RMT/RMM presentation by MSLs
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Sorry @HollyMed this one slipped through the cracks.
Per the RMT guidance document, if the piece is intended to be detailed by a rep to an HCP, it requires going through the standard PAAB review process (i.e. the piece would be subject to all PAAB Code provisions relating to APS). Presentation of the safety data would be subject to the requirements of the PAAB Code. Give the above document a read and this Q&A and let us know if they answer is still unclear.
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Thank you for your reply @Jennifer-Carroll. The document and the Q&A were helpful. I think the difference in my question is that an MSL would speak to the piece instead of a sales rep. Since MSLs do non-promotional activity, I would think that it would be okay for an MSL to speak to the RMT. Regarding the study data about risks, I would think that would be okay too assuming the at the study explores the risks associated with the product and that the study results are presented non-promotionally and do not point to a perceived benefit.
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Hi @HollyMed
While this activity would be acceptable, the RMM/RMT requires PAAB review. MSLs are representatives of a company that has a vested interest in the health product. Having an MSL detail to an RMT renders the activity subject to advertising regulations. This amplification context differs from a reactive interaction, largely driven by the HCP, in which the MSL responds to an HCP’s one-on-one inquiries. As a reminder, Health Canada’s policy document “The Distinction Between Advertising and Other Activities” emphasizes that the determination of “advertising” versus “non-advertising/promotion” depends on the nature of the activity itself rather than on job titles assigned by the sponsor.
Regarding the second part, data presentations are not automatically compliant with advertising regulations simply because they pertain to risk. Compliance depends on multiple factors including (but not limited to) completeness, significance, context, and selectivity. Even data presented in a neutral tone can mislead if not balanced or contextualized appropriately. While the activity itself can be permissible, the slides require PAAB preclearance per the PAAB Code.
