Canada: PMPRB Publishes Scoping Paper In Preparation For Upcoming Guidelines Consultations
Life Sciences Bulletin

On November 10, 2023, the Patented Medicine Prices Review Board (PMPRB) released the Scoping paper for the consultations on the Board's Guidelines (the "Scoping Paper"), which outlines themes and questions to inform the upcoming industry consultation on the development of new guidelines. To participate in the Round Table, complete the Policy Roundtable Registration Form before November 24th.

Background

The amendments to the Patented Medicines Regulations ("Regulations"), came into force on July 1, 2022. The Regulations increased the number of comparators from seven to 11 countries (PMPRB11) and reduced reporting requirements for medicines believed to be at the lowest risk of excessive pricing. Now, the PMPRB is gearing up to operationalize these changes in new guidelines, while cementing its stated commitment to modernize and simplify its administrative framework.

The PMPRB's previous draft guidelines were never implemented. We reported on this update in our bulletin, "The 2022 PMPRB Outlook for Pharmaceutical Patentees in Canada". In the meantime, the PMPRB's Interim Guidance, issued on August 18, 2022, remains in place, which benchmarks prices of new medicines to the median international price of the PMPRB11.

The Scoping Paper is intended to inform the consultation process to develop the new guidelines, by outlining themes and questions for stakeholder feedback — it does not articulate the PMPRB's position. The PMPRB intends to subsequently release a What We Heard Document in early 2024. The themes of the Scoping Paper are summarized below.

Theme 1: Efficient Monitoring of Prices Without Price Setting

The purpose of the guidelines is to explain the criteria staff will consider in determining whether the price of a patented medicine warrants an investigation, but the Scoping Paper acknowledges that not every patented medicine warrants the time an effort of a hearing. In light of this, the PMPRB wants to develop an administrative review that allows the monitoring of cases for potential excessive pricing. The Scoping Paper poses questions on how to best provide transparency in how staff analyses price information, so that rights holders will be able to evaluate the risk of a hearing. For example, what elements of the previous guidelines should be retained? Should medicines continue to be classified by therapeutic class? How should the PMPRB weigh each factor?

The PMPRB also evaluates and compares the pricing of patented medicines in Canada with other international markets. The Scoping Paper asks: what price levels should be used as a triage measure [e.g. highest international price (HIP) or median international price (MIP)]? How should the PMPRB deal with medicines that have few or no international prices? What about an expedited review based on low international prices?

Theme 2: Transition to PMPRB11 – New Versus Existing Medicines

As we mentioned, the comparator countries in the Regulations changed to the PMPRB11. The change required that all information has to be filed using the PMPRB11, regardless of the original date of introduction of the medicine (i.e., before or after July 1, 2022). The Scoping Paper asks if the guidelines ought to distinguish between medicines that existed before the introduction, and how to approach existing medicines with prices above the PMPRB11. For context, the previous and draft guidelines distinguished the investigational triggers for new and existing medicines.

Theme 3: Price Reviews during Product Life Cycle

The PMPRB's duty to monitor excessive pricing extends during the duration of the patent or certificate of supplementary protection. The Scoping Paper poses related questions about the frequency of, and the criteria used to trigger, price reviews, how to adapt factors according to the lifecycle of the medicine, the consideration of the Consumer Pricing Index and the timing for scientific review and therapeutic comparator identification.

Theme 4: Investigations and Referral to Hearing

As in Theme 1, the guidelines will continue to provide criteria that are assessed to trigger an investigation, such as price ceilings. This transparency allows rights holders to better assess the risk of being considered for a hearing. The Scoping Paper inquires into what criteria from the old guidelines should be kept, how much detail the new guidelines should provide, and if undertakings an appropriate mechanism for investigation closure.

Theme 5: Relation to Pan-Canadian Health Partners, Insurers (Private and Public); And Alignment With Broader Government Initiatives

The PMPRB intends to harmonize its priorities and objectives with other health partners in the Canadian pharmaceutical landscape. According to the PMPRB, the new guidelines present an opportunity to better coordinate and support existing regulatory and pricing bodies, as well as initiatives from federal, provincial and territorial governments. The Scoping Paper prompts stakeholders to consider what efficiencies could be gained by this coordination, and how the PMPRB can optimize its presence within the current ecosystem.

Theme 6: Engaging With Patients, Health Practitioners, Pharmacy, and Other Stakeholders

The objective of this theme is to seek feedback from stakeholders who are not rights holders by inquiring into their experience with the pricing of medicines, the role of the PMPRB in their decision-making, and how the PMPRB can better engage them.

Upcoming Roundtable and Written Submissions

The PMPRB is inviting stakeholders to participate in a Policy Round Table, informed by the themes we have discussed, on December 5 (English session) and December 6 (French session). To participate in the Round Table, complete the Policy Roundtable Registration Form before November 24th. While there are a limited number of available spots to register for in-person attendance, all interested persons can register to participate online. Interested parties can make representations at the Round Table, or by way of written submission due on December 20th.

Fasken continues to monitor all PMPRB developments, and our pricing strategy team is available to discuss your consultation submission.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.