Clarity on RMT PAAB guidance

[kshulist]

Hi there,
I'm looking for a bit of clarity on the PAAB "Guidance on RMTs" document, specifically on page 4, the first FAQ. (https://www.paab.ca/Guidance_on_Risk_Managment_Tools_(September_2016).pdf),

For context, the FAQ says:
What if the manufacturer plans to:
-Instruct/train drug representative to detail from the RMT during a sales call in order to make sure HCPs consume this important content?
-Include product claims and statements of benefits in order to establish balance in the tool?
Answer: The piece would simply be subject to all PAAB code provisions relating to APS and to standard review times.

I have two questions. The first is, do both of those bullet points have to apply for the piece to not be considered a RMT? For example, say the piece is intended to be detailed to HCPs by the reps, but they do not plan to include any claims/benefits - is it still subject to all code relating to APS or could it be submitted as a RMT?

My second question is related to the text "during a sales call" - what if the rep specifically sets up a separate RMT-related call (i.e., not a sales call), is this case, is the piece still subject to all code relating to APS or could it be submitted as a RMT?

Any help would be much appreciated! Thank you very much!

[Jennifer Carroll]

Good Morning @kshulist

The two bullets are not both required in order to be subject to the Code. If the rep is using the tool to detail, or claims/benefit copy is included, it would fall under the scope of the PAAB Code. Paragraph four on page one of the above-mentioned document states:

The purpose of RMTs is to convey important identified risks, important potential risks, and missing information about a manufacturer’s products. They do not contain claims of benefit as these tools are created solely with the aim of minimizing / managing / mitigating risk. Although distribution of such tools need not be in response to unsolicited requests, they are NOT intended or destined for promotional activities/uses and may not be used in such ways unless they undergo standard PAAB approval.

Labelling the call an RMT-related call would not be sufficient to allow for detailing of the RMT tool. Please see Code section 1.8d.

[kshulist]

@jennifer-carroll Thanks very much for clarifying!