18 Amendments of Gerben-Jan GERBRANDY related to 2011/2220(DEC)
Amendment 2 #
Proposal for a decision 1
Paragraph 1
Paragraph 1
1. ...Grants the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency's budget for the financial year 2010;
Amendment 14 #
Motion for a resolution
Paragraph 1 – introductory part
Paragraph 1 – introductory part
1. Expects the Agency to inform the discharge authority of the results of the action takenNotes the actions taken by the Agency with regard to the following issues:
Amendment 27 #
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25 a. Urges the Court of Auditors to finalise and present its current audit on conflict of interest in the Agency in order to provide Parliament with an objective assessment;
Amendment 32 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Establishes from the Agency's Report on budgetary and financial management that in 2010, appropriations totalling EUR 9 074 296,49 were cancelled compared with EUR 7 693 276,58 in 2009; notes the Agency's reply that the level of cancelled expenditure appropriations is a result of stringent monitoring of actual revenue and adjustments to expenditure; urgnotes the Agency to take immediate's actions to reduce thimprove fee lrevel of cancelled appropriations and to adopt an Action Plan with concrete measures - including aimed at a stricter estimation of the fee income and the period to be received - and deadlines to address this persistent problem by 30 June 2012nue forecasting and thereby reduce the level of cancelled appropriations;
Amendment 37 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Notes from the Agency's Report on budgetary and financial management that, in line with the Financial Regulation, during 2010, 13 transfers of a total amount of EUR 13 714 500 (15,29 % of the final appropriations) were approved; further notes that the Agency already adopted 10 transfers of a total amount of EUR 9 609 000 in 2009; calls on the Agency to adopt an Action Plan with concrete measures and deadlines to remedy this persistent problem;
Amendment 48 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Emphasises that the Agency needs to finalise the signing of MoUs on the independence of scientific evaluation, to amend internal procedures correspondingly, and to update the experts' database; takes note of the Agency's reply that MoUs on the independence of scientific evaluation have been signed as of October 2011Takes note that MoUs on the independence of scientific evaluation have been signed as of October 2011, that internal procedures have been amended accordingly, and that the experts' database was updated to allow for the direct uploading of the electronic declarations of interest into the database; calls on the Agency to inform the discharge authority of the status of implementation of these measures by 30 June 2012; also invites the IAS to inform the discharge authority when these very important recommendations are effectively implemented by the Agency;
Amendment 51 #
Motion for a resolution
Paragraph 25
Paragraph 25
25. Takes note from the Agency of the adoption on 1 February 2012 of the ‘Decision on rules relating to Articles 11a and 13 of the Staff Regulations concerning the handling of declared interests of employees of the European Medicines Agency’ by the Management Board and of the ‘Decision on rules concerning the handling of declared interests of national experts on secondment, visiting experts, trainees and interims of the European Medicines Agency’ by the Executive Director; calls on the Agency to inform the discharge authority of the concrete measures undertaken to implement these decisions by 30 June 2012 in order to enable Parliament, while awaiting the European Court of Auditors Special Report on management of conflict in selected EU agencies, in order to enable Parliament during the relevant discharge year to assess the procedures in place for handling potential conflicts of interest for all categories listed in the two decisions, plus the members of the Management Board;
Amendment 54 #
Motion for a resolution
Paragraph 26
Paragraph 26
26. Notes with concern thatmeasures taken in the financial circuits there are alsoo avoid potential conflicts of interests in processing payments due to insufficient segregation of duties; urges the Agency therefore to duly take into account this very significant risk and take immediate action to address this deficiency;
Amendment 57 #
Motion for a resolution
Paragraph 27
Paragraph 27
27. Notes that the former Executive Director of the Agency wrote to the Agency on 28 December 2010 outlining the activities which he was intending to take up at the end of his term of office; considers the first decision of 11 January 2011, taken by the Chairman of the Agency Management Board, to authorise the new activities of the former Executive Director of the Agency to be a breach of Union rules relating to conflicts of interest, in particular with regard to Title II, Article 16, of the Staff Regulations of the Officials of the European Communities; recalls that according to Title II, Article 11, and title IV, Article 91, of the Conditions of Employment of Other Servants of the European Communities, this provision applies by analogy to temporary agents and to contract employees; considers the fact that the Management Board adopted limitations on the future activities of the former Executive Director on 17 March 2011 - only after strong public protest - to be clear proof that the Agency did initially not apply the Staff Regulations properly, which in turn raises serious questions about their application of the rules in general; askWelcomes the Executive Director to present a detailed's report on the implementation of Article 16 of the Staff Regulations within the Agency;
Amendment 60 #
Motion for a resolution
Paragraph 28
Paragraph 28
28. Is seriously concerned by the failure ofUrges the Agency and its Management Board to effectively address the matter of conflict of interests; takes note that in April 2012 the Agency adopted a revised policy on the handling of conflicts of interests of Scientific Committee members and experts, as well as a breach of trust procedure for Committee members and experts; insists that implementation and concrete results are the only elements to prove the efficiency of the new policy and procedure; believes that the Agency should verify, during 2012, all declarations of interest of experts and Scientific Committee members; therefore, calls on the Agency to provide data - figures and names included - following the enforcement of this procedure; calls also on the Agency to have verified at least 75 % of the experts' declarations of interest and at least 75 % of the Scientific Committee members' declarations of interest and to provide the discharge authority with 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;
Amendment 65 #
Motion for a resolution
Paragraph 32
Paragraph 32
32. Welcomes the Agency's initiative to publish the declarations of interests of its staff occupying management positions and of the experts involved in the evaluation of medicinal products on its website; notes with interest that the list of experts also indicates their risk level in terms of conflict of interest; believes that at least the previous working places – professional background – should also be published along with the declarations of interest to allow verification of the declarations of interest and identify possible conflicts; therefore invites the Agency to provide Parliament with informationnotes the information provided on the status of implementation of these measures by 30 June 2012;
Amendment 69 #
Motion for a resolution
Paragraph 34
Paragraph 34
34. Is nevertheless concerned by the Agency's approach vis-à-vis the scrutiny of declarations of interest, which is primarily based on trust rather than on verification; is notably concerned by the fact that the comparison of the experts' declaration of interest published by the relevant national agencies and by the Agency reveals significant discrepancies in some cases; therefore 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 authorityNotes the new system of ex-post controls endorsed in March 2012 and the breach onf this matter by 30 June 2012rust procedure;
Amendment 74 #
Motion for a resolution
Paragraph 35
Paragraph 35
35. UrgNotes that the Agency towill now apply its conflict of interest policy to its Management Board;
Amendment 75 #
Motion for a resolution
Paragraph 36
Paragraph 36
Amendment 86 #
Motion for a resolution
Paragraph 42
Paragraph 42
42. Acknowledges from the Agency that 9 out of 11 ‘very important’ recommendations from the IAS still need to be implemented; notes that one of them has been reported as implemented by the Agency and is now underare addressed and ready for review by the IAS review;
Amendment 88 #
Motion for a resolution
Paragraph 43 – introductory part
Paragraph 43 – introductory part
43. Is concerninformed that seven of these ‘very important’ recommendations have been delayed by up to more than 12 monthsaddressed; notes that these recommendations concern:
Amendment 89 #
Motion for a resolution
Paragraph 43 – subparagraph 1
Paragraph 43 – subparagraph 1
Amendment 91 #
Motion for a resolution
Paragraph 44 – subparagraph 1
Paragraph 44 – subparagraph 1