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Let's talk antitrust: Discussing recent cases and emerging competition issues
Recent cases and judgments have shone a light on some emerging themes and trends that companies will want to consider as part of their risk management framework.
Canada | Publication | August 11, 2023
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 Act (FDA) and the Food and Drug Regulations (FDR).
This long-awaited update broadens the definition of advertising and promotional messages and activities and requires a contextual analysis to determine whether a particular message or activity is promotional or non-promotional in nature. This includes a consideration of the content of the message, the context in which it is delivered, the message’s sponsor, and the message’s mode of dissemination.
The prior version of the Distinction Guidance was last updated in August 2005 (the Old Guidance) and did not adequately address the evolution of advertising activities since that time, including online advertising, search engine marketing, and social media activities.
An updated version of the Distinction Guidance was first circulated for consultation in 2019. Consultation on the draft guidance ran from July 5, 2019, to September 3, 2019.
The scope of the Distinction Guidance is now broader. The Old Guidance applied only to drugs for use in humans, whereas the Distinction Guidance now applies to drugs (both prescription and non-prescription), medical devices, natural health products, biologics, vaccines, and animal health products.
The Distinction Guidance also now encompasses all messages and activities involving medical conditions and/or health-related matters regardless of the target audience in Canada, including the general public and health care professionals (HCPs).
The Distinction Guidance maintains the fact-based approach of the Old Guidance to determining whether a given message or activity is promotional.
In general, consideration will be given to the following factors:
Stakeholders should continue to ask probative questions to determine whether a message is intended to promote the sale of a drug, including: What is the context in which the message is disseminated (i.e., when, how, where, to and by whom)? Who is the target (or “primary”) audience? Are there any unintended (or “secondary”) audiences exposed to the message? Who is delivering the message? Who is sponsoring the message and how? What influence does a health product manufacturer have on the message? What is the content of the message (i.e., is it accurate, balanced, objective, and scientifically rigorous)? How frequently is the message being delivered?
Notable changes include:
For more information, please contact your IP professional at Norton Rose Fulbright Canada LLP.
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