Forum

Hey @AnetteCPC Multiple factors can potentially come into play. But the most frequent determinant tends to be whether the video is embedded in the website and is ONLY accessible on the submitted website page, then it can be submitted as part of the same review. If the video can be downloaded, shared or in some way consumed where it is not on the reviewed webpage and complete website, it requires a separate submission. Remember that APS are reviewed as a whole as there may be content on the page or website which creates context for the video, which the video alone may not contain.

Morning @constance If the product has not received NOC, a manufacturer cannot promote that a new indication is coming soon as this would be off-label promotion.

Hey @constance The information from the TMA relating to each individual product promoted does not necessarily need to be visually separated into its own distinct module within a co-promotional tool though this does appear to be one approach that would likely satisfy the statement. In essence, there should be clear delineation between characteristics/features that pertain specifically to each product. When presenting a group of products’ indications and/or various data, it is important that they appear clearly separate from each other so as not to suggest combination use, additive effect or comparative claims as some examples. In addition, when presenting features of the products, switching back and forth, grouping or mixing presentations may create erroneous impressions or lack of clarity. It’s not possible to provide an exhaustive list given the variability between products, therapeutic classes, claims placement, headline/subhead positioning and emphasis, creative, etc. If this is in reference to a specific piece, we suggest submitting for an opinion or a consult meeting.

Hey @vt Yes, you should ensure that the 4 criteria are still followed. These criteria still exist in the distinction document, they are just mentioned across the document and therefore not repeated in this section. For example, the “Content and Context Factors” section in the “Overview” states: • A message involving unauthorized health products or unauthorized indications, in a context such as educational activities, may be considered promotional if: • the message does not caution that the product’s safety and effectiveness are still under investigation and that Health Canada has not yet granted market authorization Within the Educational Activities section, things that could make the piece promotional are: • The limitations of the data and of the health products are not adequately discussed • Reports, edited scripts or recorded videos of the proceedings, in whole or in part, that concern a health product are disseminated by the sponsor or its agent to a wider audience These are in addition to the copy under the revised heading of “Canadian and International Conferences”. In general, if it is a Canadian conference, the content should be created by the Canadian office. If it is an international conference, the content should be created by the parent company and should be adequately disclaimed. Remember that the distinction document is not intended to be an exhaustive list, but a set of guiding principles with examples throughout to help assess context and content. The examples in the “Overview” section should be considered when evaluating individual activities.

Hi @NatBourre, the distinction is “company logo” versus “company name”. The code does not require a company logo. However, the company name is required on all pieces unless it contravenes other regulations, such as help-seeking messages. The distinction between “logo” and “name” was particularly relevant to the question as it featured concerns about displaying the corporate logo in the midst of a corporate branding change.

Hey @NatBourre We have not received a response at this time. We will reach out to Health Canada to see what the status of this question is. In the interim, we will continue to apply our understanding that this cannot been done as this would contravene consumer regulations.

Hello @jen_antibody Great question. To clarify, the request from RAMQ is to ensure that the coverage criteria are always clear and complete, so as not to suggest the indication is the coverage criteria (except where this is indeed the case). The document states: Coverage claims must be accompanied by reimbursement criteria (if applicable to the indications promoted in the piece). This means, that not all criteria are required in the piece. The discrete criteria which are not for the indicated population (i.e. off-label criteria), CAN be removed from the coverage criteria. All formulary claims, across Canada, for discrete off-label use would need to be removed, this is not exclusive to RAMQ. If there are additional indications for the product, which RAMQ does not cover, the formulary presentation/claim should be clearly limited to the indications with RAMQ coverage. A statement similar to “For information on availability of formulary coverage in Quebec, please visit link” would still allude to RAMQ and be subject to the RAMQ request. However, to reiterate, the RAMQ request does not preclude the removal of off-label discrete coverage.

@Jennifer-Carroll said in There are a lot of clinical trials underway on Medical Cannabis. If some of these trials are successful and Medical Cannabis companies can start making claims will they be required to submit their APS's to PAAB?: Medical cannabis is a healthcare product. Healthcare professional (HCP) advertising for medical cannabis therefore falls within the scope of the PAAB Code of Advertising Acceptance. Currently, medical cannabis advertising may not contain claims, even when directed to healthcare professionals. Advertising materials that do not contain claims are exempt from preclearance for any product category (excluding opioids). However, specific medical cannabis products that are granted a form of Terms of Market Authorization (TMA) based on evidence relating to particular therapeutic uses will presumably be permitted to make claims in HCP advertising. Of course, those materials would exceed the exemption criteria outlined in the PAAB code and would not be exempt from preclearance. Thanks Jennifer - this is very informative. We will share this with our customers.

Hey @palanski and team You are correct. Relative claims may appear as the main message (headline), when they include the absolute values. These should be presented as an integral part of the claim and should NOT be a different colour, style, size etc. All other aspects (quantification and qualification) you would normally include in the claim, still remain applicable.

Hey @rcolbear Yes, the entirety of the message delivered should meet the standards of code section 1.5E in order to not be subject to PAAB preclearance.

Hello @dmauri For a non-comparative claim regarding patient satisfaction of a patient support program (PSP), PAAB could consider data on file from the manufacturer. In other words, the sponsor’s lack of involvement does not apply in this case. The survey methodology, data, and analysis should be submitted for consideration to assess the question which may impact content required in the APS. PAAB can provide an opinion on the questions in advance (in the context of the anticipated claims) to ensure that they are asked in a manner that would be considered acceptable. As an example, it must be clear that the question is about the program and not the product or outcomes/effects of the product. Satisfaction with the program cannot be extrapolated to satisfaction with the product.

Hey @constance Due to their size, we often receive a portion of the report. The advertiser must include any content that is relevant to the APS presentation in question.

@Jennifer-Carroll said in Linking out to RAMQ website: A link to the formulary site for any province would render the piece subject to review. While a message of “now on formulary” may be considered exempt and the formulary alone is not within the scope of the PAAB code, the linking of the two pieces renders the content subject to the advertising provisions as it creates a link between the brand and a therapeutic message. As per PAAB Q&A 565, the link to RAMQ coverage would be considered a therapeutic link. Hope that helps. Thank you for clarifying Jennifer!

Thank you for your quick response!

Hey @akar The Distinction Between Advertising and Other Activities, the Health Canada document which outlines what constitutes advertising, asks a series of questions to determine the nature of the activity. The author and distributor being a medical director in and of itself, does not, in and of itself, necessarily render a piece exempt from Federal advertising regulations, the PAAB Code, or PAAB preclearance. Please see PAAB Q&A 403. While this question asks about “slides”, the same would apply to letters, emails, etc. PAAB Q&A 750 also walks through a similar set of questions to ask about the activity. A letter stating only that the sponsor’s product is available would be exempt from preclearance regardless of the source within the company. But it should be noted that certain industry association Codes do not permit such promotional materials to be signed by Medical/Scientific personnel. Similarly, a letter only indicating that the sponsor’s product is not available would also be exempt. However, in my experience, when such a letter is signed-off by medical/scientific personnel, it’s because the letter goes beyond that simple message (e.g., why the shortage exists, when the shortage is expected to be resolved, what is being done to mitigate the shortage, what prescribers can consider in the meantime, or so on). Anything on this matter beyond the fact that the product is available or unavailable would require preclearance. If you are unsure if the activity would be considered advertising, and if that advertising requires review, please submit a request for a written opinion (see fee schedule on the PAAB website).

Thanks for identifying that @palanski ! We've adjusted the privileges so that you should now have access.

Thanks @Jennifer-Carroll!

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

Hi @jennifer-carroll! Thanks for your reply. Makes total sense. The IMC ethics code for Market Research is quite brief so I appreciate you explaining the practical application. Agree with your conclusion, especially regarding breadth of audience, in this example.

@jennifer-carroll Thanks - Appreciate the reply!