30.12.2004   

EN

Official Journal of the European Union

C 324/30

1

2-5

6-14

1.

The European Agency for the Evaluation of Medicinal Products (hereinafter referred to as the Agency) was created by Council Regulation (EEC) No 2309/93 of 22 July 1993 (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. Table 1 summarises the powers and responsibilities of the Agency on the basis of the information supplied by it.

2.

This opinion is addressed to the European Parliament and the Council, pursuant to Article 185(2) of Council Regulation (EC, Euratom) No 1605/2002 (2).

3.

The Court has examined the annual accounts of the Agency for the financial year ended 31 December 2003. In accordance with Article 57a(1) of Council Regulation (EEC) No 2309/93, the budget was implemented on the responsibility of the Executive Director. This responsibility includes the drawing-up and presentation of the accounts (3) in accordance with the internal financial provisions adopted on the basis of Article 57a(11) of the same regulation. The Court is required under Article 248 of the Treaty establishing the European Community to examine these accounts.

4.

The Court carried out its audit in accordance with its auditing policies and standards, which have been adapted from generally accepted international auditing standards to reflect the specific nature of the Community context. It examined the accounting documents and applied the procedures it considered necessary in this context.

5.

The Court has thus obtained reasonable assurance that the annual accounts for the financial year ended 31 December 2003 are reliable. The Court would nevertheless draw attention to the situation described in paragraph 10. Except for the situations described in paragraphs 7 and 12, the Court has obtained reasonable assurance that the underlying transactions, taken as a whole, are legal and regular.

6.

The implementation of the appropriations for the financial year 2003 and of the appropriations carried over from the previous year is set out, in Table 2. Tables 3 and 4 set out in summary form, the revenue and expenditure account and the balance sheet published by the Agency for the financial year 2003.

7.

On 5 June 2003, the Management Board of the Agency, subject to approval by the Commission, adopted a new financial regulation and corresponding implementing rules, which came into effect as of the second half of the financial year 2003 (4). In its opinion No 6/2003 of 17 July 2003, the Court had drawn attention to differences between the Agency's own financial regulation and the framework Financial Regulation applicable to the agencies in general. In paragraph 7 of its opinion, the Court emphasised in particular that the Agency's implementing rules on the award of contracts must be in line with the provisions of the general Financial Regulation and the general implementing rules. For example, whereas the general rules provide for a committee for the evaluation of tenders to be set up for any contract involving an amount exceeding 13 800 euro, the Agency sets this threshold at 75 000 euro (Table 5 sets out the differences noted).

8.

The Agency's accounts for 2003 were drawn up on the basis of the accounting principles laid down by its new financial regulation (5). The accounting data relating to the financial year 2002 have not been processed again in accordance with the accounting rules used when the accounts for the financial year ended on 31 December 2003 were drawn up.

9.

Article 43(1)(e) of the Agency's financial regulation provides that the accounting officer shall validate the systems laid down by the authorising officer to supply or justify accounting information. This validation has not taken place.

10.

In 2003 the Agency carried out a physical inventory of fixed assets that was based on the nature of the assets, even though the fixed asset accounts are kept according to the year that the assets are acquired. This situation makes it difficult to reconcile the physical data and the accounting data. Furthermore, some assets appear in neither the inventory nor the fixed asset accounts. Their total value after depreciation was assessed at 4 188 000 euro (6) and was included in the balance sheet under the item ‘Fixed assets’. The Agency should set up a system for managing the fixed assets that ensures that the inventory data are both exhaustive and consistent with the accounting data.

11.

In the application of internal control measures, continuity is not ensured. For example, certain case-files do not contain all the supporting documents required to create a commitment or a payment order.

12.

In certain negotiated procedures the choice of supplier is based on the criterion of ‘former experience with the contractor’, which is not provided for in the implementing rules (7) for the financial regulation.

13.

An examination of the recruitment files has brought to light a significant number of shortcomings in the formalisation and the documentation: reasons are not given to support the choice of candidates invited for interview or check-lists, which are drawn up for the purpose of verifying the admissibility of the candidates, do not include all the selection criteria set out in the vacancy notices.

14.

The Agency's ‘quality assurance’ unit serves as the internal auditor. Two of its audits, carried out in 2002 on the organisation of an electronic documentation system, brought to light a significant increase in costs and time taken caused by insufficient monitoring of the project. A subsequent audit carried out by an external consultant in 2003 confirmed the weaknesses found by the internal auditor. The project undertaken at the end of 2000 ought to have started production at the beginning of 2002 at an estimated cost of 1,2 million euro. The system was still not operational in 2003 and the costs already incurred amounted to 1,7 million euro.