@jennifer-carroll Thank you.

Hello @natbourre

No, but the indication size should be proportional to the claim size Yes, it is acceptable to use the generic name.

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.

Hello @geoffls20

The document Guidance on Patient Reported Outcomes provides the limitations for use of PROs. It is not required that the study identifies it as a “key” secondary endpoint. Note that it must be identified as a “secondary endpoint” and this must be disclosed in the APS per code section 3.1.10.

The discloser of failed secondary endpoints is required when they are closely related to the other endpoints so as not to be selective. (s.5.12)

Hello @palanski

PAAB Code s2.2 pertains only to the promoted product(s). There are separate code sections that relate to other products (e.g., acknowledgement of trademarks where relevant). The sponsor’s legal department can help you ensure that you are meeting legal disclosure requirements for those other products.

Hello @mhe

Good question. Basically, all copy in a branded piece has implications for the brand. When you present the definition/criteria for “optimal benefit” you are suggesting that the product gets patients to “optimal benefit”. This is likely not substantiated as the clinical endpoint in the study was probably not “optimal benefit”. Claims, both direct and implied, must be supported by statistically significant findings from a well designed, published study.

With respect to adding a disclaimer, it is not sufficient to state or imply claims and then use a disclaimer to off-set them. That which cannot be supported should not be stated or implied.

Happy Holidays!

Hello @matt-s17

The Distinction Between Advertising and Other Activities states:

An institutional message is defined as a communication (e.g., brochure, published article, prospectus, annual report, etc.), which provides information about a pharmaceutical manufacturer, or other institution, concerning its philosophy, activities, product range (by name), financial details, area of future development or research, etc. Such a message may be a nonpromotional activity in the following circumstances:

the purpose of the communication is clearly to provide information about the institution rather than about the drugs being marketed, developed or researched, information about the drugs being marketed, developed or researched is limited to the name and therapeutic use of the drug, and no emphasis is given to any one or more products, or their benefits

The activity described above seems to place emphasis on a particular therapeutic area and class of products which the sponsor has a vested interest and therefore would fall in the scope of advertising. If the intent is for the messages mentioned above to exist in the consumer space and be targeted at consumers only, it would be subject to consumer advertising regulations and an advisory opinion may be provided by PAAB, AdStandards or sent directly to Health Canada. If there is a possibility that the message/campaign will be targeted at HCPs in any way, it would be subject to the PAAB Code and should be reviewed by PAAB.

Hey @nimisha

Unfortunately, we cannot provide this confirmation as it does not appear that the project will meet the criteria outlined in the Distinction Document (it will inherently be branded). We suggest submitting for an opinion to receive more specific feedback in this specific case.

@jennifer-carroll Thank you for the clarification.

Hello @maryssa

If there are no other changes, the files should be submitted as an FYI. If the review of the FYI prompts comments, it would be required to be submitted as a new file. If no changes are required, it can be considered solely as an FYI. When preparing the black and white version, consider things like legibility of all copy (e.g., no reduced contrast).

Hey @mhe

The answer is nuanced and context driven. While dosing has clinical relevance for appropriate use of the product, the convenience of once daily dosing does not necessarily translate into a clinical outcome such as adherence, safety, and/or efficacy. As such, a claim of “convenient once-daily dosing” would not require a disclaimer of “Clinical significance unknown” but it would not be permissible to present it in a context that suggests unsubstantiated significance.

@admin We note that modifications to RMTs require PAAB resubmission. Would this still be the case for a product logo or legalese update that does not alter any of the other content in the RMT? If PAAB resubmission is required, is there a way for a reduced fee to be applied (we note that updated legalese or logos are not part of the criteria for "Minor Update" reviews).

@danthony Thank you for the clarification!

Good morning @palanski

Great question. There has been an increase in HCP assets that direct HCPs to pre-gate spaces containing consumer content. For transparency, when you are directing this audience to a message not intended for them, they should be made clear of this fact.

URLs that direct HCPs to landing pages that contain only administrative messages such as “log in here” would not require this disclaimer.

@jennifer-carroll Thank you for your helpful response!

Hello @llmktg

Acceptability would be assessed during the review process. Linking to the homepage/cover page of the complete guidelines, is likely permissible with the understanding that they are recognized Canadian consensus guidelines. For unbranded ads, the linkage should not contravene the principles outlined in Code section 7.5. There are some scenarios where it could be challenged. As an example, if the unbranded piece speaks to a drug class for which the use is off-label in the guidelines.

Hello @joao-borges

When you link advertising and non-advertising, everything becomes advertising. Even though the abstracts are on a third-party site, you would be leading them there from an advertising space and in the context of promotional material; the abstract would become advertising. The abstracts would have to be reviewed to ensure that they meet advertising requirements. For example, you could not link to an abstract about off-label use of the product as this would be off-label promotions. Furthermore, the abstract content would be reviewed as if it were APS copy. A quick review of the Health Canada document “The distinction between advertising and other activities” may help provide additional information about questions to ask when assessing if an activity would be considered advertising.