Hi there, PAAB can provide approval to APS with links to PAAB acceptable pre-proof articles (see also Code section 3.1.2). However, it is the responsibility of the sponsor to ensure that there are no restrictions to the distribution of the pre-proof article prior to full publication (Code section 3.3).

Hi @tk2022 Reprint holders are a common term we see in advertising for the “folder” which houses the reprint. This can be as simple as the brand name, study title, and fair balance, or house complex claim copy. The content that appears is at the discretion of the sponsor as long as it meets the advertising requirements. All requirements from Section 2 of the PAAB RWE Guidance would apply. Yes, it is applicable to virtual distributions. An unaccompanied (by any form of verbal or written information designed by or on behalf of the manufacturer for the purpose of promoting a health product) study reprint pdf in its original form (i.e. unaltered) is exempt from PAAB preclearance but not advertising regulations, however if additional verbal/written messages or context is added through the distribution channel, it may not be exempt as noted in our previous response. We suggest submitting for an opinion if you are unsure.

Hi @dnewman The “Health Canada Distinction between advertising and other activities” document addresses Canadian conferences and International conferences held in Canada. General corporate APS informing HCPs of upcoming international conferences (print or digital) may be distributed to Canadian HCPs and may be subject to PAAB review per code section 7.4, depending on the content. Use in branded material would require PAAB review and may be limited to avoid linkage issues. Material (including digital), emanating from the international conference outside of Canada or from the global division of the pharmaceutical company, is outside the scope of PAAB.

Hello @zsivo It’s important to remember that the forum responses are written as general responses to general questions. Responses should not be viewed as an exhaustive explanation of the code and regulations. The above summary is not complete or exhaustive. We would suggest reviewing the questions and responses provided above in their entirety. Please note that bullet point three is inaccurate and does not reflect guidance in 175 or 419. For bullet four, we’d note that a sales call is an advertising activity, regardless of a “reactive” discussion to a distributed paper. As a reminder, the Health Canada Guidance on distinction between advertising and other activities for health products states that for “Responses to inquiries,” the information provided to an individual or organization about a health product by a manufacturer in response to a request for information may be considered promotional if the inquiry has been encouraged in any way by the manufacturer of the health product or the response to an inquiry regarding unauthorized products or indications (off-label) is communicated by sales or marketing personnel. For bullet five, per Q&A 419 “Although rep activities do not fall under the PAAB code, advertising/promotional systems (APS) are indeed covered by this code. This means that although a published and peer reviewed clinical trial which has NOT been modified in any way wouldn’t require preclearance, using the study as a rep detailing tool would render it subject to the provisions in the PAAB code.” One should not assume that all lone-standing peer-reviewed papers are aligned with the Code.

Hi @virginieb There are many considerations which would be assessed during the review process to determine whether this would be acceptable, but in general, the reprint of a PM study that is unedited and complete could be an acceptable downloadable resource on a gated HCP website. It should be disclosed where it will be placed and how it will appear (e.g. Study name? Description? Image?). This would be done as part of the review of the website to ensure that where it is placed for download is acceptable. Just one example of where it would not be acceptable: if the PM only included results of an interim analysis for an NOC/c product, we would question reprints of the final analysis even if they included the interim analysis results as NOC/c products are restricted to presentation of data from the PM only.

@jennifer-carroll Thank you for the clarification, Jennifer!

Hello @uarabi90 In general, we may consider review articles for disease state claims when the reference is published, peer-reviewed and independent of influence from the manufacturer. This however, should not be extrapolated out to health product content (e.g. if the “practice defining documents” or “clinical practice for managing the patient population” directly/indirectly refers to health products; “treatment algorithms”; “treatment recommendations”, etc.). These should come from Canadian consensus guidelines (see Code section 3.2). It would not be acceptable to distribute these types of papers in the context of drug advertising. A complete consensus guideline could be distributed. The activity of sales rep discussion does not fall under the scope of the PAAB code. As a courtesy, we invite the client to consider the following when deciding whether to move forward: Although the activity does not fall under the scope of the PAAB code, it does fall in the realm of advertising and is thus subject to the provisions of the Food and Drugs Act. If the activity is deemed to be misleading, it could be found to be in contravention of the Food and Drugs Act.

Good morning @la_01 No. You cannot link branded to unbranded in any manner. This is not limited to just the look and feel of the piece. Connecting through clicks is still a link and is not acceptable. All spaces would have to be reviewed in the context of the brand. This means, that while they may not have brand mention, the link requires the content on them to not exceed what is allowable in the context of the brand.