A non-profit company to hold marketing authorisations for repurposed cancer drugs

Regulatory systems assume a commercial marketing authorisation holder who files variations, maintains pharmacovigilance and supplies the product. For repurposed generics, no such holder has an incentive to act. Non-profit developers (Medicines Development for Global Health, DNDi, Cures Within Reach) have shown that non-profits can hold authorisations and run pharmacovigilance. The proposal is a non-profit oncology authorisation holder, funded by the repurposing fund and payers, that files new-indication applications, holds labels for repurposed generics, contracts manufacturing from generic makers, and runs the required safety monitoring.