You are correct that the non-selective addition of tabs for each heading throughout the product monograph, would not require submission to PAAB. The addition of branding colours to those tabs, in the manner described in your question, would not cause the document to require PAAB review. Any further modification may require the submission.
We recommend naming the document a Promotional/Clinical Monograph as it would appear from your description that the control number should be removed.
Modification limited to the addition of non-selective tabs, would not prompt the inclusion of fair balance. Note that changing the cover (beyond the control number removal) such as adding branding colours, elements, logos, would prompt review.
PAAB Code section 5.1 states “The compared drugs/products have an authorized indication for use in common, and the comparison is related to that use; or, in addition to the common indication for use, a second authorized indication is claimed as an added benefit of the advertised drug”. As such, this type of comparison would not be acceptable.
The fact that a website is created and controlled by a drug manufacturer’s parent company, outside of Canada, does not in and of itself render it exempt from Canadian drug advertising regulations (and the PAAB code). Even if the website URL is provided in a reactive manner, that website is likely subject to the regulations since the information that is available on the site far exceeds the question that prompted the URL to be shared.
The proposed activity could be considered exempt from the PAAB Code, PAAB Preclearance, and Canadian regulations if the mechanisms outlined in Q&A 176 were implemented. These mechanisms are provided to ensure the information provided is in response to the specific question asked. If all guiding principles from Q&A 176 are followed, this could be considered.
The PAAB can provide guidance on setting up a platform such as this, in the context of an opinion file.
As a reminder, one key aspect of the mechanism outlined, is “restricted access”. Canadians who are not HCPs must not have access to the site.
The APS category helps us to track the types of tools being submitted and reviewed. They also provide context on if they are to be rep-directed or self-directed. This can have implications for the flow of the piece. In theory, an approved slide deck can be shared after the presentation, with the assumption that if there are speaker notes, they have been reviewed and approved as part of the piece. You should also consider how you disseminate the presentation, with additional guidance in the “Dissemination” section of the PAAB Clarification regarding digitization of APS Helping healthcare product manufacturers plan for the evolving COVID-19 operational context document.
If the presentation is to be recorded and distributed, this recording would require a separate review prior to being distributed. See paab.ca/myths (5) for further elaboration
As per the document Tips on Claims Relating to Patient Assistance Programs,:
“Observational data on retention could be considered if the program has a valid and reliable mechanism to monitor when prescriptions are filled. Sufficient information about the program must be provided to enable PAAB to make this assessment. The APS claim/data from a manufacturer’s patient support programs should be non-comparative (as it relates to the manufacturer’s product), it should reflect past study findings (i.e. formatted in the past-tense), and it should be structured so as to limit the findings to the support program. Study parameters such as the time period pertaining to the claim/data could be relegated to a footnote. Note that retention data will be required to be updated every 6 months as changes in the market place can impact retention.”
Good Morning @donna
The proposed change did not go forward. Although these were intended as the beginning of an incremental process of change, following consultation it became clear that the industry felt that the guidance did not go far enough. We are therefore awaiting preliminary output from the ongoing Health Canada and CADTH collaboration on decision-grade RWE. An expert stakeholder committee will work through that output to determine which elements are applicable to drug advertising.
Section 6.6 was revised and repositioned to 1.5. Alternatively, this may have been a typo in the response letter. Please follow up with your reviewer if section 1.5 does not address the issue. With regards to archived versions of the Code, per PAAB Q&A 717, the PAAB website only contains the most recent version of the code so as to clearly promote current best practices.
This would not be acceptable as the cookies would be placed on the computer, but they would not be able verify who is using that computer. If an HCP was to sign into a verified site on a shared computer, sign out and leave that computer, the next user would be exposed to advertising without verification that they are an HCP. This would contravene consumer regulations.