Tagged with Canada

Pharma Legal Handbook 53. 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 Plaintiffs…

Pharma Legal Handbook 58. 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 out by the agency. All forms and guidelines…

Pharma Legal Handbook 66. Are there proposals for reform or significant change to the healthcare system? There are three significant changes which are currently evolving that will impact healthcare in Canada in the future.   National Pharmacare As of October 10, 2024, Canada adopted the Pharmacare Act which seeks to provide a national…

Pharma Legal Handbook CANNABINOID DRUGS 68.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. This means that Cannabinoid Drugs must be submitted…

Pharma Legal Handbook 103. 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 genetically based and appear at birth or in…

Pharma Legal Handbook 114. 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 prohibited from being distributed outside of Canada.…

Pharma Legal Handbook 123. 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 a subsequent entry version…

Canada 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…

Canada Some of the top stories coming out of Canadian healthcare and life sciences, including a new GSK flu vaccine deal, Amylyx Pharmaceuticals’ first approval for an ALS drug, and the Public Health Agency of Canada’s recent smallpox contracts with Chimerix and Bavarian Nordic.   GSK flu vaccine deal renewal (Reuters)…

North America In April, the Canadian Ministry of Health announced the government would not be proceeding with certain proposed amendments to the Patented Medicines Regulations which govern the Patented Medicine Prices Review Board (PMPRB)—amendments related to new excessive price factors. The decision, well-received by Innovative Medicines Canada, came after these controversial economic…

Global Based on IQVIA’s pharma market rankings for 2020, we give a rundown of the global top 10, key companies, important trends, and where you can go to learn more.   1. United States Way out in first place with a market value of USD 533.5 billion in sales in 2020,…

Canada In conversation in the October edition of DIA’s Global Forum magazine, Canadian Agency for Drugs and Technologies in Health (CADTH) CEO Suzanne McGurn highlights how the work of HTA bodies like CADTH has evolved, the most significant challenges in their work, international collaboration, and RWE integration.   Health technology assessment…