PAAB does not approve exempt materials. Our review service provides an opinion on whether submitted material is exempt from review. As such no proper review against the PAAB code and supporting evidence was undertaken with the exempt materials. When exempt material is linked to unbranded PAAB reviewed APS, the exempt file would be subject to PAAB review because of the linkage. The exempt material would be reviewable as unbranded, editorial APS per section 7.5 as well as applicable codes sections with respect to substantiation for the claims within.
In the example presented, the previously exempt website would no longer be exempt and should be submitted for full review. Similarly, the exempt website may not host PAAB approved unbranded APS as the linkage would render the exempt website reviewable.
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.
In general, we may consider review articles for disease state claims when the reference is published, peer-reviewed and independent of influence from the manufacturer. This however, should not be extrapolated out to health product content (e.g. if the “practice defining documents” or “clinical practice for managing the patient population” directly/indirectly refers to health products; “treatment algorithms”; “treatment recommendations”, etc.). These should come from Canadian consensus guidelines (see Code section 3.2). It would not be acceptable to distribute these types of papers in the context of drug advertising. A complete consensus guideline could be distributed.
The activity of sales rep discussion does not fall under the scope of the PAAB code. As a courtesy, we invite the client to consider the following when deciding whether to move forward:
Although the activity does not fall under the scope of the PAAB code, it does fall in the realm of advertising and is thus subject to the provisions of the Food and Drugs Act. If the activity is deemed to be misleading, it could be found to be in contravention of the Food and Drugs Act.
Corporate Advertising / Promotion Systems (APS) These are designed to create and maintain a favorable image of a company, its products and its services. See Section 1.5: Materials Not Subject to PAAB Review. These systems may be used at any time at the discretion of the advertiser but must be submitted for PAAB preclearance prior to publication. They must not contain therapeutic or other claims of product merit or status. They may contain:
1. A general statement about the pharmaceutical company, its products and its service(s) and policies.
2. A partial or complete list or illustration of products manufactured and/ or distributed by the company, along with their respective therapeutic or pharmacologic classifications
3. Product information does not have to accompany corporate advertising.
This therefore conveys that corporate messages which do not contain product information or product lists (direct or indirect) are exempt per 1.5. The remaining scope of corporate advertising is subject to review per 7.4. As an example:
“Company X employs 2000 Canadians” is a corporate message that does not speak to products or product lists. This message (as a stand-alone message), would be considered exempt.
“Company X is the proud manufacture of Product Y” is a corporate message that contains product information. This APS would be subject to review.
“Company X is dedicated to research in the treatment of condition Y” would be subject to preclearance as it alludes to products when it states “treatment”.
The copy “Product information does not have to accompany corporate advertising” refers to the fact that corporate messages may make mention of products, but do not require the fair balance or TMA link if they meet the spirit of a corporate message and are not brand promotions.
Theoretically it is possible, however there are several considerations. For example, if the PSP is therapeutic area specific, it would create a link to the other brand for which patients only on one product are not on and would not be acceptable. If the PSP is not therapeutic area specific, it would require verification that the patient was on both products and within the PSP, the content would need to have been reviewed and approved in the context of both products. If it was therapeutic area specific, the content would still require review in the context of both brands. If the products are in different therapeutic areas and the content is different based on the product, there would need to be clear delineation between therapeutic content. These are just some considerations.
We would suggest that you submit for an opinion so that we may assess and provide direction in the context of the specific program and application.
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.
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.