This article was originally authored by Abigail Smith.
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.
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.
Related Publications & Articles
-
New PMPRB Guidelines will not be implemented January 1, 2023
The Patented Medicine Prices Review Board (PMPRB) has advised that the new Guidelines will not be implemented on January 1, 2023, and that the Interim Guidance issued by the Board on August 18, 2022 w...Read More -
Ontario is the latest jurisdiction to implement a biosimilars transition policy
On December 20, 2022, Ontario announced it is implementing a biosimilars transition policy. Starting March 31, 2023, patients receiving coverage from the Ontario Drug Benefit plan for the following in...Read More -
Innovative Medicines Canada proposes framework for innovative agreements for drug reimbursement
Pharmaceutical manufacturers in Canada often enter into Product Listing Agreements (PLA), particularly with public payors, to facilitate their drug being reimbursed. It is common for PLAs to take the ...Read More