European paediatric research incentives not enough, says ABPI
Proposed regulations intended to encourage the pharmaceutical industry to test medicines specifically for use in children are too little and too late, according to the Association
of the British Pharmaceutical Industry.
“The incentive of a six-month extension to a medicines patent for
companies undertaking clinical trial work in children is a step in the
right direction,
but it needs to go further to attract such work into the UK and Europe,” said
ABPI director of medicine Richard Tiner.
The ABPI believes that the incentives should come sooner and need to
be greater to attract research from the US.
A proposed European Commission regulation, published last week (PDF 110K),
follows the form drafted six months ago and offers companies marketing
rewards
if they carry out the extra work, regardless of whether the outcome is
positive or negative (PJ, 20 March, p341).
In essence, companies will have to submit child-related safety data in
accordance with previously agreed plans whenever they apply for a marketing
authorisation, unless the product has been granted a waiver because it
is unlikely to benefit children. In return, they will get an extra six
months’ patent protection for the active ingredient. In the case
of orphan medicines, there will be an extra two years’ protection.
Manufacturers of medicines that are out of patent will also be encouraged
to test medicines for paediatric use. They will be able to apply for
new paediatric use marketing authorisations (PUMAs) and will get 10 years’ data
protection so that no other maker will be able to apply for a licence
on the back of the original company’s work.
The earliest the plans can become law will be late in 2006, almost five
years after the commission started to consider the matter. |
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Pharmaceutical Journal
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