2009/2118(DEC)

2008 discharge: European Medicines Agency EMEA

Procedure completed

General
Activities
Documents
Votes
Amendments (3)
History

2009/2118(DEC) 2008 discharge: European Medicines Agency EMEA

Role	Committee	Rapporteur	Shadows
Lead	CONT	MATHIEU Véronique (EPP)
Opinion	ENVI	HAUG Jutta (S&D)

Lead committee dossier: CONT/7/01104

Subjects

8.70.03.03 2008 discharge

Links

Activites

2010/09/25 Final act published in Official Journal
- Decision 2010/528
- OJ L 252 25.09.2010, p. 0164
2010/05/05 Text adopted by Parliament, single reading
- T7-0108/2010 summary
  
  The European Parliament adopted by 553 votes to 30, with 57 abstentions, a decision on discharge to be granted to the Executive Director of the European Medicines Agency in respect of the implementation of its budget for the financial year 2008. The decision to grant discharge is also an approval of the closure of the accounts of this EU agency. Furthermore, Parliament adopted a resolution with observations which are an integral part of the decision to grant discharge to this Agency. The main points are as follows: carry over of appropriations: Parliament is concerned that the Court of Auditors has pointed out that the budget appropriations carried over and cancelled have amounted respectively to EUR 36 million (19.7% of the budget). It points out, as noted in previous financial years, that the high level of carry-overs for administrative expenditure was mainly due to IT expenditure. It is, consequently, concerned as this situation has existed for a number of years and is at odds with the annuality principle; procurement procedures: Parliament calls on the Agency to improve the quality of its procurement procedures so as to put an end to the shortcomings identified by the Court of Auditors. It takes note of the Agency's longstanding policy of entering into a forward foreign exchange contract in order to hedge part of its administrative budget against unfavourable fluctuations in the exchange rate of sterling. Parliament expects the Agency to manage such transactions prudently and recommends that a working group be set up to observe and closely monitor the hedging strategy; revenue from fees: Parliament points out that the fees charged for evaluation services are the main source of the Agency's revenue, accounting for 70.2% of its total revenue in 2008. It notes that the Agency reported EUR 2 046 000 in income from interest in 2008. It concludes from the financial statements and from the level of the interest payments that the Agency has a permanently extremely high level of cash holdings (on 31 December 2008, the Agency's cash holdings amounted to EUR 41.887 million). It asks the Commission to examine what scope there is for helping to ensure that the cash holdings are managed entirely on a needs-orientated basis and what changes of approach are necessary in order to keep the Agency's cash holdings permanently as low as possible; internal audit: lastly, Parliament asks the Agency to implement the recommendations from the Internal Audit Service (IAS) in particular as regards the conflicts of interest. Noting that the Agency's annual accounts for the financial year 2008 are reliable, and the underlying transactions are legal and regular, Parliament approves the closure of its accounts and refers to the general recommendations that appear in the draft resolution on financial management and control of EU agencies (see 2010/2007(INI) adopted in parallel).
- Results of vote in Parliament
2010/04/21 Debate in Parliament
2010/03/26 Committee report tabled for plenary, single reading
- A7-0078/2010
2010/03/26 Committee report tabled for plenary, single reading
- A7-0078/2010
2010/03/23 Vote in committee, 1st reading/single reading
- CONT CONT/7/01104 MATHIEU Véronique EPP
- ENVI HAUG Jutta S&D
#2994
2010/02/16 Council Meeting
2010/02/03 Committee draft report
- PE430.483
2009/10/07 Committee referral announced in Parliament, 1st reading/single reading
- CONT CONT/7/01104 MATHIEU Véronique EPP
- ENVI HAUG Jutta S&D
2009/07/23 Non-legislative basic document published
- SEC(2009)1089 summary
  
  PURPOSE: to present the final accounts of the European Medicines Agency for the financial year 2008. CONTENT: this document sets out a detailed account of the implementation of the European Medicines Agency's budget for the financial year 2008. It notes that the final budget amounts to EUR 182.9 million in 2008 (compared to EUR 163.1 million in 2007), representing a 21.9% Community subsidy (excluding subsidy for orphan medicines). As regards the staffing policy, the Agency, whose head office is in London (United Kingdom), officially set out 481 posts in its establishment plan. 469 of these posts are currently occupied with 118 other posts (auxiliary agents, contract agents seconded national experts, employment agency staff) totalling 587 posts assigned to operational and administrative tasks. Throughout 2008, the Agency concentrated on coordinating the scientific evaluation of medicinal products. Medicinal Products for Human Use · replied to 103 applications for marketing authorisations and delivered 68 favourable opinions. The average evaluation time dedicated was 184 days · delivered 2 122 opinions after authorisation · drafted 193 587 Pharmacovigilance reports and 391 periodic safety update reports · delivered 263 scientific advice finalised: 263 and 14 522 procedures for mutual recognition · made 271 applications for paediatric investigation plans and relating to 395 indication(new task). Medicinal Products for Veterinary Use · replied to 13 new applications and 100 applications in respect of variants · carried out 253 inspections. Orphan Medicinal Products · made 119 applications and gave 86 favourable opinions. SMEs · replied to 242 requests for SME status · replied to 84 applications for fee reduction or deferrals. The complete version of the final accounts may be found at the following address: http://www.emea.europa.eu/htms/general/manage/ar.htm
2009/07/23 Date
2009/07/23 Non-legislative basic document
- SEC(2009)1089 summary
  
  PURPOSE: to present the final accounts of the European Medicines Agency for the financial year 2008. CONTENT: this document sets out a detailed account of the implementation of the European Medicines Agency's budget for the financial year 2008. It notes that the final budget amounts to EUR 182.9 million in 2008 (compared to EUR 163.1 million in 2007), representing a 21.9% Community subsidy (excluding subsidy for orphan medicines). As regards the staffing policy, the Agency, whose head office is in London (United Kingdom), officially set out 481 posts in its establishment plan. 469 of these posts are currently occupied with 118 other posts (auxiliary agents, contract agents seconded national experts, employment agency staff) totalling 587 posts assigned to operational and administrative tasks. Throughout 2008, the Agency concentrated on coordinating the scientific evaluation of medicinal products. Medicinal Products for Human Use · replied to 103 applications for marketing authorisations and delivered 68 favourable opinions. The average evaluation time dedicated was 184 days · delivered 2 122 opinions after authorisation · drafted 193 587 Pharmacovigilance reports and 391 periodic safety update reports · delivered 263 scientific advice finalised: 263 and 14 522 procedures for mutual recognition · made 271 applications for paediatric investigation plans and relating to 395 indication(new task). Medicinal Products for Veterinary Use · replied to 13 new applications and 100 applications in respect of variants · carried out 253 inspections. Orphan Medicinal Products · made 119 applications and gave 86 favourable opinions. SMEs · replied to 242 requests for SME status · replied to 84 applications for fee reduction or deferrals. The complete version of the final accounts may be found at the following address: http://www.emea.europa.eu/htms/general/manage/ar.htm
- DG Budget, ŠEMETA Algirdas

Documents

Non-legislative basic document published: SEC(2009)1089
Non-legislative basic document: SEC(2009)1089
Committee draft report: PE430.483
Committee report tabled for plenary, single reading: A7-0078/2010
Committee report tabled for plenary, single reading: A7-0078/2010
Decision by Parliament, 1st reading/single reading: T7-0108/2010
Results of vote in Parliament: Results of vote in Parliament
: Decision 2010/528
: OJ L 252 25.09.2010, p. 0164

Votes

Report: MATHIEU A7-0078/2010 - SINGLE VOTE

2010/05/05

Position	Total	ALDE	ECR	EFD	GUE/NGL	NI	PPE	S&D	Verts/ALE	correctional
For	553	76	0	13	0	8	243	165	48	0
Against	30	0	19	0	1	10	0	0	0	0
Abstain	57	0	22	5	27	3	0	0	0	0

Report: Mitchell A7-0078/2010 - Legislative resolution

2010/10/21

Position	Total	ALDE	ECR	EFD	GUE/NGL	NI	PPE	S&D	Verts/ALE	correctional
For	583	69	41	16	23	8	223	156	47	0
Against	6	0	0	0	0	5	1	0	0	0
Abstain	19	0	2	6	3	8	0	0	0	0

Amendments	Dossier
3	2009/2118(DEC) 2008 discharge: European Medicines Agency EMEA 2010/02/02 ENVI 2 amendments... Amendment 1 # Jutta HAUG Draft opinion Paragraph 1 1. Stresses the important role of the European Medicine Agency to ensure the evaluation and supervision of medicinal products for human and veterinary use; underlines the importance of EMEA's specific provisions for SMEs which led to financial facilitation and fostered innovation and the development of new medicinal products; Amendment 2 # Thomas ULMER Draft opinion paragraph 3 a (new) 3a. Observes that the financial relief for small and medium-sized enterprises was a success; source: PE-438.444 2010/03/03 CONT 1 amendments... Amendment 1 # Ingeborg GRÄSSLE Motion for a resolution Paragraph 4 a (new) 4a. notes that the Agency reported EUR 2 046 000 in income from interest in 2008; concludes from the financial statements and from the level of the interest payments that the Agency has a permanently extremely high level of cash holdings; notes that on 31 December 2008 the Agency’s cash holdings amounted to EUR 41 887 000; asks the Commission to examine what scope there is for helping to ensure that the cash holdings are managed entirely on a needs-orientated basis, in accordance with Article 15(5) of Regulation (EG, Euratom) No 2343/2002, and what changes of approach are necessary in order to keep the Agency’s cash holdings permanently as low as possible; source: PE-439.368

Amendments

Dossier

2009/2118(DEC) 2008 discharge: European Medicines Agency EMEA

2010/02/02 ENVI 2 amendments...

source: PE-438.444

2010/03/03 CONT 1 amendments...

source: PE-439.368

History

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

2012-02-09

activities	added	date 2009-07-23 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=JOINT-TEXT&mode=XML&reference=C7-2009-0189&language=EN text PURPOSE: to present the final accounts of the European Medicines Agency for the financial year 2008. CONTENT: this document sets out a detailed account of the implementation of the European Medicines Agency's budget for the financial year 2008. It notes that the final budget amounts to EUR 182.9 million in 2008 (compared to EUR 163.1 million in 2007), representing a 21.9% Community subsidy (excluding subsidy for orphan medicines). As regards the staffing policy, the Agency, whose head office is in London (United Kingdom), officially set out 481 posts in its establishment plan. 469 of these posts are currently occupied with 118 other posts (auxiliary agents, contract agents seconded national experts, employment agency staff) totalling 587 posts assigned to operational and administrative tasks. Throughout 2008, the Agency concentrated on coordinating the scientific evaluation of medicinal products. Medicinal Products for Human Use · replied to 103 applications for marketing authorisations and delivered 68 favourable opinions. The average evaluation time dedicated was 184 days · delivered 2 122 opinions after authorisation · drafted 193 587 Pharmacovigilance reports and 391 periodic safety update reports · delivered 263 scientific advice finalised: 263 and 14 522 procedures for mutual recognition · made 271 applications for paediatric investigation plans and relating to 395 indication(new task). Medicinal Products for Veterinary Use · replied to 13 new applications and 100 applications in respect of variants · carried out 253 inspections. Orphan Medicinal Products · made 119 applications and gave 86 favourable opinions. SMEs · replied to 242 requests for SME status · replied to 84 applications for fee reduction or deferrals. The complete version of the final accounts may be found at the following address: http://www.emea.europa.eu/htms/general/manage/ar.htm type Non-legislative basic document published title SEC(2009)1089 body type Non-legislative basic document published body EP date 2009-07-23 type Date date 2009-07-23 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=JOINT-TEXT&mode=XML&reference=C7-2009-0189&language=EN text PURPOSE: to present the final accounts of the European Medicines Agency for the financial year 2008. CONTENT: this document sets out a detailed account of the implementation of the European Medicines Agency's budget for the financial year 2008. It notes that the final budget amounts to EUR 182.9 million in 2008 (compared to EUR 163.1 million in 2007), representing a 21.9% Community subsidy (excluding subsidy for orphan medicines). As regards the staffing policy, the Agency, whose head office is in London (United Kingdom), officially set out 481 posts in its establishment plan. 469 of these posts are currently occupied with 118 other posts (auxiliary agents, contract agents seconded national experts, employment agency staff) totalling 587 posts assigned to operational and administrative tasks. Throughout 2008, the Agency concentrated on coordinating the scientific evaluation of medicinal products. Medicinal Products for Human Use · replied to 103 applications for marketing authorisations and delivered 68 favourable opinions. The average evaluation time dedicated was 184 days · delivered 2 122 opinions after authorisation · drafted 193 587 Pharmacovigilance reports and 391 periodic safety update reports · delivered 263 scientific advice finalised: 263 and 14 522 procedures for mutual recognition · made 271 applications for paediatric investigation plans and relating to 395 indication(new task). Medicinal Products for Veterinary Use · replied to 13 new applications and 100 applications in respect of variants · carried out 253 inspections. Orphan Medicinal Products · made 119 applications and gave 86 favourable opinions. SMEs · replied to 242 requests for SME status · replied to 84 applications for fee reduction or deferrals. The complete version of the final accounts may be found at the following address: http://www.emea.europa.eu/htms/general/manage/ar.htm type Non-legislative basic document title SEC(2009)1089 body EC commission DG Budget Commissioner ŠEMETA Algirdas type Non-legislative basic document date 2009-10-07 body EP type Committee referral announced in Parliament, 1st reading/single reading committees body EP responsible True committee CONT date 2009-10-01 committee_full Budgetary Control rapporteur group EPP name MATHIEU Véronique body EP responsible False committee ENVI date 2009-10-06 committee_full Environment, Public Health and Food Safety rapporteur group S&D name HAUG Jutta date 2010-02-03 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE430.483 type Committee draft report title PE430.483 body EP type Committee draft report date 2010-02-16 body CSL type Council Meeting council Economic and Financial Affairs ECOFIN meeting_id 2994 date 2010-03-23 text The Committee on Budgetary Control adopted the report by Véronique MATHIEU (EPP, FR) on discharge to be granted to the European Medicines Agency, calling on the European Parliament to grant the Executive Director of the Agency discharge in respect of the implementation of the Agency's budget for the financial year 2008. Noting that the Agency's annual accounts for the financial year 2008 are reliable, and the underlying transactions are legal and regular, MEPs 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 financial management and control of EU agencies (see 2010/2007(INI): carry over of appropriations: Members are concerned that the Court of Auditors has pointed out that the budget appropriations carried over and cancelled have amounted respectively to EUR 36 million (19.7% of the budget). They point out, as noted in previous financial years, that the high level of carry-overs for administrative expenditure was mainly due to IT expenditure. They are consequently concerned as this situation has existed for a number of years and is at odds with the annuality principle; procurement procedures: Members called on the Agency to improve the quality of its procurement procedures so as to put an end to the shortcomings identified by the Court of Auditors. They take note of the Agency's longstanding policy of entering into a forward foreign exchange contract in order to hedge part of its administrative budget against unfavourable fluctuations in the exchange rate of sterling. MEPs expect the Agency to manage such transactions prudently and recommend that a working group be set up to observe and closely monitor the hedging strategy; revenue from fees: Members point out that the fees charged for evaluation services are the main source of the Agency's revenue, accounting for 70.2% of its total revenue in 2008. They note that the Agency reported EUR 2 046 000 in income from interest in 2008. They conclude from the financial statements and from the level of the interest payments that the Agency has a permanently extremely high level of cash holdings (on 31 December 2008 the Agency's cash holdings amounted to EUR 41.887 million). They ask the Commission to examine what scope there is for helping to ensure that the cash holdings are managed entirely on a needs-orientated basis and what changes of approach are necessary in order to keep the Agency's cash holdings permanently as low as possible; internal audit: lastly, Members ask the Agency to implement the recommendations from the Internal Audit Service (IAS) in particular as regards the conflicts of interest. body EP committees body EP responsible True committee CONT date 2009-10-01 committee_full Budgetary Control rapporteur group EPP name MATHIEU Véronique body EP responsible False committee ENVI date 2009-10-06 committee_full Environment, Public Health and Food Safety rapporteur group S&D name HAUG Jutta type Vote in committee, 1st reading/single reading date 2010-03-26 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2010-0078&language=EN type Committee report tabled for plenary, single reading title A7-0078/2010 body type Committee report tabled for plenary, single reading date 2010-03-26 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A7-2010-0078&language=EN type Committee report tabled for plenary, single reading title A7-0078/2010 body EP type Committee report tabled for plenary, single reading date 2010-04-21 body EP type Debate in Parliament date 2010-05-05 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P7-TA-2010-0108 text The European Parliament adopted by 553 votes to 30, with 57 abstentions, a decision on discharge to be granted to the Executive Director of the European Medicines Agency in respect of the implementation of its budget for the financial year 2008. The decision to grant discharge is also an approval of the closure of the accounts of this EU agency. Furthermore, Parliament adopted a resolution with observations which are an integral part of the decision to grant discharge to this Agency. The main points are as follows: carry over of appropriations: Parliament is concerned that the Court of Auditors has pointed out that the budget appropriations carried over and cancelled have amounted respectively to EUR 36 million (19.7% of the budget). It points out, as noted in previous financial years, that the high level of carry-overs for administrative expenditure was mainly due to IT expenditure. It is, consequently, concerned as this situation has existed for a number of years and is at odds with the annuality principle; procurement procedures: Parliament calls on the Agency to improve the quality of its procurement procedures so as to put an end to the shortcomings identified by the Court of Auditors. It takes note of the Agency's longstanding policy of entering into a forward foreign exchange contract in order to hedge part of its administrative budget against unfavourable fluctuations in the exchange rate of sterling. Parliament expects the Agency to manage such transactions prudently and recommends that a working group be set up to observe and closely monitor the hedging strategy; revenue from fees: Parliament points out that the fees charged for evaluation services are the main source of the Agency's revenue, accounting for 70.2% of its total revenue in 2008. It notes that the Agency reported EUR 2 046 000 in income from interest in 2008. It concludes from the financial statements and from the level of the interest payments that the Agency has a permanently extremely high level of cash holdings (on 31 December 2008, the Agency's cash holdings amounted to EUR 41.887 million). It asks the Commission to examine what scope there is for helping to ensure that the cash holdings are managed entirely on a needs-orientated basis and what changes of approach are necessary in order to keep the Agency's cash holdings permanently as low as possible; internal audit: lastly, Parliament asks the Agency to implement the recommendations from the Internal Audit Service (IAS) in particular as regards the conflicts of interest. Noting that the Agency's annual accounts for the financial year 2008 are reliable, and the underlying transactions are legal and regular, Parliament approves the closure of its accounts and refers to the general recommendations that appear in the draft resolution on financial management and control of EU agencies (see 2010/2007(INI) adopted in parallel). type Decision by Parliament, 1st reading/single reading title T7-0108/2010 url http://www.europarl.europa.eu/oeil/popups/sda.do?id=18219&l=en type Results of vote in Parliament title Results of vote in Parliament body EP type Text adopted by Parliament, single reading date 2010-09-25 text PURPOSE: to grant discharge to the European Medicines Agency for the financial year 2008. LEGISLATIVE ACT: Decision 2010/528/EU of the European Parliament on the discharge for the implementation of the budget of the European Medicines Agency for the financial year 2008. CONTENT: with the present decision, the European Parliament grants discharge to the Executive Director of the European Medicines Agency for the financial year 2008. This decision is in line with the European Parliament's resolution adopted on 5 May 2010 and comprises a series of observations that form an integral part of the discharge decision (please refer to the summary of the opinion of 5 May 2010). A parallel Decision, adopted on the same day, approves the closure of the accounts of this EU agency. 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=32010D0528 title Decision 2010/528 url http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2010:252:SOM:EN:HTML title OJ L 252 25.09.2010, p. 0164
committees	added	body EP responsible True committee CONT date 2009-10-01 committee_full Budgetary Control rapporteur group EPP name MATHIEU Véronique body EP responsible False committee ENVI date 2009-10-06 committee_full Environment, Public Health and Food Safety rapporteur group S&D name HAUG Jutta
links	added
other	added	body EC dg Budget commissioner ŠEMETA Algirdas
procedure	added	dossier_of_the_committee CONT/7/01104 reference 2009/2118(DEC) title 2008 discharge: European Medicines Agency EMEA stage_reached Procedure completed type DEC - Discharge procedure final url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32010D0528 title Decision 2010/528 subject 8.70.03.03 2008 discharge

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