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ARTICLE · 07 JUNE 2017

Major Changes Proposed To Canada's Patented Medicines Regulations

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On May 16, 2017, the Federal Minister of Health, the Hon. Jane Philpott announced a number of proposed regulatory changes to the Patented Medicines Regulations (the "Regulations").

CanadaIntellectual Property
A. Chandimal Nicholas
A. Chandimal Nicholas
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On May 16, 2017, the Federal Minister of Health, the Hon. Jane Philpott announced a number of proposed regulatory changes to the Patented Medicines Regulations (the "Regulations"). The proposed regulations are being implemented with the primary intent of "protecting Canadians from excessive drug prices"1. The proposed modernization framework constitutes the most significant suite of regulatory changes in twenty years. As noted in our blog post dated July 1, 2016, these proposed changes are part of ongoing reform to Canada's regulatory framework relating to patented drug prices. 

Health Canada has released a Consultation Document that proposes five main amendments to the Patented Medicines Regulations. Central to the modernization of the framework is the shift to a "risk-based" approach to regulation – that is, "drugs with higher potential to exert market power would face a higher degree of regulatory scrutiny while drugs with medium or lower risk of excessive

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