Nytt forslag til legemiddellovgivning i EU - grunn til bekymring for barna
Endringer i EUs legemiddellovgivning har vært på høring. En vesentlig endring er å ta bort særordninger for legemidler til barn, det kalles "harmonisering". Vi har levert et felles høringssvar fra de fire landene som samarbeider om det felles pediatriske legemiddeloppslagsverket som KOBLE bygger på. Høringssvaret er på engelsk.
Her er utdrag fra høringssvaret:
The collaborative National paediatric formularies from the Netherlands, Germany, Austria and Norway have made it their mission to ensure that all children in Europe, like adults, have the right to the best possible,
knowledge-based pharmacotherapy guided by reliable information to caregivers.
We are concerned that the suggested changes to the directive and regulation imply that there will no longer be a dedicated committee or working party with paediatric expertise in this system. With no regulatory forum for paediatrics, the expertise gained will be rapidly lost. This will most likely lead to de-prioritisation at national competent authorities (NCA) level and re-assigning experts to other tasks and topics. There is a concern that the paediatric focus at the different national agencies will disappear, including the current national links between NCA,
EMA, HTA bodies and paediatric clinical communities, which could also affect access to paediatric products at national level.