520 - Health Canada's policy "The Distinction Between Advertising and Other Activities" states that materials emanating from a parent company presented during an International conference would not require PAAB review, provided that they are only used within the confines of the conference and are prominently identified as "not being authorized for sale in Canada". However, when a product presented in a promotional booth is approved in the US and in Canada as well, if: - all the material clearly specifies that all the information comes from the US labelling/Marketing Authorization, and - the target audience is from the US and not from Canada, even though some Canadian HCPs could be attending, will this be still considered as promotional activity in Canada and require a pre-clearance form PAAB?

Jennifer Carroll

No. The Canadian advertising regulations (including the PAAB code) do not apply to materials presented at international conferences as long as ALL of the following provisions from the Health Canada policy document “The Distinction Between Advertising and Other Activities” are adhered to:

• the conference must clearly be an international event, e.g., a significant proportion of the conference delegates are from other jurisdictions,
• the material must emanate from the parent company of the manufacturer,
• the material must only be for use within the confines of the conference, and
• the material is prominently identified as not being authorized for sale in Canada
Note, that the disclaimer must be modified in your case as the product is indeed authorized for sale in Canada. I elaborating a bit on the disclaimer you are proposing in your question. Specifically, I suggest prominently conveying that all the information comes from the US labelling/Marketing Authorization AND that this information is not consistent with the Canadian labelling/Market Authorization.

vt

@jennifer-carroll

The updated Health Canada Policy Document "Guidance on distinction between advertising and other activities for health products" no longer includes the above 4 criteria for International Conferences held in Canada, but instead includes the following two elements that may render these events promotional:
"• display of a drug product prior to market authorization in Canada is not prominently identified as not being
authorized for sale in Canada
• there are actions intended to target the Canadian general public directly or indirectly"

I was hoping you could help provide some clarity as to how we can ensure the materials we are presenting at an International conference held in Canada are not subject to the Canadian advertising regulations (and thus falls outside of PAAB's scope). Do we still ensure the same 4 criteria are ALL followed? Or are there any additional considerations/changes based on the updated guidance document?

Thanks in advance!

Jennifer Carroll

Hey @vt

Yes, you should ensure that the 4 criteria are still followed. These criteria still exist in the distinction document, they are just mentioned across the document and therefore not repeated in this section.

For example, the “Content and Context Factors” section in the “Overview” states:
• A message involving unauthorized health products or unauthorized indications, in a context such as educational activities, may be considered promotional if:
• the message does not caution that the product’s safety and effectiveness are still under investigation and that Health Canada has not yet granted market authorization

Within the Educational Activities section, things that could make the piece promotional are:
• The limitations of the data and of the health products are not adequately discussed
• Reports, edited scripts or recorded videos of the proceedings, in whole or in part, that concern a health product are disseminated by the sponsor or its agent to a wider audience

These are in addition to the copy under the revised heading of “Canadian and International Conferences”. In general, if it is a Canadian conference, the content should be created by the Canadian office. If it is an international conference, the content should be created by the parent company and should be adequately disclaimed. Remember that the distinction document is not intended to be an exhaustive list, but a set of guiding principles with examples throughout to help assess context and content. The examples in the “Overview” section should be considered when evaluating individual activities.