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Successful private–public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines

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posted on 2023-06-08, 18:33 authored by L Ruggieri, V Giannuzzi, P Baiardi, F Bonifazi, E H Davies, C Giaquinto, D Bonifazi, M Felisi, C Chiron, R Pressler, Heike RabeHeike Rabe, M J Whitaker, A Neubert, E Jacqz-Aigrain, I Eichler, M A Turner, A Ceci, on behalf of the GRiP Consortium
The European Paediatric Regulation mandated the European Commission to fund research on off-patent medicines with demonstrated therapeutic interest for children. Responding to this mandate, five FP7 project calls were launched and 20 projects were granted. This paper aims to detail the funded projects and their preliminary results. Publicly available sources have been consulted and a descriptive analysis has been performed. Twenty Research Consortia including 246 partners in 29 European and non-European countries were created (involving 129 universities or public funded research organisations, 51 private companies with 40 SMEs, 7 patient associations). The funded projects investigate 24 medicines, covering 10 therapeutic areas in all paediatric age groups. In response to the Paediatric Regulation and to apply for a Paediatric Use Marketing Authorisation, 15 Paediatric Investigation Plans have been granted by the EMAPaediatric Committee, including 71 studies of whom 29 paediatric clinical trials, leading to a total of 7,300 children to be recruited in more than 380 investigational centres. Conclusion: Notwithstanding the EU contribution for each study is lower than similar publicly funded projects, and also considering the complexity of paediatric research, these projects are performing high-quality research and are progressing towards the increase of new paediatric medicines on the market. Private–public partnerships have been effectively implemented, providing a good example for future collaborative actions. Since these projects cover a limited number of offpatent drugs and many unmet therapeutic needs in paediatrics remain, it is crucial foreseeing new similar initiatives in forthcoming European funding programmes.

History

Publication status

  • Published

File Version

  • Published version

Journal

European Journal of Pediatrics

ISSN

0340-6199

Publisher

Springer Verlag

Issue

4

Volume

174

Page range

481-491

Department affiliated with

  • Clinical and Experimental Medicine Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2014-09-29

First Open Access (FOA) Date

2014-09-29

First Compliant Deposit (FCD) Date

2014-09-29

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