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Questions mises à jour jusqu’au: 4 octobre 2021

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778

The product I'm working on can be self-administered by the patient. Part 3 includes the steps for self-administration, however nurses have created their own instructions for patients to self-administer. The nurse instructions don't adhere exactly to the product monograph (their instructions include more details). Is there a way to support the nurses in producing a self-administration tool for them? Perhaps by a grant and the sponsor company would not influence the content, just add some design and print it for them?

As per the Health Canada Distinction Between Advertising and Other Activities document, who sponsors the message, delivers the message, content and context all impact the assessment of whether this would qualify as advertising. Providing sponsorship to nurses to create and disseminate content about the administration of your product would fall into the category of advertising. The manufacturer could provide sponsorship, however the final product would be subject to review. Note that it is possible to provide a more detailed administration guide than that provided in part III of the TMA. The review would ensure that the copy does not contradict or go beyond the recommended steps.

777

Hello PAAB! I'm working on an unbranded piece that's for HCPs. It discusses the impact that medication adherence can have on efficacy for a specific class of drugs. Being relatively recent, my brand's drug is not discussed in most of the trials that evaluated the link between adherence and efficacy for this class of drug. Given the unbranded context, can I include data from these trials that discuss the class of drug that my brand belongs to, even though my brand was not specifically included? Thank you.

There are two considerations here. The first is the use of a study that is specific to one or more brands (this is regardless of the sponsors product inclusion). In the context of an unbranded piece, the use of this type of study would effectively brand the piece to the products used within the study. It would not be acceptable for a manufacturer to create content which refers to brands which are not their own. Any discussion of other brands should be done in the context of RCTs which meet the rigors of the code. As such, it would not be possible to create an unbranded piece about the impact of adherence on efficacy within a specific therapeutic class. As an additional point of consideration, remember that single study findings cannot be extrapolated out to class claims.

776

Hi, Is it possible to do pre-NOL PAAB submissions for a product already on the market? We know there is a new product monograph coming by the end of the year, but only minor changes to the product monograph are expected. The regulatory department from the company would do an attestation letter confirming this. Thank you.

Yes. The process would follow the same flow and logic of a pre-NOC submission. Please see PAAB resource Administrative Guideline for the Review of Pre-NOC Advertising Submissions.

775

Hi PAAB, If a pharma company who markets a vaccine sponsors a 3rd party to commission the the writing of an independently written educational article on adult vaccines, in which all treatments are discussed and this vendor distributes this article to consumers through their channels, is this considered promotional? Would the article require PAAB review? The Pharma company would not review the article.

The evaluation of whether this falls under advertising should be based on the Health Canada "Distinction Between Advertising and Other Activities" document. There is a probability that by commissioning the production of the review, this would be perceived as advertising and therefore subject to the code, especially if the final report favors the sponsors product. The question also mentions "consumers" and therefore, the consumer regulations would have to be taken into consideration (cannot exceed name, price, quantity).

We would suggest submitting for an opinion to gather a more thorough evaluation of the proposed project.

774

If launching a Patient Support Program, can a sales rep proactively distribute an unapproved PAAB enrolment form? Does the enrolment form need PAAB approval when product, disease state and eligibility criteria as well as prescription. Need to be PAAB approved?

The patient enrolment form should be submitted for review to ensure that it meets the standards of the code.

773

If an independent third party (e.g. patient advocacy group) runs a DTCA campaign, would it need to comply with DTC regulations even if they are not the sponsor or manufacturer of the drug?

Yes. An advertising campaign directed to consumers must comply with the DTC regulations regardless of if it is produced by an independent third party or by the manufacturer.

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