PMPRB NEWSLetter – Special Edition – New Guidelines

Publication of the PMPRB Guidelines

The Patented Medicine Prices Review Board (PMPRB) published its updated Guidelines for PMPRB Staff on June 30, 2025. They will take effect on January 1, 2026. The new Guidelines explain the new two-step process the PMPRB staff will use to monitor and review drug prices by comparing the prices in other countries or to other similar treatments in Canada. If a drug's price raises concerns, PMPRB staff may recommend a hearing to the Chair. These new Guidelines have been established following a comprehensive consultation process, after much consideration from the Board. They depart significantly from previous Guidelines.

As per the new Guidelines, the PMPRB will follow a two-step review process:

1. The Initial or Annual Review serves as a screening process. During this phase, the PMPRB staff will:
   1. Compare the Canadian price against prices in eleven other comparator countries to see if it is the highest;
   2. 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.
2. During an In-Depth Review the PMPRB staff compare the drug under review to similar drugs and treatments available for the same medical conditions.

The PMPRB plays a unique and important role in the Canadian health system by ensuring that prices of patented medicines are not excessive. The Guidelines provide a transparent and predictable process to be used by PMPRB staff to review drug prices once they enter the market.

Message from the Acting Chairperson

On behalf of my fellow Board Members and all employees at the PMPRB, I’m proud to announce that the PMPRB Guidelines are now available. I am very grateful to all those who participated in the consultation process by attending our meetings and events, and by submitting feedback. It has been a long and challenging journey, but one that led to the best outcome. The Board and I are confident that these put the PMPRB in the best position to fulfill its mandate to protects consumers by ensuring that the prices of patented medicines are not excessive.

I encourage you to review the new Guidelines carefully, as they are significantly different from previous guidance. The PMPRB will announce opportunities for you to learn more and ask questions about these new Guidelines in the near future, so please stay tuned.

As I like to say, the publication of the Guidelines marks not an end, but an important milestone in our ongoing journey to better serve Canadians. We have already started reviewing our hearing procedures and processes to identify opportunities for improvement and have also started developing a Strategic Plan that will guide the PMPRB over the next five years. I am looking forward to informing you on our progress on those projects in the coming months and years.

Thank you,