POLICY STATEMENT
Advertising Campaigns of Branded and Unbranded Messages
November 2000 Administrative Update: August 2005
Health Canada recently conducted an investigation
on an advertising campaign directed to consumers involving the dissemination
of branded and unbranded messages for a prescription drug. In the advertising
campaign, branded messages provided the name of the prescription drug
with no mention of its use and unbranded messages, discussed the therapeutic
indication without naming the drug.
Health Canada reviewed the advertising campaign
with respect to the application of Section C.01.044 (1) of the
Food and Drug Regulations and associated Health Canada guidelines and policies,
in particular, The Distinction Between Advertising and Other Activities.
Health Canada concluded that the Direct-to-Consumer campaign, as a whole,
did constitute a violation of C.01.044 (1) of the Food
and Drug Regulations. In order to provide guidance to independent
preclearance advertising agencies for future opinions in this area, the
following elements should be considered:
Canada's Food and Drugs Act, (FDA) defines "advertisement" to
include "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". Section C. 01.044 of the Food and Drug
Regulations requires that advertising of prescription medicines (e.g.
drugs listed in Schedule F of the Regulations) be limited to the
drug's name, price and quantity:
C.01.044. (1) Where a person advertises to the general
public a Schedule F Drug, 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.
Applying this definition and rule, a drug firm cannot combine promotional
information on a specific prescription only drug and a particular disease
or condition in a single advertisement. Further, if a typical consumer
could easily link two announcements and the messages contained in such
announcements taken together similarly contravene this prohibition then
the airing of such announcements sufficiently close in time is also prohibited
by the rule. A sponsor seeking to broadcast non-branded messages discussing
treatments and branded messages identifying a prescription drug product
in question concurrently, would contravene Section C.01.044 of the
Regulations.
Health Canada recognizes the importance to the
pharmaceutical industry and to the general public of being able to disseminate
and access non-promotional information regarding drugs for human use.
The policy "The Distinction Between Advertising and Other Activities",
issued in 1996 (http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/ actv_promo_vs_info_e.html) is intended to fulfill the need for guidance
on the distinction between advertising and non-promotional activities.
The purpose of the above-mentioned policy is to set the limits between
information and advertising. This policy does not explicitly address the
issue of advertisements which may be aired consecutively or simultaneously.
However, it does express that no one factor in itself will determine whether
or not a particular message is advertising. The content and the context
in which a message is disseminated must be evaluated.
Therefore, even though the individual ads, taken independently, met
the Food and Drugs Act and Regulations, as a whole (unbranded and
branded messages), the campaign was considered to contravene the Food
and Drugs Regulations. When a particular information piece can be
characterized as part of a larger campaign that combines promotional
information on a specific prescription only drug and a particular disease
or condition in a single advertisement then it may be part of a larger
set of activities that can be argued to constitute a violation of these
Regulations.
In the Direct-to-Consumer campaign, the fact that similar context, style,
music and actors were used in both the unbranded and branded messages
was taken into consideration.
The sponsor was advised that the basis for Health Canada's decision
must be considered when developing future advertisements.
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