On March 6, 2025, British Columbia became the second province to announce the signing of a pharmacare agreement with Canada’s federal government. Manitoba was the first province to do so, on February 27, 2025 (our report here).
British Columbia’s pharmacare agreement
The agreement follows from a September 2024 Memorandum of Understanding between the British…
Canada has made wide-ranging amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR). The amendments are intended to deliver on Health Canada’s modernization commitments, codify long-standing policies and practices, and implement regulatory agilities piloted during the COVID-19 pandemic. Some of the amendments are already in force, while others come into…
On February 27, 2025, the governments of Canada and of the Province of Manitoba announced the first-ever national pharmacare funding agreement. The two governments also announced a funding agreement under the National Strategy for Drugs for Rare Diseases.
Pharmacare Agreement
As we reported, An Act respecting pharmacare (the Pharmacare Act) came into force on…
Health Canada has proposed additional regulations intended to prevent, mitigate, and respond to drug shortages. The proposed amendments to the Food and Drug Regulations (Regulations) include new requirements for drug market authorization holders to develop shortage prevention and mitigation plans, report surges in demand, and maintain safety stocks for certain drugs. Health Canada is accepting…
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…
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 an initial screening based on a comparison to the highest international price (HIP) of the patented medicine across…
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 FC reiterated that a patent listed on the basis of a Supplementary New Drug Submission (SNDS) for a…
Canada’s emerging national systems of pharmacare and public funding for drugs for rare diseases (DRDs) had key developments last week. On December 4, the Minister of Health (Minister) asked Canada’s Drug Agency-L’Agence des médicaments du Canada (CDA-AMC) for advice on a national formulary and a bulk purchasing strategy for pharmacare. The following day, on December…
The Federal Court recently refused to order a defendant to produce samples of cell culture because there was no “reasonable possibility” that testing the samples would yield evidence of patent infringement. In pharmaceutical patent cases, testing samples of a defendant’s product – or samples from a defendant’s process – can lead to crucial evidence of…
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 the PMPRB and the Federal Court (FC) finding that a patent can pertain to a medicine based on “clinical…
