Date Created: 2010-11-03
HC Pub.: 100624
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Guidance documents are meant to provide assistance on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada's mandates and objectives should be implemented in a manner that is fair, consistent and effective.
Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternative approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternative approaches should be discussed in advance with the relevant program area to avoid possibly finding that applicable statutory or regulatory requirements have not been met.
As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.
This document should be read in conjunction with the relevant sections of other applicable guidance documents and policies. This guidance document supersedes the two policies entitled "Pharmaceutical Advertising Advisory Board and Health Canada Roles and Consultation Related to Advertising Review" (1996) and "Advertising Standards Canada and Health Canada's Roles and Consultation Related to Advertising Review and Complaint Adjudication" (1997).
Health Canada and the Canadian Advertising Preclearance Agencies (APAs) share the common goal of maintaining integrity in health product advertising. The purpose of this guidance document is to inform staff and stakeholders of the different roles these organizations play in achieving this goal.
This guidance document clarifies the roles of Health Canada and the Canadian APAs with respect to the review of health product advertising, the adjudication of complaints and processes to submit requests for clarifications. Health products include prescription and non-prescription pharmaceuticals, biologicals and natural health products intended for human use. Advertising of medical devices is not included in the scope of this document.
Health Canada is the national regulatory authority for health product advertisements and is responsible for administering and directing compliance with the Acts and Regulations. It is the responsibility of all advertisers to ensure that health product advertisements comply with the requirements of the Food and Drugs Act (F&DA) and its
Regulations, and the Controlled Drugs and Substances Act (CDSA).
When required by the F&DA andits Regulations, market authorization holders of health products will file, prior to marketing, a submission containing information and evidence to establish the safety, efficacy and quality of a health product for its intended use, and will subsequently receive marketing authorization in the form of a Notice of Compliance (NOC) and/or a Drug Identification Number (DIN), a Natural Product Number (NPN) or a Drug Identification Number for Homeopathic Medicine (DIN-HM).
For the purposes of the F&DA, advertising is defined 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. If a message regarding a drug is not considered to promote the sale or use of the drug, it is not subject to the advertising provisions of the F&DAand Regulations. The Health Canada policy The Distinction between Advertising and Other Activities clarifies the distinction between advertising to promote the sale of a drug and activities that are not primarily intended to promote the sale of a drug.
The preclearance of advertising for marketed health products is administered through an independent, self-regulatory and voluntary system. Advertising preclearance agencies are independent entities which review and preclear advertising material to help interested parties ensure compliance with the regulatory provisions of the F&DA, CDSA and respective Regulations, the Natural Health Products Regulations (NHPR), and consistency with the various Health Canada guidance documents and their own codes of advertising. The agencies also offer mechanisms to resolve complaints on advertising for authorized health products.
Numerous provisions of the F&DAand its Regulations (e.g.,the Food and Drug Regulations [F&DR]and the NHPR) and the CDSA apply to drug advertising, and are included as reference in appendix B.
Some of the following terms may be interpreted more broadly in other, non-advertising contexts; however, for the purpose of this guidance document, they are defined as follows:
Canadian APAs provide advertising material review services to advertisers and advertising agencies. They use Health Canada's guidance documents and their own codes of advertising to ensure that advertising material submitted to them, in all media, complies with the F&DA, CDSA, and respective Regulations. The APAs review advertising for consistency with the TMA and to verify that the advertising is accurate, balanced and evidence-based, and does not expand upon or conflict with the TMA. Advertisers should submit a copy of their advertising material to an APA for review prior to production to avoid costly changes to final executions. Advertising approved by the APA is assigned an approval number and/or authorization to use the APA logo or seal/mark, which signifies that the advertising has been reviewed and, in the view of the APA involved, complies with the applicable legislation, regulations, guidance documents, and the APA codes.
Canadian APAs are committed to work towards the integrity and accuracy of advertising through voluntary preclearance to achieve compliance with the F&DA, CDSA, respective Regulations, Health Canada guidance documents, and the APA codes of advertising.
Health Canada supports and encourages the use of a voluntary health product advertising preclearance system that supports adherence to federal legislative requirements.
During the preclearance review of a health product advertisement, or during the processing of an appeal or complaint, the APAs may request further clarification from Health Canada. Conversely, Health Canada may wish to bring an advertising issue to the attention of the APAs. These requests for clarification are described in this guidance document, along with complaint-handling procedures.
The APAs also offer independent complaint-resolution and appeal procedures, and administer related sanctions and remedial measures according to their internal policies, procedures and standards.
The APAs should monitor trends in health product advertising and promotion and adjust their codes and practices as required to fulfill their mandate.
The APAs may evaluate marketing claims such as comparative claims that are not included in the TMA, provided the data submitted by the advertising sponsor does not expand upon or conflict with the TMA and does not require submission of an application to Health Canada.
Some agencies also provide advisory opinions on messages directed to consumers for prescription drugs, Schedule D drugs (biologics, including vaccines) and on material discussing a medical condition/disease to ensure that they meet the regulatory requirements.
Additional information about the health product advertising preclearance system in place in Canada, including the list of Canadian APAs, is available on Health Canada Web site.
Health Canada establishes the TMA of health products and is the national regulatory authority for health product advertising. To this effect, Health Canada sets standards for health product advertising material and:
Health Canada uses the following approach in performing its roles:
The APAs review and preclear health product advertisements to determine, in their view, whether the advertisement complies with the provisions of the F&DA, the CDSA, respective Regulations, Health Canada's guidance documents, as well as with the agencies' own codes of advertising.
The List of Canadian Advertising Preclearance Agencies includes groups with distinct roles (Appendices C and D).
An agency in this category has notified Health Canada that it has publicly self-attested to meeting Health Canada's recommended criteria for the preclearance of advertising material for non-prescription drugs including natural health products directed to consumers.
The services provided would generally include the review of advertising copy for radio, television, Internet, mass print (e.g., newspapers, magazines, flyers, point of purchase), social media, and out-of-home (e.g., billboards, transit) targeting consumers. Consultation service for new product launches and advertising concepts may also be offered in this category.
An agency in this category is recognized by Health Canada for preclearance of advertising material for all health products directed to healthcare professionals. The services provided would generally include the review of advertising pieces targeting healthcare professionals in all media such as print publications (e.g., medical journals, information brochures, pamphlets, and direct mail/detail aid materials), audio (e.g., radio), audio/visual (e.g., television), electronic means of communication (e.g., the Internet, including social media), as well as any novel media not yet contemplated. Consultation service for new product launches and advertising concepts may also be offered in this category.
An agency in this category provides advisory opinions on messages directed to consumers for prescription drugs (e.g., reminder ads), material discussing a medical condition or disease (e.g., help seeking messages), Schedule D drug (biologics, including vaccines) advertisements, and other messages or materials (e.g., clinical trial recruitment announcements, press releases, institutional messages, etc.). Agencies in this category are required to forward copies of advisory opinions to Health Canada for information purposes. Advisory opinions are assessments as to whether materials, based on Health Canada's policy The Distinction between Advertising and Other Activities, are promotional, in which case they must be in accordance with the F&DAandRegulations, CDSA, and associated policy and guidance documents. Consultation service for new product launches and advertising concepts may also be offered in this category.
Note: An agency can provide services that are categorized in more than one of the above categories/groups.
The MAH, or sponsor, has a responsibility to develop advertising material that is compliant with the F&DA and associated regulations, to cooperate with complaint resolution procedures, and to discontinue or amend non-compliant advertising material in order to bring it to compliance.
The request for clarification process between The APAs and Health Canada shall be as follows:
When there is a question or concern about a health product advertising or TMA, the enquiry should be directed to Health Canada in writing, setting out:
The following information should also be provided where applicable:
The dialogue will be between the APA and Health Canada. The advertising sponsor will be apprised of the decision through the APA.
Health Canada will make every effort to conduct a preliminary review of the request for clarification and issue an acknowledgement letter to the APA within 15 business days. If a resolution has not been achieved within this period, the APAs will be provided with an estimated time frame for resolution and will be informed of the reason for delay. Requests that are brought to Health Canada's attention are often complex and may require several internal consultations within the department. For example, if it is necessary to consult with a product-specific directorate of Health Canada, it may take up to 30 days to provide a response. Health Canada will strive to provide the APA with a final assessment in a timely manner.
Clarification of Terms of Market Authorization
Issues raised with Health Canada include clarification of the advertiser's interpretation of the TMA, and any claims or statements being made which would necessitate a change to the TMA (such as changes requiring a Supplementary New Drug Submission (Division 8, Part C of the F&DR), a DIN submission (Division 1, Part C of the F&DR), or a Notifiable Change Submission).
Health Canada should not be consulted on other issues (such as therapeutic comparative claims), unless the contentious claim conflicts with, relates to, or expands upon the TMA, or if the APAs require clarification as to whether the claim is consistent with the TMA.
Regulatory/policy interpretations and emerging advertising trends
The APAs may consult Health Canada for advice on application of federal regulatory requirements and emerging advertising trends. Such issues may be posed in writing or discussed at the APA bilateral meetings with Health Canada.
When Health Canada has a concern about the review of an advertising piece or campaign, it will bring this matter to the attention of the APA providing the review and will identify:
The dialogue will be between Health Canada and the APA. If applicable, the advertising sponsor will be apprised of the decision through the APA.
The APA will make every effort to address the request for clarification and provide Health Canada with a written response and account of the actions taken, where applicable, within 15 business days.
The first route for advertising complaints adjudication of all Health Canada authorized health products is through the APAs, except as specified below. The APAs will process complaints pursuant to the provisions and time frames expressed in their internal complaint resolution procedures.
The following types of advertising complaints should be reported directly to Health Canada, bypassing the APAs:
The procedures for handling complaints received by Canadian APAs and Health Canada shall be as follows (Appendix E):
Complaints submitted to the APAs should be referred as follows:
The APAs are expected to refer to Health Canada (MHPD serves as point of contact):
For all complaints received, whether referred or directly submitted, MHPD determines non-compliance (by evaluating the advertisement against the requirements of the Acts and their Regulations) and assesses the health risk posed by the advertising material at issue. The outcome of the risk assessment is the determination of the level of health risk, which could increase or decrease at any time, given new information surrounding the circumstances of the non-compliance.
The MHPD will perform a rudimentary health risk assessment to determine the level of risk to human health posed by exposure to the advertising, prior to taking risk management actions. This will involve the use of a Risk Matrix below.
|Seriousness of Health Consequences|
|Probability/Likelihood of occurrence of Health Consequences||High||High|
Since the determination of the level of risk is based on evidence available to date, and given that the adverse health consequence and its seriousness is most often "unknown", the MHPD would utilize the precautionary principle/approach in risk assessment and management. When the rudimentary risk assessment suggests a "medium" or "high" level of health risk, an HRA may be requested from the applicable product-specific directorate.
For the purpose of the rudimentary risk assessment performed at the MHPD:
High risk: High probability/likelihood of the health consequence occurring with a high seriousness ( symptoms are life threatening or disabling).
Medium risk: Medium probability/likelihood of the health consequence occurring with a medium seriousness ( symptoms are mild and non-life threatening. Usually some form of treatment is indicated. No residual disability following treatment).
Low risk: Low probability/likelihood of the health consequence occurring with a low seriousness ( symptoms are minimally bothersome, no therapy is necessary).
Once non-compliance and the health risk level of an advertisement is determined, immediate risk management actions may be taken by Health Canada and may include but is not limited to:
Risk management actions can be taken alone or in combination, and sequentially or simultaneously. Further information on regulatory measures available to Health Canada in order to achieve compliance by regulated parties are described in Health Canada's Compliance and Enforcement Policy (POL-0001)
Complaints pertaining to advertising for authorized health products are sometimes submitted in error directly to Health Canada by the complainant. These will first be assessed for non-compliance with the Acts and Regulations and the level of health risk they pose, as described in section 3.5.2, and then handled as follows:
Complaints referred to Health Canada by the APAs will first be assessed for non-compliance with the Acts and Regulations and the level of health risk they pose, as described in section 3.5.2, and then handled as follows:
Health Canada will not otherwise become involved in the APAs complaint and appeal processes.
The Food and Drugs Act Liaison Office (FDALO) provides an impartial and confidential resource for individuals, businesses and organizations when they experience problems with how Health Canada administers the F&DA. It acts as an intermediary to help the parties arrive at a mutually agreed upon resolution. Complainants or advertisers who are not satisfied after having first attempted to resolve their issues through mechanisms described above, may wish to take advantage of the conflict resolution services offered by the FDALO.
Section 3(1): No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.
Exemption: Refer to Sections A.01.067 and A.01.068 of the F&DR, and Sections 103.2 and 103.3 of the Natural Health Products Regulations (NHPR), which exempt natural health products (NHPs) and non-prescription drugs from the F&DA's Section 3 general prohibition on labelling and advertising of preventative claims for Schedule A diseases. Therefore, as of June 1, 2008, authorized claims for the prevention of Schedule A diseases may appear on the labels of the NHPs and non-prescription drugs. Claims on product labels are to match the authorized wording. Claims used in advertising may deviate in their wording as long as the claims are consistent with the product's TMA and do not directly or indirectly exceed the scope of the TMA.
Section 9(1): No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.
In order to make informed decisions about their health, consumers should be provided with fair and balanced information about the benefits and the risks associated with the use of advertised health products. Examples of contraventions to Section 9(1) include:
Section 14(1): No person shall distribute or cause to be distributed any drug as a sample.
Exception: (2) Subsection (1) does not apply to the distribution, under prescribed conditions, of samples of drugs to physicians, dentists, veterinary surgeons or pharmacists.
Section A.01.067: A drug is exempt from subsection 3(1) of the Act with respect to its advertisement to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A to the Act.
Section A.01.068: A drug is exempt from subsection 3(2) of the Act with respect to its sale by a person where the drug is represented by label or is advertised by that person to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A to the Act.
Section C.01.007: No reference, direct or indirect, to the Act or to these Regulations shall be made upon any label of or in any advertisement for a drug unless such reference is a specific requirement of the Act or these Regulations.
Section C.01.044: Where a person advertises to the general public a Schedule F Drug (prescription drugs), the person shall not make any representation other than with respect to the brand name, proper name, common name, price and quantity of the drug.
Section C.08.002: No person shall sell or advertise a new drug unless
Section G.01.007 No person shall
Section 70: No person shall
Section 92: No reference, direct or indirect, to the Act, the Food and Drug Regulations or to these Regulations shall be made on any label of or in any advertisement for a natural health product unless the reference is specifically required by law.
Section 103.2: A natural health product is exempt from subsection 3(1) of the Act with respect to its advertisement to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A to the Act.
Section 103.3: A natural health product is exempt from subsection 3(2) of the Act with respect to its sale by a person where the drug is represented by label or is advertised by that person to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A to the Act.
The Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) promulgated on August 4, 2010, allow for the legal sale of a category of natural health products for which Health Canada has not yet issued a product licence but has completed an initial assessment to ensure that information supporting the safety, quality and efficacy of the product has been provided, and that specific safety criteria have been met.
The Guidance Document Health Canada and Advertising Preclearance Agencies' Roles Related to Health Product Advertising does not address exempt NHPs. Please refer to the Natural Health Products Compliance and Enforcement Policy (POL-0044) and the Annex to the Natural Health Products Compliance and Enforcement Policy for exempt NHPs under the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) (POL-0093) which are available on the Compliance and Enforcement section of Health Canada's Web site.
Health Canada has developed a position statement that applies to exempt NHPs in relation to preclearance and complaint adjudication of advertising materials: Health Canada's Position Statement on the Preclearance and Complaint Adjudication of Exempted Natural Health Product Advertising Materials. This position statement is available on the Health Canada Web site as well.
|Advertising Preclearance Agency||Review Advertising for:||Target Audience|
|Pharmaceutical Advertising Advisory Board (PAAB)||Rx drugs
Schedule D drugs
(Biologics, including vaccines)
|Advertising Standards Canada
(formerly Broadcast Clearance Advisory)
|Advertising Preclearance Agency||Advisory Opinions (Consumer-directed: Rx & Schedule D)||Target Audience|
|Pharmaceutical Advertising Advisory Board (PAAB)||Medical condition / disease
Schedule D drugs (including vaccines)
|Advertising Standards Canada
|Medical condition / disease
Schedule D drugs (including vaccines)