421 - Can I pharmaceutical company support the development of an independent third-party publication covering the highlights of a conference in a therapeutic area where it does not yet have an approved product? The report and a summary slide presentation with the same content is developed by an independent faculty of medical experts, who have full control of the content, and coordinated by a third-party communication agency. The content is completely unbiased (less than 10% of the content is about trials on the company's future potential product), and there is no involvement of the company in the distribution of the content. The content is housed on a third-party independent website that is distributed by this third-party and/or to medical associations only. Does the site have to be gated? Does the content have to be PAAB-reviewed or accredited? Thank you in advance for your answer.

[Jennifer Carroll]

All answers to your questions hinge on whether the document is subject to the advertising provisions or not. If it is subject to the advertising provisions, yes gating is required and yes the document should be submitted to PAAB for preclearance (assuming this would be intended for HCPs). You should note that discussion of the manufacturer’s unapproved product in drug advertising would not be permitted (per PAAB s3.1 and FDR C.08.002). If it is not subject to the advertising provisions, then gating and PAAB review is not required. The assessment of whether it is subject to the advertising provisions is made by applying the following 7 questions from the Health Canada policy document “The Distinction Between Advertising and Other Activities”:

• What is the context in which the message is disseminated?
• Who are the primary and secondary audiences?
• Who delivers the message? (the provider)
• Who sponsors the message and how?
• What influence does the drug manufacturer have on the message content?
• What is the content of the message?
• With what frequency is the message delivered?

It is important to consider each question as no single factor can determine whether the advertising provisions apply. This assessment can be done internally through the manufacturer’s own regulatory department. If you would like, PAAB can provide an objective opinion on any particular tool/material based on the aforementioned Health Canada policy document (see the fee schedule on our website www.paab.ca). As a side-note, the fact that up to 10% of the document would be on the sponsor’s potential future product is actually somewhat of a red flag. Amongst other considerations, you might want to consider whether the document includes equal emphasis on all the other potential products from other manufacturers? If a different potential product would have been covered had the sponsor of this third party tool had been a different manufacturer, you are likely dealing with advertising.