On July 5, 2019 Health Canada opened consultation on its draft guidance: The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products ("Draft Guidance"), which, when finalized is intended to replace the current policy entitled The Distinction Between Advertising and Other Activities. While the Draft Guidance is not available online, interested stakeholders can request a copy by emailing [email protected]
Significantly, the Draft Guidance is proposed to apply to "health products", versus only drugs per the current policy. Products governed by the Draft Guidance are: prescription drugs (including controlled substances), non-prescription drugs, medical devices, natural health products, biologics, vaccines and veterinary health products.
The Draft Guidance mirrors the current policy in both form and content, but includes important differences. The Draft Guidance maintains an introductory section on the general principles and factors to be applied when determining whether a message is promotional, followed by examples of non-promotional messages and activity types. Some of the examples remain very similar, with updates to reflect recent technological advances for the exchange of both promotional and non-promotional messages and related activities via social media platforms and websites. New examples have been added. The following is our selection of key changes:
Electronic Tools and Technology
Deals with information disseminated through social media and similar technologies (in addition to interactive tools, which is also dealt with in the current policy). Such information may be considered non-promotional in the following circumstances:
- the social media website, platform or tool remains unbranded (e.g., no specific product is mentioned);
- the content, user-generated comments, hyperlinks and/or other interactive features do not place additional focus or emphasis on a specific health product and its benefits;
- the available "sharing" options (e.g., email, "like", "tweet", etc.) do not modify the context by which the content is disseminated (e.g., different audience, emphasis on a specific product, etc.); and
- a person or organization and/or its representatives may sponsor the social media activity or message, but is not engaged in discussions except in a monitoring capacity (e.g., removal of inappropriate comments, etc.).
Other Learning Activities
There is a new subsection under Educational Activities for "Other Learning Activities" (in addition to continuing medical education, which is also covered by the current policy). Other learning activities are defined as unaccredited programs, events or activities where medical/scientific information is presented to health care professionals, by health care professionals, where the primary focus is the exchange of scientific and clinical information and issues.
According to the Draft Guidance, information disseminated at OLAs may be considered non-promotional in the following circumstances:
- the need for such an activity has been clearly and systematically identified through a needs assessment in collaboration with relevant health care professionals;
- the objectives of the program have been clearly outlined and the activities are meant to address an identified gap between the current situation and the desired situation;
- only health care professionals are invited or are in attendance;
- all materials for the program or activity have been developed in accordance with program objectives and are only distributed to health care professional attendees;
- any product discussions are fair and balanced, and consistent with the Canadian terms of market authorization; and
- evaluations are collected to assess whether program objectives have been met.
Additionally, for an OLA event to be considered non-promotional, a speaker/presenter must:
- appropriately disclose any conflict of interest(s) and funding;
- disclose that the safety and efficacy/effectiveness are still under investigation in the case of unauthorized health products and unauthorized uses – this implies that non-promotional off-label discussions are permitted by Health Canada ; and
- have complete editorial control of the content being presented.
New Examples of Non-Promotional Messages
The Draft Guidance contains a few new examples of non-promotional messages. One that is significant for many industry members is Patient Information Material, i.e. information in the form of a web site, application, leaflet, brochure, or booklet published by the manufacturer concerning a health product (e.g. patient support materials). Such information is considered non-promotional if it pertains only to the health product that is being, or has already been, prescribed to a patient by a health care professional and in the case of a web site, the access is gated to ensure that information is only accessible by patients. Other examples are Medical Procedure and Health-Service Related Messages issued by healthcare professionals ("HCPs") and Risk Management Plans, i.e. dynamic, stand-alone documents required or requested by Health Canada which describe a set of pharmacovigilance activities and interventions.
Other Notable Changes
Other notable changes to the Draft Guidance include the following:
Press Releases: There are new important requirements to be considered non-promotional, including that these communications must be posted on the website of the manufacturer or press release distributor for 30 days. It is also now permissible to include safety and efficacy information (previously not permitted).
Clinical trial announcements: It is now permissible to refer to the health product manufacturer's name in a clinical trial announcement and still be considered non-promotional.
Corporate messages (institutional messages under the current policy): Information about the health product being marketed/developed/researched must be included in the "investor information section" of the communication to be considered non-promotional.
Medical condition and treatment awareness related materials (consumer brochures under the current policy): There are two new requirements to be considered non-promotional:
- in the case of a disease where there is only one treatment available, the treatment must not be not alluded to, referred to, or mentioned in any way; and
- the material must emphasize the need for patients to consult a health care professional for complete information on the disease, and the available treatment options, or if they suspect they are experiencing any symptoms related to the disease.
Formulary Kits or Packages: As under the current policy, there is recognition that information about a health product provided to formulary committees may be non-promotional; the Draft Guidance makes it clear that such committees may be formed by public or private payers.
Educational Activities: It is no longer a requirement that continuing medical education (CME) events be restricted to HCPs to be considered non-promotional (just a statement that they are "generally" so restricted). International events are to be governed by the same rules as domestic conferences.
Responses to Inquiries (unsolicited requests for information under the current policy): It is now expressly stated that the response cannot be communicated by sales and marketing personnel.
The consultation is open for 60 days ending on September 3, 2019.
The purpose of this consultation is to obtain input on the revised guidance document from all relevant stakeholders (e.g., industry associations, health product manufacturers, advocacy groups, healthcare professionals, consumers, the advertising industry, provincial/territorial authorities, etc.).