News & Analysis as of

Ministry of Health Canada

Smart & Biggar

Federal Court of Appeal dismisses appeal of SPRAVATO “innovative drug” decision

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On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data protection. As...more

Smart & Biggar

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

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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

Littler

Ontario, Canada Appeal Court Affirms Finding that Midwives Were Underpaid Due to Gender Discrimination

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In Ontario (Health) v. Association of Ontario Midwives, the Court of Appeal for Ontario (OCA) was satisfied with the reasonableness of the Human Rights Tribunal of Ontario’s (HRTO) finding that the Ministry of Health (MOH)...more

Goodwin

British Columbia Announces Coverage of Three New Biosimilars for Blood Clot Prevention and Treatment

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On March 22, British Columbia’s Ministry of Health announced that three new enoxaparin biosimilars, Valero Pharmaceuticals’ REDESCA, Juno Pharmaceuticals’ NOROMBY, and Sandoz’s INCLUNOX, would be covered by PharmaCare, the...more

Smart & Biggar

Health Canada issues Interim Order respecting drug shortages related to COVID-19

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UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more

Smart & Biggar

Federal Court of Appeal refuses to grant stay of Federal Court decision remanding Health Canada’s refusal of SHINGRIX CSP

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The Federal Court of Appeal recently dismissed a motion brought by the Minister of Health (the Minister) for stay of a judgment of the Federal Court that held Health Canada’s refusal to issue a Certificate of Supplementary...more

Littler

Ontario, Canada: Employers Must Screen Workers and Essential Visitors for COVID-19

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In response to the recent increase in COVID-19 cases in Ontario, the province has imposed health screening obligations on employers. On September 25, 2020, the province’s government filed Regulation 530/20, which was made...more

Smart & Biggar

New Interim Order for COVID-19 drugs has wide-reaching impact, allowing Minister to unilaterally expand indication for...

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UPDATE: See our article here regarding transitional measures. On September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to...more

Smart & Biggar

Proposed amendments to Ontario Regulations to streamline administrative process, change OCT payment limit, and reduce government...

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On October 28, 2019, the Ontario Ministry of Health and Long-Term Care (the Ministry) published proposed changes to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee...more

Smart & Biggar

Costco Pharmacies receive $7.25M penalty for accepting drug rebates

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On February 1, 2019, the Ontario Ministry of Health and Long-Term Care (“Ministry”) announced that CWC Pharmacies (Ontario) Ltd. (“Costco Pharmacies”), a subsidiary of Costco, was ordered to pay an Administrative Monetary...more

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