March 2025 saw a flurry of developments in Canada’s emerging national funding systems of drugs for rare diseases and pharmacare. All of Canada’s 13 provinces and territories have now reached bilateral agreements with the federal government to cover certain drugs
Pharmaceuticals and life sciences
British Columbia becomes second province to sign pharmacare agreement



Agile licensing, risk, biologics, and more: Wide-ranging amendments to Canada’s drug and medical device regulations



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…
National pharmacare in Canada: First-ever funding agreement announced



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
…Drug shortages: New requirements proposed for the Food and Drug Regulations
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…
Pharma in Brief’s 2024 Year in Review and Trends for 2025
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…
Recent developments in Canadian national pharmacare and funding for drugs for rare diseases



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…
Federal Court denies samples for testing infringement of biologic process patent


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…
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…
Federal Court updates Guidelines for PMNOC proceedings


On November 28, 2024, the Federal Court updated its guidelines for proceedings under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) and other complex proceedings. While the changes are not extensive, they create some new obligations and…