The European Childhood Cancer Community Urgently Calls for the Release of the Proposal of the Revised EU Pharmaceutical legislation
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 and analysis of the EU Orphan and Paediatric Regulations since 2012.
With the current legislation, only 16 new anticancer medicines with specific paediatric indication have been approved in comparison to over 150 anticancer medicines for adults. The lack of sufficient investment and the slow pace of innovation has stalled the progress in curing paediatric cancers, which remains the first cause of death by disease in children older than one year of age in Europe.
The publication of the proposal for revision of the EU Pharmaceutical legislation was already delayed several times. Most recently, it was announced for March 29th, 2023 and now it has been postponed again to April 26th 2023.
Hence, we are calling for an urgent release of the proposal for revision of the EU Pharmaceutical legislation. Among others, we are very concerned that the delayed publication may prevent the adoption of the new legislative package within the current EU policy term. As a result, any additional delay – even if it’s only one day – is adding up to unnecessary risk for many young cancer patients placing high hopes in the revision of the EU Pharmaceutical legislation.
We urgently need this ambitious revision that will tackle inequalities and put the unmet medical needs of young cancer patients, survivors and their families at the centre of a European strategy for medicine development, which is in line with our goal to cure every child and adolescent with cancer across Europe and restore them to their full health.
We count on the European Commission’s commitment for April 26th, 2023 to be the final date of the publication of the proposal for revision of the EU Pharmaceutical legislation.
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