Case C-74/03: Reference for a preliminary ruling by the Østre Landsret by order of that Court of 14 February 2003 in the case of SmithKline Beecham plc against Lægemiddelstyrelsen; interveners being Synthon BV and Genthon BV
Date: 2003-04-26
Institutions: Court of Justice
Subjects: document, interpretation of the law, marketing, medicinal product, pharmaceutical product

26.4.2003

EN

Official Journal of the European Union

C 101/21

The applicant claims that the Court should:

— annul

the Commission’s decision of 11 December
2002 (1), in so far as it finds that the subsidising of loans
and guarantees for owners of agricultural holdings and
the extension of tax benefits to the transfer of agricultural
land and holdings constitute State aid incompatible with
the Treaty;

— order the Commission to pay the costs.

Pleas in law and main arguments

much larger amount, against which the Commission had
publicly advised but which was adopted in other Member
States such as France, Germany or Italy. It can in no
way be maintained that Spanish operators enjoyed an
economic advantage to which those of other Member
States did not have access.

— (In the alternative) If State aid is found to exist,

it is
compatible with the common market in the light of
Article 87(2)(b) EC: neither the objective nor the result of
the alleged aid was to cover loss suffered by the farmer:
the intention was to make it easier for him to obtain a
loan from financial institutions so that the loans would
make up for the lack of liquidity brought about by the
disproportionate increase in costs caused by the steep
rises in fuel prices. If, following the Commission’s rec-
ommendation not to reduce the special tax on fuel oils
or value added tax, no alternative measures were adopted,
Spanish farmers would become less competitive in their
trade by comparison with States which implemented
permitted, although not recommended, tax reductions.

(The extension of certain tax benefits to transfers of land)

— (In the alternative) Compatibility of the measures in the

light of Article 87(3)(c) EC.

— This does not constitute State aid since certain undertak-
ings or the production of certain goods are not specifically
favoured: the measure entails a lower tax burden for the
seller of the land and has an impact on the owner (farmer)
purchasing land: not as to the amount but as to the
greater availability of land for sale because of the lower
capital gains tax charge for the seller.

— (in the alternative) The aid is compatible with the
Community guidelines for State aid in the agricultural
sector: A farmer who invests in the acquisition of land,
and is the owner of a priority holding, by definition
satisfies the requirements set out in point 4.1 of the
Community guidelines as regards the economic viability
of the holding and the occupational skill required for the
grant of structural aid cofinanced by the EU under the
Regulation on improving the efficiency of agricultural
structures in force at the material time.

(The subsidising of
agricultural holdings

loans and guarantees for owners of

— This does not constitute State aid within the meaning of
Article 87 EC since it does not affect trade between
Member States: The Spanish measure entailing the sub-
sidising of loans was actually symbolic in the face of a
sector which felt that its economic viability was seriously
threatened by the exceptional fuel-price increase. It is
paradoxical that a palliative measure of such a slight
unitary significance should give rise to a decision of
incompatibility with the common market when it was
adopted as an alternative to a reduction in taxes of a

(1) Relating to measures taken by Spain to support agriculture

following the fuel price increase.

Reference for a preliminary ruling by the Østre Landsret
by order of that Court of 14 February 2003 in the case of
SmithKline Beecham plc against Lægemiddelstyrelsen;
interveners being Synthon BV and Genthon BV

(Case C-74/03)

(2003/C 101/35)

Reference has been made to the Court of
Justice of the
European Communities by order of the Østre Landsret (Eastern
Regional Court) of 14 February 2003, received at the Court
Registry on 19 February 2003, for a preliminary ruling in the
case of SmithKline Beecham plc against Lægemiddelstyrelsen
(Danish Medicinal Products Administration); interveners being
Synthon BV and Genthon BV on the following questions:

C 101/22

EN

Official Journal of the European Union

26.4.2003

Q u e s t i o n 1

Pleas in law and main arguments

Is it compatible with point 8(a)(iii) of Article 4 of the
First Medicinal Products Directive (Directive 65/65/EEC (1), as
amended) for a product to be authorised under the abridged
application procedure when a salt of the active substance in
the product is changed from the one used in the reference
product?

Article 249 EC, under which a directive shall be binding, as to
the result to be achieved, upon each Member State, carries by
implication an obligation on the Member States to observe the
period for compliance laid down in the directive. That period
expired on 17 July 2001 without Ireland having enacted the
provisions necessary to comply with the directive referred to
in the conclusions of the Commission.

Q u e s t i o n 2

(1) OJ L 201 of 17.7.1998, p. 88.

Can the abridged application procedure be used when an
applicant, on its own initiative or at the request of national
health authorities, submits additional documentation in the
form of certain pharmacological or toxicological tests or
clinical trials with a view to demonstrating that the product is
‘essentially similar to’ the reference product?

( 1) Council Directive 65/65/EEC of 26 January 1965 on the approxi-
mation of provisions laid down by Law, Regulation or Adminis-
trative Action relating to proprietary medicinal products (OJ B 22
of 9.2.1965, p. 369).

Action brought on 19 February 2003 by the Commission
of the European Communities against Ireland

(Case C-75/03)

(2003/C 101/36)

An action against Ireland was brought before the Court of
Justice of the European Communities on 19 February 2003 by
the Commission of the European Communities, represented
by Nicola Yerrell, acting as agent, with an address for service
in Luxembourg.

The Applicant claims that the Court should:

(1)

find that Ireland has failed in its obligations under the EC
Treaty by failing to adopt the laws, regulations and
administrative provisions necessary to comply with
Council Directive 98/50/EC of 29th June 1998 amending
Directive 77/187/EEC on the approximation of the laws
of the Member States relating to the safeguarding of
employees’ rights in the event of transfers of undertakings,
businesses or parts of businesses (1), or by failing to
ensure that employers’ and employees’ representatives
have introduced the necessary provisions by agreement,
and/or by failing to inform the Commission thereof; and

(2)

condemn Ireland to bear the costs of the procedure.

Action brought on 20 February 2003 by the Commission
of the European Communities against the Federal Repub-
lic of Germany

(Case C-77/03)

(2003/C 101/37)

An action against the Federal Republic of Germany was
brought before the Court of Justice of the European Communi-
ties on 20 February 2003 by the Commission of the European
Communities, represented by Claudia Schmidt, of the Euro-
pean Commission’s Legal Service, acting as Agent, with an
address for service in Luxembourg at the office of Carlos
Gómez de la Cruz, also of the European Commission’s Legal
Service, Wagner Centre C 254, Kirchberg.

The applicant claims that the Court should:

1.

declare that, by failing to bring into force the laws,
regulations and administrative provisions necessary to
comply with Directive 98/71/EC (1) of the European
Parliament and of the Council of 13 October 1998 on
the legal protection of designs and/or by failing to inform
the Commission of those provisions, the Federal Republic
of Germany has failed to fulfil its obligations under that
directive;

2.

order the Federal Republic of Germany to pay the costs.

Pleas in law and main arguments

The period for transposition expired on 28 October 2001.

(1) OJ L 289 of 28.10.1998, p. 28.