The network of associations Childhood Cancer International-Europe (CCI-Europe) hopes that the new pharmaceutical legislation (see EUROPE 13152/35) will facilitate the development and eventual entry onto the European market of specific treatments for childhood cancers, which often represent very small markets.
In an interview on Wednesday 12 April, Delphine Heenen, founder of the CCI member KickCancer, welcomed elements that could be included in the package, such as the “mechanism of action” that could be put in place under the name “molecular target”. If a drug targets a specific “Achilles heel” in one cancer and this weakness is shared in other cancers, such as childhood cancers, this mechanism would allow the paediatric investigation plan (PIP) to be made mandatory.
CCI-Europe also hopes that the package will allow the use of academic clinical trial data submitted to the European Medicines Agency (EMA), if these data prove the efficacy and safety of a new medicine in a given indication and the data is qualitative. The network wants future legislation to allow the EMA to require the pharmaceutical company to make the drug available on prescription if the EMA confirms the relevance of the data.
However, the association is concerned that there is no mechanism to compel the pharmaceutical industry to make the molecules available free of charge in academic clinical trials.
CCI-Europe would also like to see the development of medicines encouraged to the stage where this development would be ‘risk-free’ for industry, thanks to European funding from, for example, Horizon Europe, specifically dedicated to projects that enable exploratory research on paediatric cancers.
CCI-Europe is also in favour of joint purchasing of treatments at European level. (Original version in French by Émilie Vanderhulst)