Good Morning @tmcd,

The rest of the sentence quoted above reads “discussion of disease content would suggest the therapeutic use without properly limiting to the specifics of the products indication.”. The copy “arthritis” is discussion of the disease which suggests the therapeutic use.

Any HCP product advertising that identifies a disease must, disclose which patients the product can actually be considered in. In the hypothetical example, the product is not for anyone who has arthritis. The presence of the indication consequently triggers the need for the lowest level fair balance statement.

As noted above, "Drug X efficacy profile" (without mention of the disease/condition) would NOT trigger the above requirements.

@Jennifer-Carroll I've solicited feedback from ANTIBODY's Creative Director, Melisa Barrilli, who had the following thoughts to offer on the bilingual logo:

Although we rarely use bilingual logos, they do come in handy. Glad a version was created! The bilingual logo seems to have optimized the space and flows well. Legibility seems excellent for the PAAB/CCPP words. It will be interesting to see how all versions look when applied at their minimum recommended size—there's considerable size variation with the smaller type, so "Reviewed by" may become illegible if used too small.

Hope this is useful!

Hello @ABrown

No. The approval period will remain the same with the understanding that pieces will be updated accordingly. For example, if pieces have already been printed and the renewal is to use up printed stock. The manufacturer should be taking the update into consideration now and printing pieces accordingly.

If the piece is unaffected and meets the criteria outlined in the previous response above in this thread, it would not prompt the replacement of the PAAB logo prior to acceptance. Please note that it is still encouraged that the piece be updated if there are no reasons for it to remain with the old logo (i.e. using up excess printed stock).

Great question @rebeccaallen

For simplicity, we have constructed the chart below:

@jennifer-carroll Thank you for your help

Thank you @Jennifer-Carroll. Appreciate the additional clarification. Helps to have this in writing for alignment across various stakeholders.

@lilymcneil

These questions may be acceptable if the content, context, and link aligns with the general guidance provided in our prior response. Of course, copy specific guidance would be provided as part of the review process. Questions and responses need to be assessed in the context of the entire piece and with assessment of the references.

@SKW

If independent third party content on COVID-19 is being provided to a patient through a branded patient support program, an assessment of the linkage should be performed to ensure the acceptability of the content within the context of the brand. This remains true even if being sent without the brand logo (i.e. they are being sent the content because they are part of the branded patient support program). PAAB would do an assessment of the linkage to the content which could be done through an opinion file and would be subject to the four day turn around time.

@akar Great question.

Note that any of the proposed content would require review under the PAAB code. This is occasionally a point of confusion in the generic space.

If the generic product’s TMA refers to the innovator brand as the reference product, the generic manufacturer may convey this fact in the APS. For example, “… generic version of Drug X [the reference product]”.

In the unlikely event that the reference product is no longer authorized for sale, this should be conveyed through a cross-reference to the claim above. However, a manufacturer should only discuss the availability status of its own products. For example, it would be unacceptable to comment on a competitor’s drug shortage issues.

Any messages relating to switching will require support from the TMA or standard setting organizations.

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.

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.

Thanks @Jennifer-Carroll!

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).

@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.

@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!

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.

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

@NatBourre Good catch. The hyperlink was an error. We have revised the content now. Thank you.

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.

Thanks for identifying that @palanski !

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