The European Parliament adopted by 340 votes to 268,
with 14 abstentions, a decision to postpone the granting of the
discharge to the Executive Director of the European Medicines
Agency in respect of the implementation of the Agency's budget for
the financial year 2010. The Parliament also postponed the closure
of the accounts for this agency.
Parliament also adopted by 467 votes to 139, with 23
abstentions, a resolution containing observations that are an
integral part of the decision to postpone the discharge.
These observations may be summarised as
follows:
- Budget and financial management: Parliament acknowledges 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. It notes 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. It also notes weaknesses in
the Agency's system for validating creditor claims in respect of IT
contractors and invites the Court of Auditors to verify this issue
and inform Parliament in this respect;
- Carryover appropriations and
cancellations: Parliament notes that
automatic carryovers to the 2011 financial year totalled EUR 41.6
million or 20.90 % of the appropriation committed, and that one
non-automatic carryover to the 2011 financial year was requested
totalling EUR 3.5 million or 1.68 % of the final appropriation. It
considers that the Agency is not complying with the budgetary
principle of annuality. It notes 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. It urges 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: Parliament urges the Agency to introduce a system of
remuneration for services provided by national Member State
authorities based on the Member States’ real costs. It notes
in this regard that a new payment system was already presented to
the Management Board at its 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. Parliament is therefore
not ready to accept this questionable attitude from the Management
Board and calls on the Agency to adopt an Action Plan on this
matter and to inform the discharge authority by 30 June
2012;
- Human resources management: Parliament calls 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. It also calls on the Agency to use
employment-agency staff to cover short-term needs only and to grant
transparent access for contract staff positions;
- Management of conflict of interest: Parliament calls 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. Noting the measures taken in 2012, Parliament
invites the Agency to inform the discharge authority of the
concrete measures that it has taken to ensure that it can evaluate
the procedures in place to manage any eventual conflicts of
interest. It notes with concern that in the financial circuits
there are also potential conflicts of interests in processing
payments due to insufficient segregation of duties and urges
the Agency therefore to duly take into account this very
significant risk and take immediate action to address this
deficiency.
- Former director: Parliament considers the opportunity given to the
Agency’s former Executive Director to engage in new activities
that are in conflict with his previous position (he was recruited
almost immediately after his departure from the Agency, by a
consultancy firm working for pharmaceutical companies) to be a
breach of Union rules relating to conflicts of interest in
regard to members of scientific committees and experts, as well as
a breach of trust procedure for Committee members and experts. It
believes that the Agency should verify, during 2012, all
declarations of interest of experts and Scientific Committee
members and calls on it to provide the discharge authority with
detailed information on the verification results and with an Action
Plan with a calendar concerning the rest of the verification
process for declarations of interest by the end of August 2012.
Overall, Parliament has concerns over the actual independence of
the Agency. It calls for greater transparency in this regard
and welcomes the fact that the Agency has decided to publish on its
website the declarations of interest of experts involved in the
evaluation of medicinal products even if the Agency's approach
vis-à-vis the scrutiny of declarations of interest is
primarily based on trust rather than on verification. It also calls
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.
Parliament notes that the Agency has been audited by
the Court of Auditors in the framework of the Special Report on
conflicts of interest management in the Union agencies. The Report
will be published by the end of June 2012. It is 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.