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Federal Court rules on patent listing again, confirms generic not required to address patent submitted before ANDS filing but...

On January 20, 2025, Justice O’Reilly of the Federal Court dismissed Bayer’s judicial review of the Minister of Health’s decision to list Canadian Patent No. 2,970,315 (315 Patent) on the Patent Register eight days after it...more

2023-2024 Pan-Canadian Pharmaceutical Alliance impact report

On November 22, 2024, the pan-Canadian Pharmaceutical Alliance (pCPA) released its 2023-2024 impact report. According to the pCPA, estimated dollar savings for public drug plans from pCPA negotiations were $4.63 billion...more

Canada’s Drug Agency seeks input on HTA methods guide and also announces new coalition to improve medication use

HTA Methods Guide – On November 28, 2024, Canada’s Drug Agency (CDA) launched a consultation on its first-ever methods guide. The consultation seeks stakeholder input to enhance the methods guide, which describes the methods...more

Generic not required to address patent submitted before ANDS filing but listed after

On November 20, 2024, the Federal Court dismissed EMD Serono (Serono)’s judicial review of the Minister of Health’s decision to list Canadian Patent No. 3,087,419 (419 Patent) on the Patent Register one week after it was...more

Health Canada and the Competition Bureau commit to information sharing to combat false, misleading or deceptive health claims

On March 7, 2024, Health Canada published a Memorandum of Understanding (MOU) with the Competition Bureau (together, Participants) to advance their mutual interests and develop a framework of cooperation to assist in...more

Ontario Ministry of Health proposes regulatory amendments removing submission requirements for well-established drugs

On October 19, 2023, the Ontario Ministry of Health proposed regulatory amendments under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA) to align Ontario’s requirements for...more

CADTH time-limited recommendation category to enhance earlier access to promising new drugs

On September 28, 2023, the Canadian Agency for Drugs and Technologies in Health (CADTH) introduced the time-limited reimbursement recommendation category, which aims to provide early access to promising new drugs that target...more

pCPA announces new three-year pricing initiative agreement for generic drugs with CGPA, appointment of Douglas Clark as its first...

The pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association (CGPA) have agreed to a new three-year pricing initiative for generic drugs, effective October 1, 2023. This agreement, which...more

Innovative Medicines Canada proposes framework for innovative agreements for drug reimbursement

Pharmaceutical manufacturers in Canada often enter into Product Listing Agreements (PLA), particularly with public payors, to facilitate their drug being reimbursed. It is common for PLAs to take the form of a first dollar...more

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