WRITTEN QUESTION E-1199/00 by Adriana Poli Bortone (UEN) to the Commission. Medicines administered to children.
Date: 2000-04-12
Institutions: European Parliament, Provisional data
Subjects: European social policy, child protection, medicinal product

C 72 E/28

Official Journal of the European Communities

EN

6.3.2001

Due to its outstanding contribution in support of the basic development objectives (poverty alleviation,
food security and sustainable natural resources management), the Commission considers investment in the
CGIAR as highly profitable.

While the Commission recognises the important contribution of the CGIAR system in addressing key
development objectives, it nevertheless would wish the CGIAR to make progress in the formulation of the
system(cid:146)s broad vision for the period 2005-2010 and the design of structural changes and new partnerships
to adapt to a rapidly changing environment.

The Commission, meanwhile, is in the process of defining a coherent strategy in support of agricultural
research, taking into account the comparative advantages of the various players, including the CGIAR.

A financing proposal for a three year programme in support of the CGIAR is currently under appraisal.
The financial envelope for the first year (2000) amounts to € 20 million.

There is no intention, at this stage, to increase the present funding level. In fact, the Commission plans to
maintain the current focus on the CGIAR system with regard to the global level. At the same time the
Commission puts a lot of emphasis at the regional and sub-regional levels (where it will continue to assist
the national research systems and their regional bodies through regional collaborative research pro-
grammes. This second focus proves to be very effective in forging partnerships between the CGIAR and
regions.

(2001/C 72 E/030)

WRITTEN QUESTION E-1199/00

by Adriana Poli Bortone (UEN) to the Commission

(12 April 2000)

Subject: Medicines administered to children

Statistics published by the authoritative British Medical Journal show that 67 % of children in general
paediatric wards are given at least one prescription for drugs which does not meet the criteria for which
the drug was licensed.

According to the (cid:145)Mario Negri(cid:146) pharmacological research centre, this percentage can be as high as 86 % in
Italy. In view of this, can the Commission say what steps it intends to take or might envisage to tackle this
serious problem affecting children?

Can it also say whether any research is planned to improve scientific knowledge, so as to ensure efficiency
and safety and a more rational use of drugs administered to children?

Finally, can the Commission say whether it is possible to promote and defend the right of children to be
treated with drugs in accordance with (cid:145)evidence-based medicine(cid:146)?

Answer given by Mr Liikanen on behalf of the Commission

(29 June 2000)

The Commission is well aware of the matters the Honourable Member has raised. This is indeed a serious
problem, concerning not only children but the whole population.

It is true that in the vast majority of cases, and in most areas of therapy, the medicines administered to
children do not exist in a specially adapted pharmaceutical form and have not been the subject of clinical
studies geared towards that category of patients. Nor do marketing authorisations make specific mention
of administration to children. Yet the fact is that the criteria of efficacy and safety of medicinal products,
and their rational use, must also apply to medicines administered to children.

As for the Community research effort, two activities under the (cid:145)Quality of life and management of living
resources(cid:146) specific programme of
the
therapeutic arsenal is used to maximum effect in health care.

the Fifth Framework Programme are intended to ensure that

6.3.2001

EN

Official Journal of the European Communities

C 72 E/29

The first is a key action concerning the (cid:145)Cell factory(cid:146), aiming to promote the enhanced, safe and efficient
production of therapeutic substances. The second is an activity of a generic nature designed to evaluate
specific therapies in the hospital setting by means of
trials, thereby providing a
foundation for using therapies in accordance with evidence-based medicine.

large-scale clinical

Research projects now under way following calls for proposals in 1999 are looking at the best possible
therapeutic approaches to congenital metabolic disorders, congenital muscular dystrophy and rare
haematological disorders more specifically affecting children. Unfortunately, the Commission did not
receive any research proposals targeted more specifically towards the problem raised by the Honourable
Member.

New calls for proposals are due to be launched in October 2000, and again in 2001 and 2002 on the
dates published in the work programme. The Commission hopes these will attract research proposals
geared towards the improvement, efficacy and rational use of therapies specially designed for children.

(2001/C 72 E/031)

WRITTEN QUESTION E-1207/00

by Ursula Schleicher (PPE-DE) to the Council

(27 April 2000)

Subject: Bathing water Directive

On 12 December 1996 the European Parliament gave its opinion at first reading on the Commission(cid:146)s
1994 proposal for a directive (COM(94) 0036) (1) amending Directive 76/60/EEC (2) on the quality of
bathing water.

When may we expect the Council(cid:146)s common position enabling Parliament to give its opinion at second
reading on this matter?

(1) OJ C 112, 22.4.1994, p. 3.
(2) OJ L 31, 5.2.1976, p. 1.

Reply

(18/19 September 2000)

In July 1998 delegations of Member States indicated their preference for the Commission to work out a
new proposal for a Bathing Water Directive given the fact that in the meantime the 1994 Commission
proposal is outdated.

The Council has been informed that the Commission has started an intensive consultation and working
programme with a view to present a communication by June 2000 which will take into account the
comments made by Member States, and all scientific technical and management experts concerned.

(2001/C 72 E/032)

WRITTEN QUESTION E-1214/00

by Daniel Hannan (PPE-DE) to the Commission

(14 April 2000)

Subject: Van Buitenen parliamentary questions

How many written questions regarding Van Buitenen(cid:146)s allegations remain to be answered?

How long have the delays been in each instance?

What accounts for each delay?