WRITTEN QUESTION E-3063/03 by Hiltrud Breyer (Verts/ALE) to the Commission. European Parliament and Council Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Date: 2003-10-17
Institutions: European Parliament, Provisional data
Subjects: experiment on humans, pharmaceutical legislation, position of women, research method, research results

C 65 E/264

Official Journal of the European Union

EN

13.3.2004

Answer given by Mr Barnier on behalf of the Commission

(11 November 2003)

The Commission is collecting the information it needs to answer the question. It will communicate its
findings as soon as possible.

(2004/C 65 E/278)

WRITTEN QUESTION E-3047/03

by Elspeth Attwooll (ELDR), Heinz Kindermann (PSE),
John McCartin (PPE-DE) and Willi Görlach (PSE) to the Commission

Subject: Recreational fisheries and tourism statistics

(17 October 2003)

The Commission and Council are aware that there is a need to improve the common statistical base on
tourism. A common platform of know-how is a precondition for benchmarking, for change of views, for
learning and for addressing strategic problems in the tourism sector. Also that there is a need to develop
statistically valid and comparable data on tourism. A common goal is to initiate the implementation of
national Tourism Satellite Accounts (TSA) in the Member States. Recreational fisheries (angling tourism)
are a significant part of the European tourism sector.

Will the Commission make sure that recreational fisheries are measured and their figures mentioned in
their own right within the overall frame for tourism statistics?

Answer given by Mr Solbes Mira on behalf of the Commission

(18 November 2003)

The Commission would like to draw the attention to the usefulness of the existing statistical legislation
(Directive 95/57/EC) (1) for the production of internationally comparable statistics in the field of tourism.
Its implementation in the Member States has led to constant progress in the availability of valid and
comparable data on tourism. This data is published regularly by the Commission. As regards the Acceding
Countries, major progress has been made, so that they can provide the same level of information as the
present Member States at the moment when they will be joining the Union on 1 May 2004.

In the above-mentioned Directive, many breakdowns of the data are already requested, such as breakdowns
by nationality, by length of stay or by principal mode of transport. No breakdown is requested concerning
the type of holidays. As a result, it is not possible to distinguish recreational fisheries (or any other type of
holiday)
In order to limit response burden, an introduction of additional
breakdowns is not foreseen.

in the tourism statistics.

(1) Council Directive 95/57/EC of 23 November 1995 on the collection of statistical

information in the field of

tourism, OJ L 291, 6.12.1995.

(2004/C 65 E/279)

WRITTEN QUESTION E-3063/03

by Hiltrud Breyer (Verts/ALE) to the Commission

(17 October 2003)

Subject: European Parliament and Council Directive 2001/83/EC on the Community code relating to

medicinal products for human use

It has been scientifically proven that medicines affect women and men differently, yet women are
underrepresented in clinical trials and the data gathered is not systematically treated as gender-specific.

13.3.2004

EN

Official Journal of the European Union

C 65 E/265

‘The future of women-friendly healthcare in North
North Rhine-Westphalia’s Commission of Inquiry,
Rhine-Westphalia’, has put forward suggestions for a women-friendly implementation of Directive 2001/
83/EC (1). It considers that the directive needs to be amended to take women into account in research.

1.
Is the Commission planning to amend the directive accordingly for the whole EU, so that women
and men are equally represented in clinical research and the data collected is consistently recorded
separately for each gender?

Or will the Commission ensure that the Member States implement the directive in a way that is

2.
suitable for both genders?

(1) OJ L 311, 28.11.2001, p. 67.

Answer given by Mr Liikanen on behalf of the Commission

(19 November 2003)

The Directive 2001/83/EC, as amended by Commission Directive 2003/63/EC of 25 June 2003 (1), sets out
in its Annex I the analytical, pharmacotoxicological and clinical standards and protocols in respect of the
testing of medicinal products for the purpose of granting a marketing authorisation.

In Part I point 5.2. (f) of this Annex, it is foreseen that the clinical observations shall be summarised for
each trial indicating:

(1)

the number and sex of the subject treated;

the selection and age-distribution of

(2)
comparative tests …

the groups of patients being investigated and the

…

details concerning patients who may be at increased risk, e.g. elderly people, children, women

(6)
during pregnancy or menstruation …

The general rule, as foreseen in Directive 2001/83/EC, is therefore that an appropriate study design should
be chosen and the clinical trial must be conducted in a way that the results of the trials, including the
statistical assessment, must provide a positive efficacy of the indication, which supports a marketing
authorisation of the medicinal product without a gender specific restriction.

Exceptions to this general obligation are only accepted for marketing authorisations of medicines with
gender specific indications.

(1) OJ L 159, 27.6.2003.

(2004/C 65 E/280)

WRITTEN QUESTION P-3078/03

by Bart Staes (Verts/ALE) to the Commission

(14 October 2003)

Subject: European standard EN-1078

Two Flemish professors at the Catholic University of Louvain (CUL) have carried out a study of 86 cycling
accidents and have come to the conclusion that when a rider falls it makes little difference whether or not
he or she is wearing a helmet. They go on to argue for helmets to be completely redesigned.

The academics acknowledge that it is safer to wear a helmet when cycling. However, current helmets do
not prevent the cranial vibrations which can be caused by a fall and fail to provide full protection for the
temple area.