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2016/2902(RSP) Resolution on the regulation on paediatric medicines

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI GROSSETÊTE Françoise (icon: PPE PPE), LA VIA Giovanni (icon: PPE PPE), GENTILE Elena (icon: S&D S&D), PIECHA Bolesław G. (icon: ECR ECR), RIES Frédérique (icon: ALDE ALDE), MÉLIN Joëlle (icon: ENF ENF) RIVASI Michèle (icon: Verts/ALE Verts/ALE), PEDICINI Piernicola (icon: EFDD EFDD)
Lead committee dossier:
Legal Basis:
RoP 136-p5

Events

2017/07/04
   EC - Commission response to text adopted in plenary
Documents
SP(2017)243
2016/12/15
   EP - Results of vote in Parliament
Documents
Results of vote in Parliament
2016/12/15
   EP - Decision by Parliament
Details

The European Parliament adopted by 441 votes to 97, with 8 abstentions, a resolution on the regulation on paediatric medicines tabled by the Committee on the Environment, Public Health and Food Safety.

Although the Paediatric Medicines Regulation has had a substantial impact on paediatric medicine development, Members considered that not enough progress has been made in a number of fields, in particular paediatric oncology and neonatology.

Childhood cancer remains the first cause of death by disease in children aged one year and over. 6 000 young people die of cancer each year in Europe . Fewer than 10 % of children with a non-curable life-threatening relapse have access to new, experimental drugs in clinical trials from which they could benefit.

Parliament called on the Commission to present a report which identifies an in-depth analysis of the obstacles currently hampering innovation in medicinal products targeting the paediatric population.

On the basis of those findings, the Commission should consider making changes, including through a legislative revision of the Paediatric Medicines Regulation , that give due consideration to:

mechanism-of-action-based, rather than only disease-type-based, paediatric development plans, disease and drug prioritisation models that take account of unmet paediatric medical needs and feasibility, earlier and more feasible paediatric investigation plans (PIPs), incentives that better stimulate research and more effectively serve the needs of the paediatric population, while ensuring there is an evaluation of the research and development costs and full transparency of the clinical results, and strategies to avoid paediatric off-label use where authorised paediatric medicines exist.

Parliament stressed that paediatric needs and drugs from different companies should be prioritised , on the basis of scientific data, in order to match the best available therapies to the therapeutic needs of children, especially those affected by cancers, and would allow the resources used for research to be optimised.

Members stressed the urgent need to assess how different types of funding and rewards – including the numerous tools based on delinkage mechanisms – can be best utilised to drive and accelerate paediatric drug development in areas of need, in particular drugs for neonatology and childhood cancers.

The Commission is urged to:

work as a matter of urgency on any possible regulatory changes that could help improve the situation in the meantime; renew in Horizon 2020 the funding provisions developed to support high-quality paediatric clinical research , following a critical review of the projects currently funded; strengthen the role of European networking for paediatric clinical research , and to ensure that Member States enact measures to support research into and the development and availability of medicinal products for paediatric use.

Documents
T8-0511/2016
2016/12/15
   EP - End of procedure in Parliament
2016/12/14
   EP - Motion for a resolution
Documents
B8-1340/2016
2016/12/14
   EP - Debate in Parliament
Documents
Debate in Parliament
2016/11/24
   EP - Oral question/interpellation by Parliament
Documents
B8-1818/2016
2016/11/11
   EP - Amendments tabled in committee
Documents
PE593.984
2016/06/30
   EP - GROSSETÊTE Françoise (PPE) appointed as rapporteur in ENVI
2016/06/30
   EP - LA VIA Giovanni (PPE) appointed as rapporteur in ENVI
2016/06/30
   EP - GENTILE Elena (S&D) appointed as rapporteur in ENVI
2016/06/30
   EP - PIECHA Bolesław G. (ECR) appointed as rapporteur in ENVI
2016/06/30
   EP - RIES Frédérique (ALDE) appointed as rapporteur in ENVI
2016/06/30
   EP - MÉLIN Joëlle (ENF) appointed as rapporteur in ENVI

Documents

Activities

Votes

B8-1340/2016 - Am 1 #

2016/12/15 Outcome: -: 461, +: 160, 0: 19
EL IE CY LV LU NL AT EE SI MT DK FI LT HR SE FR HU IT PT BE SK CZ BG ES GB RO PL DE
Total
17
9
5
6
5
24
18
6
7
5
12
12
8
11
19
61
17
59
19
20
12
19
15
46
52
26
48
81
icon: GUE/NGL GUE/NGL
43

Greece GUE/NGL

5

Ireland GUE/NGL

3

Cyprus GUE/NGL

2

Netherlands GUE/NGL

3

Denmark GUE/NGL

For (1)

Rina Ronja KARI
1

Finland GUE/NGL

For (1)

Merja KYLLÖNEN
1

Sweden GUE/NGL

For (1)

Malin BJÖRK
1

France GUE/NGL

3

Italy GUE/NGL

3

Portugal GUE/NGL

4

Czechia GUE/NGL

2

Spain GUE/NGL

8

Germany GUE/NGL

7
icon: Verts/ALE Verts/ALE
42

Latvia Verts/ALE

1

Luxembourg Verts/ALE

For (1)

Claude TURMES
1

Netherlands Verts/ALE

2

Austria Verts/ALE

3

Estonia Verts/ALE

For (1)

Indrek TARAND
1

Slovenia Verts/ALE

For (1)

Igor ŠOLTES
1

Denmark Verts/ALE

For (1)

Margrete AUKEN
1

Finland Verts/ALE

For (1)

Heidi HAUTALA
1

Croatia Verts/ALE

For (1)

Davor ŠKRLEC
1

Sweden Verts/ALE

3

France Verts/ALE

5

Hungary Verts/ALE

2

Belgium Verts/ALE

2

Spain Verts/ALE

4

United Kingdom Verts/ALE

4

Germany Verts/ALE

10
icon: ENF ENF
33

Netherlands ENF

4

Austria ENF

4

France ENF

16

Italy ENF

5

Belgium ENF

For (1)

Gerolf ANNEMANS
1

United Kingdom ENF

Abstain (1)

Janice ATKINSON
1

Poland ENF

For (1)

Michał MARUSIK
1

Germany ENF

For (1)

Marcus PRETZELL
1
icon: EFDD EFDD
34

Lithuania EFDD

For (1)

Rolandas PAKSAS
1

Sweden EFDD

2

France EFDD

1

Italy EFDD

16

United Kingdom EFDD

13

Poland EFDD

1
icon: NI NI
16

Greece NI

5

France NI

For (1)

Bruno GOLLNISCH

Against (1)

Aymeric CHAUPRADE
2

Hungary NI

2

Italy NI

Against (1)

Renato SORU
1

United Kingdom NI

For (1)

Diane JAMES

Abstain (2)

Diane DODDS, Steven WOOLFE
3

Poland NI

1

Germany NI

For (1)

Udo VOIGT

Against (1)

Martin SONNEBORN
2
icon: ECR ECR
57

Greece ECR

For (1)

Notis MARIAS
1

Netherlands ECR

2

Denmark ECR

3

Finland ECR

Against (1)

Jussi HALLA-AHO
2

Lithuania ECR

Against (1)

Waldemar TOMASZEWSKI
1

Croatia ECR

Against (1)

Ruža TOMAŠIĆ
1

Italy ECR

Against (1)

Remo SERNAGIOTTO
1

Belgium ECR

4

Slovakia ECR

3

Czechia ECR

2

Bulgaria ECR

2

United Kingdom ECR

11

Romania ECR

Against (1)

Monica MACOVEI
1

Poland ECR

19

Germany ECR

4
icon: ALDE ALDE
60

Ireland ALDE

Abstain (1)

Marian HARKIN
1

Luxembourg ALDE

Against (1)

Charles GOERENS
1

Netherlands ALDE

5

Austria ALDE

Against (1)

Angelika MLINAR
1

Estonia ALDE

3

Slovenia ALDE

Against (1)

Ivo VAJGL
1

Denmark ALDE

3

Finland ALDE

3

Lithuania ALDE

3

Croatia ALDE

For (1)

Ivan JAKOVČIĆ

Against (1)

Jozo RADOŠ
2

Sweden ALDE

3

France ALDE

6

Portugal ALDE

1

Belgium ALDE

5

Czechia ALDE

4

Bulgaria ALDE

4

Spain ALDE

7

Romania ALDE

3

Germany ALDE

4
icon: S&D S&D
170

Greece S&D

4

Ireland S&D

For (1)

Nessa CHILDERS
1

Cyprus S&D

2

Latvia S&D

1

Luxembourg S&D

Against (1)

Mady DELVAUX
1

Netherlands S&D

3

Austria S&D

5

Estonia S&D

Against (1)

Marju LAURISTIN
1

Malta S&D

3

Denmark S&D

3

Finland S&D

2

Lithuania S&D

1

Croatia S&D

2

Sweden S&D

6

France S&D

Abstain (1)

Edouard MARTIN
11

Hungary S&D

3

Italy S&D

25

Portugal S&D

8

Belgium S&D

4

Slovakia S&D

3

Czechia S&D

4

Bulgaria S&D

3

Spain S&D

13

United Kingdom S&D

20

Romania S&D

12

Poland S&D

5

Germany S&D

24
icon: PPE PPE
184

Greece PPE

2

Ireland PPE

4

Cyprus PPE

Against (1)

Lefteris CHRISTOFOROU
1

Latvia PPE

4

Luxembourg PPE

2

Netherlands PPE

For (1)

Esther DE LANGE
5

Austria PPE

5

Estonia PPE

Against (1)

Tunne KELAM
1

Slovenia PPE

5

Malta PPE

2

Denmark PPE

Against (1)

Bendt BENDTSEN
1

Finland PPE

3

Lithuania PPE

2

Croatia PPE

5

Sweden PPE

4

France PPE

17

Hungary PPE

10

Italy PPE

8

Portugal PPE

6

Belgium PPE

For (1)

Claude ROLIN
4

Slovakia PPE

6

Czechia PPE

7

Bulgaria PPE

6

Spain PPE

14

Romania PPE

For (1)

Csaba SÓGOR
10

Poland PPE

21

Germany PPE

29

History

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

2021-12-18Show (6) Changes | Timetravel
committees/0/rapporteur/5
name
ECK Stefan
date
2016-06-30T00:00:00
group
European United Left - Nordic Green Left
abbr
GUE/NGL
docs/0/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE593.984
New
https://www.europarl.europa.eu/doceo/document/ENVI-AM-593984_EN.html
docs/2/docs/0/url
Old
http://www.europarl.europa.eu/doceo/document/B-8-2016-1340_EN.html
New
https://www.europarl.europa.eu/doceo/document/B-8-2016-1340_EN.html
events/0/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20161214&type=CRE
New
https://www.europarl.europa.eu/doceo/document/CRE-8-2016-12-14-TOC_EN.html
events/2
date
2016-12-15T00:00:00
type
Decision by Parliament
body
EP
docs
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summary
events/2
date
2016-12-15T00:00:00
type
Decision by Parliament, 1st reading/single reading
body
EP
docs
url: http://www.europarl.europa.eu/doceo/document/TA-8-2016-0511_EN.html title: T8-0511/2016
summary
2020-01-19Show (3) Changes | Timetravel
docs/2/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=MOTION&reference=B8-2016-1340&language=EN
New
http://www.europarl.europa.eu/doceo/document/B-8-2016-1340_EN.html
docs/3/body
EC
events/2/docs/0/url
Old
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2016-0511
New
http://www.europarl.europa.eu/doceo/document/TA-8-2016-0511_EN.html
2019-09-04Show (2) Changes | Timetravel
committees/0
type
Responsible Committee
body
EP
committee_full
Environment, Public Health and Food Safety
committee
ENVI
associated
False
rapporteur
shadows
committees/0
type
Responsible Committee
body
EP
committee_full
Environment, Public Health and Food Safety
committee
ENVI
associated
False
date
rapporteur
shadows
2019-07-06Show (13) Changes | Timetravel
activities
  • date: 2016-12-14T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20161214&type=CRE type: Debate in Parliament title: Debate in Parliament body: EP type: Debate in Parliament
  • date: 2016-12-15T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2016-0511 type: Decision by Parliament, 1st reading/single reading title: T8-0511/2016 body: EP type: Decision by Parliament, 1st reading/single reading
commission
  • body: EC dg: Health and Food Safety commissioner: ANDRIUKAITIS Vytenis Povilas
committees/0
type
Responsible Committee
body
EP
committee_full
Environment, Public Health and Food Safety
committee
ENVI
associated
False
date
rapporteur
shadows
committees/0
body
EP
shadows
responsible
True
committee
ENVI
date
committee_full
Environment, Public Health and Food Safety
rapporteur
docs
  • date: 2016-11-11T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE593.984 title: PE593.984 type: Amendments tabled in committee body: EP
  • date: 2016-11-24T00:00:00 docs: title: B8-1818/2016 type: Oral question/interpellation by Parliament body: EP
  • date: 2016-12-14T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=MOTION&reference=B8-2016-1340&language=EN title: B8-1340/2016 type: Motion for a resolution body: EP
  • date: 2017-07-04T00:00:00 docs: url: /oeil/spdoc.do?i=28013&j=0&l=en title: SP(2017)243 type: Commission response to text adopted in plenary
events
  • date: 2016-12-14T00:00:00 type: Debate in Parliament body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20161214&type=CRE title: Debate in Parliament
  • date: 2016-12-15T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=28013&l=en title: Results of vote in Parliament
  • date: 2016-12-15T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2016-0511 title: T8-0511/2016 summary: The European Parliament adopted by 441 votes to 97, with 8 abstentions, a resolution on the regulation on paediatric medicines tabled by the Committee on the Environment, Public Health and Food Safety. Although the Paediatric Medicines Regulation has had a substantial impact on paediatric medicine development, Members considered that not enough progress has been made in a number of fields, in particular paediatric oncology and neonatology. Childhood cancer remains the first cause of death by disease in children aged one year and over. 6 000 young people die of cancer each year in Europe . Fewer than 10 % of children with a non-curable life-threatening relapse have access to new, experimental drugs in clinical trials from which they could benefit. Parliament called on the Commission to present a report which identifies an in-depth analysis of the obstacles currently hampering innovation in medicinal products targeting the paediatric population. On the basis of those findings, the Commission should consider making changes, including through a legislative revision of the Paediatric Medicines Regulation , that give due consideration to: mechanism-of-action-based, rather than only disease-type-based, paediatric development plans, disease and drug prioritisation models that take account of unmet paediatric medical needs and feasibility, earlier and more feasible paediatric investigation plans (PIPs), incentives that better stimulate research and more effectively serve the needs of the paediatric population, while ensuring there is an evaluation of the research and development costs and full transparency of the clinical results, and strategies to avoid paediatric off-label use where authorised paediatric medicines exist. Parliament stressed that paediatric needs and drugs from different companies should be prioritised , on the basis of scientific data, in order to match the best available therapies to the therapeutic needs of children, especially those affected by cancers, and would allow the resources used for research to be optimised. Members stressed the urgent need to assess how different types of funding and rewards – including the numerous tools based on delinkage mechanisms – can be best utilised to drive and accelerate paediatric drug development in areas of need, in particular drugs for neonatology and childhood cancers. The Commission is urged to: work as a matter of urgency on any possible regulatory changes that could help improve the situation in the meantime; renew in Horizon 2020 the funding provisions developed to support high-quality paediatric clinical research , following a critical review of the projects currently funded; strengthen the role of European networking for paediatric clinical research , and to ensure that Member States enact measures to support research into and the development and availability of medicinal products for paediatric use.
  • date: 2016-12-15T00:00:00 type: End of procedure in Parliament body: EP
links
other
  • body: EC dg: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers commissioner: ANDRIUKAITIS Vytenis Povilas
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2016-12-18Show (2) Changes | Timetravel
activities/1
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2016-12-17Show (4) Changes | Timetravel
activities/0/docs
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2016-12-16Show (1) Changes | Timetravel
activities/0/type
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2016-12-10Show (2) Changes | Timetravel
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2016-12-03Show (5) Changes
activities
  • date: 2016-12-15T00:00:00 body: EP type: Debate in plenary scheduled
committees
  • body: EP shadows: group: Verts/ALE name: RIVASI Michèle group: EFD name: PEDICINI Piernicola responsible: True committee: ENVI date: 2016-06-30T00:00:00 2016-06-30T00:00:00 2016-06-30T00:00:00 2016-06-30T00:00:00 2016-06-30T00:00:00 2016-06-30T00:00:00 2016-06-30T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: EPP name: GROSSETÊTE Françoise group: EPP name: LA VIA Giovanni group: S&D name: GENTILE Elena group: ECR name: PIECHA Bolesław G. group: ALDE name: RIES Frédérique group: GUE/NGL name: ECK Stefan group: ENF name: MÉLIN Joëlle
links
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  • body: EC dg: url: http://ec.europa.eu/dgs/health_consumer/index_en.htm title: Health and Consumers commissioner: ANDRIUKAITIS Vytenis Povilas
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ENVI/8/06980
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2016/2902(RSP)
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Paediatric medicines
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Rules of Procedure of the European Parliament EP 128-p5
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