Legal & Regulatory > Canada

On March 29 2023, the Quebec Health Minister (the “Minister”) introduced Bill 15, an Act to make the health and social services system more effective (the “Bill”). The Bill, which is still at the detailed study stage, proposes a major renewal of the framework for the health and social services system. Its purpose is to put in place a more effective system, particularly by facilitating access to services, enhancing coordination of the different components of the system and bringing communities…

Biosimilars and biologics in Canada: A legal guide. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. Are biosimilar medicines considered the same as generic medicines in your country? A biosimilar is not a generic biologic product since it is not identical to its reference product; its authorization does not constitute evidence of pharmaceutical equivalence, bioequivalence or clinical equivalence.[1] A biosimilar is…

Want to know more about the localization in Canada? Read on! Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? As of November, 2021, drugs intended for the Canadian market that could cause or exacerbate a shortage are…

All legal aspects surrounding orphan drugs and rare diseases in Canadian Pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. What is the definition of Rare Diseases in your country? In Canada, “Rare Diseases” are defined as “life-threatening, debilitating or serious, and chronic conditions affecting a small number of patients, many of which predominantly affect children, as these diseases are often…

The legal framework for cannabinoid drugs, medical cannabis and opioids in Canada. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes. Cannabinoids can be the active ingredient of a drug product in Canada, provided that such product meets applicable safety, effectiveness and quality requirements under the Food and Drugs Act and its regulations.…

An insight into upcoming regulatory reforms affecting Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? There are three significant changes which may affect or impact healthcare in Canada. NATIONAL PHARMACARE Currently, Canada is the only member country of the Organization for Economic Co-operation and Development with universal public health…

The low-down on the situation regarding patents and trademarks in Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. What are the basic requirements to obtain patent and trademark protection? In order to obtain patent or trademark protection, one must submit an application to the Canadian Intellectual Property Office (“CIPO”) and comply with the formalities of the application process set…

All about product liability in Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. What types of liability are recognized in your jurisdiction? In general terms, product liability arises from claims in contract or civil wrongs under the common law or civil code, depending on the province. Plaintiffs can hold manufacturers concurrently liable in either contract or civil wrongs. Contractual Liability…

An intro to the legal situation for traditional products and OTC medicines in Canada. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In Canada, traditional, herbal, complementary or alternative medicines are included under the previously defined term “NHPs.” NHPs are governed by the Food and Drugs Act and the…

The ins and outs of the marketing, manufacturing, packaging & labeling, and advertising in Canadian pharma. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other…

Preclinical and clinical trial requirements for pharma in Canada – a comprehensive legal overview. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There is no requirement to conduct local trials of a new drug to receive marketing approval. Rather, in order to obtain…

A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Canada. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Health Canada is the federal authority responsible for regulating pharmaceutical drugs, biologicals, and medical devices for human use. Health Canada’s…

Biosimilar uptake initiatives are gaining traction across Canada and have already been implemented in several provinces. Dara Jospé and Lina Bensaidane of Fasken examine the impact of these policies on patients, prescribers, and pharmacists thus far, and the implications should non-medical biosimilar switching become a nationwide norm.   In the last few years, several provinces in Canada have decided to introduce a biosimilar policy, through which only the biosimilar version of a given biologic drug is reimbursed by the public…

Fasken Canada’s Dara Jospe and Denis Douville examine Canada’s COVID-19 vaccine strategy, from the steps the country has taken to expedite the approval process to its funding of R&D projects and the preparations needed for ensuring the necessary supply and distribution infrastructure is in place.   Vaccination is a historically successful strategy to prevent the spread of infectious diseases. The immunization of a large enough proportion of a population will reduce the percentage of vulnerable hosts to a level below…

It is not a secret anymore, many in the industry now know that Health Canada is working on a new version of the policy entitled: The Distinction Between Advertising and Other Activities, dated more than 20 years ago. Earlier this week, Health Canada provided some insights about the reformed policy and offered target timelines for publication and entry into force.   The new Distinction Policy should be published in a draft format before the end of this month, in late…