At long last! Health Canada delivers long-promised, revamped guidance on the Distinction Between Advertising and Other Activities

In Canada, advertising health products to healthcare professionals (HCPs) and the public is restricted by regulations under the Food and Drugs Act¹ and the Controlled Drugs and Substances Act². For example, a manufacturer cannot both name a prescription drug and describe its intended use in an ad directly targeting Canadian consumers. Prescription drugs without market authorization in Canada cannot be identified to Canadian doctors as available for sale. Restricting prescription drug advertising is a health protection measure intended to curb promotional messaging that can influence Canadians to ask for drugs that may be clinically inappropriate for them, thereby affecting prescribing volume and informed treatment choices.

However, Health Canada recognizes that there are legitimate instances where it is necessary and beneficial for the health product industry to share non-promotional information on human and animal health products to HCPs, limited audiences or the general public. To this end, Health Canada published its revised (and final) guidance, Distinction Between Advertising and Other Activities for Health Products (the Guidance), to help industry thread the needle between promoting a health product for sale and providing information to applicable stakeholder audiences.

What you need to know

• Administrative tool. Guidance documents are administrative tools and do not have the force of law. The Guidance itself is not a legal instrument but can help industry decide if their messaging is promotional and therefore subject to the advertising provisions of the Food and Drugs Act and other laws.
• Broader scope. The Guidance supersedes the 2005 version and captures a broader scope of “health products” including: vaccines, biologics, medical devices, prescription drugs, controlled substances, non-prescription drugs, animal health products and natural health products. The previous guidance applied only to human drugs.
• Broader application. The content of the Guidance and the examples provided of non-promotional messaging and activities have been updated to reflect various ways of disseminating information common to using today’s tools and technology (e.g., social media, websites, “sharing” features, etc.). The Guidance applies to any form of media (such as television, radio, print, online, digital platforms) or setting regardless of the target audience.
• New examples. Thirteen examples are set out in the Guidance to illustrate and apply the principles and factors used to determine whether a particular message or activity is promotional or non-promotional. Several new categories are included as examples: medical condition and treatment awareness materials, other learning activities (educational activities), medical procedure and health service messages, and risk management plans.

General principles and factors for consideration

Health Canada will follow these general principles when deciding if a message or activity is promotional in nature:

• each message will be evaluated on its own merit in its entirety with a view to the context within which the message is being delivered;
• any linkages (e.g., hyperlinks or proximity) to various materials related to the message will be considered; and
• a non-exhaustive list of factors (discussed below) will be considered, but generally, no single factor alone will determine if a particular message is promotional.

Is the message promotional?

When assessing whether a message is non-promotional or primarily promoting the sale of a health product, stakeholders should ask the following questions:

• What is the content of the message and how frequently is it delivered?
• What is the context in which the message is disseminated?
• Who is the audience and who is delivering the message (e.g., independent party)?
• Who sponsors the message and how?
• What influence does the manufacturer have on the message?

A message or activity that is product-focused is likely considered promotional if it (i) uses a layout and design that is associated with a product (e.g., brand colours and graphics), (ii) makes direct or implied comparative therapeutic claims, (iii) emphasizes the benefits of a health product, or (iv) minimizes, omits or ignores risks in any way. Other contextual factors to consider are whether the message is combined or disseminated at the same time as promotional material or by the manufacturer themselves.

Notable promotional examples (and exceptions) in the final version

Clinical trial and investigational testing recruitment material

Recruitment materials directed to patients or investigators for a clinical trial must disclose the name of the manufacturer of the investigative drug to be considered non-promotional. This reverses Health Canada’s earlier position that recruitment messaging should omit the manufacturer’s name.

Medical condition and treatment awareness materials

Medical condition and treatment awareness materials will not be promotional merely because manufacturers declare their sponsorship by name or logo. Materials should direct patients to HCPs, focus on the disease and use a balanced approach in discussing available treatment options (e.g., must not minimize risks and exaggerate benefits of certain health products). Further, such materials must not refer to an unauthorized health product or indication or to the availability of a product via the Special Access Program (SAP). In earlier drafts, Health Canada restricted alluding to, referring to or mentioning single-source treatments. This restriction has been removed from the Guidance suggesting that Health Canada heeded industry feedback that such a restriction was arbitrary.

Medical procedure and health service messages

Medical procedures and services (e.g., cosmetic services) offered by HCPs in their clinics can be advertised to the general public as long as specific products are not 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 or make therapeutic or safety comparative claims. 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., should not modify the context by which the content is disseminated (e.g., different audience, emphasis on a specific product, etc.); otherwise, the message may be deemed as promotional. A sponsor of the social media activity or message cannot engage in discussions with platform users except in a monitoring capacity.

Other learning activities (educational activities)

Two subcategories of educational activities are generally deemed as non-promotional: continuing medical education, scientific/medical exhibits and conferences (CME); and other learning activities (OLA). The definitions and requirements relating to CME and OLA programs in the Guidance align with the Innovative Medicines Canada (IMC) Code of Ethical Practices.

CME events are accredited programs for HCPs. Manufacturers can also present at these events when allowed by event organizers. Commercial exhibits and advertisements are allowed if they are located in an area that is separate from the primary CME event. Manufacturers cannot develop or influence the content of the agenda or the content of presentations by others.

OLAs are unaccredited programs, events or activities where medical/scientific information is presented to HCPs by HCPs and which are identified through a needs assessment in collaboration with HCPs or health organizations. Presenters at OLAs must disclose funding and conflicts of interest and have complete editorial control.

The primary focus of these learning activities must be the exchange of scientific and clinical information, and materials must be developed in accordance with such objectives and consistent with the Canadian terms of market authorization (or, if an unauthorized product is discussed, the presenter must disclose this fact to the attendees). Patients, patient groups, experts in a given field, sales representatives and other non-health care professionals may only attend these events if their participation is justified and allowed by event organizers. Members of the public should not attend. During the events, samples cannot be distributed, and sales representatives must not engage in promotional activities.

International conferences

International conferences held in Canada are not promotional, provided that any drug product displayed and not authorized in Canada is so identified.

Responses to inquiries

Information relating to a health product can be provided by a manufacturer in response to an unsolicited request for information if the request was not encouraged by the manufacturer in any way. Where the inquiry concerns an unauthorized product or off-label indication, the response must not be communicated by the manufacturer’s sales or marketing personnel; otherwise, it may be considered promotional.

Corporate messages, press releases and press conferences

Corporate messages (e.g., websites, brochures, published articles, press releases, shareholder information) are promotional if they focus more on the health products than the manufacturer; provide excessive information about the health product; or do not mention, for unauthorized drugs or indications, that safety and efficacy is still under review.

More detailed health product information when required by Canadian securities laws may be non-promotional. In initial drafts of the Guidance, one factor that would suggest a press release or announcement was promotional was if it was published for more than a maximum of 30 days. After receiving comments from industry on conflicts with securities law and other disclosure requirements, Health Canada removed this as an indicator of promotional messaging and currently advises that a press release or announcement may be considered promotional if it is kept indefinitely on the landing page of a Canadian website despite no longer being considered as “news” (e.g., posted for more than 1 year from the initial date of publication and not archived).

Additionally, under the Guidance, information on safety or efficacy and comparisons to other treatments in corporate messaging may be considered non-promotional if factually based. Further, a health product can be described as a “breakthrough” if it is accompanied by a statement that the USFDA granted a breakthrough therapy designation.

Market access/formulary kits

Formulary kits and market access applications continue to be permissible, provided that they don’t exceed the information required to support an application to public or private formularies or hospitals and are not disseminated to a wider audience than a health technology assessment agency.

Patient support group activities and literature

Manufacturers can work with patient support groups, and such activities would not be promotional if the group informs its members of the current manufacturer’s funding and of the group’s role (and such role is consistent with ethics board approval). The group’s role cannot change based on manufacturer funding levels. Patient groups and their members can participate at conferences and learning activities, provided that the content is disease-focused, and no emphasis is placed on one product or drug class. Patient support group literature should declare sponsorships, and such declarations do not make the information promotional, provided that the content is disease focused and treatment options and risks are discussed objectively.

Risk management plans

A risk management plan (RMP) is required (or requested) by Health Canada and describes a set of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks related to drugs. To be considered non-promotional, an RMP, and associated risk minimization tools (RMTs), must be scientifically accurate and consistent with the Canadian Product Monograph. RMTs may not be used as detailing aids or distributed to health care professionals by sales and/or marketing staff.

Advertising regulation in Canada

Health Canada is the regulatory authority for all health product advertising in Canada and is responsible for interpreting and enforcing advertising laws and regulations. The regulator delegates some of its oversight to advertising preclearance agencies (APAs), including the Pharmaceutical Advertising Advisory Board (PAAB) and Ad Standards Canada, who provide stakeholders with case-by-case assessments and advisory opinions on specific messages or activities and can validate that they are either non-promotional or in compliance with the legislation. APAs rely on Health Canada’s published guidelines to ensure their codes and standards align with federal laws. While Health Canada encourages a manufacturer to seek advice from an APA, there is no legislative requirement to do so. Industry organizations such as IMC require its members to consult with APAs through their member codes.

APAs typically have an internal complaints resolution process in cases of non-compliance. While they do not have the authority to compel stakeholders to comply with their rulings, ultimately, complaints can be forwarded to Health Canada for enforcement when needed. Further, anyone can make an advertising complaint directly to Health Canada for review. Penalties for failing to comply with applicable law governing the advertising of health products can range from an order to take corrective actions to the cancellation of market authorization.

For additional information, please see our earlier bulletin on the draft version of the Guidance.