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

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Working Paper

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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 openended criteria and marketbased 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


Research Papers, Working Papers, Conference Papers