[ParlTrack]

Proposal for a decision 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 2010;

2012/03/07
Committee: CONT

Monica MACOVEI

Proposal for a decision 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;

2012/09/12
Committee: CONT

Monica MACOVEI

Proposal for a decision 2
Paragraph 1

1. ~~...~~Approves the closure of the accounts of the European Medicines Agency for the financial year 2010;

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Recital A

A. whereas the Court of Auditors, in its report on the annual accounts of the European Medicines Agency for the financial year 2009, qualified its opinion on the legality and regularity of the underlying transactions,deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Proposal for a decision 2
Paragraph 1

1. ~~...~~Postpones the closure of the accounts of the European Medicines Agency for the financial year 2010;

2012/03/07
Committee: CONT

Monica MACOVEI

Motion for a resolution
Recital A a (new)

A a. whereas on 10 May 2012, the European Parliament postponed its decision on the discharge and closure of the accounts of the Agency for the financial year 2010,

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 2

2. Calls on the Agency and on the IAS to immediately verify whether all the actions mentioned in the audit reports, including the one for 2010, were fully implemented and to inform the discharge authority accordingly;

2012/03/07
Committee: CONT

Monica MACOVEI

Motion for a resolution
Recital A b (new)

A b. whereas the Agency addressed to a large extent the weaknesses highlighted in the report of 10 May 2012 and provided the discharge authority with substantial information by letters of 2 and 6 July 2012 and of 2, 7 and 24 August 2012,

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 3

3. ~~Is concerned that the Management Board of the Agency never sent the Action Plan and insists on receiving it immediately~~Notes from the Agency that on 15 December 2011 the Management Board endorsed the proposal for the Agency to present at the June 2012 Management Board the detailed implementing measures related to: - establishment of the new structure and scope of the Advisory Committee on Procurement and Contract, - implementation of a multiannual procurement plan, - establishment of the responsibility of the above; insists that the Management Board of the Agency sends the Action Plan to the discharge authority at the latest by 30 June 2012;

2012/03/07
Committee: CONT

Monica MACOVEI

Motion for a resolution
Recital B

B. whereas in its Decision of 10 May 2011, Parliament decided to postpone its decision on granting the Executive Director of the Agency discharge in respect of the implementation of its budget for 200916 but then granted it in its Decision of 25 October 201117 ,deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Recital C

C. whereas on 25 October 2011 Parliament granted the Executive Director of the Agency discharge for implementation of the Agency's budget for the financial year 2009, and in its resolution accompanying the discharge decision, inter alia: – emphasises that the discharge authority should 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 Internal Audit Service (IAS), – called on the Agency to inform the discharge authority of the action taken on issues relating to effective compliance with its Code of Conduct as regards the management of conflicts of interest, – insisted, but also warned the Agency, that all the action 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,deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 8

8. Notes weaknesses in the Agency's system for validating creditor claims in respect of IT contractors; ~~calls therefor~~takes note onf the Agency ~~to promptly address the situ~~'s statement that the weaknesses noticed by the Court of Auditors were related to a human error and corrected, that it has strengthened its ex-ante operational and fin~~form the discharge authority on the acti~~ancial control of invoices and that no further weaknesses have been detected; invites the Court of Auditors to verify and inform Parliament ons t~~aken~~his matter;

2012/03/07
Committee: CONT

Monica MACOVEI

Motion for a resolution
Recital D

D. whereas the Court of Auditors has stated that it has obtained reasonable assurances that the annual accounts for the financial year 2010 are reliable and that the underlying transactions are legal and regular,deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Recital E

~~E. whereas the budget of the Agency for 2010 was EUR 208 400 000, which represents an increase of 7,20 % over the financial year 2009;~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Recital F

F. whereas the initial contribution of the Union to the budget of the Agency for 2010 was EUR 28 279 600 compared with EUR 36 390 000 in 200918 , and whereas the overall contribution of the Union to the budget of the Agency for 2010 was EUR 36 600 100,deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 1

1. Expects the Agency to inform the discharge authority of the results of the action taken with regard to the following issues: – the process of adoption by the Management Board of the action plan with specific measures and a timetable for implementation to remedy the shortcomings identified in the procurement procedures; – the thorough verification of the effective use of the existing procedures for the identification and management of conflicts of interest for its staff and experts; calls on the Court of Auditors to give reasonable assurances that the Agency has effectively addressed its shortcomings relating to procurement procedures, and on the IAS to give assurances the discharge authority on the effective use of existing procedures for the management of conflicts of interest for the Agency's staff and experts;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
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 the actual revenue and adjustments to the expenditure; urges the Agency to take immediate action to decrease the level 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 2012;

2012/03/07
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 2

2. Calls on the Agency and on the IAS to immediately verify whether all the action specified in the audit reports, including that for 2010, were fully implemented and to inform the discharge authority accordingly;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 3 – introductory part

3. Notes ~~from the Agency that on 15 December~~that on 7 June 20112 the Management Board endorsed ~~a proposal for the Agency to p~~the new structure and scope of the Advisory Committee on Procuresment a~~t the June 2012 meeting of the Management Board the detailed implementing measures related to the:~~nd Contract; welcomes that the Agency put in place a multiannual procurement plan for 2012- 2014 as requested by the discharge authority in its report on the discharge for the financial year 2009;

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 3 – indent 1

~~– establishment of the new structure and scope of the Advisory Committee on Procurement and Contract,~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 3 – indent 2

~~– implementation of a multiannual procurement plan,~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 17

17. Notes that by refusing a new payment system, the Management Board accepts and takes direct responsibility for very important risks, such as the non- compliance with legislative requirements, the potential financial impact of the current remuneration system, and reputation; is therefore not ready to accept this questionable attitude from the Agency's ~~Governing~~Management Board and calls upon them to ~~take immediate a~~adopt an Action Plan on this and to inform the discharge authority by 30 June 2012;

2012/03/07
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 3 – indent 3

~~– establishment of the responsibilities for the above;~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 21

21. U~~rges also~~nderlines that the Agency needs to finalise the signing of an MoU on independence of scientific evaluation, amend internal procedures correspondingly, and update the experts' database; ~~calls on the Agency and~~takes note of the Agency's reply that MoUs on independence of scientific evaluation have been signed as of October 2011 and that the experts database was updated to allow direct upload of the e- DoI into the database; calls on the Agency to inform the discharge authority on 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;

2012/03/07
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 3 – subparagraph 1

~~insists that the Management Board sends the Action Plan to the discharge authority at the latest by 30 June 2012;~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Subheading 2

~~Budget and financial management~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 4

4. Recalls that the initial Union contribution to the Agency for 2010 amounted to EUR 26 335 100; notes however that EUR 10 265 000 coming from the recovery of surplus, was added to that amount which, as a result, makes a total Union contribution of EUR 36 600 100 for 2010;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 23

23. CTakes 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 provide the discharge authority with the ~~guidelin~~concrete measures aund ~~assessment criteria on~~ertaken to implement these Decisions by 30 June 2012 in order to enable Parliament to assess the concrete handling of potential conflicts of interest ~~of staff member~~for all categories listed in the two Decisions;

2012/03/07
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 5

5. Stresses that the general budget of the European Union for the financial year 2010, as definitively adopted, presents two different figures as the initial contribution of the Union to the budget of the Agency, i.e. EUR 28 279 600 and EUR 26 335 100; urges, therefore, the Commission to inform the discharge authority of the exact subsidy allocated to the Agency;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 6

6. 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; finds from the Annual Activity Report 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;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 7

~~7. Finds from the Annual Activity Report that 17 exceptions were entered in the register of exceptions in 2010;~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 8

8. Notes weaknesses in the Agency's system for validating creditor claims in respect of IT contractors; takes note of the Agency's statement that the weaknesses noted by the Court of Auditors related to a human error and were corrected, that it has strengthened its ex-ante operational and financial control of invoices and that no further weaknesses have been detected; invites the Court of Auditors to verify and inform Parliament in this respect;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 25 a (new)

25 a. Recalls that, following the employment of the Agency's former Executive Director by a consultancy that advises, among others, pharmaceutical companies almost immediately after he left the Agency, the discharge authority raised concerns on the actual independence of the Agency and the way its Management Board implemented Article 16 of the Staff Regulations; is furthermore concerned by the allegations that the Agency's former Executive Director created his own consultancy firm while still in office; calls on the Agency to provide the discharge authority with further information on this matter by 30 June 2012;

2012/03/07
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 9

9. Acknowledges from the Agency's Report on budgetary and financial management that automatic carryovers to the 2011 financial year totalled EUR 41 655 049,44, or 20,90 % of the appropriation committed, and that one non-automatic carryover to the 2011 financial year was requested totalling EUR 3 500 000, or 1,68 % of the final appropriation;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 10

10. ~~Is concerned~~Reminds that the Court of Auditors ~~has once more~~ reported a high carryover of EUR 17 600 000 in Title II (Administrative expenditure); stresses that this situation indicates delays in the implementation of activities financed from Title II of the Agency's budget and that the Agency is not complying with the budgetary principle of annualitylevel of carryovers for the financial year 2010 as well as a lack of compliance with the budgetary principle of annuality; welcomes the fact that the Agency has strengthened its procedures of fee revenue forecasting by creating a team which analyses, in close cooperation with the pharmaceutical industry, the status of pharmaceutical product research before submission to the Agency; notes the Agency's firm commitment to work with Directorate General Budget in order to achieve a stable framework with the current revision of the Framework Financial Regulations;

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 11

11. 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;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 25 b (new)

25 b. Welcomes the Agency's initiative to publish the declarations of interests of its staff members 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 publish along with the declarations of interest to allow verification of the declarations of interest and identify possible conflicts; invites therefore the Agency to provide the Parliament information on the status of implementation of these measures by 30 June 2012;

2012/03/07
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 12

12. Points out that the Court of Auditors had already reported a high level of carryovers in previous financial years; notes, in particular, that in the 2009 budget the Court of Auditors reported a carryover of EUR 19 500 000 (38 % of the Agency's commitments) and in 2008 it was EUR 36 000 000 (19,7 % of the 2008 budget);deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
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; urges the Agency to take immediate action to reduce the level 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 2012;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 25 c (new)

25 c. 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 agency and by the Agency reveals significant differences in some cases; calls therefore on the Agency to establish a genuine mechanism enabling for a proper scrutiny of the declarations of interest received by the Agency and to inform the discharge authority on this matter by 30 June 2012;

2012/03/07
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 25 d (new)

25 d. 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; acknowledges from the Court of Auditors that the aforementioned Special Report will be published by the end of June 2012; is of the opinion that, given the extent of criticisms questioning conflict of interest issues in the Agency, the decision on the discharge should be postponed until the publication of the Special Report to take into account the findings of the Court of Auditors on this matter;

2012/03/07
Committee: CONT

Monica MACOVEI

Motion for a resolution
Subheading 4

~~Procurement Procedures and Transfers~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 14

14. Ascertains from the Annual Activity Report that, in addition to the 165 specific contracts concluded under framework contracts, 70 new procurement contracts exceeding EUR 25 000 in value were concluded by the Agency during 2010;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 15

15. Notes from the Agency's Report on budgetary and financial management that, 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;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 16

16. Urges the Agency to introduce a system of remuneration for services provided by national Member State authorities based on the Member States' real costs; also calls on the Agency to promptly inform the discharge authority when this system is put in place; notes in this regards that a new payment system was already presented to the Management Board at their meeting of 10 December 2009 but it, in the end, rejected the proposal;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 17

17. SGives full supports to all efforts at the executive and administrative levels of the Agency to reform the payment system for services provided by Member States' authorities which should clearly be based on the real costs; ~~urges the Management Board to move forward on this issue~~welcomes therefore the Agency's initiative to prepare a new proposal to be submitted to the Management Board; urges and expects the Management Board to discuss and decide on this payment system without delay;

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 18

18. Notes that 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; 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;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Subheading 6

~~Human resources management~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 19

19. Urges the Agency to strengthen its recruitment processes and ensure that its documentation is correctly managed; calls in particular 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;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 20

20. Acknowledges also from the Court of Auditors that the Agency did not distinguish sufficiently between employment-agency staff and contract staff recruitment; calls therefore on the Agency to use employment-agency staff to cover short-term needs only and grant transparent access for contract staff positions;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Subheading 7

Transparency and Management of conflict of interest

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 21

21. Urges the Agency to provide central coordination for the development of a common experts' assessment methodology applicable to all national competent authorities and for its monitoring; notes that, after the Memorandum of Understanding (MoU) signed between the Agency and each national competent authority on the monitoring of the scientific level of the experts became effective on 4 July 2011, the Agency still has responsibility for developing and coordinating a common experts' assessment and experts' methodology;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 21 a (new)

21 a. Takes note that the Agency is organising in November a workshop gathering a broad range of interested parties in the view of developing the modalities of providing public access to clinical trial data and that the selection and training of the Agency's scientific staff aimed at strengthening the analysis of raw data is well advanced;

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
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 2011 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;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 23

23. Calls on the Agency to inform the discharge authority of the way in which it ensures that procedures for the involvement of experts are fully applied until the MoUs on the independence of scientific evaluation have been signed by all national competent authorities;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 24

~~24. 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;~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 25

25. Takes note ~~from~~that 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 handl~~has improved the scope and methodology of the systematic ex-ante and ex-post controls related to the screening of dDeclared 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 onation of Interest, also welcomes the Agency's decision to perform a yearly evaluation of its revised policy on Declaration of Interest; invites therefore the Agency to ~~inform~~keep the discharge authority ~~of the concrete measures undertaken to implement these decisions by 30 June 2012 in order to enable Parliament to assess the procedures in place for h~~informed on the implementation of its revised policy andl ing p~~otential conflicts of interest for all categories listed in the two decisions, plus the members of the Management Board~~articular of its systematic ex-ante and ex-post controls on a 6-month basis;

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 25 a (new)

25 a. Notes with satisfaction that the Agency has started publishing the minutes of some Scientific Committees' meetings, starting with the Paediatric Committee (PDCO) in July 2012; takes note that the publication process of the minutes for all Scientific Committee meetings will be completed only by the end of 2013;

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 26

26. Notes withat the concern ~~that in~~s raised with regard to the financial circuits ~~there are also~~and the 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~~ were addressed by the Agency with the introduction of SAP accounting software as its central financial system;

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
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; asks the Executive Director to present a detailed report on the implementation of Article 16 of the Staff Regulations within the Agency;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 27 a (new)

27 a. 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; takes note that the Executive Director of the Agency launched a review of the work performed by the former Head of Legal Service; invites the Agency to inform the discharge authority on the outcomes of this review by the end of 2012;

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 28

28. Is seriously concerned by the failure of 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;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 28 a (new)

28 a. Takes note 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; notes that around 54% of the experts and committee members provided the Agency with updated curriculum vitae; calls on the Agency to inform the discharge authority on the timeframe and outcomes of the screening process for the remaining 46% by the start of the next discharge procedure;

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 29

29. Recalls that, following the employment of the Agency's former Executive Director by a consultancy that advises, among others, pharmaceutical companies almost immediately after he left the Agency, the discharge authority raised concerns over the actual independence of the Agency and the way in which its Management Board implemented Article 16 of the Staff Regulations; is furthermore concerned by the allegations that the Agency's former Executive Director created his own consultancy firm while still in office; calls on the Agency to provide the discharge authority with further information on this matter by 30 June 2012;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 30

~~30. Urges the Court of Auditors to finalise and present its current audit of conflict of interest in the Agency;~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 31

31. Regrets the fact that many of the experts failed to publish their declarations of interests, and that the comparison of declarations of interests published by the relevant national agencies and by the Agency shows significant differences in some cases; deplores, furthermore, the fact that at least one member of the Management Board of the Agency, also substitute member of the Committee for Medicinal Products for Human Use, failed to declare his recent management responsibilities in a pharmaceutical firm;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 32

32. Welcomes the Agency's initiative to publish on its website 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 information on the status of implementation of these measures by 30 June 2012welcomes the Agency's commitment to publish next to the declarations of interest the professional and educational profiles of the scientific experts belonging to its Expert Database from first quarter 2013 and will follow closely the publication process during the future discharge procedures;

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 33

33. Urges the Agency to carry out checks on the declarations of interests submitted to it, and a detailed check on a random basis, notably by implementing a system under which declarations are cross- checked against information held by industry and by the relevant national agencies;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
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 authority on this matter by 30 June 2012;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 34 a (new)

34 a. Acknowledges the Agency's efforts to address the discharge authority's concerns with regards to the prevention and management of conflict of interest; notes in particular the reports of 29 June 2012 and 7 August 2012 received by the discharge authority on the review of the conflict of interest management cases identified by the IAS and on the review of potential conflicts of interest of experts involved in assessing the medicinal product Pandemrix;

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 34 b (new)

34 b. 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, which shall include inter alia: - the number of alleged conflict-of- interest cases verified, - the number of revolving door cases, - the measures taken in each category of cases, - the number of breach of trust procedures launched and their outcomes - the sanctions applied;

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 35

~~35. Urges the Agency to apply its conflict of interest policy to its Management Board;~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 36

36. 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; acknowledges from the Court of Auditors that the above- mentioned Special Report will be published by the end of June 2012; 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;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 37

~~37. Considers that the effective management of conflict of interest is crucial to maintain public trust in the work of the Agency;~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 38

38. Acknowledges the Agency's willingness to publish the Declarations of Interests of experts involved in the evaluation of medicinal products; but deplores the fact that many of the experts have yet to publish their Declarations of Interests;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 39

39. Takes note of the fact that the Management Board adopted limitations on the subsequent professional activities of the former Executive Director on 17 March 2011 after public protest supported by Parliament regarding its decision in January 2011 to authorise his new activities fully; recalls in this context that a delegation of the Committee on the Environment, Public Health and Food Safety visited the Agency in June 2011 to follow up this case and to receive further information on the improved procedures; recalls, furthermore, that the Committee held an exchange of views with the Executive Director - designate in July 2011 where the issue was addressed again in order to avoid future recurrences;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Subheading 8

~~Performance~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 40

40. Considers the assessment of the adequacy and effectiveness of the systems in place to support the provision of scientific advice for human medicines in the Agency as an important tool to measure the Agency's performance;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 41

41. Takes note of the increased number of products and services (opinions, reports, scientific advice, inspections) compared with 2009; is also satisfied with the implementation of Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products19 and encourages the Agency to continue its action to provide incentives for research, development and placing on the market of designated orphan medicinal products;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Subheading 9

~~Internal audit~~deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 42

42. Acknowledges from the Agency that 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 under the IAS review;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 43

43. Is concerned that seven of these ‘very important’ recommendations have been delayed by up to more than 12 months; notes that these recommendations concern: – the compliance with Article 110 of the Staff Regulations; – the recruitment process; – the use of databases; – the definition of rules on filing for products; – the guidelines on the management of potential conflicts of interest of staff; – the procedures on involvement of experts; – the segregation of duties in the financial circuits; urges the Agency therefore to promptly address these deficiencies identified by the IAS and to inform the discharge authority of the measures taken;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 44

44. Is further concerned that the Agency rejected two ‘very important’ recommendations relating to: – the fees paid to national agencies; – the reduction in the number of consultants working in-house; urges the Agency to explain immediately to the discharge authority the rejection of these two recommendations;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 45

45. Notes that if the IAS in its follow-up report of September 2010 continues to find ‘inadequate assessment of the independence of the experts’, the Executive Director should publish a list of all the authorised medicinal products concerned and report how the Agency intends to rectify these procedures;deleted

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 46

~~46. Draws attention to its recommendations from previous discharge reports, as set out in the A~~deleted (The deletion of this paragraph leads to the deletion of the table annexed to th~~is resolution;~~e draft report.)

2012/09/12
Committee: CONT

Monica MACOVEI

Motion for a resolution
Paragraph 47

47. Refers, in respect of the other observations accompanying its Decision on discharge, which are of a horizontal nature, to its resolution of 10 May 201220 on the performance, financial management and control of the agencies.deleted

2012/09/12
Committee: CONT

Activities of Monica MACOVEI related to 2011/2220(DEC)

Reports (2)

Amendments (86)

ParlTrack - 2011-2024