To find answers and understand their importance, we first start with The Food and Drug Act and Regulations. These are laws passed by parliament that govern anything to do with the manufacturing, distribution and advertising of both OTC and prescription drugs.
Like any set of laws, they have to be applied in the real world. Health Canada is the Federal Government agency that interprets and enforces the Food and Drug Act and sets all the Guidelines that govern the day-to-day application of the Act.
Educational Information vs. Promotional Advertising
Health Canada’s overall mandate is to protect the health and safety of Canadians. As part of that mandate, Health Canada recognizes the importance to consumer health of non-promotional health information.
Health Canada therefore encourages the distribution of consumer health information that is fair, balanced, objective, and educational.
Educational consumer health materials that meet these criteria are called Direct-To-Consumer Information (DTCI). Promotional materials whose primary function is to advertise are called Direct-To-Consumer Advertising (DTCA). To distinguish between DTCI and DTCA, Health Canada has published official Guidelines to follow when developing DTCI materials.
Why is the distinction between DTCI and DTCA so important?
Consumer health materials that are produced in accordance with the Health Canada Guidelines are automatically classified as DTCI. There is no pre-clearance or approval process to follow for DTCI programs. Only voluntary adherence to the Health Canada Guidelines is required.
According to Health Canada, DTCI complies with the Food and Drug Act, is not advertising, and can be distributed directly to consumers and made available in physician waiting rooms.
What about ASC and PAAB?
If consumer health materials do not comply with Health Canada’s Guidelines for DTCI then they are classified as DTCA (advertising) and Health Canada’s advertising regulations apply.
Health Canada mandates two agencies to review and pre-clear advertising materials for prescription drugs: Advertising Standards Canada (ASC) and the Pharmaceutical Advertising Advisory Board (PAAB).
Advertising that is distributed to or through physicians (including compliance and adherence programs) is pre-cleared by the PAAB according to the PAAB Code and given a PAAB number. Pre-clearance of physician materials and adherence to the PAAB Code for Advertising is a requirement for all Innovative Medicines Canada members.
Advertising distributed directly to consumers (DTCA) is pre-cleared by ASC. Most broadcasting and mass-media outlets will not publish an advertisement without an ASC approval number.
ASC and PAAB are not mandated by Health Canada to pre-clear or approve DTCI materials.
Can we still ask ASC or PAAB to review DTCI materials?
Yes, and DTC Direct recommends that our clients do so.
Although it is not required by Health Canada, you may voluntarily ask ASC or PAAB for their ‘advisory opinion’. This is not pre-clearance or approval; it is simply an opinion as to whether your materials follow the Health Canada Guidelines. After either agency has given their ‘advisory opinion’ it is sent to Health Canada. An approval number is not issued.
ASC in particular has published an excellent Guide to producing DTCI materials that conform to the Health Canada Guidelines.
How does DTC Direct communicate with consumers?
We don’t advertise, we educate.
DTC Direct inspires, motivates and educates consumers to become informed partners in the management and treatment of their condition.
All of our programs follow the Health Canada Guidelines for DTCI. In fact, in over 20 years of communicating with consumers and patients on behalf of Innovative Medicines Canada members, our programs have not logged one single complaint with PAAB, ASC, Health Canada, PIPEDA or any other regulatory organization.
The Distinction Between Advertising and Other Activities
Health Canada August 2005
Overview of Health Product Advertising
Health Canada: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/index-eng.php
Home > Drugs & Health Products > Regulatory Requirements for Advertising
Health Canada’s Role
Health Canada is the national regulatory authority for health product advertisements. We:
Provide policies to effectively regulate marketed health products,
Put in place guidelines for the interpretation of the Regulations, and
Oversee regulated advertising activities.
Our department is committed to ensuring that information in a health product advertisement is not false, misleading or deceptive. We may intervene when an advertisement poses a significant safety concern, in the event that resolution is not achieved through the independent agencies’ complaints mechanism, when a prescription drug is illegally advertised to the general public or when an unauthorized health product is promoted.
Administrative Update: August 2005 PAAB and Health Canada Roles and Consultation Related to Advertising Review
From the Health Products and Food Branch
PAAB Role: The PAAB role is to review and clear advertising material prior to exposure to the health professional, and to administer a complaints and appeals procedure and related sanctions and remedial measures as outlined in the PAAB Code. . . .
Administrative Update: August 2005 Advertising Standards Canada and Health Canada and Consultation Related to Advertising Complaint Adjudication
From the Health Products and Food Branch
ASC Role: ASC role is to review and clear advertising materials prior to being disseminated to consumers via the broadcast media and mass-media print publications; to monitor other print media by an alternative mechanism; and to administer complaints and appeals referenced in the ASC Advertising Standards. . . .
Drugs and Health Products: Regulatory Requirements for Advertising
Who reviews advertisements?
Health product advertisements are reviewed and pre-cleared by independent agencies. The List of Canadian Advertising Preclearance Agencies may be consulted for their contact information and roles.
Advertising material for all health products directed to health professionals: is reviewed and pre-cleared by the Pharmaceutical Advertising Advisory Board (PAAB), an independent agency recognized by Health Canada.
Advisory opinions on messages directed to consumers for prescription drugs and on educational material discussing a medical condition/disease: The PAAB, as well as Advertising Standards Canada (ASC), provide advisory opinions on messages directed to consumers for prescription drugs and on educational material discussing a medical condition/disease to ensure that they meet the regulatory requirements.