Incentivising drug development for paediatric cancers in Europe

A recent study published in Cancer Medicine proposes strategies which could help incentivise the development of drugs specifically intended for paediatric cancers in Europe and the United States. While such incentives already exist for both paediatrics and rare diseases, these have not been sufficient when it comes to therapeutics for childhood cancers. Instead, their development has remained largely dependent on adult cancers and their potential markets, which fails to adequately address the particular needs of paediatric patients.

In order to address this gap, a working group from the multi-stakeholder platform ACCELERATE proposes revisions to the EU’s Paediatric Medicines Regulation (PMR) and Regulation on Orphan Medicinal Products to specifically encourage the development of drugs for paediatric oncology. First, they propose the PMR require paediatric studies to be initiated earlier in the drug development process in cases where the drug’s mechanism of action is thought to be applicable to both adult and paediatric indications, as is already the case under the Research to Accelerate Cures and Equity Act (RACE) in the US. Next, they suggest modifying the Orphan Regulation creating earlier incentives that are specific to paediatric drugs beyond market exclusivity. Such incentives should deliver a more immediate economic benefit, such as tax reductions or transferable vouchers.

These recommendations are made in the context of the ongoing revision of the PMR and Orphan Regulation. It is the hope of the authors that their proposals can be taken into account to help ensure that the revised legislation is more effective at encouraging the development of paediatric oncology drugs, and improves the lives of young cancer patients living in Europe.

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