In 7.1.2, regarding retaining a stakeholder to do speaking/chairing meetings, etc —- slides/presentation of this stakeholder is not subject to PAAB review? Please confirm.
For everyone else’s sake, you are of course referring to section 7.1.2 of the Rx&D code. Not 7.1.2 of the PAAB code. I won’t speak to or clarify the Rx&D code, but I will respond to whether materials used in speaking events (e.g. slides, handouts) require PAAB review. I believe this is what you are asking.
The answer to your question hinges on whether this is advertising or not. If it is advertising, the materials are subject to the advertising regulations and PAAB review. To demarcate between advertising and non-advertising, 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 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
Note that there are additional important Rx&D code and HCP association code (e.g. CMA) considerations to keep in mind in this scenario.