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:

• the factors under each section are met or
• circumstances indicate that the purpose of the message is not to promote the sale of a health product

On this page

• Clinical trial and investigational testing recruitment material
• Corporate messages
• Medical condition and treatment awareness materials
• Electronic tools and technology
• Formulary kits or packages
• Educational activities
• Publication supplements
• Medical procedure and health service messages
• Patient information materials
• Patient support group activities and literature
• Risk management plans
• Reference texts, peer-reviewed journal articles
• Responses to inquiries

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:

• does not give the manufacturer's name or participant recruitment agency
• does not clearly identify the intent to recruit clinical trial/investigational testing participants or clinical investigators
• does not indicate the patient profile required (for example, the disease/symptoms to be treated, age) and the purpose of the clinical trial or investigational testing
• does not include contact information, such as a telephone number, email address and website link, where people can obtain further information on the clinical trial or investigational test
• makes claims about the product's safety and effectiveness
• makes comparative claims with other treatments
• makes direct or indirect reference to the name of the product under investigation
  • including the study title may not render the message promotional, but including the name of the product under investigation in the title may indicate the purpose is promotional

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:

• they seem to provide information about the health products being marketed, developed or researched rather than the manufacturer or organization
• there is far more information about the health product being marketed, developed or researched than simply its name and the therapeutic area
• in the case of unauthorized drugs or an unauthorized indication, there is no mention that the product's safety and efficacy is still under investigation and that Health Canada has not yet granted market authorization

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:

• by mail
• in retail outlets
• online, such as:
  • email
  • websites
  • social media
  • digital applications
• in waiting rooms of health care professionals

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:

• they do not emphasize the need for patients to consult a health care professional for complete information on the condition and available treatment options
• they believe they have the symptoms of the disease
• the content is focused on the product rather than the disease
• they do not discuss available treatment options (consistent with the health product's terms of market authorization issued by Health Canada) and the product's risks and benefits fairly and objectively, for example:
  • emphasis is on 1 product or 1 drug class through the use of capital letters, bold text and links
  • risks are minimized and benefits exaggerated
  • there is no discussion about non-health product treatment options
    • all recognized treatment options, including those that don't involve drugs (such as massage and acupuncture) should be discussed
• they make direct or indirect therapeutic or safety comparative claims
• the material refers to an unauthorized health product or indication
• the material refers to the product's availability through the Special Access Program (SAP)

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 social media website or platform is branded
• the content, user-generated comments, hyperlinks and/or other interactive features, which are under the sponsor's control, place additional focus or emphasis on a specific health product and its benefits
• the "sharing" options (such as email, "like", "tweet", "re-tweet", "comment") could modify the context by which the content is disseminated
  • for example, reach different audiences, emphasize a specific product
• a person or organization and/or its representatives sponsor the social media activity or message and is engaged in discussions beyond in a monitoring capacity
  • monitoring includes removing inappropriate comments, reporting adverse events and giving a general message such as "thank you for your comment" or "talk to your doctor for more information"

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:

• a quiz
• a chat room
• clinical software
• an online banner ad
• a web-based or mobile application
• a keyword, such as a metadata tag
• a search engine optimization (SEO) tool
• decision-making support tools used by HCPs

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:

• is branded
• provides links or search results/outputs to material that emphasizes a specific product and its benefits
• makes direct or indirect therapeutic or safety comparative claims

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:

• exceed that which would normally be required to support such an application (as described by the public and private formularies)
  • are disseminated, in whole or in part, to a wider audience at the same time or at a later date, except when submitted to health technology assessment agencies
    • submissions to these agencies via patient and health care professional groups would be examined on a case-by-case basis to determine if they are promotional
• involve sample distribution, unless required by the formulary committee

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:

• They provide a forum for exchanging information on related clinical and scientific issues.
• 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.
• The sponsor or its representatives can present at these events when their participation is allowed by event organizers.
• Commercial exhibits or advertisements must be arranged in a location that is clearly and completely separated from the CME event.

Information distributed at these events may be considered promotional if:

• a health product manufacturer sponsors only specific portions of the agenda or conference that are related to a product
• the sponsor's role and any financial relationships between the sponsor and the speakers and organizers of the event is not clearly disclosed
• the content of the agenda and individual presentations from non-manufacturer/sponsor members are not independently developed and are influenced by the sponsor, manufacturer or any entity acting on behalf of the sponsor or manufacturer
• inducement is provided to participants
• there are direct or indirect promotional activities relating to health products, including sample distribution, during the event
• sales representatives are engaging in promotional activities related to health products during the event
• the limitations of the data and of the health products are not adequately discussed
• reports, edited scripts or recorded videos of the proceedings, in whole or in part, that concern a health product are disseminated by the sponsor or its agent to a wider audience

For further requirements, please consult:

• national standard for accredited continuing medical education/continuing professional development activities of the Royal College of Physicians and Surgeons of Canada
• code of ethics (In French only) of the Conseil québécois de développement professionnel continu des médecins

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:

• display of a drug product prior to market authorization in Canada is not prominently identified as not being authorized for sale in Canada
• there are actions intended to target the Canadian general public directly or indirectly

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:

• the need for such an activity has not been identified through a needs assessment, in collaboration with relevant health care professionals or their organizations
• the objective of the program is not clearly outlined and the activities are not meant to address the gaps as identified in the needs assessment
• the purpose of associated activities is unclear
• materials for the program or activity have not been developed in accordance with clear program objectives identified through a needs assessment and are distributed widely beyond those participating in the event
• inducement is provided to participants
• there are direct or indirect promotional activities relating to health products, including sample distribution during the event
• product presentations are not fair and balanced
  • with respect to unauthorized health products and/or unauthorized uses, there is no mention that safety and effectiveness are not established by Health Canada and that market authorization has not been granted in Canada
• sales representatives engage in promotional activities during the event
• evaluations are not collected to assess whether program objectives have been met, as identified in the needs assessment for the activity

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

• disclose any conflict of interest(s) and funding, including with respect to the sponsor
• disclose that Health Canada has not established the safety and effectiveness of an unauthorized health product and that market authorization has not been granted in Canada
  • if the presenter chooses to discuss or present on an unauthorized health product
• have complete editorial control of the content being presented with respect to the sponsor or its agents
  • individual presentation has not been independently developed and is influenced directly or indirectly by the sponsor, manufacturer or any entity acting on behalf of the sponsor or manufacturer

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:

• published as a separate issue of the journal or as an addendum to a regular issue
• funded by sources other than the journal publisher (such as a health product manufacturer)

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

• the content does not include a variety of treatment approaches for the same medical condition
• it is targeted to an audience beyond the publication's usual readership
• there's a link between promotional materials and the supplement (for example, by proximity within the publication)
• sponsorship by the manufacturer is either not declared or in such a way that there is obvious link to a health product that is being discussed
• it is not clearly identified as being distinct from the regular publication
• it is disseminated by the sponsor in whole
• the sponsor, manufacturer or any entity acting on behalf of the sponsor or manufacturer has modified an article in the supplement
• a supplement consisting of symposium proceedings that address a variety of issues related to different diseases, medical conditions or health products is edited by the sponsor/manufacturer or any entity acting on its behalf

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:

• a specific health product is being promoted
• they do involve the sale or purchase of a health product rather than of the service

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:

• it also contains information on a product that is not prescribed to the patient by a health care professional
• it is distributed to consumers to whom the product was not prescribed
• in the case of a website, access is restricted to ensure that information is only accessible by the patient for whom the product was prescribed

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:

• the group does not inform its members or make public the funding it received from the sponsor of the clinical trial/investigational testing for this and previous trials
• the group does not inform its members or make public the full extent of its role, which should be limited to the one described and approved by the Ethical Review Board
• any deviation or change in funding or role is not made public and reported to the members
• the group's role changes depending on the sponsor's funding level for similar study requirements and products

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:

• the content is product-related rather than disease-focused
• the treatment options and their respective risks and benefits are not discussed objectively without emphasis placed on 1 product or drug class

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:

• the content is focused on the product rather than on the disease
• the treatment options and their respective risks and benefits are not discussed objectively
  • emphasis is placed on 1 product or drug class (by using capital letters, bold text and links)
  • risks are minimized and benefits exaggerated
  • emphasis is placed on 1 health product or its merit (by overly using a brand name or describing the product as a "breakthrough")

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

• promises or implies a certainty of cure or other benefit beyond what is contained in the protocol and the informed consent document
• coerces, states or implies a certainty of favourable outcome or other benefits beyond what is outlined in the consent document and the protocol
• claims (explicitly or implicitly) that the health product under study is safe or effective for the purposes under investigation, or that the test article is equal or superior to other health products
• uses terms such as "new treatment," "new medication" or "new drug" without explaining that the test is investigational

Press releases and press conferences

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

• a notice of compliance is issued
• a new drug is launched
• a new indication for use is included in the terms of market authorization for a previously authorized product
• changes are made to reimbursement status or formulary coverage

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

• the announcement is kept indefinitely on the landing page of a Canadian website of the manufacturer and its subsidiaries and/or the press release distributor's website, although no longer considered as news
  • for example, posted for more than 1 year from the initial date of publication and not archived
• statements about the degree of safety or efficacy and comparisons to other treatments are not factual
• an attempt is made to influence the pick-up or placement of the announcement
  • for example, payment is made by the manufacturer to influence the visibility in the press and for subsequent publications or broadcasts
• reference is made to a health product or its merit by, for example:
  • using a brand name excessively
  • describing the product as a "breakthrough"
    • defined as a health product that is proven to be therapeutically more beneficial compared to existing therapies based on clinically significant endpoints
    • lacks a statement that the product has been granted a breakthrough therapy designation by the U.S. Food and Drug Administration

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:

• it is not scientifically accurate and inconsistent with the Canadian product monograph
• the product benefits (direct or implied) that are not necessary for defining the risk are included
  • for example, a risk associated with a use or strength
• it contains unauthorized safety or benefit claims and/or comparative claims
• it is inconsistent with the RMM objectives
• it is distributed to health care professionals by sales or marketing staff for the purpose of promoting the sale of a product, such as being used as detailing aids during a sales call

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

• the activity is not clearly intended as a risk minimization measure or the need for such an activity has not been clearly and systemically identified through a needs assessment in collaboration with relevant HCPs or their organizations
• the information is distributed in a manner that may be considered promotional according to the section on Educational activities

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:

• they are not in their original form and are accompanied by any form of verbal or written information designed by or on behalf of the manufacturer for the purpose of promoting a health product (for example, a detail aid, summary or interpretation of the text)
• they have been solely written or edited by an employee or agent of the manufacturer

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:

• the inquiry has been encouraged in any way by the manufacturer of the health product
• the response to an inquiry regarding unauthorized products or indications (off-label) is communicated by sales or marketing personnel