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Hello. We are turning some HCP Printed pieces into PDFs and would like to know the following: 1. If the printed tool has already been submitted and approved by PAAB, do we need to resubmit for it to be used as a PDF, even if there are no changes to content or flow? 2. If these PDFs are distribuited specifically to HCPs via direct links, do these links (which are de-indexed from Google) need to be gated, or password protected? Thank you!
Please see Clarification of Digitization of APS guidance provided on the PAAB website. If you are sending the PDF links out to a controlled list of verified HCPs, and the PDFs are de-indexed, these two steps in combination should sufficiently gate the piece.
Hi, I just wanted to confirm that Patient Information is exempt from PAAB-clearance if it is direct from and consistent with the Product Monograph or when the information is solicited by the patient directly from the manufacturer (s. 1.5) AND if there’s no discussion of drug therapy (by product, class or category) and there is no discussion of drug issues (https://pmcq.qc.ca/en/ask-paab?question_id=321). As such, would a document explaining a PSP program created for HCPs to distribute to patients about reimbursement, logistics, etc. be exempt from PAAB review if it met all of the above requirements? Thank you in advance for your answer!
S1.4D of the code states: The Code applies to all Advertising/Promotion Systems and corporate messages directed to licensed members of the professions of medicine, dentistry, naturopathy, homeopathy, nursing, pharmacy and related health disciplines, to institutions, and to patient information that will be distributed by or recommended by a healthcare professional. The Section 1.5 copy refers to content provided directly to the patient from the manufacturer. As per your question, the content will be created for HCPs to distribute and therefore is subject to the PAAB code. Additionally, reimbursement is indeed a drug issue.
I have a quick question regarding how PAAB should be represented on an approved material (branded and unbranded). Is the PAAB logo displayed on an approved material sufficient or do we also need to display the approval number on our materials?
The PAAB logo is all that is required on the ad. As of October 1st, we will be moving forward with the new PAAB logo. Please check out paab.ca for more details.
We are wondering about the regulations around a disease state information website created for HCPs, which does mention various treatment options but is non-branded (no product branding nor even company logo). Would such a site have to be gated, or is it sufficient to ensure the URL is not searchable by the general public? Along that same line, can company reps disseminate the website url to HCPs via printed materials (which would also go through the PAAB for review of course)? Or would we have to ensure that the company behind the website is unidentifiable in every way, including when disseminating the URL? In the case of the latter, what are some acceptable ways of disseminating the website URL to HCPs?
It would be important to be clear about the nature of the piece and its use when submitting to PAAB. Gating, content, audience etc. would be assessed at that time as there are many combinations which can render a piece acceptable or not. In general, controlled distribution of a de-indexed site is considered sufficient gating. The regulations require that the sponsor be disclosed unless prohibited by other regulations (i.e. help seeking messages). If the intent is for the content to be directed to HCPs, the sponsor should be disclosed.
As a general point, we strongly suggest first submitting an opinion request containing a detailed description of the planned APS and the linkages. Linking the “unbranded” piece to branded patient information will cause that “unbranded” piece to be viewed under a branded lens.
We want to develop an unbranded, ungated website that illustrates on-label dosing scenarios from the product monograph. It is not a dose calculator. It will be a valuable resource for all HCPs which can answer onlabel dosing questions. Does it require PAAB approval ? Will gating be required?
Note that an ungated website is accessible by consumers and therefore will be subject to consumer regulations. In addition, it will be direct to HCPs and therefore is subject to the PAAB code. This is regardless of whether it is branded or unbranded. In short, yes, this piece requires review and gating requirements will be based on the content you wish to house on the site and if it meets consumer regulations or not. Note that if this is a prescription product, the content likely exceeds that which is permissible in a consumer accessible space.
If you have a product approved for rare diseases and based on three single-arm studies from the 90's (where standard RCTs are unlikely to be available given patient numbers), are you limited to the data from the studies in the monograph or are you able to use newer, single-arm data to support your efficacy and safety claims?
When studies from outside of the TMA are used, they should meet the standards of high-quality evidence. This means that they are randomized control trials which have been published and peer-reviewed. As the current scenario does not appear to meet these requirements, it would not be accepted. If you would like further information on your specific scenario, you can submit the study for an opinion through the PAAB opinion process.
Are unadjusted p-values acceptable as part of a claim?
Please see response to Unadjusted p-values
If a representative is conducting a virtual lunch and learn with PAAB approved materials, is a PAAB approval required to send the clinic attendees/office manager an email indicating the brand they will be speaking about (no claims), meeting link, date and time?
This email would require PAAB review. Please see Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context, which states “Emails used to distribute digitized APS in an unsolicited fashion DO NOT fall under the person-to-person correspondence exemptions in the PAAB code or advertising regulation exemptions in the Health Canada Policy Document “The Distinction Between Advertising and Other Activities”. These emails with attached APS are subject to PAAB review.” Think of virtual lunch information emails as digitized APS in this case example.
Hello, I'm planning an OLA and I would like to communicate this unbranded, not search engine (Google) indexed and not gated event registration page (but unique password and link needed to attend the event) through a 3rd party. If the 3rd party can guarantee that non-HCPs and non-Canadian HCPs cannot access the content or receive a communication from them (we would need something to have written proof that we did our due diligence on that end), is this sufficient from a PAAB perspective to use this 3rd party as a channel to drive Canadian HCP traffic? Thank you Bill
A manufacturer can choose to promote on HCP platforms which have a mechanism in place to ensure the validity of the users as HCPs. If this third party can effectively deliver on assurances they provided you, this sounds as though it would be an acceptable gating mechanism.
Can a company website that contains Health Canada approved product monographs also contain brand logos and product photos? The website is not gated and publicly available.
Our understanding of the term “product photos” refers to pack shots. It is acceptable to have pack shots in a consumer space, as long as no content on that pack shot goes beyond the consumer regulations (name, price, quantity). If there are claims or additional information on the pack shot, they should be blurred out.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising
