The European Parliament adopted a decision concerning
the discharge to be granted to the Executive Director of the
European Medicines Agency (EMA) in respect of the implementation of
the Agency’s budget for the financial year 2010. The
decision to grant the discharge shall also constitute the closure
of the accounts for this Agency.
To recap, in May 2012, Parliament postponed the discharge
decision for the Agency chiefly because there was a problem of
conflict of interest of some staff (as reported in the summary
dated 10/05/2012).
Parliament approved the closure of the Agency accounts
for the 2010 financial year and made a series of recommendations to
take into account on the granting of the discharge:
- transparency and management of conflict of
interest: Parliament notes that the
Agency is organising for November 2012 a workshop gathering a broad
range of interested parties in the view of developing the
modalities of providing public access to clinical trial data with a
view to strengthening transparency. It also notes that the Agency
has improved the scope and methodology of the systematic ex-ante
and ex-post controls related to the screening of declaration of
interest and that it will perform a yearly evaluation of its
revised policy on declaration of interest. It invites the Agency to
keep the discharge authority informed on the implementation of its
revised policy on a 6-month basis;
- a “revolving door” case: Parliament underlines that, in June 2012, a
“revolving door” case occurred in the Agency, the former
Head of Legal Service joined as senior counsel a US-based law firm
having a number of pharmaceutical industry companies as clients. It
takes note that the Executive Director of the Agency launched a
review of the work performed by the former Head of Legal Service
and expects the Agency to inform the discharge authority on the
outcomes of this review by the end of 2012;
- screening process of declarations of
interest: Parliament welcomes the
fact that the Agency proceeded to a screening process of the
declarations of interest of its experts and committee members who
have been actively involved in the Agency’s activities between
1 January and 31 May 2012 against their curriculum vitae. It also
welcomes the Agency’s initiative to publish on its website the
declarations of interests of its staff occupying management
positions as well as other initiatives going in the direction of
improved transparency. However, it agrees with the Agency that a
high level of reliability and honesty concerning the declaration of
interests can only be achieved if pharmaceutical companies
themselves make public the list of experts and research centres
with which they work, and the sums concerned in their financial
links with them;
- for steps to be taken in cases of
non-compliance: Parliament considers
that steps have to be taken should cases of non-compliance with
existing rules occur with a view to remedying the shortcomings.
Either the European Parliament or the European legislator has to
address these problems by changing the existing rules and
regulations to eliminate possible loopholes. In the meantime, it
calls on the Agency to introduce in each of its annual activity
report a special section describing the actions taken to prevent
and manage conflict of interest;
- report on follow-up to the discharge: Parliament calls on the Agency to introduce in its
annual activity reports a special section describing the actions
taken to prevent and manage conflict of interest, which should
include, inter alia: i) the number of alleged cases of conflict of
interest verified; ii) the number of revolving door cases; iii) the
measures taken in each category of cases; iv) the number of breach
of trust procedures launched and their outcomes; and v) the
penalties applied.
Overall, Parliament welcomes the agreement on the
Joint Statement and Common Approach adopted in June 2012 by the
European Parliament, the Council and the Commission on
decentralised agencies in which certain elements of importance to
the discharge have been addressed and taken up.