593

We would like to do an unbranded piece based on treatment guidelines. There are no Canadian treatment guidelines for this disease. Can we use a European guideline (not for a particular country but from a European society (endorsed or recognized by an authoritative medical body)? Can we use two guidelines together, the European and the US guideline? If some of the products are not authorized in the same way in Canada as recommended in the guidelines, should we not mention that use or we should clarify that is not the way that is indicated in Canada? Thank you for your help.

For place in therapy and treatment goals we look first to Canadian consensus guidelines, to ensure consistency with current Canadian medical opinion. (s3.2) In the absence of Canadian guidelines we can consider US or North American guidelines. In the absence of those, we can consider international guidelines. When an international guideline is being submitted, we require authoritative support that the International guidelines are endorsed by a recognized Canadian health professional organization representing this therapeutic area.

In the scenario described above where guidelines lower in the aforementioned hierarchy are being used over the available US guidelines, evidence must be provided to support that these guidelines are a true reflection of Canadian practice. A letter from the recognized Canadian health professional organization for the particular therapeutic area is required to clearly support that the international guidelines are endorsed and more widely used by Canadian HCPs than the recent American guidelines (i.e. An official statement from the organization (not a personal letter from a KOL) on official letterhead demonstrating that it has been vetted by the entire group).

With respect to off-label content, guidelines cannot be used to support advertising content which extend beyond a product’s monograph, even in unbranded advertising. Off-label uses should not be mentioned.

593

Laisser un commentaire

Votre adresse e-mail ne sera pas publiée.

5 × 3 =

Retour en haut