374 - Do slide presentations for industry-sponsored satellites at an international congress held in Canada require PAAB approval? Are there any circumstances in which unlicensed products can be discussed in such a forum?

  • · Please read the following excerpts about CME/Scientific Symposia/Exhibits and International Conferences respectively from the Health Canada policy document “The Distinction Between Advertising and Other Activities” as background then read the answer to your question below the excerpts. BACKGROUND: CME/Scientific Symposia/Exhibits: CME events and scientific symposia related to drugs are sometimes sponsored by pharmaceutical manufacturers. Such activities may not be advertising when they provide a forum for exchange of information on related clinical and scientific issues. The key factor in determining the status of such an activity is the degree to which the programme is independent of the drug manufacturer. The information may be nonpromotional in the following circumstances: sponsorship by a drug manufacturer is not targeted to specific aspects of the agenda, the sponsor's role is adequately disclosed, the programme is directed to scientists and/or health professionals, the programme allows for exchange of information/debate, the content of the agenda is not influenced by the sponsor, the content of an individual presentation is not influenced by the sponsor where it concerns a drug manufactured by that sponsor, there is no inducement provided to participants, there are no ancillary commercial or promotional activities relating to drug products, the limitations of the data and of the drug are adequately discussed, discussion of an unauthorized drug or indication for use includes a statement indicating that the drug/indication has not been authorized for marketing in Canada, and no reference is made to the availability of unauthorized drugs through the Special Access Programme. Such an activity may be advertising where any of the aforementioned conditions are not met or where other factors indicate that the primary purpose of the activity is to promote the sale of a specific drug. Moreover, reports, edited scripts or recorded videos of the proceedings, in whole or in part, that concern a specific drug may be advertising if they are disseminated by the sponsor, or the sponsor's agent, to a wider audience after the meeting. International Conferences: The considerations described above for scientific symposia also apply to international medical/scientific conferences held in Canada (emphasis added). However, in the context of an international conference, display of a drug product prior to market authorization in Canada, or a product that is labelled for a use that has not been authorized in Canada, may be a nonpromotional activity in the following circumstances: the conference must clearly be an international event, e.g., a significant proportion of the conference delegates are from other jurisdictions, the material must emanate from the parent company of the manufacturer, the material must only be for use within the confines of the conference, and the material is prominently identified as not being authorized for sale in Canada. ANSWER: Canadian advertising regulations prohibit the advertising of unlicensed products (FDA c.08.002). Therefore, activities and content communicating information about unlicensed products could contravene the law except in cases where such activities/content are not subject to the advertising regulations. Here are two considerations that jump out regarding the proposed messaging: If all provisions above relating to “CME/Scientific Symposia/Exhibits” are met, PAAB review of the meeting materials is not required. This is true whether it is a Canadian conference or an international conference. Note that the provision “no ancillary commercial or promotional activities relating to drug products” has implications on how the event is promoted (e.g. the event promotion should not be product advertising in and of itself AND the event should not be promoted in the context of drug advertising). Note that materials prepared for a promotional meeting (e.g. slides) would require PAAB review. This is true regardless of whether it is a standalone meeting or an extension of a Canadian conference or an international conference in Canada (assuming this is permitted by the organizer). In the context of an international conference in Canada, displays in a separate exhibit hall are exempt from the Canadian advertising regulations (including PAAB preclearance) if all provisions under “International Conferences” above are met.