Gross domestic product per capita
Starting July 1, 2021, the amended Patented Medicines Regulations require patentees to report prescribed information relating to cost-utility analyses prepared by publicly funded Canadian health technology assessment (HTA) agencies, for which the outcomes are expressed as the cost per quality-adjusted life year (QALY) for each indication that is the subject of the analysis. The requirement applies if any cost for the medicine as identified in the analysis is or would be, when pro-rated to account for that medicine’s use over a 12-month period, greater than or equal to 50 percent of the gross domestic product per capita in Canada at the time of publication of the analysis.
The GDP per capita is also referenced in the Guidelines (paragraph 57), which indicate that a new medicine will be classified as Category I High Cost if its 12-month treatment cost is greater than 150% of GDP per capita.
The information required to determine the applicable gross domestic product per capita in any given year may be retrieved from Statistics Canada, which publishes both the gross domestic product (GDP) and the population estimates. Based on this information, the most up-to-date annual GDP per capitaFootnote 1 is for 2019 and it is $61,466. The PMPRB will update the GDP per capita estimates on its website annually.
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