BETA


2021/2132(DEC) 2020 discharge: European Medicines Agency (EMA)

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead CONT ZDECHOVSKÝ Tomáš (icon: EPP EPP) CHINNICI Caterina (icon: S&D S&D), CSEH Katalin (icon: Renew Renew), EICKHOUT Bas (icon: Verts/ALE Verts/ALE), KUHS Joachim (icon: ID ID), CZARNECKI Ryszard (icon: ECR ECR), 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: GUE/NGL GUE/NGL), Ljudmila NOVAK (icon: PPE PPE), Michèle RIVASI (icon: Verts/ALE Verts/ALE), Alexandr VONDRA (icon: ECR ECR)
Lead committee dossier:

Events

2022/10/05
   Final act published in Official Journal
2022/05/04
   EP - Debate in Parliament
2022/05/04
   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 2020 and to approve the closure of the accounts for that year.

Noting that the Court of Auditors has stated that it has obtained reasonable assurance that the Agency's annual accounts for the financial year 2020 are reliable and that the underlying transactions are legal and regular, Parliament adopted, by 559 votes to 55 with 27 abstentions, a resolution containing a series of recommendations which form an integral part of the discharge decision and which complement the general recommendations set out in the resolution on the performance, financial management and control of EU agencies.

Agency’s financial statements

The Agency's final budget for the year 2019 was EUR 369 749 000, which represents an increase of 6.63% compared to 2019. In 2020, 84% of the Agency's revenue came from fees paid by the pharmaceutical industry for services provided.

Budgetary and financial management

Budget monitoring efforts during 2020 resulted in a budget implementation rate of 98.83 %, representing an increase of 0.27 % compared to 2019. The payment appropriations execution rate was 78.47 %, representing a decrease of 4.58 % compared to 2019.

Parliament noted the Agency’s decision to waive all fees for scientific advice applications from developers of potential COVID-19 therapeutics or vaccines, as of 13 March 2020, and welcomed the waiving of all fees for provision of scientific advice to academic researchers developing orphan medicines from 19 June 2020. It considered that other instances of waiving fees subject to specific criteria set out by the Agency, in particular regarding

small and medium-sized enterprises (SMEs), should follow;

Other observations

Parliament also made a series of observations concerning performance, staff, conflicts of interest, internal controls and Covid-19.

In particular, it noted that:

- the Agency played an important role in the preparation of the Union’s response to the Covid-19 pandemic and effectively analysed and quickly approved vaccines against Covid-19 in the Member States;

- the Agency recommended 97 new human medicines for marketing authorisation, including 39 new active substances, and 20 new veterinary medicines, including 13 new active substances;

- there is a need to strengthen the capabilities of the Agency so as to improve its resilience and effectiveness during periods of emergency;

- the EMA is revising its set of indicators and metrics with the objective of further reducing complexity, increasing transparency and extending the efficacy of monitoring its activities;

- the Covid-19 pandemic has highlighted the need for the EU to reach the highest possible level of self-sufficiency in the development and production of medicines;

- on 31 December 2020, the establishment plan was 100% implemented, with 596 temporary agents appointed out of 596 temporary agents authorised under the Union budget (compared to 591 authorised posts in 2019);

- the Agency should closely monitor the workload burden allocated to staff, especially under exceptional peak periods related to Covid-19;

- additional resources should be allocated to the Agency to cover the increasing workload and to improve its competence in the fight against medicine shortages;

- the pandemic dominated the Agency’s activities in 2020 which resulted in substantial resources being allocated to respond to the public health crisis. Consequently, the scope of the Agency’s 2020 work programme had to be reduced, with important public health activities either delayed or suspended;

- no internal whistleblowing case was reported, however, 25 reports of external whistleblowing cases were received;

- the Agency’s should continue efforts to increase the level of transparency of its decision making and further steps should be taken in order to enhance the transparency of the Agency’s activities following consistent concerns about the lack of transparency about vaccine contracts with pharmaceutical companies, even though it is the Commission who is party in those contracts;

- the Agency’s defensive cybersecurity capabilities were enhanced following a cyberattack in December 2020;

- the Agency developed and implemented a communication plan for 2020 that aimed to broaden the reach of its communication activities, especially those related to the unprecedented situation of the COVID-19 pandemic.

Documents
2022/04/07
   EP - Committee report tabled for plenary, single reading
Documents
2022/04/07
   EP - Committee report tabled for plenary
Documents
2022/03/31
   EP - Vote in committee
2022/03/29
   EP - Amendments tabled in committee
Documents
2022/03/02
   EP - Amendments tabled in committee
Documents
2022/02/16
   CSL - Supplementary non-legislative basic document
Documents
2022/01/19
   EP - Committee draft report
Documents
2022/01/17
   EP - Committee opinion
Documents
2021/10/29
   CofA - Court of Auditors: opinion, report
2021/09/29
   EP - CANFIN Pascal (Renew) appointed as rapporteur in ENVI
2021/09/14
   EP - Committee referral announced in Parliament
2021/07/28
   EP - ZDECHOVSKÝ Tomáš (EPP) appointed as rapporteur in CONT
2021/06/30
   EC - Non-legislative basic document
2021/06/30
   EC - Non-legislative basic document published

Documents

Votes

Décharge 2020: Agence européenne des médicaments - Discharge 2020: European Medicines Agency - Entlastung 2020: Europäische Arzneimittel-Agentur - A9-0103/2022 - Tomáš Zdechovský - Proposition de résolution (ensemble du texte) #

2022/05/04 Outcome: +: 559, -: 55, 0: 27
DE ES IT PL FR RO PT NL HU CZ SE BG BE IE AT DK EL SK LT FI HR LV SI CY LU MT EE
Total
88
56
71
46
66
27
21
27
19
19
20
14
20
13
18
14
19
12
10
13
12
7
7
6
6
4
6
icon: PPE PPE
160

Hungary PPE

1

Denmark PPE

For (1)

1

Latvia PPE

2

Slovenia PPE

3
2

Luxembourg PPE

2

Malta PPE

For (1)

1

Estonia PPE

For (1)

1
icon: S&D S&D
130

Czechia S&D

For (1)

1

Greece S&D

2

Slovakia S&D

2

Lithuania S&D

2

Finland S&D

1

Latvia S&D

For (1)

1

Slovenia S&D

2

Cyprus S&D

2

Luxembourg S&D

For (1)

1

Estonia S&D

2
icon: Renew Renew
95

Italy Renew

3

Poland Renew

1

Hungary Renew

2
3

Ireland Renew

2

Austria Renew

For (1)

1

Lithuania Renew

1

Finland Renew

3

Croatia Renew

For (1)

1

Latvia Renew

For (1)

1

Slovenia Renew

2

Luxembourg Renew

2

Estonia Renew

2
icon: Verts/ALE Verts/ALE
65

Spain Verts/ALE

3

Poland Verts/ALE

For (1)

1

Portugal Verts/ALE

1

Netherlands Verts/ALE

3

Czechia Verts/ALE

3

Sweden Verts/ALE

2

Belgium Verts/ALE

3

Ireland Verts/ALE

2

Austria Verts/ALE

3

Denmark Verts/ALE

2

Lithuania Verts/ALE

For (1)

1

Finland Verts/ALE

3

Luxembourg Verts/ALE

For (1)

1
icon: The Left The Left
37

Netherlands The Left

For (1)

1

Czechia The Left

1

Sweden The Left

For (1)

1

Belgium The Left

For (1)

1

Denmark The Left

1

Finland The Left

For (1)

1

Cyprus The Left

2
icon: ECR ECR
56

Germany ECR

1

Netherlands ECR

Abstain (1)

4

Sweden ECR

Abstain (1)

3

Bulgaria ECR

1

Belgium ECR

2

Greece ECR

Against (1)

1

Slovakia ECR

For (1)

1

Lithuania ECR

1

Croatia ECR

1

Latvia ECR

2
icon: NI NI
38

France NI

2

Slovakia NI

Against (1)

2

Lithuania NI

1

Croatia NI

2

Latvia NI

1
icon: ID ID
60

Netherlands ID

Against (1)

1

Czechia ID

Against (2)

2

Austria ID

3

Denmark ID

Against (1)

1

Finland ID

2

Estonia ID

Against (1)

1
AmendmentsDossier
20 2021/2132(DEC)
2021/12/08 ENVI 20 amendments...
source: 700.624

History

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

events/4/docs
  • url: https://www.europarl.europa.eu/doceo/document/CRE-9-2022-05-04-TOC_EN.html title: Debate in Parliament
events/6
date
2022-10-05T00:00:00
type
Final act published in Official Journal
procedure/final
title
OJ L 258 05.10.2022, p. 0303
url
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2022:258:TOC
procedure/stage_reached
Old
Procedure completed, awaiting publication in Official Journal
New
Procedure completed
docs/1
date
2021-10-29T00:00:00
docs
type
Court of Auditors: opinion, report
body
CofA
events/5/docs/0/url
https://www.europarl.europa.eu/doceo/document/TA-9-2022-0161_EN.html
docs/7
date
2022-05-04T00:00:00
docs
title: T9-0161/2022
type
Text adopted by Parliament, single reading
body
EP
events/5/summary
  • The European Parliament decided to grant discharge to the Executive Director of the European Medicines Agency (EMA) for the financial year 2020 and to approve the closure of the accounts for that year.
  • Noting that the Court of Auditors has stated that it has obtained reasonable assurance that the Agency's annual accounts for the financial year 2020 are reliable and that the underlying transactions are legal and regular, Parliament adopted, by 559 votes to 55 with 27 abstentions, a resolution containing a series of recommendations which form an integral part of the discharge decision and which complement the general recommendations set out in the resolution on the performance, financial management and control of EU agencies.
  • Agency’s financial statements
  • The Agency's final budget for the year 2019 was EUR 369 749 000, which represents an increase of 6.63% compared to 2019. In 2020, 84% of the Agency's revenue came from fees paid by the pharmaceutical industry for services provided.
  • Budgetary and financial management
  • Budget monitoring efforts during 2020 resulted in a budget implementation rate of 98.83 %, representing an increase of 0.27 % compared to 2019. The payment appropriations execution rate was 78.47 %, representing a decrease of 4.58 % compared to 2019.
  • Parliament noted the Agency’s decision to waive all fees for scientific advice applications from developers of potential COVID-19 therapeutics or vaccines, as of 13 March 2020, and welcomed the waiving of all fees for provision of scientific advice to academic researchers developing orphan medicines from 19 June 2020. It considered that other instances of waiving fees subject to specific criteria set out by the Agency, in particular regarding
  • small and medium-sized enterprises (SMEs), should follow;
  • Other observations
  • Parliament also made a series of observations concerning performance, staff, conflicts of interest, internal controls and Covid-19.
  • In particular, it noted that:
  • - the Agency played an important role in the preparation of the Union’s response to the Covid-19 pandemic and effectively analysed and quickly approved vaccines against Covid-19 in the Member States;
  • - the Agency recommended 97 new human medicines for marketing authorisation, including 39 new active substances, and 20 new veterinary medicines, including 13 new active substances;
  • - there is a need to strengthen the capabilities of the Agency so as to improve its resilience and effectiveness during periods of emergency;
  • - the EMA is revising its set of indicators and metrics with the objective of further reducing complexity, increasing transparency and extending the efficacy of monitoring its activities;
  • - the Covid-19 pandemic has highlighted the need for the EU to reach the highest possible level of self-sufficiency in the development and production of medicines;
  • - on 31 December 2020, the establishment plan was 100% implemented, with 596 temporary agents appointed out of 596 temporary agents authorised under the Union budget (compared to 591 authorised posts in 2019);
  • - the Agency should closely monitor the workload burden allocated to staff, especially under exceptional peak periods related to Covid-19;
  • - additional resources should be allocated to the Agency to cover the increasing workload and to improve its competence in the fight against medicine shortages;
  • - the pandemic dominated the Agency’s activities in 2020 which resulted in substantial resources being allocated to respond to the public health crisis. Consequently, the scope of the Agency’s 2020 work programme had to be reduced, with important public health activities either delayed or suspended;
  • - no internal whistleblowing case was reported, however, 25 reports of external whistleblowing cases were received;
  • - the Agency’s should continue efforts to increase the level of transparency of its decision making and further steps should be taken in order to enhance the transparency of the Agency’s activities following consistent concerns about the lack of transparency about vaccine contracts with pharmaceutical companies, even though it is the Commission who is party in those contracts;
  • - the Agency’s defensive cybersecurity capabilities were enhanced following a cyberattack in December 2020;
  • - the Agency developed and implemented a communication plan for 2020 that aimed to broaden the reach of its communication activities, especially those related to the unprecedented situation of the COVID-19 pandemic.
procedure/subject/8.70.03.10
2020 discharge
docs/0
date
2021-06-30T00:00:00
docs
type
Non-legislative basic document
body
EC
docs/0
date
2021-06-30T00:00:00
docs
type
Non-legislative basic document
body
EC
docs/6
date
2022-04-07T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/A-9-2022-0103_EN.html title: A9-0103/2022
type
Committee report tabled for plenary, single reading
body
EP
docs/7
date
2022-05-04T00:00:00
docs
title: T9-0161/2022
type
Text adopted by Parliament, single reading
body
EP
events/0
date
2021-06-30T00:00:00
type
Non-legislative basic document published
body
EC
docs
events/0
date
2021-06-30T00:00:00
type
Non-legislative basic document published
body
EC
docs
events/3/docs
  • url: https://www.europarl.europa.eu/doceo/document/A-9-2022-0103_EN.html title: A9-0103/2022
events/4
date
2022-05-04T00:00:00
type
Debate in Parliament
body
EP
events/5
date
2022-05-04T00:00:00
type
Decision by Parliament
body
EP
docs
title: T9-0161/2022
forecasts
  • date: 2022-05-02T00:00:00 title: Indicative plenary sitting date
procedure/stage_reached
Old
Awaiting Parliament's vote
New
Procedure completed, awaiting publication in Official Journal
procedure/subject/8.70.03.10
2020 discharge
forecasts
  • date: 2022-05-02T00:00:00 title: Indicative plenary sitting date
forecasts
  • date: 2022-05-02T00:00:00 title: Indicative plenary sitting date
events/3
date
2022-04-07T00:00:00
type
Committee report tabled for plenary
body
EP
procedure/stage_reached
Old
Awaiting committee decision
New
Awaiting Parliament's vote
events/2
date
2022-03-31T00:00:00
type
Vote in committee
body
EP
docs/5/date
Old
2022-03-28T00:00:00
New
2022-03-29T00:00:00
docs/5/date
Old
2022-03-22T00:00:00
New
2022-03-28T00:00:00
docs/5
date
2022-03-22T00:00:00
docs
title: PE729.970
type
Amendments tabled in committee
body
EP
docs/3
date
2022-02-16T00:00:00
docs
title: 06003/2022
type
Supplementary non-legislative basic document
body
CSL
docs/3/docs/0/url
https://www.europarl.europa.eu/doceo/document/CONT-AM-704733_EN.html
docs/3
date
2022-03-02T00:00:00
docs
title: PE704.733
type
Amendments tabled in committee
body
EP
forecasts
  • date: 2022-05-02T00:00:00 title: Indicative plenary sitting date
docs/1
date
2022-01-17T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/ENVI-AD-699211_EN.html title: PE699.211
committee
ENVI
type
Committee opinion
body
EP
docs/1
date
2022-01-14T00:00:00
docs
title: PE698.974
type
Committee draft report
body
EP
docs/2
date
2022-01-19T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/CONT-PR-698974_EN.html title: PE698.974
type
Committee draft report
body
EP
docs/1
date
2022-01-14T00:00:00
docs
title: PE698.974
type
Committee draft report
body
EP
committees/1/rapporteur
  • name: CANFIN Pascal date: 2021-09-29T00:00:00 group: Renew Europe group abbr: Renew
events/1
date
2021-09-14T00:00:00
type
Committee referral announced in Parliament
body
EP
procedure/dossier_of_the_committee
  • CONT/9/06735
procedure/stage_reached
Old
Preparatory phase in Parliament
New
Awaiting committee decision
committees/0/shadows/4
name
CZARNECKI Ryszard
group
European Conservatives and Reformists Group
abbr
ECR
commission
  • body: EC dg: Budget commissioner: HAHN Johannes
committees/0
type
Responsible Committee
body
EP
committee_full
Budgetary Control
committee
CONT
associated
False
rapporteur
name: ZDECHOVSKÝ Tomáš date: 2021-07-28T00:00:00 group: Group of European People's Party abbr: EPP
shadows
committees/0
type
Responsible Committee
body
EP
committee_full
Budgetary Control
committee
CONT
associated
False