E-DRUG: EU Paediatric drugs plan faces setback
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[E-drug recently reported about this EU plan to provide patent extension in
exchange for paediatric clinical trials. The new EU Commission seems not
to have enough money or given priority to this. Copied as fair use. WB]
Source: European Voice
Volume 10 Number 30
9 September 2004
Paediatric drugs plan faces setback
By Peter Chapman
PLANS to boost research into the effects of �out of patent� drugs on
children could be scrapped because European commissioners cannot agree on a
budget line for the initiative.
The then enterprise commissioner Erkki Liikanen inserted the plan into a
broader regulation boosting the market for paediatric medicine expected to
be launched on 29 September by his successor Olli Rehn.
But European Voice understands that it could be scrapped because
commissioners � including budget chief Michaele Schreyer � say the EU
executive has no spare cash to pay for it.
The issue is still being debated by the advisors to all interested
commissioners in the so-called �inter-service consultation� that precedes
the launch of draft laws by the EU executive.
�For the time being they have taken reference to this study programme out.
It is not that they are unwilling to have it � it is just that they don�t
know where the money would come from,� said one Commission insider.
The �Medicines Investigation for the Children of Europe� plan � MICE for
short � would have funded �high quality ethical research� into the
paediatric use of drugs that are no longer covered by patents and which were
originally developed for use on adults.
EU cash would have been channelled to research institutes and universities
on problems such as the correct dosage of anti-depressant drugs for
children � or the potential for targeting specific paediatric illnesses with
�compounds� aimed primarily at other diseases.
Companies selling out of patent generic medicines normally have little
research funds of their own � and are not set up for R&D work.
On the other hand, R&D-led pharmaceuticals companies concentrate most of
their efforts and budgets on developing and patenting new drugs.
Experts say the plan would have helped to fill a vacuum in the drugs sector
because many drugs marketed for years have never been properly tested on
children.
�What most paediatricians have done for years is come up with their own
doses,� said one regulatory expert with Anglo-American drugs giant GSK.
�Some are calculated according to body mass. But that is not a very good way
of doing it�children are not just young versions of adults,� he added.
<i>peterchapman@economist.com</i>
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