Pangaea Express: PMPRB Publishes Draft Guidelines

As promised, the PMPRB did indeed publish their draft Guidelines before the end of 2024. Given the posting date of Dec 19, the 90-day consultation period will end March 19, 2025. The Review Process regarding prices of patented drugs will involve the following:

Step 1: Initial Review or Annual Review will result in either: (a) no further review or (b) referral for In-Depth Review

Step 2: In-Depth Review will result is either: (a) recommendation for closure of the In-Depth Review or (b) recommendation for a hearing

Included in these Guidelines are the following high-level elements:

• Highest International Price (HIP) will be used for international price comparisons
• Existing Medicines – HIP will be used for all New Medicines and Existing Medicines. Existing Medicines will be reviewed starting 1 year from the date the Guidelines go into effect.
• Consumer Price Index (CPI) will be a factor upon which list prices are reviewed. 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 – PMPRB staff will conduct a Therapeutic Class Comparison – both international (ITCC) and domestic (dTCC) may be used. Generics or biosimilars may be included in dTCC review if considered appropriate based on the available evidence
• Complaints that would lead to an in-depth review are only accepted from:
  • the Federal Minister of Health or any of their Provincial or Territorial counterparts
  • Publicly-funded drug programs
  • Canadian life and health insurance companies and their trade association(s)
  • All others must raise their concerns with their relevant Minister(s) of Health, drug program, or insurance company, who may choose to make a complaint to the PMPRB on their behalf.

Patented generic medicines, over the counter medicines and veterinary medicines are only subject to In-Depth Reviews based on complaints. No other “drugs” as defined* in the Guidelines were identified in this group (e.g., biosimilars or vaccines).

In the feedback to the July Discussion Guide, IMC and BIOTECanada, as well as CAPDM all advocated for the HIP to be the International Price Comparator. However, they did recommend Existing Medicines be exempt from a new pricing policy, which represent 85% of patented medicine sales. At the very least CAPDM had asked for a three-year implementation period to allow for a washout period to turnover higher-valued inventory. We will await to see how these associations and other stakeholders respond to these Draft Guidelines.

• “drug” is defined as “a substance or a mixture of substances manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals; or (b) restoring, correcting or modifying organic functions in human beings or animals.”

For more information, please contact Suzanne Solman at ssolman@pangaea-consultants.com or Marla Weingarten at mweingarten@pangaea-consultants.com