Pangaea Express: Health Canada's 2023 Distinction Between Advertising and Other Activities
Health Canada has released its updated Guidance on the Distinction Between Advertising and Other Activities. First published in 1996 with an updated version in 2005, this latest version contains revisions as well as new elements to help determine whether a message is promotional in nature or not. This Guidance applies to various health products (prescription and non-prescription drugs, vaccines, medical devices, animal health products and natural health products) and pertains to messages and activities involving medical conditions and/or any health-related matters, regardless of the target audience in Canada.
Many of the key factors that contribute to a promotional determination remain similar to the 2005 version, along with new specifics on Context, Content, Sponsorship and Dissemination.
Context and Content:
The message may be promotional if it is mainly product focused or if it is emphasizing the benefits without the risk such as in an editorial or opinion. Other examples include:
- If the layout and design can be associated with a specific health product (brand colours, logo-like graphics and other visual cues)
- The message is disseminated in the context of the target medical condition when directed to the general public (e.g. messages about health products in women’s magazines for medical problems affecting only women)
- In the context of educational activity for unauthorized products or indications, it could be promotional if there is no mention of the product being under investigation and not granted market authorization or if there is mention the product may be available through SAP
Sponsorship and Dissemination:
- A third-party message or activity may be promotional if it is not disseminated by a government authority (PHAC, provincial ministries of health or provincial formularies) or if samples are involved. A good overall question to ask: would my competitor be willing to sponsor and deliver the message? If no, it may be promotional Health Canada provides many examples of activities and types of messages to help determine if promotional.
- Several of the important updates from the 2005 version include: Clinical trial recruitment materials, educational activity and press releases
- New to the 2023 Guidance are examples of electronic tools and technology, medical procedure and health service messages, and risk management plans among others
Activities Updated from 2005
- Clinical trial recruitment materials - manufacturer's name or participant recruitment agency are to be identified or it may be considered promotional. This is very different from the 2005 version where no reference could be made to the drug manufacturer's name, or to the name of the drug under investigation.
- Educational Activity - While CME was identified in the 2005 version, Other Learning Activities (OLAs) are called out in this 2023 update. For example Information distributed at OLAs may be considered promotional if:
- The need for such an activity has not been identified through a needs assessment, in collaboration with relevant health care professionals or their organizations
- The purpose of associated activities is unclear
- Evaluations are not collected to assess whether program objectives have been met, as identified in the needs assessment for the activity
- Press releases – may be promotional if the announcement is kept indefinitely on the landing page of a Canadian website of the manufacturer and its subsidiaries and/or the press release distributor's website, (e.g., > 1 year)
New Activities Identified in the 2023 Guidance
- Electronic tools:
- Messages on social media may be promotional if the content, user-generated comments, hyperlinks and/or other interactive features, which are under the sponsor's control, place additional focus or emphasis on a specific health product and its benefits
- the "sharing" options (such as email, "like", "tweet", "re-tweet", "comment") could modify the context by which the content is disseminated (ie., reach different audiences, emphasize on a specific product)
- a person or organization and/or its representatives sponsor the social media activity or message and is engaged in discussions beyond a monitoring capacity (monitoring includes removing inappropriate comments, reporting adverse events and giving a general message such as "thank you for your comment" or "talk to your doctor for more information"
- Medical procedures and health service messages from a Health care professional may be promotional:
- If a specific health product is promoted or they are promoting the sale/purchase of health product rather than a service
- Risk Management Plans (RMPs) – Risk Minimization Tools (RMTs) may be promotional if among other criteria:
- They are inconsistent with the objectives of the risk management measures (RMMs) or interventions
- The tools are used as detailing aids during a sales call
- Even when communicated as educational activities, RMTs may be promotional if the activity is not clearly intended as a risk minimization measure (e.g., not identified through a needs assessment in collaboration with relevant HCPs or their organizations)
While at its core, the 2023 updated Guidance keeps the same principals for determining whether an activity may be promotional as the previous version. There are, however, important criteria that have changed from 2005 or are completely new to the 2023 version. With respect to OLA’s, the importance of a needs assessment and evaluations are not only required to comply with the IMC code but now, they are needed to comply with Health Canada’s Guidance or the activity may be deemed promotional and as such the Canadian legislative and regulatory requirements on advertising would apply. This Guidance recommends seeking consultation from advertising preclearance agencies (APAs), to validate whether specific messages or activities are either non-promotional or in compliance. Though there is still no legislative or regulatory requirement to do so.