Amendments to the Patented Medicines Regulations came into force on July 1, 2022. Following these amendments the Patented Medicines Prices Review Board (PMPRB) introduced interim guidance for reviewing the prices of patented medicines during a transitional period. The interim guidance was intended to remain in place until further notice, as the PMPRB planned to consult with stakeholders and develop new pricing guidelines by 2024.
However, the extended interim period has led to a backlog of patented medicines that have not undergone price reviews by the PMPRB. To address this issue, the Board is proposing amendments to the interim guidance. The proposal aims to expedite the assessment of prices for these new medicines while allowing for a more comprehensive consultation process on the new guidelines.
The PMPRB is inviting stakeholders to comment on proposed updates to the approach for conducting interim price reviews on new medicines. This approach will continue until new pricing guidelines are developed.
The deadline to submit written feedback is Monday, August 21, 2023. No in-person submissions or meetings are anticipated, and stakeholders are requested to submit a form with their comments. To access the form, click here.
Proposed Amendments to Interim Guidelines
The Board has provided the following table comparing the wording of the current approach for the interim period and proposed price review approach for 2023.
The Board proposes that the provisions of the Interim Guidance related to the patented medicines without a Maximum Average Potential Price (MAPP) or projected Non-Excessive Average Price (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 (Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden and the United Kingdom). New Medicines that do not meet this criterion will continue to be under review until new guidelines are in place.
| Issue | Interim period Final Decision, August 18, 2022 | Interim period Proposed Amendment, June 2023 |
| 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: 1. its national average transaction price (N-ATP) remains at or below the NEAP (Non-Excessive Average Price) as projected in the most recent compliance letter from PMPRB staff to the relevant patentee, and; 2. its list price does not increase. 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. |