Activities of Monica MACOVEI related to 2010/2173(DEC)
Shadow reports (2)
SECOND REPORT on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2009 PDF (164 KB) DOC (88 KB)
REPORT on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2009 PDF (199 KB) DOC (124 KB)
Amendments (35)
Amendment 1 #
Proposal for a decision on discharge
Citation 11 a (new)
Citation 11 a (new)
- having regard to the final follow-up report on the audits of 2009, 2008 and 2006 of the IAS on the Agency,
Amendment 5 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the Agency’s budget is financed both from the Union budget, which accounted for 18.52% of total revenue in 2009, and, to a greater extent, from fees paid by pharmaceutical companies, and whereas the Union’s general contribution consequently decreased by 9.2% between 2008 and 2009;
Amendment 7 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Acknowledges receipt of a letter of the Chair of the Agency's Management Board of 17 June 2011 in which it is stated that the Agency has taken actions to address the 2009 shortcomings; also takes note of the documents and annexes received byfrom the Agency in response to Parliament's abovementioned resolution of 10 May 2011; regrets, however, that not all the information requested was submitted;
Amendment 7 #
Motion for a resolution
Paragraph 1 – introductory part
Paragraph 1 – introductory part
1. Is seriously concerned with the Agency'’s replies to significant issues raised by the Court of Auditors and the Internal Audit Service, such as:
Amendment 8 #
Motion for a resolution
Paragraph 2
Paragraph 2
Amendment 10 #
Motion for a resolution
Paragraph 3 – introductory part
Paragraph 3 – introductory part
3. Notes, in particular, that the Agency should continue to inform the discharge authority onUnderlines that the discharge authority will continue to carefully monitor during the upcoming discharge procedures the level of implementation of the measures undertaken to address the Agency's serious weaknesses disclosed by the reports from both the Court of Auditors and the IAS; expects, therefore, the Agency to inform the discharge authority on the actions implemented and their results and to submit the documents requested, especially with regard to the following issues:
Amendment 10 #
Motion for a resolution
Paragraph 2 – point iii
Paragraph 2 – point iii
iii. potential deficiencies in staff/experts' recruitment which could not only lead to disqualification of competent candidates and/or recruitment of less qualified candidates but also might have adverse effects on the quality of the Agency’s scientific assessment work and, consequently, on public health;
Amendment 11 #
Motion for a resolution
Paragraph 5 – subparagraph 1 a (new)
Paragraph 5 – subparagraph 1 a (new)
takes note therefore, that the Agency again failed to comply with various requirements of the relevant procurement regulations;
Amendment 12 #
Motion for a resolution
Paragraph 3 – point a
Paragraph 3 – point a
a. the process of the adoption by the Governing Board of anthe action plan to remedy the shortcomings in the procurement procedures to be drafted by the Agency's Executive Director, in cooperation with the IAS and the parent directorate-general (DG) of the Commissionwith specific measures and a timetable for implementation to remedy the shortcomings in the procurement procedures,
Amendment 12 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Agency to set up a multi- annual procurement plan which shall ensure stronger technical and procedural controls and to report to the discharge authority on this matter by 30 June 2011;
Amendment 13 #
Motion for a resolution
Paragraph 3 – point b a (new)
Paragraph 3 – point b a (new)
ba. the submission of the IAS reports;
Amendment 13 #
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Calls on the Agency to ensure that the results of procurement procedures are verified before contracts are awarded; expects that detailed technical specifications shall always be prepared, in view of the Court of Auditors’ findings;
Amendment 14 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Notes the information received relating to the control system which sets out to avoid or detect in time the persistent errors in procurement procedures; accordingly reminds the Agency to continue improving the quality of itsexpects to receive the multi-annual procurement systemplan;
Amendment 16 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Expects the Agency to prudently manage its longstanding policy of entering into a forward foreign exchange contract in order to hedge part of its administrative budget against unfavourable fluctuations in the sterling exchange rate; points out that even though this is a recurrent observation made by the Court of Auditors no concrete action has been taken to date by the Agency; accordingly, calls on the Agency to consider reassessing its treasury policy in the light of the losses and risks incurredexpects the Agency to manage such transactions to avoid exchange losses, such as those in 2009 of EUR 900 000; points out that this is a recurrent observation made by the Court of Auditors;
Amendment 17 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Takes note of the Agency's replies on the compliance with its Code of Conduct by setting out principles and guidance on independence and confidentiality applicable to the Management Board and members of committees, experts and the Agency's staff; accordingly expects the Agency to assess thoroughly, before the allocation of project team leaders to products, whether the interests declared by staff members might influence their impartiality and independence; expects that the Agency's documents on the conflicts of interest will be updated;
Amendment 18 #
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Notes from the Agency that the treasury policy has been revised, adopted and formally approved by the Agency’s Audit Advisory Committee; calls on the Agency to provide Parliament with an overview of the implementation of the revised treasury policy before 30 June 2011;
Amendment 19 #
Motion for a resolution
Subheading after paragraph 11
Subheading after paragraph 11
Amendment 20 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls onUrges the Agency to apply the relevant rules effectively , and to assess the independence of experts before those experts participate in any evaluation of human medicines;
Amendment 22 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Agency to continue to inform the discharge authority on actions taken on issues relating to the effective compliance with its Code of Conduct as regards the management of conflicts of interest;
Amendment 22 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Takes note of the transfer of the Agency’s Director to a consultancy that advises, among others, pharmaceutical companies on developing new medication and reducing the period to their market introduction; stresses that the transfer casts some doubt on the actual independence of the Agency; notes that Article 16 of the Staff Regulations grants wide discretionary power on the Management Board to allow or forbid this type of transfer; asks, therefore, that the Agency provide the discharge authority, by 30 June 2011, with a report that lists all comparable cases that have occurred since the creation of the Agency and explains thoroughly the Management Board's decision in each case;
Amendment 23 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. UrgesConsiders it unacceptable that the Agency is noto complying effectively with its Code of Conduct by setting out principles and guidance on independence and confidentiality applicable to the Management Board and committees'’ members, experts and Agency'’s staff; calls on, also,expects the Agency to assess thoroughly, before the allocation of Project Team Leaders to products, whether the interests declared by staff members might influence their impartiality and independence; urges, in addition, the Agency to document and assess its controls and file the relevant allocation decisions;
Amendment 24 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Takes note of the Agency's reply in which it is stated that it has corrected the deficiencies identified by the IAS for contract agent selection and that revised work instructions and templates have been put in place and the staff have received specific training; accordingly calls on the Agency to keep the discharge authority updated on the level of implementation of these actions; looks forward to receiving the same assurance from the Court of Auditorsthe 2010 report of the Court of Auditors to establish whether the assurance from the Agency is well founded;
Amendment 25 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses that the Agency's reputation could be affected in cases where evaluations can be challenged on the grounds of possible conflict of interests; notes that the Agency is alleged to bear some responsibility for the benfluorex health scandal in France, through the systems it has in place for the provision of scientific advice in respect of human medicines, and that concerns are being raised in some quarters about a possible conflict of interests;
Amendment 26 #
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Urges the Agency to inform the discharge authority of the steps it has taken to ensure the independence of its experts since its inception;
Amendment 27 #
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Wonders why the Court of Auditors’ reports since 2006 on the Agency’s annual accounts make no mention of any deficiencies with regard to the assessment of experts’ independence;
Amendment 32 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls ononsiders it unacceptable for the Agency to ensure thatallow the information included in the product files to support the procedure underpinning the authorisation of its files on human medicines is to be incomplete; urges, in this respect, the Agency to guarantee that key information is easily retrieved and all relevant guidelines on the filing system are in place;
Amendment 33 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls, moreover, on the AgencyAsks the Agency, moreover, to complete and regularly update the European Experts Database as required by the Agency's regulation, and to keep the discharge authority informed; urges also the Agency to allow SIAMED and Product Overview databases for efficient retrieval of information;
Amendment 34 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Agency to strengthen its recruitment process and ensure its documentation is correctly managed; acknowledges, in fact, that the IAS found deficiencies in this respect; stresses, also, that insufficient documentation in recruitment procedures reduces the possibility for the Agency to respond to allegations of unequal treatment of candidates and/or arbitrary decisions on recruitment of staff; considers, furthermore, that to the extent that competition is limited, resulting recruitment may not represent the optimal choice and human and that financial resources may be used inefficiently; asks the Agency to provide the discharge authority with the terms of this agreement since its inception, along with a detailed record of how it has evolved over time;
Amendment 35 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Considers it unacceptable that the Executive Director’s statement of assurance, dated 13 May 2010, does not mention any reservations, and is consequently not consistent with the undertaking given in the Code of Conduct adopted by the Agency in the light of the statements of assurance from the IAS and the Court of Auditors;
Amendment 36 #
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19b. Points out that the Director’s report is required to contain a summary of the reports from the Internal Audit Service (IAS) to the discharge authority, including: i) the number and types of internal audits conducted by the IAS, ii) all the recommendations made (including any that may have been rejected by the Agency), and (iii) all the measures taken on the basis of those recommendations; wonders whether these requirements were fulfilled in previous years, and asks the Agency to forward the IAS’s reports since 2007 to the discharge authority by 30 June 2011;
Amendment 37 #
Motion for a resolution
Paragraph 20
Paragraph 20
20. WelcomNotes the Agency'’s initiative of providing the discharge authority with the IAS' Annual Internal Audit Report on the Agency; considers this a sign of transparency and a best practice to be followed by all other Agencies; at this should be the normal practice of transparency and expects that all other Agencies will follow this practice;
Amendment 38 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Acknowledges that, out of 32 recommendations of the IAS, one is ‘"critical’" on the implementing procedures involving experts and 13twelve are ‘"very important’" mainly on human resources management, on management of staff's conflicts of interest and on other procedures supporting the provision of scientific evaluation for human medicines in the Agency; calls, accordingly, ontherefore, on the Agency to inform the discharge authority about the precise content of these recommendations without delay; urges the Agency to rapidly implement the IAS recommendations and informto provide the discharge authority of withe action taken; call complete overview of measures taken and implemented to properly address these recommendations by 30 June 2011; asks, in addition, on the Court of Auditors to monitor and inform the discharge authority of the efficiency of the measures taken;
Amendment 39 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Acknowledges that, out of 32 recommendations of the IAS, one is "critical" on the implementing procedures involving experts and 13 are "very important" mainly on human resources management, on management of staff's conflicts of interest and on other procedures supporting the provision of scientific evaluation for human medicines in the Agency; calls, accordingly, onurges the Agency to rapidly implement the IAS recommendations and inform the discharge authority of the action taken; calls, in addition, on the Court of Auditors to monitor and inform the discharge authority of the efficiency of the measures taken;
Amendment 42 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls onUrges the Agency's Director, in cooperation with the IAS, to undertake a thorough verification of the effective use of the existing procedures regarding the identification and management of conflicts of interests for its staff and experts and to communicate the results to the discharge authority by 30 June 2011;
Amendment 45 #
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Calls on the Agency, therefore, to inform the discharge authority by 30 June 2011 of the measures taken and the improvements made in respect of all these areas of concern;