334 - A product is not yet approved in Canada but approved in the US and Europe. In an international conference held in Canada, can we invite Canadian healthcare professionals to attend an company-sponsored talk within the conference auspices...and the presentation includes the unapproved product?

  • No. Targeting Canadian HCPs and inviting them specifically to this segment of the event appears to render the segment subject to Canadian advertising regulations. Advertising activities targeted to Canadian healthcare professionals (HCPs) are required to be consistent with the Health Canada approved Terms of Market Authorization per PAAB code s3.1. The proposed activity would appear to contravene section 9.1 of the Food and Drugs Act and section C.08.002 of the Food and Drug Regulations. Our position is also based on the Health Canada policy document "The Distinction Between Advertising and Other Activities" which provides a list of 7 questions which help differentiate between promotional and non - promotional activities and 4 additional provisions relating specifically to international conferences. In addition to considering the aforementioned codes, regulations, and policies, its generally a good idea to reflect on the optics of potential marketing activities. Although it may not actually be your intent, it may appear that your intent is to promote to Canadian HCPs drugs and uses which are not approved in Canada (i.e. off-label). A consideration may be for the Global headquarters (not the Canadian subsidiary) to promote the international conference itself (rather than this specific segment) to HCPs from multiple areas across the globe where this is permitted (i.e. including Canadian HCPs but not targeting them specifically). Make sure you refer to the relevant provisions in the Inovative Medicines code and follow the advice of your legal department.