{"entity":{"id":"idea-fund-repurposing-indication-exclusivity","kind":"idea","name":"A repurposing label pathway with short exclusivity that non-profits can hold","aka":[],"tldr":"Create a way for a charity or university to get a cheap old drug officially approved for a new cancer use, with a few years of protection on that use so trial costs can be recovered without high prices.","summary":"A dedicated regulatory pathway for new oncology indications of off-patent drugs, accessible to non-commercial sponsors, with three to five years of indication-specific data exclusivity that can be assigned to a non-profit or public body. The exclusivity is for reimbursement of the indication rather than for the molecule, so generic supply for existing uses is unaffected; a modest per-indication payment from payers repays the trial. Without this, academic repurposing results cannot reach the label and remain off-label and unevenly used.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Incentives reward me-too drugs and marginal gains): Upadhaya et al., PD1/PDL1 inhibitor clinical trial landscape (Nat Rev Drug Discov 2022)","url":"https://doi.org/10.1038/d41573-022-00030-4"}],"tags":[],"related":["idea-fund-open-source-repurposing-leads","idea-fund-nonprofit-pharma","idea-fund-shelved-asset-escrow"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-incentive-misalignment","b-generic-repurposing"],"keyPapers":["paper-upadhaya-nat-rev-drug-discov"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"A repurposing pathway with assignable indication exclusivity increases label changes for off-patent drugs in oncology from near zero to several per year within five years and raises guideline adoption of positive academic repurposing trials.","rationale":"The EU's STAMP working group and the Belgian and Dutch repurposing frameworks have identified the missing label pathway as the key barrier; the orphan-drug precedent shows that indication-level exclusivity can be designed. The Anticancer Fund's and Cures Within Reach's pipelines provide immediate candidates.","test":"Legislate a pilot pathway in one region and run two repurposing labels through it, measuring time to label, payer uptake and price.","maturity":"speculative","actor":"regulator","cost":"small","horizonYears":4},"route":"/ideas/idea-fund-repurposing-indication-exclusivity/","neighbours":{"idea":[{"id":"idea-fund-nonprofit-pharma","kind":"idea","name":"A non-profit pharmaceutical company for the cancers markets ignore","route":"/ideas/idea-fund-nonprofit-pharma/"},{"id":"idea-fund-shelved-asset-escrow","kind":"idea","name":"Automatic offer of shelved cancer assets to non-profits after two years","route":"/ideas/idea-fund-shelved-asset-escrow/"},{"id":"idea-fund-open-source-repurposing-leads","kind":"idea","name":"Patent-free open-source development of repurposed and off-patent cancer drugs","route":"/ideas/idea-fund-open-source-repurposing-leads/"}],"bottleneck":[{"id":"b-incentive-misalignment","kind":"bottleneck","name":"Incentives reward me-too drugs and marginal gains","route":"/bottlenecks/b-incentive-misalignment/"},{"id":"b-generic-repurposing","kind":"bottleneck","name":"No incentive to repurpose cheap drugs","route":"/bottlenecks/b-generic-repurposing/"}],"paper":[{"id":"paper-upadhaya-nat-rev-drug-discov","kind":"paper","name":"Challenges and opportunities in the PD1/PDL1 inhibitor clinical trial landscape","route":"/key-papers/paper-upadhaya-nat-rev-drug-discov/"}]}}