Council Resolution of 14 December 2000 on paediatric medicinal products
Date: 2000-12-14
Institutions: Council of the European Union
Subjects: child, child protection, medical research, medicinal product, paediatrics, public health

19.1.2001

EN

Official Journal of the European Communities

C 17/1

I

(Information)

COUNCIL

COUNCIL RESOLUTION

of 14 December 2000

on paediatric medicinal products

(2001/C 17/01)

THE COUNCIL OF THE EUROPEAN UNION,

(1) RECALLS that a high level of health protection is to be
ensured in the definition and implementation of all
Community policies and activities and that Community
action, complementing national policies, is to be directed
towards improving public health, preventing human illness
and diseases, and obviating sources of danger to human
health.

(2) NOTES that nearly 20 % of the Community population, i.e.

75 million people, is under the age of 16.

(3) NOTES that, as regards

treatment, children have
their
characteristics which vary with their age and which mean
that in most cases they cannot be treated like adults. In
particular, a medicinal product administered to a child has
specific characteristics in terms of pharmaco-kinetics, effec-
tiveness and undesirable effects. Furthermore, a medicinal
product intended for children requires appropriate phar-
maceutical presentation, to ensure easy and safe adminis-
tration.

(4) NOTES that a large number of

the medicinal products
administered to children have not been assessed specifically
for paediatric use and may therefore not meet the criteria
of quality, safety and effectiveness required in the case of
adults.

(5) OBSERVES that the prescription of medicinal products to
therefore very often not covered by the
children is
marketing authorisation and that, taking into account the

shortage of paediatric pharmaco-vigilance data, safety of
use in this population group cannot therefore be docu-
mented by monitoring studies after marketing.

(6) RECOGNISES that making paediatric medicinal products
available involves difficulties of pharmaceutical devel-
clinical development. The necessary
and of
opment
research and development
amortised
because of the small number of children affected by each
disorder in each age bracket.

are not

costs

(7) CONSIDERS that the development of paediatric medicinal
products and clinical
trials involving children may give
rise to specific ethical concerns and that children must
benefit from special protection.

(8) CONSIDERS that all Member States face this problem and
that a European approach offers advantages from the
epidemiological, public health and economic points of
view,

(9) ACCORDINGLY INVITES THE COMMISSION to make appro-
soon as possible in the form of
priate proposals as
incentives,
supporting
regulatory measures or other
measures in respect of clinical research and development,
taking account of the ethical aspects of clinical trials on
children,
for
children and medicinal products already on the market
are fully adapted to the specific needs of that population
group, and taking into account also the internationally
the protection of minors
acknowledged standards
with regard to medical scientific research.

to ensure that new medicinal products

for