SUPPLEMENTARY GUIDELINE FOR MARKET SHARE CLAIMS IN ADVERTISING

We are pleased to distribute the attached supplementary guideline for market share claims used in advertising subject to PAAB review. The guidelines have come into existence because IMS has informed the PAAB that they will no longer validate advertising claims based on IMS data.

The principles are not new. The guidelines are a written compilation of previous practice and we have consulted with the PAAB stakeholders, selected companies and the two major pharmaceutical market share data companies in Canada.

Please distribute these guidelines to your colleagues. They are also available on the PAAB website www.paab.ca

If you have any questions about the guidelines please call the PAAB office at 905-509-2275.

SUPPLEMENTARY PAAB GUIDELINE FOR THE REVIEW OF MARKET SHARE CLAIMS IN ADVERTISING

These supplementary guidelines have the same status as explanatory notes to the PAAB Code of Advertising Acceptance, and are intended to clarify the application of the PAAB Code within this category of non-clinical market share claims.

• The guidelines apply to all market share claims regardless of the source and sponsors must also adhere to market research company guidelines. Market share claims must be based on an authoritative recognized independent source that is reflective of the Canadian market place.
• Market share claims must refer to the sponsor's own products and may cite data that references its own products. A company may not cite statistics that pertain to other individual products or companies in an unfair and disparaging manner.
• Comparisons must relate to products within the same category and must not be selective with regards to individual products.
• Market share claims must accurately reflect the findings of the source and the appropriate wording must be used.
• Product claims must be based on product-specific data and may not be extrapolated from ingredients or components of a drug.
• Market share claims are based on non-clinical parameters and may not imply any clinical significance. A disclaimer may be required such as "Comparative clinical significance has not been established". Market share data are not accepted as reference to support claims referring to medical practice, such as "recommendation", "preference" or "choice".
• Sponsors must adequately reference the data source (i.e. identify specific service, the measured parameters, the appropriate universe used, the time period measured and any proprietary acknowledgement).
• For claims of market position, such as "leader" within a logical market definition, there must be a minimum lead of at least 5% (absolute) over all other products in the same category during the most recent 12-month period and during each of the last 6 consecutive months.
• For "fastest growing" claims, there must be a minimum growth of at least 5% (absolute) over all other products in the same category during each of the last 6 consecutive months and the product must have been on the market for at least one year.
• For claims including the phrase "most", the pharmaceutical product should have the majorityof the market share defined as more than 50% (based on the last 12-month period).