Health Canada updates its guidance on promotion of health products

Health Canada has published its draft guidance document “The Distinction Between Promotion and Non-Promotional Messages and Activities for Health Products” (guidance document). Health Canada has invited stakeholders to provide feedback before September 3.

What you need to know

• This is the first substantive update to Health Canada’s policy on health product communications which was published in 1996 (the 1996 policy document).
• The guidance document relates to promotion of all health products including prescription drugs (including controlled substances), non-prescription drugs, medical devices, natural health products, biologics, vaccines and veterinary health products.
• The guidance document reflects the evolved advertising landscape and includes commentary on the use of the internet and social media in health product advertising.
• Most examples of non-promotional messaging and activity types from the 1996 policy document remain in the guidance document. However, Health Canada provides examples of additional circumstances in which a message or activity related to a health product may be considered non-promotional.

The details

The guidance document outlines factors that contribute to categorizing a message or activity as promotional while providing examples of non-promotional communications. The guidance document introduces new concepts compared to the 1996 policy document, in particular: it applies to all health products including prescription drugs (including controlled substances), non-prescription drugs, medical devices, natural health products, biologics, vaccines and veterinary health products (rather than only to drugs for human use); it contemplates internet and social media advertising; and it includes promotion of medical procedures and services by health care professionals in addition to promotion of health products by manufacturers.

General principles

In determining if a message or activity is subject to the legislative and regulatory requirements for advertising, Health Canada will follow these general principles:

• each message will be evaluated on its own merit in its entirety;
• the factors for consideration listed in the guidance document are not exhaustive;
• generally, no single factor alone will determine if a particular message is promotional; and
• any linkages to various materials within a message will be considered (e.g., links to a website or proximity to promotional materials and the publication).

The guidance document includes 14 specific categories of communications and examples of non-promotional messages, including three new categories/subcategories: Other Learning Activities; Medical Procedure and Health Service-Related Messages; and Risk Management Plans.¹ The highlights are summarized below.

Clinical trial and investigational testing recruitment material

An announcement intended to assist in the recruitment of patients or investigators for a clinical trial is considered non-promotional even if there is a reference to the health product manufacturer’s name or participant recruitment agency. This is in contrast to the 1996 policy document, which indicated that a recruitment communication could not make reference to the name of a drug manufacturer.

Medical condition and treatment awareness related materials, patient information materials and packages

Medical condition treatment awareness related materials that do not accompany a health product at the time of sale/dispensing are generally non-promotional. All materials must direct patients to consult a health care professional for information on the disease, available treatment options, any symptoms related to the disease, and for a disease where only one treatment is available, the materials cannot refer to the health product.

Gated-access websites directed to patients (i.e., individuals that have been prescribed a drug by a health care professional) can include information about a prescription drug and continue to be deemed as non-promotional.

Medical procedure and health service related messages

Health care professionals may advertise the availability of medical procedures and services (e.g., medical cosmetic services) offered in their clinics to the public if no specific health product is named and the advertising is related to the services and not the sale of a health product.

Electronic tools and technology

Information disseminated through social media and other interactive tools may be non-promotional if it remains unbranded and does not mention a specific product. The communication must not place any focus or emphasis on a specific health product or its benefits. For dissemination of information through social media, the “sharing” options such as email, “like”, “tweet”, etc., must not modify the context by which the content is disseminated (e.g., different audience, emphasis on a specific product, etc.). Any sponsor of the social media activity or message cannot be engaged in discussions with platform users except in a monitoring capacity.

Educational activities

The guidance document now refers to two subcategories of learning activities that will generally be deemed as non-promotional: Continuing Medical Education, Scientific Symposia/Exhibits and Conferences (CME), and Other Learning Activities (OLA), which generally align with the Innovative Medicines Canada (IMC) Code of Ethical Practices on educational activities.

CME events are accredited programs generally restricted for health care professionals. However, having members of the public in attendance does not deem the CME event to be promotional.

OLAs include unaccredited programs, events or activities where medical/scientific information is presented to health care professionals, by health care professionals. The primary focus of these events must be the exchange of scientific and clinical information, and materials must be developed in accordance with such objective and consistent with the Canadian terms of market authorization.

Formulary kits or packages

As under the 1996 policy document, information concerning a health product prepared for review by formulary committees are non-promotional. The guidance document now clarifies that formulary committees may include public and private payers.

Responses to inquiries

This category is similar to the “Unsolicited Requests for Information” category in the 1996 policy document and includes information provided to an individual or organization about a health product by a health product manufacturer in response to a request for information or a request for proposal. An additional requirement for an inquiry to be non-promotional is that the response to the inquiry must not be communicated by sales and/or marketing personnel.

Corporate messages, press releases and press conferences

As in the 1996 policy document, communications to investors will generally be non-promotional if limited to the name of the health product and the therapeutic area. This includes providing information about drugs which are in development.

Press releases and information disseminated at a press conference published on the manufacturer website and/or the press release distributor’s website may be non-promotional if it is published for a maximum of 30 days. Further, factual and observed information on safety or efficacy and comparison to other treatments may be non-promotional.

Risk management plans

A Risk Management Plan (RMP) describes a set of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks related to drugs, and the assessment of the effectiveness of those interventions. To be considered non-promotional, an RMP must be required or requested by Health Canada and contain scientifically accurate and consistent information with the Canadian Product Monograph. It must not contain any product benefits, comparative safety or claims, product logos or branding. Further, an RMP may not be distributed to health care professionals by sales and/or marketing staff.

What’s next

The consultation will remain open until September 3.² Once all comments from stakeholders have been considered, a final guidance document will be published by Health Canada. Once published, the guidance document will provide additional clarity on the distinction between promotional and non-promotional messages and activities for health products that have been revised to reflect the modern Canadian advertising landscape.

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¹ There are three categories of examples where circumstances in which the message or activity may be considered non-promotional remain unchanged from the 1996 policy document: Publication Supplements; Patient Support Group Literature; and Reference texts, Peer-reviewed Journal Articles.

² Comments may be emailed to [email protected].