On 3 March
2015 Advocate General Szpunar delivered his opinion in joined cases C-544/13 and C-545/13 Abcur.
The Swedish
case, which led to the preliminary questions assessed by Szpunar, deals with a
dispute between Apoteket, a State-owned company which produces and markets two
products without having obtained an authorisation for
sale as a medicinal product pursuaent to Regulation (EC) No 726/2004 and Abcur, a pharmaceutical
company which manufactures
and markets two similar products and which has obtained an authorisation pursuant to Regulation
(EC) No 726/2004. Abcur’s complaint against Apoteket concerns the fact
that Apoteket manufactures the products without an authorisation and some measures
employed by Apoteket to present the products. Among 7 complex questions
referred to the Court, these of special interest for consumer law covers the question,
whether Directive 2005/29/EC on unfair commercial practices advertising are
also applicable for medicinal
products for human use falling under Directive 2001/83/EC and whether Directive 2006/114/EC on
misleading and comparative can apply to advertising falling outside the scope
of Directive 2001/83.
According
to Szupnar, Directive 2005/29 and Directive 2001/83 can apply, in principle, in
parallel (para 58). Szpunar points out that the directive is without prejudice to Union
or national rules relating to health and safety aspects of products (Article
3(3) of Directive 2005/29) and that Article 3(4) of the directive
states that in the case of conflict between its provisions and other Community
rules regulating specific aspects of unfair commercial practices, the latter
shall prevail and apply to those specific aspects. Moreover, a combined reading
of Article 7(5) of and Annex II to Directive 2005/29 demonstrates the
complementary character of Directive 2005/29 and Directive 2001/83 – information
required by EU law in relation to commercial communication including
advertising or marketing is to be regarded as material information for the
purposes of defining a misleading omission (paras 58–61).
The
referring court does not relate to the substantive requirements of Directive
2005/29. Nevertheless, Szpunar underlines that the scope of the directive is
limited to business-to-consumer commercial practices and it addresses
commercial practices directly related to influencing consumers’ transactional
decisions in relation to products. Consequently, only information accessible to
consumers can be regarded as falling within the scope of the directive whereas
the medicinal product in question can only be acquired through a prescription
by a doctor (par. 65–68). In that case, the consumer is adequately protected by
the doctor. However, Directive 2005/29 can be applied if a court finds that
there is “a connection between the information provided and influence on the
doctor to prescribe the product at the
instigation of the consumer/patient” (para 69).
As regards Directive 2006/114 Szpunar recalled that
the directive’s scope is
confined with respect to misleading advertising to business-to-business
relations. The directive applies to any particular sector of economic activity,
unless there are specialised rules governing such a sector. In the absence of
an explicit exclusion of Directive 2006/114, it should be applicable.
Therefore, Directive 2006/114 is
applicable also to medicinal products which fall outside the scope of Directive
2001/83 (paras 80–83).
Finally, Szpunar clarifies the term ‘advertising’ defined in Article 2(a)
of Directive 2006/114 as making of a representation in any form in connection
with a trade, business, craft or profession in order to promote the supply of
goods or services. It has been confirmed by the Court that this is a particularly
broad definition which covers various forms of advertising. However, Article 86(2)
of Directive 2001/83 excludes from the application of Title VIII on
Advertising a range of measures like labelling and accompanying package
leaflets and factual, informative announcements, and reference material relating,
for example, to pack changes, adverse-reaction warnings as part of general drug
precautions, trade catalogues and price lists, provided that they include no
product claims. These measures cannot constitute ‘advertising’ for the purpose
of Article 2(a) of Directive 2006/114, because the general rule on
advertising to which economic operators are subject should not be stricter than
a special rule. Though, it has to be borne in mind that the crucial element is
whether it can be objectively determined that the representation has been made
with a view to promoting the supply of a good or service. The Court held in MSD Sharp & Dohme that Article 86(1)
of Directive 2001/83 did not, in principle, preclude the possibility that
published or distributed material which includes only objective information
could be regarded as advertising and that ‘[i]f the message is designed to
promote the prescription, supply, sale or consumption of medicinal products, it
is advertising for the purposes of that directive. However, material which is
purely informative, without promotional intent,
is not covered by the provisions of that directive relating to advertising of
medicinal products.’ (paras 86–90 and MSD Sharp & Dohme, para 35). It is therefore for the
referring court to establish these factual matters so as to determine whether
and to what extent the activities at issue in the main proceedings constitute
advertising within the meaning of Directive 2006/114 (para 92).
To
be confirmed by the Court of Justice of the European Union…
