WRITTEN QUESTION E-1692/03 by Elly Plooij-van Gorsel (ELDR) to the Commission. Paediatric medicine.
Date: 2003-05-21
Institutions: European Parliament, Provisional data
Subjects: action programme, health policy, medicinal product, paediatrics, pharmaceutical legislation, research and development, research project

C 280 E/174

Official Journal of the European Union

EN

21.11.2003

(2003/C 280 E/192)

WRITTEN QUESTION E-1692/03

by Elly Plooij-van Gorsel (ELDR) to the Commission

(21 May 2003)

Subject: Paediatric medicine

Improved medicines developed specifically for children should be regarded as a priority. In December
2000 the Council called for a package of measures to be drafted as soon as possible to promote research
and development in the area of paediatric medicine and effective medication. In February 2002 the
Commission produced a consultation document on this subject. This gave rise to hope among the parties
concerned (patients’ organisations, scientific institutes and the pharmaceutical industry) that the necessary
measures would be implemented rapidly and effectively. However, so far the Commission has still taken no
action resulting in a specific proposal to the Council and Parliament.

In the United States measures of this kind in the area of paediatric medicine already exist, providing
incentives for research and development since as long ago as 1997. As a result, the United States has a
clear edge over Europe in the sphere of paediatric medicine.

1.

Is the Commission aware of this situation?

If so, does the Commission not share the view that measures to promote research and development

2.
in the sphere of paediatric medicine should be taken as soon as possible?

If so, what initiatives or practical measures does the Commission envisage taking and on what

3.
timescale?

Answer given by Mr Liikanen on behalf of the Commission

(19 June 2003)

The Commission intends to present a final text of the proposal for a Regulation on medicinal products for
paediatric use before the end of 2003. A first draft was prepared in September 2002. The Member States
and the European Medicines Evaluation Agency were consulted on the basis of this draft.

The Commission has decided that this proposal should be among the 43 important proposals within the
framework of the 2003 legislative and work programme, which should undergo an extended impact
assessment. The extended impact assessment is an important element of the Commission’s better regulation
action plan.

The Commission has now started preparing this impact assessment and intends to conduct it as swiftly as
possible in order to be able to adopt the proposal. It is anticipated that the impact assessment will be
completed by the end of 2003. In the meantime, the Commission has established an informal working
group of the Pharmaceutical Committee to discuss the informal draft proposal.

Concerning the research activities of the Commission in this sector, a number of research projects
addressing issues of clinical trials in children, especially in the area of rare diseases which predominantly
affect children, have already been supported or are supported.

Furthermore, the specific programme for the 6th Framework programme of the Community for research,
technological development and demonstration activities, adopted on 30 September 2002, clearly indicates
in its thematic priority ‘Life sciences, genomics and biotechnology for health’ (1) that attention will be paid
to childhood diseases and related treatments, whenever appropriate.

In this thematic priority, the following research actions are of particular relevance for that sector:

(cid:1) ‘Technological platforms for the developments in the fields of new diagnostic, prevention and
therapeutic tools’ where rational and accelerated development of new, safer and more effective drugs
including pharmacogenomics approaches are expected to deliver better therapies for children.
An indicative topic on ‘Medicines for children’ is already foreseen for the second call,

21.11.2003

EN

Official Journal of the European Union

C 280 E/175

(cid:1) ‘Combating cardiovascular disease, diabetes and rare diseases’ and especially research activities on rare

diseases which are expected to be naturally mostly dedicated to children,

(cid:1) ‘Combating resistance to antibiotics and other drugs’ which includes the development of vaccines and
alternative therapeutic strategies to circumvent the problem of antimicrobial and other drug resistance
will also undoubtedly be of interest for children,

(cid:1) ‘Studying the brain and combating diseases of the nervous system’ where the development of strategies
for prevention and management of neurological and mental disorders and diseases is expected to have
specific research action towards children,

(cid:1) ‘Studying human development and the ageing process’, where the understanding of human
development from conception to adolescence is expected to have application as regards child health.

The thematic priority 5 ‘Food quality and safety’ is also expected to contribute to several aspects of child
health and especially in the following research actions:

(cid:1) ‘Epidemiology of food-related diseases and allergies’ where epidemiological studies of the effect of diet,
food composition and lifestyle factors on the health of children and the prevention or development of
specific diseases, allergies and disorders will be tackled,

(cid:1) ‘Impact of food on health’ and ‘Environmental health risks’ where specificity of children is clearly

addressed.

(1) OJ L 294, 29.10.2002.

(2003/C 280 E/193)

WRITTEN QUESTION E-1701/03

by Ian Hudghton (Verts/ALE) to the Commission

(22 May 2003)

Subject: Traditional herbal remedies

The UK Flower Essence Producers Association believes that the Commission’s rejection of Amendment 13
to the Traditional Herbal Remedies Directive puts ‘Bach Flower Remedies’ and its related products under
threat. Could the Commission comment on the following concerns expressed by the Association.

The methods of production required by the Directive will render Bach Flower Remedies products as

1.
being incorrectly labelled as a flower essence and ineffective as a flower essence.

2.
The required method of production is inimical to the traditional methods of making flower essences.
Accordingly, even if products, say from Nelson Bach, were registered under the Directive, they would no
longer be classified as flower essences. They might be able to be classified as homeopathic, but, by default,
and under the Trades Descriptions Act, they could no longer be marketed as ‘Bach Flower Remedies’ as
they would not be made in the way that Edward Bach laid down in 1936.

3. Within the range of Bach Flower Remedies there are several which would not be on the positive
herbal list (i.e. Star of Bethlehem). This would deplete the list of traditional products.

Could the Commission also comment on the UK Flower Essence Producers Association’s concerns that the
impact of the Directive on Bach Flower Remedies will seriously damage this traditional British industry and
have wide-ranging economic impacts.