Hey @maryssa The relevant standards of the PAAB Code of Advertising Acceptance are applicable to APS directed at HCPs and APS directed at patients when there is HCP involvement. This remains true regardless of how else the APS may be used. In questions 1 and 2, leaving physical copies of APS in an HCP's practice constitutes distribution involving the HCP. The HCP maintains full control over which materials are allowed to remain in their practice. It would be prudent, as a best practice, to seek permission from the HCP before leaving such materials in their practice. In question 3, the messaging is directed specifically to the HCP. The fact that the messaging is about a consumer campaign does not exempt it from the applicable provisions of the PAAB Code for the message itself. If inclusion of the DTC website/material is for awareness only, it would not subject to PAAB review. However, should there be copy that suggests the material is intended for consumption by the HCP or disseminated to patients through the HCP, e.g. “Tools and resources…”, “Learn more at…”, then the website/material would be subject to PAAB review. Conversely, in question 4, the HCP is receiving the message as a member of the general public. Therefore, the PAAB Code does not apply. While the question may be framed humorously (I would hope), the general public includes individuals from all walks of life, even HCPs. Don't forget the Advisory - APS in Patient Interaction Areas as well.

@jennifer-carroll ok that clarifies things, thank you very much!

Hello @gmc As per our response above, there are many aspects that would impact acceptability. It is highly probable that the proposed link above would present an issue because the patient would know certain things about the medication that was prescribed to them (i.e. the indication). By linking to a pre-gate page that has a second medication which the patient has likely not been prescribed, it may be considered direct to consumer advertising. This is because the patient could start drawing inferences/conclusions about that second medication, even if they only see the name of it on a pre-gate landing page. This would be assessed and discussed during the review process.

Hello @ap Schedule 2 in this case appears to be referring to NAPRA. For drug advertising, one should refer to Health Canada schedules. Since the question was posted under the category “DTCI” we will assume you’re asking about the consumer regulations. The Food and Drug Regulations, Food and Drug Act, relation to conditions listed on Schedule A and the Health Canada document Therapeutic Comparative Advertising: Directive and Guidance Document should be applied. For content directed to healthcare professionals, the PAAB Code applies and all aspects of the Code should be met.

Hey @username We are not aware of additional guidance documents from Health Canada. As a broad concept, you would want to consider if the usable item or experiential event could be seen to have implications for the use of the product which would create a link to therapeutic use. Wifi sponsorship appears low risk where as a claim such as “Concert brought to you by Brand X” for a concert supporting breast cancer, would be problematic. When in doubt, we suggest submitting for DTC opinion

@creativecurio In this specific scenario, there is more to consider than the message. While the intended audience are patients prescribed a drug within an HCP controlled space, the waiting room/examination room area is also a direct to consumer space, i.e. individuals that have not been prescribed the drug will see the poster. As such, both the DTC regulations and the PAAB code will apply and as patient directed information, the poster would be generally subject to PAAB review. Note that both sets of regulations are applicable whether the message is for the promotion of the drug or promotion of the patient support program. The main DTC regulation to note is that the message may not allude to therapeutic use. Please see our website resources for the relevant regulations.

@healthymind The Health Canada Distinction between advertising and other activities document is separate from the PAAB code which is for advertising directed to health care professionals and patients as per Code Section 1.3B. Code section 7.5 provides guidance for editorial advertising/promotion systems (APS) and states that it should be clearly identified as advertising to distinguish from other editorial presentations; hence, this requires that the manufacturer’s name be included in unbranded editorial APS. Note that code section 1.4K.A. also provides direction for digital media for various content including unbranded information and indicates that the pharmaceutical company sponsor should be clearly stated in the advertising.

Hey @mef Yes, direct to consumer information (DTCI) help-seeking messages for vaccine-related diseases would require disclosure of the sponsor.

Hey @hrj2021 As the piece is being handed out in a consumer space, it would be required to meet the consumer regulations requirements (Distinction Between Advertising and Other Activities). Since the handout appears to have been developed/reviewed as a product specific HCP-patient interaction tool, there may be an inherent link to the brand. We would suggest that this piece be submitted for a DTC review to ensure there is no brand mention, no link to a brand, and it meets the consumer requirements. It would also be pertinent to disclose the nature and other copy at the booth as links may make distribution of the piece unacceptable.

@jennifer-carroll said in Sharing DTC info with HCPs: he unbranded communication linking to it are exempt from PAAB preclearance when targeted Thank you. That really helps aid in understanding. Have a great weekend.

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.

Hi @ramy The original question was for an exempt APS and if there was an issuing linking to the PM. If it was linked to the PM, the ad is no longer considered exempt. As a PAAB reviewable APS, we likely would not object. The answer remains the same when applied to the scenario presented, i.e. the exempt APS is no longer exempt when it links to post gate PAAB approved content. However, as a PAAB reviewable APS, we may not object to this linkage if the content is acceptable.

Hello @danielle Firstly, I apologize for the delay in response as I was on vacation. We’ll look to modify internal processes for the future. An HCP reminder ad in a gated space, limited to the indication, brand colors and logo with no creative/visuals, would prompt the inclusion of the lowest level fair balance regardless of the black box warning. There are no additional requirements for lowest level fair balance for products with black box warnings. Be careful, as the question above is about DTC. As noted in the response, “reminder ads” in the DTC space are limited to “name, price, quantity” (no reminder ads are permitted for controlled products). If the ad is going to appear in an ungated space, it should not contain the indication or allude to therapeutic use.

@lags The “no objection” number has an expiry date because product monographs may change, new products come to market and some Health Canada regulations are in a state of transition. What may be in line with regulations today may not be necessarily true in the future. The renewal/re-submission process helps ensure that previously reviewed ads continue to meet regulations.

Hello @jd Yes, it is acceptable to inform HCPs of a DTCI campaign. The communication would be subject to the PAAB code and should be clear that it is consumer information or advertising. The inclusion of the manufacturers name would be required. The communication of the DTCI campaign does not automatically render the DTCI campaign subject to review by PAAB, though the content should be submitted with the review of the HCP communications so that PAAB may ensure that the totality of the message is acceptable. As one example, it would not be acceptable to tie a brand to the DTCI campaign for the HCP if the content within the DTCI campaign went beyond what would be allowable for the brand.

Good morning @georgian21 As per the Services page on the PAAB website, PAAB’s goal is to provide a first response for all DTC pieces within 4-days. If the piece has a secondary audience of patients or HCPs, it will be subject to the 10-day turn around. [image: 1638287067682-6e82b4d3-a81f-49f6-990d-3a50a1e675ac-image.png]

Hey @username An image of the device may still suggest its route of administration and therefore may not be acceptable. The proposed home setting would also have to be assessed to determine if it fully aligns with the complete administration instructions from the TMA. Based on the nuances of the image and variables needed for proper assessment, it may be beneficial to submit for an opinion prior to creating the full campaign.

@kshulist Yes, two brands can share a landing page. It does not matter regarding the indications as they should not appear on the pre-gate portion of the website as per the Food and Drugs regulations, C01.044. The regulation does not permit advertising of prescription medications to the general public beyond name, price and quantity. The content on the page should also meet this regulation.

Happy Friday @tmcd Health Canada recognizes both ASC and PAAB as bodies who can provide advisory opinions on information directed to consumers (DTC) on educational material discussing a medical condition/disease (see HC link). Should the context of the piece change through distribution or additional linkages, the audience may no longer be restricted to just consumers. If this is the case, we must assess the new context and audience. As an example, pieces which will be provided to HCPs (e.g., for distribution to their patients), now requires review for adherence to the standards of the PAAB code as per section 1.3 (The scope of the Code of Advertising Acceptance applies to all Advertising/Promotion Systems in both official languages of Canada (English and French) distributed via all media to healthcare professionals and patients) even if they have been reviewed by another preclearance agency. When HCPs are simply informed of DTC campaigns, the PAAB asks to see (not review) the DTC piece to ensure the linkage between the two assets (e.g. DTC and APS) is permissible.

Hello @Username If the piece is truly DTCi, than yes, it would be acceptable to have mention of controlled substances. As the risks are higher with controlled substances, it is highly important to ensure that the piece truly meets the DTCi regulations and is not advertising.