WRITTEN QUESTION E-0446/01 by Graham Watson (ELDR) to the Commission. The labelling of animal extracts in medicines.
Date: 2001-02-16
Institutions: European Parliament, Provisional data
Subjects: consumer information, labelling, medicinal product, pharmaceutical legislation

18.9.2001

EN

Official Journal of the European Communities

C 261 E/117

Answer given by Mr Kinnock on behalf of the Commission

(11 April 2001)

The Commission has recruited 5 119 permanent officials through open competitions from January 1991
until end of February 2001.

Year

Number

1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001 (two months)

316
305
361
543
562
731
565
493
480
627
136

Total

5 119

The table comprises the officials recruited on the Operational Budget (budget de fonctionnement) and it
includes figures for the Office for Official Publications and the European anti-fraud office (OLAF).

A table concerning the breakdown by nationality, category and grade is being sent direct
Honourable Member and to the Parliament(cid:146)s Secretariat.

to the

Of these officials, 171 (3,34 %) have terminated their employment with the Commission on a permanent
basis since 1991. The main reasons are resignation (94), transfer to another European Institution (54) and
invalidity (15). A table concerning the breakdown by nationality, category and grade is being sent direct to
the Honourable Member and to the Parliament(cid:146)s Secretariat.

Currently (as of early March 2001), 194 (3,79 %) of these new officials are on unpaid leave (CCP). A table
concerning the breakdown by nationality, category and grade is being sent direct to the Honourable
Member and to the Parliament(cid:146)s Secretariat.

(2001/C 261 E/125)

WRITTEN QUESTION E-0446/01

by Graham Watson (ELDR) to the Commission

(16 February 2001)

Subject: The labelling of animal extracts in medicines

Ingredients of animal origin are essential to the manufacture of a large proportion of medicines. Since this
is a matter of concern to some vegetarians, what plans has the EU(cid:146)s Pharmaceutical Committee to indicate
on the labels of medicinal products whether they contain material extracted from animals?

Answer given by Mr Liikanen on behalf of the Commission

(25 April 2001)

Medicines are products administered to humans to either prevent or treat illnesses or to make a medicinal
diagnosis (1).

The purpose of Community legislation is to guarantee that safe and effective medicines are placed on the
market and to provide information for patients.

C 261 E/118

Official Journal of the European Communities

EN

18.9.2001

The labelling of medicines is therefore intended to indicate the active ingredients of medicines in
qualitative and quantitative terms, plus the list of excipients having a known action or effect i.e. having
either an effect on the metabolism or producing allergic reactions in certain patients.

In addition, to ensure that patients are fully informed, the leaflet for users is to state in full the active
ingredients and excipients in qualitative terms (2). All other information in leaflets and on labels, also given
in full, is intended to permit the correct use of medicines. Patients are therefore given access to detailed
information on the contents of medicines.

In accordance with the objectives of Community legislation in force, ingredients of animal origin are not
specifically indicated as such. There are no plans to change this legislation.

However, health professionals will be able to provide interested patients with more information.

(1) Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation

or administrative action relating to proprietary medicinal products, OJ B 22 of 9.2.1965.

(2) Council Directive 92/27/CEE of 31 March 1992 on the labelling of medicinal products for human use and on

package leaflets, OJ L 113 of 30.4.1992.

(2001/C 261 E/126)

WRITTEN QUESTION E-0447/01

by Arlindo Cunha (PPE-DE) to the Commission

(16 February 2001)

Subject: Tomato aids in 1999/2000

In June 1999 the Commission agreed that the price and aid levels to apply for the 2000 marketing year
would include, in the calculation formula, the figures for tomato exports from the People(cid:146)s Republic of
China.

All the producer Member States voted against in the Management Committee when it debated the price
and aid proposal submitted by the Commission.

Within the Commission, Commissioner Franz Fischler appears to have expressed his willingness to review
the regulation under which aid was cut by 20,54 % for the 2000 marketing year, should the decision-
making background significantly change.

Should the data for China be included for purposes of calculating the aid, the result would be a level of aid
significantly different from that which has hitherto applied.

There is a legal precedent from 1987, in a case relating to sultanas brought by Greece.

The level of aid (cid:129) € 34,5 per tonne (cid:129) set by the COM for the 2001 marketing year confirms the
unfairness of the abnormally low and penalising level established for the 2000 marketing year. By
accepting the former level (cid:129) higher than that initially proposed in the process of reform of the COM (cid:129)
the Commission tacitly recognised that an injustice had been done.

In view of the above, it may be concluded that the most elementary principles of fairness and ethics, as
well as technical considerations, dictate that the aid level for the 2000 marketing year should be set at the
same level as that which will apply for the 2001 marketing year.

Can the Commission state how it intends to compensate industrial units in respect of the difference
between the two levels of aid?