Guidance on distinction between advertising and other activities for health products: Promotional examples

The examples presented in this page illustrate and apply the general principles and factors outlined in the overview page. The examples are a guide and should not be considered exhaustive. As a real-life case may not fall neatly within a single category, stakeholders may rely on a combination of factors to determine if a message or activity is promotional.

A message or activity can be promotional if:

On this page

Clinical trial and investigational testing recruitment material

As defined in the Food and Drug Regulations (FDR), a clinical trial is:

"an investigation in respect of a drug for use in humans that involve human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamics effects of a drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug"

Investigational testing is a systematic investigation of 1 or more human subjects, undertaken to assess the safety and/or effectiveness of a medical device.

An announcement used to recruit patients or clinical investigators for a clinical trial or investigational test concerning a health product may be considered promotional when the purpose is to promote the sale of the product. For example:

Corporate messages

A corporate message is a communication (such as a website, brochure, published article, prospectus or annual report) that gives information about a health product manufacturer or organization. This information could be on the philosophy, activities, product range (by name), financial details and/or area of future development or research.

Corporate messages, or information disseminated through corporate messages, may be considered promotional if:

However, a health product manufacturer may give detailed information about the health products being marketed, developed or researched when required by Canadian law (for example, as a requirement of the filing system for Canadian securities).

Medical condition and treatment awareness materials

Medical condition and treatment awareness materials raise awareness and provide information about a medical condition or treatment. They do not accompany a health product or branded health product materials for the same medical condition.

A manufacturer, or another organization, makes these materials available to the public, directly or indirectly. Various means are used, for example:

Declaration of sponsorship of such materials, by name or logo, is required and does not in itself render the material promotional.

Medical condition and treatment awareness materials may be considered promotional if:

Electronic tools and technology

Social media

Social media encompasses websites and applications that make it possible for health care professionals, patients and/or the public to share, create, discuss and modify content. Examples of social media channels include Facebook, Twitter, Instagram, LinkedIn, blogs and forums. A person or organization and/or its representatives may sponsor the social media activity or message.

information disseminated through social media may be considered promotional if:

The criteria applicable to social media apply to all types of messages, regardless of the type of message, in addition to the elements outlined for the specific type of message.

Other interactive tools

Electronic interactive tools encompass a wide variety of technologies used to communicate information to a large number of people in a user-friendly manner. These tools may take the form of:

In addition to the elements outlined in the previous section, information disseminated through interactive tools and technologies may be considered promotional if the tool and/or technology:

Formulary kits or packages

Formulary kits are packages prepared for formulary committees (public, including hospital formulary, and private payers) to review. These committees then decide whether to include a health product in a formulary.

Formulary kits or information disseminated through these kits may be considered promotional if they:

Educational activities

Continuing medical education, scientific/medical exhibits and conferences

Continuing medical education (CME) events are accredited programs for health care professionals or scientific/medical symposia focused on health products. These events are sometimes sponsored by health product manufacturers.

The key factor in determining the status of such an activity is the degree to which the program is independent of the drug manufacturer.

Key aspects of these events include the following:

Information distributed at these events may be considered promotional if:

For further requirements, please consult:

Canadian and international medical/scientific conferences

The factors mentioned in the Overview page apply also to Canadian and international medical/scientific conferences held in Canada. Conference participants may freely exchange information to achieve conference goals. Additional elements that may render these events promotional are:

Other learning activities

Other learning activities (OLAs) are unaccredited programs, events or activities where medical/scientific information is presented to health care professionals by their peers. The main focus of and reason for sponsoring or participating in OLAs is to exchange scientific and clinical information.

The intended audience is health care professionals and staff involved in patient care. Patients, patient groups, experts in a given field, sales representatives and other non-health care professionals attend only when their participation is justified and allowed by event organizers. Members of the public should not attend.

Information distributed at OLAs may be considered promotional if:

An OLA event may also be considered promotional if a speaker/presenter does not:

Publication supplements

Supplements in a publication (such as a magazine and a journal, in digital or print form) usually consist of a collection of articles that deal with related issues or topics. They are:

A publication supplement that is sponsored, in whole or in part, by a health product manufacturer may be considered promotional if:

Medical procedure and health service messages

Health care professionals may promote medical procedures and services (such as medical cosmetic services) offered in their clinics to the general public.

These messages may be considered promotional if:

Patient information materials

Separate package inserts, prescribing information, fact sheets, consumer/patient medication information (such as patient leaflets), patient diaries or other material that is to be distributed to a patient for whom the health product is prescribed may be considered promotional if:

Note: Some of these materials may be considered as part of the labelling. Relevant labelling requirements for the type of health product will apply to this material and must be consistent with the terms of the marketing authorization.

Patient support group activities and literature

Patient support group activities

Patient groups play an expanded role in health care, including in participating and contributing to how clinical trials are designed and conducted.

The involvement of patient support groups in clinical trials may be considered promotional if:

Patient groups and their members are sometimes invited to attend conferences and learning activities sponsored by industry.

Attendance at and participation in these activities may be considered promotional when:

Patient support group literature

Patient support groups often publish information in the form of websites and brochures or leaflets. These are intended to help members (and potential members) better understand a disease and its treatment.

Declaration of sponsorship of the websites and brochures/leaflets by a health product manufacturer does not render the brochure promotional. Patient group publications that include information on health products may be considered promotional if:

In the case of clinical research or studies, messages disseminated by patient support groups to their members may be considered promotional when the message:

Press releases and press conferences

Health product manufacturers commonly release information on new research developments about a product when:

A press release or information disseminated at a press conference concerning a health product may be considered promotional if:

Risk management plans

A risk management plan (RMP) is required or requested by Health Canada. This document describes a set of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks related to a health product and to assess the effectiveness of those interventions. An RMP reflects emerging, known and unknown clinical and non-clinical safety data. It is updated throughout the product's life cycle upon discussion and agreement between Health Canada and the sponsors/market authorization holders.

Risk minimization measures (RMMs) are interventions intended to prevent or reduce the occurrence of adverse reactions associated with being exposed to a health product or to reduce their severity or impact on the patient. Measures may include warnings on the label or providing information in educational materials used by health care professionals. They form part of an RMP.

Risk minimization tools (RMTs) are documents or materials developed for additional RMMs, such as guides for health care professionals or patients. An RMT may be considered promotional if:

Where RMTs are communicated in a context such as educational activities, they may be considered promotional if:

Reference texts, peer-reviewed journal articles

As a courtesy, a manufacturer may disseminate reference texts (textbooks and chapters of textbooks), government publications or reprints of published, peer-reviewed articles from medical or scientific journals.

These disseminated resources or information may be considered promotional if:

Responses to inquiries

Information provided to an individual or organization about a health product by a manufacturer in response to a request for information may be considered promotional if:

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