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
Pharmacare Act becomes law in Canada
On October 10, 2024, Canada’s federal government passed legislation that will introduce pharmacare, a program of national universal drug coverage. The federal government must now take steps to implement the first phase of pharmacare, including reaching agreements with the provinces
Pharmacare: BC first to announce partnership with federal government
On September 12, 2024, the Governments of Canada and of the Province of British Columbia (BC) announced partnering to provide universal access to contraception, diabetes medication, and hormone replacement therapy. The Canada-BC Memorandum of Understanding is the first
Pharmacare Update: Budget 2024
Drug price negotiations: pCPA Temporary Access Process launched
The pan-Canadian Pharmaceutical Alliance (pCPA) has launched its Temporary Access Process (pTAP) to facilitate early market access to new drugs that were assessed under the time-limited reimbursement recommendation (TLR) pathway at the Canada Drug
National Pharmacare bill tabled
On February 29, 2024, the federal government tabled Bill C-64, An Act respecting pharmacare (the Pharmacare Act). The Pharmacare Act outlines the “foundational principles” for the first phase of a national universal drug coverage plan in Canada. The legislation
Health Canada disclosing more information on pending generic drug submissions
On February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent. Specifically, for generic drug submissions accepted into review on or after April 1, 2024, Health Canada will