360 - A client wishes to produce some material that will be strictly used by their medical team (i.e. MSLs, Med Affairs, Medical Education Specialists). It will contain product efficacy outcomes that will be balanced with safety and AEs, and thus will be strictly used in a non-promotional manner. The piece itself will meet the requirements of Health Canada as NOT being advertising, but they wish to have a PAAB exemption letter. QUESTION: Looking at section 6.6(iv) of the code, one of the exemption scenarios involves: Use of drug name only in a context not linked to therapeutic or promotional messages, other than those listed in in any way. Could you clarify what 'therapeutic message' entails? Would efficacy charts be considered a therapeutic message?
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Creating and distributing materials through the medical department does not automatically render those materials exempt from the advertising regulations. Even when the materials are created and distributed solely through the medical department, it is critical to pause and reflect on whether the content is subject to the provisions in the Food and Drugs Act, the Food and Drugs Regulations and the PAAB code. The Health Canada policy document "The Distinction Between Advertising and Other Activities" is a valuable tool in determining whether the materials are subject to the advertising regulations. PAAB code s1.5 speaks to exemptions from PAAB review while PAAB guidance document "Guidance on Which HCP Materials Require PAAB Review" (see: http://www.paab.ca/resources/pdfs/Guidance-on-which-HCP-materials-require-PAAB-review.pdf) provides additional help in distinguishing between what requires PAAB review and what doesn't. From the sounds of it, the piece you are describing would only be exempt if used by the medical team in response to unsolicited requests. From the provided description, the piece would be subject to the advertising regulatory provisions (and preclearance) if used proactively. It sounds as though it is about the benefits and risks of the manufacturer's product. PAAB approved advertising is balanced with respect to risk and benefit also (i.e. this alone does not make it non-advertising). Yes, efficacy charts would be considered clinical messages. Please call if you have any questions.
