The Federal Court of Appeal (FCA) has set aside a decision of the Federal Court (FC), which had invalidated Health Canada’s decision to disclose records in response to a request (ATI Request) made pursuant to the Access to Information Act
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Federal Court finds Minister of Health’s refusal to grant CSP based on the “Timely Submission Requirement” unreasonable
SUMMARY
The Federal Court has granted Merck Canada Inc.’s (Merck) application for judicial review of a decision of the Minister of Health (Minister) denying a Certificate of Supplementary Protection (CSP) for Canadian Patent No. 2,670,892 (892 Patent) and the drug…
Continue Reading Federal Court finds Minister of Health’s refusal to grant CSP based on the “Timely Submission Requirement” unreasonable
Canada seeks leave to appeal to the Supreme Court in PMPRB excessive-pricing case
The Attorney General of Canada has sought leave to appeal to the Supreme Court in an excessive-pricing case regarding the drug SOLIRIS.
As we reported, Alexion Pharmaceuticals Inc. was successful before the Federal Court of Appeal in an application…
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ONSC dismisses Apotex’s second monopolies action
The Ontario Superior Court of Justice has released the second decision in a series of summary judgment motions relating to Apotex’s claims against innovative drug companies under various causes of action pursued above and beyond the section 8 damages regime…
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Health Canada reports on a national strategy for rare disease drugs
Health Canada has published a report on its public consultation on building a national strategy to address access to drugs for rare diseases. This report follows the Government of Canada’s commitment to create a national strategy for drugs for rare…
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Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations
On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations (FDR) and the Medical Devices Regulations in the spring of 2022. The proposed amendments are intended to modernize the…
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PMPRB excessive price decision quashed by Federal Court of Appeal
The Federal Court of Appeal has quashed an excessive-price decision of the Patented Medicine Prices Review Board (PMPRB) in a proceeding concerning the drug SOLIRIS. The matter has been remitted to the PMPRB for redetermination.
Procedural background
The PMPRB issued…
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CADTH convenes Advisory Panel on a pan-Canadian prescription drug list
CADTH has convened a pan-Canadian Advisory Panel on a Framework for a Prescription Drug List (the Panel). The Panel will provide recommendations on developing a potential pan-Canadian prescription drug list (or formulary). Stakeholder consultations are scheduled to take place in…
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PMPRB Guidelines update: consultation on changes re delayed implementation
The Patented Medicine Prices Review Board (PMPRB) has launched a consultation on proposed changes to its new Guidelines (the New Guidelines). These changes include revisions to the price tests for some medicines marketed prior to the anticipated coming-into-force date of…
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Certain COVID-19 medical devices no longer hold urgent public health need status under Interim Order No. 2
Health Canada has issued a notice explaining a policy change to the review of applications for COVID-19 medical devices. As of July 16, 2021, Health Canada is no longer accepting applications for certain categories of medical devices under Interim Order …
Continue Reading Certain COVID-19 medical devices no longer hold urgent public health need status under Interim Order No. 2