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We would like to know if we can make a claim about the % of patients who would recommend a specific treatment to other patients. The % is published in a retrospective study done on patients who were taking this specific therapy. It is a patient reported outcome that is not in the Product Monograph. Please advise if there is any way to put such a claim through.
References used to support treatment recommendations in drug advertising should be based on Canadian Consensus Guidelines, as treatment recommendations should be consistent with current Canadian medical opinion and practice. A retrospective study reporting patient opinion would not meet these rigors. (PAAB code section 3.2)
Hi PAAB, Section 1 of the Code provides that it applies to APS directed to HCPs (as well as patient information distributed via HCPs). Corporate websites target consumers rather than HCPs. However, it seems that PAAB considers corporate websites presenting information on the company's products as corporate APS (s. 7.4 of the Code) that must be submitted to PAAB. Does it mean that the Code also applies to material that does not target HCPs? If the corporate website presents general information on a disease or a class of products, does it need to be submitted to PAAB or would it be considered as DTCI? Thank you.
A non-gated corporate website is intended for the general public and would be subject to the consumer federal regulations, not the PAAB code (assuming that you are not somehow linking HCP advertising to particular pages of the corporate site other than the home page). The PAAB offers an opinion service for DTC pieces including institutional messages. The Health Canada document "The Distinction Between Advertising and Other Activities" is used as the basis of this assessment.
A consumer facing institutional message is a communication which provides information about a pharmaceutical manufacturer concerning topics such as its philosophy, activities, and product range. There must be no emphasis on one or more products. The central purpose must clearly be to inform broadly about the institution rather than its products.
If the corporate message is directed at Healthcare professionals, PAAB Code section 7.4 should be applied.
Could you please clarify the formulary message for the province of Québec. If a company mentions the following message: “Drug X: Now on RAMQ formulary (médicament d’exception code)” and not linked in any way to additional product messages or disease/corporate messages. We would not allude to the indicated use and will add the RAMQ TM. Is the above mentioned text still PAAB exempt or not. Are we in the obligation in Québec to provide code and coverage criteria every time we mention RAMQ reimbursement (then subject to PAAB). I have read the information on the PAAB website, but still having different interpretation/confusion on this. • Memo dated April 15, 2016 - Advisory regarding use of Régie de l’assurance maladie du Québec (RAMQ) in APS • PAAB ADVISORY guidance on Provincial Formulary Coverage Statements • Q 519 in the Ask PAAB section
The formulary message above is exempt from PAAB review. There is no obligation to provide a formulary code or coverage criteria, as long as the statement is not linked to a therapeutic message or the products indicated use. However, if formulary code and/or coverage criteria are included, then this message is subject to PAAB review.
Based on advisory board recommendations for supportive tools, a company would like to create an unbranded "reference tool" which documents the metabolic pathways for drugs in a particular therapeutic area. This would be a service item distributed by the representatives. Information would be taken primarily from Product monographs and in a few cases, the literature. Is there any reason this would not be allowed? what would be the constraints?
It is feasible to create a piece which includes a side-by-side comparison of product properties such as metabolic pathways. These comparisons are reviewed based on section 5.10.2 of the PAAB code which specifies that the information must be from the individual Product Monographs, we would question the use of other sources for this type of comparison. We caution that the presentation should not imply comparative clinical significance, and must be complete, in that other data relevant to the presentation also contained in the Product Monographs must not be omitted. This is also critical when creating an unbranded (i.e. editorial) tool as the piece must contain objective and balanced information with no emphasis on information about the sponsor’s product. We caution that selectively choosing a product property/feature (e.g. metabolic pathways), which may create a comparison that is beneficial to the sponsor’s product will not be acceptable in an unbranded context. A good rule of thumb is, if you can identify the sponsors product based on the information presented, then it is not an editorial (s. 7.5).
If an advertiser is looking to target an ad to healthcare professionals, what is the accepted definition of "healthcare professional" and how strictly enforced by Health Care Canada is the requirement of that targeting?
For the purposes of the PAAB code, a healthcare professional is defined in s11 as licensed members of the professions of medicine, dentistry, naturopathy, homeopathy, nursing, pharmacy and other related disciplines. I am not sure what you mean with regards to enforcement of targeting requirements by Health Canada. The sponsor must ensure that there is a mechanism to prevent secondary audiences from accessing the content which exceeds the restrictions for consumer materials (i.e. HCP content must be restricted to HCP audiences). This can be done through controlled distribution of the content or, in the context of materials accessed through the internet, a gating mechanism.
Can we develop a sales aid where the user can select specific topics (efficacy, safety, cost) and then present these to a physician? The concept is to create a custom presentation based on the needs of the physician. So if a physician only wants to hear about efficacy and cost, those would be the only sections to appear. This would be like adding tabs to a print sales aid but since digital, we can create the sections that will appear based on the customers need
To accomplish this, the e-detail tool would need to be separated into a core deck (which includes at least the indication & FB). The core deck would be intended to always be presented. The rest of the content would be separated by the client into expansion decks. The core deck and each expansion deck are submitted as separate files. The expansion decks would be reviewed with the understanding that none, some, or all of those decks may be presented in any sequence but always after the core deck. i.e. review judgements will be made with this flexibility in mind. For more info see Q&A # 307 & 198.
I realize that ads with only name, price, and/or quantity are considered exempt. If I was to compare the price of Drug X to Drug Y, and have a statement that said "Drug X offers a __% savings vs Drug Y", would this be considered promotional and render it non-exempt?
PAAB code section 6.6iv addresses what is considered exempt. It states that “company price lists containing no therapeutic claims, price comparisons or claims of company or product merit, status or issues” are exempt. As a claim of “offers savings vs a competitor” would be viewed as a price comparison, this message would not be exempt.
As follow-up to Questions #291, #328 and #500, would medical device (class II)-sponsored advertising be subject to PAAB review, if comparisons were made between the medical device and a non-medical (drug-containing) device?
It is our understanding that you wish to compare features of a drug-delivery system for a class II medical device and a drug-delivery system which is not classified as a medical device. The latter cannot be presented as a stand-alone device, but must be presented in the context of the drug & device. Although it may be possible to make non-therapeutic comparisons of the device features, the content is subject to the PAAB code provisions.
Exactly when does a 'consumer' become a 'patient' -- is it the point at which they receive a prescription for a specific brand, or when they are dispensed a specific brand? In certain therapeutic categories (eg., epinephrine, insulin), patients receive a prescription for the molecule, which can be associated with multiple brands. At this point before a specific brand is selected, is it permissible for an HCP to expose the 'consumer/patient' to branded material, in order to facilitate brand selection? This scenario assumes that all brand options would contain the identical active molecule.
A patient is someone who has been instructed to take a healthcare product (e.g. someone prescribed a product) or someone for whom the HCP is considering providing such instruction and deems it appropriate to provide information about the product. It is the role of healthcare professionals to distribute health and treatment related information to patients. Given a scenario where multiple brand products contain the same active ingredient, it is at the HCPs discretion to provide the patient with information about a specific brand. As the manufacturer, you are simply providing the HCP with patient information which they may or may not choose to distribute to the patient. The key point here is that the HCP is making the decision for which brand product they are recommending. HCPs should not be instructed by manufacturers to provide information about drug X to patients on drug Y. However, the HCPs may choose to do so unprompted (that’s just medical practice).
If we are developing a postcard with a link to a patient education website on it (website will go through ASC approval) that is designed for the sales rep to give to an HCP to give to their patients, will PAAB have to review the entire website who's link is on the card? The website will have nothing brand specific, it will display all treatment options for patients, however it will have the company logo on it. Thanks!
Patient information, whether branded or unbranded, which is provided via the healthcare professional is subject to the PAAB code (See PAAB code section 1.1). The postcard is intended to be distributed to patients by the HCP and therefore requires PAAB preclearance. PAAB requires that websites controlled/influenced by drug manufacturers included in APS containing the PAAB logo undergo preclearance by an agency recognized by Health Canada for providing advisory opinions relating to DTCI Rx (i.e. PAAB or ASC). The website content in this case has been reviewed by ASC for adherence to provisions relating to consumer information. There is generally no need for PAAB to re-review consumer information because patients are being directed to it. However, the PAAB will require to review the linkage between the postcard and the website. As such, the website will need to be provided to PAAB as part of the postcard review.
Jennifer Carroll
Réviseur principal en communications
Le Conseil Consultatif de
