WRITTEN QUESTION P-0626/03 by Peter Liese (PPE-DE) to the Commission. European Commission's proposal for a regulation on medicinal products for paediatric use.
Date: 2003-02-25
Institutions: European Parliament, Provisional data
Subjects: drafting of EU law, health policy, impact study, medicinal product, paediatrics, pharmaceutical legislation

C 192 E/202

Official Journal of the European Union

EN

14.8.2003

(2003/C 192 E/243)

WRITTEN QUESTION E-0564/03

by Frédérique Ries (ELDR) to the Commission

(27 February 2003)

Subject: Proposal for a regulation on paediatric medicines

In December 2000 the Council unanimously adopted a resolution calling on the Commission to propose
regulatory measures to improve availability of paediatric treatment. The Council acknowledged that there
was a genuine deficiency in this area of healthcare. The Commission undertook to respond to this call
from the Council. Although the Commission several times confirmed this undertaking during the recent
debates in Parliament on the occasion of the revision of the pharmaceutical legislation, the obligation to
submit the draft paediatric regulation to an economic impact assessment once again raises the fear that
there will be further delays in the publication of the text. The imperative deadlines that the European
institutions will have to meet in 2004 could well delay the completion of this project.

Does the Commission intend to submit a proposal for a regulation on this subject in the near future?

(2003/C 192 E/244)

WRITTEN QUESTION P-0626/03

by Peter Liese (PPE-DE) to the Commission

(25 February 2003)

Subject: European Commission’s proposal for a regulation on medicinal products for paediatric use

European Commission’s proposal for a regulation on medicinal products for paediatric use In its resolution
of 14 December 2000 on paediatric medicinal products (1), the Council invited the European Commission
to ‘make appropriate proposals as soon as possible’
in order to improve the availability of suitable
medicines for children.

Medicinal products for children need to be tested scientifically before widespread use. This can only be
achieved by ensuring that medicines which are likely to be of significant clinical value in children are fully
studied.

In February 2002, the European Commission launched its public consultations on ‘Better Medicines for
Children’. In the summary overview of responses in June 2002, it was stated that ‘an overarching concern
expressed throughout the comments was the urgency of this matter’. In its working plan for 2003, the
Commission announced the release of the legislative proposal by March 2003, more than two years after
the Council resolution.

Can the Commission guarantee that the proposal will be released without further delay so that there is at
least a chance of an adoption under codecision procedure before the enlargement of the European Union?

(1) OJ C 17, 19.1.2001, p. 1.

Joint answer
to Written Questions E-0564/03 and P-0626/03
given by Mr Liikanen on behalf of the Commission

(3 April 2003)

The Commission intends to present a final text of the proposal for a Regulation on medicinal products for
paediatric use as soon as possible. A first draft had been prepared in September 2002. On the basis of this
draft, the Member States and the European Medicines Evaluation Agency were consulted. This consultation
process took longer than expected as the Member States during the Pharmaceutical Committee of
November 2002 asked for a prolonged deadline for comments.

14.8.2003

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Official Journal of the European Union

C 192 E/203

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 as swiftly as possible to
conduct it in order to be able to adopt the proposal.

(2003/C 192 E/245)

WRITTEN QUESTION E-0582/03

by Erik Meijer (GUE/NGL) to the Commission

(28 February 2003)

Subject: Phasing out of carcinogenic impregnated wood following the ban on new use and labelling of used

material as toxic waste

1.
Is the Commission aware that since the 1980s the Dutch company Billiton, a subsidiary of Shell, has
been able to dispose of a yearly 300 000 kilos of arsenic compounds (creosote salts) as a wood
preservative by impregnating European wood with them, giving it the more durable characteristics of
tropical hardwoods, and that this was possible because arsenic acid, which had long been considered toxic,
and which even in small quantities can penetrate the human skin on contact, damaging genetic material
and causing cancer, had been referred to in official records by the deceptive name of ‘arsenic pentoxide’?

2.
Are there reliable and accessible data on the length of time during which, and the extent to which, in
the EU Member States and the candidate countries wood for children’s playground equipment, house
building, garden furniture, fences, harbour installations, telegraph poles and agricultural fencing has been
treated with arsenic acid or the possibly even more dangerous chrome VI? In which Member States did this
happen most, and in which least?

Does the Commission recall that, in accordance with the recently adopted Directive 2003/02/EC (1),
3.
impregnated waste wood is deemed to be toxic waste and impregnation of wood with arsenic acid is to be
prohibited in future, but that currently there is still a loophole in the protective rules in that impregnated
wood still being used for its original purpose can remain in use, with the proviso that gloves must always
be worn to handle it?

4. Why is a difference made in the treatment of impregnated wood that is still in use and that of the
carcinogenic material asbestos, which was also frequently used as an inexpensive and practical building
material, and which is now being actively removed from structures intended for habitation, work or
recreation?

5.
How, in the opinion of the Commission, is the elimination (cid:1) and, pending that, the screening off (cid:1)
of current applications to take place? What complementary measures does the Commission expect from
the Member States and the candidate countries, how much longer will it take for solutions to be found,
and what EU incentives does it plan to implement after the introduction of Directive 2003/02/EC?

Source: the Dutch newspaper Algemeen Dagblad, 12 February 2003

(1) OJ L 4, 9.1.2003, p. 9.

Answer given by Mr Liikanen on behalf of the Commission

(4 April 2003)

1.
The Commission is not aware of the alleged activities of the company referred to. As regards the
current use of arsenic in the treatment of wood, Council Directive 89/677/EEC of 21 December 1989 (1)
which amends for the eighth time Council Directive 76/769/EEC of 27 July 1976 on the marketing and