Health Canada recently published a draft guidance document, “The Distinction Between Promotion and Non-Promotional Messages and Activities for Health Products.” The draft guidance represents the first substantive update to Health Canada’s policy on health product communications since it was originally published in 1996 and relates to promotion of all health products including prescription drugs (including controlled substances), non-prescription drugs, medical devices, natural health products, biologics, vaccines and veterinary health products.
While most examples of non-promotional messaging and activity types from the 1996 document remain the same, Health Canada offered additional circumstances in the draft document in which a message or activity related to a health product may be considered non-promotional. Some examples touch upon the use of internet and social media in today’s advertising context.
Content and Context
Under the guidance document, content and context matter in determining whether a message or activity is promotional. Contextual factors that may contribute towards a determination that the message or activity is non-promotional include: the content is accurate, objective and is consistent with the terms of market authorization; it is not product-focused or does not emphasize the benefits of a health product while minimizing, omitting, or ignoring risks in any way (e.g., editorial comments, opinions, suggestions, etc.); it is not influenced by the sponsor or manufacturer or any entity acting on behalf of the sponsor or manufacturer; it is presented in a layout and design that cannot be associated with a specific health product; and the message or activity is not combined or disseminated concurrently with any promotional messages or activities.
When it comes to unauthorized health products, or unauthorized indications, the content of the message must caution that the safety and efficacy/effectiveness are still under investigation and that market authorization has not yet been granted by Health Canada. Additionally, no reference can be made suggesting that the health product is available through the Special Access Programme (SAP) for drugs and medical devices, or the Emergency Drug Release (EDR) Program for drugs for veterinary use.
Electronic Tools and Technology
Social Media
In 1996, social media was unheard of, and therefore, the original document did not address ways information could be disseminated through social media. The draft document does address this, essentially defining social media as “websites and applications that enable health care professionals, patients and/or the general public, through virtual communities, to share, create, discuss and modify content. A few examples of social media channels include Facebook, Twitter, Instagram, LinkedIn, blogs, and forums.”
In addition to elements previously outlined in the document, information disseminated through social media may be considered non-promotional in the following circumstances:
- the social media web site or platform remains unbranded (e.g., no specific product is mentioned);
- the content, user-generated comments, hyperlinks and/or other interactive features do not place additional focus or emphasis on a specific health product and its benefits;
- the available “sharing” options (i.e., email, “like”, “tweet”, etc.) do not modify the context by which the content is disseminated (i.e., different audience, emphasis on a specific product, etc.); and
- a person or organization and/or its representatives may sponsor the social media activity or message but is not engaged in discussions except in a monitoring capacity (e.g., removal of inappropriate comments, etc.).
Other Interactive Tools
The draft document also addresses “other interactive tools” that encompass a wide variety of technologies that are being developed and used to communicate information to a large number of people in a user-friendly manner. Examples given include a “keyword (such as a metadata tag), a web-based or mobile application, a chat room, an online banner ad, a search engine optimization (SEO) tool, a quiz, clinical software, decision-making support tools used by health care professionals and/or other technologies.”
In addition to other elements outlined in the document, information disseminated via interactive tools and technologies may be considered non-promotional in the following circumstances: the tool and/or technology remains unbranded (e.g., no specific product); and the tool does not provide links or search results/outputs to material emphasizing a specific product and its benefits.
Stakeholders have been asked to provide feedback prior to September 3, 2019.