BETA


2020/0128(COD) Conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI
Lead committee dossier:
Legal Basis:
RoP 163, TFEU 114-p1, TFEU 168-p4

Events

2020/07/17
   Final act published in Official Journal
2020/07/15
   CSL - Draft final act
Documents
2020/07/15
   EP/CSL - Act adopted by Council after Parliament's 1st reading
2020/07/15
   CSL - Final act signed
2020/07/15
   EP - End of procedure in Parliament
2020/07/10
   EP - Text adopted by Parliament, 1st reading/single reading
Documents
2020/07/10
   EP - Decision by Parliament, 1st reading/single reading
Documents
2020/07/01
   EP - Decision by committee, without report
2020/06/19
   EP - Committee referral announced in Parliament, 1st reading/single reading
2020/06/17
   EC - Legislative proposal published
Details

PURPOSE: to provide a temporary derogation from EU legislation on GMOs in order to avoid delays in the conduct of clinical trials with investigational medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: EU legislation requires that applications for marketing authorisation for a medicinal product, in a Member State or in the Union, be accompanied by a dossier containing the results of clinical trials carried out on the product. Sponsors are required, before the commencement of any clinical trial, to request authorisation from the competent authority of the Member State in which the clinical trial is to be conducted.

Clinical trials necessitate the performance of multiple operations which may fall within the scope of Directive 2001/18/EC (Directive on the deliberate release into the environment of genetically modified organisms) or Directive 2009/41/EC (Directive on the contained use of genetically modified micro-organisms) in cases where the investigational medicinal product contains or consists of GMOs.

Experience shows that, in clinical trials with investigational medicinal products containing or consisting of GMOs, the procedure to achieve compliance with the requirements of Directives 2001/18/EC and 2009/41/EC as regards the environmental impact assessment and authorisation by the competent authority of a Member State is complex and may take a significant amount of time.

The complexity of that procedure increases greatly in the case of multi-centre clinical trials conducted in several Member States, as sponsors of clinical trials need to submit multiple requests for authorisation to multiple competent authorities in different Member States in parallel.

The Commission considers that it is of paramount importance that clinical trials with investigational medicinal products against COVID-19 containing or consisting of GMOs can be conducted within the Union, that they can begin as soon as possible, and that they are not delayed due to the complexity of differing national procedures put in place by Member States in implementation of Directives 2001/18/EC and 2009/41/EC.

CONTENT: in the public health emergency created by the COVID-19 pandemic, the proposed Regulation aims to ensure that clinical trials with medicinal products for human use containing or consisting of GMOs to treat or prevent COVID-19 can start swiftly and without a prior environmental risk assessment and/or prior consent under Directive 2001/18/EC or Directive 2009/41/EC.

The Regulation shall apply for as long as COVID-19 is considered a pandemic by the World Health Organisation (WHO) or declared an emergency situation in accordance with Decision No 1082/2013/EU and remains so.

Documents

Votes

Demande d'application de la procédure d'urgence: Conduite d’essais cliniques réalisés avec des médicaments à usage humain contenant des organismes génétiquement modifiés ou consistant en de tels organismes et destinés à traiter ou prévenir la maladie à coronavirus, ainsi qu’à la fourniture de ces médicaments - C9-0185/2020 - 2020/0128(COD)

2020/07/08 Outcome: +: 618, -: 62, 0: 13
FR DE PL IT ES RO NL HU SE AT BG BE EL CZ PT SK DK HR FI LT LV SI IE MT LU EE CY
Total
79
92
51
75
58
32
29
20
21
19
17
21
20
21
21
14
14
11
14
10
8
8
13
6
6
7
6
icon: PPE PPE
182

Denmark PPE

For (1)

1

Latvia PPE

2

Malta PPE

2

Luxembourg PPE

2

Estonia PPE

For (1)

1
2
icon: S&D S&D
144

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
97

Italy Renew

For (1)

1

Hungary Renew

2

Austria Renew

For (1)

1

Slovakia Renew

2

Croatia Renew

For (1)

1

Finland Renew

3

Lithuania Renew

2

Latvia Renew

For (1)

1

Slovenia Renew

2

Ireland Renew

2

Luxembourg Renew

2

Estonia Renew

3
icon: ECR ECR
62

Germany ECR

For (1)

1

Romania ECR

Against (1)

1

Bulgaria ECR

2

Greece ECR

1

Croatia ECR

For (1)

1

Lithuania ECR

1

Latvia ECR

2
icon: Verts/ALE Verts/ALE
65

Spain Verts/ALE

2

Netherlands Verts/ALE

3

Sweden Verts/ALE

3

Austria Verts/ALE

3

Belgium Verts/ALE

3

Czechia Verts/ALE

3

Portugal Verts/ALE

1

Denmark Verts/ALE

2

Finland Verts/ALE

Against (1)

3

Lithuania Verts/ALE

For (1)

Abstain (1)

2

Latvia Verts/ALE

1

Ireland Verts/ALE

2

Luxembourg Verts/ALE

For (1)

1
icon: ID ID
76

Netherlands ID

Against (1)

1
3

Czechia ID

For (1)

Against (1)

2

Denmark ID

For (1)

1

Finland ID

2

Estonia ID

Abstain (1)

1
icon: NI NI
28

Germany NI

Against (1)

2

Netherlands NI

1

Hungary NI

1

Slovakia NI

Against (1)

2

Croatia NI

Abstain (1)

2
icon: GUE/NGL GUE/NGL
39

Netherlands GUE/NGL

Against (1)

1

Sweden GUE/NGL

Against (1)

1

Belgium GUE/NGL

Against (1)

1

Czechia GUE/NGL

Against (1)

1

Portugal GUE/NGL

4

Denmark GUE/NGL

Against (1)

1

Finland GUE/NGL

Against (1)

1

Ireland GUE/NGL

For (1)

4

Cyprus GUE/NGL

2

History

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

docs/1/docs/0/url
Old
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:[%SECTOR]2020[%DESCRIPTOR]00028:EN:NOT
New
http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=[%n4]%2F20&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC
events/7
date
2020-07-17T00:00:00
type
Final act published in Official Journal
docs
procedure/final
title
Regulation 2020/1043
url
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32020R1043
procedure/stage_reached
Old
Procedure completed, awaiting publication in Official Journal
New
Procedure completed
docs/1/docs/0/url
Old
http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=[%n4]%2F20&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC
New
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:[%SECTOR]2020[%DESCRIPTOR]00028:EN:NOT
events/4
date
2020-07-15T00:00:00
type
Act adopted by Council after Parliament's 1st reading
body
EP/CSL
procedure/stage_reached
Old
Awaiting Council 1st reading position / budgetary conciliation convocation
New
Procedure completed, awaiting publication in Official Journal
docs/1/docs/0/url
Old
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:[%SECTOR]2020[%DESCRIPTOR]00028:EN:NOT
New
http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=[%n4]%2F20&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC
docs/1/docs/0/url
Old
http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=[%n4]%2F20&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC
New
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:[%SECTOR]2020[%DESCRIPTOR]00028:EN:NOT
events/4
date
2020-07-15T00:00:00
type
Final act signed
body
CSL
events/5
date
2020-07-15T00:00:00
type
End of procedure in Parliament
body
EP
docs/0
date
2020-07-10T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2020-0203_EN.html title: T9-0203/2020
type
Text adopted by Parliament, 1st reading/single reading
body
EP
events/3
date
2020-07-10T00:00:00
type
Decision by Parliament, 1st reading/single reading
body
EP
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2020-0203_EN.html title: T9-0203/2020
procedure/stage_reached
Old
Awaiting Parliament's position in 1st reading
New
Awaiting Council 1st reading position / budgetary conciliation convocation
docs/0/docs/0/url
Old
https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:[%SECTOR]2020[%DESCRIPTOR]00028:EN:NOT
New
http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=[%n4]%2F20&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC
docs/0
date
2020-07-15T00:00:00
docs
url: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:[%SECTOR]2020[%DESCRIPTOR]00028:EN:NOT title: 00028/2020/LEX
type
Draft final act
body
CSL
docs/0
date
2020-06-17T00:00:00
docs
type
Legislative proposal
body
EC
events/2
date
2020-07-01T00:00:00
type
Decision by committee, without report
body
EP
forecasts
  • date: 2020-07-08T00:00:00 title: Vote in plenary scheduled
procedure/legal_basis/0
Rules of Procedure EP 163
procedure/stage_reached
Old
Awaiting committee decision
New
Awaiting Parliament's position in 1st reading
forecasts/0/title
Old
Indicative plenary sitting date, 1st reading/single reading
New
Vote in plenary scheduled
events/0/summary
  • PURPOSE: to provide a temporary derogation from EU legislation on GMOs in order to avoid delays in the conduct of clinical trials with investigational medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19.
  • PROPOSED ACT: Regulation of the European Parliament and of the Council.
  • ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
  • BACKGROUND: EU legislation requires that applications for marketing authorisation for a medicinal product, in a Member State or in the Union, be accompanied by a dossier containing the results of clinical trials carried out on the product. Sponsors are required, before the commencement of any clinical trial, to request authorisation from the competent authority of the Member State in which the clinical trial is to be conducted.
  • Clinical trials necessitate the performance of multiple operations which may fall within the scope of Directive 2001/18/EC (Directive on the deliberate release into the environment of genetically modified organisms) or Directive 2009/41/EC (Directive on the contained use of genetically modified micro-organisms) in cases where the investigational medicinal product contains or consists of GMOs.
  • Experience shows that, in clinical trials with investigational medicinal products containing or consisting of GMOs, the procedure to achieve compliance with the requirements of Directives 2001/18/EC and 2009/41/EC as regards the environmental impact assessment and authorisation by the competent authority of a Member State is complex and may take a significant amount of time.
  • The complexity of that procedure increases greatly in the case of multi-centre clinical trials conducted in several Member States, as sponsors of clinical trials need to submit multiple requests for authorisation to multiple competent authorities in different Member States in parallel.
  • The Commission considers that it is of paramount importance that clinical trials with investigational medicinal products against COVID-19 containing or consisting of GMOs can be conducted within the Union, that they can begin as soon as possible, and that they are not delayed due to the complexity of differing national procedures put in place by Member States in implementation of Directives 2001/18/EC and 2009/41/EC.
  • CONTENT: in the public health emergency created by the COVID-19 pandemic, the proposed Regulation aims to ensure that clinical trials with medicinal products for human use containing or consisting of GMOs to treat or prevent COVID-19 can start swiftly and without a prior environmental risk assessment and/or prior consent under Directive 2001/18/EC or Directive 2009/41/EC.
  • The Regulation shall apply for as long as COVID-19 is considered a pandemic by the World Health Organisation (WHO) or declared an emergency situation in accordance with Decision No 1082/2013/EU and remains so.
forecasts
  • date: 2020-07-08T00:00:00 title: Indicative plenary sitting date, 1st reading/single reading
events/1
date
2020-06-19T00:00:00
type
Committee referral announced in Parliament, 1st reading/single reading
body
EP
procedure/dossier_of_the_committee
  • ENVI/9/03351
procedure/stage_reached
Old
Preparatory phase in Parliament
New
Awaiting committee decision
otherinst
  • name: European Economic and Social Committee
  • name: European Committee of the Regions
procedure/other_consulted_institutions
European Economic and Social Committee European Committee of the Regions