Illegal marketing of prescription drugs
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Prescription drugs are pharmaceutical and biological drug products that:
- are for human or veterinary use
- need a prescription in order to be dispensed to a patient or a caregiver
Prescription drugs may:
- pose a high level of risk
- not have been on the market for a long period of time
- have a narrow margin of safety between their risks and benefits
- require individualized instructions and/or direct supervision by a health care provider
Requirements to advertise prescription drugs in Canada
Advertising prescription drugs is regulated in Canada under the:
Anyone who promotes the sale of a specific health product is subject to this legislation. This includes health care providers.
However, not all messages about prescription drugs are advertising. Messages may be non-promotional information if they do not promote a health product.
Our guidance document, The distinction between advertising and other activities, explains how we use certain factors to help determine if a message is information or advertising.
These factors include:
- who pays for the message
- who delivers the message
- influence by the manufacturer
- context in where and how it is distributed
- the message's content, purpose or audience
We use these factors to assess each message on a case-by-case basis.
Certain types of messages are less likely to be advertising. These include:
- press releases
- journal articles
- scientific exhibits
- educational websites
However, even these may be found to be promotional in some instances, based on context.
For example, information on diseases may discuss prescription drugs and other therapeutic options, as long as there is no emphasis on a specific drug.
The distinction is important: if a message is considered advertising, it must comply with federal advertising requirements.
We strongly encourage health product advertisers to take advantage of Canada's voluntary advertising preclearance system.
A drug product's official Health Canada authorized product monograph is a factual, scientific document about the product.
A product monograph:
- does not contain any promotional material
- describes the properties, claims, indications and conditions of use of the drug product
- may be posted on a corporate website if the website doesn't have any promotional material
However, the context in which the product monograph is displayed or published is important in determining if it meets federal advertising requirements.
Information for health care providers
The Food and Drugs Act and its associated regulations do not apply to advertising of services.
However, advertising any prescription drugs to the general public for the treatment, prevention or cure of certain serious diseases is prohibited.
If you promote specific products on your website, you must comply with the federal advertising requirements.
We have received complaints about direct-to-consumer advertising of prescription drugs on the websites of health care providers. In addressing the complaints, we noted this practice was widespread.
We want to:
- help you comply with federal advertising requirements
- increase your awareness of federal advertising requirements and the requirements that apply to you, specifically
This information relates only to federal regulatory requirements. Each province may have its own requirements for health care provider advertising which may impose additional restrictions.
Information for prescription drug manufacturers
Websites of pharmaceutical manufacturers must either:
- be non-promotional in nature
- comply with federal advertising requirements
We allow 2 types of prescription drug messages directed to consumers:
- reminder ads, which:
- are limited to the name, price and quantity of a prescription drug
- do not include reference to a disease state
- help-seeking messages, which:
- discuss a disease state
- make no reference to a specific prescription drug product
- meet the criteria outlined in the policy "The distinction between advertising and other activities"
Poster to share
What to watch for in prescription drug advertising
Direct-to-consumer marketing of prescription drugs is restricted. Any drug product listed in the Prescription Drug List is subject to Section C.01.044 of the Food and Drug Regulations. This prohibits advertising prescription drugs to consumers beyond:
Prescription drug advertising to health care providers does not have this restriction.
Botox is an example of a prescription drug that health care providers and clinics sometimes market to consumers. No direct or indirect reference can be made to its therapeutic use and/or benefits.
Commonly encountered marketing issues identified with Botox include:
- videos describing the procedures
- before and after treatment pictures
- pictures alluding to the indications of the drug
- testimonials regarding the therapeutic benefits
How health care providers can help stop illegal marketing
Health care providers can help stop illegal marketing by:
- reporting it to Health Canada
- learning about and complying with federal advertising requirements
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