DTC for OTCs is out of the PAAB Code’s scope. We do not comment on, or endorse, any particular agency in the DTC space for OTCs. The PAAB encourages preclearance of DTC/OTC materials by a Health Canada recognized agency.
No. You cannot link branded to unbranded in any manner. This is not limited to just the look and feel of the piece. Connecting through clicks is still a link and is not acceptable. All spaces would have to be reviewed in the context of the brand. This means, that while they may not have brand mention, the link requires the content on them to not exceed what is allowable in the context of the brand.
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.
It is possible to create an HCP directed website with multiple products. Each individual product section would be treated as a separate APS (both from an administrative and from a fee perspective). As this appears to be a specific project with multiple components where acceptability may be context driven and the submission process may be more complex, we suggest submitting for a written opinion to elaborate on the structure and high-level messaging so that we can provide more tailored feedback in consideration of the particular products that this tactic will pertain to.
Yes, inclusion in the logo qualifies. The answer above is based on an older version of the code. The current code section 2.2 states: In all APS for pharmaceutical products, the brand or trade name, the non-proprietary or generic name and the Federal drug schedule of the product must appear in juxtaposition at least once within advertising copy and must be in good contrast and be legible.
It can appear anywhere in the piece as long as it appears at least once.
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.
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).
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.
PAAB does not regulate representative activities but agree with the primary principles of not promoting off label use for drug products and not distributing unbranded materials in a branded booth. The PAAB Code requires use of PAAB reviewed materials. Please note that respective pharmaceutical trade associations generally have a code of ethics/conduct that may help guide representative activities. In addition, the Food and Drug Regulations apply to all advertising activities.
Without additional details, it’s difficult to provide specific direction. In general, providing an exhaustive list of things to keep in mind is not possible. As the tool is being given to patients, ensure it meets s.6 requirements for patient information, particularly regarding promotional claims, as well as the spirit of 2.8. If you are unsure if the tool would meet these criteria, we would recommend submitting for an opinion.
No. The exemption criteria states: Use of a healthcare product name may only be used in a context not linked to therapeutic or promotional messages. Suggesting number of patients that could be covered for the product is a promotional claim and does not meet the exemption criteria 1.5Dii.
It appears that the intent is to develop a help-seeking message. What you’ve described does not meet the criteria of a help-seeking message per the Distinction Between Advertising and Other Activities as the addition of the company name would violate the requirements. The direct link to sites that only have the sponsors brand and listing the sponsors brand as what is offered at those sites would also brand the site.
If you are going the help-seeking route, all criteria listing in the distinction document should be followed.
Since this is a vaccine, DTC advertising which links the product to it’s therapeutic use could be considered. If this option is selected, all advertising regulations would be required to be met.
Code section 1.4.D states “The Code applies to all Advertising/Promotion Systems and corporate messages directed to licensed members of the professions of medicine, dentistry, naturopathy, homeopathy, nursing, pharmacy and related health disciplines, to institutions, and to patient information that will be distributed by or recommended by a healthcare professional.”.
From the provided description, it appears that these pieces would be considered patient materials that are subject to the PAAB code.
Independent third party lifestyle apps may be promoted within branded apps if they do not contradict copy within the brands TMA. PAAB would ask to see the app content to ensure the link is acceptable.
The review of linked 3rd party apps focused on lifestyle and nutrition vs lifestyle, nutrition and disease information is not different however there is increased opportunity for content which is not acceptable to arise when disease information is discussed.
Additional clarification would be required on the last question that would be better suited for an opinion submission so that all aspects of the activity can be assessed. For example, is the 3rd party app only accessible through the PSP (not open to the public)? When this is the case, clarity over influence, sponsorship and distribution may impact if the content requires PAAB review.
The answers to your questions hinge on whether the document is subject to the advertising provisions or not.
The assessment of whether it is subject to the advertising provisions is made by applying the following 7 questions from the Health Canada policy document “The Distinction Between Advertising and Other Activities”:
• What is the context in which the message is disseminated?
• Who are the primary and secondary audiences?
• Who delivers the message? (the provider)
• Who sponsors the message and how?
• What influence does the drug manufacturer have on the message content?
• What is the content of the message?
• With what frequency is the message delivered?
Assuming that the audience is HCPs, you would need to assess who sponsored the program; what influence did the manufacturer have; what is the content of the message across the program; and the frequency of the messages throughout the learning program. It is important to consider each question as no single factor can determine whether the advertising provisions apply. This assessment can be done internally through the manufacturer’s own regulatory department. If you would like, PAAB can provide an objective opinion on any particular tool/material based on the aforementioned Health Canada policy document. If the activity was deemed to be advertising, the pieces would be subject to the PAAB code.
Mention of the sponsor on content they create would be required unless precluded by other regulations (i.e. help seeking messages).
The type of information within the piece would be dependent on the type of review you are looking for. An RMT should convey important risk information about the manufacturers product. If the proposed “disease information” does not appear to serve the intent of an RMT, it may be questioned. This would be assessed during the review.
Patient information can contain disease information as well as risk information. Disease information which does not align with part III of the TMA would not be acceptable in the context of a branded patient information piece.
Yes, radiopharmaceuticals are drug products that fall under the Scope of the Code. Please see Code sections 1.3 and 1.4, and particularly 1.8 (definition of “healthcare product” which is covered by the Code).
Please see Q&A 634, particularly the PAAB Advisory Guidance on which HCP materials require PAAB review, which contains a decision tree to describe the key elements in the assessment. To make an assessment, we would require further elaboration on the content, nature of the sponsorship and selection of the author group. We would also require elaboration on the “3rd party distribution”. If the sponsor has influence on choosing the topic and/or plays a role in the distribution by the 3rd party, we would recommend submitting for an opinion. The opinion would be to assess the influence of the sponsorship (as noted in the above guidance, examples of “influence” include control or input on the specific topic, content, author selection, audience, frequency, etc.) and the overall message of the piece. The standard litmus test is “could a reader identify the sponsor” and “would a competitor be equally as likely to promote this tool”.
Please see the response to Q&A Email update on CADTH recommendations. The letter of intent (LOI) is viewed similarly to the CADTH recommendation. It is not acceptable to position the pan-Canadian Pharmaceutical Alliance (pCPA) coverage negotiations as a positive feature of the product or suggest endorsement. Formulary messages should be restricted to clear, complete coverage criteria and not suggest the endorsement of a product.
The addition of such content would prompt a new review as you are changing the piece.
While Class I-IV medical devices do not fall under the scope of PAAB review, the piece in question combines drug-related content and device-specific content. Any change to the former OR the latter would trigger the requirement for re-assessment. Changes in the device-specific content could potentially impair acceptability of the previously approved drug content through various contextual or linkage factors. Based on the information provided in the question, some of the key focuses of our review might include:
Whether the added content is indeed device-specific.
Whether the drug-related and device-specific content are separate and distinct from each other. For example, the device-specific content must not impact the meaning/interpretation of the drug content through context or linkage.
Whether the device-specific content suggests therapeutic outcomes or contains promotional claims for the drug brand. For example, if the claim was to state “Drug Brand X: pain free injections with S-pen”, we would question the link between the drug brand and “pain” in the absence of support. For copy to be considered “device” claims, it should be limited to the device and not positioned as a feature of the drug brand.
As the assessment is largely contextual in nature, references are not typically required for the Class I-IV medical device-specific content. Particularly as the manufacturer is solely responsible for ensuring that the medical device claims adhere with all applicable marketing rules and regulations. The reviewer will request references, on an as needed basis, wherever this content could potentially relate to the drug product.
Change to copy post approval generally requires a new file and new fee. In the scenario described above, it sounds as though one option from the drop-down menu will be removed/de-activated. PAAB does not require that all options within the drop-down options list, remain active. If that is the intent of the revision and question, it would not require resubmission. However, addition of new content (e.g. replacing or adding options) that requires assessment post-approval requires a new file and new fee. If we have not fully captured the request, please reach out to admin to set up a call with the reviewer. It may be easier to assess the actions when looking at the file in question.