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CADTH to Transform into Canada’s Drug Agency

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By Sarah Pennington, Christopher A. Guerreiro & Kristin Wall on May 6, 2024

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…

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Pharmacare Update: Budget 2024

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By Sarah Pennington, Kristin Wall & Paul Jorgensen on April 16, 2024

Canada’s federal 2024 budget has set aside $1.5 billion over five years to launch pharmacare, which will introduce national universal drug coverage to Canada.

Background

As we reported, on February 29, 2024, the federal government tabled Bill C-64…

Drug pricing: PMPRB announces next steps in Guidelines consultation

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By Kristin Wall & Christopher A. Guerreiro on April 14, 2024

The Patented Medicine Prices Review Board (PMPRB) has announced new details regarding the progress of its consultation on new price review Guidelines.

Phase 2: Discussion Guide

The next phase of the PMPRB’s consultation will begin in summer 2024…

Drug price negotiations: pCPA Temporary Access Process launched

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By Sarah Pennington, Kristin Wall & Paul Jorgensen on April 10, 2024

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

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By Sarah Pennington, Kristin Wall & Paul Jorgensen on March 1, 2024

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…

Federal Court of Appeal clarifies law on patentability of methods of medical treatment

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By Christopher A. Guerreiro, Brian R. Daley & Pardeep Heir on February 29, 2024

The Federal Court of Appeal (FCA) has held that in order to determine whether a patent claims an unpatentable method of medical treatment (MMT), it is necessary to determine whether the use of the invention requires…

Health Canada disclosing more information on pending generic drug submissions

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By Sarah Pennington, Kristin Wall & Paul Jorgensen on February 25, 2024

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…

Drug pricing: PMPRB releases “What We Learned” Report on guidelines consultation

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By Kristin Wall & Christopher A. Guerreiro on February 16, 2024

The Patented Medicine Prices Review Board (PMPRB or Board) has released a “What We Learned” Report (the Report), marking the next step along the path to new Guidelines. The Report was prepared by Phoenix Strategic Perspectives Inc.…

Federal Court finds trademark confusion between the names of two approved biologics

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By Kristin Wall, Christopher A. Guerreiro & Fiona Sarazin on February 13, 2024

The Federal Court (FC) has found the brand name of a biologic drug to be confusingly similar to the brand name of a drug used to treat the same disorder, but with a different active ingredient. The application…

Dormant drug status can trigger generic access to an alternate Canadian Reference Product

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By Sarah Pennington, Kristin Wall & Paul Jorgensen on February 8, 2024

On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product (CRP) in the Food and Drug Regulations (Regulations). The Notice advises that if an innovative drug is…

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