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 Consultation on the draft guidance ran from July 5, 2019 to September 3, 2019.
Distinction Guidance Approach
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:
- Content and context. Consider the focus of the message; the message’s accuracy, objectiveness, consistency with the terms of market authorization; sponsor/manufacturer influence; layout and design; linkages to other promotional messages or activities; comparative therapeutics claims; and whether the message is disseminated in the context of a target medical condition.
- Sponsorship and dissemination. Sponsorship is defined as “support of a third party-owned message or activity.” Third party messages or activities may be promotional if they are not disseminated by a government authority, are not sponsored and delivered by a competitor, are delivered by sales or marketing staff, and/or involve distributing samples.
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?
Highlights of Changes
Notable changes include:
- Technology updates. The Distinction Guidance now contemplates the dissemination of information through technology, such as websites, social media, digital applications, and email. It outlines certain factors that need to be taken into consideration in this context, including the use of hyperlinks and other interactive features, “sharing” options (e.g., “re-tweets”), whether a social media website or platform is branded, and whether the sponsor is engaged in discussions beyond a monitoring capacity on a given post.
- New examples. New examples are explored in the Distinction Guidance, such as Other Learning Activities and Risk Management Plans. The Distinction Guidance outlines when these new activities will be considered promotional. Meanwhile, other examples from the Old Guidance have been omitted, such as 1-800 Telephone Numbers.
- Message linkages. One of the Distinction Guidance’s general principles dictates that “any linkages to various materials related to the message” will be considered when making a determination if a message or activity is promotional. For example, what are the linkages between the information in the message, the message’s provider, the message’s writer, and/or the product’s manufacturer? Is the message or activity combined or disseminated at the same time as other promotional messages or activities?
- Press releases and conferences. Any announcement posted on a manufacturer’s website should not be kept indefinitely on the landing page. Press releases should be archived before 1 year from their initial date of publication and there should not be an attempt to influence pick-up of the press release. Caution should be exercised in making “excessive” use of a brand name and in describing a product as a “breakthrough” unless it is disclosed that the breakthrough designation was granted by the U.S. FDA.
- Definition of “general public”. The “general public” has been defined as “ordinary people, especially all the people who are not members of a particular medical, pharmaceutical or scientific organization or who do not have any special type of medical or scientific knowledge”. Unlike the draft guidance circulated for feedback, the definition now also explicitly excludes patients prescribed a drug by an HCP. Health Canada’s stance on the meaning of the “general public” is important, as the FDA and FDR place limits on advertising to the general public.
- Clinical trial recruitment. The Distinction Guidance indicates that the manufacturer’s name should be included in clinical trial recruitment messages. This reverses the position in the Old Guidance, which indicated that a manufacturer’s name should be excluded from these messages.
- Patient information. Under the Old Guidance, Patient Information Booklets that accompanied a drug product were considered part of the labelling, and labelling requirements applied. Under the Distinction Guidance, Patient Information Materials are defined to include “[s]eparate package inserts, prescribing information, fact sheets, consumer/patient medication information (such as patient leaflets), patient diaries or other material that is to be distributed to a patient.” There is no requirement that these materials accompany a drug in order to potentially be considered part of the label, and for labelling requirements to apply. Materials may be considered promotional if they pertain to a health product that has not been prescribed to the patient or consumer, or if they are published on an ungated website that is accessible to consumers who have not been prescribed the product.