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
Pharmaceuticals and life sciences
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…
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…
Drug pricing: PMPRB launches next phase of the Guidelines consultation
The Patented Medicine Prices Review Board (PMPRB) has released a new Discussion Guide for consultation on new price review Guidelines. The Discussion Guide outlines a proposed new price review process and requests stakeholder feedback on several specific topics…
CADTH to Transform into Canada’s Drug Agency
Canada’s Drug and Health Technology Agency (CADTH) has announced that, as of May 1, 2024, its new operating name will be Canada’s Drug Agency / l’Agence des médicaments du Canada (CDA-AMC). The official launch will occur…