Case C-43/03: Action brought on 3 February 2003 by the Commission of the European Communities against the Italian Republic
Date: 2003-03-22
Institutions: Court of Justice
Subjects: EU control, European Commission, Italy, action for failure to fulfil an obligation, animal nutrition, food inspection, national implementing measure

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.

22.3.2003

EN

Official Journal of the European Union

C 70/17

The Commission claims that the Court should:

— declare that by failing to adopt the laws, regulations
and administrative provisions necessary to comply with
Directive 2000/77/EC of the European Parliament and of
the Council of 14 December 2000 fixing the principles
governing the organisation of official inspections in the
field of animal nutrition or, in any event, by failing to
inform the Commission thereof the Italian Republic has
failed to fulfil its obligations under Article 2(1) of that
directive and under the EC Treaty.

— order the Italian Republic to pay the costs of

the

proceedings.

Pleas in law and main arguments

Article 249 EC, under which a directive is binding on a
Member State, as to the result to be achieved, entails that the
Member States must respect the period for implementation
prescribed by the directive. That period ended on 29 December
2001 without the Italian Republic having adopted the necess-
ary provisions to comply with the directive which is the
subject of the Commission’s claims.

b.

c.

d.

a subsequent decision taken on a date unknown to
the United Kingdom in December 2002 or January
2003 to decommit those sums;

any steps taken pursuant to such decisions including
the act of decommitting those sums;

a Commission decision contained in the letter dated
22 November 2002 to issue a recovery order for the
sum of 9 272 767 Euros of ERDF money already
paid to the United Kingdom in respect of expendi-
ture incurred on MST 2; and

e.

any steps taken pursuant to such decision.

Pursuant to Article 231 EC make a declaration that each
of the said measures is void.

that

the Commission’s

Pursuant to Article 241 EC make a declaration that in the
event
of
Article 52(5) of Regulation 1260/99 (1) and/or Article 10
of Annex to the Commission Decision C(92)1358/8 is
correct, the said measures are inapplicable against the
United Kingdom.

interpretation

(2)

(3)

(4) Make an order that the Commission pay the United
Kingdom the costs of and occasioned by this Application
and these proceedings.

Action brought on 7 February 2003 by the United
Kingdom of Great Britain and Northern Ireland against
the Commission

Pleas in law and main arguments

(Case C-46/03)

(2003/C 70/27)

An action against the Commission was brought before the
Court of Justice of the European Communities on 7 February
2003 by the United Kingdom of Great Britain and Northern
Ireland, represented by P. Ormond, acting as agent, assisted by
D. Lloyd Jones QC and S. Lee, Barristers, with an address for
service in Luxembourg.

The Applicant claims that the Court should:

(1)

Pursuant to Articles 230 and 231 EC make an order
annulling the following measures:

a.

a Commission decision contained in a letter dated
22 November 2002 to decommit
the sum of
11 632 600 Euros in respect of expenditure incurred
on the Manchester/Salford/Trafford 2 operational
programme, or MST 2;

1) T h e D e c o m m i t m e n t o f 1 1 6 3 2 6 0 0 E u r o s

o f E R D F A s s i s t a n c e

The Applicant submits that, in concluding that the United
Kingdom had not complied with Article 52(5) of Regulation
1260/1999, and in its conclusions as to the effect of any such
non-compliance, the Commission erred in law and/or erred in
interpretation and/or made a manifest error in assessment.

The Applicant maintains that
the sanction imposed by
Article 52(5) of the Regulation applies only where an appli-
cation for final payment has not been received by 31 March
2001 and that the Regulation requires no more than that an
application for final payment has been received by the
stipulated date. The Regulation does not require the submission
of an application in any particular form.

In particular, the Regulation does not require that an appli-
cation for final payment must be made in the standard form
ERDF Certification of Expenditure which is usually employed
for this purpose. The Commission therefore erred in law in
concluding that failure to make an application for final
payment in that form led to the imposition of the sanction
imposed by Article 52(5).