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 February 2024, the federal government tabled much-anticipated legislation providing for national, universal, publicly funded drug coverage. An Act respecting pharmacare (the Pharmacare Act) came into force in October 2024 (our report here) and will be rolled out in phases.

In the first phase, the Minister of Health (Minister) is to make bilateral agreements with provincial and territorial governments to fund prescription drugs (and related products) for contraception and diabetes (our report here). In September 2024, one province – British Columbia – committed to negotiating a bilateral agreement (our report here).  However, as of January 2025, no bilateral agreement has been announced with any province or territory.

The Minister has also been taking steps under the Pharmacare Act to advance pharmacare beyond its first phase. Specifically, the Minister has established a Committee of Experts to recommend options for operating and financing pharmacare (our report here). The Minister has also asked the Canadian Drug Agency-L’Agence des médicaments du Canada (CDA-AMC) for advice on (i) a national formulary and (ii) a national bulk purchasing strategy (our report here).

2. PMPRB: Guidelines in development and jurisdiction confirmed by the FCA

New guidelines. Over the course of 2024, the Patented Medicine Prices Review Board (PMPRB) began to reveal its plans for a revised set of price-review guidelines for reviewing the prices of patented medicines. Following a February 2024 “What We Learned” Report (our report here) and a June 2024 Discussion Guide for stakeholder feedback (our report here), the PMPRB released the Draft Guidelines for consultation in December 2024 (our report here). The Draft Guidelines outline a new price-review process for Board Staff. An “In-Depth” price investigation is triggered by Canadian prices above the highest international price in the PMPRB11[1], price increases exceeding the CPI, or a complaint from an “authorized individual”. Consultation on the Draft Guidelines is open until March 19, 2025.

Limits on Board jurisdiction. Also in December 2024, the Federal Court of Appeal confirmed that the test for determining whether a patent “pertains” to a medicine under the Patent Act cannot be interpreted to give the Board jurisdiction over the prices of unpatented medicines. In doing so, the Court rejected an attempt by the Board to extend its jurisdiction on the basis of “clinical similarities” to a different patented medicine containing the same medicinal ingredient (our report here).

3. Canada’s rare disease strategy unfolds

In 2024, Canada’s National Strategy for Drugs for Rare Diseases came to fruition. The strategy, announced by the federal government in March 2023, includes up to $1.4 billion of funding over 3 years for the provinces and territories through bilateral agreements (our report here). The funding is intended to improve access to new and emerging drugs for rare diseases, and to support enhanced access to existing drugs, screening, and early diagnosis.

In July 2024, the federal and British Columbia governments announced the first bilateral funding agreement (our report here). Since then, five other provinces have reached agreements with the federal government, most recently Ontario on January 24, 2025. Health Canada’s website posts a common list of new drugs for rare diseases and notes which drugs each province and territory has elected to make available under a bilateral agreement.

4. Regulatory and market access round-up

  • Impact of “Dormant” status. A January 2024 Health Canada Notice opened the door for generic versions of “Dormant” innovative drugs (our report here). “Dormant” status means that the drug is not currently sold in Canada, but has not been withdrawn from the market. “Dormant” status could be triggered by, for example, a supply shortage or a manufacturing issue. According to Health Canada, if an innovative drug is categorized as “Dormant” in the Drug Product Database, then a generic manufacturer can compare its drug against an alternate Canadian Reference Product – which could be another generic drug – when filing its submission.
  • Updates to the GSUR List. In February 2024, Health Canada announced that, for generic drug submissions accepted into review on or after April 1, 2024, the Generic Submissions Under Review List  will start disclosing: (i) the year and month that the submission was accepted for review; and (ii) the company sponsoring the generic drug (our report here).
  • CADTH is now the CDA-AMC. As of May 1, 2024, Canada’s Drug and Health Technology Agency (commonly known as CADTH) now operates as the CDA-AMC (our report here). The CDA-AMC’s mandate and functions extend beyond those of its predecessor (i.e., health technology assessments, post-market safety, and effectiveness) into initiatives such as improving the appropriate prescription and use of medications and specific mandates under the Pharmacare Act (discussed above).
  • pTAP launched. In April 2024, the pan-Canadian Pharmaceutical Alliance (pCPA) launched its Temporary Access Process (pTAP) to facilitate early market access for new drugs assessed under CADTH’s time-limited reimbursement recommendation (TLR) pathway (our report here). Under the TLR pathway, a drug can be conditionally approved for sale (by Health Canada) and its clinical and cost-effectiveness assessed using preliminary evidence (by CADTH) while the manufacturer collects further evidence confirming the product’s effectiveness. The pTAP addresses whether and how a conditionally approved drug will be temporarily funded by the provinces’ and territories’ public plans.

5. Case law updates

  • What’s in a name? In a rare trademark battle in the Canadian pharma space, the Federal Court found the brand name of a biologic drug to be confusingly similar to the brand name of a biosimilar, which had a different active ingredient but was used to treat the same disorder (our report here). Notably, in the test for confusion, patients were held to be a relevant consumer and Health Canada’s prior approval of the product names did not impact the test for confusion.
  • Patent listing eligibility – change in use. The Federal Court held that a patent listed on the Patent Register on the basis of a Supplementary New Drug Submission for a change in use must claim the “very change in use” approved by the issued Notice of Compliance (our report here).
  • Case splitting is an abuse of process. The Federal Court of Appeal held that it is an abuse of process for a generic or biosimilar manufacturer to split its case across multiple notices of allegation  in disputes under the Patented Medicines (Notice of Compliance) Regulations (our report here).
  • Updated Court Guidelines. In November 2024, the Federal Court updated its guidelines for proceedings under the PM(NOC) Regulations and other complex proceedings, including mandatory pre-trial conferences (our report here)  
  • Scope of implied licenses for patented medicines. The Federal Court of Appeal held that selling a single dose of a patented multi-dose regimen does not provide an implied license to use the entire patented dosing regimen of a product (our report here).

6. Areas to watch in 2025

We expect the following to be hot topics in the Canadian pharma space in 2025:

  • PMPRB Guidelines. The PMPRB intends to finalize and implement its new guidelines in 2025. Stakeholders have until mid-March 2025 to make submissions on the Draft Guidelines.
  • National pharmacare. This year could see more steps taken to implement pharmacare, including by the Minister, the Committee of Experts, and the CDA-AMC to advance pharmacare beyond its first phase.  At the same time, it is unclear whether national pharmacare will survive the outcome of the next federal election, which may be held as early as this spring.  
  • Supreme Court to consider the scope of patentable subject-matter. In February 2024, the Federal Court of Appeal opined on the test for determining whether a patent claims an unpatentable method of medical treatment (our report here). The Supreme Court of Canada granted leave to appeal this decision in September 2024 and a hearing is expected in 2025 (our report here).

The Pharma in Brief Team thanks you for your readership in 2024. We will continue to keep you informed of the latest developments in 2025 and beyond.


[1] The PMPRB11 countries are: Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, and the United Kingdom.