OnCo
ideasIdea

Grant extra exclusivity only in exchange for binding low prices in poorer countries

Companies get longer monopolies for rare and paediatric cancer drugs. That reward should come with a commitment to sell at cost in low-income countries.

Orphan, paediatric and data exclusivity extensions are valuable regulatory rewards granted without access conditions. The proposal is that regulators condition these extensions on a registered commitment: tiered pricing at or near cost in all low- and lower-middle-income countries, filing for registration in those countries within a year of first approval, and participation in pooled procurement. Non-compliance would shorten the exclusivity. Similar conditionality is used in some public research funding agreements and in the EU's 2023 pharmaceutical reform proposals linking exclusivity to launch in all member states.

Hypothesis
Conditional exclusivity increases the proportion of new oncology drugs registered and available at tiered prices in low-income countries within two years of first approval from a small minority to a majority, without reducing the number of orphan and paediatric oncology programmes.
Rationale
Exclusivity is a public grant; attaching access conditions costs high-income payers nothing and gives companies a clear, predictable requirement rather than ad hoc pressure.
What would test it
Model the revenue impact for recent orphan oncology approvals; implement the condition in one major jurisdiction and track LMIC registration and pricing over five years.
Maturity
speculative
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
5
Bottlenecks it attacks
  • Prices and value · New cancer drugs routinely cost over $150,000 a year, often for months of benefit. Systems cannot afford them and patients go bankrupt.
  • Most of the world has almost no cancer care · Seven in ten cancer deaths happen in low- and middle-income countries, where radiotherapy, pathology, surgery and drugs are scarce.

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