Yes. See page 8 of the following document: http://www.paab.ca/resources/pdfs/code-revision/Guidance_on_Submission_Process.pdf
Afin de soutenir la demande croissante, nous avons modifé la section Demandez au CCPP et l'avons rendu plus facile d'utilisation. Vous pouvez désormais sélectioner la catégorie qui vous interesse dans le menu déroulant et voir les questions qui ont déjà été posées et répondues. Vous pouvez également faire une recherche parmis les questions déjà soumises au CCPP depuis les débuts.
If I buy keywords that are associated to a gated website does it have to be submitted to PAAB? The targeted audience is consumer and not HCP. Thank you.
Yes. See page 8 of the following document: http://www.paab.ca/resources/pdfs/code-revision/Guidance_on_Submission_Process.pdf
If the Canadian affiliate creates materials for a booth (panels, TV screen, etc.) at an international conference being held in Canada, can handouts from the US affiliate be included/distributed?
This is not a good idea. Those materials would be subject to Canadian advertising regulations as they appear in a Canadian booth and/or alongside Canadian materials. Through the inclusion of Canadian materials, you’d be targeting Canadian delegates. Canadian HCPs should not be targeted with product advertising which do not reflect the Canadian TMA (or advertising for products which aren’t approved in Canada).
We’d advise to have the affiliate secure a booth for the affiliate’s materials. Please refer to the Health Canada policy document “The Distinction Between Advertising and Other Activities” for general provision relating to international conferences.
Medical information relating to Rx products would exceed the name, price, quantity restriction in C.01.004 of the Food and Drug Regulations. It is important that the information appear after a gate which restricts access to HCPs AND that the manufacturer takes effective steps to ensure that post gate pages do not appear as organic search results when enable the composite of the keyword, the meta title, the meta descriptors, the link URL, and the link webpage to exceed name, price, and quantity. A no index robot command on each page post gate is a robust mechanism for accomplishing this objective. Note that the issue is not whether the search engine has the ability to crawl the post gate pages. Rather, the issue is whether they have the ability to report what they see while crawling in search results. Adding the no-index tag to pages in the section preserves your PageRank as Google is still able to crawl it (but it won’t index it).
Also note that pregate pages do not require the no-index command.
Can DTC and HCP branded materials have the same headline/creative, if the DTC ad is approved by ASC and the HCP ad by PAAB? Can the DTC ad, if it is digital, link to a gated HCP portal?
I’ll assume that this question relates to an Rx product and that both the DTC and the HCP materials are product branded. Even with this assumption, there are a lot of parts to unpack here. The answer ultimately falls in the “maybe but not necessarily” category. The question entails several variables which complicate the task of narrowing the answer. These variables include:
With respect to the audience:
HCP advertising regulations are very different from consumer advertising regulations. These regulatory differences will invariably impact the content in the HCP & DTC pieces and may therefore impact the context in which the creative/headline is interpreted. For example, DTC regulations restrict branded advertising of prescription drugs to name, price, quantity. HCP advertising can (and likely will) include content pertaining to selection or use of the product. The context in which the headline/creative appears will therefore be different in the DTC and HCP ads. This may impact the meaning(s) of the headline/creative and therefore cause them to be questioned in some HCP APS even though it is not questioned in DTC APS (and vice versa).
With respect to content:
The interpretation(s) of some creatives/headlines are more context sensitive than others. The content is therefore in and of itself an important variable to consider when answering your question.
With respect to the nature of the linkage:
Note that PAAB needs to be informed of all materials which link to or from the HCP portal. Please ensure that the initial submission includes this information. We will need to see the DTC ad referred to in your question as it is part of the campaign leading traffic to the HCP portal. The link from the DTC ad should be to the pregate portion of the HCP portal (as the review of the pregate content considers the fact that consumers are a secondary audience for this segment). As the DTC ad leading to the portal is product branded, it is critical that the pregate portion falls within the restrictions of branded DTCRx. For example, I’ve recently seen the following scenario which we had to question. A DTC banner ad was created which simply identified the product name and dose, and linked to the pregate landing page of the HCP website. The landing page of the HCP website stated the therapeutic area but did not include any mention of the product name. So, on its own the landing page did not exceed the consumer regulations. However, by linking the DTC banner ad which identified the product to the landing page which identified the therapeutic area, the combined content exceeded the consumer regulations.
Note that Q&A 371 covers related (but different) linkage issues which should also be considered.
The preclearance agency:
There are two preclearance agencies that are recognized by Health Canada to review DTCRx (i.e. PAAB and ASC). This is outlined in the Health Canada guidance document “Health Canada and Advertising Preclearance Agencies’ Roles Related to Health Product Advertising”
PAAB and ASC are distinct organizations.
They are therefore governed and operated separately and independently. Although yearly Health Canada bilateral meetings are attended by both PAAB and ASC to promote consistency, it is possible for different preclearance agencies to come to different conclusions about APS messaging due to nuances in approach and/or values. I would therefore caution against expecting that everything which was not questioned by one agency will not be questioned by the other. We can consult with Health Canada for clarification as needed.
In many cases, the product branded HCP advertising can have the same creative/headlines as product branded DTC advertising. But this is not always the case. If you need help for a specific scenario/campaign, feel free to send in a request for written opinion to the PAAB (see the fee schedule on our website www.paab.ca).
Can you please advise if CADTH Common Drug Review publications can be used as evidence for efficacy, pharmacoeconomic or recommendation claims?
No. These reviews have important uses (e.g. explaining recommendations for funding decisions) but they are not designed or intended to support product claims in drug advertising. Please refer to the PAAB Tips document Marketing Benefit Claims http://www.paab.ca/Marketing_Benefit_Claims_-_June_22.pdf for the evidentiary requirements relating to common types of claims.
Hello, Suppose a vaccine product launches a branded Facebook page: The rules surrounding promotional posts are relatively clear, but what are the guidelines are on content curation? For example, including a link to an article from a publisher such as the CBC that discusses the condition but with no mention of the brand, or sharing a post from a lifestyle blog that similarly does not reference the brand/vaccine but may be relevant to followers of the page. The Health Canada policy on "The Distinction Between Advertising and Other Activities" does not seem to include this particular type of scenario explicitly. Could you provide some guidance or a link to the relevant guidelines? Thank you.
For vaccines which are schedule D products only [i.e. do not have a dual drug schedule (schedule D and prescription)], manufacturers may promote the therapeutic use of their vaccines for the prevention of the indicated disease in consumer advertising. When creating a branded Facebook page, it is important to remember that promotional environments that have been created by a Canadian sponsor or for a Canadian audience is subject to Canadian advertising regulations. Any links/posts on this site are inherently linked to the brand, even if the link/post content is strictly related to the disease/condition AND even if the links/posts were independently generated as described in your question. As such, these links/posts should be assessed to ensure that they may be connected to the brand (e.g. no potential off-label implications). The PAAB can provide an advisory review for Rx & Schedule D consumer materials based on interpretation of the Food and Drugs Regulations and the Health Canada policy document “The distinction between advertising and other activities”, the interim guidance on fair balance in DTC advertising of vaccines, the Food and Drugs Act and the Food and Drug Regulations. See the fee schedule on our website for details.
When submitting an APS for approval, can we submit the piece with the intent that it will be presented to HCPs in both a print format and a digital format as one submission? (Note - the content and layout of the piece will appear exactly the same in both modes of delivery).
Often digital tools contain elements which are not available in print format. For example, linkages to other APS, the ability to swipe/tap/scroll, and other functional elements. If the digital format contains any additional functions beyond the print version then the piece would require separate PAAB review.
If the same content/layout /flow is maintained in the digital and print version, and the APS context (e.g. branded vs. unbranded) and target audience remain unchanged, then the two pieces may be considered as part of a single submission. For example:
What are the implications, if any, for a Product having "monotherapy" in the dosing section vs in the indication section of the PM? Does it matter that it's under "dosing considerations" as opposed to "indication" if it's still on the Product Monograph? How would PAAB limit advertising for this? Would the sponsor only be able to mention monotherapy, if at all, if: (1) they use the verbatim statement from the PM, (2) they don't put that statement with the indication statement and (3) they don't make monotherapy the main theme of the APS?
The PAAB considers the TMA in it’s totality when ultimately determining what is and is not acceptable in advertising. It’s therefore impossible to predict the best approach for your situation given the limited information we have. We will however do our best to provide information which steers you in the right direction.
The indication statement describes the Health Canada approved use for the drug and sets the boundaries for patient selection. If the indication limits use of the product to “monotherapy” then all information in advertising would be restricted likewise. Any discussion of combination use would be considered off-label advertising. While inclusion of “monotherapy” in the dosing section may not appear to have the same degree of limitations, it is important to remember that APS are still required to be consistent with and within the limitations of the product monograph. Promotion of combined use would still be questioned without the appropriate supporting copy from the TMA (i.e. studied in combination in clinical trials, dosing section, etc.).
There are many PM factors which could impact the answer to your question. For example, if the indication states that the product is generally to be combined with other therapies, and the dosing section of the PM provides a specific scenario in which monotherapy may be considered, content relating to use in combination therapy would be required to be presented as the primary message. This content could be followed by content completely & accurately capturing the PM scenario in which the product may be considered as monotherapy. As there are many different possible PM scenarios, we invite you to submit your scenario through the PAAB’s opinion review service (see the fee schedule on the PAAB website).
Can a sales rep use a slide deck that discusses the study design, inclusion/exclusion criteria, and patient characteristics for study in an indication for which they don't yet have approval?
In this scenario it is important to differentiate between completed studies and ongoing studies.
If the off-label study is no longer in the data gathering stage (i.e. it is completed), then the study cannot be discussed in an APS until the TMA is adjusted accordingly.
A study which discusses outcomes outside of the Terms of Market Authorization can be discussed if it is on-going. The discussion should be limited as per PAAB code section 3.2.3:
"Reference to research or ongoing studies may be made in a nonpromotional context with no prominence on information that has not been authorized by Health Canada. A study involving off-label use, that has been completed or has been presented at a medical meeting, and includes information that is not included in the Health Canada Terms of Market Authorization, should not be mentioned in advertising". PAAB defines “ongoing” studies as studies which are still within the data gathering stage. Once data gathering is complete and/or an interim analysis is conducted, the study no longer meets the definition criteria for an “ongoing” study, even if the data has not been published, made public, or a follow-up/extension study is underway.
Note: If the product does not have any indications in Canada, then even the use of ongoing studies in advertising would not be acceptable.
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