Case C-39/03 P: Appeal brought on 3 February 2003 by Commission of the European Communities against the judgment delivered on 26 November 2002 by the Second Chamber, Extended Composition, of the Court of First Instance of the European Communities in Joined Cases T-74/00, T-76/00, T-83/00 to T-85/00, T-132/00, T-137/00 and T-141/00 between Artegodan GmbH, Bruno Farmaceutici and Others, Schuck GmbH, Laboratorios Roussel Lda, Laboratoires Roussel Diamant Sàrl, Roussel Iberica SA, Gerot Pharmazeutika GmbH, Cambridge Healthcare Supplies Ltd and Laboratoires pharmaceutiques Trenker SA and Commission of the European Communities
Date: 2003-03-22
Institutions: Court of Justice
Subjects: EU Member State, European Commission, General Court (EU), action for annulment (EU), dangerous substance, market approval, medicinal product, pharmaceutical industry, withdrawal from the market

22.3.2003

EN

Official Journal of the European Union

C 70/15

The applicant claims that the Court should:

(a) Declare that,

— by laying down the technical criteria to be met by
wheelchairs in order to be eligible for reimbursement
by social security in such a way as to exclude from
the list of wheelchairs eligible for reimbursement
those bearing EC markings but which do not meet
the relevant criteria, namely, as regards the diameter
of the front and rear wheels, the cover and filling of
the seat and back, the dimensions of the flat sections
and crossbars, head rests and/or foot or leg rests;

— by laying down more general criteria which the
economic operator must meet
to be
included on the list of reimburseable wheelchairs,
namely special conditions for manual wheelchairs,
as well as special conditions for power wheelchairs
according to which such wheelchairs must be avail-
able in a minimum number of seat sizes;

in order

— by having been too rigid in its updating of the list of
equipment eligible for the reimbursement scheme,
the Kingdom of Belgium has failed to fulfil
its
obligations under Article 28 EC;

(b) Order the Kingdom of Belgium to pay the costs.

Pleas in law and main arguments

is decisive in the choice of

Wheelchairs are medical devices within the meaning of Council
Directive 93/42/EEC of 14 June 1993 concerning medical
devices (1). It follows that wheelchairs bearing an EC marking,
provided for in Article 17 of that directive, must be freely
placed on the market in all the Member States. Eligibility for
reimbursement determines to a large extent access to the
Belgian market in wheelchairs, the cost of which is in many
cases considerable and in respect of which eligibility for
reimbursement
the patient.
Keeping in place technical criteria conditioning eligibility for
reimbursement of wheelchairs is not justified by public health
reasons, since all wheelchairs bearing EC markings are deemed
to satisfy the safety criteria laid down by Directive 93/42/EEC.
Moreover, the Belgian authorities have not shown in what way
making reimbursement for wheelchairs contingent on the
satisfaction of certain technical criteria could contribute to
maintaining the financing of the health insurance system in
equilibrium. The requirement that wheelchairs should be
available in a minimum range of chair sizes is not such as to
offer greater protection for the health and safety of users and
other persons. None of the objectives relied upon by the

Belgian authorities (reliable scale of costs for patients and
realities of the market) has to date been identified by the Court
of Justice as an overriding requirement capable of justifying a
measure having an effect equivalent to quantitative restrictions.
The Commission is of the view that a period of up to 9 months
for including on the list of reimburseable wheelchairs those
bearing EC markings which, accordingly, meet the require-
ments of public health and safety laid down in Directive 93/
42, cannot be considered to be reasonable.

(1) Council Directive 93/42/EEC of 14 June 1993 concerning medical

devices (OJ 1993 L 169, p. 1).

Appeal brought on 3 February 2003 by Commission of the
European Communities against the judgment delivered on
26 November 2002 by the Second Chamber, Extended
Composition, of the Court of First Instance of the Euro-
pean Communities in Joined Cases T-74/00, T-76/00, T-83/
00 to T-85/00, T-132/00, T-137/00 and T-141/00 between
Artegodan GmbH, Bruno Farmaceutici and Others,
Schuck GmbH, Laboratorios Roussel Lda, Laboratoires
Roussel Diamant Sàrl, Roussel Iberica SA, Gerot Pharma-
zeutika GmbH, Cambridge Healthcare Supplies Ltd and
Laboratoires pharmaceutiques Trenker SA and Com-
mission of the European Communities

(Case C-39/03 P)

(2003/C 70/25)

An appeal against the judgment delivered on 26 November
2002 by the Second Chamber, Extended Composition, of the
Court of First Instance of the European Communities in Joined
Cases T-74/00, T-76/00, T-83/00 to T-85/00, T-132/00,
T-137/00 and T-141/00 between Artegodan GmbH, Bruno
Farmaceutici and Others, Schuck GmbH, Laboratorios Roussel
Lda, Laboratoires Roussel Diamant Sàrl, Roussel Iberica SA,
Gerot Pharmazeutika GmbH, Cambridge Healthcare Supplies
Ltd and Laboratoires pharmaceutiques Trenker SA and Com-
mission of the European Communities was brought before the
Court of Justice of the European Communities on 3 February
2003 by the Commission of the European Communities,
represented by R. Wainwright and H. Støvlbæk, assisted by
B. Wägenbauer, with an address for service in Luxembourg.

C 70/16

EN

Official Journal of the European Union

22.3.2003

The appellant claims that the Court should:

— set aside the judgment of the Court of First Instance of
the European Communities of 26 November 2002 in
Joined Cases T-74/00, T-76/00, T-83/00 to T-85/00,
T-132/00, T-137/00 and T-141/00;

— order the defendants to pay the costs.

Pleas and main arguments

that chapter. The interpretation of

— Misinterpretation of Articles 15a(1) and 12 of Second
Council Directive 75/319/EEC of 20 May 1975 on
the approximation of provisions laid down by Law,
Regulation or Administrative Action relating to pro-
prietary medicinal products (1): The Court of First Instance
was wrong to refrain from examining the wording of
Article 15a(1) of Directive 75/319/EEC. If that article was
intended to be restricted solely to the procedure for
mutual recognition provided for in Article 10(2), the
Community legislature would have indicated as much by
means of specific wording. The effect of the reading of
the Court of First Instance is to reduce Chapter III, which
is none the less composed of Articles 8 to 15c, to a single
provision of
the
wording of Article 15a(1) as referring to the whole of
Chapter III of Directive 75/319 is confirmed by the
purpose of that provision as well as by the division of
powers between the Member States and the Community.
Article 15a (the ‘follow-up’ procedure) and Articles 10,
11 and 12 of Directive 75/319 share a common purpose,
and it is reasonable to interpret Article 15a as applying
to all the procedures referred to in Chapter III. The
misinterpretation, by the Court of First Instance, of the
distribution of powers in connection with Article 15a(1)
is the result of a failure to understand the division of
powers which characterises the whole of the other
provisions in Chapter III of Directive 75/319. That
chapter does not lay down an ‘exclusive competence of
the Commission’ as against an ‘exclusive competence of
the Member States’ as the Court of First Instance wrongly
introduces procedures which are
claims. Chapter III
intended to attain the common objective, namely that of
protecting public health and the completion of
the
internal market in medicinal products, by means of the
instruments in Articles 10, 11 and 12 and of the ‘follow-
up’ procedure in Article 15a. Each of those provisions
forms part of
framework of shared and
complementary competences, namely the Member States
retain responsibility for marketing authorisation of med-
icinal products for human use and the Community,
represented by the Commission, intervenes whenever the
various circumstances mentioned in the abovementioned
articles require it. It is the Member States which then
implement the decisions adopted by the Commission in
that context.

the logical

— Misinterpretation of Article 11 of Directive 65/65/EEC
on the approximation of provisions laid down by law,
regulation or administrative action relating to medicinal
products (2): By requiring the existence of new ‘scientific
data or information’ for the suspension or withdrawal of
a marketing authorisation, the Court of First Instance
relies on a criteria which does not appear in Article 11. By
restricting the concept of ‘scientific data or information’
to only data concerning medicinal products properly
speaking, the Court of First Instance ignores that one of
the elements to be taken account of when suspending or
withdrawing a marketing authorisation is ‘therapeutic
efficacy’. The Court of First Instance further ignores that
the definition of what is to be understood by ‘therapeutic
efficacy’ hinges on an assessment carried out by scientific
experts, on the basis of a scientific report, so that medical
and scientific data concerning the substance cannot be
artificially separated from the assessment of its efficacy
or effects which, by the inextricable nature of the links
between them, constitute as such scientific data which
cannot be overlooked in the context of Article 11 of
Directive 65/65/EEC.

— (In the alternative) Breach of the precautionary principle.

— Breach of the principle of burden of proof: It is not for
the Commission but for the holders of the marketing
authorisations to show that the medicinal products in
question have the therapeutic efficacy required by the
new scientific criteria.

— Disregard for the limits of judicial review: The Court of
First Instance substitutes its assessment of the guidelines
laid down by the Committee for Proprietary Medicinal
Products and the national guidelines referred to in the
opinion of that committee of 31 August 1999 for that of
the scientists who drew up and assessed the guidelines in
question.

— Distortion of the facts.

(1) OJ 1975 L 147, p. 13.
(2) OJ, English Special Edition 1965-1966, p. 20.

Action brought on 3 February 2003 by the Commission
of the European Communities against the Italian Republic

(Case C-43/03)

(2003/C 70/26)

— (In the alternative) Misinterpretation of Article 15a of
Council Directive 75/319/EEC: That article does indeed
apply to national marketing authorisations harmonised
by the Member States following the consultation pro-
cedure under Article 12.

An action against the Italian Republic was brought before the
Court of Justice of the European Communities on 3 February
2003 by the Commission of the European Communities,
represented by Luca Visaggio, acting as Agent, with an address
for service in Luxembourg.