European Union Health Ministers are to meet in December to begin drawing up
new regulations to encourage pharmaceutical companies to develop medicines for
paediatric use.
At present there is no requirement for companies to investigate new medicines
for children and this has led to a lack of information about the administration
of medicines to under-18-year-olds.
In an effort to overcome this, EU proposals will include obliging companies
to conduct paediatric studies for medicinal products for different age groups,
from premature babies to adolescents. Public funding may be available to help
overcome financial constraints to conducting clinical trials with children and
a period of extended exclusivity may be offered to stimulate research.
The proposed regulations follow the adoption of a new paediatric rule in the
United States which became effective in April, 1999. This required manufacturers
to provide data on the effects of new medicines on children, particularly if
they had significant advantages over existing therapies or were expected to
be widely used in paediatric treatment.
New European guidelines on the clinical investigation of medicines in children,
prepared by the European Agency for the Evaluation of Medicinal Products, come
into operation in January, 2001.