Over the past 2 years there has been an overt drive by the European Parliament to improve patient access to information on
medicines. However, there is growing concern that some of the proposals put forward will lead to direct-to-consumer (DTC)
advertising.1 Historically, in Europe, DTC has been considered an inappropriate means for pharma companies to communicate with patients
because it bypasses the healthcare professional.
DTC in the US
In the US, DTC advertising is firmly entrenched, characterised by low government intervention in the market. Historically,
advertising was always directed at healthcare professionals, but the increasing involvement of patients in healthcare decisions
prompted some companies to change tactics.2 The first print DTC advertisement in the US appeared in 1981 from Boots for its ibuprofen product, Rufen. This was shortly
followed by a similar approach from Merck for Pneumovax, its pneumonia vaccine.
These developments took the FDA by surprise and it was forced to quickly react to the situation. In 1982, the agency asked
pharma companies for a voluntary moratorium on DTC advertisements while it researched the issue. Its surveys revealed a desire
from patients for more information about medicines, so in 1985 the agency decided that DTC was permissible provided that it
met the same legal requirements as advertising directed at healthcare professionals. At this stage, DTC took off and with
time the number of promotional routes increased to take in radio and television.
One of the main problems for the FDA was that official regulations were not designed to cover advertising. The 1906 Food and
Drugs Act, which represented the basis of future regulations, only focused on the information provided on the medicine's label
— advertising was never specifically mentioned. Another issue was that the advertising itself was under the jurisdiction of
the Federal Trade Commission (FTC), which could only act if a company's promotional advertising adversely affected that of
another company. Deceptive advertising itself was not covered.
It was only in the early 1960s that regulatory authority over prescription drug advertising was transferred from the FTC to
the FDA. Within the FDA, drug advertising is now regulated by the Division of Drug Marketing, Advertising and Communications
(DDMAC); however, no official regulations specifically mention DTC. This vagueness effectively means that the agency has been
playing catch up in trying to regulate novel advertising developments. The appearance of the internet as a promotional channel
is one such example.
Despite its existence, DTC advertising has a number of opponents in the US. For a start, many observers do not like the fact
that it is difficult to determine exactly how much is being spent by the pharma industry on such promotional measures.3 When dealing with the media, the pharma industry likes to stress its investment in R&D, but while stating that promotion
is vital to its work, the industry appears reluctant to provide financial figures.
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Those who favour DTC believe that it heightens patient interest in their health and brings them information on new products
that they might otherwise not know about.4 Others, however, believe that pharma companies do not provide impartial information, which puts the physician under pressure
when a patient asks about a product they have seen advertised. Also, many consumer groups believe that drug prices are becoming
too high, fuelled by DTC.
Outside the US, New Zealand, Bangladesh and South Korea allow limited DTC advertising, while in some other markets limited
advertising has been permitted for certain vaccines.5 Most attention, however, has been on whether Europe will ever permit DTC — particularly as European regulators have often
adapted a number of US regulations for the region.
DTC advertising for Europe?
Previous efforts to introduce DTC approaches in Europe have been rejected. In 2002, the EC introduced a proposal to allow
pharma companies to answer patient requests in three disease areas: diabetes, asthma and HIV/AIDS.6,7 The intention was to allow a 3year trial period, but these measures were strongly rejected by the European Parliament. Surprisingly,
the measures were also rejected by the pharma industry, which made it clear that it had not sought to change the existing
regulations regarding the direct provision of information to patients. Nevertheless, the industry did use the opportunity
to express irritation in the way it was monitored. For example, it asked why specific laws stood in the way of it communicating
with patients over its products, even when others could. Presumably, this meant information communicated by the media about
new medicines. In this regard, the restrictions on the pharma industry contrast with the freedom enjoyed by manufacturers
of vitamins and herbal remedies, who routinely advertise products to patients. The pharma industry also asked why companies
manufacturing foods containing unhealthy ingredients were not prevented from freely communicating with the public.
While not advocating DTC advertising outright, the European pharma industry has consistently held the position that in a regulated
environment there should be some means for companies to communicate directly with patients regarding their medicines. Given
the carefully worded statements from the pharma industry suggesting that it is not openly seeking change, it is therefore
surprising that DTC proposals continue to be put forward for debate in the European Parliament.