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Friday, January 26, 2007
More medicines designed especially for children will be available
across Europe and more paediatric clinical research will take place
in the UK as a result of new EU legislation that comes into force
today (January 26), the Association of the British Pharmaceutical
Industry (ABPI) predicted today.
The new rules seek to prevent children being subjected to unnecessary
clinical trials, but acknowledge that ethical concerns are off-set
by the current risks in giving off-label medicines. The UK is well-placed
to take up the expected increase in paediatric clinical research.
England, Scotland and Wales all have children’s research networks
of leading paediatricians in NHS paediatric hospitals sharing knowledge
with scientists in industrial and academic institutions.
“This new legislation represents a huge opportunity for European
research into children’s medicines and the UK is probably the
most prepared country in the EU to take this forward,” said
ABPI Medical Director, Dr Richard Tiner. “Clinical trials obviously
raise questions of ethics, plus each stage of a child’s development
from infant to teenager requires different formulations. As a result
patient numbers per drug may be small – especially for rare
conditions - in the past this made it difficult for drug companies
to recoup the massive costs of research.”
The European legislation makes distinctions to ensure that medicines
target the very different needs of various age groups from premature
babies, through newborns (0-1 months), infants (1-23 months), young
children (2-12years) and adolescents (12-18 years). Every medicine
that is submitted for licence in Europe will now need a detailed
‘Paediatric Investigation Plan’ (PIP) that specifies for
which age groups the medicine will need to be studied before it
can be made available to patients.
Although some medicines apply for exemption if they would never
be used in young age groups – HRT treatments, for example –
the burden is now on companies to provide compelling evidence that
paediatric research does not need to be carried out. The rules apply
for both new and existing medicines.
In return for taking on the time and cost of such difficult research,
companies will receive a six-month extension to the patent life
of new medicines in Europe. For older medicines that are already
off-patent, a ten-year data exclusivity incentive is provided for
the company that undertakes the research.
The healthcare sector has long agreed that far too few medicines
are specifically licensed for children, making prescribing a matter
of skilled intuition for doctors. The lack of child-orientated medication
means that doctors frequently have to make dosage estimates with
adult-designed products (called off-label prescribing). This can
mean an increased risk of dangerous side-effects or ineffective
treatment because of under-dosage.
“While paediatricians are skilled and experienced at making
such decisions, it is still one that allows greater room for error,
and it would be better for both patient and doctor if a licensed
medicine was at their disposal,” added Dr Tiner. “The
problems with developing children’s medicines have prevented
many of these treatments coming to light in the past.”
Currently, more than 90 per cent of children in neonatal intensive
care receive off-label or unlicensed medicines; this is also the
case for 45 per cent of medicines used in general paediatric wards
and even in general practice this applies for 10-20 per cent of
the medicines prescribed.
For further information, please contact:
Crispin Slee 020 7747 1410 (office)
Roz Britton-Elliott 020 7747 1441 (office)
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