Hi @mimic909

A PAAB approved tool may not be linked to an exempt APS without PAAB review. The order of navigation does not make a difference. The email copy is intended to be consumed and is linked to the PAAB approved APS. As the messages are connected, both are PAAB reviewable.

@jennifer-carroll Thanks Jennifer, this is helpful!

@jennifer-carroll Thanks for clarifying! I understand now

@stet

An unbranded APS may be created for physiology or pathophysiology of the signaling pathway. However, the APS may not make reference to potential treatment or exogenous intervention at the target site as that would brand the APS if there are no other agents that work at that target.

@dmauri

PAAB does not approve exempt materials. Our review service provides an opinion on whether submitted material is exempt from review. As such no proper review against the PAAB code and supporting evidence was undertaken with the exempt materials. When exempt material is linked to unbranded PAAB reviewed APS, the exempt file would be subject to PAAB review because of the linkage. The exempt material would be reviewable as unbranded, editorial APS per section 7.5 as well as applicable codes sections with respect to substantiation for the claims within.

In the example presented, the previously exempt website would no longer be exempt and should be submitted for full review. Similarly, the exempt website may not host PAAB approved unbranded APS as the linkage would render the exempt website reviewable.

@jennifer-carroll Thank you Jennifer. That does help.

Afternoon @adriana-c1

In general, the piece you are describing could be created if executed properly. During creation, look to ensure that the copy is written in patient friendly language, non-promotional, supported by standard setting organizations, and does not favour one product/class of products. Asking yourself the following two questions can also help guide your content creation:

Could a reader guess who the sponsor of the piece was (in the absence of the sponsor's logo)? Would a competitor be equally as willing to sponsor this unbranded piece?

The answers should be “no” and “yes” respectively. Ensure that it is clear that the intent is for the piece to be a patient counselling tool.

Hey @georgian21

This does give us pause to consider the nuance of the scenario. The main concern is separation. When we put unbranded content with branded, it creates an association that brands everything. Even if it is a separate therapeutic area, the question is, can we ensure that there is no suggestion that the product has implications (e.g. safety/efficacy) in that therapeutic area? We’d also have to consider the therapeutic areas as some are more closely related than others.

Example:
- Drug A (renal or CV drug); Drug B/C (diabetes)
- Drug A (lipid drug); Drug B/C (HIV)

This type of question might be more suited for an opinion so that we may assess the intricacies.

Hey @tmcd

The PAAB code applies to Canadian companies or to companies targeting content to Canadian healthcare professionals and patients. Please see the Health Canada document “The Distinction Between Advertising and Other Activities” for further clarification on how the content and role of the sponsor may impact if a piece is considered advertising.

In the example provided in your question, a truly disease state only piece with no messaging about treatment and no direct or implied link to a product the sponsor has a vested interest in, may be exempt from PAAB review. There are variables that could render the piece subject to review (e.g. focusing on a disease mechanism of action for which only exogenous compounds target or are being developed to target; inclusion of a link to a brand page or treatment-related information, etc.). Another note of caution is that this would likely be considered direct to consumer advertising and would be subject to consumer regulations as well.

@jennifer-carroll Thank you for your help

@jennifer-carroll Thank you very much for the advice.