Demandez au CCPP

760

What type of gating is required for a HCP website for a schedule 1 product (narcotic)? is de-indexing considered a form of gating? What type of information can be available pre-gate? can information around a patient support program be made available pre-gate for a schedule 1 (narcotic) product?

Yes, de-indexing is considered a form of gating. Note that the de-indexed URL should also be something that is not easily guessable (controlled distribution). For example, “BrandX.ca” would not be acceptable. Neither would “BrandXHCP.ca” or “BrandXresources.ca”. There should be some aspect of the URL which is not easily guessed. We suggest a set of random characters/numbers.

Note that advertising of narcotics falls under the Narcotic Control Regulations and the Controlled Drugs and Substances Act. Advertising of narcotics is prohibited to the general public (this includes reminder ads that would be limited to only the product name, price and/or quantity). As such, it would not be acceptable to have a landing page which makes mention of the narcotic. In addition, the inclusion of promotions for a patient support program in a public space, would not be acceptable.

Please also be advised that Health Canada has provided additional guidance on the promotions of opioids. Please see: https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/submission-targeted-rm-plans-commitments-prescription-opioid-containing-products-guidance-industry/document.html#a3.2.3.3 and https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/additional-restrictions-advertising-opioids.html

759

We want to develop an unbranded, ungated website that we plan to send to ASC. The content is about adherence and as such is appropriate for all audiences. Can we develop unbranded promotional tools, like banner ads on NEJM, that direct HCPs to this site?

The content and execution of this tool will impact the answer. In general, if the primary objective is to direct HCP to the tool to learn and implement, then the tool should be reviewed and approved by PAAB as it requires assessment for an HCP audience. If the objective is to inform HCP’s that a tool exists which they can direct consumers towards, then an assessment of the link would be required. PAAB would assess if the linked content was acceptable in the context of the message copy as the primary audience is HCPs. 

758

In the PAAB Fair Balance guidance, for lowest level FB, it states “messages which do not relate to the healthcare product (e.g. disease information)”. Question is: If the message does not relate to the product and only disease info, why would we require any FB at all? it is not advertising. Or could you provide an example for this scenario?

You’ll note that the “Scope” of the document states “This document applies only to healthcare professional advertising/promotions systems (APS) that require fair balance per PAAB code 2.1, 2.4, 3.5 and 7.3”.

Mention of the brand or branding elements, and discussion of disease content would suggest the therapeutic use without properly limiting to the specifics of the products indication. The brands indication and lowest level fair balance should be presented so as to accurately convey the limitations of use.

757

My question is specifically regarding a sales rep emailing a (known, consented) HCP one on one with: A) A one line message that a product has now received Health Canada approval with approved indication. No claims, data etc B) A request to HCP to discuss Patient Support Program which may include info on the PAAB approved patient enrolment form Is this communication different if a Medical Affairs staff member sends the email? thanks very much.

Yes this message requires review. B) Yes this would also require review. It remains an unsolicited message to promote a product or offering from the company and therefore would not be perceived as different if it came from medical affairs. We would also recommend reviewing industry codes such as the Innovative Medicines Canada Code of Ethical Practices which state that medical/regulatory/scientific personnel may not sign promotional materials. See question above.

756

If I am developing a patient brochure for a medication, I know I am restricted to Part 3 of the PM. However, structurally, am I able to flow content in a way that is more digestible and clear to the patient – or am I subject to the structure Part 3 lays out? I find the content jumps all around and is very challenging to follow, and I am looking to restructure so that the flow is more friendly from a patient information consumption perspective. Everything will be referenced to Part 3 as required. Is this ok?

You are not required to follow the same flow as part III. Review of the patient piece will assess that the revised flow does not emphasize or deemphasize aspects of the product or create links where they are not deemed to be acceptable.

755

I’ve reviewed your forum and website but my colleagues and I still have varying views. If a product receives Health Canada NOC, may an employee in a sales role email an HCP with this information with no efficacy claims? Would an employee in a medical affairs position be able to send same email? Is there a difference in who may send communication? Thank you.

We must first determine if this action is advertising by asking the questions in the Health Canada document “Distinction Between Advertising and Other Activities”. Who is providing the message? If the message is coming from a sales representative then the message is most likely advertising and therefore would require review. Has the information been solicited or is it unsolicited. If it is unsolicited, it may be advertising and therefore should be submitted for opinion or review. The document also asks the content of the message. A message of “now available” is exempt, however if any additional messages are included (e.g. indication or therapeutic category [direct or indirect, including visuals]), this may not be exempt. The distinction between advertising and non-advertising is not limited to “who delivers the message”. The other questions in the distinction document should be considered.  If you remain uncertain if the activity is advertising or not, the PAAB can provide an opinion based on review of the copy and intended actions.