WRITTEN QUESTION P-3078/03 by Bart Staes (Verts/ALE) to the Commission. European standard EN-1078.
Date: 2003-10-14
Institutions: European Parliament, Provisional data
Subjects: European Committee for Standardisation, European standard, safety device, scientific report, standardisation, two-wheeled vehicle

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.

C 65 E/266

Official Journal of the European Union

EN

13.3.2004

Cycling helmets must comply with European standard EN-1078. The two academics describe that standard
as too vague and as not being based on reliable scientific data, with the result that helmets fail to meet the
purpose for which they are designed.

Is the Commission aware of the study carried out by the two CUL professors?

Does it share their conclusion that European standard EN-1078 is too vague and not based on reliable
scientific data and, if not, what arguments can it put forward to counter that view?

Is the Commission prepared to release resources to fund scientific studies into the production of the safest,
most comfortable and cheapest cycling helmets possible, and if not, why not?

Answer given by Mr Liikanen on behalf of the Commission

(11 November 2003)

The standard EN 1078 was elaborated by the European Committee for Standardisation (CEN) which means
that a group of international experts had developed this product standard in the light of the technical state-
of-the-art and that the standard had been voted by the CEN signatories after due verification.

The Commission published the reference of this standard in accordance to Article 5.4 of Council Directive
89/686/EEC of 21 December 1989 on the approximation of the laws of the Members States relating to
personal protective equipment (1) (PPE). Thus the standard was accepted for supporting the implementation
of this Directive since it directly addressed the essential health and safety requirement of its Annex II.

So far no research results challenging the protective performance of the standard have been mentioned by
any of the Member States representatives which meet twice a year with the Commission in two different
groups,
the Expert Group ‘PPE’ and the Group of administrative co-operation related to market
surveillance: the Commission service responsible for the Directive mentioned above is not aware of the
study quoted by the Honourable Member.

The Commission would also like to emphasise its interest
to be informed about research finding
concluding that a product standard is not fully satisfying and thus potentially exposing the European
citizen to safety and health hazards.

The Commission will put this issue on the agenda of the forthcoming meeting of the Member State’s
market surveillance authorities scheduled for December 2003 in order to investigate about the European
dimension of the problem raised.

The Commission will also discuss the issue with CEN directly in order to explore the need for action. The
issue could be tackled within the routine revision of product standards organised by CEN. Alternatively, it
could be included in the Commission’s mandates to CEN, using the framework within which the
Commission funds substantially the European standardisation work.

(1) OJ L 399, 30.12.1989.

(2004/C 65 E/281)

WRITTEN QUESTION P-3093/03

by Harald Ettl (PSE) to the Commission

(14 October 2003)

Subject: Inclusion of the active substance paraquat on the positive list in Directive 91/414/EC

At the meeting of the Standing Committee on the Food Chain and Animal Health on 2 and 3 October
2003, a decision was taken to include the herbicide paraquat on the positive list (Annex I) set out in
Directive 91/414/EC (1) concerning the placing of plant protection products on the market.