WRITTEN QUESTION E-3878/03 by Johannes Blokland (EDD) to the Commission. Research into the effects of medicinal products on children.
Date: 2003-12-16
Institutions: European Parliament, Provisional data
Subjects: EU financing, European Medicines Agency, medical research, medicinal product, paediatrics, pharmaceutical legislation, scientific report

C 78 E/666

Official Journal of the European Union

EN

27.3.2004

In this respect, the Commission would add that it is aware of the fact that the national competition
authority has sent a number of recommendations to the Consip which seek to avoid excessive restrictions
on competition in the invitations to tender it launches (cid:1) recommendations which the Consip does in fact
seem to follow. In addition, the national political and administrative authorities,
i.e. the government,
Parliament and Consip, have recently held talks on how to limit the potential negative effects of the
aforementioned centralised procurement system on the activities of small and medium-sized enterprises.

The Commission would point out that the recent Decree-Law No 143/2003, which was converted into
Law No 212/2003 published in the national Official Journal 131/L of 11 August 2003, made significant
changes to the field in question (cid:1) including, in particular, the annulment of Article 24(3) in Law No 289/
2002 mentioned by the Honourable Member (cid:1) precisely in order to reduce the impact of the centralised
procurement system on the activities of small and medium-sized enterprises. According to information
currently at the Commission’s disposal, other changes to the legislation in force are planned as part of the
process of approving the financial law for 2004.

(1) This possibility is, moreover, explicitly covered by the aforementioned directives, which lay down (cid:1) see Article 13
of Directive 93/36/EEC for supplies and Article 21 of directive 92/50/EEC for services (cid:1) that contracting
authorities may arrange for the publication in the Official
Journal of the European Communities of notices
announcing public supply and service contracts which are not subject to the publication requirement laid down in
these Directives.

(2004/C 78 E/0709)

WRITTEN QUESTION E-3878/03

by Johannes Blokland (EDD) to the Commission

(16 December 2003)

Subject: Research into the effects of medicinal products on children

Is the Commission aware that the majority (cid:1) possibly 70 % (cid:1) of medicinal products prescribed for

1.
children have not undergone any research to ascertain their effects on patients of this age group?

2. What percentage of medicinal products evaluated by the European Agency for the Evaluation of
Medicinal Products (EMEA) have also been found to be suitable for use by children?

3. What efforts is the Commission making to encourage manufacturers to perform more research into
the effects of medicinal products on children?

Is Community funding made available for such research, and if so, what are the relevant

4.
appropriations and how are they being used?

Answer given by Mr Liikanen on behalf of the Commission

(30 January 2004)

The Commission is fully aware that many medicines used to treat children are not specifically studied

1.
nor authorised for such use, and is working to remedy the situation.

2.
In October 2003, the European Medicines Evaluation Agency (EMEA) performed a review of the
authorisation status for children of the 191 active substances used in medicines authorised through the
Community procedure, on the basis of an EMEA scientific evaluation. Sixty-two (32 %) were appropriately
authorised for the use of children. Of the remaining active substances 51 (27 %) were medicines indicated
for diseases not relevant to children (e.g. cancers occurring only in adults).

Current Community pharmaceutical legislation does not compel industry to study medicines for the
3.
use on children. However,
the existing regulatory framework already provides incentives to orphan
products. Regulation (EC) No 141/2000 of the Parliament and of the Council of 16 December 1999 on

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Official Journal of the European Union

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orphan medicinal products (1) provides incentives to the pharmaceutical industry to develop and authorise
medicinal products for serious, rare diseases where no satisfactory method of treatment exists. This
legislation applies equally to diseases affecting children and adults.

In 2000, following major input from the Union, the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline E11: ‘Clinical
Investigation of Medicinal Products in the Paediatric Population’ was finalised and implemented in the
Union.

In 2001, the European Medicines Evaluation Agency set up the Paediatric Expert Group of the Committee
for Proprietary Medicinal Products. The Paediatric Expert Group provides advice on the study and use of
medicines for children and is developing guidance for investigators and the industry on such use.

Following a resolution of the Council of Ministers, the Commission has been developing and consulting on
proposals for a new Regulation that aims specifically to address the need for greater study and
authorisation of medicines for children. The Commissions’ proposals are currently the subject of an
extended impact assessment (EIA) that is due to report in the first quarter of 2004. Following the results of
the EIA, it will be possible to finalise the proposals for adoption by the Commission. Pending the results of
the EIA, to speed up the legislative process, the Commission has set up an informal ad-hoc working group
of the Pharmaceutical Committee (which has representation from all Member States) to advice on its
informal draft proposal. In addition, the Commission is continuing its discussions with other stakeholder
groups.

4.
An emphasis is also put on child health in Priority 1 of the Union’s 6th Framework Programme for
Research and Technological Development. This thematic priority will stimulate and sustain multi-
disciplinary basic research to exploit the full potential of genome information to underpin applications to
technological development and demonstration:
human health. The specific programme for research,
‘Integrating and strengthening the European Research Area’ (2002-2006) mentions that ‘attention will be
paid to childhood diseases and related treatments, whenever appropriate’. Some topics of the Work
Programmes of this Priority are clearly devoted to children, for instance ‘Medicines for children’, or ‘Rare
autoimmune disorders: from genes to individualised medicine’ including paediatric diseases. Even if topics
do not specifically mention children, proposals selected for funding may contain parts referring to, or
centred on, children health. It is then to be expected that the results deriving from those projects will
directly benefit children, for instance through the better understanding of disease mechanisms, and the
development of new diagnostic tools and new therapeutic agents.

As regards the public health programme, there are possibilities to fund projects on public health aspects of
pharmaceuticals. The priorities and the specific research areas are identified in the annual work plans.

(1) OJ L 18, 22.1.2000.

(2004/C 78 E/0710)

WRITTEN QUESTION E-3882/03

by Cristina Gutiérrez-Cortines (PPE-DE),
Bernd Lange (PSE), Karl-Heinz Florenz (PPE-DE)
and Ria Oomen-Ruijten (PPE-DE) to the Commission

(16 December 2003)

Subject: Inspire initiative

EU policies with spatial incidence such as Natura 2000 Network, the Framework Directive on Water and
information based on
the future policy on Soil Protection, amongst others, need wide environmental
cartography in order to be implemented.

The European Parliament urged the Commission to tackle this issue rapidly in its report on the Thematic
Strategy on Soil Protection (A5-0354/03), passed on 19 November.