Guidance on distinction between advertising and other activities for health products: Overview
Organization: Health Canada
Date published: 2023-07-31
On this page
Health Canada recognizes that it is important for industry to disseminate non-promotional, accessible information on human and animal health products to health care professionals (HCPs) and the general public. Since advertising is for the purpose of promoting the sale of a health product, it is critical to determine whether the purpose of a message is to promote the sale of a health product or to provide information. This is in accordance with the Food and Drugs Act (FDA).
This guidance document outlines the factors that contribute to rendering a message or activity promotional. When deciding if advertising legislative and regulatory provisions apply, one needs to first determine whether a particular message or activity is promotional or non-promotional.
This guidance document applies to the following health products:
- those regulated under Health Canada
- medical devices
- prescription drugs
- includes controlled substances
- non-prescription drugs
- animal health products
- natural health products
This document applies to the following messages and activities:
- those involving medical conditions and/or any health-related matters, regardless of the target audience in Canada
- although the target audience is a factor to be considered in assessing the nature of the messages and activities
- those targeting consumers through any messaging media (such as television, radio, print, online, digital platforms) or setting
This document does not constitute part of the FDA, CDSA or their associated regulations. If there is inconsistency or conflict between the acts or regulations and this document, the acts or regulations take precedence. This is an administrative document to help the regulated party comply with the FDA, CDSA, their regulations and applicable administrative policies.
There are numerous provisions within the FDA, CDSA and their respective regulations that apply to health product advertising.
The FDA concerns food, drugs, cosmetics and medical devices. Health products, including controlled substances that are sold in Canada, must meet relevant requirements as set out in this act and its associated regulations. The requirements establish a product’s terms of market authorization (TMA), which includes:
- the notice of compliance (NOC)
- drug identification number (DIN)
- natural product number (NPN)
- DIN-homeopathic medicines (DIN-HM)
- veterinary health product (VHP) notification number (NN)
- medical device licence
These in turn authorize the sale of a health product in Canada.
Section 2 of the FDA defines “advertisement” as “including any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device.” Health Canada will rely, as a general principle, on the ordinary meaning of “promote” as encouraging or inciting the sale of a health product.
The CDSA concerns the control and sale of controlled substances and their precursors. It is not used to establish the TMA but provides provisions for stakeholders to legally handle and conduct activities with these substances.
Similarly, Section 2(1) of the Narcotic Control Regulations (NCR), which is a set of regulations made under the CDSA, defines advertisement as “including any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of a narcotic.”
Section 1 of the Benzodiazepines and Other Targeted Substances Regulations (BOTSR), which is a set of regulations under the CDSA, defines advertisement as “in respect of a targeted substance, includes any representation by any means for the purpose of promoting, directly or indirectly, the sale or other disposal of the targeted substance”.
Part G of the Food and Drug Regulations (FDR), which is a regulation under the authority of the CDSA, defines advertisement as “includes any representation by any means whatever for the purpose of promoting, directly or indirectly, the sale or other disposal of a controlled drug”.
Promotional messages and activities , as specified in the FDA and CDSA, are considered advertising.
Sections 9(1) and 20(1) of the FDA prohibit advertising any drug or device in a manner that is:
- false, misleading or deceptive or
- likely to create an erroneous impression regarding its character, value, quantity, composition, merit, design, construction, performance, intended use or safety
Section C.08.002 of the FDR for a new drug and section 27(a) of the Medical Devices Regulations (MDR) prohibit promoting a health product before market authorization.
If a message about a health product is not considered to promote the sale of a health product, it is not subject to the advertising provisions.
It is necessary to determine if a message or activity is promotional (considered advertising) in order to establish if the legislative and regulatory requirements on advertising apply. When making such a determination, the following principles will be upheld:
- Each message will be evaluated on its own merit in its entirety, with consideration given to the context within which the message is being delivered.
- Any linkages to various materials related to the message will be considered as well.
- As the following list of factors is not exhaustive, other factors or circumstances will also be considered if they provide insight on whether the purpose of the message or activity is to promote the sale of a specific health product.
In general, no single factor will determine if a particular message is promotional.
In addition to this guidance, Health Canada recommends that stakeholders consult advertising preclearance agencies (APAs), where applicable, for assistance in conducting these case-by-case assessments. These agencies will provide advisory opinions on specific messages or activities and can validate that they are either non-promotional or in compliance. Notwithstanding that a manufacturer may seek advice from an APA, there is no legislative or regulatory requirement to use an APA.
Note that Health Canada is the regulatory authority for all health product advertising in Canada.
Factors that contribute to a promotional determination
The following questions will help stakeholders determine whether the message is primarily intended to promote the sale of a drug:
What is the context in which the message is disseminated?
For example, when and how is the message delivered? What is the milieu or medium of dissemination? Is it a science-based message delivered to scientists or health care professionals by an expert, such as a researcher at a conference with a varied agenda. Or is it a product-related message delivered to a group of health care professionals by the sales representative of the product manufacturer at a meeting with a specific agenda?
Who are the primary and secondary audiences?
For example, are the target audiences limited or unlimited in scope? Are the primary and the secondary audiences the same? Where they are different, did the manufacturer or a third party contracted by the manufacturer engage in distribution beyond the primary target audience? Where the message is not limited to the primary audience, it is more likely to be promotional. For example, a subset of patients with a particular medical condition constitutes the primary audience of a message. Should this message appear in a public newspaper, it would be targeting a secondary audience or would be unlimited in scope.
Note: Primary audiences are considered the intended target group. Secondary audiences are “unintended” and are also exposed to the message.
Who delivers the message (the provider)?
For example, is the message delivered by the health product manufacturer, its agent or an independent third party (such as a patient support group)? The message is more likely promotional if it is not delivered by an independent party.
Who sponsors the message and how?
For example, is the sponsor the manufacturer, its agent or an independent third party? Is the sponsorship funding targeted to a specific message or is it added to the general operating budget of an organization or conference? If the message is sponsored by the manufacturer or its agent and the funding is not added to the general operations budget, the message is more likely to make it promotional. A fee that is paid by the manufacturer to have the message disseminated is more likely promotional.
What influence does a health product manufacturer have on the message?
For example, what are the linkages between the information, the provider and the manufacturer, the provider and the writer? Content that is influences by the manufacturer (prepared, edited) is more likely promotional.
What is the content of the message?
For example, are the facts described objectively in a balanced manner or is emphasis placed on a particular health product or its merits? Is the message balanced with respect to describing both risks and benefits of a treatment option? Can the message withstand a test for scientific rigour? Is the information set in an appropriate context (for example, a discussion of disease management, scientific research)? Messages that are not balanced, objective, set in a proper context, scientifically rigorous or that emphasize a particular health product are more likely advertising.
How frequently is the message delivered?
For example, is it delivered once or repeatedly? A message that is repeated is more likely promotional.
Other factors that may render a message or activity promotional can be divided into 2 categories:
- content and context factors
- sponsorship and dissemination factors
Content and context factors
A message or activity may be determined to be promotional if it:
- is mainly product-focused
- emphasizes the benefits of a health product or minimizes, omits or ignores risks in any way
- through editorial comments, opinions or suggestions
- is affected directly or indirectly by the sponsor or manufacturer or any entity acting on behalf of the sponsor or manufacturer
- is presented in a layout and design that can be associated with a specific health product
- such as brand colours, logo-like graphics and other visual cues, unique packaging, setting or decor
- is combined or disseminated at the same time as other promotional messages or activities
- includes direct or implied comparative therapeutic claims
- in terms of ingredients, brands or therapeutic category
- is disseminated in the context of the target medical condition when directed to the general public
- such as messages about health products in women’s magazines for medical problems affecting only women
A message involving unauthorized health products or unauthorized indications, in a context such as educational activities, may be considered promotional if:
- the message does not caution that the product’s safety and effectiveness are still under investigation and that Health Canada has not yet granted market authorization
- for medical devices, they are advertised in a way other than in a catalogue that, the message does not include a clear and visible warning that the devices may not have been licensed in accordance with Canadian law
- there's a suggestion the health product is available through the Special Access Program (SAP) for drugs and medical devices or the Emergency Drug Release (EDR) Program for animal health products
SponsorshipNote de bas de page * and dissemination factors
A third-party message or activity may be determined to be promotional if it:
- is not disseminated by a government authority
- such as the Public Health Agency of Canada, provincial ministries of health or provincial formularies
- is not sponsored and delivered by a competitor
- is delivered by sales or marketing staff
- involves distributing samples
Note about guidance documents in general
Guidance documents provide assistance on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.
Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a health product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.
This document should be read along with the relevant sections of other applicable guidance documents and policies. This guidance document supersedes the 2005 policy The Distinction Between Advertising and Other Activities.
- Date modified: