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
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 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
Pharmacare: Committee of Experts established
On November 14, 2024, the Government of Canada announced the establishment of a Committee of Experts as the next step in its implementation of a national pharmacare program. The Committee is tasked with providing the Government with practical advice on