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What is the equivalent of product monographs for NHPs? Is it the Product Label , the Product Insert, or the Evidence Summary Report that we are submitting to Health Canada? For instance, if we want to include some precise figures in the promotional material for HCPs, do we need to include them in the Evidence Summary Report? Also, to obtain the right to have a graph or a table in the promotional material to HCPs, is the mention of the figures enough in the document that acts as an equivalent to the Product Monograph, or do we need to include also the graphs/tables?
Generally, it is a Product License. The evidence summary report is not accepted as support for claims in NHP advertising. Issuance of license to sell the product in Canada does not necessarily mean that Health Canada has approved all statements in the report. We’d need evidence that Health Canada approved the claims you’d like to use in NHP advertising.
On an unbranded, consumer-facing, disease state website, it is permissible to discuss differential diagnosis? As in, could you "compare" the symptoms of the website condition with another, similar condition with overlapping symptoms?
I’ll presume you are referring to a help-seeking message or consumer brochure meeting all applicable requirements of the Health Canada policy document “The Distinction Between Advertising and Other Activities”. In that case, the answer is yes provided that the way you’ve executed the differential diagnosis does not render the piece to be advertising (e.g. does not favour or add emphasis to the sponsor’s product in a consumer brochure)
Can you please clearly define what is meant by a non-clinical claim? Non-clinical claims can include anything from IMS data (#1 prescribed claims), dosing, administration and quality of life. How do these fit under one umbrella?
Sorry. I don’t quite follow your question. The listed claim types do not fall under one claim-type umbrella. Are you trying to grasp the level of evidence required for any given claim or the level of safety disclosure required? Might be more productive to discuss your question over the phone. Please give me a call.
Hi PAAB. Do communications sent in the context of a patient assistance program need PAAB preclearance? here is the situation. we have a patient assistance program for which we would like the vendor to use a standardized and automated system to communicate information pertinent to patient's enrollment status, notifications regarding reimbursement investigations, reminders of missing information to proceed with the service etc... The issue is that all of our Patient assistance programs are named after the therapeutic area (XYZ-Onclogy; XYZ hep C, XYZ HIV...) and within the body of the letter we have to specify the name of the product for HCP to know which product the communication is related to. These communications begin after a physician has made the decision to prescribe the product and decided to enroll his patient into the program either for reimbursement investigation or compassionate drug provision. We were wondering since we want the communication to be standardized (create template with blank space to be filled with the patient's name or initial and appropriate identifiers) and send through an automated system, and since the designation of the program mentions the indication (hep C for instance) and the body of the letter has the name of the product, do we need PAAB preclearance or would these type of communication be exempt as per PAAB code. thank you.
Yes, these piece fall within the scope of PAAB preclearance.
Hello, I would like clarification on how efficacy data and mechanism of action data can be presented together in a promotional piece. My understanding is the MOA is considered non-clinical and therefore must be physically separate from efficacy or clinical claims. Is this assumption correct? I am not sure why this would be. Can you please explain why I cannot mention how a product works and how well it works together in a page? Thank you,
Correct. Clinical and non-clinical messages must appear as separate and distinct presentations so as not to suggest associations between both messages which have not been substantiated. This does not necessarily mean that the information must be presented on separate pages. Your reviewer would be able to explain how to present these messages on the same page while still keeping them separate and distinct. Note though that this may require significant revisions to the page layout which might ultimately compel you to simply present the information on different pages.
Can the "Summary Basis of Decision" from Health Canada be used for advertising claims?
Yes. Provided the content referenced from it is not inconsistent with the product monograph.
We currently have an APS submitted for PAAB review. We have experienced a delay in the project and we may not be able to respond to the last PAAB letter that we received for another 4-6 months. Is there an expiration on how long an unapproved e-file will stay open within our "Submissions" portal for PAAB to receive a response?
Yes. 6 months.
Health Canada's policy "The Distinction Between Advertising and Other Activities" states that materials emanating from a parent company presented during an International conference would not require PAAB review, provided that they are only used within the confines of the conference and are prominently identified as "not being authorized for sale in Canada". However, when a product presented in a promotional booth is approved in the US and in Canada as well, if: - all the material clearly specifies that all the information comes from the US labelling/Marketing Authorization, and - the target audience is from the US and not from Canada, even though some Canadian HCPs could be attending, will this be still considered as promotional activity in Canada and require a pre-clearance form PAAB?
No. The Canadian advertising regulations (including the PAAB code) do not apply to materials presented at international conferences as long as ALL of the following provisions from the Health Canada policy document “The Distinction Between Advertising and Other Activities” are adhered to:
Note, that the disclaimer must be modified in your case as the product is indeed authorized for sale in Canada. I elaborating a bit on the disclaimer you are proposing in your question. Specifically, I suggest prominently conveying that all the information comes from the US labelling/Marketing Authorization AND that this information is not consistent with the Canadian labelling/Market Authorization.
We are sending an announcement to HCPs informing them that a product is now covered on the provincial formulary and providing the the reimbursement criteria. My questions are: Are we required to include the reimbursement criteria? What level of fair balance is required?
The coverage criteria is required when the advertisement includes details relating to coverage (such as formulary codes or eligibility criteria). Note that the presentation should be complete e.g. inclusion criteria, exclusion criteria, definitions, notes, etc. where applicable. This is indicated in the following PAAB advisory:
http://www.paab.ca/resources/pdfs/declarations.pdf
For pieces discussion provincial coverage in Quebec, you are required to disclose the criteria in ALL pieces that mention or alludes to the indicated use (even if a coverage codes or details are not provided). This is a request from RAMQ as per the following PAAB advisory:
http://www.paab.ca/Advisory_regarding_use_of_RAMQ_in_APS.pdf
Lowest level fair balance (and the indication) generally satisfies the safety disclosure requirements provided the stated coverage criteria do not include claims requiring middle or highest level fair balance as indicated in the following document. See the following link for tips on matching the fair balance level to the claim types presented in the piece:
http://www.paab.ca/Tips_and_checklist_for_creating_and_selecting_fair_balance_(October_2015).pdf
Commercial employee asked a presenter AFTER presentation at a scientific conference why DRUG X has not been included in his presentation. DRUG X has not yet been approved by Health Canada but belongs to the employee's company pipeline. DRUG X efficacy/safety properties have not been discussed. Does this interaction constitutes off label promotion?
The PAAB code applies to advertising materials. The code does not cover questions asked during a live exchange of medical information. Nonetheless, it would appear prudent to instruct your commercial employees not to ask public questions (or provide answers) during sessions involving scientific exchanges of information in order to avoid the perception of promotion. The speaker could be trained to respond with something along the lines of “Because drug X is not indicated for condition Y” if a commercial employee from another manufacturer where to ask this question.
I can’t imagine an issue if the employee asks the question privately after the session (i.e. one-on-one between employee and speaker).
Jennifer Carroll
Réviseur principal en communications
Le Conseil Consultatif de
