Tools promoting medical education program
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My client has a learning program that is unbranded that has been developed by 3rd parties. We realize that this does not require PAAB review. Our question is regarding the communication of the learning program; the content of the promotion consist of the name of the learning app, an image and a logo that identify the therapeutic area, directions and a QR code to access the online site of the learning program, logo of the program.
The invitation would be disseminated via an interactive banner in online medical journals, fax and email (the last two will be managed by a 3rd party and the list will not be shared with the sponsor).
Do the communication materials needs to be reviewed by PAAB? Is it acceptable for the sponsor company to be mentioned, and vice-versa is it acceptable for the sponsor to not be mentioned in the communication assets?
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Hey @natbourre
The answers to your questions hinge on whether the document is subject to the advertising provisions or not.
The assessment of whether it is subject to the advertising provisions is made by applying the following 7 questions from the Health Canada policy document “The Distinction Between Advertising and Other Activities”:
• What is the context in which the message is disseminated?
• Who are the primary and secondary audiences?
• Who delivers the message? (the provider)
• Who sponsors the message and how?
• What influence does the drug manufacturer have on the message content?
• What is the content of the message?
• With what frequency is the message delivered?Assuming that the audience is HCPs, you would need to assess who sponsored the program; what influence did the manufacturer have; what is the content of the message across the program; and the frequency of the messages throughout the learning program. It is important to consider each question as no single factor can determine whether the advertising provisions apply. This assessment can be done internally through the manufacturer’s own regulatory department. If you would like, PAAB can provide an objective opinion on any particular tool/material based on the aforementioned Health Canada policy document. If the activity was deemed to be advertising, the pieces would be subject to the PAAB code.
Mention of the sponsor on content they create would be required unless precluded by other regulations (i.e. help seeking messages).
