PURPOSE: presentation of the EU Court of
Auditors’ report on the annual accounts of the European
Medicines Agency for the financial year 2011, together with the
Agency’s reply.
CONTENT: in accordance with the tasks conferred on the
Court of Auditors by the Treaty on the Functioning of the European
Union, the Court presents to the European Parliament and to the
Council, in the context of the discharge procedure, a Statement of
Assurance as to the reliability of the annual accounts of each
institution, body or agency of the EU, and the legality and
regularity of the transactions underlying them, on the basis of an
independent external audit.
This audit concerned, amongst others, the annual
accounts of the European Medicines Agency (EMA).
In the Court’s opinion, the Agency’s
Annual Accounts fairly present, in all material respects, its
financial position as of 31 December 2011 and the results of
its operations and its cash flows for the year then ended, in
accordance with the provisions of its Financial
Regulation.
The Court also considers that the transactions
underlying the annual accounts of the Agency for the financial
year ended 31 December 2011 are, in all material respects, legal
and regular.
The report confirms that the Agency’s 2011 budget
amounted to EUR 208.863 million and that the number of staff
employed by the Agency at the end of the year was 728.
The report also makes a series of observations on the
budgetary and financial management of the Agency, accompanied by
the latter’s response. The main observations may be summarised
as follows:
Court’s comments:
- carry-overs: the Court notes again that the level of
carry- over is excessive and at odds with the principle of
annuality;
- public procurement: the Agency increased in 2011 the
financial envelope of an irregular framework contract for IT
services concluded in 2009 for which the Court had qualified its
opinion on the legality and regularity of the transactions
underlying the Agency’s 2009 accounts. According to the Court,
there is scope for improving the transparency of procurement
procedures as regards the justification of the estimated contract
volumes and the definition, publication and application of
selection criteria;
- recruitment: the Court identified a need to improve
the transparency of staff selection procedures.
Agency’s replies:
- the Agency states that since 2008 it has made every
effort to reduce its level of carry-over to an acceptable level. It
has in fact achieved a continuous reduction. As the operations of
the Agency are of a multi-annual nature and not linked to the
calendar year, a certain level of carry-overs is
unavoidable;
- the Agency considers that the IT framework contract
was not irregular. As a consequence, the extension of the framework
contract is considered not irregular as well;
- the Agency has taken note of the Court’s comments
and updated its procedures with a view to transparency and timely
documentation.
Lastly, the Court of Auditors’ report contains a
summary of the Agency’s activities in 2011. This is
focused on the following:
- applications for marketing authorisations for 100
medicines for human use ;
- pharmacovigilance activities;
- mutual recognition procedures and decentralised
procedures: started 6 401; (6 715 ended
positively);
- scientific advice;
- applications for paediatric investigation plans: 187
relating to 220 indications;
- applications for marketing authorisations for 11
medicinal products for veterinary use;
- 449 inspections;
- herbal medicinal products;
- 166 applications for orphan medicinal products (111
favourable opinions);
- requests for SME status: 433 requests and 350
applications for fee reduction or deferrals.