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To whom it may concern, I am looking for some clarification regarding the definition of a “therapeutic message” per section 6.6 (iv) of the code regarding exemptions: “Use of drug name only in a context not linked to therapeutic or promotional messages, other than those listed in any way.”
Specifically, we would like to send a fax to pharmacists announcing the approval/availability of a new medication along with details required for their ordering systems (i.e. product code, D.I.N., etc.) Can we simply say the name + the type of medication + disease state? For example: Product X, an SSRI for treating depression, is now available in Canada? This doesn’t link to HOW X treats depression or what an SSRI does...
Including either “an SSRI” or “depression” (or both) in the product ad described above would trigger the need for preclearance in addition to the indication and lowest level fair balance. In the exempt realm, you could go so far as saying “Product X is now available” + product code & DIN.
What types of claims (if any) are acceptable in email subject lines directed to HCPs?
You’ve got multiple options when it comes to claims in an email subject line. But first, let’s remind ourselves of the most applicable disclosure requirement. As per PAAB code 2.10 and as described in Q&A # 446, the indication (or at least a statement conveying all boundaries of patient selection) must be presented among or prior to the first set of marketing benefit claims in the APS. This requirement applies regardless of the media.
Some of the main strategies used by clients include:
This is analogous to the approaches one can use with respect to indication on the first frame of banner ads (Q&A 434).
Is it permissible to present efficacy results from real patient cases (provided the cases are anonymous and align with the TMA)?
Case studies and testimonials are not considered “evidence” in and of themselves per PAAB code s3.1.3. They may, however, be used to illustrate the findings of a randomized, controlled trial (RCT) that is presented in close proximity within the APS. In such cases, note the following provisions.
The case must be aligned with the RCT with regards to the following provisions relating to “What?”, “How much?”, “When?”, and “Who?”:
These same provisions would apply for a completely fictitious case. It is the disclaimer wording which distinguishes real from fictitious patients.
For more information, see the tip following tip document on the types of evidence required for particular types of claims: http://www.paab.ca/Marketing_Benefit_Claims_-_June_22.pdf
Can unbranded patient materials (covering disease state) have a look & feel/creative that is consistent with a DTC campaign?
Disease state materials provided by physicians to their patients are not truly “unbranded” if the recipients can readily create a link to product branded materials such as DTC Rx advertising employing similar look & feel (e.g. product television commercials). As unbranded disease materials are distributed by physicians to patients based on their condition (as opposed to which medications they are taking), the materials should be unbranded with no link to a particular product.
Is DTC advertising (i.e. patient support website, journal ads, and waiting room brochures) allowed for a schedule D biologic that is not used to treat or cure a schedule A disease?
Yes. Take vaccines for example. Use the following to guide creation of the advertisement:
Note that Health Canada is updating the consumer advertising guidelines to include provisions explicitly for vaccines. Please ensure that the product is not dual scheduled (i.e. both schedule D + schedule prescription). Otherwise the prescription product restrictions (name/price/qty) set the advertising restrictions.
Hi Patrick, We are planning a card that is for patients to carry with them, showing that they have been prescribed product X, which dose, physician contact info, etc (basically a wallet card). We are also preparing a stand for these cards that would sit in the physician's office. Each time they prescribe a patient product X, they grab a card from the stand and fill it out with the patient. The objective of the card is to instruct patients they need to show this card to other HCPs, to ensure these HCPs do not co-administer certain products with product X. Our question: can the card be submitted as patient-directed and the holder as physician-directed, as the holder will never leave the physician's office? The holder really is meant as instruction for the physician. Thank you.
Yes. In this case, the patient card would be submitted as a patient information APS. With regards to the holder, it would be submitted as an HCP APS if, and only if, it will not be visible to people who aren’t HCPs. However, content which is openly visible in the examination room would need to follow the provisions in the following link:
http://www.paab.ca/resources/pdfs/Guidance%20for%20APS%20E%2011%2018%202009.pdf
This link is not relevant if the material is intended to be kept out of sight from consumers and patients in the physician’s office.
Dear PAAB. Can information from Section I and II be used in patient information? Secondly, how does PAAB define something as "promotional" versus factual information for patient information? Thank you.
Section II cannot be used. Some parts of section 1 can be used, see page 2 of the following document for which ones:
http://www.paab.ca/resources/pdfs/code-revision/External_Branded_Patient_Information_Guidance_Doc_July_16_2015.pdf
As for how PAAB differentiates between “promotional” and non-promotional, see page 1 & 2 of the above document.
Hi sir. What are the guidelines and regulations for advertising an OTC drug and please can you provide the links?
The following guidelines will help you avoid contravening section 9.1 of the Food and Drugs Act.
Consumer Advertising
https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents.html
ASC and/or Extreme Reach can help ensure your advertising is consistent with this guideline.
HCP Advertising
PAAB code of Advertising acceptance:
http://www.paab.ca/resources/pdfs/PAAB%20Code%20Eng%20Nov%2023%202012.pdf
See section 2.4.3 for disclosure requirements which are unique to these products. The entire code’s provisions regarding evidence for claims of benefit apply equally to prescription and non-prescription products. The PAAB preclearance system helps ensure compliance with the PAAB code.
I'm working in a branded patient-information brochure that includes disease information and dosing. All the content is consistent with part III of the TMA. Does this piece require fair balancing copy? If so, what information is required in the fair balance for patient pieces?
With regards to when risk information is required in a patient information piece, refer to page 3 of the following document:
http://www.paab.ca/resources/pdfs/code-revision/External_Branded_Patient_Information_Guidance_Doc_July_16_2015.pdf
With regards which information is required as general risk disclosure, any content emphasized in part III of the TMA (e.g. appearing boxed or bolded) and any content and an HCP (e.g. physician or pharmacist) would be particularly compelled to warn a patient about. It is a best practice to include part III of the TMA (or a link to it) with the piece.
What are PAAB's guidelines or restrictions (if any), regarding boosting posts or promoting a corporate (unbranded) social media page (including Twitter, Facebook, Instagram, LinkedIn)?
This matter relates to consumer advertising. PAAB does not set “restrictions” relating to DTC advertising/information. Rather, we interpret Health Canada guidance documents such as “The Distinction Between Advertising and Other Activities” and Health Canada linkage policies. By “booster posts”, I presume you mean you have a post which already meets all applicable consumer advertising regulations and you’ll boost that post to help it reach a broader audience. Targeting tools are typically an essential part of a successful boosting strategy. They also provide opportunities to unknowingly contravene the consumer regulations by creating unacceptable links to the ad. Always pause and consider whether the targeting tools you are using when boosting creates links which cause the otherwise compliant ad to become non-compliant. For example, I’ve likely exceeded those regulations if I have a product name-only ad for a Rx arthritis product and I target its boost to people who have an interest in arthritis (i.e. the manufacturer has taken action which associated the drug product to its therapeutic use). The same would apply if I have an unbranded ad which mentions a condition and I target the boost to people who have an interest in the product (drug X). As with any other scenario, always assess the linkages you generate carefully.
Jennifer Carroll
Réviseur principal en communications
Le Conseil Consultatif de
