The Committee on the Environment, Public Health and Food Safety (ENVI) met on November 10th at the European parliament for an exchange of views with the European Commission and European Medicines Agency (EMA) on the “Policy on the Conditions for a Paedriatic Investigation Plan/Waiver”. In the light of the disappointing response, it is clear that we need to continue to fight hard for important changes to save children’s lives.
The action from the initial meeting on 16th June was for the EMA to respond to a question about the implementation of Clause 11b in the Paediatric Regulation, a clause determining how a waiver is still issued based on disease as opposed to mechanism of action. Scientific understanding is such that mechanism of action is the way forward and the basis for development of new treatments for diseases.
Mme Grossetête, French MEP rapporteur for the Pediatric Regulation and Mrs Willmott, UK MEP rapporteur for the Clinical Trial Regulation presented their strong requests for an urgent review of the class waiver system to the Pediatric Medicines Regulation.
Despite Mme Grossetête’s repeated request for urgent action, the European Commission maintained its position that the Regulation need not be reviewed before the 2017 planned review.
Cancer is the leading cause of death by disease in children across Europe. Each year, 35,000 children and adolescents are diagnosed with cancer, and 6000 of them will die. Of the survivors, 40% will be left with severe long-term side-effects which impact their daily life.
Unite2Cure calls for immediate change to European Paediatric Medicine Regulation to save more lives of children and teens with cancer.
The time for action is NOW.