July 12, 2019
Helen Kalra, Associate Managing Director
Marla Weingarten, Director
The draft Guidance document regarding The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products has been posted by Health Canada.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whether an activity is promotional in nature or not, are comparable in philosophy to the previous version, but the 2019 draft Guidance divides the general principles into two categories:
New to this 2019 version is, not surprising, a section regarding “Electronic Tools and Technology” that includes rules around social media such as:
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:
Beyond the new sections, there are important additions from the 2005 version such as:
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”.
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