A non-profit company to hold marketing authorisations for repurposed cancer drugs
Someone must legally own a drug's licence to update its label and monitor safety. A non-profit could do this for old drugs proven to work in cancer that no company wants.
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.
- No incentive to repurpose cheap drugs · Old, cheap drugs with anti-cancer signals never get the trials they need because no one profits from the result.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.