Accepted Paper:

Developing a Canadian Orphan Drug Policy: A Stalled Initiative  

Author:

Carlos Novas (Carleton University)

Paper short abstract:

This paper will explore the political-economic, patient advocacy and policy nexus that has contributed to the absence of a Canadian orphan drug policy from the mid-1990s to the present.

Paper long abstract:

This paper explores the absence of a Canadian orphan drug policy. While other jurisdictions such as the United States developed orphan drug legislation in 1983, and the European Union developed orphan drug regulations in 1999, Canada has not followed suit. In contrast to these jurisdictions which developed specific legislation and regulations in relation to orphan drugs, Health Canada in a mandate issued in 1996 claimed that Canada did not need to develop an orphan drug policy as Canadian's had access to these pharmaceuticals through the normal drug approval process. More recently, Health Canada (2012) announced an Orphan Drug Framework that promised to spur research into new treatments for rare diseases and encourage patient participation. Despite consultations with the pharmaceutical industry and patients' organizations, Canada still does not have an orphan drug policy. What makes the Canadian case interesting and puzzling is that a well-organized patient advocacy movement exists in the form of the Canadian Organization for Rare Disorders. This paper will explore the political-economic, patient advocacy and policy nexus that has contributed to the absence of a Canadian orphan drug policy.

Panel T017
STS for pharmaceuticals and public health policy