Good Afternoon @aboucouvalas

It’s important to note that the naming convention mentioned above is to allow for pieces to be attached to a standardized email template and therefore will not have the indication and appropriate level of fair balance associated with it. If you wish to send an email with three different patient information tools for one brand across three indications, it may be worth considering a branded email. At this point, the email could contain the appropriate level of fair balance and allow for the identification of the therapeutic area within the naming convention. Note that should you take this route, the name of all attached tools should be included in the email submission.

Hello @healthymind

By October 1, 2021, the vast majority of APS in the market place will bear the new logo. Although this date will mark the end of our 1-year transition period, it is understood that straight renewals (pieces with absolutely no changes) bearing the old logo will continue to be disseminated / distributed until stock is depleted. Our expectation is that, upon reprinting, the logo change will be implemented. With the understanding that the updated logo will adhere to our style guide, this change does not trigger a need for resubmission. To be clear, at no point are manufacturers expected to destroy old stock on account of the logo change.

@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!

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.

Thank you for your quick response!

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 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!

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.

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

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.