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.
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.
Linking a message to an email signature used by Brand Managers has the potential to have implications for the product/brand, so it would depend on what the actual “commitment message” is. The following are just general principles to consider for different target audiences:
When directed at a non-HCP audience, Brand Manager sign-offs should meet the applicable DTCA regulations (e.g., name/price/quantity for Rx and no mention if narcotic or controlled substance, for the totality of the message in the communication).
With respect to HCP communications, the PAAB Code should be considered. Code section 1.5E states that to be considered an exempt corporate message there should be no product mention. In addition to product mention, “commitment message” is vague and could easily become problematic. This type of addition to signatures would likely render the piece reviewable. Additionally, note that a 1:1 communication is exempt on the predication that the user has requested the information in an unsolicited manner and that the information being provided is done to address the specific request, not to provide additional unsolicited content (e.g. “commitment message”)
We would also question brand managers messaging patients and note that patient information cannot be promotional in nature.
Let’s begin by setting a common understanding of what is market research (and what isn’t market research).
Market research has the sole purpose of pointing out and defining marketing opportunities and issues; generating, refining, and evaluating marketing programs; monitoring marketing performance; identifying patient and prescriber needs and improving understanding of the marketing process. The planning, implementation, evaluation, and utilization of market research should reflect that sole purpose. The activity is not considered market research if the purpose includes promotion of a health product (or the features/properties of that product). The content, its context and tone should reflect these facts as should the type and number of participants (and the nature of the agreement/contract where applicable). We invite you to refer to the “General Principles” section of the Distinction Document to determine whether the activity is potentially subject to advertising regulations (and consequently subject to PAAB preclearance if targeting HCPs). The IMC Code of Ethical Practices is an additional resource for standards/factors pertaining broadly to market research and for some specific examples of market research.
True market research is generally not considered subject to advertising regulations. And consequently, the PAAB Code standards and preclearance are not applicable. However, please note that some activities that are believed to be market research are actually promotional in nature. If there is any doubt, you are welcome to use the PAAB advisory opinion service to confirm whether any particular activity is indeed exempt from advertising regulations (see our fee schedule for more information).
Please note that communication of market research findings in advertising is subject to preclearance.
1.4D 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.” Please also see Code section 7.4 for direction of corporate advertising.
The Code also states that a corporate message may be considered exempt if it meets 1.5E “Corporate Messages that do not Contain Product Information or Product Lists”.
The Distinction Between Advertising and Other Activities states: *Corporate messages - A corporate message is a communication (such as a website, brochure, published article, prospectus or annual report) that gives information about a health product manufacturer or organization. This information could be on the philosophy, activities, product range (by name), financial details and/or area of future development or research. Corporate messages, or information disseminated through corporate messages, may be considered promotional if:
they seem to provide information about the health products being marketed, developed or researched rather than the manufacturer or organization
there is far more information about the health product being marketed, developed or researched than simply its name and the therapeutic area
in the case of unauthorized drugs or an unauthorized indication, there is no mention that the product's safety and efficacy is still under investigation and that Health Canada has not yet granted market authorization*
Given that we do not know the specifics of the content, it is hard to say if this would qualify as an exempt or non-promotional message. It seems probable that a discussion around manufacturing practices and processes may have implications for brands (e.g., manufacturing process of monoclonal antibodies could easily have implications for the safety and efficacy of the brands mentioned and linked on the parent company website) rather than the manufacturer’s philosophy, activities, or areas of future research and development. We would recommend submitting for an opinion. As a courtesy, if it requires review and you know you will proceed with that review should that be the case, we suggest including something similar to “If this does not meet exemption criteria we would like to proceed with a full review” in the cover letter so as to not incur a new file new fee upon submission for review (see PAAB Policy and Procedure for Exemption Requests).
It is hard to answer this question without the context of the headline copy. As both pieces are branded, we would assume that the claim has been accepted in the context of the brand. A consideration is that content written for consumers (who you cannot promote its therapeutic use for Schedule F drugs) can sometimes be inappropriate for HCP advertising since HCPs would link the message with the therapeutic use, which could change the meaning of the statement. This could impact acceptability of use in HCP pieces.
Brand-specific "fair balance" as a term outlined by PAAB, is in reference to promotion of a healthcare product. Unbranded material should not place emphasis on information specifically about the sponsor’s product(s) as this would render the piece branded. Fair balance is inherently branded as it is specific to the brand and would make mention of the brand. There is no way to put brand-specific “fair balance” on an unbranded piece.
This should not be confused with the requirement for the piece to be balanced and complete. An unbranded piece should still be balanced.
@jennifer-carroll Hi Jennifer, thank you for your detailed response. I was simply wondering if there was an example of a paid social submission provided in any of the online guidance resources. From your response, I don't believe there are any.
The PAAB Code applies to advertising directed to HCPs and information provided to patients through an HCP. Direct to consumer advertising of healthcare products and is reviewed against the Food and Drug Act and Food and Drug Regulations. Both PAAB and Ad Standards can provide this review. When the primary audience is patients, it should be reviewed by PAAB. If it will also be visible to consumers, this should be disclosed to PAAB at the time of review. PAAB can concurrently provide a DTC review (i.e. the piece would be subject to the applicable sections of the Food and Drugs Act and Regulations, policy and guidance documents pertaining to advertising, and the PAAB Code). Regardless of who reviews the content, it should be sent to Health Canada by the respective agency per Health Canada’s request to see all DTC advertising.
We are assuming that you mean “a resource in Veeva which is a PAAB approved HCP email”. If so, yes, it is possible to use patient feedback. Claims should be limited to the program features. If it’s a branded PSP, copy may have implications for the brand. Additional nuances may arise during the review process.
In the scenario described above, the HCP is the secondary audience. Why do we say that? We say that because a brochure intended to be shared with a patient should be written in patient friendly language (content is based off part III of the TMA). A HCP should not be detailed to off a patient brochure. They are the secondary audience as they will see the brochure before handing it to the patient, but they’ll be viewing it with the understanding that it is patient information.
Depending on where the holder is intended to be placed, you may also need to consider the consumer regulations. For example, if the holder is intended to be placed in a context that is visible to anyone who enters the examination room, then any openly visible element on the holder (and any exposed section of the brochure) must not exceed the consumer regulations (see Q&A 240 for additional guidance).
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.