652 - I understand that for international conferences held in Canada the following conditions need to be meet for being exempt for PAAB review according to (Health Canada policy document “The Distinction Between Advertising and Other Activities) I. the conference must clearly be an international event, e.g., a significant proportion of the conference delegates are from other jurisdictions, II. the material must emanate from the parent company of the manufacturer, III. the material must only be for use within the confines of the conference, and IV. the material is prominently identified as not being authorized for sale in Canada. The question I have is for the use of material that is non-branded and no product specific that ...
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continued ... makes reference to a therapy area/class for which several products are approved in Canada for sale by the local subsidiary. Would this non-branded, no-product specific material (banner), that talks about a therapy area/class would it be considered PAAB exempt for use at an international conference?
Response: Are all 4 criteria you listed met? For example, I am unsure from your question whether the material emanates from the non-Canadian parent company. If all 4 criteria are indeed met, the material is exempt from Canadian advertising regulations and, consequently, outside of the scope of the PAAB code. This is true regardless of whether or not the products are approved for use in Canada (i.e. available from the corresponding Canadian subsidiary). This is also true regardless of whether the material is product branded or not. If, on the other hand, the material emanates from a Canadian manufacturer, the material would be subject to PAAB preclearance even if it is not product-branded. After all, the material in question would be used in Canada, it would emanate from the Canadian manufacturer, and it would feature one or more products/classes in the context of a therapeutic area in which the manufacturer has a vested interest. The material would therefore be subject to Canadian advertising regulations (including the PAAB code provisions). It is easy to come to the flawed conclusion that materials that are not product-branded are not advertising. Don’t fall into that trap. Advertising is defined in the Food and Drugs Act as "any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device". The definition matters because Canadian drug advertising is subject to Canadian drug advertising regulations. For example, the provisions in the PAAB code apply to drug advertising directed to HCPs. Whether materials emphasize/favor a specific brand does not in and of itself determine whether the materials are subject to advertising regulations. In fact, the PAAB code has provisions that relate to unbranded editorial advertising such as section 7.5 (i.e. the PAAB code is not limited to product-branded advertising). We’d need to review the piece to determine whether it is indeed editorial advertising or product-branded advertising but this does not impact whether review is actually required (it only impacts the nature of the review).
