Promotional messages and activities regarding a health product are subject to the advertising provisions under the Food and Drugs Act (FDA), the Controlled Drugs and Substances Act and/or their associated regulations. For example, subsections 9(1) and 20(1) of the FDA prohibit advertising any drug or device in a manner that is:
- false, misleading or deceptive; or
- likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety or (for devices) its design, construction, performance or intended use.
On July 31, 2023, Health Canada published guidance on factors that contribute to a determination of whether a message or activity in respect of a health product is promotional (i.e., considered advertising): Guidance on distinction between advertising and other activities for health products (Guidance). The Guidance was released following Health Canada’s July 2019 consultation.
Pursuant to the Guidance, the following principles are to be upheld when determining whether a message or activity is promotional:
- Each message will be evaluated on its own merit in its entirety, with consideration given to the context within which the message is being delivered.
- Any linkages to various materials related to the message will be considered as well.
- As the [list of factors in the Guidance] is not exhaustive, other factors or circumstances will also be considered if they provide insight on whether the purpose of the message or activity is to promote the sale of a specific health product.
In addressing the factors that contribute to a promotional determination, the Guidance provides the following questions to help determine whether a message is primarily intended to promote the sale of a drug:
- What is the context in which the message is disseminated?
- Who are the primary and secondary audiences?
- Who delivers the message (the provider)?
- Who sponsors the message and how?
- What influence does a health product manufacturer have on the message?
- What is the content of the message?
- How frequently is the message delivered?
Other factors discussed in the Guidance include content and context factors, and sponsorship and dissemination factors. For example, a message or activity may be promotional if it is mainly product-focused or combined or disseminated at the same time as other promotional messages or activities. As a further example, a third-party message or activity may be promotional if it is delivered by sales or marketing staff, as opposed to being disseminated by a government authority.
The Guidance also contains a non-exhaustive list of example messages and activities that could be promotional depending on whether factors under the Guidance are met (or in view of other circumstances). This list includes (amongst other messages and activities): clinical trial and investigational testing recruitment material, information disseminated through social media, information disseminated through formulary kits, various educational activities (e.g., continuing medical education, scientific/medical exhibits and conferences), patient support group activities and literature, and risk management plans.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.