403 - Are the presentations/slides of our medical directors subject to PAAB review? Under what circumstances can our medical director or medical scientific liaisons provide learning programs? Must it be a solicited request for education?
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Please read this answer in the context of the Health Canada policy document “The Distinction Between Advertising and Other Activities”. Whether materials/activities fall in the advertising realm is multifactorial. An individual factor (e.g. having the title “Medical”) does not in and of itself eliminate the potential for materials/activities to be subject to the advertising provisions. When applying the principles of the aforementioned Distinctions document to presentations created & delivered by medical, it is helpful to incorporate the marketing concept of “push” vs “pull” into your thought process. Imagine that the information is a physical package. This package initially resides with the manufacturer. Is that package pulled by the HCP from the manufacturer (by a request that has not been solicited in any way by the manufacturer) or, is that package pushed by the manufacturer onto the HCP? Consider that analogy as you read the following scenarios: Scenario 1: Informational slide decks prepared by a pharmaceutical company’s medical department (or equivalent) which will be provided to HCPs only in response to unsolicited request are not subject to advertising provisions (and PAAB preclearance). In order to remain exempt from the advertising provisions and PAAB preclearance, the provided content must be limited to that which was requested (i.e. such that additional content is not “pushed” to accompany the requested/pulled content) and the content/tone must be non-promotional. Scenario 2: Similarly, if a particular institution makes an unsolicited request that staff from the manufacturer’s medical department (or equivalent) delivers an informational presentation for that institution’s staff, the presentation is not subject to advertising provisions (and PAAB preclearance). This is true even though the content is shared with an audience rather than an individual; however, that audience is exclusively comprised of staff/members from the institution mandating the session. Again, in order to remain exempt from the advertising provisions and PAAB preclearance, the presented content must be limited to that which was requested (i.e. such that additional content is not “pushed” to accompany the requested/pulled content) AND the content/tone must be non-promotional. Note that the non-advertising status would be compromised by incorporating or linking to promotional content/activities. Scenario 3: If the manufacturer were to hold a session and invite HCPs to attend (i.e. manufacturer is “pushing” content/materials), the slidedeck would require a PAAB submission even if created and presented by staff from the medical department. The same would apply if the presentation is prepared by and/or conducted by an external health care professional on behalf of the medical department at an unaccredited event. Note that there are additional industry ethics standards codes and HCP association (e.g. CMA) considerations to keep in mind in this scenario. Bottom line, is that the 7 factors listed in the Health Canada policy document “The Distinction Between Advertising and Other Activities” must be considered. Given that no single factor alone can determine whether material or activities are subject to advertising regulations, the fact that the creator and/or deliverer of the presentation is from medical or is an HCP does not necessarily exempt the materials from the advertising regulations. It is important to consider aspects including (but not limited to): *Content (e.g. is there drug discussion – particularly with respect to areas in which you have a vested interest? Tonality of the messaging? Is it balanced?…etc) *Context of dissemination (e.g. to pick to poles of a spectrum: is this a promotional meeting? Is it an accredited CME event? It clearly does not sound like accredited CME if you are selecting and paying the speaker and setting the agenda) *Audience (e.g. an institution that requested and internal session Vs an audience invited by the manufacturer. It is your event therefore you are the sole entity inviting people so you are selecting/influencing the make-up of the audience) Who delivers the message (e.g. internal sales rep vs medical staff? External HCP?) *Frequency (e.g. are you sending this HCP on a speaking tour across Canada to deliver this message?) *Sponsorship (i.e. this presenting/meeting is occurring due to your sponsorship. In fact this specific event would not have occurred without it. Even if another manufacturer would have held a session in your place on the same day, the agenda might have differed, the speaker might have differed, the audience would have differed) *Whether influence comes with that sponsorship. Note that influence can be direct (as in the case of editing rights, selecting the agenda) or indirect (as in the case of the manufacturer selecting the particular external HCP, influencing the audience which may impact ensuing discussion). Any influence, whether direct or indirect, must be considered when it is exerted by an entity which has a vested interest in particular drug products *If you have any additional questions, please call the PAAB office.
