The Committee on Budgetary Control adopted the report
by Monica Luisa MACOVEI (EPP, RO) on discharge to be granted in
respect of the implementation of the budget of the European
Medicines Agency for the financial year 2010. The committee calls
on the Parliament to postpone its decision on granting the
Executive Director of the European Medicines Agency discharge in
respect of the implementation of the Agency's budget for the
financial year 2010. However, they make a number of
recommendations, in addition to the general recommendations that
appear in the draft resolution on
performance, financial management and control of EU
agencies:
- Budget and financial management: Members acknowledge that the Agency's budget is
financed both from the Union budget and from fees paid by the
pharmaceutical industry when applying for, obtaining or maintaining
Union marketing authorisations. They state that in 2010, 73% of the
revenue of the Agency is estimated to have derived from the fee
revenue and that, in parallel with the increase in the fee-based
revenue, the relative percentage income from the Union contribution
fell from 23 % in 2006 to 14 % in 2010. They also note weaknesses
in the Agency's system for validating creditor claims in respect of
IT contractors and invite the Court of Auditors to verify this
issue and inform Parliament in this respect;
- Carryover appropriations and
cancellations: Members note that
automatic carryovers to the 2011 financial year totalled EUR 41 655
049,44, or 20.90 % of the appropriation committed, and that one
non-automatic carryover to the 2011 financial year was requested
totalling EUR 3 500 000, or 1.68 % of the final appropriation. They
state that the Agency is not complying with the budgetary principle
of annuality. They note with concern the additional comment
from the Court of Auditors that only 36 % of the appropriations
carried forward to 2011 correspond to expenditure accrued from
2010, while the remaining 64 % of amounts carried over did not
relate to the 2010 financial year. Members urge the Agency to take
immediate action to reduce the level of cancelled appropriations
and to adopt an Action Plan with concrete measures;
- System of remuneration for services: Members urge the Agency to introduce a system of
remuneration for services provided by national Member State
authorities based on the Member States’ real costs. They note
in this regards that a new payment system was already presented to
the Management Board at their meeting of 10 December 2009 but it,
in the end, rejected the proposal. By refusing a new payment
system, the Management Board accepts and takes direct
responsibility for very important risks, such as non-compliance
with legislative requirements, the potential financial impact of
the current remuneration system, and reputation. Members are
therefore not ready to accept this questionable attitude from the
Management Board and call on the Agency to adopt an Action Plan on
this matter and to inform the discharge authority by 30 June
2012;
- Human resources management: Members call on the Agency to improve the
documentation of the recruitment files for contract agents and on
the Appointing Authority to adopt the reserve lists proposed by the
selection committees. They also call on the Agency to use
employment-agency staff to cover short-term needs only and grant
transparent access for contract staff positions;
- Management of conflict of interest: Members call on the Agency to report on its
involvement in the organisation of conferences by private
organisations such as the Organisation for Professionals in
Regulatory Affairs. They note with concern that in the financial
circuits there are also potential conflicts of interests in
processing payments due to insufficient segregation of duties and
urge the Agency therefore to duly take into account this very
significant risk and take immediate action to address this
deficiency. Members urge the Court of Auditors to finalise
and present its current audit of conflict of interest in the
Agency. They regret the fact that many of the experts failed to
publish their declarations of interests, and that the comparison of
declarations of interests published by the relevant national
agencies and by the Agency shows significant differences in some
cases. They deplore, furthermore, the fact that at least one member
of the Management Board of the Agency, also substitute member of
the Committee for Medicinal Products for Human Use, failed
to declare his recent management responsibilities in
a pharmaceutical firm. They therefore call on the Agency to
establish a genuine mechanism enabling proper scrutiny of the
declarations of interest received by the Agency and to inform the
discharge authority on this matter by 30 June 2012. They also urge
the Agency to apply its conflict of interest policy to its
Management Board. Lastly, Members are of the opinion that, given
the extent of criticisms questioning conflict of interest issues in
the Agency, the decision on discharge should be postponed until
the publication of the Special Report to take into account the
findings of the Court of Auditors in this respect;
- Internal
audit: Members acknowledge from the Agency that 11 "very
important" recommendations from the IAS still need to be
implemented. Efforts should be made as regards this issue.