Pangaea Express: Promotional/Non-Promotional Messages & Activities for Health Products
The draft Guidance document regarding The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products has been posted by Health Canada. Considering the last version of this guidance (“the Distinction Between Advertising and Other Activities”) was developed in 2005, before the onset and consequent flood of social media, it was definitely time for an update.
The scope of this guidance document pertains to prescription drugs (including controlled substances), non-prescription drugs, medical devices, natural health products, biologics, vaccines, and veterinary health products.
The considerations from which to determine whether an activity is promotional in nature or not, are comparable in philosophy to the previous version, but the 2019 draft Guidance divides the general principles into two categories:
- Content and Context
- The content must be accurate and objective, must not be product focused, nor influenced by sponsor etc.
- Sponsorship and Dissemination
- The message or activity is sponsored by a government authority (e.g., the Public Health Agency of Canada, the provincial ministries of health, provincial formularies, etc.)
- A competitor would be willing to fund, sponsor, and deliver the same message
- The message or activity is delivered by non-sales and/or marketing staff etc.
New to this 2019 version is, not surprising, a section regarding “Electronic Tools and Technology” that includes rules around social media such as:
- Social media web site or platform remains unbranded (e.g., no specific product is mentioned);
- User-generated comments, hyperlinks etc. do not place additional focus on a specific health product and its benefits;
- Organizations may sponsor social media activity but cannot be engaged in discussions except in monitoring capacity (e.g. removal of inappropriate comments etc.)
Another noted addition to the updated Guidance is a section regarding “Other Learning Activities” (OLA) that was added within “Educational Activities”. There are a number of requirements to ensure OLA is not promotional, some of which include:
- The need for such an activity has been identified through needs assessment
- The objectives have been clearly outlined and address a specific gap in the current situation
- Only health care professionals are invited or are in attendance
- Speakers must disclose any conflict of interest and funding and have complete editorial control of the content being presented
Beyond the new sections, there are important additions from the 2005 version such as:
- Unsolicited requests: while the inquiry still must not be encouraged in any way by the manufacturer of the health product, the response to the inquiry cannot be communicated by sales and/or marketing personnel
- Patient Information Materials and Packages (previously Patient Information Booklets): for information via web site, access must be gated to ensure that information is only accessible by patients
- Clinical Trial Recruitment: the manufacturers name or participant recruitment agency may now be stated
Please refer to the link above for other new sections (Medical Procedure and Health Service-Related Messages and Risk Management plans) as well as additional modifications from the 2005 version.
Health Canada is seeking feedback from Academia, Health product manufacturers, Health care professionals and the General public. The sixty-day consultation period closes September 3, 2019.
While the gist of the Guidance document is not unlike the previous version regarding the core message and general principles, there are certainly a number of changes to help industry and other stakeholders answer the question, “is this activity promotional or not”.