Decision on the Amended Interim Guidance Consultation

September 27, 2023

Background

On June 20, 2023, the Board started a consultation on proposed Amended Interim Guidance, inviting its stakeholders, and interested members of the public to provide feedback during a 60-day consultation period. The proposed Amended Interim Guidance would provide an expedited assessment for New Medicines’ prices to indicate that they will be considered as reviewed if their list price is below the median international price for the PMPRB11 countries. New Medicines that do not meet this criterion would continue to be under review until new guidelines are in place.

By the end of the consultation period, the PMPRB had received 45 submissions from a range of stakeholders.

All submissions are now available on the PMPRB website. The Board thanks all participants in the consultation for their feedback. In reaching its decision, the Board carefully considered the viewpoints expressed in all the submissions it received.

Board’s Decision

The Board has decided to adopt the Amended Interim Guidance, effective immediately.

This decision is guided by the following considerations:

Short-term Duration

The Amended Interim Guidance constitutes measures that will apply during a brief period. It does not constitute a full “guideline.” It is instead designed as a simple and temporary process that allows rights holders to have some ability to predict how their international price filings based on the new Schedule (PMPRB11) will affect the level of scrutiny applied during internal administrative price reviews at the PMPRB, in the absence of full guidelines. Namely, “reviewed” medicine prices will not be subject to further price review during the Interim Guidance period, whereas medicines whose price is “under review” may be subject to further review during that period.

Therefore, and because of the Amended Interim Guidance’s short-term duration and the lack of other applicable guidelines at this time, the Amended Interim Guidance is solely focused on information that rights holders know in advance: namely their own Canadian and international prices. For the same reasons, the Amended Interim Guidance does not look at therapeutic class comparisons (“TCC”) or changes in the Consumer Price Index (“CPI”).

Administrative Efficiency  

The reasons supporting the Board decision include:

1. The median international price (“MIP”) is simple to calculate, known in advance by rights holders, and based on rights holders’ filings.
2. Initial internal analysis of 2022 data indicates that the list prices of approximately 55% of medicines introduced during that period were below the MIP. Therefore, the PMPRB is using the MIP as an administrative tool to help streamline its investigative process until final guidelines are issued.
3. The Amended Interim Guidance permits a significant number of rights holders with New Medicines to have a greater degree of confidence regarding the status of their list prices vis-à-vis the PMPRB as they negotiate discounted pricing with private and public payors.

Jurisdiction

The Amended Interim Guidance is not binding and does not “set” price ceilings for rights holders nor does it constitute a decision that prices above the MIP are excessive. The MIP is not a mandated criterion and is being used solely for administrative purposes. The PMPRB cannot, outside of the context of a hearing, make any binding decisions or issue orders regarding whether the price of a particular patented medicine is excessive.

Towards New Guidelines – Announcement

The Board is pleased to announce that it intends to launch a consultation on themes relevant to new guidelines in the coming weeks. The Board, like its stakeholders, looks forward to achieving clarity and predictability under the new Regulations implementing the PMPRB11. An invitation will be forthcoming. We hope a broad segment of Canadians will participate.

The new consultation will be an iterative process conducted in stages to allow for engagement and active dialogue with stakeholders. The Board will approach the consultation with a fresh and open mind. The first stage will be based on themes selected from the diverse issues and trends that impact health care, pharmaceuticals and the vast inter-connected ecosystem from lab bench to patients in Canada and around the world. The second stage of consultation, in 2024, will focus on the development of new guidelines.

The Board notes that many of the submissions received included feedback pertaining to the development of new full guidelines. For example, a significant number of comments referred to the exclusion of CPI from the Interim Guidance. The Board wants to reassure stakeholders that the CPI matter will be studied as the consultation evolves and as the new guidelines are developed.