# CE2004065EN.01026402.xml

| 13.3.2004 | EN | Official Journal of the European Union | CE 65/264 |
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13.3.2004

EN

Official Journal of the European Union

CE 65/264

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(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

Subject:

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.

North Rhine-Westphalia's Commission of Inquiry, ‘The future of women-friendly healthcare in North 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.

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| 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? |
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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?

| 2. | Or will the Commission ensure that the Member States implement the directive in a way that is suitable for both genders? |
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2.

Or will the Commission ensure that the Member States implement the directive in a way that is suitable for both genders?

Answer given by Mr Liikanen on behalf of the Commission

(19 November 2003)

(19 November 2003)

The Directive 2001/83/EC, as amended by Commission Directive 2003/63/EC of 25 June 2003 (2), 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.

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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; |
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(1)

the number and sex of the subject treated;

| (2) | the selection and age-distribution of the groups of patients being investigated and the comparative tests
  ... |
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(2)

the selection and age-distribution of the groups of patients being investigated and the comparative tests

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| (6) | details concerning patients who may be at increased risk, e.g. elderly people, children, women during pregnancy or menstruation ... |
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(6)

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

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

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(2)  OJ L 159, 27.6.2003.

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