PMPRB update: Revised compliance timelines for grandfathered and gap medicines and proposed regulatory amendments directed to CSPs

Smart & Biggar

Revised compliance timelines for Grandfathered and Gap medicines

On April 16, 2021, in view of COVID-19, the Patented Medicine Prices Review Board (PMPRB) reversed its position on compliance timelines for Grandfathered and Gap medicines: compliance with the Maximum List Price for these medicines will now be assessed after two filing periods (previously one, see our article here). In the result, the operative date for assessing compliance for Grandfathered and Gap Medicines with the amendments coming into force on July 1, 2021 is now July 1, 2022.

Forward Regulatory Plan 2021-2023: proposed amendments to the Patented Medicines Regulations and PMPRB Rules of Practice and Procedure

Pursuant to the CETA Implementation Act, amendments to the Patent Act relating to the PMPRB’s jurisdiction over Certificates of Supplementary Protection (CSP) holders will come into force on a date to be fixed by order of the Governor in Council (s. 138(5)). The relevant amendments will define a “rights holder” as “a patentee and a person for the time being entitled to a [CSP] for that invention” (section 79(1)) and amend section 80(1) to require a rights holder to provide the PMPRB with pricing information (section 80(1)).

As part of its Forward Regulatory Plan for 2021-2023, which outlines regulatory initiatives for the next two years, Health Canada has announced its intention to amend both the Patented Medicines Prices Review Board Rules of Practice and Procedure (plan here, with final amendments expected in winter 2021) and the Patented Medicines Regulations (plan here, with final amendments expected in spring 2021) to reflect the above expansion of the jurisdiction of the PMPRB to rights holders of CSPs.  The amendments to the Patent Act are expected to come into force in the spring of 2021.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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