Norton Rose Fulbright (LexBlog Canada)

As artificial intelligence (AI) regulation takes shape globally, public companies face the challenge of navigating this evolving landscape. In Canada, securities regulators are actively deliberating on how best to regulate AI, while in the US, companies are already making AI-related disclosure. In October 2023, the Ontario Securities Commission (OSC) published a report detailing the use...

Canada’s federal 2024 budget has set aside $1.5 billion over five years to launch pharmacare, which will introduce national universal drug coverage to Canada. Background As we reported, on February 29, 2024, the federal government tabled Bill C-64, An Act respecting pharmacare (the Pharmacare Act). The Pharmacare Act outlines the first phase of a national...

On February 29, 2024, the federal government tabled Bill C-64, An Act respecting pharmacare (the Pharmacare Act). The Pharmacare Act outlines the “foundational principles” for the first phase of a national universal drug coverage plan in Canada. The legislation includes a commitment to first launch diabetes medication and contraceptives coverage for Canadians through a universal,...

The Canadian case of Moffatt v. Air Canada considers a dispute concerning a refund for a bereavement fare. Jake Moffatt, the applicant, booked flights with Air Canada following the death of his grandmother. He was informed by an AI powered chatbot on Air Canada’s website that he could apply for bereavement fares retroactively. However, when...

On February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent.  Specifically, for generic drug submissions accepted into review on or after April 1, 2024, Health Canada will start disclosing: (i) the year and month that the submission was accepted for review; and...

The Federal Court (FC) has found the brand name of a biologic drug to be confusingly similar to the brand name of a drug used to treat the same disorder, but with a different active ingredient. The application of the ordinary test for trademark confusion was not affected by the fact that the names of...

As you start the new year, allow us to recap 2023’s important legal and regulatory developments for Canadian pharma. We also flag what to watch out for in 2024.  The most significant legal development in 2023 was the introduction of a system of patent term adjustment (PTA). On the regulatory front, seemingly all of Canada’s...

On January 5, 2024, the US Food and Drug Administration (FDA) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program (SIP) by the FDA. Whether Florida is able to import drugs from Canada, including in light of Canadian regulations controlling drug exports, remains to...

The Government of Canada has announced the creation of the Canadian Drug Agency (CDA). According to the government, the CDA “will provide the dedicated leadership and coordination needed to make Canada’s drug system more sustainable and better prepared for the future, helping Canadians achieve better health outcomes.” As we reported, the genesis of the CDA...

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations (Regulations), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators.  Since their genesis, the Regulations have been the focal point of most of the pharmaceutical patent litigation...

In a world where generative AI is driving innovation and technology is outpacing legislation, there’s a lot for companies to consider to maintain operational effectiveness and minimize risk. To help provide some guidance, Norton Rose Fulbright Canada hosted its 2023 technology, privacy and cybersecurity virtual summit. Our leading lawyers were joined by prominent industry leaders...

In Sharp v. Autorité des marchés financiers, 2023 SCC 29, the Supreme Court of Canada recognized the transnational nature of modern securities regulation in holding there was a “real and substantial connection” between alleged perpetrators of a “pump-and-dump” scheme and Québec. This connection allowed the province’s Financial Markets Administrative Tribunal (FMAT) to assume jurisdiction over...

In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product. The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations.  These distinctions are important as...

On October 5, the Minister of Innovation, Science and Industry (ISED) wrote a letter to the Standing Committee on Industry and Technology proposing amendments to Artificial Intelligence and Data Act (AIDA), which was introduced as part of Bill C-27 in June 2022. Further information on AIDA can be found in our previous update. The letter...

On September 27, the Minister of Innovation, Science and Industry released a voluntary code of conduct specific to generative AI. This GenAI code follows the proposed Artificial Intelligence and Data Act (AIDA), which was introduced as part of Bill C-27 in June 2022 but will not likely be in force until 2025. Beyond risk mitigation,...

Canada’s Drug and Health Technology Agency (CADTH) has published its procedures for a new time-limited reimbursement recommendation category. This recommendation category is intended to help provide earlier access to new therapies for severe, rare, or debilitating conditions where there is an unmet medical need. The pathway includes mechanisms to revisit the clinical and economic evidence...

The Federal Court has upheld a decision of the Minister of Health (Minister) that the new owner of a biosimilar new drug submission (NDS) could adopt the notice of allegation (NOA) served by its predecessor.  Consequently, the new owner was properly added as a defendant to an on-going action under subsection 6(1) of the Patented...

Norton Rose Fulbright Canada invites you to our annual technology, privacy and cybersecurity virtual summit. Navigating the evolving world of technology is not easy for companies today. From AI to effective company records management, privacy considerations, and cybersecurity breaches, there’s a lot to consider as businesses work to maximize operational effectiveness and minimize risk. Join...

In a previous blog post, we covered the impact of Bill C-11 and how the proposed legislation would regulate social media and streaming companies in Canada. In spring 2023, Bill C-11 received Royal Assent, becoming the Online Streaming Act, and began amending the Broadcasting Act. This included the Canadian Radio-television and Telecommunications Commission (CRTC) developing...

On August 8, 2023, the Federal Court overturned Health Canada’s decision that a cannabis product, Edison Jolts, was to be classified as edible cannabis and not cannabis extract.   The Court found that Health Canada had breached the duty of procedural fairness by relying on a product classification factor in an internal guidance document that Health...

Beginning January 1, 2024, the Canadian Intellectual Property Office (CIPO) will implement the first substantial increases to its service fees since 2004. Many fees will increase by 25% of more, though some “low materiality fees” will remain capped at $150. Meanwhile, an increase to the employee cap for “small entity” status will increase the number...

On August 7, 2023, the Canadian Intellectual Property Office (CIPO) launched a consultation on proposed features of regulations on patent term adjustment (PTA) in Canada (the Consultation). The PTA system is intended to compensate patentees for “unreasonable delays” by CIPO in issuing a patent. The Consultation seeks feedback on proposals that would impact the length of...

On July 31, 2023, Health Canada published its updated Guidance on distinction between advertising and other activities for health products (the Distinction Guidance). The Distinction Guidance outlines the factors that contribute to rendering a message or activity promotional in nature. Promotional messages and activities are subject to the advertising provisions of the Food and Drugs...

The pan-Canadian Pharmaceutical Alliance (pCPA) has recently published a set of principles and conditions for a pCPA Temporary Access Process (pTAP) which will inform the negotiation process and potential product listing agreements (PLAs) for drug products following the Canada Drug and Health Technology Agency (CADTH) time-limited recommendation pathway.  CADTH Time-Limited Reimbursement...

On June 22, 2023, Canada’s federal government passed legislation (Bill C-47) introducing a system of general patent term adjustment (PTA). The provisions amending the Patent Act to introduce PTA passed without substantive amendment and are scheduled to come into force no later than January 1, 2025. Canada’s new PTA system is intended to compensate patentees...

On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection (CSP Guidance).  The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations (CSP Regulations) and to reflect changes to Health Canada’s administrative...

Government institutions and businesses in Canada must soon comply with new legislation aimed at combatting forced labour and child labour or “modern slavery”. Bill S-211, an Act to enact the Fighting Against Forced Labour and Child Labour in Supply Chains Act and to amend the Customs Tariff (the Act), passed its third reading by the...

On April 27, 2023, the Supreme Court of Canada dismissed an application by Apotex Inc. and Apotex Pharmachem Inc. (Apotex) for leave to appeal from a decision of the Ontario Court of Appeal (ONCA), dismissing its claim for damages in the Ontario courts under the Statutes of Monopolies and other novel causes of action. In the Courts below, Apotex...

Children are generally recognized by both industry and government to be a vulnerable or special audience when it comes to advertising. On June 28, 2023, a new advertising code will be coming into effect as released by Ad Standards Canada. It is intended to expand upon legislative, regulatory, and self-regulatory regimes that already exist in...

On April 20, 2023, the federal government tabled legislation (Bill C-47) that would amend the Patent Act to bring, for the first time, a system of general patent term adjustment (PTA) into Canada. Canada is required under the Canada-United States-Mexico Agreement (CUSMA) to adopt a PTA system by 2025. The PTA system is intended to...