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

Source: https://onco.cc/ideas/idea-reg-tiered-pricing-for-exclusivity/  
OnCo record `idea-reg-tiered-pricing-for-exclusivity` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed test: 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
- Actor: regulator

## Sources

- Bottleneck evidence (Prices and value): Prasad, De Jesús & Mailankody, The high price of anticancer drugs: origins, implications, barriers, solutions (Nat Rev Clin Oncol 2017): https://doi.org/10.1038/nrclinonc.2017.31

## Connected records

- bottlenecks: [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/), [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/)
- key papers: [The high price of anticancer drugs: origins, implications, barriers, solutions](https://onco.cc/key-papers/paper-prasad-nat-rev-clin-oncol/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/)

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