When Everyone is an Orphan: Against Adopting a US-Styled Orphan Drug Policy in Canada

Accountability in Research: Policies and Quality Assurance Volume 20, Issue 4, 2013, pp. 227-269

83 Pages Posted: 29 Jun 2013

See all articles by Matthew Herder

Matthew Herder

Dalhousie University - Faculties of Medicine and Law; Dalhousie University - Faculty of Medicine

Date Written: June 27, 2013

Abstract

Putting aside whether diseases that affect only small numbers of people ("rare diseases") should be prioritized over diseases that are otherwise orphaned, in this paper I argue that a new approach to rare, orphan diseases is needed. The current model, first signaled by the United States’ Orphan Drug Act and subsequently emulated by several other jurisdictions, relies on a set of open-ended criteria and market-based incentives in order to define and encourage drug therapies for rare, orphan diseases. Given a) the biopharmaceutical industries’ growing interest in orphan diseases, b) progress in the sphere of personalized medicines enabling more and more common diseases to be reclassified as rare, and c) empirical evidence suggesting that the most orphan drugs target only a limited, lucrative subset of rare diseases, I argue that Canada, which recently announced plans to develop its own "orphan drug framework" should not follow the United States’ orphan drug model.

Keywords: Orphan Drug, Rare Disease, Market Exclusivity, Patents, Pharmaceutical Policy

Suggested Citation

Herder, Matthew, When Everyone is an Orphan: Against Adopting a US-Styled Orphan Drug Policy in Canada (June 27, 2013). Accountability in Research: Policies and Quality Assurance Volume 20, Issue 4, 2013, pp. 227-269, Available at SSRN: https://ssrn.com/abstract=2286779

Matthew Herder (Contact Author)

Dalhousie University - Faculties of Medicine and Law ( email )

6225 University Avenue
Halifax, Nova Scotia B3H 4H7
Canada

Dalhousie University - Faculty of Medicine ( email )

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