A Therapy Against National BarriersLiberalization Of European Pharmaceutical Advertising
Cause And Effect
In retrospect, the European pharmaceutical industry may well
wonder why it owes the liberalization of advertising to a
ginseng product. Ginseng is usually not the first ingredient
that springs to mind when thinking of pharmaceutical products
in Europe. However, it's true that small causes can have
great effects: what started out as just one of the hundreds of
disputes initiated in Germany each year over pharmaceutical
advertising triggered the most significant ruling on European
pharmaceutical advertising to date, resulting in the creation
of a uniform legal framework for advertising throughout Europe
and the liberalization of national restrictions.
This butterfly whose flapping wings caused not a tornado but
a fresh breeze was the German advertising campaign of a
distributor of ginseng products. The campaign used patient
testimonials as well as a prize drawing in which consumers
could win the product in questionadvertising tools that are
both prohibited by German law. In its appearance, the campaign
did not differ much from the campaigns of distributors of
comparable products; its impact, however, differed a great
deal. Not only did the case, initiated by a fair-trade
association, go all the way to the German Federal Supreme Court
("Bundesgerichtshof"), but the court
requested a preliminary ruling of the European Court of Justice
("ECJ") on whether the German legislation was
compatible with Directive 2001/83/EC of the European Parliament
and of the Council of November 6, 2001, on the Community Code
Relating to Medicinal Products for Human Use, as amended
("the Community Code").
Minimum Standards vs. Maximum Standards
The first question put to the ECJ, which lends the case its
fundamental importance, concerned the relationship of the
Community Code to national legislation with regard to
advertising. Does the Community Code provide minimum standards
only, allowing the Member States of the European Union to
impose stricter rules on advertising, or does it at the same
time set a definitive maximum standard, limiting regulation by
the Member States? This question had also been disputed among
the Member States, the majority taking the stance that the
Community Code sets minimum standards and allows for stricter
national legislation. The ECJ, however, in its judgment dated
November 8, 2007, took the latter position (Gintec
International Import-Export GmbH v Verband Sozialer Wettbewerb
eV, Case C-374/05). The court held that the Community Code
aims to remove barriers to trade between Member States.
Disparities in national legislation on advertising may impair
the functioning of the internal market. The Community Code
expressly states in which cases Member States may adopt
stricter legislation on advertising. In the absence of such an
option, the Community Code sets not just a minimum standard but
a maximum at the same time. This is in line with a decision
rendered two months earlier in which the ECJ decided that the
procedures for obtaining a marketing authorization laid down in
the Community Code are exhaustive, preventing the Member States
from implementing additional procedures (judgment dated
September 20, 2007, The Netherlands v Antroposana et
al., Case C-84/06).
No Cure For The Defense
One of the ironies of the case lies in the futility of the
ginseng distributor's efforts to defend the advertising
campaign in question. By answering two further, specific
questions on the prohibitions of German law, the ECJ pointed
out that the campaign in question was not in line with the
Community Code either. First, the testimonials claimed to
improve health in general. This is incompatible with the
prohibition of the Community Code on any suggestion that the
health of the subject could be enhanced by taking the medicine.
At the same time, the testimonials attributed effects to the
product that in all likelihood had to be considered misleading,
as the product did not possess such properties. Second, while
prize drawings in general are not prohibited under the
Community Code, the court pointed out that any excessive and
ill-considered advertising is prohibited. Advertising must
encourage the rational use of medicine, and offering a
medicinal product as a prize does not encourage rational use.
Also, according to the court, offering this product as a prize
has to be equated with free distribution, which violates the
prohibition on direct distribution of medicinal products to the
public by the pharmaceutical industry for promotional purposes.
(The distribution of free samples is limited, under specific
conditions, to persons who prescribe medicinal products.)
Therefore, the German Federal Supreme Courtwhich has not yet
rendered its final decision subsequent to the ruling of the
ECJmight have decided the case directly because European law,
in this specific case, does not lead to a different result than
German law. However, that would have prevented the ECJ's
landmark decision.
A Therapy Against National...
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