WRITTEN QUESTION E-0900/00 by Hanja Maij-Weggen (PPE-DE) to the Commission. Medicines for children.
Date: 2000-03-25
Institutions: European Parliament, Provisional data
Subjects: European social policy, child protection, medical research, medicinal product

C 46 E/74

Official Journal of the European Communities

EN

13.2.2001

(2001/C 46 E/077)

WRITTEN QUESTION E-0900/00

by Hanja Maij-Weggen (PPE-DE) to the Commission

(25 March 2000)

Subject: Medicines for children

Is the Commission aware that in Europe 67 % of children in hospitals have medicines administered to
them which are not intended specifically for children (unlicensed and off-label medicines)? In the case of
newborn babies, the figure is as high as 90 % (see annex).

In the United States,
the Government has amended legislation so as to encourage pharmaceutical
companies to carry out research into medicines specifically for children. Subsidies have also been paid to
provide further encouragement.

Will the Commission likewise arrange for such research to be carried out in Europe and make the
necessary funding available for it?

Will the Commission propose a directive on the administration of medicines specifically to children, along
the lines of the US legislation?

Answer given by Mr Liikanen on behalf of the Commission

(17 May 2000)

It is quite true that in the vast majority of cases and in most therapeutic areas the medicines administered
to children are not in a suitable pharmaceutical form and have not been subjected to clinical studies that
have been targeted on that category of patient. Thus, in those instances, the marketing licences do not
provide for administration to children. Doctors needing to treat their patients use medicines intended for
adults, basing themselves on the limited amount of data available, although these have not been evaluated,
adjust the doses, and have pharmaceutical forms that can be administered to children prepared in hospital
dispensaries.

Following the example of orphan drugs, this can be explained by their lack of profitability and also by the
difficulty in producing a range of dose rates that are suitable for the various age categories. Indeed, only
the liquid pharmaceutical forms enable a practical adjustment to be made. However, most of the active
ingredients are in solid form, which as a general rule is more stable.

It is certain that access to treatment of that category of patient should move towards incentives such as
those provided in the United States. This being the case the set of regulations for orphan drugs just drawn
up by the Commission could serve as a basis for a set of regulations by adopting the criteria set.

(2001/C 46 E/078)

WRITTEN QUESTION E-0903/00

by Anna Karamanou (PSE) and Minerva Malliori (PSE) to the Council

Subject: Steep rise in drug abuse among European schoolchildren

(24 March 2000)

According to the annual report of the UN Commission on Narcotic Drugs, the use of cannabis among
European schoolchildren has risen very sharply: about one third of pupils in secondary education in
France, 25 % of thirteen year-olds in the United Kingdom and 69 % of young people who go to techno
music parties in Germany have experimented with the drug; there has also been an increase in the use of
the synthetic drugs Ecstasy and LSD, since young people associate these drugs with having fun. The report
also states that Albania has become a major producer of cannabis which is channelled mainly through
Greece, Italy and Slovenia; furthermore, the provision of information about the cultivation of the plant and
its derivatives through the Internet has led to a sharp increase in domestic production of drugs. Will the
Council say whether it knows which factors are responsible for the dramatic increase in the use of
cannabis and what steps have been taken to harmonise legislation and the position of the European Union
on the use of various narcotic substances?