Activities of Bart STAES 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 (44)
Amendment 2 #
Proposal for a decision on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2009
Paragraph 1
Paragraph 1
1. .....Postpones 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 2009;
Amendment 4 #
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
- having regard to the Internal Audit Service's Annual Internal Audit Report on the European Medicines Agency for 2009;
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 1 – point ii
Paragraph 1 – point ii
ii. the lack of respect to, and frequent lack of, implementing procedures regarding the identification and management of conflicts of interest for its staff and experts,
Amendment 9 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Notes, however, that the Agency should continue to inform on a three-monthly basis the discharge authority on the results of the actions requested by the discharge authority;
Amendment 9 #
Motion for a resolution
Paragraph 2 – point ii
Paragraph 2 – point ii
ii. potential risks to the independence of experts/staff involved in the evaluation of medicinal products, which could have not only detrimental consequences to the Agency's reputation should the evaluation of products be formally questioned, but also might have negative effects on public health;
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 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 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 15 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Agency for better coordination between its financial and scientific services in order to remedy the unacceptable, long delay for recovery orders; notes, in fact, that the Court of Auditors reported that two recovery orders (EUR 226 200 and EUR 110 200), out of ten tested, had a very long delay (21 and 5 months respectively), in breach of the Agency's internal rules;
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. 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 incurred; requests the Agency to communicate its revised treasury policy to Parliament's competent committee without delay;
Amendment 18 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Takes note of the Agency's intention to apply the IAS' recommendation from its 2010 follow-up audit by adopting a risk- based approach and focusing checks on staff who declare interests; calls on the Agency to inform the discharge authority on the timing and plan to apply this IAS' recommendation before the end of 2011;
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
Paragraph 12
Paragraph 12
12. Acknowledges, nevertheless, the Agency's reply in which it is stated that there is no onus on it to request or monitor the annual declaration of financial interests of experts responsible for evaluating medicinal products, as this lies with the Member States' competent authorities (Article 126b of Directive 2001/83/EC19 as amended by EC Directive 2004/27/EC20 ); calls therefore on the Commission to remind the respective authorities in the Member States of their obligations in this matter;
Amendment 19 #
Motion for a resolution
Subheading after paragraph 11
Subheading after paragraph 11
Amendment 20 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Stresses that it is not only the Agency's reputation that could be affected in cases where evaluations can be challenged on the grounds of possible conflicts of interest but also that such conflicts of interest do not guarantee the optimal protection of European citizens' health;
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 21 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls onFinds it unacceptable that the Agency does noto apply the relevant rules effectively, and to assess the independence of experts before those experts participate in any evaluation of human medicinesresulting in the fact that there is absolutely no guarantee that the evaluation of human medicines is performed by independent experts; points out that twelve "very important" and one "critical" recommendation from several earlier IAS' Annual Audit Reports on the Agency, most of them concerning the independence of experts, were still not implemented in 2009, while the oldest recommendation dates back to 2005;
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 14 a (new)
Paragraph 14 a (new)
14 a. Insists, but also warns the Agency, that all the actions mentioned in the respective audit reports, including the one for the year 2010, should be fully implemented before the start of the next discharge procedure;
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 13
Paragraph 13
13. Urges the Agency to comply 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, the Agency to assess, 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 which must be made available on its website;
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 28 #
Motion for a resolution
Subheading after paragraph 14 b (new)
Subheading after paragraph 14 b (new)
The Mediator case
Amendment 29 #
Motion for a resolution
Paragraph 14 c (new)
Paragraph 14 c (new)
14c. Is of the opinion that the Agency's main task is to improve and to contribute to the best possible healthcare as far it concerns the marketing and use of pharmaceutical products in the Union, that it is the Agency's duty to take all measures and precautions to prevent the marketing of potentially dangerous products in the Union, but considers, based on information from different sources including a report from the Inspection générale des affaires sociales (IGAS) in France, that the Agency in the case of the antiobesity product Mediator did not act according to its core business, namely to protect citizens against harmful and dangerous medical products;
Amendment 30 #
Motion for a resolution
Paragraph 14 d (new)
Paragraph 14 d (new)
14d. Points out that any final decision on whether or not to grant discharge cannot be taken before Parliament has been fully informed on the circumstances which led to the very late withdrawal from the market of Mediator (benfluorex), a so- called slimming pill; expects a full and extensive report from the Agency explaining why it took 10 years after the first warning of the possible dangerous side effects of this drug were communicated to the Agency, before this final decision was taken to withdraw the drug in 2009;
Amendment 31 #
Motion for a resolution
Paragraph 14 e (new)
Paragraph 14 e (new)
14e. Asks to be informed if and how the experts and staff dealing with the "Mediator case" were screened on their independence and how their interests declared were verified;
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 40 #
Motion for a resolution
Subheading after paragraph 21
Subheading after paragraph 21
Actions to be taken by the Agency by 30 June 2011
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 43 #
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 44 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Expects the Governing Board swiftly to adopt an action plan to remedy the shortcomings in the procurement procedures; asks, in particular, the Agency's Director, in cooperation with the IAS and the parent directorate-general (DG), to draft this action plan which shall include specific measures and a timetable for implementation; expects the Agency to communicate these specific measures 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;