The Paediatric Regulation: Are Children Still Missing Out on Potentially Life-Saving Treatments?

15-09-2015

This report summarises the presentations and discussions of the Workshop on "The Paediatric Regulation: Are children still missing out on potentially life-saving treatments?" held at the European Parliament in Brussels, on Tuesday 16 June 2015. The aim of the workshop was to discuss the main challenges and future perspectives related to the treatment of children in Europe in view of a potential future revision of the Paediatric Regulation. The first part of the workshop discussed the state of play of the implementation of the Paediatric Regulation. The European Commission presented an overview of the findings of the 2013 Commission progress report on the Paediatric Regulation highlighting the remaining challenges. Some key problems, such as the difficulty to recruit quickly and to find a sufficient number of children patients to conduct clinical trials, were also presented from the industry perspective. The second part of the workshop focused on practical experiences and policy options for improved medicines for children. Still too often, children die from diseases which could be cured with the right treatments. All participants agreed that the Regulation provides a good basis, but that it needs further improvements and fine-tuning to ensure that children are not missing out on life-saving treatments. This workshop and the respective document were prepared by the Policy Department A at the request of the Committee on Environment, Public Health and Food Safety.

This report summarises the presentations and discussions of the Workshop on "The Paediatric Regulation: Are children still missing out on potentially life-saving treatments?" held at the European Parliament in Brussels, on Tuesday 16 June 2015. The aim of the workshop was to discuss the main challenges and future perspectives related to the treatment of children in Europe in view of a potential future revision of the Paediatric Regulation. The first part of the workshop discussed the state of play of the implementation of the Paediatric Regulation. The European Commission presented an overview of the findings of the 2013 Commission progress report on the Paediatric Regulation highlighting the remaining challenges. Some key problems, such as the difficulty to recruit quickly and to find a sufficient number of children patients to conduct clinical trials, were also presented from the industry perspective. The second part of the workshop focused on practical experiences and policy options for improved medicines for children. Still too often, children die from diseases which could be cured with the right treatments. All participants agreed that the Regulation provides a good basis, but that it needs further improvements and fine-tuning to ensure that children are not missing out on life-saving treatments. This workshop and the respective document were prepared by the Policy Department A at the request of the Committee on Environment, Public Health and Food Safety.

Zunanji avtor

Olga SOLOMON, Magda CHLEBUS, Karen and Mr Kevin CAPEL and Andrea BIONDI