Second Interim Guidance Proposed by the PMPRB
In the latest instalment in the saga to implement the amended Patented Medicines Regulations that came into force on July 1, 2022, the Patented Medicine Prices Review Board (PMPRB) has published a second Interim Guidance proposal. This proposal would amend the first Interim Guidance issued by the PMPRB to allow them to address over half of the current backlog of New Medicines until new permanent guidelines can be put in place.
The proposed changes impact only New Medicines. New Medicines are defined as medicines without a projected Non-Excessive Average Price (NEAP) or a Maximum Average Potential Price (MAPP) as of July 1, 2022.
New Medicines will be considered as “Reviewed” by the PMPRB if their list price is below the median international price for the new basket of 11 comparator countries (i.e., the PMPRB11).
The PMPRB11: Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden, and the United Kingdom
New Medicines that do not meet this criterion, i.e. that have a list price higher than the median international price of the PMPRB11, are not impacted by the proposed amendments. They will not be reviewed by the PMPRB until the new permanent guidelines are in place. However, the proposed Interim Guidance reiterates that the PMPRB will not retrospectively target the revenues of rights holders for any sales of New Medicines made during the interim period.
The PMPRB has reported that roughly 55% of New Medicines have list prices below the median international price of the PMPRB11, thus indicating that the proposed Interim Guidance may streamline the review of all but 45% of New Medicines.
No further changes were proposed to the previous Interim Guidance, which is still in effect.
The PMPRB is encouraging stakeholders to provide them with comments on the new Interim Guidance proposal. Submissions can be made to PMPRB.Consultations.CEPMB@pmprb-cepmb.gc.ca until Monday, August 21, 2023.
Within the coming months, the PMPRB plans to further consult stakeholders on proposed permanent guidelines that they intend to finalize in 2024, which would end the period of Interim Guidance.
For additional information on the ongoing process to implement the amended Regulations, see our other articles, including:
- Proposed Canadian Drug Pricing Rules Delayed by Feds and Battered by Courts
- Canada Drops its Most Controversial Patented Drug Pricing Amendments
- PMPRB Regulations Saga Coming to an End? New Draft Guidelines Issued
- Patented Medicines Regulations: The Problem Is Not in Collecting the Data, but in How You Use It!