OnCo
ideasIdea

Three years of indication-specific exclusivity for proving a new cancer use of an old drug

Nobody funds trials of old drugs because competitors can sell the result for free. A short exclusive period for the new use, like the one given for children's studies, would change that.

Paediatric exclusivity in the US and the EU's one-year data protection for a new indication of a well-established substance show that time-limited rewards can induce trials on old drugs. For oncology repurposing the reward is too weak to matter. The proposal is a three-year indication-specific exclusivity (marketing protection for the new oncology indication, with the drug remaining generic for existing uses) granted to any sponsor, including generic manufacturers and non-profits, that obtains approval of a new oncology indication for an off-patent drug on the basis of an adequately powered trial, with a price ceiling for the new indication tied to the trial cost.

Hypothesis
The reward induces at least ten new registered phase 3 oncology trials of off-patent drugs within five years, sponsored by generic companies or non-profits, without materially raising prices for existing uses.
Rationale
Generic manufacturers have the manufacturing and regulatory capacity to sponsor trials but no way to recoup the cost; a modest, indication-limited exclusivity is a more targeted incentive than transferable vouchers and has precedent in paediatric legislation.
What would test it
Legislate the reward in one jurisdiction and count new repurposing trial registrations with generic or non-profit sponsors against the prior five years.
Maturity
speculative
Who has to act
policy
Cost to try
Small (under $1M)
Years to first evidence
5
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Incentives reward me-too drugs and marginal gainsNo incentive to repurpose cheap drugs