Summary of key PAAB rulings in agreement with the complainant:
The complaint pertained to a Relpax journal ad and a co-promotional Xalatan / Xalacom journal ad. Both journal ads were precleared by PAAB.

These ads featured the following text:

The complainant's position was that this messaging suggests that the patient is assured to receive the brand-name product if the prescriber writes "no sub". The complainant clarified that this is not the case as the Ontario Ministry will not reimburse the full cost of the higher-cost interchangeable unless the prescriber fills and signs a form confirming that the patient experienced an adverse reaction on two lower-cost interchangeable products (where available). Although the complainant focused specifically on patients who have public coverage, the PAAB ruling considered the interplay with other potential sources of funding as the APS presentation was not limited to patients with any particular form of coverage. Additionally, the APS clearly outlined three steps, not simply the one step of writing "no sub".

The PAAB did not initially consider the “no sub” messaging to be misleading. However, the complaint triggered consultation which confirmed the complainant's position that prescribers can reasonably interpret that performing the three listed steps ensures patients will receive the brand-name product. Although the term "help" is included, this was not consistently viewed as offsetting the absolute nature of "make sure". The presentation therefore contravenes PAAB s2.1 and 2.6 as an absolute impression would be inaccurate per the rationale outlined below.

Following the listed steps could conceivably result in many patients receiving the brand-name product even where there is a gap between what the Ministry reimburses for the lower-cost interchangeable and the cost of the higher-cost interchangeable. For example, patients may fall into any of the following categories:

• Willing to pay the difference out of pocket
• Use a manufacturer issued payment assistance card to pay up to that difference (the patient can register for these cards through the URL included in step 3 of the APS presentation)
• Have private insurance coverage that pays up to that difference
• Any combination of the above

Although following the three steps listed in the APS may result in many patients receiving the brand-name product, it will not result in ALL of them doing so (i.e, patients are not assured to receive the brand-name product). There are several reasons why a patient might not be dispensed the brand-name product in spite of the prescriber's intentions and efforts. For example:

• Some pharmacies do not accept the manufacturer-issued payment cards (and the patients may choose to stick with their pharmacy).
• Even where the pharmacy accepts these cards, the portion of the difference covered by the card varies by product and province. It is, therefore, conceivable that the remainder exceeds the amount that the patient is willing to pay out-of-pocket.
• Some patients may not wish to enroll into the manufacturer issued payment card program (whether it be due to perceived privacy concerns or unwillingness to invest the requisite effort/time).

Ultimately, PAAB ruled that future versions of the "no sub" presentation will require modifications to avoid creating an absolute impression. The addition of disclosure statements for clarity and transparency will also be required (see below).

The HCP also found it difficult to read the non-proprietary name in the logo block. Although the non-proprietary name had appropriate legibility on the electronically submitted PDF assessed by PAAB, we agreed that it was not easily legible on the printed version of the journal ad. Some variables, including properties of the paper and/or ink, can impact legibility in ways that can be difficult to predict. Notwithstanding this fact, the advertiser was made aware of this issue and committed to taking steps to address this issue in future APS.

Requested Action:
A two pronged approach will be applied to improve future versions of APS with similar "no sub" messages across the the manufacturer's product portfolio (and across the the entire industry) so as not to suggest that the patient is assured to receive the brand-name product where this is not necessarily the case:

• PAAB will no longer accept “help make sure” associated with “your patients get”. “Help make sure” may still be connected to other concepts like “you make your intention is clear” (or equivalent) as this does not speak to the outcome of the patient receiving the brand-name product. Alternatively, copy along the lines of “help your patients get it by...” would be acceptable (i.e., without "make sure" or "ensure" or the likes). The PAAB can also consider messages like "If you want to help them receive brand X...”. Other potential solutions may be discussed during the preclearance reviews.
• Insertion of a prominent disclaimer conveying that some insurers limit full-cost coverage for higher-cost interchangeable drugs to patients who meet certain criteria and that, in some instances, documentation is required. The disclaimer should also disclose that there is a possibility that the patient may need to contribute out-of-pocket where those conditions are not met.

Note that BOTH of the above are required. The revisions are intended to convey that even if all three steps are performed as outlined, the patient may still not get the brand-name product. On the surface, this point may sound trivial. However, as explained in the advertiser’s response, there may be medically important reasons why a patient should receive the brand-name product. When that is indeed the case, the prescriber’s misplaced belief that the patient is assured to receive the brand-name product could potentially lead to suboptimal outcomes. Particularly as, in some provinces, the prescriber need not be informed of the that a substitution took place despite the “no sub” instruction (at the direction of the patient).

As these improvements will be required for similar messaging across the industry, the PAAB generated an advisory document.

With respect to the legibility of the non-proprietary name, the manufacturer committed to taking steps to improve it in future APS.

Follow-up:
The advertiser confirmed understanding of the ruling and its basis.

Summary of key PAAB rulings in agreement with the complainant:
The complaint pertained to some of the materials used by the advertiser at the Canadian Liver Meeting (CLM) in Montreal on February 28 to March 1, 2020. The materials in question included the sponsored Wi-Fi password, sponsored post, official program footers, and Wi-Fi signage. These are subsequently referred to as "Wi-Fi materials". The advertiser did not seek preclearance as these sorts of materials are often exempt from PAAB preclearance. However, several factors converged to disqualify the WiFi materials from being exempt in this particular case.

The privilege of selecting the Wi-Fi password was bestowed upon the advertiser through sponsorship. Although this fact alone does not necessarily trigger the requirement for preclearance under the PAAB code, the particular password that was selected ultimately caused the materials upon which it was affixed to become subject to the standards of the PAAB code and to require PAAB preclearance in accordance to this code.

The advertiser selected "8weeks" as the password. In the presented context the password “8weeks” acted as a representation for Maviret AND it conveyed a characteristic of Maviret (i.e., the duration of the course of treatment in some patients). The password alluded to Maviret due to the interplay between the context of the Canadian Liver Meeting, the message "Sponsored by Abbvie" on some of the Wi-Fi materials, and (most significantly) the prominence of 8-week dosing featured in Abbvie's Maviret-branded conference panels. The association between the password and a feature of Maviret (i.e., it's dosing) was further strengthened by the fact that this dosing was emphasized throughout much of Maviret's advertising campaign.

As the advertiser-determined password was to be included in the Wi-Fi materials, those materials cannot be considered to have been generated independently from the advertiser. This is true even if the advertiser was not involved in designing and reviewing those materials.

Aside from the fact that the Wi-Fi materials required PAAB review, the PAAB considered these materials to be incomplete and therefore potentially misleading. Although, the Maviret TMA speaks to an 8-week duration of treatment for some patients, that duration would not be appropriate for some patients. The message is potentially misleading in the absence of prominent copy-specific disclosure outlining which populations the dosing duration pertains to. This required copy-specific disclosure was not included in Wi-Fi materials thus contravening sections 2.1 & 3.1 of the PAAB code. The complaint ruling also noted that messages promoting product features must be accompanied by standard risk disclosures in addition to the copy-specific disclosures mentioned above. These standard disclosures include the indication and the appropriate level of fair balance. Their omission contravened sections 2.10 & 2.4 of the PAAB Code.

The complaint ruling acknowledged the advertiser’s position that PAAB preclearance of the Wi-Fi materials would have been challenging from a logistic point of view as the manufacturer was not involved in the creation of these materials. In such instances, it is important to select a password which does not promote the sale of a product. For example, the materials in question would not have been promotional vis-à-vis a drug product if the password had been the manufacturer name, the name of a corporate initiative which does not allude to a particular product (e.g., “AbbvieCares”), a sequence of alphanumeric text/numbers, or even a neutral topic that applied to a large subsection of products featured at the conference (e.g., “liver”). Sometimes, all it takes is a word or two to render documents promotional and subject to advertising regulations. This present case is one such example.

The complaint ruling emphasized that the PAAB is NOT taking the position that materials outlining how to access Wi-Fi during a conference should generally be submitted for preclearance. In fact, the opposite is typically true. However, in circumstances where manufacturer-controlled elements (like a password in this case) cause those materials to become promotional, they enter into the scope of the PAAB Code and the preclearance mechanism. Where preclearance is deemed impractical by the marketing authorization holder, the materials should be revised so as to become non-promotional, thus removing the need for preclearance. Outside of the preclearance process, the PAAB can provide guidance along these lines in response to a submitted request for opinion. We are here to help.

Although the Wi-Fi materials where not submitted for preclearance. It is noteworthy that the Maviret conference panels were approved by PAAB and thus contained the required disclosures. However, this did not offset the aforementioned issues in the Wi-Fi materials.

Requested Action:
Given the advertiser’s history of preclearance and adherence to the PAAB code, AND given that the Wi-Fi materials were no longer in use, it was deemed that there was no need to impose additional PAAB sanctions.

Follow-up:
The advertiser confirmed understanding of the ruling and its basis. It was also confirmed that learnings from the ruling would be communicated internally.