Guidance for making a #1 dispensed claim
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What are the requirements for making a #1 dispensed claim? I understand the guidance here: https://www.paab.ca/resources/paab-guidance-documents-for-market-share-claims-in-advertising-/ for making the claim but when does the product lose the ability to say they are #1? If they are not #1 for 1 month but then regain the leader position the following month what does that mean for making the claim if they remained as the leader for the last 12 months?
Also, when a product loses the #1 position, what happens to all the marketing material currently in circulation? Do they have to be pulled from the field? -
What are the requirements for making a #1 dispensed claim? I understand the guidance here: https://www.paab.ca/resources/paab-guidance-documents-for-market-share-claims-in-advertising-/ for making the claim but when does the product lose the ability to say they are #1? If they are not #1 for 1 month but then regain the leader position the following month what does that mean for making the claim if they remained as the leader for the last 12 months?
Also, when a product loses the #1 position, what happens to all the marketing material currently in circulation? Do they have to be pulled from the field?@mimic909
As per the guidance document that was mentioned in the question (PAAB : Resources : PAAB Guidance Documents for Market Share Claims in Advertising), there are essentially 2 separate requirements to support a “#1 dispensed” claim. The first is a minimum absolute lead of 5% market share over all other products in the logical category over the most recent 12-month period. The second is that requirement #1 must hold true for each of the last 6 consecutive months. If, for example, the #1 dispensed drug product no longer meets requirement #1 the next month, then it loses this status and the timeline “restarts” for the requirement of “each of the last 6 consecutive months”.
For the second question, while a single recent month in which a product was not #1 would prevent approval for a future 12-month period, it does not necessarily render a claim to be presently false and misleading. We would need to assess the specifics in the case (whether it be in the context of a submission from the sponsor or a complaint from the manufacturer) to determine the appropriateness for the APS to remain in the field.
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@mimic909
As per the guidance document that was mentioned in the question (PAAB : Resources : PAAB Guidance Documents for Market Share Claims in Advertising), there are essentially 2 separate requirements to support a “#1 dispensed” claim. The first is a minimum absolute lead of 5% market share over all other products in the logical category over the most recent 12-month period. The second is that requirement #1 must hold true for each of the last 6 consecutive months. If, for example, the #1 dispensed drug product no longer meets requirement #1 the next month, then it loses this status and the timeline “restarts” for the requirement of “each of the last 6 consecutive months”.
For the second question, while a single recent month in which a product was not #1 would prevent approval for a future 12-month period, it does not necessarily render a claim to be presently false and misleading. We would need to assess the specifics in the case (whether it be in the context of a submission from the sponsor or a complaint from the manufacturer) to determine the appropriateness for the APS to remain in the field.
@jennifer-carroll Thanks for the clarification. How recent should the market share data be when submitting an APS to PAAB that contains a #1 dispensed claim? For example, if a #1 claim was approved on numerous pieces with expiry dates throughout the year, as each was coming up to expiry and being renewed through PAAB would we need new data for each renewal or would data from within the last 6 months be sufficient?
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@jennifer-carroll Thanks for the clarification. How recent should the market share data be when submitting an APS to PAAB that contains a #1 dispensed claim? For example, if a #1 claim was approved on numerous pieces with expiry dates throughout the year, as each was coming up to expiry and being renewed through PAAB would we need new data for each renewal or would data from within the last 6 months be sufficient?
@mimic909
Please see our guidance document on Retention and Market Share Claims and the P.A.A.B.: Supplementary Guideline for Market Share Claims in Advertising. Market share data should be the most current, since the various market factors that can impact market share are very dynamic. As such, the most recently-available data collected by an authoritative recognized independent source that is reflective of the Canadian market place should be used at the time of renewal.
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@mimic909
As per the guidance document that was mentioned in the question (PAAB : Resources : PAAB Guidance Documents for Market Share Claims in Advertising), there are essentially 2 separate requirements to support a “#1 dispensed” claim. The first is a minimum absolute lead of 5% market share over all other products in the logical category over the most recent 12-month period. The second is that requirement #1 must hold true for each of the last 6 consecutive months. If, for example, the #1 dispensed drug product no longer meets requirement #1 the next month, then it loses this status and the timeline “restarts” for the requirement of “each of the last 6 consecutive months”.
For the second question, while a single recent month in which a product was not #1 would prevent approval for a future 12-month period, it does not necessarily render a claim to be presently false and misleading. We would need to assess the specifics in the case (whether it be in the context of a submission from the sponsor or a complaint from the manufacturer) to determine the appropriateness for the APS to remain in the field.
I had a follow-up question regarding the 2 requirements needed to support a “#1 dispensed” claim:
What is the minimum amount of time that a competitor product in the same category needs to be available in Canada (i.e., NOC received) before a “#1 dispensed” claim would be considered acceptable? (Assuming all other requirements as per the Guidance document were met).
Would it be acceptable to make such a claim if all other product(s) in the same category received NOC less than 12 months ago?
Thank you!
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I had a follow-up question regarding the 2 requirements needed to support a “#1 dispensed” claim:
What is the minimum amount of time that a competitor product in the same category needs to be available in Canada (i.e., NOC received) before a “#1 dispensed” claim would be considered acceptable? (Assuming all other requirements as per the Guidance document were met).
Would it be acceptable to make such a claim if all other product(s) in the same category received NOC less than 12 months ago?
Thank you!
Hi @vt,
This appears to be about a specific product and class. We would assess on a case-by-case basis considering the totality of the market. In these instances, we suggest going through the review process.
