Guidance on Gating Mechanisms for HCP Digital Asset
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Hello @Manufacturer and @Agency
We are pleased to announce that guidance on gating mechanisms for HCP digital assets has now been posted.
In the recent years, it has come to the attention of PAAB and Health Canada, that there has been variance in the application of "sufficient barrier" when it comes to limiting healthcare professional advertising from being accessible by consumers. Considering this, PAAB has worked with Health Canada to generate guidance on the creation and implementation of gating mechanisms which would qualify as presenting a sufficient barrier between the general public and healthcare professional advertising.
The gating requirements have not changed. This guidance clarifies the existing Health Canada requirements and provides insight into how those requirements can be met. In fact, a new option is outlined to further assist advertisers in meeting gating requirements. The new option is modeled after the gating methodology that is currently predominantly used across this industry. However, as the option addresses areas in which current gates fail to meet requirements, some gates will need to be fortified. It is understood that this will take time. Until January 2024, insufficiently robust gating mechanism noted through our monitoring activities will simply trigger a courtesy email informing the manufacturer of the gating deficiencies and providing potential solutions where applicable.
Where relevant during preclearance reviews, the PAAB will continue to remind advertisers that an effective gating mechanism will be required.
PAAB will not provide "approvals" for gates, however we can assess if the approach and guardrails proposed by the company would appear to be sufficient in the context of a formal opinion submission.
We hope that you find this guidance helpful. If you have any questions, please post them below or in this category: HCP Gating.
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Hello @Manufacturer and @Agency
We are pleased to announce that guidance on gating mechanisms for HCP digital assets has now been posted.
In the recent years, it has come to the attention of PAAB and Health Canada, that there has been variance in the application of "sufficient barrier" when it comes to limiting healthcare professional advertising from being accessible by consumers. Considering this, PAAB has worked with Health Canada to generate guidance on the creation and implementation of gating mechanisms which would qualify as presenting a sufficient barrier between the general public and healthcare professional advertising.
The gating requirements have not changed. This guidance clarifies the existing Health Canada requirements and provides insight into how those requirements can be met. In fact, a new option is outlined to further assist advertisers in meeting gating requirements. The new option is modeled after the gating methodology that is currently predominantly used across this industry. However, as the option addresses areas in which current gates fail to meet requirements, some gates will need to be fortified. It is understood that this will take time. Until January 2024, insufficiently robust gating mechanism noted through our monitoring activities will simply trigger a courtesy email informing the manufacturer of the gating deficiencies and providing potential solutions where applicable.
Where relevant during preclearance reviews, the PAAB will continue to remind advertisers that an effective gating mechanism will be required.
PAAB will not provide "approvals" for gates, however we can assess if the approach and guardrails proposed by the company would appear to be sufficient in the context of a formal opinion submission.
We hope that you find this guidance helpful. If you have any questions, please post them below or in this category: HCP Gating.
I've heard conflicting advice about website gating for Unbranded HCP Websites.
Does the guidance above still apply to Unbranded HCP APS Websites?
What about Unbranded HCP Websites that are PAAB-exempt (no mention of drug therapy)?
A previous forum question (https://forum.paab.ca/topic/2497) indicated that controlled distribution of a deindexed URL would be considered as an acceptable gating mechanism for an HCP unbranded website. I imagine that this still holds true, since it aligns with D9 of this guidance (so long as the URL is not easily guessable, which is likely the case for an unbranded website).
Appreciate you shedding some more light on this matter!
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Hi @dmauri
Good question. The guidance document and the response to the previous PF Q above deal with different considerations. The guidance is how you can properly gate a website that requires restricted access to only HCP. The question quoted speaks to using a de-indexed URL and if that would make it exempt from gating. The de-indexed URL doesn’t change whether it’s exempt or not in a HCP-directed unbranded disease state only context.
For unbranded pieces which meet Health Canada consumer regulations (e.g. disease state with no mention of treatment), a gate is likely not required. But an unbranded piece can have mention of classes of products or therapeutic targets which wouldn't meet the consumer brochure requirements and would prompt gating requirements to limit to HCPs. If you're unsure, an opinion request can help determine if the content would prompt gating requirements.
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Hi @dmauri
Good question. The guidance document and the response to the previous PF Q above deal with different considerations. The guidance is how you can properly gate a website that requires restricted access to only HCP. The question quoted speaks to using a de-indexed URL and if that would make it exempt from gating. The de-indexed URL doesn’t change whether it’s exempt or not in a HCP-directed unbranded disease state only context.
For unbranded pieces which meet Health Canada consumer regulations (e.g. disease state with no mention of treatment), a gate is likely not required. But an unbranded piece can have mention of classes of products or therapeutic targets which wouldn't meet the consumer brochure requirements and would prompt gating requirements to limit to HCPs. If you're unsure, an opinion request can help determine if the content would prompt gating requirements.
@jennifer-carroll Thank you for your response!
Based on what you've said, it sounds like we need to look to the Health Canada consumer regulations, which I interpret to be the bulleted list of items that could render "Medical condition and treatment awareness materials" promotional (from the July 2023 HC guidance).
If the Unbranded Website is considered promotional based on this bulleted list, this means that it needs to be restricted to an HCP audience (and thus gated). Please let me know if my understanding is correct. Health Canada's guidance helps identify whether or not activities are "promotional", but the consequent implications are not always clear.
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@jennifer-carroll Thank you for your response!
Based on what you've said, it sounds like we need to look to the Health Canada consumer regulations, which I interpret to be the bulleted list of items that could render "Medical condition and treatment awareness materials" promotional (from the July 2023 HC guidance).
If the Unbranded Website is considered promotional based on this bulleted list, this means that it needs to be restricted to an HCP audience (and thus gated). Please let me know if my understanding is correct. Health Canada's guidance helps identify whether or not activities are "promotional", but the consequent implications are not always clear.
Good Morning @dmauri
Point 1 - It would be against any part of the distinction document, not restricted to “medical condition and treatment awareness materials”. The document deals with principles which render something advertising. The general application of this document is less focused in how the sponsor categories the piece and more focused on the overall content, audience, and use of the piece in question.
Point 2 - Correct. If the piece is promotional and exceeds consumer regulations, it must appear behind the gate. (i.e. a mechanism to restrict access to the appropriate audiences must be in place).
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Good Morning @dmauri
Point 1 - It would be against any part of the distinction document, not restricted to “medical condition and treatment awareness materials”. The document deals with principles which render something advertising. The general application of this document is less focused in how the sponsor categories the piece and more focused on the overall content, audience, and use of the piece in question.
Point 2 - Correct. If the piece is promotional and exceeds consumer regulations, it must appear behind the gate. (i.e. a mechanism to restrict access to the appropriate audiences must be in place).
@jennifer-carroll Thank you for clarifying these points. Highly appreciated.
