Europe to offer child medicine research incentives
Children have been left behind by developments in drug technology |
Pharmaceutical manufacturers are to be given incentives to carry out child-safety studies on medicines for use in Europe. Special paediatric licences will also be available for generic medicines to give generics manufacturers an incentive to do the work.
Following consultation which started two years ago (PJ, 16 March 2002,
p349), the European Commission has published proposed new medicines legislation
that will extend the market exclusivity of patented products or grant
new exclusive paediatric licences when such studies are conducted.
A draft commission regulation says that applications for new marketing
authorisations or applications for new indications, dosage forms or routes
of administration for existing products still under patent must include
the results of studies in children conducted according to previously
agreed paediatric investigation plans.
There will be a waiver and deferral system to make sure that child research
is only carried out to meet the therapeutic needs of children and when
it is safe and ethical to do so. Products for which data are submitted
will get an extra six months patent protection, regardless of whether
the data show positive or negative results.
Different rules are proposed for generic medicines because there are
no patents to extend. In these cases, paediatric safety studies will
be rewarded with paediatric use marketing authorisations (PUMAs) exclusive
to the manufacturer that generates the data. Generics manufacturers do
not generally have substantial resources for research and development
beyond equivalence studies and have little experience of clinical trials,
so the EU will provide money to fund or part-fund such studies through
a MICE (Medical Investigation for the Children of Europe) fund.
Sharon Conroy, chairman of the Neonatal and Paediatric Pharmacists Group,
said: “This is likely to be the most important legislation on children’s
medicines that we will see in the foreseeable future. It is likely to
change the situation we have been in for many years where we have not
got suitable licensed medicines for children. It will be good to get
it up and running as soon as possible.”
She said that the current situation means that there is a lack of science-based
dosing information for children which leads to dangers of toxicity or
ineffectiveness of medicines. New dosage forms would also be helpful.
“
Children have been left behind by developments in pharmaceutical technology,” she
added. “For example, the new melt technology would be wonderful
for kids. It would overcome such a lot of the problems we have in formulating
medicines for children. They can’t spit it out.”
The draft regulation is open for comment until 9 April. |
The
Pharmaceutical Journal