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Call PAAB. The commissioner answers all correspondence. Perhaps it didn't make it into the PAAB office. A phone call can solve your problem.
In section 6.1 of the PAAB Code is the following: Journal advertisements are designed to promote an advertiser's products to health professionals via the media of single [11.9] or multi-sponsored publications.
Section 11.9 clarifies that: For purposes of this Code, Private/Single Sponsor Journals, newsletters and other publications are defined as any commissioned communication prepared or controlled by the manufacturer or its agent. When can a publication be considered a journal? I ask because I am interested in supporting a single-sponsor publication by placement of an ad, but am uncertain whether this publication is actually a journal or a service-oriented vehicle. Can I place a journal ad in a service-oriented vehicle?
A medical journal is independently published on a regular, periodic basis. The nature of the content is approved by an advisory board e.g. cardiology information, and the editor is responsible for ensuring the integrity of the information that is provided and how it is presented. In single-sponsor journals, the sponsor usually has a vested interest in the nature of the content knowing that information about their products will appear. We have seen examples of independently produced single-sponsor journals, rarely. Usually there is a promotional element to them and that would require PAAB review. Placing advertising in a single-sponsored publication usually makes the whole thing advertising, based on a Health Canada policy on combining branded and non-branded information. You can place a previously PAAB-approved journal ad in a service-oriented vehicle during the 12 month clearance period, and we ask you to inform the PAAB that you are doing that. It does not require a new re view if the ad has not been altered in any way. The PAAB may ask to see the whole thing for an opinion, because context of the advertisement is important. Similarly you can convert a journal ad into a detail aid during the clearance period, let us know. Any newly created ads or modifications of existing ads destined for a service-oriented vehicle would require PAAB review. You can call the PAAB for an opinion on the review requirement of a single-sponsor publication if you are intending to do one.
I am trying to understand how Sections 6 and 7 of the PAAB code fit together. Can these be viewed as "alternate" classification schemes for APS? For example, can you have a Service-oriented Vehicle (section 6.4) that is a Full-disclosure APS (section 7.4)? A Service-oriented Vehicle that is an Editorial/Advertising APS? etc..
It almost appears that sections 7.7 and 7.8 belong in Section 6, since they appear to define additional categories of APS, and are relatively silent on disclosure information. And how do Section 6.4 and Section 7.8 connect with each other?
Section 6 is titled "Advertising/Promotion Systems (APS) Categories". That covers the different types of media used to promote healthcare products and it is fairly comprehensive of the current marketplace. See section 1 "Scope".We classify the type of advertising activity based on this section. Section 7 is titled "Disclosure/Prescribing Information Requirements". That covers the placement and format requirements for the additional prescribing information. They are separate entities and are not considered "alternate" classification schemes for APS. They are complementary in purpose. The PAAB uses both sections of the code to classify individual APS. If you see a PAAB file number on submission review correspondence you will see a letter code that combines the two e.g. DAF which would be a detail aid (s6.3) that requires Full Disclosure (s7.4). It is possible to have a Service-oriented Vehicle (section 6.4) that is a Full-disclosure APS (section 7.4) anda Service-oriented Vehicle that is an Editorial/Advertising APS etc..
Sections 7.7 and 7.8 does not require additional prescribing information if the advertising meets the requirements in those sections. These types of ads can appear in any of the media stated in section 6 and, thus, are complementary. One way sections 6.4 and 7.8 could be connected is if you were providing patient information of an editorial nature controlled by the sponsor to healthcare professionals for distribution to patients. This would include telling HCPs to advise patients of a website. That would require PAAB review.
The PAAB Code defines single sponsor publications in section 11.9, and notes in section 6.1 that branded content inserted into same are Journal Advertisement APS. Is the balance of the content of a single-sponsor publication exempt from PAAB review? Or is it considered service-oriented or detail aid APS?
What if the ad is placed in a publication for the purpose of sponsorship of an ongoing title offered by an Independent Publisher?
First, you should check the definition of "advertising" in PAAB CODE s11.1. Also see code s7.8 for Editorial Advertising. Most single sponsored journals are considered to be advertising unless the independence of the publisher can be well defined. That is usually difficult to do because the publisher is usually acting as an agent for the company. There are some single-sponsored journals that do have independent editorial control. According to Health Canada policy about combining branded ads with nonbranded information, if you place a product ad in a single sponsored journal it can make the whole vehicle advertising and thus, it would be subject to PAAB review if the information is related to product use. If you have an independently produced single-sponsor journal, the ad would be considered under code s6.4 service oriented vehicles. The PAAB provides an advisory opinion on the PAAB Code advertising status of specific promotional tools. Phone call advice is free of charge and written opinions are charged a fee.
How do you know when to submit an APS as a Detail Aid APS (s. 6.3) or a Service-Oriented Vehicle (s. 6.4)? Are there characteristic hallmarks that tell you which way one should go?
Detail aids (s6.3) are product advertising tools that are used by company sales representatives. They are used to directly promote a product's risks and benefits to health professionals. They contain only promotional messages. Service oriented vehicles (6.4) are promotional tools that have a component that may be useful to a health professional even if the advertising component was removed. Examples are anatomical charts or drawings, patient information, patient aids, disease information etc.
PAAB Code s6.4 applies to patient information. PAAB Code s2.8 states "Promotional items offered in advertisements must be related directly to the product or its use(s), or be of practical value to the health professional. Such gifts must withstand professional and public scrutiny. Items intended for distribution to patients via a health professional must be useful as aids to patients' understanding of, or adaptation to, their condition(s) or for encouraging compliance with recommended therapy." Therefore, this question is not relevant to s2.8 because the giveaways are not being offered in an ad. The Rx&D Code of Conduct applies to service-oriented items such as the purse etc in this example and to "special promotions". If the "consumer products" were nonprescription drugs, federal sample laws would apply.
All requirements of the code apply regardless of the APS category. See section 1 for the Scope of the PAAB Code. PAAB code section 6 states "Prescribing information (when required) should form an integral part of the presentation or be attached to it." PAAB Code section 7 states the actual PI requirements that correspond with the type of advertising.
To provide complete information for the reader as required by the PAAB Code s2.1 and s7, you should provide the Prescribing Information (PI) in both languages to accompany the ad that is pesented in both languages.
Yes. The PAAB code applies to advertising of healthcare products including drugs, biologicals and natural health products to health care professionals.
When new data is published outside of the Product Monograph, can this data be used for promotional pieces?
Section 3.1 of the PAAB Code of Advertising Acceptance states "Advertising / Promotion systems (APS) must be consistent with, and within the limitations of the Health Canada Terms of Market Authorization" (that includes the product monograph).
Section 3.2 states that studies used as references in promotional material should be "within the limitations of the Health Canada accepted product monograph ...".
Therefore, if the data are used to support a claim that is not within the limitations of the product monograph, the advertising will not be accepted by the PAAB. As an example: if a product was approved for an indication of reducing blood pressure at x dose and you produced a study that was not in the product monograph but included an evaluation of the product in reducing blood pressure at x dose, the PAAB would accept the advertising. Conversely, if the new study showed a rate of efficacy or safety of 80% and the data in the product monograph showed a different number e.g. 60%, the PAAB would not likely accept the 80% claim. You can call the PAAB office and ask a reviewer for a verbal opinion if you have specific questions about whether specific data claims would be acceptable within the limitations of the current product monograph.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising