 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 supervision of medicinal products for human or veterinary use (2).

2.

The Agency’s 2010 budget amounted to 208,4 million euro, compared with 194,4 million euro the previous year. The number of staff employed by the Agency at the end of the year was 698, as compared with 664 in the previous year.

3.

Pursuant to the provisions of Article 287(1), second subparagraph, of the Treaty on the Functioning of the European Union, the Court has audited the annual accounts (3) of the Agency, which comprise the ‘financial statements’ (4) and the ‘reports on the implementation of the budget’ (5) for the financial year ended 31 December 2010, and the legality and regularity of the transactions underlying those accounts.

4.

This Statement of Assurance is addressed to the European Parliament and the Council in accordance with Article 185(2) of Council Regulation (EC, Euratom) No 1605/2002 (6).

5.

As authorising officer, the Director implements the revenue and expenditure of the budget in accordance with the financial rules of the Agency, under his own responsibility and within the limits of the authorised appropriations (7). The Director is responsible for putting in place (8) the organisational structure and the internal management and control systems and procedures relevant for drawing up final accounts (9) that are free from material misstatement, whether due to fraud or error, and for ensuring that the transactions underlying those accounts are legal and regular.

6.

The Court’s responsibility is to provide, on the basis of its audit, a statement of assurance as to the reliability of the annual accounts of the Agency and the legality and regularity of the transactions underlying them.

7.

The Court conducted its audit in accordance with the IFAC and ISSAI (10) International Auditing Standards and Codes of Ethics. Those standards require the Court to comply with ethical requirements and to plan and perform the audit so as to obtain reasonable assurance as to whether the accounts are free of material misstatement and whether the underlying transactions are legal and regular.

8.

The Court’s audit involves performing procedures to obtain audit evidence of the amounts and disclosures in the accounts and of the legality and regularity of the transactions underlying them. The procedures selected, including its assessment of the risks of material misstatement of the accounts or of illegal or irregular transactions, whether due to fraud or error, depend on its audit judgement. In making those risk assessments, internal controls relevant to the entity’s preparation and presentation of accounts are considered in order to design audit procedures that are appropriate in the circumstances. The Court’s audit also includes evaluating the appropriateness of the accounting policies used and the reasonableness of the accounting estimates made by management, as well as evaluating the overall presentation of the accounts.

9.

The Court believes that the audit evidence obtained is sufficient and appropriate to provide a basis for the opinions set out below.

10.

In the Court’s opinion, the Agency’s Annual Accounts (11) fairly present, in all material respects, its financial position as of 31 December 2010 and the results of its operations and its cash flows for the year then ended, in accordance with the provisions of its Financial Regulation.

11.

In the Court’s opinion, the transactions underlying the annual accounts of the Agency for the financial year ended 31 December 2010 are, in all material respects, legal and regular.

12.

The comments which follow do not call the Court’s opinions into question.

13.

The Agency experienced delays in implementing Title II ‘Administrative expenditure’ of its budget. Appropriations carried forward to 2011 on Title II totalled 17,6 million euro, 33,3 % of the corresponding appropriations. Just 36 % of the appropriations carried forward correspond to accrued expenditure of the year, meaning 64 % of the amounts carried over did not relate to the 2010 financial year. This situation was at odds with the budgetary principle of annuality.

14.

Weaknesses were noted in the Agency’s system for validating creditor claims in respect of IT contractors.

15.

The Agency did not distinguish sufficiently between employment-agency staff and contract staff recruitments. It should use employment-agency staff to cover short-term needs only and grant transparent access to contract staff positions.

16.

In previous reports, the Court has noted the need for the Agency to introduce a system of remuneration for services provided by national Member State authorities based on the Member States’ real costs. Up to now, despite some efforts by the Agency, this has not been done. There is room for progress on this issue.