SIOPE and EURORDIS-Rare Diseases Europe Call for the Introduction of a Dedicated “First-in-Child” Incentive in the Legislative Text
SIOP Europe, the European Society for Paediatric Oncology shared on LinkedIn:
“As the revision of the EU Pharmaceutical Legislation proceed in the trilogues, the time to act for children with cancer and other rare diseases is now.
Today, SIOPE and EURORDIS-Rare Diseases Europe join forces with a clear, united message to EU co-legislators: we call for the introduction of a dedicated ‘first-in-child’ incentive in the legislative text.
A first-in-child orphan drug incentive would encourage the development of innovative treatments specifically for children and adolescents with cancer or other rare diseases where commercial interest is otherwise lacking.
These young patients face high unmet medical needs all over Europe. Yet, the current regulatory framework fails to support innovation where no adult equivalent exists., The lack of age-appropriate formulations, and the absence of economic incentives have left many young patients behind.
Our ask:
An extra year of market exclusivity when an orphan drug is first developed for a rare paediatric indication.
Read our Joint Statement here.”
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