Hello @tmcd

As per the document Tips on Claims Relating to Patient Assistance Programs,:
“Observational data on retention could be considered if the program has a valid and reliable mechanism to monitor when prescriptions are filled. Sufficient information about the program must be provided to enable PAAB to make this assessment. The APS claim/data from a manufacturer’s patient support programs should be non-comparative (as it relates to the manufacturer’s product), it should reflect past study findings (i.e. formatted in the past-tense), and it should be structured so as to limit the findings to the support program. Study parameters such as the time period pertaining to the claim/data could be relegated to a footnote. Note that retention data will be required to be updated every 6 months as changes in the market place can impact retention.”

Hello @llotter
No, the video is not considered exempt. If the review of the deck did not include the voiceover and/or there are any other additional features (e.g. animations, zoom, pop-ups, footnote presentation etc.), these could all impact the review. This video would require it’s own review.

Hello @username

It is possible to allow the doctor to choose aspects of the patient to build a patient case. However, variable elements which may be subject to quantification, would be required to have support within the piece. These are things like goal statements, comorbidities, concomitant therapy, consequences of the disease/condition, or observed outcomes. Also, undue emphasis (e.g. repetition, a common theme/trend, etc.) on any patient characteristic(s), would require product-specific support within the APS. This includes the “occupation” field if there appears to be a theme/trend related to this field.

Each permutation with quantifiable claims would require a separate submission.

Hello @healthymind

By October 1, 2021, the vast majority of APS in the market place will bear the new logo. Although this date will mark the end of our 1-year transition period, it is understood that straight renewals (pieces with absolutely no changes) bearing the old logo will continue to be disseminated / distributed until stock is depleted. Our expectation is that, upon reprinting, the logo change will be implemented. With the understanding that the updated logo will adhere to our style guide, this change does not trigger a need for resubmission. To be clear, at no point are manufacturers expected to destroy old stock on account of the logo change.

Hi @jennifer-carroll!

Thanks for your reply. Makes total sense. The IMC ethics code for Market Research is quite brief so I appreciate you explaining the practical application. Agree with your conclusion, especially regarding breadth of audience, in this example.

Hello @sil

There are ways in which a company can create content which speaks to a disease state they may not yet have a product in.

An institutional APS can convey that the manufacturer is committed to conducting research in a specific therapeutic area. They must not contain or imply any product claims, or state or imply that a new product or indication is coming soon. These pieces should be submitted to PAAB as they relate to investigational drug research.

An editorial APS which is intended to increase the HCPs awareness and understanding of a therapeutic area is acceptable. The APS should not contain the message that a new product (or indication) is coming soon as this would contravene section C.08.002 of the Food and Drug Regulations. Even if pharmacotherapy is not discussed, pre-NOC editorials about physiology or pathophysiology should be submitted as they relate to investigational drug research.

As a cautionary note, creating an entire editorial campaign may be considered pre-NOC advertising as this changes the frequency of messaging and breadth of formats/media used to convey the content.

Audience is always a consideration and the type of message will impact whether it can be presented to the general public or will require limitations to HCPs.

While it is acceptable to make reference to a disease state on the company social media, be cognizant of the fact that there should be no link to the product in development. If there are other posts about ongoing trials, recently reported findings, investment in treatment for this therapeutic area etc., this may be considered pre-NOC advertising. Standard monitoring and moderating requirements would also be required.

Good Morning @georgian21

Rep emails are considered PAAB exempt when they are true one-to-one communications. If this is not truly a one-to-one communication (pre-prepared, sent to many etc.) it would not be considered exempt. (See Dissemination” in the document Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context)
To address the various scenarios:

This would be acceptable This would likely be acceptable upon confirmation from the Canadian medical body in the respective field (What constitutes current medical opinion) An assessment of the link and linked content would be made during the review process Link to specific sections would not be acceptable. Linking to the homepage of authoritative consensus guidelines may be considered

Good Morning @ali

Assuming that the manufacturer has vaccines, this message inherently promotes the sale of healthcare products which it has a vested interest in. Exemption criteria in 1.5E of the PAAB Code is for corporate messages that do not contain product information or product lists. Mention of vaccination is a message about a healthcare product. This piece would not be considered exempt.

Hello @jen_antibody

Great question. To clarify, the request from RAMQ is to ensure that the coverage criteria are always clear and complete, so as not to suggest the indication is the coverage criteria (except where this is indeed the case). The document states: Coverage claims must be accompanied by reimbursement criteria (if applicable to the indications promoted in the piece). This means, that not all criteria are required in the piece. The discrete criteria which are not for the indicated population (i.e. off-label criteria), CAN be removed from the coverage criteria. All formulary claims, across Canada, for discrete off-label use would need to be removed, this is not exclusive to RAMQ. If there are additional indications for the product, which RAMQ does not cover, the formulary presentation/claim should be clearly limited to the indications with RAMQ coverage.

A statement similar to “For information on availability of formulary coverage in Quebec, please visit link” would still allude to RAMQ and be subject to the RAMQ request. However, to reiterate, the RAMQ request does not preclude the removal of off-label discrete coverage.

Good Afternoon @aboucouvalas

It’s important to note that the naming convention mentioned above is to allow for pieces to be attached to a standardized email template and therefore will not have the indication and appropriate level of fair balance associated with it. If you wish to send an email with three different patient information tools for one brand across three indications, it may be worth considering a branded email. At this point, the email could contain the appropriate level of fair balance and allow for the identification of the therapeutic area within the naming convention. Note that should you take this route, the name of all attached tools should be included in the email submission.

Hello @username
If the endpoint in the study is one that would not be acceptable for presentation within the piece (such as an exploratory endpoint), it would not be acceptable to mention, even in a claim neutral manner, regardless of whether the study was open-label, double blinded, single-arm, or placebo-controlled.

Good Morning @munitalp

As the recruitment piece is not target to HCPs, there should be no reference to the manufacturers product, generic name or brand name. Furthermore, the copy should not state the company name. It should be limited to something similar to “a Canadian manufacturer” and “investigating a product”. The trial name, study acronym or logo can be easily linked to the company and products and therefore would also not be acceptable for a clinical trial recruitment piece under the distinction document.

Inclusion criteria which restrict to patients which have had prior treatment with specific products can be referred in a non-promotional way.

Good morning @karen-taylor
The following is a review of the concept that you’ve proposed and not a line-by-line review of the copy

It is acceptable to promote coverage that has been granted and is within the limitations of the indication. The promotion of a request for coverage may suggest that the company expects coverage for the criteria or indication listed. This would be speculative (as provinces may elect to follow the coverage recommendation or not) which would not be acceptable in advertising. Please also note that use of the CADTH and INESSS recommendations would not be acceptable in advertising as these are intended to inform provincial decisions to cover or not cover. They are not intended to guide HCP treatment decisions.

Happy Friday @palanski

A letter should be provided (a written statement within the initial cover letter or a separate letter) with a written statement confirming both aspects ((1) representatives will be adequately trained on proper use of open text fields; (2) there is an audit-type mechanism in place to monitor and ensure compliance with this directive). As inferred above, yes, this should be uploaded with the initial submission.

As the list of restricted words would not be exhaustive, it is not required as part of the submission.

Hey @cchong

Web banners have a small viewing area which amplifies the negative impact that scrolling has on the reading experience. Their geometry combined with the incidental/secondary nature of the attention they are afforded, makes web banner ads particularly sensitive to features that increase the barriers to consumption. The principle that claims and balancing text must be treated equally is always important, but even more so for web banner ads.

Either of the following are appropriate web banner ad approaches*:

The product claims and balancing copy are presented complete and whole within one fixed section. The product claims and balancing copy are presented as one entity and the whole entity scrolls automatically (such that claims and balancing copy are treated equally). A multi-frame APS that flips from frame to frame automatically (such that no action is required for consumption of the entire APS).

*Approaches cannot be combined

Hello @healthymind

As per the response to PAAB Q&A 308, the PAAB code section 1.5 defines "personal correspondence as" single letters carrying a personal response or message. BUT it goes on to explain that this exemption does not apply to multiple personal letters initiated by the company. The above mentioned activity would not be considered a person-to-person communication. It is possible that the message is exempt from PAAB review even though it is not considered a person-to-person communication. However, it is also possible that some aspect of the activity discloses a therapeutic message, such as the content of the representatives business card or product logo. For this reason, we suggest an opinion to exemption review.

PAAB Q&A: Mention of new indications in 1X1 email to HCP may also provide additional learnings.

Happy Friday @tmcd

Health Canada recognizes both ASC and PAAB as bodies who can provide advisory opinions on information directed to consumers (DTC) on educational material discussing a medical condition/disease (see HC link).

Should the context of the piece change through distribution or additional linkages, the audience may no longer be restricted to just consumers. If this is the case, we must assess the new context and audience. As an example, pieces which will be provided to HCPs (e.g., for distribution to their patients), now requires review for adherence to the standards of the PAAB code as per section 1.3 (The scope of the Code of Advertising Acceptance applies to all Advertising/Promotion Systems in both official languages of Canada (English and French) distributed via all media to healthcare professionals and patients) even if they have been reviewed by another preclearance agency.

When HCPs are simply informed of DTC campaigns, the PAAB asks to see (not review) the DTC piece to ensure the linkage between the two assets (e.g. DTC and APS) is permissible.

Hey @valeries

As there seem to be a lot of moving parts to this question, we will attempt to provide some broad guiding principles.

See PAAB Q&A 169 for key suggestions. While it speaks to HCP quotes, it can be extrapolated to experts in their respective fields (yoga, stress management and goal setting).

If the patient-focused app community is branded, all content accessed through it (including podcasts) would be subject to advertising regulations.
To help reduce the number of post recording changes, we generally suggest having a pre-reviewed script. When this is not possible, we suggest review of talking points so that the speaker is generally guided in the right direction. Post recording, a full script should be submitted to PAAB. Any copy which does not meet the regulations, will be requested to be removed.

A similar thought process can be applied to patient interviews. While it is acceptable to have them, they must meet the limitations of patient information. For example, they should not be promotional. Like in PAAB Q&A 169, we suggest having a pre-approved script, or if this is not possible, a list of reviewed questions. The final script will be required for review and approval.

Hello @andrewleeson

The added clarification copy “however, linking a name-only banner ad to the TMA renders it non-exempt from preclearance as this constitutes a link to therapeutic messages” was added so as to help avoid the misinterpretation that just because there “should not be an issue linking such banner” meant that the banner remained exempt. The activity of linking the banner to a therapeutic message renders it no longer exempt. We did not believe that was clear with the initial response.

We will remove 517 to help reduce confusion. Please consider the response in 330 to be accurate: “A piece containing only the message "Drug X is coming soon" with absolutely no other message (implied or stated) within the piece AND absolutely no link to therapeutic or promotional messages is exempt. Note that the manufacturer is responsible for ensuring that this message is employed only AFTER the product has been approved by Health Canada. It is prohibited to advertise a drug product prior to Health Canada approval.”