OnCo
ideasIdea

A repurposing label pathway with short exclusivity that non-profits can hold

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.

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.

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.
What would test it
Legislate a pilot pathway in one region and run two repurposing labels through it, measuring time to label, payer uptake and price.
Maturity
speculative
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
4
Bottlenecks it attacks

Connected

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