The amended Patented Medicine Prices Review Board (PMPRB) regulations came into force on 1 July 2022, and at that time an interim approach to pricing was proposed (for further details, see "New PMPRB regulations in force").
The interim approach proposed a "status quo" to pricing until guidelines could be established relating to the final regulations. The final regulations included the new "basket" of foreign reference countries but repealed the provisions relating to:
- additional price regulatory factors and related reporting requirements; and
- the collection of price and revenue information net of third-party rebates.
For further details, see "Slam dunk! New basket of countries for PMPRB reporting remain, controversial amendments to Patented Medicines Regulations dropped".
Neither the current guidelines (last updated in February 2017) nor the 2020 guidelines (for further details, see "Final PMPRB guidelines released") address the final regulations.
The PMPRB had invited comments on the proposed interim approach to pricing and has published the 37 submissions received.
A final decision on the interim approach was announced on 18 August 2022. The PMPRB has largely maintained its proposed approach, noting the distinctions shown in Figure 1 between the original proposal and the final decision.
Figure 1: distinctions shown between the original proposal and the final decision
The announcement also answers the following questions:
- How can patentees know what non-excessive average price (NEAP) will apply to the price of a medicine during the interim period?
- Will the NEAPs continue to apply to the price of medicines if new guidelines are not in place by the end of 2022?
- How will the PMPRB address the value of free and compassionate goods during the interim period?
- Will Human Drug Advisory Panel meetings continue on their current timelines for new (and future) medicines?
Guideline consultations are expected to begin in September 2022, and the PMPRB has committed to completing the consultation process and issuing new guidelines before 1 January 2023.
For further information on this topic please contact Daphne Lainson or Nancy Pei at Smart & Biggar by telephone (+1 416 593 5514) or email ([email protected] or [email protected]). The Smart & Biggar website can be accessed at www.smartbiggar.ca.