January 17 2018
On December 2 2017 the governor in council published the proposed Regulations Amending the Patented Medicines Regulations for comment (for further details please see "Canada releases proposed amendments to patented medicines pricing regulations"). On December 11 2017 the Patented Medicine Prices Review Board (PMPRB) released the PMPRB Guidelines Scoping Paper – High Level Overview of Potential New Framework (Canada Gazette, Part I). According to the paper, it aims to provide a non-binding outline of preliminary thoughts on how best to implement the proposed changes and should be read in conjunction with the proposed amendments and the regulatory impact analysis statement.
The scoping paper describes the framework as a risk-based approach to pricing review comprising:
The paper concludes that the proposed amendments would allow the PMPRB to move to a risk-based framework that scrutinises drugs with the greatest potential for excessive pricing to consider their value and the financial impact on consumers when setting prices. Finally, the paper encourages specific questions to be considered in consultations on the new proposed guidelines and states that a first draft of new PMPRB guidelines is expected to be made public in Spring 2018. This will be followed by technical roundtables, with a view to having new guidelines in place by early 2019.
For further information on this topic please contact Katie Lee at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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