{"entity":{"id":"idea-reg-nonprofit-marketing-authorisation-holder","kind":"idea","name":"A non-profit company to hold marketing authorisations for repurposed cancer drugs","aka":[],"tldr":"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.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (No incentive to repurpose cheap drugs): Pantziarka et al., The Repurposing Drugs in Oncology (ReDO) Project (ecancer 2014)","url":"https://doi.org/10.3332/ecancer.2014.442"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-generic-repurposing","b-regulatory-fragmentation"],"keyPapers":["paper-pantziarka-ecancermedicalscience"],"journals":[],"dependsOn":[],"notes":[],"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.","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","cost":"medium","horizonYears":4},"route":"/ideas/idea-reg-nonprofit-marketing-authorisation-holder/","neighbours":{"bottleneck":[{"id":"b-generic-repurposing","kind":"bottleneck","name":"No incentive to repurpose cheap drugs","route":"/bottlenecks/b-generic-repurposing/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}],"paper":[{"id":"paper-pantziarka-ecancermedicalscience","kind":"paper","name":"The Repurposing Drugs in Oncology (ReDO) Project","route":"/key-papers/paper-pantziarka-ecancermedicalscience/"}]}}