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Picture this – your company is about to launch a new pharmaceutical brand in Canada!
Your Canadian brand team has just received global marketing material and are now tasked to adapt it for the Canadian market. However, upon reviewing the material against the Canadian Product Monograph (PM), the brand team has flagged that the PM doesn’t provide adequate support for the claims suggested by the creative, the secondary endpoints that have been featured, or the mechanism of action (MOA) language that resonated in global market research.
Once the Pharmaceutical Advertising Advisory Board (PAAB) has reviewed these pieces against the PM, the creative intent will be compromised, the secondary endpoints will be eliminated, and MOA messaging will not be included.
What could have been done differently?
Given the importance of the Product Monograph – it fully represents the extent of what you will be able to include in your marketing material – we cannot stress enough how important it is for your entire brand team, specifically your marketing department, to review the draft Product Monograph through a marketing lens. PAAB will always hold the Product Monograph as the golden standard. PAAB refers to the “TMA” or Terms of Market Authorization, which are comprised of all labeling information (e.g., PM, prescribing information, inserts, etc.) that accompanies the Notice of Compliance (NOC) and/or in the document that assigns a Drug Identification Number (DIN), Natural Product Number (NPN) or Drug Identification Number for Homeopathic Medicines (DIN-HM) and any related labelling material for health products. Even if the Product Monograph contradicts the New England Journal of Medicine’s published version of the key pivotal trial(s), the Product Monograph will always have the final word: what it says, defines what you will be able to say, in more ways than you might expect.
Take home message – marketing should always have a seat at the table!
At every opportunity prior to NOC, engage Marketing – ideally with the support of an experienced marketing agency – to review the Product Monograph against the “must-have” key selling messages. Together, you can make sure the indication is worded appropriately. Fight to include that quality-of-life data or other relevant key secondary endpoints. Specifically word that MOA section to highlight the key features of the drug. Even review Part III of the Product Monograph to ensure that the attributes your team would want your patients to know about can eventually be included within the patient brochures. Once that Product Monograph is finalized, the die is cast, and that document represents what can or cannot be said in all Canadian marketing material.
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Stay-tuned for a future article about medical-related challenges.