Permissive regulation: A critical review of the regulatory history of buprenorphine formulations in Canada

We identified inconsistencies in Suboxone's regulatory history that suggest Health Canada's functions of health protection and promotion were compromised in favour of an “innovations” agenda that supports profit-making. Despite six years of market exclusivity in Canada, there was no evidence suggesting Suboxone achieved formal exclusivity (i.e., through patent or data protection). Health Canada's process to address safety concerns of Suboxone were compromised by reliance on the manufacturer to carry out post-market education, allowing the manufacturer to create and market a branded “education” program for its product. Similar inconsistencies have afforded market exclusivity for two related products despite marginal innovation.