Health Canada announces consultations on changes to Patented Medicines Regulations
Annual drug market entry report
Annual public drug plan expenditure for 2015 to 2016
Health Canada announces consultations on changes to Patented Medicines Regulations
As previously reported, on May 16 2017 Minister of Health Jane Philpott announced a consultation regarding proposed amendments to the Patented Medicines Regulations that would significantly affect the Patented Medicines Prices Review Board's (PMPRB's) approach to drug price evaluation.
Key proposed changes include:
- new factors in determining whether the price of a drug is excessive;
- expanding the list of comparator countries used to determine whether a price is excessive, but excluding the United States and Switzerland; and
- requiring the disclosure of all indirect price reductions, such as rebates and discounts.
The consultation period is open until June 28 2017.(1) Based on remarks provided by Philpott to the Economic Club of Canada, the proposed regulatory amendments are expected to be published in Autumn 2017 in Part I of the Canada Gazette for further feedback, with ultimate implementation no later than the end of 2018.
The vice chair of the PMPRB issued a statement welcoming the actions to "strengthen and modernize [the PMPRB's] pricing framework to reduce the cost of prescription drugs".
Annual drug market entry report
On April 11 2017 the PMPRB published the first edition of Meds Entry Watch, a new annual publication that provides information on recently launched drugs in Canada and select international markets. The inaugural edition provides an analysis of Canadian and select international markets for 2009-2014 and a preliminary analysis of drugs launched in 2015.
Annual public drug plan expenditure for 2015 to 2016
On May 24 2017 the PMPRB released the third edition of CompassRx, an annual report published under the National Prescription Drug Utilisation Information System research initiative. CompassRx provides insight into drivers of drug expenditures in select Canadian public drug plans. The key findings of the report include:
- prescription drug expenditures of Canadian public drug plans increased by 9.9% (C$1 billion) over the previous fiscal year, after years of low growth; and
- drug costs, which accounted for almost 75% of the total expenditures, increased by 12%, driven primarily by the increased use of higher-cost patented drugs.
For further information on this topic please contact Daphne Lainson at Smart & Biggar/Fetherstonhaugh by telephone (+1 613 232 2486) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
Endnotes
(1) The consultation document can be found here.