2024 saw no shortage of headlines in the Canadian pharma space. Here we look back on the year’s most notable legal and regulatory developments and look forward to areas to watch in 2025.
1. National pharmacare comes to Canada
In
Drug Pricing Update: PMPRB launches consultation on Draft Guidelines for price review
The Patented Medicine Prices Review Board (PMPRB or Board) has released a draft of its new price review Guidelines (the Draft Guidelines) for consultation. The Draft Guidelines outline a proposed new price-review process for Board Staff, with
Federal Court declares patent ineligible for listing during PM(NOC) infringement action
The Federal Court (FC) has provided fresh guidance on applying the test for challenging patent-listing eligibility in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). Granting the delisting motion before it, the
Federal Court of Appeal confirms that the PMPRB has no jurisdiction over unpatented medicines
The Federal Court of Appeal (FCA) has confirmed that the Patented Medicine Prices Review Board (PMPRB or Board) does not have jurisdiction over the prices of unpatented medicines. In doing so, the FCA overturned decisions of
Supreme Court of Canada grants leave to appeal methods of medical treatment patentability decision
On September 19, 2024, the Supreme Court of Canada granted an application for leave to appeal in a case concerning the scope of patentable subject-matter in Canadian law, focusing on an area known as “methods of medical treatment” (MMT
Federal Court addresses treatment and formulation patent claims in PMNOC case
The Federal Court (FC) has upheld the validity of a patent concerning treatment of idiopathic pulmonary fibrosis (IPF) and granted injunctive relief against the generic in an infringement action under section 6 of the Patented Medicines
British Columbia signs first funding agreement under the national rare disease strategy
Drug pricing: PMPRB launches next phase of the Guidelines consultation
The Patented Medicine Prices Review Board (PMPRB) has released a new Discussion Guide for consultation on new price review Guidelines. The Discussion Guide outlines a proposed new price review process and requests stakeholder feedback on several specific topics
CADTH to Transform into Canada’s Drug Agency
Canada’s Drug and Health Technology Agency (CADTH) has announced that, as of May 1, 2024, its new operating name will be Canada’s Drug Agency / l’Agence des médicaments du Canada (CDA-AMC). The official launch will occur
Drug pricing: PMPRB announces next steps in Guidelines consultation
The Patented Medicine Prices Review Board (PMPRB) has announced new details regarding the progress of its consultation on new price review Guidelines.
Phase 2: Discussion Guide
The next phase of the PMPRB’s consultation will begin in summer 2024