Activites

• 2014/04/03 Decision by Parliament, 1st reading/single reading
  • T7-0316/2014 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 2012. The vote on the discharge decision approved the closure of the accounts (in accordance with Annex VI, Article 5(1) of the Rules of Procedure of the European Parliament. Noting that the Court of Auditors stated that it has obtained reasonable assurances that the annual accounts of the Agency for the financial year 2012 are reliable, and that the underlying transactions are legal and regular, Parliament adopted by 493 votes to 65, with 20 abstentions, a resolution containing a series of recommendations that form an integral part of the discharge decision and as well as the general recommendations that appear in the draft resolution on performance, financial management and control of EU agencies. These recommendations are summarised as follows: Reliability of the accounts - legality and regularity of transactions: Parliament noted that the Agency applies differing recognition criteria for fee revenues and associated expenditure and that the revenue from application fees is recognised on a straight-line basis over a set time period. It also regretted that the Agency has not yet validated its accounting system in the area of intangible fixed assets, which, given the considerable investment in the development of information and communications technology (ICT), is a crucial part of the whole accounting system. It called on the Agency to inform the discharge authority on progress in this regard within the framework of the 2012 discharge follow-up. Parliament also noted with concern that in order to cover higher school fees, the Agency grants staff whose children attend primary or secondary school a top-up allowance, which amounted to some EUR 389 000 in 2012, allowances that may be considered irregular. They acknowledged that this situation is due to the lack of European Schools in the city where the Agency is based. Budget and financial management: Parliament noted that the rate of committed appropriations carried over was high for operating expenses at 27% even though it acknowledged that this relates primarily to the Agency’s planned move to a new premises in 2014 (EUR 4 million) and to the development of ICT systems (EUR 1.6 million). Commitments and carryovers: Parliament took note that the reduced amount carried over to 2013 in comparison with 2010 and 2011 and stated that this is partly related to the new building project. They reminded the Agency of the importance of respecting the budgetary principle of annuality. Prevention and management of conflicts of interests and transparency: Parliament welcomed the fact that for the second year in a row, the Agency held a public workshop on conflicts of interests, aimed at defining the right balance between ensuring the impartiality and independence of experts involved in the Agency's work and securing the best possible scientific expertise. It stated that the Agency revised its policy on the handling of conflicts of interests by the Scientific Committees' members and experts which is expected for endorsement by the Management Board in March 2014. It called on the Agency to present that revised policy to the discharge authority once adopted. Parliament also noted that the Agency works together closely with a variety of patient, healthcare and consumer organisations in order to take their opinions into account; calls on the Agency to request public disclosure regarding the funding of any patient, consumer and healthcare organisation it works with, and to carry out a conflict of interests check regarding those organisations. Performance: Parliament requested that the Agency communicate the results and impact its work has on European citizens in an accessible way, mainly through its website. Members also made a series of observations on transfers, procurement and recruitment procedures as well as comments on internal controls.

• 2014/04/02 Debate in Parliament
  • Debate in Parliament
• 2014/03/21 Committee report tabled for plenary, single reading
  • A7-0227/2014 summary

    The Committee on Budgetary Control adopted the report by Petri SARVAMAA (EPP, FI) in which it recommended the European Parliament to grant discharge to the Executive Director of the European Medicines Agency (EMA) in respect of the implementation of the Agency's budget for the financial year 2012. Noting that the Court of Auditors stated that it has obtained reasonable assurances that the annual accounts of the Agency for the financial year 2012 are reliable, and that the underlying transactions are legal and regular, Members approved the closure of the Agency’s accounts. They made, however, a number of recommendations that needed 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. Reliability of the accounts - legality and regularity of transactions: Members noted that the Agency applies differing recognition criteria for fee revenues and associated expenditure and that the revenue from application fees is recognised on a straight-line basis over a set time period. They also regretted that the Agency has not yet validated its accounting system in the area of intangible fixed assets, which, given the considerable investment in the development of information and communications technology (ICT), is a crucial part of the whole accounting system. They called on the Agency to inform the discharge authority on progress in this regard within the framework of the 2012 discharge follow-up. Members also noted with concern that in order to cover higher school fees, the Agency grants staff whose children attend primary or secondary school a top-up allowance, which amounted to some EUR 389 000 in 2012, allowances that may be considered irregular. They acknowledged that this situation is due to the lack of European Schools in the city where the Agency is based. Budget and financial management: Members noted that the rate of committed appropriations carried over was high for operating expenses at 27% even though they acknowledged that this relates primarily to the Agency’s planned move to a new premises in 2014 (EUR 4 million) and to the development of ICT systems (EUR 1.6 million). Commitments and carryovers: Members took note that the reduced amount carried over to 2013 in comparison with 2010 and 2011 and stated that this is partly related to the new building project. They reminded the Agency of the importance of respecting the budgetary principle of annuality. Members also made a series of observations on transfers, procurement and recruitment procedures as well as comments on internal controls. Lastly, they acknowledged that the Agency revised its policy on the handling of conflicts of interests by the Scientific Committees' members and experts which is expected for endorsement by the Management Board in March 2014. They called on it to present that revised policy to the discharge authority once adopted. Members noted that the Agency works together closely with a variety of patient, healthcare and consumer organisations in order to take their opinions into account. They called on the Agency to request public disclosure regarding the funding of any patient, consumer and healthcare organisation it works with, and to carry out a conflict of interests check regarding those organisations.

• 2014/03/17 Vote in committee, 1st reading/single reading
• 2013/10/22 Committee referral announced in Parliament, 1st reading/single reading
• 2013/07/26 Non-legislative basic document published
  • COM(2013)0570 summary

    PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2012, as part of the 2012 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 2012 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 2012, 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 on the basis of a centralised procedure; ·        the Agency's budget for the 2012 financial year: the Agency’s budget for 2012, as presented in the Commission document on the consolidated annual accounts of the European Union, gives the following figures: §         Commitment appropriations: - committed : EUR 226 million; - paid : EUR 222 million; - carried over : 0. §         Payment appropriations: - committed : EUR 262 million; - paid : EUR 215 million; - carried over : EUR 41 million. See also the final accounts of the EMA.

  • DG {'url': 'http://ec.europa.eu/dgs/budget/', 'title': 'Budget'}, ŠEMETA Algirdas

Documents

• Non-legislative basic document published: COM(2013)0570
• Committee report tabled for plenary, single reading: A7-0227/2014
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 1st reading/single reading: T7-0316/2014

Amendments

Dossier

29

2013/2215(DEC) 2013/12/18 ENVI 9 amendments... Amendment 1 # Jutta HAUG Draft opinion Paragraph 1 1. Notes that in 2012 the European Medicines Agency had resources available of EUR 222.489 000 of which EUR 28.966 000 had been EU budget contributions; likes to stress that this amount represents 0.021% of the overall EU budget; is satisfied that 575 of 590 available posts had been occupied and notes that 160 contract agents and seconded national experts were employed by the end of 2012 which are 17 less than in 2011; Amendment 2 # Anna ROSBACH Draft opinion Paragraph 3 3. RecogniStresses the three comments made by the Court of Auditors which focuses on the reliability of the accounts, on the legality and regularity of transactions and on the budget management; recognises the Agency's reply; considers the explanations given by the Agency on the introduction of the SAP accounting system to recognise revenue for all fee application types with more precision as well as the information on the validation of its accounting system for intangible assets as fully sufficient; has to point out that the decision taken by the European Court of Justice on the salary method for 2011 from 19 November 2013 has also consequences for payments with regard to the correction coefficient as well as for the applicable exchange rate from EUR to GBP as the salary adjustment package includes also these two issues; invitessists that the Agency, in close cooperation with the Commission, to finds a solution in the interest of the employees and in compliance with the rules; wonders why the Court has not commented on the issue of fees payable to schools in previous years, supports the argumentation of the Agency with regard to the payment of school fees in the absence of a European School; has taken note of the reduced amount carried over to 2013 in comparison with 2010 and 2011; is aware that the carry-over is partly related to the new building project; reminds the Agency however on the annuality principle fir the budget; Amendment 3 # Julie GIRLING Draft opinion Paragraph 3 3. RecogniStresses the three comments made by the Court of Auditors which focuses on the reliability of the accounts, on the legality and regularity of transactions and on the budget management; recognises the Agency's reply; considers the explanations given by the Agency on the introduction of the SAP accounting system to recognise revenue for all fee application types with more precision as well as the information on the validation of its accounting system for intangible assets as fully sufficient; has to point out that the decision taken by the European Court of Justice on the salary method for 2011 from 19 November 2013 has also consequences for payments with regard to the correction coefficient as well as for the applicable exchange rate from EUR to GBP as the salary adjustment package includes also these two issues; invitessists that the Agency, in close cooperation with the Commission, to finds a solution in the interest of the employees and in compliance with the rules; wonders why the Court has not commented on the issue of fees payable to schools in previous years, supports the argumentation of the Agency with regard to the payment of school fees in the absence of a European School; has taken note of the reduced amount carried over to 2013 in comparison with 2010 and 2011; is aware that the carry-over is partly related to the new building project; reminds the Agency however on the annuality principle fir the budget; Amendment 4 # Antonyia PARVANOVA Draft opinion Paragraph 3 3. Recognises the three comments made by the Court of Auditors which focuses on the reliability of the accounts, on the legality and regularity of transactions and on the budget management; recognises the Agency's reply; considers the explanations given by the Agency on the introduction of the SAP accounting system to recognise revenue for all fee application types with more precision as well as the information on the validation of its accounting system for intangible assets as fully sufficient; has to points out that the decision taken by the European Court of Justice on the salary method for 2011 from 19 November 2013 has also consequences for payments with regard to the correction coefficient as well as for the applicable exchange rate from EUR to GBP as the salary adjustment package includes also these two issues; invites the Agency, in close cooperation with the Commission, to find a solution in the interest of the employees and in compliance with the rules; wonders why the Court has not commented on the issue of fees payable to schools in previous years, supports the argumentation of the Agency with regard to the payment of school fees in the absence of a European School; has taken note of the reduced amount carried over to 2013 in comparison with 2010 and 2011; is aware that the carry-over is partly related to the new building project; reminds the Agency however on the annuality principle fior the budget; Amendment 5 # Antonyia PARVANOVA Draft opinion Paragraph 4 4. Reiterates the important role of the Agency in protecting and promoting public and animal health by assessing and supervising medicines for human or veterinary use; welcomes the policy on the handling of conflict of interests, last updated and endorsed by the Management Board in March 2012; welcomes the adoption of the Agency draft policy on publication and access to clinical-trial data. Amendment 6 # Anna ROSBACH Draft opinion Paragraph 4 a (new) 4a. Believes that the discharge decision 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 framework for all European institutions and bodies; Amendment 7 # Julie GIRLING Draft opinion Paragraph 4 a (new) 4a. Believes that the discharge decision 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 framework for all European institutions and bodies; Amendment 8 # Anna ROSBACH Draft opinion Paragraph 5 5. Recommends, on the basis of the facts available, that discharge 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 2012. Amendment 9 # Julie GIRLING Draft opinion Paragraph 5 5. Recommends, on the basis of the facts available, that discharge 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 2012. source: PE-526.144 2014/02/25 CONT 20 amendments... Amendment 1 # Petri SARVAMAA 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 2012 / 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 2012; Amendment 10 # Monica MACOVEI Motion for a resolution Recital A a (new) Aa. whereas according to its financial statements, the overall contribution of the Union to the Agency's budget for 2012 amounted to EUR 31 341 107.18, representing a decrease of 6, 50 % compared to 2011, Amendment 11 # Bart STAES Motion for a resolution Paragraph 4 4. Regrets that the Agency has not yet validated its accounting system in the area of intangible fixed assets, which, given the considerable investment in the development of information and communications technology (ICT), is a crucial part of the whole accounting system; calls on the Agency to inform the discharge authority on progress in this regard within the framework of the 2012 discharge follow-upbefore October 2014; Amendment 12 # Ryszard CZARNECKI, Marta ANDREASEN, Philip BRADBOURN, Andrea ČEŠKOVÁ, Derk Jan EPPINK Motion for a resolution Paragraph 8 8. Notes with concern that in 2012, the Agency issued multiple framework contracts for the provision of services; expresses concern that the procurement procedure presented some irregularities affecting the principle of transparency and demands that the Agency address this issue; Amendment 13 # Monica MACOVEI Motion for a resolution Subheading 6 a (new) Prevention and management of conflicts of interests and transparency Amendment 14 # Rina Ronja KARI Motion for a resolution Subheading 6 a (new) Conflicts of interests Amendment 15 # Monica MACOVEI Motion for a resolution Paragraph 10 a (new) 10a. Welcomes the fact that for the second year in a row, the Agency held a public workshop on conflicts of interests, aimed at defining the right balance between ensuring the impartiality and independence of experts involved in the Agency's work while securing the best possible scientific expertise; Amendment 16 # Rina Ronja KARI Motion for a resolution Paragraph 10 a (new) 10a. Looks forward to the revised version of the Agency's conflicts of interests policy; emphasises that the Agency should continue its work to further strengthen its conflicts of interest policy; Amendment 17 # Monica MACOVEI Motion for a resolution Paragraph 10 b (new) 10b. Acknowledges that the Agency revised its policy on the handling of conflicts of interests by the Scientific Committees' members and experts which is expected for endorsement by the Management Board in March 2014; calls on the Agency to present its revised policy to the discharge authority once adopted; Amendment 18 # Rina Ronja KARI Motion for a resolution Paragraph 10 b (new) 10b. Notes that the Agency works together closely with a variety of patient, healthcare and consumer organisations in order to take their opinions into account; calls on the Agency to request the public disclosure of funding information of any patient, consumer and healthcare organisation and to carry out a conflicts of interests check before the Agency involves them in its work; Amendment 19 # Gerben-Jan GERBRANDY, Chris DAVIES, Jan MULDER Performance Amendment 2 # Karin KADENBACH 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 2012 / 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 2012; Amendment 20 # Gerben-Jan GERBRANDY, Chris DAVIES, Jan MULDER Motion for a resolution Paragraph 11 a (new) 11a. Requests that the Agency communicate the results and impact its work has on European citizens in an accessible way, mainly through its website; Amendment 3 # Ryszard CZARNECKI, Marta ANDREASEN, Philip BRADBOURN, Andrea ČEŠKOVÁ 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 2012 / 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 2012; Amendment 4 # Bart STAES 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 2012 / 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 2012; Amendment 5 # Ryszard CZARNECKI, Marta ANDREASEN, Philip BRADBOURN, Andrea ČEŠKOVÁ, Derk Jan EPPINK Proposal for a decision 2 Paragraph 1 1. Approves the closure of the accounts of the European Medicines Agency for the financial year 2012 / Postpones its decision on the closure of the accounts of the European Medicines Agency for the financial year 2012; Amendment 6 # Petri SARVAMAA Proposal for a decision 2 Paragraph 1 1. Approves the closure of the accounts of the European Medicines Agency for the financial year 2012 / Postpones its decision on the closure of the accounts of the European Medicines Agency for the financial year 2012; Amendment 7 # Karin KADENBACH Proposal for a decision 2 Paragraph 1 1. Approves the closure of the accounts of the European Medicines Agency for the financial year 2012 / Postpones its decision on the closure of the accounts of the European Medicines Agency for the financial year 2012; Amendment 8 # Elena BĂSESCU Motion for a resolution Citation 10 a (new) – having regard to the previous discharge reports of the Parliament; Amendment 9 # Monica MACOVEI Motion for a resolution Recital A A. whereas, according to its financial statements, the final budget of the European Medicines Agency (‘"the Agency’") for the financial year 2012 was EUR 222 489 000, representing an increase of 6,52 % compared to 2011, source: PE-521.807

History

(these mark the time of scraping, not the official date of the change)