Notice and Comment - Amendment to the Interim Guidance re: New Medicines
The Patented Medicine Prices Review Board (PMPRB) invited stakeholders to comment on its proposed update to the approach for conducting interim price reviews on new medicines, pending the development of new Guidelines.
The Board announced the decision resulting from this consultation on September 27, 2023.
All submissions are now available.
The amendments to the Patented Medicines Regulations came into force on July 1, 2022, and on August 18, 2022, the PMPRB announced its approach for reviewing the prices of patented medicines for an interim period (the “Interim Guidance”) to allow for time to consult on new pricing guidelines. Following its guideline consultation in the fall of 2022, the Board decided that the Interim Guidance would remain in place until further notice.
The PMPRB intends to re-engage its stakeholders in the coming months and consult on a new set of guidelines, which are anticipated to be finalized in 2024. The Board recognizes that this further extends the interim period beyond the anticipated length, with implications on the growing backlog of patented medicines that have not been subject to price reviews by PMPRB staff (the “New Medicines”).
In order to address the increasing number of New Medicines whose price is yet to be reviewed by the PMPRB, the Board is consulting on a proposal to amend the Interim Guidance. The proposal aims to provide an expedited assessment for these New Medicines’ prices while at the same time affording more time to advance a fulsome consultation process on the new guidelines.
An analysis of recent filings found that approximately 55% of New Medicines have list prices that are below the median of the new basket of comparator countries (PMPRB11). This presents an opportunity to provide rights holders of these medicines with greater predictability on their pricing as quickly as possible.
The Board proposes to implement the new basket of PMPRB11 countries without further delays by prioritizing New Medicines.
Interim Guidance: Certain Aspects Not Changed
The Interim Guidance established a process for the continued review of existing medicines based the relevant NEAP (Non-Excessive Average Price) projected in the 2021 compliance letter sent by the PMPRB staff to the relevant patentee in
March 2022. No changes to the process for such existing medicines is proposed with this amendment.
New Medicines without a Maximum Average Potential Price (MAPP) or projected NEAP as of July 1, 2022 that are not addressed by the present amendment will continue to not be subject to price review by PMPRB staff during the consultation process on the new guidelines.
Proposed Amendments to the Interim Guidance
In order for the PMPRB to move forward with implementing the basket of comparator countries, the Board proposes to amend the Interim Guidance to give early guidance and greater predictability to certain New Medicines (i.e. medicines without a MAPP or NEAP as of July 1, 2022) regarding their review status.
This proposal is responsive to the feedback received during the PMPRB’s recent consultations and aligns with the intent of the regulatory amendments.
The Board proposes that the provisions of the Interim Guidance related to the patented medicines without a MAPP or projected NEAP be amended 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 will continue to be under review until new guidelines are in place.
For ease of reference, the following table compares the wording of the current approach for the interim period and proposed price review approach for 2023:
|Issue||Interim period |
August 18, 2022
|Interim period |
For patented medicines with a MAPP or projected NEAP as of July 1, 2022
During the interim period, the price of a patented medicine will not trigger an investigation if:
For greater clarity, an increase in the list price of a medicine will not trigger an investigation if it was taken in accordance with the CPI-based price-adjustment factor during the first filing period of 2022.
In cases where the N-ATP of a patented medicine is above the NEAP, the PMPRB will only open an investigation if this results in excess revenues greater than $50,000, as is currently the case.
|[text remains the same]|
For patented medicines without a MAPP or projected NEAP as of July 1, 2022 (“New Medicines”)
Medicines without a MAPP (Maximum Average Potential Price) or NEAP (Non-Excessive Average Price) as of July 1, 2022, will not be subject to price reviews by PMPRB staff during the interim period.
Furthermore, once new guidelines are in place, no potentially excess revenues will be calculated by staff retrospectively for any such medicines for sales made during the interim period.
Medicines without a MAPP (Maximum Average Potential Price) or NEAP (Non-Excessive Average Price) as of July 1, 2022, are considered reviewed if their list price is below the median international price for the PMPRB11 countries.
The rights holders of these products will receive a Status Report letter once the assessment is completed.
Medicines that do not meet this criterion, are considered “under review” until new guidelines are in place.
Once new guidelines are in place, no potential excess revenues will be calculated by staff retrospectively for any New Medicines for sales made during the interim period.
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