Procedure completed
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | CONT | GERBRANDY Gerben-Jan (ALDE) | SARVAMAA Petri (PPE), AYALA SENDER Inés (S&D), STAES Bart (Verts/ALE), BRADBOURN Philip (ECR), SØNDERGAARD Søren Bo (GUE/NGL), ANDREASEN Marta (EFD), EHRENHAUSER Martin (NI) |
Opinion | ENVI | HAUG Jutta (S&D) |
Activites
- 2013/11/16 Final act published in Official Journal
-
2013/04/17
Decision by Parliament, 1st reading/single reading
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T7-0150/2013
summary
The European Parliament adopted a decision on 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 2011. The vote on the decision to grant discharge covers the closure of the accounts (in accordance with Annex VI, Article 5(1) of the European Parliament’s Rules of Procedure). Noting that the Court of Auditors stated that it has obtained reasonable assurances that the annual accounts of the Agency for the financial year 2011 are reliable and that the underlying transactions are legal and regular, Parliament adopted a resolution containing a number of recommendations that need to be taken into account when the discharge is granted, in addition to the general recommendations that appear in the draft resolution on performance, financial management and control of EU agencies: Financing, budget and financial management: Parliament recalls that the Agency's budget for 2011 was EUR 208 863 000, which represents a nominal increase over the financial year 2010. It recalls that the total Union contributions amounted to EUR 39 765 191.39 for 2011, which represents an 8.65% increase compared to the previous year and that the rest was financed by fees paid by the pharmaceutical industry when applying for, obtaining or maintaining Union marketing authorisations. Members state that a large amount of the Agency's revenue is estimated to have derived from the fee revenue, which continues to increase year on year. Members are concerned as regards the need to introduce a system of remuneration for services provided by Member States’ authorities, based on their real costs. Implementation rate of appropriations: Parliament observes that in terms of committed and paid appropriations, the Agency's execution rate stands at 95.21% and 81.97% respectively. It calls on the Agency to continue its efforts to improve its execution rate of payment. It is concerned that once again, the Court of Auditors reported that payment appropriations for Title II ("Administrative expenditure") have been carried over to 2012, representing 29% of the budget which is excessive and at odds with the principle of annuality. Recruitment procedures: Parliament states the lack of transparency in the staff selection procedures. It states that there was no evidence of any action taken to address the issues. Conflicts of interest: noting the problems as regards the conflict of interest in the light of the previous discharge procedure, Parliament welcomes the efforts made but state that the Agency did not adequately manage conflict of interest situations. It welcomes the Agency's commitment to undertake in the first half of 2013 a review of the implementation of its revised policy on the handling of conflicts of interests and that an ex ante and ex post check on the handling of conflicts of interests is currently being developed for implementation in the second quarter of 2013. The Agency is called upon to keep the discharge authority informed on their respective outcomes. Lastly, Parliament made a series of observations concerning the procurement procedures and controls carried out by this Community Agency.
-
T7-0150/2013
summary
- 2013/04/16 Debate in Parliament
-
2013/03/22
Committee report tabled for plenary, single reading
-
A7-0098/2013
summary
The Committee on Budgetary Control adopted the report by Gerben-Jan GERBRANDY (ADLE, NL) on 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 2011. Noting that the Court of Auditors stated that it has obtained reasonable assurances that the annual accounts of the Agency for the financial year 2011 are reliable and that the underlying transactions are legal and regular, Members approve the closure of the Agency’s accounts. However, they make a number of recommendations that need to be taken into account when the discharge is granted, in addition to the general recommendations that appear in the draft resolution on performance, financial management and control of EU agencies: Financing, budget and financial management: Members recall that the Agency's budget for 2011 was EUR 208 863 000, which represents a nominal increase over the financial year 2010. They recall that the total Union contributions amounted to EUR 39 765 191.39 for 2011, which represents an 8.65% increase compared to the previous year and that the rest was financed by fees paid by the pharmaceutical industry when applying for, obtaining or maintaining Union marketing authorisations. Members state that a large amount of the Agency's revenue is estimated to have derived from the fee revenue, which continues to increase year on year. Members are concerned as regards the need to introduce a system of remuneration for services provided by Member States’ authorities, based on their real costs. Implementation rate of appropriations: Members observe that in terms of committed and paid appropriations, the Agency's execution rate stands at 95.21% and 81.97% respectively. They call on the Agency to continue its efforts to improve its execution rate of payment. They are concerned that once again, the Court of Auditors reported that payment appropriations for Title II ("Administrative expenditure") have been carried over to 2012, representing 29% of the budget which is excessive and at odds with the principle of annuality. Conflicts of interest: noting the problems as regards the conflict of interest in the light of the previous discharge procedure, Members welcome the efforts made but state that the Agency did not adequately manage conflict of interest situations. They welcome the Agency's commitment to undertake in the first half of 2013 a review of the implementation of its revised policy on the handling of conflicts of interests and that an ex ante and ex post check on the handling of conflicts of interests is currently being developed for implementation in the second quarter of 2013. The Agency is called upon to keep the discharge authority informed on their respective outcomes. Lastly, Members made a series of observations concerning the recruitment and procurement procedures and controls carried out by this Community Agency.
-
A7-0098/2013
summary
-
2013/03/19
Vote in committee, 1st reading/single reading
-
2012/09/13
Committee referral announced in Parliament, 1st reading/single reading
-
2012/07/25
Non-legislative basic document published
-
COM(2012)0436
summary
PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2011, as part of the 2011 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 2011 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 2011, 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 and its role is the coordination of 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 2011 financial year: the Agency’s budget for 2011, as presented in the Commission document on the consolidated annual accounts of the European Union, gives the following figures: forecasted income budget: EUR 209 million; entitlements established: EUR 220 million; amounts received: EUR 199 million; outstanding: EUR 21 million. 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/2012/07/WC500129887.pdf
- DG {'url': 'http://ec.europa.eu/dgs/budget/', 'title': 'Budget'}, ŠEMETA Algirdas
-
COM(2012)0436
summary
Documents
- Non-legislative basic document published: COM(2012)0436
- Committee report tabled for plenary, single reading: A7-0098/2013
- Debate in Parliament: Debate in Parliament
- Decision by Parliament, 1st reading/single reading: T7-0150/2013
- : Decision 2013/584
- : OJ L 308 16.11.2013, p. 0254
Amendments | Dossier |
36 |
2012/2190(DEC)
2012/12/20
ENVI
11 amendments...
Amendment 1 #
Draft opinion Paragraph 1 a (new) 1a. Points to the role of the European Medicines Agency in protecting and promoting public and animal health by assessing and supervising medicines for human or veterinary use;
Amendment 10 #
Draft opinion Paragraph 8 a (new) 8a. Believes that the discharge decision for the Agency should be based upon OECD guidelines to ensure high-quality internationally recognised accounting, audit and financial disclosure standards; invites the European institutions to incorporate and commit to introducing OECD guidelines within a common working framework for all European institutions and bodies;
Amendment 11 #
Draft opinion Paragraph 8 b (new) 8b. Is of the opinion that the Agency should not be granted discharge in respect of the implementation of the Agency budget for the financial year 2011 until the general budget of the European Union is given an unqualified statement of assurance by the Court of Auditors.
Amendment 2 #
Draft opinion Paragraph 1 a (new) 1a. Draws attention to the Health and Consumer Protection Commissioner’s pledge to pursue an initiative for a common rulebook governing the auditing and management of the Agency and to tackle the various instances of conflicts for interest, whilst examining the scope for cuts to its operating budget;
Amendment 3 #
Draft opinion Paragraph 2 2. Thinks it is noteworthy in this context that the special report on Conflict of Interests by the Court of Auditors concluded that none of the agencies scrutinised, including the EMA, dealt properly with conflicts of interest; notes that the report is not taking into account to the full the latest developments and improvements put in place by the Agency; therefore, notes with satisfaction the improvement of all procedures related to transparency and possible conflicts of interest in the Agency; intends to ascertain that those procedures are in fact being implemented, especially as regards ex ante and ex post checks on declarations of interests, and will support the Executive Director in hi
Amendment 4 #
Draft opinion Paragraph 2 2. Thinks it is noteworthy in this context that the special report on Conflict of Interests by the Court of Auditors is not taking into account to the full the latest developments and improvements put in place by the Agency; therefore, notes with satisfaction the improvement of all procedures related to transparency and possible conflicts of interest in the Agency, recalls, however, the importance of continuously working for strengthening and enhancement of all policies related to transparency and independence and will support the Executive Director in hi
Amendment 5 #
Draft opinion Paragraph 2 2. Thinks it is noteworthy in this context that the special report on Conflict of Interests by the Court of Auditors is not taking into account to the full the latest developments and improvements put in place by the Agency; therefore, notes
Amendment 6 #
Draft opinion Paragraph 2 a (new) 2a. Looks to the Agency to produce a report on the implementation of the system of ex ante and ex post verification of declarations of interests; shares the view of the Agency’s Executive Director that, given its scope, a system of that kind is beyond the Agency’s capacity and remit; believes, therefore, that one option to consider should be a legislative initiative whereby holders of a marketing authorisation (MA) for a pharmaceutical product would be obliged to publish agreements and all benefits in cash or in kind that they provided, directly or indirectly, to experts or bodies with whom they worked;
Amendment 7 #
Draft opinion Paragraph 7 7. Acknowledges the efforts by the executive level of the Agency to encourage a decision by the Management Board to revise the system of remuneration of Member States services based on real costs;
Amendment 8 #
Draft opinion Paragraph 8 Amendment 9 #
Draft opinion Paragraph 8 8.
source: PE-502.119
2013/02/27
CONT
25 amendments...
Amendment 1 #
Proposal for a decision 1 Paragraph 1 1.
Amendment 10 #
Motion for a resolution Paragraph 4 a (new) 4a. Observes that in terms of committed and paid appropriations the Agency's execution rate stands respectively at 95.21% and 81.97% against 95.65% and 79.10% in 2010; calls on the Agency to continue its efforts to improve its execution rate of payment;
Amendment 11 #
Motion for a resolution Paragraph 5 5. Notes with concern that as in its
Amendment 12 #
Motion for a resolution Paragraph 7 7. Notes with concern the difference between the Court of Auditors' conclusion and the Agency's reply as regards the framework contract for IT services concluded in 2009, for which the Court had qualified its opinion on the legality and regularity of the transactions underlying the Agency's 2009 accounts; notes that the Court of Auditors considers the increase of the original contract ceiling to be irregular, while the Agency considers that the IT framework contract was not irregular, and therefore does not consider its extension as irregular either; urges the Agency to provide
Amendment 13 #
Motion for a resolution Paragraph 8 a (new) 8a. Notes that in 2011, the Agency advertised 15 vacancies for temporary agent positions and that at year-end the total number of staff at the Agency increased from 656 to 689; (To be placed under subtitle "recruitment procedures")
Amendment 14 #
Motion for a resolution Paragraph 9 9. Acknowledges from the Court of Auditors the need to improve the transparency of staff selection procedures;
Amendment 15 #
Motion for a resolution Paragraph 9 9. Acknowledges from the Court of Auditors the need to improve the transparency of staff selection procedures; acknowledges that Selection Board members did not always complete their conflict of interest declarations or did not do so in a timely manner, and there was no evidence of any action taken to address the issues raised by these declarations; acknowledges that the documentation of the Selection Board’s proceedings was not always adequate and that there is no evidence as to how the method for the short-listing of candidates was established and that the questions for the written tests or interviews were set before the examinations, and therefore urges the Agency, in common with other agencies and authorities, to appoint an ethics adviser for these procedures;
Amendment 16 #
Motion for a resolution Paragraph 10 10. Notes from the Agency that it has taken note of the Court of Auditors' comments
Amendment 17 #
Motion for a resolution Paragraph 11 a (new) 11a. Notes that according to the findings of the Court of Auditors, at the time of completion of the field work (October 2011), the Agency did not adequately manage conflict of interest situations but has developed one of the most advanced policies and procedure for declaring, assessing and managing conflicts of interest;
Amendment 18 #
Motion for a resolution Paragraph 11 a (new) 11a. Notes with concern that according to the findings of the Court of Auditors, at the time of completion of the field work (October 2011), the Authority did not adequately manage conflict of interest situations; notes, however, that the Authority had already developed advanced policies for managing conflicts of interest;
Amendment 19 #
Motion for a resolution Paragraph 12 – introductory part 12.
Amendment 2 #
Proposal for a decision 1 Paragraph 1 1.
Amendment 20 #
Motion for a resolution Paragraph 12 – introductory part 12. Notes that the Agency has taken a number of steps following the discharge authority's recommendations for 2010, the Court of Auditors' audit and the publication of Special Report 15/2012, in particular:
Amendment 21 #
Motion for a resolution Paragraph 12 a (new) 12a. Welcomes the Agency's commitment to undertake in the first half of 2013 a review of the implementation of its revised policy on the handling of conflicts of interests and that an ex ante and ex post check on the handling of conflicts of interests is currently being developed for implementation in the second quarter of 2013; calls on the Agency to keep the discharge authority informed on their respective outcomes;
Amendment 22 #
Motion for a resolution Paragraph 12 b (new) 12b. Welcomes that after the former Head of Legal Service left the Agency to join as senior counsel a US-based law firm having a number of pharmaceutical industry companies as clients in June 2012 the Executive Director of the Agency launched a review of his work as Head of the Legal Service, Chair of the Joint Committee, Chair of the Disciplinary Committee and member of the Advisory Committee on Procurement and Contracts; acknowledges that no evidence of conflicts of interest nor breach of obligations provided in Articles 11 and 11a of the Staff Regulations could be identified ; welcomes that in accordance with Article 16 of the Staff Regulations the Executive Director imposed some restrictions to the activities of the former Head of Legal Service for a period of two years following his leaving the EMA; calls on the Agency to provide the discharge authority with detailed information on those restrictions;
Amendment 23 #
Motion for a resolution Paragraph 12 – subparagraph 1 urges the Agency to report to the discharge authority on a 6 months basis on the implementation of the abovementioned policies and procedures, as well as on any further developments as regards management of conflict of interest;
Amendment 24 #
Motion for a resolution Paragraph 12 – subparagraph 1 urges the Agency to continue implementing the Court of Auditors' recommendations in order to avoid any conflict of interest in its various structures of governance and operation, and to report to the discharge authority on the implementation of the abovementioned policies and procedures, as well as on any further developments as regards management of conflict of interest;
Amendment 25 #
Motion for a resolution Paragraph 12 – subparagraph 1 a (new) Calls on the agency to start a structured dialogue with civil society on matters relating to conflicts of interest and to invite those organisations concerned at least twice a year to discuss matters of common interest based on a agreed agenda and to inform the discharge authorities on the outcome of these deliberations;
Amendment 3 #
Proposal for a decision 1 Paragraph 1 1.
Amendment 4 #
Proposal for a decision 2 Paragraph 1 1.
Amendment 5 #
Proposal for a decision 2 Paragraph 1 1.
Amendment 6 #
Proposal for a decision 2 Paragraph 1 1.
Amendment 7 #
Motion for a resolution Recital D D. whereas the overall contribution of the Union to the Agency's budget for 2011 was EUR 39 765 191,39
Amendment 9 #
Motion for a resolution Paragraph 1 1.
source: PE-497.879
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The European Parliament adopted a decision on 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 2011. The vote on the decision to grant discharge covers the closure of the accounts (in accordance with Annex VI, Rule 5(1) of the European Parliaments Rules of Procedure). Noting that the Court of Auditors stated that it has obtained reasonable assurances that the annual accounts of the Agency for the financial year 2011 are reliable and that the underlying transactions are legal and regular, Parliament adopted a resolution containing a number of recommendations that need to be taken into account when the discharge is granted, in addition to the general recommendations that appear in the draft resolution on performance, financial management and control of EU agencies:
Lastly, Parliament made a series of observations concerning the procurement procedures and controls carried out by this Community Agency. New
The European Parliament adopted a decision on 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 2011. The vote on the decision to grant discharge covers the closure of the accounts (in accordance with Annex VI, Article 5(1) of the European Parliaments Rules of Procedure). Noting that the Court of Auditors stated that it has obtained reasonable assurances that the annual accounts of the Agency for the financial year 2011 are reliable and that the underlying transactions are legal and regular, Parliament adopted a resolution containing a number of recommendations that need to be taken into account when the discharge is granted, in addition to the general recommendations that appear in the draft resolution on performance, financial management and control of EU agencies:
Lastly, Parliament made a series of observations concerning the procurement procedures and controls carried out by this Community Agency. |
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PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2011, as part of the 2011 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 2011 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 2011, the tasks and budget of this agency were as follows:
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/2012/07/WC500129887.pdf New
PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2011, as part of the 2011 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 2011 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 2011, the tasks and budget of this agency were as follows:
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