46 - As a follow up to Question 45, if the off-label content of a peer reviewed journal article is not the focus and will not be discussed by the rep, can a disclaimer be added indicating that the product should not be used off-label, any off-label content is not applicable in Canada and to refer to appropriate product monographs?

  • Yes, that would be an option if you meet all of the Health Canada guideline requirements. You can provide it in a complete manner, you should not promote the contents.

    This is verbatim from the Health Canada Policy:

    "Dissemination of full, unedited reference texts (textbooks, chapters of textbooks), government publications or reprints of published, peer-reviewed articles from medical or scientific journals, that are identified as being provided courtesy of a pharmaceutical manufacturer, may be a nonpromotional activity provided that:

    • no link between the text and promotion of a drug is established by the manufacturer.
      Such material may be considered to be advertising where the aforementioned condition is not met or where other factors indicate that the primary purpose is to promote the sale of a drug, for example:
    • the material is accompanied by any form of additional information (e.g., printed, word of mouth) designed by or on behalf of the manufacturer for the purpose of promoting a drug (e.g., detail aid),
    • the material was written or edited by an employee or agent of the pharmaceutical manufacturer,
    • a summary or interpretation of the text prepared by the pharmaceutical manufacturer or his agent accompanies the material,
    • reference is made to the availability of an unauthorized drug through the Special Access Programme."