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ARTICLE · 23 DECEMBER 2025

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Final Patented Medicines Pricing Guidelines From The PMPRB Take Effect On January 1, 2026: What This Means For Innovative Pharma

McCarthy Tétrault
McCarthy Tétrault
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Effective January 1, 2026, the Patented Medicine Prices Review Board (PMPRB) will implement new Guidelines for monitoring patented medicine prices in Canada.

CanadaIntellectual Property
TechLex Blog
TechLex Blog
Bohdana Tkachuk
Bohdana Tkachuk
Daniella Febbraro
Daniella Febbraro
James S.S. Holtom
James S.S. Holtom
Sanjaya Mendis
Sanjaya Mendis
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Effective January 1, 2026, the Patented Medicine Prices Review Board (PMPRB) will implement new Guidelines for monitoring patented medicine prices in Canada. These Guidelines introduce a two-step review process designed to improve the predictability and administrative efficiency of the PMPRB's processes, while clarifying the PMPRB's role in monitoring rather than regulating prices.

While the Guidelines do not have the force of law, we anticipate that the PMPRB will adhere to them absent special circumstances.

Two-Step Review Process

Step 1: Initial and Annual Review

  • PMPRB compares a patented medicine's Canadian list price to the Highest International Price (HIP) among the PMPRB11 countries [Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, United Kingdom] and also compares price increases against the Consumer Price Index (CPI).

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