The PAAB website only contains the most recent version of the code so as to clearly promote current best practices.
We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.
How can I access archival copies of the PAAB Code? I am looking for the version relevant to 1996. Many thanks.
The PAAB website only contains the most recent version of the code so as to clearly promote current best practices.
Hello, I'm looking for where to find guidance regarding regulations for executing a 'help seeking' DTC campaign for vaccines at the same time as a branded DTC vaccine campaign. Given the DTC nature, pre-clearance would likely be through ASC. I've reviewed the guidance from Health Canada at length and am well aware of the criteria for help seeking. My understanding is that the help seeking and branded campaigns must be different (ie: in colour, tag lines etc) and not linked in any way, but I'm unable to find specific direction. I'd like to be more clear on how the campaigns must be different, assuming they are not linked in anyway (visually or otherwise), and if/how they may be executed concurrently. ie: can a vaccine help seeking TV ad be on during the same time a vaccines DTC branded banner ad or social media campaign is running (again, assuming not linked in any way). Thank you in advance for your assistance.
Your assessment is correct in that help-seeking messages, which are reviewed as DTC information, cannot be linked to DTC branded advertising as this would render all content subject to advertising regulations. The key here is understanding how linkages are created. To assess this we consider a number of factors, including:
If any of these factors would create a link between the two campaigns, such as concurrent airing/viewing of the messages, it would violate the regulations.
Hi, I'm from the Arthritis Society. I have a company that is currently developing a product; in phase 2. They want to support/sponsor one of our tool in a field that is relevant to their upcoming indication. Content and material will be elaborate by the Society without any interference by the pharma company. Would that interfere with any regulation in Canada. If so, which one? Thanks Ken Gagnon kgagnon@arthritis.ca
The content and message of the piece that they are planning to sponsor/support would dictate the acceptability of the activity. If the content speaks to therapy, it should be reviewed to ensure that there is no competitive bias or off-label content. For example, if the piece were to discuss modulating a pathway for which there are no approved drugs with that specific mechanism of action, this would be deemed pre-NOC advertising and would not be acceptable. As such, we suggest that this type of content be reviewed as an opinion, to ensure that the content meets the regulations.
If a representative during a social meal mentions to an HCP a reference to a slide that was viewed at another meeting to HCP's with regards to utilization rates of a genericized molecule, is this considered a violation?
The PAAB code applies to all advertising pieces (i.e. detail aid, website, email, etc.) distributed via all media (i.e. print, audio, visual, electronic, etc). A verbal communication between the representative and the healthcare professional does not fall under the scope of the PAAB code. However, verbal communication between a rep and an HCP is covered by the Food & Drugs Act and Regulations. If you are unsure about a specific topic or claim, a good rule of thumb is that if the content would not be approved in a print piece, the rep should likely not be discussing it verbally with a physician.
Can ongoing studies for a group of products (same therapeutic category) be discussed in a Corporate APS, or must this be done in individual branded APS? For example, a company has a portfolio of diabetes drugs that with ongoing research into weight loss indications, and would like to produce a single piece discussing all trials.
The main message conveyed in a corporate APS must be related to the company and its programs or services. If the messaging in the piece is strictly related to broad program-level messaging (e.g. a total of 1000 patients across studies in our cardiovascular research program), then the piece may meet the requirements of a corporate APS. That said, discussion of ongoing studies for an existing portfolio of products would likely be reviewed as a branded APS, as it relates to individual brands. This information could potentially be presented in a single APS as a co-promotional tool, with the information relating to each individual brand being separate and distinct. Reference to the ongoing studies must be made in a non-promotional context, with no prominence on information that has not been authorized by Health Canada. Be mindful that as branded tools, these pieces will require the indication and fair balance copy. Refer to AskPAAB Question #223 for more information on how we review ongoing studies, including studies involving off-label use, in branded APS.
We have an online newsletter where we post healthcare-related information, as well as society news pertaining to our association. Our member and supporter base primarily consists of hospital pharmacists as well as a small number of architects, students, and pharmaceutical companies. We can set-up advertising on the site to require a login to limit access by the general public. My concern is with the students who are not yet healthcare professionals, the pharmaceutical organizations, and the small number of architect members. Would their exposure to pharmaceutical advertising go against PAAB standards, even if we include a disclaimer that the advertisements are meant for healthcare professionals only? When we used to have a print journal that contained advertising for pharmaceutical products, the same individuals would have received copies of it. To my knowledge, this was not an issue in the past. However, we would appreciate some guidance to ensure we are being PAAB compliant, as online advertising is new to our association. Thank you kindly.
The regulations that are applicable to your question emanate from Health Canada rather than the PAAB. In other words, the question in this case should be are you Health Canada compliant rather than are you PAAB compliant. Nonetheless, we can provide an advisory opinion on the matter.
It sounds as though the publication does not target Healthcare Professionals specifically. As such, the consumer advertising regulations set the boundaries for which ads are permissible in the publication. These regulations differ based on the Federal Drug Schedule of the product being promoted. As an example, direct-to-consumer advertising for prescription drugs is limited to name, price, quantity and direct-to-consumer advertising of narcotics is prohibited. These regulations apply to both digital and print pieces.
Can patient survey data from CADTH be used for an unbranded tool on current patient experience and behaviour?
CADTH is an important tool for explaining recommendations for funding decisions, but it is not designed or intended to support product claims in drug advertising. See AskPAAB Question #541 for more information on this topic.
For claims related to patient experience and behaviour which do not relate to pharmacotherapy (i.e. disease attitude and opinions), then we may consider surveys as a source depending on the design, and execution of the survey. However, the primary source to support these claims should be the survey itself, not the CADTH document.
For Help-Seeking Announcements, the Distinction Between Advertising and Other Activities states "there is no implication that a drug is the sole treatment available". Does this mean no implication for a single brand within the context of available drug treatments, or no implication for drug treatment over non-drug treatment?
The Health Canada Distinction Document has the following three provisions relating to Help Seeking Announcements:
Although the question relates to the 2nd point, it is important to interpret it in the context of the 1st. Generally, when PAAB has evoked the 2nd provision, it has tended to relate to the statement referring the patient to the HCP. For example, the statement “If you have any of these symptoms, consult your physician for discussion about the treatment for condition X” would evoke the 2nd provision. Even if there is only one indicated healthcare product, the statement should refer to treatment options or management options (includes non-pharm options) so as not to suggest there is only one treatment available for the condition.
For a product with two different administration formats (eg. syringe and pen), is it permissible to only advertise one format in APS (with no mention of the other device)?
Similar to AskPAAB 704, there are a number of scenarios which could result in either requiring both administration formats to be included in the APS, or allowing the focus on just one. These would depend on both the content in the TMA and the claims which are being made in the APS. For example, if the piece is promoting an indication in which the product is administered using the pen, then the selective promotion of administration with the syringe would be questioned. As the answer to this question is dependant on the specific TMA and the claims made in the APS, we suggest submitting this to PAAB as an opinion request.
If Product-A is a combination of Drug-B and Drug-C, can the mechanism of action information from the Drug-B and Drug-C Product Monographs be used in Product-A advertising? The Product Monographs for combination products usually contain less information regarding their components (for brevity), however mechanisms of action should be identical regardless of formulation.
The review of mechanism of action claims for drug A would be based on the Product Monograph for drug A. We would not accept the assumption that combining the two products does not in any way impact the mechanism of action of either of the individual drugs. This concept would require direct support from the drug A PM, in which case, content from drug B and drug C PMs may be considered. This assessment would be conducted on a case-by-case basis and would depend greatly on the information/language in the drug A PM. For example, if the PM for drug A says “Please refer to the individual product monographs for Drug B and Drug C for more information on the mechanism of action” then we could consider the MOA content from the respective PMs.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising