WRITTEN QUESTION E-3464/02 by Cristiana Muscardini (UEN) to the Commission. Withdrawal of a medicinal product in Italy.
Date: 2002-12-06
Institutions: European Parliament, Provisional data
Subjects: Italy, market approval, marketing, medicinal product, national law, pharmaceutical industry, pharmaceutical legislation, single market, tropical disease

C 137 E/212

Official Journal of the European Union

EN

12.6.2003

Enclosed herein there are results obtained in the Structural Business Statistics-Framework with data for
reference year 1999 for seven participating Member States. For more detailed information, the publication
‘Foreign-owned enterprises’ with data for reference year 1997 and the Statistics in Focus ‘Foreign-owned
enterprises’ with data for reference year 1998 are sent direct
to the Honourable Member and to
Parliament’s Secretariat (1)

Contribution of foreign-controlled
enterprises to business economy
in seven Member States, 1999

Member State

Value added at factor cost

(%)

Denmark

Spain

France

Netherlands

Portugal

Finland

Sweden

9,2

15,4

15,6

17,4

13,2

13,7

19,8

For France and Luxembourg the number of employees is used as a proxy

Business economy: NACE Sections C to I, and K

However, this measure is not available for all Member States and not for the Union aggregate. A draft
Regulation on the structure and activity on foreign affiliates is presently under discussion following
Eurostat initiative. This legal framework would enable to provide the requested information for all Member
States and for the Union as a whole.

(1) See also answer given by the Commission to written question E-3453/02 by the Honourable Member, See p. 210.

(2003/C 137 E/239)

WRITTEN QUESTION E-3464/02

by Cristiana Muscardini (UEN) to the Commission

(6 December 2002)

Subject: Withdrawal of a medicinal product in Italy

‘Leishmaniosi
is a tropical disease transmitted by an insect bite. Over the last few years it has been
spreading through various parts of Italy and has even become endemic (i.e. firmly established in the
regions concerned). In humans the disease manifests itself in the form of cutaneous eruptions which are
easily treatable. Problems arise when it adopts its canine form, in which it is fatal. There exists an effective
medicinal product produced by the Avensis pharmaceutical company under the name of Glucantin. It used
to cost three euros per box (cid:1) used to, because it has been unavailable in Italy for some time.’

This information is taken from the 17 November 2002 edition of the Italian daily newspaper Libero.

Can the Commission answer the following:

1. What reasons have prompted the manufacturer to withdraw the product in question from circulation

within Italy?

2.

3.

Is the product still freely available in other European countries?

If so, is this on account of the fact that its price is much higher there than in Italy?

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Official Journal of the European Union

C 137 E/213

4.

5.

In any event, is it true that the product is still being manufactured by Avensis?

If so, is it right that, within a single internal market, a given product can be sold only in certain
countries and not in others?

Answer given by Mr Liikanen on behalf of the Commission

(22 January 2003)

1.
According to information given by the competent authority in Italy, Ministero della Sanita, Aventis
requested by 12 November 2002 a temporary suspension of the marketing authorisation for Glucantin in
Italy due to manufacturing problems.

2.

The product is still available in France and Spain.

3.
Pricing and reimbursement of medicinal products fall within the responsibility of Member States.
The Commission has no information in respect to pricing and reimbursement of the medicinal product
Glucantin in the different Member States.

4.

The manufacturing site is Livron/France. The manufacturer is Aventis.

National marketing authorisations for Glucantin were given according to Directive 2001/83/EC (1) by
5.
the competent authorities in the different Member States. This directive provides that medicinal products
have to be authorised for the marketing in each Member State. There is no provision in the Community
legislation obliging the marketing authorisation holder to ask in all Member States for a marketing
authorisation.

(1) Directive 2001/83/EC of the Parliament and of the Council of 6 November 2001 on the Community code relating

to medicinal products for human use, OJ L 311, 28.11.2001.

(2003/C 137 E/240)

WRITTEN QUESTION E-3476/02

by Jan Mulder (ELDR) to the Commission

(6 December 2002)

Subject: European framework regulation for BSE costs consumer levy

Since introduction of the compulsory BSE test for groups of cattle, various Member States have been
giving support to producers to offset the costs associated with such tests. This support takes the form of
direct subsidies or a levy on the (end) product.

In its answer to Written Question P-3134/01 (1) the Commission says that after it has assessed the
information on support measures for ‘the cost of BSE’ which it obtained in 2001, it will decide what steps
should be taken for further harmonisation.

1.

Has the Commission now carried out such an assessment, and what conclusions has it produced?

2.
Has the Commission thus reached the conclusion that there is no longer a crisis situation, partly
because the price of beef has returned to its old level, and because the internal market ought once more to
operate without distortion?

3.
Does the Commission agree that, in view of the substantial scale of BSE testing costs in relation to
the animal’s value, and hence the enormous impact of the support measures in distorting competition,
a European regulation should be drafted to counteract that distortion?

4.
Does the Commission agree that a framework regulation giving Member States the opportunity to
introduce a levy on the end product would be a suitable instrument for dealing with the distortion of
competition caused by the cost of compulsory BSE testing on the European market?

(1) OJ C 115 E, 16.5.2002, p. 230.