634 - Hi PAAB, If a pharma company who markets a vaccine sponsors a 3rd party vendor for the writing of an independently written article on adult vaccines in which all treatments are discussed and this vendor distributes this article to HCP through their channels is this considered advertising and would the article require PAAB review? The Pharma company would not review the article. If the distribution by the vendor is to consumers does it require pre-clearance by PAAB? Could the sponsorship be identified at the article “This independently written article was sponsored by XYZ Pharma Co”? Given that the topic is vaccination and it is Schedule D, could we link an ASC approved ad with the consumer article as you mention in Question 153? Would this PAAB require pre-clearance? Thank you.
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The Health Canada policy document "The Distinction Between Advertising and Other Activities" is a valuable tool in determining whether materials are subject to the advertising regulations. The complete distinction document can be found at: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php. The document poses 7 questions to consider when determining if a message falls within the definition of advertising, including “Who sponsors the message and how?”.Whether the HCP piece would require PAAB preclearance depends on the type of entity which is creating the piece and the relationship between the sponsor and that entity. Various possible scenarios and the corresponding answers are covered in the following document: http://code.paab.ca/pdfs/advisories/Guidance-on-which-HCP-materials-require-PAAB-review.pdf Submit an opinion request if you have remaining questions about a particular tool or process (see the fee schedule on our website www.paab.ca) With respect to your second question, you are not required to submit an APS for review if it is destined for the general public (provided that it won’t also be disseminated in a manner which is targeted to HCPs or to patients through their HCP). Nonetheless, the PAAB offers an opinion service to DTC communications. We can provide assurance that your consumer pieces are in alignment with the Health Canada regulations & guidances. See the fee schedule on our website www.paab.ca. Q&A 153 deals with linkage between independently generated editorial content about a disease and a branded ad. Such linkage in the DTC realm is technically “possible” for a vaccine as regulatory provisions restricting linkage between name and therapeutic use do not apply for these products. However, it is unlikely acceptable as the editorial would typically include content that is off-label with respect to the linked product. With respect to the tool in your particular question, it sounds as though it would be a consumer brochure. Linking such document to a product ad would render it subject to advertising regulations. From your description of the tool, this execution would be particularly problematic as the piece would now be viewed as comparative advertising in the DTC realm. For example, the document would likely be inconsistent with Health Canada’s policies on therapeutic comparisons in DTC advertising. Short answer: It would generally be advisable to avoid such link, and this is especially true when dealing with a consumer brochure.
