WRITTEN QUESTION P-0428/00 by Pietro-Paolo Mennea (ELDR) to the Commission. Inclusion of a symbol on medicine packages showing which medicaments contain banned substances.
Date: 2000-02-11
Institutions: European Parliament, Provisional data
Subjects: European social policy, labelling, medicinal product, performance drugs

24.10.2000

EN

Official Journal of the European Communities

C 303 E/191

(2000/C 303 E/218)

WRITTEN QUESTION E-0415/00

by Torben Lund (PSE) to the Commission

(23 February 2000)

Subject: Copyright

On the basis of the Berne Convention and Council Directive 93/98/EEC (1) harmonising the term of
protection of copyright and certain related rights will the Commission please state:

1. To what extent the lawful reproduction of an original work, regardless of the method used to

reproduce it, influences the term of protection enjoyed by the work under EU rules?

2. Whether the lawful reproduction of a work, regardless of the method used, means that other
reproductions may be made against the interests of the rightholder before the end of the term of
protection enjoyed by the work under EU rules?

(1) OJ L 290, 24.11.1993, p. 9.

Answer given by Mr Bolkestein on behalf of the Commission

(10 April 2000)

Council Directive 93/98/EC harmonising the term of protection of copyright and certain related rights not
only defines the Community terms for each category of works or subject matter protected, but also
specifies the event which gives rise to the start of this term in each specific case. In fact, in order to fulfil
the task of completing a true internal market within which there is free movement of goods and services
protected by intellectual property rights, total harmonisation has been achieved, with all the factors which
may affect the terms of protection being taken into consideration.

The lawful reproduction of a work is a normal act of exploitation which has no influence on the term of
protection. It is difficult to imagine a situation in which the lawful reproduction of a work could lead to
other reproductions being made against the interests of the rightholder, as such reproductions should also
be subject to the rightholder(cid:146)s authorisation or fall into one of the categories of legally authorised use. In
any case, a situation of this nature does not in any way affect the term of protection.

(2000/C 303 E/219)

WRITTEN QUESTION P-0428/00

by Pietro-Paolo Mennea (ELDR) to the Commission

(11 February 2000)

Subject: Inclusion of a symbol on medicine packages showing which medicaments contain banned

substances

Sport has an important role in society and may now be considered as an integral part of the culture of all
Community countries:

(cid:129) taking into consideration that it has an educational, cultural and recreational function recognised in

the Amsterdam Treaty;

(cid:129) it is important in safeguarding the health of athletes who practise various kinds of sport;

(cid:129) it has been demonstrated that drug abuse has serious immediate and long-term consequences for the

health and physical integrity of people, including sportsmen;

(cid:129) the serious damaging effects vary according to the category of drugs used and other variables, such as
the dose, the duration of treatment, the combining of different kinds of drugs and the presence of
diseases which may aggravate the toxic effects;

(cid:129) in general the risks inherent in taking such drugs are underestimated;

C 303 E/192

Official Journal of the European Communities

EN

24.10.2000

(cid:129) a young athlete may be the final link in a chain of abuse and unlawful, even criminal, practices which

often go undetected and unpunished;

(cid:129) in view of the fact that most sportsmen do not know enough about the specific properties of

medicaments; and

(cid:129) that the Union must be at the forefront of the fight against doping.

Can the Commission say whether, in compliance with EEC directives and European drug legislation, it
intends to oblige the pharmaceutical industries to include a symbol on the packaging of newly introduced
drugs and clear warnings in the enclosed leaflets telling both doctors and sportsmen which drugs contain
banned substances?

Answer given by Mr Liikanen on behalf of the Commission

(8 March 2000)

As stated in the (cid:145)Community support plan to combat doping in sport (1)(cid:146) the Commission feels that
stepping up the supply of information on medicines is a highly important factor in the fight against the
use of drugs in sport.

Article 12 of Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for
human use (2) provides the Commission with scope for formulating certain special warnings for certain
categories of medicinal product. Moreover, Article 2 of that same directive provides that the outer
packaging (of medicines) may include symbols or pictograms designed to clarify certain items of
information concerning a medicine, and which is useful for health education, to the exclusion of any
element of a promotional nature.

As part of this, in order to provide further information on medicines containing active substances classified
as drugs, the Commission put this matter on the agenda of the next meeting of the pharmaceuticals
committee, which will be held on 22-23March 2000. The Member States and the European Agency for the
Evaluation of Medicinal Products are represented on this. The Commission has drawn up a questionnaire
enabling an inventory to be made of what has already been introduced at national level in certain Member
States. The aim is to put forward harmonised entries on both the labelling and package leaflets for
the summary of product
medicines that are intended to inform patients, and on the wording of
characteristics intended to provide information for professional healthcare providers.

(1) COM(1999) 643 final (cid:129) Communication from the Commission to the Council, Parliament, the Economic and

Social Committee and the Committee of the Regions of 1 December 1999.

(2) OJ L 113, 30.4.1992.

(2000/C 303 E/220)

WRITTEN QUESTION P-0437/00

by Richard Howitt (PSE) to the Commission

(11 February 2000)

Subject: Legal possibilities for Parliament to downgrade or halt political contact with a Member State

Bearing in mind my Amendment No 1 to resolution B5-0101/2000 on the current situation in Austria,
can the Commission inform me what possibilities exist, consistent with Parliament(cid:146)s obligations under the
Treaty on European Union, for Parliament to downgrade or halt altogether contacts at political level with a
European Union Member State?

Could the Commission address this question separately and specifically in relation to the following: access
and entry into any of Parliament(cid:146)s premises; diplomatic and protocol contacts between the President and
the other Members acting in a representative capacity on behalf of Parliament; participation in the
conciliation procedure; representation by a Member State(cid:146)s political representatives during that state(cid:146)s
Presidency of the European Union; participation by political representatives of a Member State not holding