Thank you so much @jennifer-carroll for your detailed answer! I’ll probably send an email then with the eFile number and additional details soon.

Hey @constance. Please find response below.

Phase 1 is not complete. There will be rounds of consultation with industry prior to launching to ensure that we are developing as efficiently and in the most supportive manners. Please stay tuned as we look for assistance in finalizing technical validations, user testing, and ensuring adequate support resources are in place. We anticipate these steps will be completed by the end of Q2 and will communicate a go live date as we approach completion.

Manufacturers have been informed about the initiative through communications and the townhall. PAAB has also spoke to this initiative at a number of conferences. We have also invited manufacturers to reach out with specific questions especially surrounding privacy and security. We anticipate that the level of understanding may vary. The purpose of the debrief meeting is to ensure that both agencies and manufacturers have a shared understanding of the initiative while also inviting feedback and suggestions as we develop and scale. As their agencies, your role is pivotal in supporting their implementation efforts, but the debrief aims to equip everyone with the necessary context and clarity to move forward confidently. Please rest assured that we will develop training and guidance related to the new policies and procedures to ensure both agencies and manufacturers are equipped with the knowledge they need to successfully utilize the new features’.

We anticipate that there will be a mixture of manufacturers alone and agencies in collaboration with the manufacturers participating in these meetings. Who participates is at the discretion of the manufacturer. If agencies have agency specific questions, we are also happy to set up these meetings. It may also be possible that the first meeting will be solely with the manufacturer and then they may opt to bring in agencies as it becomes necessary. Please note that currently, these debriefs are not training sessions for the use of new features. These debriefs are intended to discuss security, privacy, and whether/how proprietary manufacturer generated content will be used as we progress through Phase 1 and 2 of the initiative”.

We hope that helps. Thank you for the questions and continued engagement.

@mgregory

Our apologies. The above was posted prematurely.

Please note that as per PAAB code 7.3.1a, "The URL may be supplemented, but not replaced, by an electronic coding system, such as a QR code or a bar code".

For print media, please be reminded that the telephone number must be accompanied with the URL +/- the QR code.

Hi @maryssa

Although 'price' generally refers to the monetary amount associated with the patient's acquisition of the sponsor's prescription product, insurance coverage and corporate service programs addressing acquisition costs could also potentially be presented in a manner that complies with the name, price, and quantity restriction. Acceptability of the proposed claim in the above question may be possible depending on the balance of the context. This can be addressed during the review process.

@jennifer-carroll Thank you 🙂 this helps!

Hi @dnewman

The “Health Canada Distinction between advertising and other activities” document addresses Canadian conferences and International conferences held in Canada. General corporate APS informing HCPs of upcoming international conferences (print or digital) may be distributed to Canadian HCPs and may be subject to PAAB review per code section 7.4, depending on the content. Use in branded material would require PAAB review and may be limited to avoid linkage issues. Material (including digital), emanating from the international conference outside of Canada or from the global division of the pharmaceutical company, is outside the scope of PAAB.

Hey @vt

Yes, you should ensure that the 4 criteria are still followed. These criteria still exist in the distinction document, they are just mentioned across the document and therefore not repeated in this section.

For example, the “Content and Context Factors” section in the “Overview” states:
• A message involving unauthorized health products or unauthorized indications, in a context such as educational activities, may be considered promotional if:
• the message does not caution that the product’s safety and effectiveness are still under investigation and that Health Canada has not yet granted market authorization

Within the Educational Activities section, things that could make the piece promotional are:
• The limitations of the data and of the health products are not adequately discussed
• Reports, edited scripts or recorded videos of the proceedings, in whole or in part, that concern a health product are disseminated by the sponsor or its agent to a wider audience

These are in addition to the copy under the revised heading of “Canadian and International Conferences”. In general, if it is a Canadian conference, the content should be created by the Canadian office. If it is an international conference, the content should be created by the parent company and should be adequately disclaimed. Remember that the distinction document is not intended to be an exhaustive list, but a set of guiding principles with examples throughout to help assess context and content. The examples in the “Overview” section should be considered when evaluating individual activities.

Hello @dmauri

The guidance does not apply to NOC/c products and therefore has no bearing on data reviews for NOC/c products. The standard NOC/c approach remains the same (see Guidance on Advertising for Drugs with Notice of Compliance with Conditions (NOC/c)). If the data or study are presented within the TMA, we will allow it in the same context within promotional pieces. When assessing copy similar to “the results of the extension study were consistent with those of the earlier analysis”, clarity on which endpoints and the same tonality and direction will be required. Additional comments may arise pending review of the language used throughout the TMA.

Hey @tk2022

It sounds like this might be a specific question about a specific case. We’d suggest submitting for review as the forum is guiding principles. Each case is assessed based on it’s merits in the context of all relevant documents. The answer provided below is with the caveat that it is a general response.

In general, an RWE study is not excluded from advertising based on a pre-planned evaluation of a subgroup which would be within the limitations of the indication. “Consistent with the TMA” with respect to patient population states “1.1.2 Patient population: The APS presentation must be derived from analysis of patients that fall within the indicated population and are aligned with any relevant contraindications from the TMA. In instances where an overall study population exceeds the product’s indication, it may be possible to present data from a pre-planned patient subset that reflects the indicated patient population or relevant subset thereof.”

@jennifer-carroll Thank you kindly for the response 🙂

Hey @maryssa

We’re not sure of the specifics to the case that you’re referencing in the beginning of the question so we cannot confirm your understanding. We can provide general guidance on place in therapy claims.

Place in therapy can be supported by guidelines when it’s consistent with the indication. The PAAB document “What constitutes current medical opinion & practice” states “PAAB has received requests from consensus groups to ensure that the proprietary drug name [brand name] is not included within a claim directly referring to the guideline if the guideline recommendation only cites the non-proprietary drug name [generic name]”. We refer you to the examples in the above-mentioned document. Therefore, a claim that a product is recommended first-line per guidelines X, would require that the brand name be specifically mentioned in the guideline recommendation. Otherwise, the generic name should be used.

For the second scenario (“BRAND NAME X has an indication in its PM, in combination with generic name Y. Could we have a header in an APS that says "BRAND NAME X + BRAND NAME Y" supported by the combined indication from BRAND NAME X's product monograph?), the answer is no, as per the principle outlined above (consistency with the authorized indication). We are also aware of cases where Drug Y does not have an authorized indication for combination with Drug X. If the question was intended to be in reference to guidelines, the above response (direct mention by brand name in the guidelines) would also be required.

Hello @tk2022

The feature of being phase 3b/4 does not in and of itself disqualify a study from either RWE or study duration.

Hey @sabrinab

Minimal changes such as those mentioned, would not void “direct pick-up”. We’d ask that you identify in the submission letter and highlight (versus shade) the specific instances. This can appear overtop of the shading. In this example it would not be considered direct pick-up. For efficiency sake, we’d ask that you identify the previously approved file, the content removed, and for extra support, providing the rationale can help.

Hey @copycallosum

It’s difficult to capture all aspects that may make this activity exempt versus an advertising/promotion system (APS) subject to pre-clearance review without seeing all the tools and how they are used.

The general response is that when you link advertising (APS) and non-advertising, everything becomes advertising (this is regardless of whether it is branded or unbranded). If HCPs are being encouraged to link disease state information to a consumer campaign, all aspects of the consumer campaign should be considered in the context of the dual audience (HCP and consumer). We’d suggest submitting for opinion as mention of management can be implicit or explicit and is broader than just mention of a product/brand.

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Hey @afpjjim

The principle to consider is in the “Dissemination” section of the document referenced. The copy reads “If the intent is for the email template to be used across many brands (and therefore not contain fair balance), the document naming convention should not trigger the addition of fair balance. This means that it should not contain claims or copy that links the brand to therapeutic use.” If the brand name appears in the piece and there is a study name, this would create that link (see Attachment of clinical reprints in an RTE). During the submission process, you would define the naming convention as “Study acronym_study_safety_data” and convey that studies across multiple brands could be attached in the same email. The reviewer would assess if indication and fair balance are required.