Pangaea Express: Guidelines for PMPRB Staff

July 8, 2025

By Marla Weingarten

Following the review of 54 feedback submissions, the PMPRB went ahead with new Guidelines that are not much different from the Draft Guidelines published December 2024. These Guidelines, published June 30, 2025, will come into effect January 1, 2026.
 
The review process in these Guidelines has not changed from the December draft version in that there are two “screening” steps:

  1. Initial Review or Annual Review - PMPRB staff will:
  • Compare the Canadian price against prices in eleven other comparator countries to see if it is the highest (PMPRB11)
  • Use the consumer price index to identify if a price increase is higher than the inflation rate

If one of these comparisons raises concerns, or if a complaint is received from an approved individual or organization, the PMPRB will then start a more in-depth review.

  1. In-Depth Review - the PMPRB staff compare the drug under review to similar drugs and treatments available for the same medical conditions.

Some adjustments made to the updated Guidelines to be implemented Jan 1, 2026, include:

  • Existing medicines (patented medicines first sold before July 1, 2022) will be reviewed starting 2 years from the date the Guidelines go into effect (vs the 1 year identified in the Draft Guidelines)
  • Complainants - approved individuals or organizations whose complaints lead to In-Depth Reviews may only include:
    • The Federal Minister of Health or any of their Provincial or Territorial counterparts
    • Senior officials who are authorized to represent Canadian publicly-funded drug programs

Note: Canadian life and health insurance companies and their trade association(s) were removed from the Draft Guidelines’ approved list
 
Highlights - Below is more information on high-level elements of the Guidelines (most of which are consistent with the Draft Guidelines Dec 2024):

  • Highest International Price (HIP) remains the threshold for international price comparisons
  • New Medicines - Patented medicines first sold on or after July 1, 2022
  • Existing Medicines – Patented medicines first sold before July 1, 2022. Will be reviewed starting 2 years from the date the Guidelines go into effect
  • Consumer Price Index – remains a criterion for prices using the one-year lagged CPI (e.g. for patented medicines reviewed in 2028, Staff will compare list price increases taken in 2027 against the 2026 CPI factors, published by Statistics Canada in January 2027)
  • In-depth Review - Reasons that trigger an in-depth review are:
    • list price exceeds the HIP during an initial or annual review
    • list price increases by an amount greater than the change in the CPI in any given year
    • An approved complainant submits a complaint alleging excessive pricing regardless of whether HIP or CPI were exceeded
  • In-Depth Review - Staff scientific team identifies the comparators for conducting a Therapeutic Class Comparison (“TCC”):
    • Domestic (dTCC) - generic products or biosimilars (patented or otherwise) may be included in the dTCC if considered appropriate based on the available evidence
    • International (iTCC) – lists of comparators for each relevant Schedule Country; mostly used in situations where the science is particularly complex
    • Rights Holders may provide input on TCC assessment - rationale for level of comparability, drug products for comparison purposes, and comparable dosage regimens including evidence on the medicine’s indications, potential comparators, its place in therapy and summary of clinical evidence
    • Timeframe - In-Depth Reviews can take between 12 and 28 months to complete, depending on its complexity (e.g. number of comparators during the Scientific Review, IPC calculations)
    • The Human Drug Advisory Panel (HDAP) provides recommendations on comparators and comparable dosage regimens to assist the PMPRB’s scientific staff but NOT adjudicate disputes between Staff and Rights Holders over the selection or relative weights of comparators
  • Complaints
    • Complaints from other parties (not approved individuals or organizations) do not lead to In-Depth Reviews. These other parties must raise their concerns with the approved individuals
    • Patented generic medicines, over the counter medicines and veterinary medicines are only subject to In-Depth Review if a complaint is received from an approved individual or organization

Note to manufacturers: 
The new Guidelines do not call out any deviations for tendered products such as vaccines or blood products to be reviewed only on a complaint-basis, as asked for by IMC in their feedback to the Draft Guidelines. 
 
It is important to fully understand your options during an In-depth review considering this process can take up to 28 months depending on the complexity. 
 
The Guidelines do not offer greater clarity and predictability with In-depth reviews and therapeutic comparability as sought by several industry associations and members in their feedback to the Draft December 2024 Guidelines. Industry’s ask that In-depth reviews not be automatically applied in face of a complaint where pricing is consistent with the HIP, was not applied in the Guidelines for PMPRB Staff.
 
As reiterated in this updated version, these Guidelines are NOT a pricing framework, will not set prices or calculate price ceilings, non-excessive prices or potential excess revenues. They do not provide Rights Holders with certainty on price outcomes. 
 
 
For more information, please contact Suzanne Solman at ssolman@pangaea-consultants.com or Marla Weingarten at mweingarten@pangaea-consultants.com

Back to Blog