Proposing new incentives
The 10 year EU commission report concluded that “in economic terms, the Regulation provides overall positive results from a socioeconomic perspective” and “the combination of obligations and rewards seems effective to shift focus to paediatric product development”. The reward is a one size fits all and have been used for only 55% of the completed PIPs. In paediatric oncology, both the EU Paediatric Medicines Regulation and the Orphan Drug Regulation failed to adequately incentivize science-driven development of new oncology products for children, in particular products targeting molecular alterations exclusively or mainly found in paediatric malignancies.
Leveraging from the proposals made by ACCELERTAE Working Group 2, the goal will be to make new proposals to better incentivize new oncology drug development for children.