2011/2220(DEC) | [ParlTrack]

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Procedure completed

2011/2220(DEC) 2010 discharge: European Medicines Agency (EMA)

Role	Committee	Rapporteur	Shadows
Lead	CONT	MACOVEI Monica (PPE)	HERCZOG Edit (S&D), GERBRANDY Gerben-Jan (ALDE), STAES Bart (Verts/ALE), CZARNECKI Ryszard (ECR), SØNDERGAARD Søren Bo (GUE/NGL), ANDREASEN Marta (EFD), EHRENHAUSER Martin (NI), HARTONG Lucas (NI)
Lead	CONT	MACOVEI Monica (PPE)
Opinion	ENVI	HAUG Jutta (S&D)
Opinion	ENVI	HAUG Jutta (S&D)

Lead committee dossier: CONT/7/07238;CONT/7/09685

Subjects

8.70.03.05 2010 discharge

Links

Activites

2012/12/20 Final act published in Official Journal
- Decision 2012/802
- OJ L 350 20.12.2012, p. 0082
2012/10/23 Decision by Parliament, 1st reading/single reading
- T7-0366/2012 summary
  
  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.
2012/10/02 Committee report tabled for plenary, single reading
- A7-0298/2012 summary
  
  The Committee on Budgetary Control adopted the second reading report of Monica Luisa MACOVEI (PPE, RO) on the discharge of the European Medicines Agency (EMA) which calls on the European Parliament to grant the Executive Director of the European Medicines Agency discharge in respect of the implementation of the Agency’s budget for the financial year 2010. To recall, 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). Members 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: Members take note 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. They also note 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. They invite the Agency to keep the discharge authority informed on the implementation of its revised policy on a 6-month basis; · a “revolving door” case: Members underline 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. They take note that the Executive Director of the Agency launched a review of the work performed by the former Head of Legal Service and expect the Agency to inform the discharge authority on the outcomes of this review by the end of 2012; · screening process of declarations of interest: Members welcome 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. They also welcome 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, they agree 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: Members consider 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, Members call 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. In general, Members welcome 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.
2012/09/26 Vote in committee, 1st reading/single reading
2012/05/10 Results of vote in Parliament
- Results of vote in Parliament
- Debate in Parliament
- T7-0175/2012 summary
  
  The European Parliament adopted by 340 votes to 268, with 14 abstentions, a decision to postpone the granting of the discharge to the Executive Director of the European Medicines Agency in respect of the implementation of the Agency's budget for the financial year 2010. The Parliament also postponed the closure of the accounts for this agency. Parliament also adopted by 467 votes to 139, with 23 abstentions, a resolution containing observations that are an integral part of the decision to postpone the discharge. These observations may be summarised as follows: Budget and financial management: Parliament 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. It notes 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. It also notes weaknesses in the Agency's system for validating creditor claims in respect of IT contractors and invites the Court of Auditors to verify this issue and inform Parliament in this respect; Carryover appropriations and cancellations: Parliament notes that automatic carryovers to the 2011 financial year totalled EUR 41.6 million or 20.90 % of the appropriation committed, and that one non-automatic carryover to the 2011 financial year was requested totalling EUR 3.5 million or 1.68 % of the final appropriation. It considers that the Agency is not complying with the budgetary principle of annuality. It 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. It urges the Agency to take immediate action to reduce the level of cancelled appropriations and to adopt an Action Plan with concrete measures; System of remuneration for services: Parliament urges the Agency to introduce a system of remuneration for services provided by national Member State authorities based on the Member States’ real costs. It notes in this regard that a new payment system was already presented to the Management Board at its meeting of 10 December 2009 but it, in the end, rejected the proposal. 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. Parliament 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; Human resources management: Parliament calls 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. It also calls on the Agency to use employment-agency staff to cover short-term needs only and to grant transparent access for contract staff positions; Management of conflict of interest: Parliament 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. Noting the measures taken in 2012, Parliament invites the Agency to inform the discharge authority of the concrete measures that it has taken to ensure that it can evaluate the procedures in place to manage any eventual conflicts of interest. It notes with concern that in the financial circuits there are also potential conflicts of interests in processing payments due to insufficient segregation of duties and urges the Agency therefore to duly take into account this very significant risk and take immediate action to address this deficiency. Former director: Parliament considers the opportunity given to the Agency’s former Executive Director to engage in new activities that are in conflict with his previous position (he was recruited almost immediately after his departure from the Agency, by a consultancy firm working for pharmaceutical companies) to be a breach of Union rules relating to conflicts of interest in regard to members of scientific committees and experts, as well as a breach of trust procedure for Committee members and experts. It believes that the Agency should verify, during 2012, all declarations of interest of experts and Scientific Committee members and calls on it to provide the discharge authority with detailed information on 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. Overall, Parliament has concerns over the actual independence of the Agency. It calls for greater transparency in this regard and welcomes the fact that the Agency has decided to publish on its website the declarations of interest of experts involved in the evaluation of medicinal products even if the Agency's approach vis-à-vis the scrutiny of declarations of interest is primarily based on trust rather than on verification. It also 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. Parliament 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. The Report will be published by the end of June 2012. It 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.
2012/04/04 Committee report tabled for plenary, single reading
- A7-0107/2012 summary
  
  The Committee on Budgetary Control adopted the report by Monica Luisa MACOVEI (EPP, RO) on discharge to be granted in respect of the implementation of the budget of the European Medicines Agency for the financial year 2010. The committee calls on the Parliament to postpone 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. However, they make a number of recommendations, in addition to the general recommendations that appear in the draft resolution on performance, financial management and control of EU agencies: Budget and financial management: Members acknowledge 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. They state 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. They also note weaknesses in the Agency's system for validating creditor claims in respect of IT contractors and invite the Court of Auditors to verify this issue and inform Parliament in this respect; Carryover appropriations and cancellations: Members note 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. They state that the Agency is not complying with the budgetary principle of annuality. They note 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. Members urge the Agency to take immediate action to reduce the level of cancelled appropriations and to adopt an Action Plan with concrete measures; System of remuneration for services: Members urge the Agency to introduce a system of remuneration for services provided by national Member State authorities based on the Member States’ real costs. They note 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. 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. Members are therefore not ready to accept this questionable attitude from the Management Board and call on the Agency to adopt an Action Plan on this matter and to inform the discharge authority by 30 June 2012; Human resources management: Members call 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. They also call on the Agency to use employment-agency staff to cover short-term needs only and grant transparent access for contract staff positions; Management of conflict of interest: Members call 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. They note with concern that in the financial circuits there are also potential conflicts of interests in processing payments due to insufficient segregation of duties and urge the Agency therefore to duly take into account this very significant risk and take immediate action to address this deficiency. Members urge the Court of Auditors to finalise and present its current audit of conflict of interest in the Agency. They regret 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. They deplore, 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. They therefore call 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. They also urge the Agency to apply its conflict of interest policy to its Management Board. Lastly, Members are 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; Internal audit: Members acknowledge from the Agency that 11 "very important" recommendations from the IAS still need to be implemented. Efforts should be made as regards this issue.
2012/03/27 Vote in committee, 1st reading/single reading
2011/10/12 Committee referral announced in Parliament, 1st reading/single reading
2011/07/26 Non-legislative basic document published
- COM(2011)0473 summary
  
  PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2010, as part of the 2010 discharge procedure. Analysis of the accounts of the European Medicines Agency (EMEA). CONTENT: this Commission document sets out the consolidated annual accounts of the European Union for the financial year 2010 as prepared on the basis of the information presented by the institutions, organisations and bodies of the EU, in accordance with Article 129 (2) of the Financial Regulation applicable to the EU's General Budget, including the European Medicines Agency (EMEA). In 2010, the tasks and budget of this agency were as follows: description of the Agency's tasks: the European Medicines Agency, which is located in London, was created by Council Regulation (EEC) No 2309/93, which was replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council. The Agency operates through a network and coordinates the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use; the Agency's budget for the 2010 financial year: the Agency's 2010 budget amounted to EUR 208.4 million, compared with EUR 194.4 million the previous year. The number of staff employed by the Agency at the end of the year was 698, as compared with 664 the previous year. The complete version of the Agency's final accounts may be found at the following address: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/07/WC500108349.pdf
- DG {'url': 'http://ec.europa.eu/dgs/budget/', 'title': 'Budget'}, ŠEMETA Algirdas

Documents

Non-legislative basic document published: COM(2011)0473
Committee report tabled for plenary, single reading: A7-0107/2012
Results of vote in Parliament: Results of vote in Parliament
Debate in Parliament: Debate in Parliament
Decision by Parliament, 1st reading/single reading: T7-0175/2012
Committee report tabled for plenary, single reading: A7-0298/2012
Decision by Parliament, 1st reading/single reading: T7-0366/2012
: Decision 2012/802
: OJ L 350 20.12.2012, p. 0082

Amendments	Dossier
157	2011/2220(DEC) 2011/12/21 ENVI 7 amendments... Amendment 1 # Corinne LEPAGE, Vladko Todorov PANAYOTOV, Michèle RIVASI Draft opinion Paragraph 1 1. ~~Welcomes clearly~~Notes the work of the European Medicines Agency in evaluating and supervising medicines for human and veterinary use in the Union; Amendment 2 # Corinne LEPAGE, Vladko Todorov PANAYOTOV, Michèle RIVASI Draft opinion Paragraph 2 a (new) 2a. Acknowledges the EMA’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 and that, when the declarations published for individual experts by the relevant national agency and by the EMA are compared, significant differences are apparent in some cases; deplores, furthermore, the fact that at least one member of the Management Board has failed to declare recent links with the pharmaceutical industry; urges the EMA accordingly to carry out detailed checks on the declarations of interests submitted to it and to implement a system under which declarations of interests are cross-checked against information held by industry and by the relevant national agencies; Amendment 3 # Corinne LEPAGE, Vladko Todorov PANAYOTOV, Michèle RIVASI Draft opinion Paragraph 6 a (new) 6a. Notes that the former Executive Director of EMA wrote to the Agency on 28 December 2010 outlining the activities he was intending to take up at the end his term of office; considers the decision dated 11 January 2011 taken by the Chairman of the European Medicines Agency's (EMA) Management Board to authorize the new activities of its former Executive Director a breach of EU 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; 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 - a clear proof that EMA did initially not apply the Staff Regulations properly in this high-profile case, which in turn raises serious questions about their application of the rules in general; considers that the limitations set out therein as regards the former Executive Director are not sufficient, in particular in the light of recent reports that the former Executive Director set up his new activities as early as November 2010, while he was still in office; asks the Executive Director of EMA to present a detailed report of the implementation of Article 16 of the Staff Regulations within the Agency; Amendment 4 # Michèle RIVASI Draft opinion Paragraph 6 a (new) 6a. Calls for the Internal Audit Report of the Commission's services of the European Medicines Agency for the year 2010 to be made available to Members of Parliament without any delay in the light of the serious problems found with regard to the assessment of the independence of experts involved in the evaluation of medicinal products in the audit report for 2009; Amendment 5 # Michèle RIVASI Draft opinion Paragraph 6 b (new) 6b. Calls on the Commission to publish a list of all authorised medicinal products for which the internal auditors found inadequate assessment of the independence of the experts in the assessment team; calls on the Executive Director of EMA to report how EMA intends to rectify these procedures; Amendment 6 # Corinne LEPAGE Draft opinion Paragraph 7 a (new) 7a. Considers inappropriate the co- organisation by EMA with the Organisation for Professionals in Regulatory Affairs (TOPRA) of annual conferences presented as reviews of the year; asks the EMA to report on potential financial participation to co-organise these events; Amendment 7 # Corinne LEPAGE, Vladko Todorov PANAYOTOV, Michèle RIVASI Draft opinion Paragraph 8 8. ICalls ofn the ~~opinion, on the basis of the data available, that discharge can be granted~~Agency, therefore, to inform the discharge authority by June 2012 of the measures taken and the improvements made in respect of all these areas of concern and considers that discharge to the Executive Director of the European Medicines Agency in respect of the implementation of the A~~genc~~uthority's budget for the financial year 2010 should be postponed until the problems mentioned above have been resolved.. source: PE-478.634 2012/03/07 CONT 43 amendments... Amendment 1 # Corinne LEPAGE, Sonia ALFANO, Antonyia PARVANOVA Proposal for a decision 1 Paragraph 1 1. ~~...~~Calls on the Agency to inform the discharge authority by the 30 June 2012 of the measures taken and of the improvements made in respect of all the areas of concern and decides to postpone the discharge to 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 10 # Edit HERCZOG Motion for a resolution Paragraph 8 8. Notes weaknesses in the Agency's system for validating creditor claims in respect of IT contractors; calls therefore on the Agency to ~~promptly~~ address the situation and inform the discharge authority on the actions taken; Amendment 11 # Edit HERCZOG Motion for a resolution Paragraph 10 10. ~~Is concerned~~Notes 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 in accordance with the budgetary principle of annuality~~; Amendment 12 # Edit HERCZOG 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 accrued expenditure of 2010 while the remaining 64 % of amounts carried over did not relate to the 2010 financial year; Amendment 13 # 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; Amendment 14 # Edit HERCZOG 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; ~~urges~~calls on the Agency to take ~~immediate~~ action to decrease the level of cancelled appropriations and to adopt an Action Plan with concrete measures and deadlines to address this persistent problem; Amendment 15 # Edit HERCZOG Motion for a resolution Paragraph 16 16. ~~Urges~~Calls on the Agency to introduce a system of remuneration for services provided by national Member State authorities based on the Member States' real costs; calls also 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; Amendment 16 # Edit HERCZOG 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 Board and calls upon them to take immediate action on this;deleted Amendment 17 # Ingeborg GRÄSSLE 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~~al risks; therefore ~~not ready to accept this questionable attitude from the Agency's Governing Board and calls upon them to take immediate action~~asks the Agency's Management Board to take action on this, and inform the discharge authority before the end onf thise year; Amendment 18 # 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; Amendment 19 # 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; Amendment 2 # Monica MACOVEI 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; Amendment 20 # Corinne LEPAGE, Sonia ALFANO, Antonyia PARVANOVA Motion for a resolution Paragraph 22 a (new) 22 a. Calls the Agency to report on its involvement in the organization of conferences by private organizations such as the Organisation for Professionals in Regulatory Affairs (TOPRA) ; Amendment 21 # Corinne LEPAGE, Sonia ALFANO, Antonyia PARVANOVA Motion for a resolution Paragraph 23 23. ~~Calls on~~Urges the Agency to provide the discharge authority with the guidelines and assessment criteria on handling potential conflicts of interest of staff members, experts and members of the Management Board; Amendment 22 # 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; Amendment 23 # Edit HERCZOG Motion for a resolution Paragraph 24 24. Notes with concern that also in the financial circuits there are potential conflict of interests in processing payments due to insufficient segregation of duties; urges the Agency therefore to duly take into account this very important risk and take immediate action to address this deficiency;deleted Amendment 24 # Corinne LEPAGE, Sonia ALFANO, Antonyia PARVANOVA Motion for a resolution Paragraph 24 a (new) 24 a. Notes that the former Executive Director of the Agency wrote to the Agency on 28 December 2010 outlining the activities he was intending to take up at the end of his term of office; considers the first decision dated 11 January 2011 taken by the Chairman of the Agency Management Board to authorize the new activities of its former Executive Director 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 Conditions of Employment of Other Servants of the European Communities, this disposal 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 - a 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 of the Agency to present a detailed report of the implementation of Article 16 of the Staff Regulations within the Agency; Amendment 25 # Edit HERCZOG Motion for a resolution Paragraph 25 ~~25. Is seriously concerned by the failure of the Agency and its Management Board to effectively address the matter of conflict of interests;~~deleted Amendment 26 # 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; Amendment 27 # Gerben-Jan GERBRANDY Motion for a resolution 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 28 # Corinne LEPAGE, Sonia ALFANO, Antonyia PARVANOVA Motion for a resolution Paragraph 25 a (new) 25 a. Regrets the fact that many of the experts failed to publish their declarations of interests (DoI), and that the comparison of DoI published by the relevant national agency 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 (CHMP), failed to declare his recent management responsibilities in a pharmaceutical firm ; Amendment 29 # 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; Amendment 3 # Edit HERCZOG 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; Amendment 30 # Corinne LEPAGE, Sonia ALFANO, Antonyia PARVANOVA Motion for a resolution Paragraph 25 b (new) 25 b. Urges the Agency to carry out checks on the declarations of interests submitted to it, and a detailed check on a random basis, notably in implementing a system under which declarations are cross-checked against information held by industry and by the relevant national agencies; Amendment 31 # 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; Amendment 32 # Corinne LEPAGE, Sonia ALFANO, Antonyia PARVANOVA Motion for a resolution Paragraph 25 c (new) 25 c. Urges the Agency to apply its conflict of interest policy to its Management Board ; Amendment 33 # 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; Amendment 34 # Corinne LEPAGE, Sonia ALFANO, Antonyia PARVANOVA Motion for a resolution Paragraph 25 e (new) 25 e. Considers that the effective management of conflict of interest is crucial to maintain public trust in the work of the Agency; Amendment 35 # Edit HERCZOG Motion for a resolution Paragraph 28 – introductory part 28. ~~Is concerned~~Notes that seven of these ~~‘very important’~~ recommendations have been delayed up to more than 12 months~~; notes that these recommendations concern:~~. Amendment 36 # Edit HERCZOG Motion for a resolution Paragraph 28 – indent 1 ~~– the compliance with Article 110 of the Staff Regulations;~~deleted Amendment 37 # Edit HERCZOG Motion for a resolution Paragraph 28 – indent 2 ~~– the recruitment process;~~deleted Amendment 38 # Edit HERCZOG Motion for a resolution Paragraph 28 – indent 3 ~~– the use of databases;~~deleted Amendment 39 # Edit HERCZOG Motion for a resolution Paragraph 28 – indent 4 ~~– the definition of rules on filing for products;~~deleted Amendment 4 # Edit HERCZOG Proposal for a decision 2 Paragraph 1 1. ~~...~~Approve the closure of the accounts of the European Medicines Agency for the financial year 2010; Amendment 40 # Edit HERCZOG Motion for a resolution Paragraph 28 – indent 5 ~~– the guidelines on the management of potential conflicts of interest of staff;~~deleted Amendment 41 # Edit HERCZOG Motion for a resolution Paragraph 28 – indent 6 ~~– the procedures on involvement of experts;~~deleted Amendment 42 # Edit HERCZOG Motion for a resolution Paragraph 28 – indent 7 ~~– the segregation of duties in the financial circuits;~~deleted Amendment 43 # Edit HERCZOG Motion for a resolution Paragraph 28 – subparagraph 2 ~~urges~~Calls on the Agency t~~herefore to promptly~~o address these deficiencies identified by the IAS and to inform the discharge authority on the measures taken; Amendment 5 # 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; Amendment 6 # 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; Amendment 7 # 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; Amendment 8 # Edit HERCZOG Motion for a resolution Paragraph 3 3. ~~Is concerned that~~Asks the Management Board of the Agency ~~never~~to sentd the Action Plan ~~and insists on receiving it immediatel~~to the discharge authority; Amendment 9 # 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; source: PE-483.611 2012/08/31 ENVI 13 amendments... Amendment 1 # Kartika Tamara LIOTARD Draft opinion Paragraph 3 3. Is firmly convinced that necessary steps have to be taken should cases of non- compliance with existing rules occur; believes that, in such cases, the Agency has to draw up an action plan aiming to remedy the shortcomings and its implementation should be monitored by the European Parliament and either the European Parliament or the European legislator has to address, as a matter of priority, these problems by changing the existing rules and regulations to eliminate possible loopholes; Amendment 10 # Corinne LEPAGE Draft opinion Paragraph 9 9. Believes that the discharge decision for the EMA cannot be based upon additional requirements, e.g. OECD guidelines, when the implementation of those requirements have neither been officially asked for by the EU legislator nor by specific arrangements within the Agencies during the respective discharge procedure; invites the European institutions to examine whether it is advisable to incorporate and to commit to additional guidelines in a possible common framework for all European institutions and bodies;deleted Amendment 11 # Marina YANNAKOUDAKIS, Anna ROSBACH Draft opinion Paragraph 9 9. Believes that the discharge decision for the EMA ~~cannot~~should be based upon additional requirements, e.g. OECD guidelines, when the implementation of those requirements have neither been officially asked for by the EU legislator nor by specific arrangements within the Agencies during the respective discharge procedureOECD guidelines to ensure high quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to ~~examine whether it is advisable to~~ incorporate and to commit to ~~additional~~introducing OECD guidelines within a ~~possible common~~common working framework for all European institutions and bodies; Amendment 12 # Kartika Tamara LIOTARD Draft opinion Paragraph 9 9. Believes that the discharge decision for the EMA cannot be based upon additional requirements, e.g. OECD guidelines, when the implementation of those requirements have neither been officially asked for by the EU legislator nor by specific arrangements within the Agencies during the respective discharge procedure; invites the European institutions to examine, as a matter of priority, whether it is advisable to incorporate and to commit to additional guidelines in a possible common framework for all European institutions and bodies; Amendment 13 # Marina YANNAKOUDAKIS, Anna ROSBACH Draft opinion Paragraph 10 10. Is of the opinion that, on the basis of the information available, discharge ~~can~~should not be granted to the Executive Director of the European Medicines Agency in respect of the implementation of the Agency's budget for the financial year 2010. Amendment 2 # Corinne LEPAGE Draft opinion Paragraph 3 3. Is firmly convinced that necessary steps have to be taken should cases of non- compliance with existing rules occur; believes that, in such cases, the Agency has to draw up an action plan aiming to remedy the shortcomings, with a precise timetable, and its implementation should be monitored by the European Parliament and either the European Parliament or the European legislator has to address these problems by changing the existing rules and regulations to eliminate possible loopholes; Amendment 3 # Marina YANNAKOUDAKIS, Anna ROSBACH Draft opinion Paragraph 5 5. ~~Has already addressed the problematic of~~Notes that concerns remain over the institutional failings that led to high carry- overs, doubts over the propriety of the subsequent professional activities of the former Executive Director, ~~the~~ missing Declarations of Interests by a number of experts involved in the evaluation of medicinal products also mentioned in the Internal Audit Service follow-up report and the overdue decision by the Management Board to reform the payment system for services provided by Member States' authorities in its first opinion to the responsible committee; ~~is of the opinion that EMA has already made significant efforts to strengthen its internal procedures to assure the independence of its experts and~~requests that the European Parliament its ~~staff and has asked to be~~ informed twice a year about the ~~improved~~ implementation of ~~the~~remedial measures that are being taken in this regard; Amendment 4 # Corinne LEPAGE Draft opinion Paragraph 5 5. Has already addressed the problematic of high carry-overs, the subsequent new professional activities of the former Executive Director~~, the missing~~ which infringe Article 16 of the Staff Regulations of Officials and Conditions of Employment of Other Servants of the European Communities , the missing, incomplete or incorrect Declarations of Interests by a number of experts involved in the evaluation of medicinal products also mentioned in the Internal Audit Service follow-up report and by the Management Board, and the overdue decision by the Management Board to reform the payment system for services provided by Member States' authorities in its first opinion to the responsible committee; is of the opinion that EMA has ~~already made significant~~made efforts to strengthen its internal procedures to assure the independence of its experts and its staff and has asked to be informed twice a year about the improved implementation of the measures taken in this regard; Amendment 5 # Corinne LEPAGE Draft opinion Paragraph 5 a (new) 5a. Welcomes the announcement by the Agency that it plans to introduce an ex- ante and ex-post system for Declarations of Interest, notably by means of comparison with CVs and information furnished by experts at national level; asks the Agency to provide the budgetary control authority with a precise timetable for the implementation of this new system; Amendment 6 # Corinne LEPAGE Draft opinion Paragraph 5 b (new) 5b. 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; agrees with the Agency that thought should be given to whether a legislative initiative in this field would be pertinent; Amendment 7 # Corinne LEPAGE Draft opinion Paragraph 5 c (new) 5c. Recognises that it is important for the Agency to have exchanges with stakeholders, but considers that insufficient information has been furnished about its involvement in the organisation of conferences by private bodies such as TOPRA (The Organisation for Professionals in Regulatory Affairs); asks the Agency to make it clear to the budgetary control authority whether or not it contributes financially to the organisation of events with this organisation; Amendment 8 # Marina YANNAKOUDAKIS, Anna ROSBACH Draft opinion Paragraph 6 6. Points out again that the Court of Auditors made observations on carryovers, IT contracts and the payment system for services provided by national authorities but despite these inconsistencies, considered the Agency's accounts of 2010 reliable, legal and regular; Amendment 9 # Marina YANNAKOUDAKIS, Anna ROSBACH Draft opinion Paragraph 8 8. Welcomes, in general, the agreement on the Joint Statement and the Common Approach of the European Parliament, the Council and the Commission on decentralised agencies; recalls that certain elements of importance to the discharge have been addressed and taken up; ~~believ~~stresses that the roadmap on the follow-up to the Common Approach ~~will~~must duly take ~~due~~into account of those issues; source: PE-494.704 2012/09/12 CONT 94 amendments... Amendment 1 # Jens GEIER, Edit HERCZOG Proposal for a decision 1 Citation 11 a (new) - having regard to the Joint Statement and Common Approach adopted (in June 2012) by the European Parliament, the Council and the Commission, resulting from the work of the Inter Institutional Working Group on decentralised agencies, and in particular the sections on governance, operations, programming, accountability and transparency, Amendment 10 # 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 Amendment 11 # 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 Amendment 12 # 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 Amendment 13 # 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 Amendment 14 # Gerben-Jan GERBRANDY Motion for a resolution Paragraph 1 – introductory part 1. ~~Expects the Agency to inform the discharge authority of the results of the action taken~~Notes the actions taken by the Agency with regard to the following issues: Amendment 15 # 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 Amendment 16 # 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; Amendment 17 # 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 Amendment 18 # Monica MACOVEI Motion for a resolution Paragraph 3 – indent 2 ~~– implementation of a multiannual procurement plan,~~deleted Amendment 19 # Monica MACOVEI Motion for a resolution Paragraph 3 – indent 3 ~~– establishment of the responsibilities for the above;~~deleted Amendment 2 # Edit HERCZOG, Jens GEIER, Gerben-Jan GERBRANDY 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; Amendment 20 # 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 Amendment 21 # Monica MACOVEI Motion for a resolution Subheading 2 ~~Budget and financial management~~deleted Amendment 22 # 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 Amendment 23 # 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 Amendment 24 # 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 Amendment 25 # 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 Amendment 26 # 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 Amendment 27 # 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 Amendment 28 # 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; Amendment 29 # 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 Amendment 3 # 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; Amendment 30 # 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 Amendment 31 # 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 Amendment 32 # Gerben-Jan GERBRANDY 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; ~~urg~~notes the Agency ~~to take immediate~~'s actions to ~~reduce th~~improve 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 33 # Edit HERCZOG, Jens GEIER Motion for a resolution Paragraph 13 13. ENotes that 80% of the Agency's budget derives from fees on services requested by the pharmaceutical sector and notes that the speed of these payments is variable and out of the Agency's control, nevertheless establishes from the Agency's Report on budgetary and financial management that in 2010, there was a cancellation rate of 4,35% of final 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; ~~urg~~also notes the Agency ~~to take immediate~~'s action to ~~reduce th~~improve 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 in the future; Amendment 34 # Monica MACOVEI Motion for a resolution Subheading 4 ~~Procurement Procedures and Transfers~~deleted Amendment 35 # 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 Amendment 36 # 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 Amendment 37 # Gerben-Jan GERBRANDY Motion for a resolution 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 38 # 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 Amendment 39 # 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; Amendment 4 # 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; Amendment 40 # 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 Amendment 41 # Monica MACOVEI Motion for a resolution Subheading 6 ~~Human resources management~~deleted Amendment 42 # 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 Amendment 43 # 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 Amendment 44 # Monica MACOVEI Motion for a resolution Subheading 7 Transparency and Management of conflict of interest Amendment 45 # 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 Amendment 46 # 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; Amendment 47 # 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 Amendment 48 # Gerben-Jan GERBRANDY 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 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 49 # 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 Amendment 5 # 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 Amendment 50 # 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 Amendment 51 # Gerben-Jan GERBRANDY Motion for a resolution 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 52 # 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; Amendment 53 # 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; Amendment 54 # Gerben-Jan GERBRANDY Motion for a resolution Paragraph 26 26. Notes ~~with concern that~~measures taken in the financial circuits t~~here are also~~o 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 55 # 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; Amendment 56 # 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 Amendment 57 # Gerben-Jan GERBRANDY 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; ~~ask~~Welcomes the Executive Director ~~to present a detailed~~'s report on the implementation of Article 16 of the Staff Regulations within the Agency; Amendment 58 # 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; Amendment 59 # 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 Amendment 6 # 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, Amendment 60 # Gerben-Jan GERBRANDY Motion for a resolution Paragraph 28 28. ~~Is seriously concerned by the failure of~~Urges 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 61 # 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; Amendment 62 # 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 Amendment 63 # 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 Amendment 64 # 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 Amendment 65 # Gerben-Jan GERBRANDY Motion for a resolution 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 information~~notes the information provided on the status of implementation of these measures ~~by 30 June 2012~~; Amendment 66 # 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; Amendment 67 # 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 Amendment 68 # 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 Amendment 69 # Gerben-Jan GERBRANDY 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~~Notes the new system of ex-post controls endorsed in March 2012 and the breach onf t~~his matter by 30 June 2012~~rust procedure; Amendment 7 # 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, Amendment 70 # Jens GEIER, Edit HERCZOG Motion for a resolution Paragraph 34 34. ~~Is nevertheless concerned by~~Notes that 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; has been strengthened to include ex-post cross checks on their correctness, and also a breach-of-trust procedure, and furtherefmore 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 2012looks forward to receiving information about the implementation of these new aspects; Amendment 71 # 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; Amendment 72 # 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; Amendment 73 # Monica MACOVEI Motion for a resolution Paragraph 35 ~~35. Urges the Agency to apply its conflict of interest policy to its Management Board;~~deleted Amendment 74 # Gerben-Jan GERBRANDY Motion for a resolution Paragraph 35 35. ~~Urg~~Notes that the Agency towill now apply its conflict of interest policy to its Management Board; Amendment 75 # Gerben-Jan GERBRANDY 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 Amendment 76 # 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 Amendment 77 # 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 Amendment 78 # 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 Amendment 79 # 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 Amendment 8 # 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 Amendment 80 # Cristina GUTIÉRREZ-CORTINES, Pilar AYUSO Motion for a resolution Paragraph 39 – point 2 (new) (2) Invites the European institutions to examine if it is advisable to incorporate and to commit to additional guidelines, legislation and procedures in a possible common framework for all European institutions and bodies; Amendment 81 # Monica MACOVEI Motion for a resolution Subheading 8 ~~Performance~~deleted Amendment 82 # 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 Amendment 83 # 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 Amendment 84 # Monica MACOVEI Motion for a resolution Subheading 9 ~~Internal audit~~deleted Amendment 85 # 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 Amendment 86 # Gerben-Jan GERBRANDY Motion for a resolution 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 under~~are addressed and ready for review by the IAS ~~review~~; Amendment 87 # 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 Amendment 88 # Gerben-Jan GERBRANDY Motion for a resolution Paragraph 43 – introductory part 43. Is ~~concern~~informed that seven of these ‘very important’ recommendations have been ~~delayed by up to more than 12 months~~addressed; notes that these recommendations concern: Amendment 89 # Gerben-Jan GERBRANDY Motion for a resolution Paragraph 43 – subparagraph 1 ~~urge~~Requests the Agency ~~therefore to promptly address these deficiencies identified by the IAS and~~ to inform the discharge authority of the detailed measures taken; Amendment 9 # 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 Amendment 90 # 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 Amendment 91 # Gerben-Jan GERBRANDY Motion for a resolution Paragraph 44 – subparagraph 1 ~~urges the Agency to explain immediately~~Takes note of the explanation to the discharge authority ~~the rejection of~~regarding these two recommendations; Amendment 92 # 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 Amendment 93 # 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.) Amendment 94 # 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 source: PE-494.821

Amendments

Dossier

157

2011/2220(DEC)

2011/12/21 ENVI 7 amendments...

Amendment 1 #

Corinne LEPAGE, Vladko Todorov PANAYOTOV, Michèle RIVASI

Draft opinion
Paragraph 1

1. ~~Welcomes clearly~~Notes the work of the European Medicines Agency in evaluating and supervising medicines for human and veterinary use in the Union;

Amendment 2 #

Corinne LEPAGE, Vladko Todorov PANAYOTOV, Michèle RIVASI

Draft opinion
Paragraph 2 a (new)

2a. Acknowledges the EMA’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 and that, when the declarations published for individual experts by the relevant national agency and by the EMA are compared, significant differences are apparent in some cases; deplores, furthermore, the fact that at least one member of the Management Board has failed to declare recent links with the pharmaceutical industry; urges the EMA accordingly to carry out detailed checks on the declarations of interests submitted to it and to implement a system under which declarations of interests are cross-checked against information held by industry and by the relevant national agencies;

Amendment 3 #

Corinne LEPAGE, Vladko Todorov PANAYOTOV, Michèle RIVASI

Draft opinion
Paragraph 6 a (new)

6a. Notes that the former Executive Director of EMA wrote to the Agency on 28 December 2010 outlining the activities he was intending to take up at the end his term of office; considers the decision dated 11 January 2011 taken by the Chairman of the European Medicines Agency's (EMA) Management Board to authorize the new activities of its former Executive Director a breach of EU 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; 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 - a clear proof that EMA did initially not apply the Staff Regulations properly in this high-profile case, which in turn raises serious questions about their application of the rules in general; considers that the limitations set out therein as regards the former Executive Director are not sufficient, in particular in the light of recent reports that the former Executive Director set up his new activities as early as November 2010, while he was still in office; asks the Executive Director of EMA to present a detailed report of the implementation of Article 16 of the Staff Regulations within the Agency;

Amendment 4 #

Michèle RIVASI

Draft opinion
Paragraph 6 a (new)

6a. Calls for the Internal Audit Report of the Commission's services of the European Medicines Agency for the year 2010 to be made available to Members of Parliament without any delay in the light of the serious problems found with regard to the assessment of the independence of experts involved in the evaluation of medicinal products in the audit report for 2009;

Amendment 5 #

Michèle RIVASI

Draft opinion
Paragraph 6 b (new)

6b. Calls on the Commission to publish a list of all authorised medicinal products for which the internal auditors found inadequate assessment of the independence of the experts in the assessment team; calls on the Executive Director of EMA to report how EMA intends to rectify these procedures;

Amendment 6 #

Corinne LEPAGE

Draft opinion
Paragraph 7 a (new)

7a. Considers inappropriate the co- organisation by EMA with the Organisation for Professionals in Regulatory Affairs (TOPRA) of annual conferences presented as reviews of the year; asks the EMA to report on potential financial participation to co-organise these events;

Amendment 7 #

Corinne LEPAGE, Vladko Todorov PANAYOTOV, Michèle RIVASI

Draft opinion
Paragraph 8

8. ICalls ofn the ~~opinion, on the basis of the data available, that discharge can be granted~~Agency, therefore, to inform the discharge authority by June 2012 of the measures taken and the improvements made in respect of all these areas of concern and considers that discharge to the Executive Director of the European Medicines Agency in respect of the implementation of the A~~genc~~uthority's budget for the financial year 2010 should be postponed until the problems mentioned above have been resolved..

source: PE-478.634

2012/03/07 CONT 43 amendments...

Amendment 1 #

Corinne LEPAGE, Sonia ALFANO, Antonyia PARVANOVA

Proposal for a decision 1
Paragraph 1

1. ~~...~~Calls on the Agency to inform the discharge authority by the 30 June 2012 of the measures taken and of the improvements made in respect of all the areas of concern and decides to postpone the discharge to 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 10 #

Edit HERCZOG

Motion for a resolution
Paragraph 8

8. Notes weaknesses in the Agency's system for validating creditor claims in respect of IT contractors; calls therefore on the Agency to ~~promptly~~ address the situation and inform the discharge authority on the actions taken;

Amendment 11 #

Edit HERCZOG

Motion for a resolution
Paragraph 10

10. ~~Is concerned~~Notes 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 in accordance with the budgetary principle of annuality~~;

Amendment 12 #

Edit HERCZOG

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 accrued expenditure of 2010 while the remaining 64 % of amounts carried over did not relate to the 2010 financial year;

Amendment 13 #

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MACOVEI Monica Luisa body: EP responsible: True committee: CONT date: 2011-03-03T00:00:00 committee_full: Budgetary Control rapporteur: group: PPE name: MACOVEI Monica Luisa body: EP responsible: False committee: ENVI date: 2012-07-10T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: S&D name: HAUG Jutta body: EP responsible: False committee: ENVI date: 2011-10-05T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: S&D name: HAUG Jutta date: 2012-04-04T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2012-107&language=EN type: Committee report tabled for plenary, single reading title: A7-0107/2012 body: EP type: Committee report tabled for plenary, single reading date: 2012-05-10T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=21444&l=en type: Results of vote in Parliament title: Results of vote in Parliament url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20120510&type=CRE type: Debate in Parliament title: Debate in Parliament url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-175 type: Decision by Parliament, 1st reading/single reading title: T7-0175/2012 body: EP type: Results of vote in Parliament date: 2012-09-26T00:00:00 body: EP type: Vote in committee, 1st reading/single reading committees: body: EP shadows: group: S&D name: HERCZOG Edit group: ALDE name: GERBRANDY Gerben-Jan group: Verts/ALE name: STAES Bart group: ECR name: CZARNECKI Ryszard group: GUE/NGL name: SØNDERGAARD Søren Bo group: EFD name: ANDREASEN Marta group: NI name: EHRENHAUSER Martin group: NI name: HARTONG Lucas responsible: True committee: CONT date: 2011-03-03T00:00:00 committee_full: Budgetary Control rapporteur: group: PPE name: MACOVEI Monica Luisa body: EP responsible: True committee: CONT date: 2011-03-03T00:00:00 committee_full: Budgetary Control rapporteur: group: PPE name: MACOVEI Monica Luisa body: EP responsible: False committee: ENVI date: 2012-07-10T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: S&D name: HAUG Jutta body: EP responsible: False committee: ENVI date: 2011-10-05T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: S&D name: HAUG Jutta date: 2012-10-02T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2012-298&language=EN type: Committee report tabled for plenary, single reading title: A7-0298/2012 body: EP type: Committee report tabled for plenary, single reading date: 2012-10-23T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2012-366 type: Decision by Parliament, 1st reading/single reading title: T7-0366/2012 body: EP type: Decision by Parliament, 1st reading/single reading date: 2012-12-20T00:00:00 type: Final act published in Official Journal docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012D0802 title: Decision 2012/802 url: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2012:350:TOC title: OJ L 350 20.12.2012, p. 0082
committees	body: EP shadows: group: S&D name: HERCZOG Edit group: ALDE name: GERBRANDY Gerben-Jan group: Verts/ALE name: STAES Bart group: ECR name: CZARNECKI Ryszard group: GUE/NGL name: SØNDERGAARD Søren Bo group: EFD name: ANDREASEN Marta group: NI name: EHRENHAUSER Martin group: NI name: HARTONG Lucas responsible: True committee: CONT date: 2011-03-03T00:00:00 committee_full: Budgetary Control rapporteur: group: PPE name: MACOVEI Monica Luisa body: EP responsible: True committee: CONT date: 2011-03-03T00:00:00 committee_full: Budgetary Control rapporteur: group: PPE name: MACOVEI Monica Luisa body: EP responsible: False committee: ENVI date: 2012-07-10T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: S&D name: HAUG Jutta body: EP responsible: False committee: ENVI date: 2011-10-05T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: S&D name: HAUG Jutta
links
other	body: EC dg: url: http://ec.europa.eu/dgs/budget/ title: Budget commissioner: ŠEMETA Algirdas
procedure	dossier_of_the_committee CONT/7/07238;CONT/7/09685 reference 2011/2220(DEC) title 2010 discharge: European Medicines Agency (EMA) stage_reached Procedure completed Modified legal basis Rules of Procedure of the European Parliament EP 150 type DEC - Discharge procedure final url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32012D0802 title: Decision 2012/802 subject 8.70.03.05 2010 discharge

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