Health Canada has published its long-awaited updated guidance on the distinction between advertising and other activities for health products. The updated guidance, published on the Health Canada website on July 31, 2023, replaces the previous version that was last updated in August 2005.
Like its predecessor, the new guidance sets out the circumstances under which Health Canada may consider certain forms of communications to be "non-promotional" in nature (and therefore not in violation of the prohibitions against the advertising of health products set out in the Food and Drugs Act and its regulations). Whether or not Health Canada will consider a specific activity to be "non-promotional" depends on several factors, including how the information is being delivered and who the target audience of the information is.
Amongst the updates, the scope of the new guidance has been expanded from "drugs for use in humans" to "health products", which includes vaccines, biologics, medical devices, prescription drugs, non-prescription drugs, animal health products, and natural health products. New example categories of activities have been added, including electronic tools and technology (including social media and websites), other learning activities, medial procedure and health service messages, patient support group activities, and risk management plans.
Some of the original example categories of activities have also been updated and revised. This includes a new requirement that clinical trial recruitment materials state the name of the manufacturer or recruitment agency, which is contrary to the previous guidance which prohibited such disclosure in patient recruitment materials. Other updates include a one year time limit for keeping press releases about a health product posted on a manufacturer's website landing page and limits to the involvement of sales and marketing personnel in responses to inquiries about an unauthorized health product or off-label use of a product.
New and existing materials should be reviewed to ensure compliance with the updated guidance.
We are happy to assist if you are unsure how the new guidance may affect your organization or its activities and materials.