350 - Is sponsorship of an accredited CME event considered marketing on the part of a pharmaceutical company? Can the CME provider include therapeutics that are not (as yet?) approved for use in Canada for a specific indication? The product has been approved in Europe and the USA for that same indication. There is no off-label issue. Only the scientific evidence will be presented concerning the drug.
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Although many would say sponsored CME is a "Marketing " activity, you should be more concerned about whether or not the activity is covered under the regulations as "advertising". The reason this latter distinction is more important is that advertising is subject to the advertising provisions (and content relating to unapproved products would contravene those regulations). Importantly, sponsorship alone does not render content subject to the advertising regulations.
The Health Canada policy document 'The Distinction Between Advertising and Other Activities' says the following: 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.
