OnCo
ideasIdea

Escrow a share of adult revenue until the paediatric study is done

Companies often delay the childhood cancer studies they are required to do. A slice of the adult drug's revenue would be held back until the paediatric trial is completed.

Under the US RACE for Children Act and EU Paediatric Regulation, companies must plan paediatric studies for molecularly relevant cancer drugs, but deferrals and waivers are common and completion lags years. A rule would place a small percentage (for example 2%) of adult sales into escrow from launch, released on completion of the agreed paediatric study or forfeited to a paediatric oncology trials fund after the deadline. This aligns commercial interest with timely paediatric evidence without new appropriations.

Hypothesis
Revenue escrow reduces the median delay from adult approval to paediatric study completion by at least two years and lifts on-time completion above 75% for drugs approved under the rule.
Rationale
Deferral without financial consequence is why paediatric plans drift; financial holdbacks are standard tools in construction and procurement contracts. The RACE Act closed the loophole of indication-based exemption but left timing weakly enforced.
What would test it
Implement in one jurisdiction for newly approved oncology drugs with paediatric requirements and compare completion timelines with the prior cohort.
Maturity
speculative
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
4
Bottlenecks it attacks

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