PURPOSE: presentation
of the EU Court of Auditors’ report on the annual accounts of
the European Medicines Agency, 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 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.
The Court also considers that 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.
The report confirms that the Agency’s 2010 budget
amounted to EUR 208.4 million and that the number of
staff employed by the Agency at the end of the year was
698.
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:
The Court’s observations:
- budgetary and financial management: the Agency experienced delays in implementing
‘Administrative expenditure’ of its budget.
Appropriations carried forward to 2011 totalled EUR 17.6 million,
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;
- recruitment: the Agency
did not distinguish sufficiently between employment-agency staff
and contract staff recruitments;
- follow-up on previous findings: in previous reports, the Court had 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.
The Agency’s response:
- the Agency
indicates that it has continuously improved its administrative
carry-over since 2008. The amounts in question for 2010 are for
multiannual Telematics ICT projects. These Telematics projects are
of an operational nature and as a consequence will be accounted for
from 2011. Therefore from 2011/12 the Agency expects a reduction in
carry-over in administrative expenditure to a maximum of around 30
% (corresponding to a reduction of EUR 10 million);
- the Agency notes
that action has been taken to improve transparency by ensuring that
all contract agent positions are more clearly publicised externally
prior to being filled and that the EMA implementing rules on
selection and recruitment of contract agents are correctly
followed;
- a proposal for a
new payment system was presented to the Management Board at their
meeting of 10 December 2009. The Management Board rejected the
proposal. EMA will try again to instigate the discussions at
forthcoming Management Board meetings and remind the Board of the
need to move forward on this topic.
Lastly, the Court of Auditors’ report contains a
summary of the Agency’s activities in 2010. This is focused on
the following:
- applications for marketing authorisations for 91
medicines for human use ;
- pharmacovigilance activities;
- mutual recognition procedures and decentralised
procedures: started 21 433; (ended positively
11100);
- scientific advice finalised;
- applications for paediatric investigation plans: 326
relating to 403 indications;
- applications for marketing authorisations for 18
medicinal products for veterinary use;
- 300 inspections;
- herbal monographs;
- 174 applications for orphan medicinal products (123
favourable opinions);
- requests for SME status: 251 requests and 161
applications for fee reduction or deferrals.