On April 14, 2022, Health Canada announced that the government will:
- Proceed only with the proposed amendments to the Regulations pertaining to schedule of reference countries (the PMPRB11 replacing the PMPRB7).
- Not proceed with new excessive price factors (cost effectiveness, market size, GDP) nor the reporting of third-party rebates.
- Publish the amendments to the Regulations in the Canada Gazette in late Spring 2022.
On April 22, 2022, the PMPRB announced their intentions with respect to the Guidelines responding to Health Canada’s announcement:
- The Board will consult on a de novo set of guidelines in the coming months as both the current (2017) and proposed (2020) Guidelines are inconsistent with the new regulatory framework.
- Accordingly, neither the current nor the 2020 guidelines will be in force as of July 1st
- It is anticipated that consultations on new draft guidelines perhaps as early as Summer 2022.
- PMPRB will announce interim price tests that will apply while neither the old nor the new guidelines are in effect.
- These temporary interim price tests will be the subject to an expedited consultation but only after the amended Regulations have been published in the Canada Gazette.
- As of July 1, 2022, patentees will be required to report the new PMPRB11 reference countries.
As more information regarding the consultations and transition measures becomes available, PDCI will share further insights and implications with patentees. Stay tuned for further PDCI hosted webinars in the coming weeks.
Please contact Dylan.LambPalmer@pdci.ca with any questions.