2019/2073(DEC) 2018 discharge: European Medicines Agency (EMA)
Lead committee dossier:
Progress: Procedure completed
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | CONT |
CZARNECKI Ryszard ( ECR)
|
NOVAKOV Andrey ( EPP),
WOLTERS Lara ( S&D),
CSEH Katalin ( Renew),
EICKHOUT Bas ( Verts/ALE),
KUHS Joachim ( ID),
OMARJEE Younous ( GUE/NGL)
|
| Committee Opinion | ENVI |
CANFIN Pascal ( Renew)
|
Stanislav POLČÁK ( PPE)
|
Lead committee dossier:
Subjects
Events
2020/12/11
Final act published in Official Journal
2020/05/13
EP - Results of vote in Parliament
Documents
2020/05/13
EP - Decision by Parliament
Details
The European Parliament decided to grant discharge to the Executive Director of the European Medicines Agency (EMA) for the financial year 2018 and to approve the closure of the accounts for the financial year in question.
Noting that the Court of Auditors has stated that it has obtained reasonable assurances that the Agency’s annual accounts for the financial year 2018 are reliable and that the underlying transactions are legal and regular, Parliament adopted by 607 votes to 79 with 7 abstentions, a resolution containing a series of recommendations, which form an integral part of the decision on discharge and which add to the general recommendations set out in the resolution on performance, financial management and control of EU agencies:
Agency’s financial statements
The European Medicines Agency’s final budget for the financial year 2018 was EUR 337 761 000, representing an increase of 1.96 % compared to 2017. The Agency is a fee-funded agency, with 90 % of its 2018 revenue stemming from fees paid by the pharmaceutical industry for services provided, and 10 % stemming from the Union budget.
Budget and financial management
Budget monitoring efforts during the financial year 2018 resulted in a budget implementation rate of 89.14 %, representing a decrease of 1.91 % compared to 2017. The payment appropriations execution rate was 73.64 %, representing a decrease of 2.98 % compared to 2017. The Agency is called on to improve its budget implementation and payment appropriations execution rate.
Other observations
Members also made a series of observations regarding performance, staff, procurement and internal controls.
In particular, they noted that:
- that EudraVigilance, an information system used to report suspected side effects of medicines, and other telematics projects had to be postponed or reduced due to the United Kingdom’s decision to withdraw from the European Union. The Agency acknowledged that the Agency reassures that the projects and activities under the Brexit preparedness business continuity plan were carried out in a way which did not affect the functioning of the safety monitoring system for medicines in the Union and allowed all parties involved (industry, the Agency and national competent authorities) to continue complying with their legal obligations under the Union pharmaceutical legislation;
- in 2018, the Agency recommended 94 new medicines for marketing authorisation (84 for human use and 10 for veterinary use), and that those included 46 new active substances (42 for human use and 4 for veterinary use). It recommended the immediate suspension of the sale of and recall of a medicine for multiple sclerosis due to it causing serious and sometimes fatal immune reactions, and the suspension of the sale of several antibiotics;
- delays were observed in the development of the EU clinical trials portal and database;
- the Agency’s data centre was successfully moved to Hamburg in 2018;
- on 31 December 2018, the establishment plan was 98.31 % executed, with 581 temporary agents appointed out of 591 temporary agents authorised under the Union budget;
- the Agency received 21 reports on cases of whistleblowing from an external source raising the problem of maladministration at the Agency, 5 of which were closed in 2017 and 17 cases are still ongoing;
- as regards Brexit, the Agency worked closely with the Commission and the network to ensure an orderly redistribution of the work so far carried out by the United Kingdom. A successful move to Amsterdam was made, however, significant resources and new tasks had to be redistributed following the relocation to Amsterdam, with the consequent loss of short term contract staff combined with a reduction of 10 % of the Agency’s establishment plan imposed since 2014 and an increased workload. Outstanding legal and financial issues are highlighted notably as regards the cancellation of the lease agreement of the London premises.
Documents
2020/05/13
EP - End of procedure in Parliament
2020/03/04
EP - Committee report tabled for plenary, single reading
Documents
2020/03/04
EP - Committee report tabled for plenary
Documents
2020/02/19
EP - Vote in committee
2020/02/06
CSL - Supplementary non-legislative basic document
Documents
2020/01/31
EP - Amendments tabled in committee
Documents
2020/01/22
EP - Committee opinion
Documents
2019/12/05
EP - Committee draft report
Documents
2019/10/01
EP - CZARNECKI Ryszard (ECR) appointed as rapporteur in CONT
2019/09/18
EP - Committee referral announced in Parliament
2019/09/04
EP - CANFIN Pascal (Renew) appointed as rapporteur in ENVI
2019/06/27
EC - Non-legislative basic document
Documents
2019/06/26
EC - Non-legislative basic document published
Documents
Documents
- Results of vote in Parliament: Results of vote in Parliament
- Decision by Parliament: T9-0119/2020
- Committee report tabled for plenary, single reading: A9-0076/2020
- Committee report tabled for plenary: A9-0076/2020
- Supplementary non-legislative basic document: 05761/2020
- Amendments tabled in committee: PE644.998
- Committee opinion: PE641.162
- Committee draft report: PE639.917
- Non-legislative basic document: COM(2019)0316
- Non-legislative basic document: EUR-Lex
- Non-legislative basic document published: COM(2019)0316
- Non-legislative basic document published: EUR-Lex
- Non-legislative basic document: COM(2019)0316 EUR-Lex
- Committee draft report: PE639.917
- Committee opinion: PE641.162
- Amendments tabled in committee: PE644.998
- Supplementary non-legislative basic document: 05761/2020
- Committee report tabled for plenary, single reading: A9-0076/2020
Votes
A9-0076/2020 - Ryszard Czarnecki - Décision #
2020/05/13 Outcome: +: 558, -: 121, 0: 11
NIA9-0076/2020 - Ryszard Czarnecki - Résolution #
2020/05/14 Outcome: +: 607, -: 79, 0: 7
| Amendments | Dossier |
| 32 |
2019/2073(DEC)
2019/12/11
ENVI
7 amendments...
Amendment 1 #
Draft opinion Paragraph 2 2. Recalls that the Agency is a fee- funded agency, with 89,69 % of its 2018 revenue stemming from fees paid by the pharmaceutical industry, 10,28 % stemming from the Union budget and 0,03 % stemming from external assigned revenue; and stresses its concerns that the high reliance on direct fees from industry may compromise the public perception of the Agency's independence;
Amendment 2 #
Draft opinion Paragraph 5 5. Stresses that a number of the Agency’s activities were scaled back, delayed or postponed due to Brexit or other external circumstances; notes with concern that the Agency pointed to a lack of adequate resources for facing a workload that is increasing due to new tasks and legislation, and specifically to the loss of short term contract staff due to relocation and specifics of labour legislation in the Netherlands; calls on all the relvant authorities, including the Dutch authorities, to take action to ensure that the agency is moved as quickly and efficiently as possible to its permanent headquarters so that its work and the assessment of medicine safety are not adversely affected;
Amendment 3 #
Draft opinion Paragraph 5 5. Stresses that a number of the Agency’s activities were scaled back, delayed or postponed due to Brexit or other external circumstances; notes with concern that the Agency pointed to a lack of adequate resources for facing a workload that is increasing due to new tasks and legislation, and specifically to the loss of short term contract staff due to relocation and specifics of labour legislation in the Netherlands; regrets that the implementation of the Agency's policy on publication of clinical data has been put on hold as part of its business continuity plan, which was put in place to deal with the consequences of Brexit;
Amendment 4 #
Draft opinion Paragraph 6 6. Highlights the fact that in 2018, the Agency recommended 94 new medicines for marketing authorisation (84 for human use and 10 for veterinary use), and that those included 46 new active substances (42 for human use and 4 for veterinary use);
Amendment 5 #
Draft opinion Paragraph 7 7. Notes that in 2018 the second and third phases of the business continuity plan were implemented, in order to safeguard the core activities of the Agency; stresses, in this respect, the need to ensure maximum transparency, expertise and independence in the agency's work;
Amendment 6 #
Draft opinion Paragraph 8 8. Is concerned about the delays observed in the development of the EU clinical trials portal and database; draws attention, in that connection, to the need to solve the problem of the agency's IT infrastructure, which is under heavy strain;
Amendment 7 #
Draft opinion Paragraph 8 a (new) 8 a. Welcomes that, in February 2018, the General Court upheld, in three landmark judgments, the Agency's decision to release documents in accordance with Regulation (EC) No 1049/20011a regarding public access to European Parliament, Council and Commission documents; whereas two decisions of the General Court have been appealed by pharmaceutical companies; _________________ 1aRegulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
source: 641.163
2020/02/03
CONT
25 amendments...
Amendment 1 #
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
Amendment 10 #
12. Stresses that the Agency’s clients - pharmaceutical industry companies - pay for the procedure, not for the outcome of the Agency’s assessments; understands that, according to the Agency, its recommendations are made independently and therefore do not create conflicts of interest; notes with satisfaction that the Agency ensures that its scientific committee members and experts, staff and management board members, do not have any financial or other interests in the pharmaceutical industry; expresses concerns however about the potential conflict of interest in case of fee-financed agencies, where agencies have to rely on membership fees as their main source of income;
Amendment 11 #
Motion for a resolution Paragraph 12 a (new) 12 a. Recalls that the Agency is a fee- funded agency, with 89,69 % of its 2018 revenue stemming from fees paid by the pharmaceutical industry, 10,28 % stemming from the Union budget and 0,03 % stemming from external assigned revenue; is concerned that he high reliance on direct fees from industry may compromise the public perception of the Agency's independence;
Amendment 12 #
Motion for a resolution Paragraph 13 13. Acknowledges the Agency’s existing measures and ongoing efforts to secure transparency, prevent and manage conflicts of interest, and provide whistleblower protection;
Amendment 13 #
Motion for a resolution Paragraph 13 a (new) 13 a. Welcomes that, in February 2018, the General Court of the European Court of Justice upheld, in three landmark rulings, the Agency's decision to release documents in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council on Access to European Parliament, Council and Commission Documents;
Amendment 14 #
Motion for a resolution Paragraph 13 b (new) 13 b. Welcomes that, on 22 January 2020, the Court of Justice upheld the Agency’s policy of Access to documents in its appeal rulings in the following cases: PTC Therapeutics International/EMA and MSD Animal Health Innovation and Intervet international/EMA;
Amendment 15 #
Motion for a resolution Paragraph 13 c (new) 13 c. Regrets that the implementation of the Agency's policy on publication of clinical data has been put on hold as part of its business continuity plan, which was put in place to deal with the consequences of the United Kingdom's decision to withdraw from the European Union;
Amendment 16 #
Motion for a resolution Paragraph 14 14. Notes that the Agency meets with
Amendment 17 #
Motion for a resolution Subheading 6 a (new) Ombudsman recommendations (To be inserted before paragraph 16 a(new))
Amendment 18 #
Motion for a resolution Paragraph 16 a (new) 16 a. Notes that in its inquiry on how the Agency engages with medicine developers in the period leading up to applications for authorisations to market new medicines in the Union, the Ombudsman suggested the Agency should introduce improvements to: - Ensure that there is a separation between those responsible for providing scientific advice to a medicine developer and those subsequently involved in evaluating an MAA for the same medicine; - take into account whether individuals were already involved as coordinators in providing advice on the same medicine in the pre-submissionstage when appointing rapporteurs to evaluate MAAs; - document and publish the reasons for its decision to appoint as a rapporteur an expert who had a prominent role in providing advice for the same medicine during the pre-submission phase, - ensure that at least one of the two rapporteurs had no prominent role in the pre-submission activities concerning that medicine; - attach to the EPAR a detailed log of all relevant pre-submission activities, including the names of the experts involved;
Amendment 19 #
Motion for a resolution Paragraph 17 17. Notes that the Court issued an emphasis of matter paragraph in relation to the two London-based agencies, concerning the United Kingdom’s decision to withdraw from the European Union; notes that the seat of the Agency moved to Amsterdam in March 2019 and that the Agency’s accounts at 31 December 2018, included provisions for related costs amounting to EUR 17 800 000; regrets that the lease agreement for the London based premises sets a rental period until 2039 with no exit clause; also regrets that on 20 February 2019, the High Court of Justice of England and Wales ruled against EMA’s request to cancel the lease; notes, however, that the lease agreement allows reassignment or subletting of the premises to third parties, subject to the landlord’s consent; deeply regrets that the notes to the accounts at 31 December 2018 disclosed an amount of EUR 468 000 000 remaining rent until 2039, of which an amount of EUR 465 000 000 for the lease period after the Agency’s planned move to Amsterdam is disclosed as a contingent liability;
Amendment 2 #
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
Amendment 20 #
Motion for a resolution Paragraph 17 17. Notes that the Court issued an emphasis of matter paragraph in relation to the two London-based agencies, concerning the United Kingdom’s decision to withdraw from the European Union; notes that the seat of the Agency moved to Amsterdam in March 2019 and that the Agency’s accounts at 31 December 2018, included provisions for related costs amounting to EUR 17 800 000; regrets that the lease agreement for the London based premises sets a rental period until 2039 with no exit clause; also regrets that on 20 February 2019,
Amendment 21 #
Motion for a resolution Paragraph 17 17. Notes that the Court issued an emphasis of matter paragraph in relation to the two London-based agencies, concerning the United Kingdom’s decision to withdraw from the European Union; notes that the seat of the Agency moved to Amsterdam in March 2019 and that the Agency’s accounts at 31 December 2018, included provisions for related costs amounting to EUR 17 800 000; regrets that the lease agreement for the London based premises sets a rental period until 2039 with no exit clause; also regrets that on 20 February 2019, the High Court of Justice of England and Wales ruled against EMA’s request to cancel the lease; notes, however, that the lease agreement allows reassignment or subletting of the premises to third parties, subject to the landlord’s consent; deeply regrets that the notes to the accounts at 31 December 2018 disclosed an amount of EUR 468 000 000 remaining rent until 2039, of which an amount of EUR 465 000 000 for the lease period after the Agency’s planned move to Amsterdam is disclosed as a contingent liability; urges the Commission together with the Agency to do
Amendment 22 #
Motion for a resolution Paragraph 17 a (new) 17 a. Is concerned that the Agency, being a Union public health agency, will have to manage commercial property in a third country and will remain liable for paying rent until June 2039; requests that solutions to release the Agency from its contractual and financial liabilities in respect of its former UK premises are sought in the ongoing negotiations between the Union and the UK if responsibility cannot be established;
Amendment 23 #
Motion for a resolution Paragraph 17 a (new) 17 a. Is concerned that the Agency will have to manage commercial property in a third country and will remain liable for paying rent until June 2039; suggests that solutions to release the Agency from its contractual and financial liabilities in respect of its former UK premises are sought in the ongoing negotiations between the Union and the UK;
Amendment 24 #
Motion for a resolution Paragraph 19 Amendment 25 #
Motion for a resolution Paragraph 19 a (new) 19 a. Calls upon the Agency to aim its focus on disseminating the results of its research to the general public, and to reach out to public via the social media and other media outlets;
Amendment 3 #
1. Approves the closure of the accounts of the European Medicines Agency for the financial year
Amendment 4 #
Motion for a resolution Paragraph 1 1. Notes with concern that budget monitoring efforts during the financial year 2018 resulted in a budget implementation rate of 89,14 %, representing a decrease of 1,91 % compared to 2017; notes furthermore that the payment appropriations execution rate was 73,64 %, representing a decrease of 2,98 % compared to 2017; calls on the Agency to improve its budget implementation and payment appropriation execution rate;
Amendment 5 #
Motion for a resolution Paragraph 1 a (new) Amendment 6 #
Motion for a resolution Paragraph 3 3. Notes with concern that EudraVigilance, an information system used to report suspected side effects of medicines, and other telematics projects had to be postponed or reduced due to the United Kingdom’s decision to withdraw from the European Union; however, acknowledges that the Agency reassures that the projects and activities under the Brexit Business Continuity Plan (BCP) were carried out in a way which did not affect the functioning of the safety monitoring system for medicines in the Union and allowed all parties involved (industry, the Agency, national competent authorities) to continue complying with their legal obligations under the Union pharmaceutical legislation;
Amendment 7 #
Motion for a resolution Paragraph 6 a (new) 6 a. Encourages the Agency to pursue the digitalisation of its services;
Amendment 8 #
Motion for a resolution Paragraph 6 a (new) 6 a. Notes that the Court has identified a horisontal trend across agencies in the use of external staff hired in IT consultancy roles; calls for the dependency on external recruitment in this important and sensitive area to be reduced as much as possible to limit any potential risks;
Amendment 9 #
Motion for a resolution Paragraph 7 a (new) 7 a. Notes that further efforts are needed for achieving an even gender balance among senior managers (in 2018: 17 men and 11 women) and the management board members (20 men and 13 women);
source: 644.998
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http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE641.162New
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE641.162&secondRef=02 |
2020-02-03Show (1) Changes | Timetravel
| docs/3/docs/0/url |
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE644.998
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2020-02-02Show (1) Changes | Timetravel
| docs/2/docs/0/url |
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http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE641.162&secondRef=02New
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE641.162 |
2020-01-31Show (1) Changes | Timetravel
| docs/3 |
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2020-01-30Show (1) Changes | Timetravel
| docs/2/docs/0/url |
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http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE641.162New
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE641.162&secondRef=02 |
2020-01-29Show (1) Changes | Timetravel
| docs/2/docs/0/url |
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE641.162&secondRef=02New
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE641.162 |
2020-01-27Show (1) Changes | Timetravel
| docs/2/docs/0/url |
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE641.162New
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE641.162&secondRef=02 |
2020-01-26Show (1) Changes | Timetravel
| docs/2/docs/0/url |
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE641.162&secondRef=02New
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE641.162 |
2020-01-24Show (1) Changes | Timetravel
| docs/2/docs/0/url |
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE641.162New
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE641.162&secondRef=02 |
2020-01-22Show (1) Changes | Timetravel
| docs/2 |
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2020-01-19Show (1) Changes | Timetravel
| committees/0/shadows/1/mepref |
5392
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| docs/1 |
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| forecasts |
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2019-10-15Show (1) Changes | Timetravel
| committees/0/shadows/4 |
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2019-10-04Show (1) Changes | Timetravel
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2019-09-19Show (3) Changes | Timetravel
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Preparatory phase in ParliamentNew
Awaiting committee decision |
2019-09-06Show (1) Changes | Timetravel
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2019-08-07Show (2) Changes
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