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

Source: https://onco.cc/ideas/idea-reg-nonprofit-marketing-authorisation-holder/  
OnCo record `idea-reg-nonprofit-marketing-authorisation-holder` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: The non-profit holder secures labelled oncology indications for at least three repurposed drugs within five years and maintains supply at generic prices, with pharmacovigilance meeting regulatory standards.
- Rationale: The gap is institutional rather than scientific or financial: someone must be the accountable holder. A purpose-built non-profit fills the role at low cost and removes the dependence on unwilling commercial holders.
- Proposed test: Incorporate the entity, take on one repurposed indication with completed phase 3 evidence, and file in two regions; report time to approval and running costs.
- Maturity: speculative
- Actor: philanthropy

## Sources

- Bottleneck evidence (No incentive to repurpose cheap drugs): Pantziarka et al., The Repurposing Drugs in Oncology (ReDO) Project (ecancer 2014): https://doi.org/10.3332/ecancer.2014.442

## Connected records

- bottlenecks: [No incentive to repurpose cheap drugs](https://onco.cc/bottlenecks/b-generic-repurposing/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)
- key papers: [The Repurposing Drugs in Oncology (ReDO) Project](https://onco.cc/key-papers/paper-pantziarka-ecancermedicalscience/)

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