367
Where in the code does it stipulate the requirements for communication between Health Care Professional to Health Care Professional?
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Voir réponse [+]
The scope of the PAAB code is described in section 1 of the code. Most of the provisions throughout the PAAB code apply to drug advertising which is directed to HCPs. The provisions apply regardless of whether the advertising is distributed directly from the manufacturer to the HCP or through an intermediary. For example, advertising which a manufacturer arranged to have presented by an HCP to other HCPs would not be exempt from PAAB review. Please keep in mind that some healthcare professional codes prohibit "Peer-selling" (though there is no such provision in the PAAB code). Also note that while the scope of the PAAB Code covers messages to HCPs from drug companies, the Food and Drugs Act covers all healthcare product advertising to all audiences.
366
If the product is in a therapeutic area where we cannot use IMS data because of market definitions, can we use patient chart study or any other form of study to show our performance in the market. Are there specific guidelines on sample or methodology?
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Voir réponse [+]
This sounds like a case I have not encountered before. Please call me at the office so we can discuss as I'll need more background information. Thanks, Patrick.
365
Are reports published from unaccredited CME events (ie. symposia) subject to PAAB approval?
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Voir réponse [+]
Please refer Q&A #350 and #129 for relevant excerpts from the PAAB code and the Health Canada policy document "The Distinction Between Advertising and Other Activities". Ultimately, the answer to your question is another question. Is the report drug advertising? If so, yes the report is subject to the advertising regulations in the Food and Drugs Act, the Food and Drug Regulations, and the PAAB code. If the report is not advertising, the answer to your question is no.
For example, the report is likely advertising if the manufacturer exerted any direct or indirect influence over the event or the report's creation (e.g. selecting author, input on scope, review of contentÂ…etc) and the report either emphasises or favours this manufacturer's products (or the classes in which this manufacturer has a vested interest). Feel free to use our written opinion service for an opinion on your specific report (see the fee schedule on our website).
364
Hello, Can text from Part III/Consumer Information of a PM be used as a reference within and HCP directed piece? For example, if we were to define patient types that a product is indicated for and use the language defining such patients from Part III, would this be acceptable in HCP directed materials?
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Voir réponse [+]
For an HCP targeted piece, disease information defining the patient type(s) in which the product is indicated may not come from part III of the PM. For example, the content in Part III is not intended to inform the prescriber (or other HCP) about the breadth/scope/definition of the indication, related outcomes or subpopulations. This information must come from Part I of the PM (specifically the Indication and Clinical Use section). Canadian consensus guidelines can be used to elaborate on place in therapy within the indication parameters set in part I of the PM.
363
Can you please remind me of the rules related to printing and distributing your product monograph? I believe you can reprint it exactly as is and to do so would be PAAB exempt. However, if you add a cover with your brand identity, your logo and indication statement(s), yet no claims, is that now classified as a "commercial" PM and thus requires PAAB review? Or is it only if you make a claim on a branded front cover? TIA
362
Are poster presentations in medical conferences acceptable as a reference for promotional materials?
361
Has there been any code infraction of late that you can share to us? And what does PAAB do about it?
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Voir réponse [+]
The stage 2 complaint decisions are published in our quarterly newsletter. Refer to the January 2014 newsletter for a report on the entire year of 2013. The January, April and July newsletters are also available for 2014 statistics.
All PAAB quarterly newsletters can be accessed here: https://www.paab.ca/resources.htm#category=Newsletters-/-Blogs&category_id=4
Note that we only publish information about stage 2 complaints. Code infractions discovered in Stage 1 complaints, monitoring notices, and the review process are confidential.
360
A client wishes to produce some material that will be strictly used by their medical team (i.e. MSLs, Med Affairs, Medical Education Specialists). It will contain product efficacy outcomes that will be balanced with safety and AEs, and thus will be strictly used in a non-promotional manner. The piece itself will meet the requirements of Health Canada as NOT being advertising, but they wish to have a PAAB exemption letter.
QUESTION: Looking at section 6.6(iv) of the code, one of the exemption scenarios involves: Use of drug name only in a context not linked to therapeutic or promotional messages, other than those listed in in any way. Could you clarify what 'therapeutic message' entails? Would efficacy charts be considered a therapeutic message?
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Voir réponse [+]
Creating and distributing materials through the medical department does not automatically render those materials exempt from the advertising regulations. Even when the materials are created and distributed solely through the medical department, it is critical to pause and reflect on whether the content is subject to the provisions in the Food and Drugs Act, the Food and Drugs Regulations and the PAAB code. The Health Canada policy document "The Distinction Between Advertising and Other Activities" is a valuable tool in determining whether the materials are subject to the advertising regulations. PAAB code s6.6 speaks to exemptions from PAAB review while PAAB guidance document "Guidance on Which HCP Materials Require PAAB Review" (see: http://www.paab.ca/resources/pdfs/Guidance-on-which-HCP-materials-require-PAAB-review.pdf) provides additional help in distinguishing between what requires PAAB review and what doesn't.
From the sounds of it, the piece you are describing would only be exempt if used by the medical team in response to unsolicited requests. From the provided description, the piece would be subject to the advertising regulatory provisions (and preclearance) if used proactively. It sounds as though it is about the benefits and risks of the manufacturer's product. PAAB approved advertising is balanced with respect to risk and benefit also (i.e. this alone does not make it non-advertising). Yes, efficacy charts would be considered clinical messages. Please call if you have any questions.
359
Referring to PAAB Code 6.5.4 - The sponsor may link to corporate global sites only by linking to the global site home page. The sponsor should not link to the global site product pages or sections.
Please confirm if we can link to the homepage of our Corporate website for Canada (.ca) or do we have to link to the global site (.com)?
Lastly, our source for product monographs is our local corporate website. Please confirm that we can link directly to our product monograph from our promotional websites for quality control.
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Voir réponse [+]
Yes. HCP gated websites can link back to the corporate website for Canada (.ca). Yes you can link directly to the PM which happens to be housed on the corporate site from product branded HCP pieces in order to satisfy the PAAB code s7.3 requirements.
Note that, based on direction from Health Canada, the product branded pre-gate portions of prescription drug websites must not contain a hyperlink or URL to a corporate website containing product monographs. This is true even though, when taken separately, the pre-gate section of the branded site (reminder ad) and the corporate Web site (corporate message) are compliant. Health Canada considers the link between the two to exceed the restriction set out in Section C.01.044 of the Food & Drug Regulations.
Also note that the same principle applies to non-prescription products which are indicated for the treatment of a schedule A disease (per the restrictions set out in Section 3 of the Food and Drugs Act).
358
Can you please advise what is required to substantiate a market share claim for a prescription product (i.e. will IMS data suffice)? How long must a market leadership position be maintained in order to make such a claim? How long is the claim valid?
