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The European Society for Paediatric Oncology (SIOP Europe), the single united European organisation representing healthcare professionals and researchers in paediatric oncology, and Childhood Cancer International – Europe (CCI Europe), the largest European patient organisation representing childhood cancer patients, parents and survivors, have been involved in the review, analysis and proposing of recommendation to improve the EU Paediatric and Orphan Regulations since 2012.

On the 26th of April 2023, the European Commission published the long-awaited proposal for the revision of the EU Pharmaceutical legislation, which also includes provisions on medicines for rare diseases and children.

SIOPE and CCI-E have analysed the proposal by the European Commission and outlined in a joint statement the areas that we believe should be upheld during the negotiation process as well as those where amendments can further strengthen the reform and ultimately, the fate of patients with unmet medical needs such as young cancer patients.