European Court of Justice Rules on Advertising for Prescription Drugs
Information on Prescription Drugs
The (German branch of) pharmaceutical company MSD Sharp
& Dohme GmbH (“MSD”) had posted information on its website
about three drugs available only on prescription: Vioxx, Fosamax
and Singulair. This information consisted of a reproduction of the
packaging of the product concerned, the therapeutic indication and
the leaflet containing instructions for use of the product.
Competitor Merckle GmbH (“Merckle”) was of the opinion that this
should not be permitted. It argued that the posting of the
information by MSD conflicted with European legislation on drug
advertising (as mentioned in Directive 2001/83/EC, last amended by
Directive 2004/27/EC, to be referred to below as the “Directive”).
In addition, Merckle claimed that posting the information amounted
to unfair competition. The latter was likely the most important
reason for Merckle to go to court and to request that MSD cease and
desist its acts.
Preliminary Ruling
Eventually, the case was dealt with by the Bundesgerichthof.
Because the Bundesgerichtshof hesitated about the
interpretation of the Directive, it referred a question for a
preliminary ruling to the European Court of Justice (“ECJ”). This
question related to – in short - the lawfulness of giving
information about a drug by the manufacturer of that drug, if this
information is factual and is not offered as unsolicited
information.
Advertising?
The ECJ considers that in order to answer the question
of the Bundesgerichtshof, the first important question is
whether it concerns a prescription-only drug (in that case rules
with respect to advertising are more strict). That is the case, as
appears from the information provided by the
Bundesgerichtshof. Secondly, it must be assessed whether the
provision of factual information is “advertising” within the
meaning of Article 88 (1) under a of the Directive.
In this respect the ECJ follows the text of Article 86 (1) of
the Directive, which stipulates that advertising for drugs is
regarded as “all forms of door-to-door information, canvassing
activity or inducement designed to promote the prescription,
supply, sale or consumption of medicinal products”. The ECJ rules
that this makes clear that the definition of advertising for drugs
is very broad, and may therefore, in principle, also include merely
informative expressions. According to the ECJ, the objective
of such expression is decisive for the question of whether there is
advertising; if this expression is aimed towards the promotion of
the sale (or the supply, the prescription or the consumption) of
the drug, it must be considered advertising.
Making Available Factual Information Is Not Advertising
Despite this broad definition of the concept of
advertising for drugs and the strict legislation in this field, the
ECJ rules that the provision of only factual information about the
drug, as done by MSD, is not advertising within the meaning of the
Directive. In this respect the ECJ considered that:
- the mere fact that the manufacturer of the drug about which
information is provided has a financial interest in marketing
its product, is in itself not sufficient to assume a
promotional objective;
- any potential interest of consumers cannot lead directly to
a decision to purchase (after all, the drug is only available
on prescription);
- the provision of the information may be useful for
patients, for instance if they have lost the patient
information leaflet;
- it has advantages that already at an early stage a patient
has access to objective information from a reliable
source;
- the information appearing on the packaging and the patient
information leaflet of a drug have been approved by the
competent authorities. Thus, the information is not only
objective, the ECJ rules, but furthermore does not constitute
any health risks.
On the basis of these considerations the ECJ decides that the
provision of information about drugs by the pharmaceutical company
that produces these drugs is allowed, provided that this
information constitutes a faithful reproduction of the packaging,
and is a literal and complete representation of the patient
information leaflet or the summary of the product’s characteristics
as approved by the competent authorities (consideration 43). The
information may not be accompanied by any additional element which
would support its classification as advertising.
No “Push” Service
In this respect the ECJ also deems it important that the
information about the drug is not offered by a “push” service, but
is only available to patients who actively take steps to obtain it.
Therefore, providing information through news feeds and pop-ups is
probably out of the question, because these means tend towards
advertising too much.
Interest for Consumers/Patients
The judgment of the ECJ makes clear that pharmaceutical
companies are free to provide information about prescription drugs,
if this concerns factual, objective information and provided that
the conditions mentioned above are met. This seems to be an
appropriate decision: after all, patients benefit from objective
information being available about the drug they are using or are
going to use – as long as this information is not imposed on
them.