PMPRB Adopts Amended Interim Guidelines to Expedite New Patented Medicine Price Reviews
This article provides an update on PMPRB’s measures to expedite patented medicine price review to clear its review backlog.
Interim Guidelines Now in Effect
The PMPRB recently decided to adopt its Amended Interim Guidance, effective immediately (see our firm’s article on the amendments here). The Amended Interim Guidance indicates that unreviewed new medicines in the backlog (“New Medicine”) will be considered as “reviewed” if their list price is below the median international price for the PMPRB11 basket of comparator countries (i.e. Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden, and the United Kingdom). New Medicines that do not meet this criterion would continue to be “under review” until the new guidelines are in place.
The highly contentious amended Patented Medicines Regulations (the “Regulations”) came into force on July 1, 2022. The Patented Medicines Price Review Board (the “PMPRB”) has not published the New Guidelines to complement and operationalize the new Regulations. In this interim period, the PMPRB provided Interim Guidance, which is the basis for the most recent amended and adopted text described at the start of this article.
On August 18, 2022, the PMPRB provided its initial Interim Guidance provided a process for the continued price review of existing medicines in the Interim Period between the coming into force of the new Regulations, and the publication of its new PMPRB Guidelines.
The PMPRB released its much-awaited Draft Guidelines in the fall of 2022, and after a 50-day comment period, the PMPRB announced that the new Guidelines would not be implemented on January 1, 2023, as initially expected, and that the Interim Guidance would remain in place until further notice. Meanwhile, the PMPRB’s extension of the Interim Period and the delay in the publication of the new Guidelines has resulted in the current backlog of reviews on the pricing of New Medicines.
In order to address the backlog while the consultation process on the new Guidelines continues, on June 20, 2023, the PMPRB invited stakeholders to comment on a proposed amendment to its Interim Guidance (the “Amended Interim Guidance”) which aims to provide an expedited assessment for New Medicines’ prices. The amendment was adopted in September 2023, after receipt of 45 submissions from a range of stakeholders.
The Board has also announced that it intends to launch a consultation on themes relevant to new guidelines in the coming weeks. The first stage of the consultation 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, to begin in 2024, will focus on the development of new guidelines.
The PMPRB intends to finalize the New Guidelines in 2024.