How DTCA Influences Prescription Pharmaceutical Markets - Innovation and Marketing in the Pharmaceutical Industry - page 643

any information regarding the disease. Thus, reminder messages are by requirement
more combative or “destructive,” generating market power rather than informing,
since they exclusively promote the brand. These two types of ads are not subject to any
regulations. However, product claim advertisements , which combine both brand and
disease information, are regulated by FDA to comply with the fair balance require-
ment , which necessitates a fair representation of risks and benefits of the drug.
Australia, the European Union, and Canada prohibit DTCA. However, in Canada,
pharmaceutical firms can use certain types of consumer-directed advertisements, on
account of reinterpretation of the provisions (Peppin 2006 ). Rules regarding adver-
tisement of pharmaceutical drugs are outlined in the Food and Drugs Act and
Regulations (FDR) and governed by Health Canada. According to Section C.01.044
(1) of Canada's Food and Drugs Act, advertising of prescription medicines (e.g.,
drugs listed in Schedule F of the Regulations ) should be limited to the drug's name,
price, and quantity, essentially allowing for reminder type messages. Two policy
statements released by Health Canada in 1996 and 2000 essentially provided a rein-
terpretation of the Act and its regulations. The first statement aiming to clarify the
boundaries between information and advertising, stated that the agency “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” (Health Canada, January, 1996 ). This declaration implicitly served as
an approval for help - seeking advertisements . The second statement relaxed the FDR
even further and explained that firms can advertise prescription drugs as long as
they do not combine “…promotional information on a specific prescription only
drug and a particular disease or condition in a single advertisement.” The same rule
prohibits the airing of such announcements sufficiently close in time, the use of
same actors, and common executional elements such as music and mood, to inhibit
typical viewers easily link the two messages (Health Canada, November, 2000 ). In
sum, pharmaceutical firms can use reminder (brand-only), or help-seeking (disease-
only) messages, but product claim ads that combine brand and disease information
are prohibited by the federal legislation.
Although the responsibility of governing and enforcing regulations lies with
Health Canada, other bodies such as the Pharmaceutical Advertising Advisory
Board (PAAB) and Advertising Standards Canada (ASC) became influential and are
partially accountable for the intricate nature of DTCA practice in Canada. PAAB is
made up of various stakeholders, such as industry representatives, health practitio-
ner organizations, journal editors, and consumer organizations, and is mainly
responsible for the preclearance of physician-directed prescription drug advertising.
ASC's primary focus is the advertising of over-the-counter drugs to the public.
Although there is no preclearance option for consumer-directed advertising, PAAB
and ASC provide regulatory advice on the compliance of promotional messages
with the federal regulations in response to the voluntary requests from the pharma-
ceutical firms. The complaints, however, are only handled by Health Canada.
Table 22.1 , adapted from Kolsarici and Vakratsas ( 2010 ), provides a global
taxonomy of DTC advertising with respect to regulations. We use two classification
criteria to capture regulatory effects: content, which refers to the information each