BETA


2019/2073(DEC) 2018 discharge: European Medicines Agency (EMA)

Progress: Procedure completed, awaiting publication in Official Journal

RoleCommitteeRapporteurShadows
Lead CONT CZARNECKI Ryszard (icon: ECR ECR) NOVAKOV Andrey (icon: EPP EPP), WOLTERS Lara (icon: S&D S&D), CSEH Katalin (icon: Renew Renew), KUHS Joachim (icon: ID ID), EICKHOUT Bas (icon: Verts/ALE Verts/ALE), OMARJEE Younous (icon: GUE/NGL GUE/NGL)
Committee Opinion ENVI CANFIN Pascal (icon: Renew Renew) Monika BEŇOVÁ (icon: S&D S&D), Kateřina KONEČNÁ (icon: Group of the European United Left - Nordic Green Left Group of the European United Left - Nordic Green Left), Stanislav POLČÁK (icon: PPE PPE), Jutta PAULUS (icon: Verts/ALE Verts/ALE), Anna ZALEWSKA (icon: ECR ECR)
Lead committee dossier:

Events

2020/05/13
   EP - Decision by Parliament, 1st reading/single reading
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, single reading
Documents
2020/02/19
   EP - Vote in committee, 1st reading/single reading
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, 1st reading/single reading
2019/09/04
   EP - CANFIN Pascal (Renew) appointed as rapporteur in ENVI
2019/06/27
   EC - Non-legislative basic document
2019/06/27
   EC - Non-legislative basic document published

Documents

Votes

A9-0076/2020 - Ryszard Czarnecki - Décision

2020/05/13 Outcome: +: 558, -: 121, 0: 11
DE PL ES RO FR NL HU BG PT AT CZ BE SK EL SE LT DK HR LV SI IE FI MT LU EE CY IT
Total
90
50
58
33
78
29
21
17
21
19
21
21
14
20
21
11
13
11
8
8
13
13
6
6
7
6
75
icon: PPE PPE
184

Latvia PPE

2

Malta PPE

2

Luxembourg PPE

2

Estonia PPE

For (1)

1
2
icon: S&D S&D
142

Greece S&D

2

Lithuania S&D

2

Latvia S&D

2

Slovenia S&D

2

Luxembourg S&D

For (1)

1

Estonia S&D

2

Cyprus S&D

2
icon: Renew Renew
98

Hungary Renew

2

Austria Renew

For (1)

1

Slovakia Renew

2

Lithuania Renew

2

Croatia Renew

For (1)

1

Latvia Renew

For (1)

1

Slovenia Renew

2

Ireland Renew

2

Finland Renew

3

Luxembourg Renew

2

Estonia Renew

3

Italy Renew

For (1)

1
icon: Verts/ALE Verts/ALE
64

Spain Verts/ALE

2

Netherlands Verts/ALE

3

Portugal Verts/ALE

1

Austria Verts/ALE

3

Czechia Verts/ALE

3

Belgium Verts/ALE

3

Sweden Verts/ALE

3

Lithuania Verts/ALE

2

Denmark Verts/ALE

2

Latvia Verts/ALE

1

Ireland Verts/ALE

2

Finland Verts/ALE

2

Luxembourg Verts/ALE

For (1)

1
icon: ECR ECR
61

Germany ECR

For (1)

1

Netherlands ECR

4

Bulgaria ECR

2

Greece ECR

1
3

Lithuania ECR

1

Croatia ECR

For (1)

1

Latvia ECR

2
icon: NI NI
28

Germany NI

Against (1)

2

Netherlands NI

Abstain (1)

1

Hungary NI

1

Slovakia NI

Abstain (1)

2

Greece NI

Abstain (1)

3

Croatia NI

2
icon: GUE/NGL GUE/NGL
39

Netherlands GUE/NGL

Against (1)

1

Portugal GUE/NGL

4

Czechia GUE/NGL

Against (1)

1

Belgium GUE/NGL

Against (1)

1

Sweden GUE/NGL

Against (1)

1

Denmark GUE/NGL

Against (1)

1

Ireland GUE/NGL

For (1)

4

Finland GUE/NGL

Against (1)

1

Cyprus GUE/NGL

2
icon: ID ID
74

Netherlands ID

Against (1)

1

Austria ID

3

Czechia ID

Against (2)

2

Denmark ID

For (1)

1

Finland ID

2

Estonia ID

Against (1)

1

A9-0076/2020 - Ryszard Czarnecki - Résolution

2020/05/14 Outcome: +: 607, -: 79, 0: 7
DE ES PL RO FR NL PT HU AT IT BG CZ EL BE SE SK IE LT DK FI HR LV SI CY MT LU EE
Total
92
58
51
33
78
27
21
21
19
75
17
21
21
21
21
14
13
11
13
14
11
8
8
6
6
6
7
icon: PPE PPE
185

Latvia PPE

2
2

Malta PPE

2

Luxembourg PPE

2

Estonia PPE

For (1)

1
icon: S&D S&D
141

Greece S&D

2

Lithuania S&D

2

Latvia S&D

2

Slovenia S&D

2

Cyprus S&D

2

Luxembourg S&D

For (1)

1

Estonia S&D

2
icon: Renew Renew
98

Hungary Renew

2

Austria Renew

For (1)

1

Italy Renew

For (1)

1

Slovakia Renew

2

Ireland Renew

2

Lithuania Renew

2

Finland Renew

3

Croatia Renew

For (1)

1

Latvia Renew

For (1)

1

Slovenia Renew

2

Luxembourg Renew

2

Estonia Renew

3
icon: Verts/ALE Verts/ALE
66

Spain Verts/ALE

2

Netherlands Verts/ALE

3

Portugal Verts/ALE

1

Austria Verts/ALE

3

Czechia Verts/ALE

3

Belgium Verts/ALE

3

Sweden Verts/ALE

3

Ireland Verts/ALE

2

Lithuania Verts/ALE

2

Denmark Verts/ALE

2

Finland Verts/ALE

3

Latvia Verts/ALE

1

Luxembourg Verts/ALE

For (1)

1
icon: ECR ECR
62

Germany ECR

For (1)

1

Romania ECR

1

Netherlands ECR

4

Bulgaria ECR

2

Greece ECR

1
3

Lithuania ECR

1

Croatia ECR

For (1)

1

Latvia ECR

2
icon: GUE/NGL GUE/NGL
38

Germany GUE/NGL

Against (1)

4

Netherlands GUE/NGL

Against (1)

1

Czechia GUE/NGL

1

Belgium GUE/NGL

For (1)

1

Sweden GUE/NGL

For (1)

1

Denmark GUE/NGL

Against (1)

1

Finland GUE/NGL

For (1)

1

Cyprus GUE/NGL

2
icon: NI NI
28

Germany NI

2

Netherlands NI

Abstain (1)

1

Hungary NI

1

Slovakia NI

Abstain (1)

2

Croatia NI

Against (1)

1
icon: ID ID
75
3

Czechia ID

Against (2)

2

Denmark ID

For (1)

1

Finland ID

2

Estonia ID

Abstain (1)

1
AmendmentsDossier
32 2019/2073(DEC)
2019/12/11 ENVI 7 amendments...
source: 641.163
2020/02/03 CONT 25 amendments...
source: 644.998

History

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

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  • 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.
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