Clinical Paper
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It is my understanding that a pharmaceutical manufacturer is responsible for the clinical papers that a Rep has access to i.e., in their bag or on their iPad. If nothing is being done to change or enhance the clinical paper in any way (to brand it as an example) then the clinical paper does not need to be sent to PAAB and the manufacturer takes responsibility for the papers that a Rep holds. Please confirm.
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@jennifer-carroll Many thanks
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@jennifer-carroll Thank you for taking the time to explain the nuances! Just to have clarity, this is how I interpret your answers:
- Needs to be in a peer-reviewed journal, complete and unmarked
- Needs to be consistent of Marketing Authorization
- Can be review papers, disease state papers, sub studies of phase 3 trials in line with the marketing authorization
- If used by sales, papers should not be used as detail aid, or combined with any detail aid, but can be discussed reactively and not distributed.
- Needs to respect the PAAB code, sections that you mentioned, although these pertain more to APSs, so I assume a lone-standing peer-reviewed paper is in alignmnet with this.
Thank you!!
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Hello @zsivo
It’s important to remember that the forum responses are written as general responses to general questions. Responses should not be viewed as an exhaustive explanation of the code and regulations. The above summary is not complete or exhaustive. We would suggest reviewing the questions and responses provided above in their entirety.Please note that bullet point three is inaccurate and does not reflect guidance in 175 or 419.
For bullet four, we’d note that a sales call is an advertising activity, regardless of a “reactive” discussion to a distributed paper. As a reminder, the Health Canada Guidance on distinction between advertising and other activities for health products states that for “Responses to inquiries,” the information provided to an individual or organization about a health product by a manufacturer in response to a request for information may be considered promotional if the inquiry has been encouraged in any way by the manufacturer of the health product or the response to an inquiry regarding unauthorized products or indications (off-label) is communicated by sales or marketing personnel.
For bullet five, per Q&A 419 “Although rep activities do not fall under the PAAB code, advertising/promotional systems (APS) are indeed covered by this code. This means that although a published and peer reviewed clinical trial which has NOT been modified in any way wouldn’t require preclearance, using the study as a rep detailing tool would render it subject to the provisions in the PAAB code.” One should not assume that all lone-standing peer-reviewed papers are aligned with the Code.
