This article was originally authored by Abigail Smith.
Update: On October 28, 2021, the PMPRB provided an update on this consultation, announcing that patentees will have at least two reporting periods to comply with any forthcoming changes to either the current Guidelines or the new Guidelines that were published in October of 2020. On December 17, 2021, the Board indicated it decided not to proceed with the changes proposed on July 15, 2021.
On July 15, 2021, the Patented Medicines Prices Review Board (PMPRB) announced a consultation on proposed changes to the new Guidelines (which, like the amendments to the Patented Medicines Regulations, are now slated to come into effect on January 1, 2022 (see our article here)):
- Definition of Gap medicine: The PMPRB has proposed to revise the definition of Gap medicine to align with the further delay in the coming-into-force of the amendments. Under the new definition, Gap medicines would be medicines for which a Drug Identification Number (DIN) was assigned on or after August 21, 2019 and prior to January 1, 2022 and was first sold in Canada prior to January 1, 2022.
- Comparator countries: The PMPRB has proposed to refer to the comparator countries set out in the Regulations as “Schedule Countries”, rather than the “PMPRB11”.
- International price tests for Grandfathered medicines and their Line Extensions: For both Grandfathered medicines and Line Extensions, the new Guidelines had set the maximum list price (MLP) at the lower of (1) the highest international price (HIP) for the PMPRB11 countries for which the patentee has provided information; or (2) the medicine’s price ceiling under the old Guidelines (the non-excessive average price, or NEAP). The PMPRB is proposing to set the MLP as the lower of the median international price (MIP) for the Schedule Countries for which the patentee has provided information for the reporting period ending June 30, 2021 (Schedule as per SOR/2008-70, s. 6)* or the NEAP. For Grandfathered medicines and their Line Extension medicines first filed with the PMPRB for the reporting period(s) ending December 31, 2021 or later, the MLP is to be set by the HIP for the Schedule Countries for which the patentee has provided information.
The PMPRB will accept feedback in writing on the proposed changes up to August 31, 2021 (extended from the previous deadline of August 15).
For our detailed summary of the new Guidelines, see our article here.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
*Article revised on July 26, 2021.