WRITTEN QUESTION E-3830/02 by Michl Ebner (PPE-DE) to the Commission. Medication — drugs abuse.
Date: 2003-01-09
Institutions: European Parliament, Provisional data
Subjects: consumer information, labelling, medicinal product, packaging, performance drugs, pharmaceutical legislation, sport

C 155 E/194

Official Journal of the European Union

EN

3.7.2003

In the light of this loophole, would the Commission consider introducing legal measures that harmonise
postal laws, in an attempt to blanket ban fraudulent mailings across EU and non-EU countries?

Answer given by Mr Byrne on behalf of the Commission

(17 February 2003)

The Commission receives an increasing number of complaints related to fraudulent prize-winning games
and including prize offers communicated by e-mail. Currently prize-winning games are not regulated at
Community level. However, the Commission proposal for a Parliament and Council Regulation concerning
sales promotions in the Internal Market (1) plans to cover a sub-category of prize-winning games.

Prize-winning games which are of a promotional nature (e.g., promoting a good or service) are covered by
the proposed Regulation on sales promotions. This proposal has received strong support from the
Parliament and is currently being discussed in the Council.
information
requirements which the promoter has to fulfil, in particular on any costs involved other than the purchase
of the promoted good or service, the likely chances of winning, the commercial value of the prize, the
closing date for receipt of entries etc. This information should be provided in a ‘clear and unambiguous
manner’.

It sets out a number of

involving a wagering stake (including in the form of a handling fee) are
Other prize-winning games,
considered to be gambling activities which are, as far as the Commission is aware, strictly regulated in all
Member States.

The subject of the question of the Honourable Member concerns more specifically fraudulent non-
promotional prize-winning games, involving false claims concerning won prizes. As far as the Commission
is aware fraudulent prize-winning games, are banned in all Member States. If, as the Honourable Member
suggests, such offers are emanating from one Member State, such problems could be reduced through
improved cross-border co-operation. Following the large measure of support given to the Commission’s
Green paper on Community consumer protection (2), the Commission has included in its work programme
instrument on administrative co-operation between public bodies
for 2003 a proposal
responsible for consumer protection which should be adopted in the near future.

for a legal

Since the problem highlighted by the Honourable Member does not appear to result from lack of
harmonisation of national laws on postal services, the Commission, therefore, has no plans to modify
Directive 97/67/EC of the Parliament and of the Council of 19 December 1997 on common rules for the
development of the internal market of Community postal services and the improvement of quality of
service (3) as amended by Directive 2002/39/EC of the Parliament and of the Council of 10 June 2002,
with regard to the further opening to competition of Community postal services (4).

(1) OJ C 75 E, 26.3.2002.
(2) COM(2001) 531 final.
(3) OJ L 15, 21.1.1998.
(4) OJ L 176, 5.7.2002.

(2003/C 155 E/215)

WRITTEN QUESTION E-3830/02

by Michl Ebner (PPE-DE) to the Commission

(9 January 2003)

Subject: Medication (cid:1) drugs abuse

Athletes are constantly being accused of drugs abuse, having taken medication which contains ingredients
included on the International Olympic Committee’s official list of banned substances.

Would it not be possible to make such substances readily identifiable (for example by means of a red dot
on the packaging) thereby on the one hand, facilitating matters for athletes and their managers and, on the
other hand, depriving those discovered to have been taking drugs of any possible excuse?

3.7.2003

EN

Official Journal of the European Union

C 155 E/195

Answer given by Mr Liikanen on behalf of the Commission

(25 February 2003)

The current Community legislation on labelling, i.e. the information on the immediate or outer packaging,
and on package leaflets for medicinal products for human use is contained in Title V of 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 (1).

According to Article 59(1)(c) of Directive 2001/83/EC, the package leaflet shall include among other things
a list of information which is necessary before taking the medicinal product. This includes information on
special warnings and on appropriate precautions for use, a specific example of which is the information
that the use of the product could have an effect on anti-doping tests. In particular, the package leaflet must
state whether use of the product could produce a positive analysis result in such a test. The obligation to
provide this information in the package leaflet extends both to nationally-approved medicinal products and
to medicinal products with a Community-wide authorisation. This means that sportsmen and their teams
already get all the necessary information.

Unlike for the package leaflet, there is no provision for special warnings or appropriate precautions for use
to be given on the outer packaging. Title V of Directive 2001/83/EC therefore does not permit the
inclusion of any specific symbol on potential effects of the product in anti-doping tests. This is appropriate
inasmuch as the information contained on the outer packaging has to be reduced to a minimum,
consisting only of the main information of general importance, in order to focus the user’s attention fully
on it. More detailed information is reserved for the package leaflet.

As a result, the Commission considers that the provisions laid down in Directive 2001/83/EC are adequate
for providing consumers with relevant information on the risks of a positive result in anti-doping tests.
The Commission has no plans at present to amend the provisions in force.

(1) OJ L 311, 28.11.2001.

(2003/C 155 E/216)

WRITTEN QUESTION E-3831/02

by Mihail Papayannakis (GUE/NGL) to the Commission

Subject: Implementation of Directive 97/36/EC

(9 January 2003)

Complaints have been made that most Greek TV channels interrupt the transmission of feature films at
regular intervals. It should be borne in mind that Article 11(3) of Directive 97/36/EC (1), which amended
Directive 89/552/EEC (2) on the co-ordination of certain provisions laid down by law, regulation or
television broadcasting activities,
administrative action in Member States concerning the pursuit of
provides that ‘the transmission of audiovisual works such as feature films and films made for television
(excluding series, serials, light entertainment programmes and documentaries), provided their scheduled
duration is more than 45 minutes, may be interrupted once for each period of 45 minutes.’

Will the Commission say whether the provision in question is being correctly implemented in Greece?

(1) OJ L 202, 30.7.1997, p. 60.
(2) OJ L 298, 17.10.1989, p. 23.

Answer given by Mrs Reding on behalf of the Commission

(17 February 2003)

The Commission monitors compliance with the principles
laid down in the ‘Television without
frontiers’ (1) directive, and in particular compliance with the rules concerning televised advertising. In this
context, the Commission has been notified of problems relating to the application of Article 11(3) of the
directive to which the Honourable Member refers. The Commission in fact made mention of this in its