# A legal right to obtain marketed cancer drugs at cost for combination trials

Source: https://onco.cc/ideas/idea-fund-compulsory-combination-access/  
OnCo record `idea-fund-compulsory-combination-access` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

If a company refuses to supply its approved drug for a well-designed independent trial combining it with a rival's drug, the law would let the trial buy it at manufacturing cost, with results shared back.

## Summary

A research-access provision, analogous to compulsory licensing but for trial supply: an independent scientific committee can certify an academic or non-profit combination trial as in the public interest, after which the patent holder must supply the drug at a regulated cost-of-goods price or license a generic maker to do so, in exchange for full access to the trial's data and a right to use results in labelling. The provision only bites when voluntary agreement fails and so mostly changes bargaining positions. It addresses the documented pattern of companies declining to supply comparators or partners for trials that might disadvantage their product.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Introducing a certified research-access right increases the number of cross-company combination and head-to-head academic trials started per year by at least half in the jurisdiction, with the right actually invoked in fewer than one in five cases because voluntary supply improves.
- Rationale: Research exemptions in patent law exist in most jurisdictions but do not cover supply; the mere existence of compulsory licensing has repeatedly lowered prices in negotiations without being used. Trials such as STAMPEDE and the RT-IO platforms have been delayed or reshaped by supply refusals.
- Proposed test: Enact in one jurisdiction with a five-year sunset and track combination and comparative trial starts, supply refusals reported to the committee, and invocations.
- Maturity: speculative
- Actor: policy

## Sources

- FDA guidance on codevelopment of two or more investigational drugs: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/codevelopment-two-or-more-new-investigational-drugs-use-combination

## Connected records

- ideas: [An antitrust safe harbour for cross-company combination trials and data pooling](https://onco.cc/ideas/idea-fund-antitrust-safe-harbour/), [An oncology patent pool for combination trials across companies](https://onco.cc/ideas/idea-fund-combination-patent-pool/), [Require head-to-head trials against the best in class for later entrants](https://onco.cc/ideas/idea-fund-head-to-head-mandate/)
- bottlenecks: [Secrecy and intellectual property block collaboration](https://onco.cc/bottlenecks/b-ip-collaboration/), [Too many combinations to test](https://onco.cc/bottlenecks/b-combination-space/)

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