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The European Paediatric Initiative its Impact on Medicines for Children

Children (particularly those 0-28 days oldpatent protection. This patent protection is
i.e. neonates) respond to drugs in a veryfurther extended for Orphan-designated
different way to adults. Typically, doses inmedicines by another 18 months giving a total
children are calculated by weight andof 12 years of exclusivity (as opposed to 10
occasionally by body surface area but theyears).
dose should never exceed the maximum adult
dose. This, however, is only a guide as forExisting  product  marketing  authorisations
some drugs children require a higher dose per
kilogram than adults because of their higherFrom 26 January 2009, the requirements above
metabolic rates. In addition, working outwill also apply to marketing authorisation
dosage by weight should not be applied to anvariations.
overweight child as it could result in a much
higher dose being administered than isPaediatric-use Marketing Authorisation (PUMA)
actually necessary, safe or desirable. In
this instance, the dose has to be calculatedThis is a new marketing authorisation which
using the ideal weight and not actual weight.applies to off-patent medicines which have
To say that a child is half the size of anbeen developed specifically for paediatric
adult and therefore should receive half theuse. Again, product development must comply
adult dose is too simplistic and could wellwith the agreed PIP and provided there is
be  dangerous.compliance, a pharmaceutical company will
benefit  from  10  years  of data protection.
The British National Formulary (BNF) for
Children provides healthcare professionalsPaediatric  Investigation  Plans  (PIPs)
with up-to-date information on the use of
medicines for treating children both withinOtherwise known as a "drug development
the realms of the medicine's licenceplan" this is a development plan which
(Marketing Authorisation) and forensures the collection of relevant data from
"off-label" use i.e. the use ofstudies in children (when it is safe to do
licensed medicines (in adults) for unlicensedso). It must include details of these
uses. This resource is invaluable for thestudies and the ways in which the medicine
effective  and  safe  treatment  of children.has been adapted to make it suitable for
children. For example, children will more
The use of unlicensed andreadily swallow a syrup than a tablet. In
"off-label" medicines in childrensome instances studies in children will be
has caused concern, however, throughout thedeferred until the studies in adults have
EU for a number of years now as at least 50%been completed. This ensures that studies in
of medicines used to treat children havechildren are carried out only when it is
never been tested in children, only adults.safe, and ethical, to do so. Of course,
This lack of supporting data for thethere are some illnesses which do not affect
treatment of children was felt to havechildren which means a PIP will not be
contributed to an unacceptable number ofrequired  and  hence  'waived'.
adverse events. As a result of this, and the
overall need to improve on the informationFor many companies the Paediatric Regulation
available, the European Paediatric Initiativeis a completely new challenge and, up until
came into being with a new EU Paediatricrecently, they will not have incorporated it
Regulation1 entered into force on 26 Januaryinto their business strategy. With ever
2007.decreasing headcount, it is becoming more and
more difficult to keep up-to-speed with all
This new regulation has several implicationsthe latest legislation and the implications
with the overall purpose being to provideof enforcement. Regulatory Consultancies
"better medicines for children"2such as GRS can help companies by offering
and  these  are  as  follows:the services of senior regulatory
professionals who already have working
New  product  marketing  authorisationsknowledge and experience of the Paediatric
Regulation. With the pharmaceutical
From July 2008 any new products which wereindustry, the Health Authorities and
not authorised within the EU before 26regulatory professionals working together we
January 2007 have to include results ofcan have a positive effect on the
studies carried out in children. Thesedevelopment, availability and safety of
studies must comply with an agreed Paediatricmedicines for the treatment of children and
Investigation Plan (PIP) unless, of course, aimprove the availability of information on
deferral or waiver has been agreed with thethe use of these medicines. This new
EMEA. A waiver may be granted, for example,legislation may be challenging and time
when a new medicine is intended to treat aconsuming however it will provide a safer
condition which only occurs in adults (forfuture  for  our  children.
example Parkinson's disease). As an
incentive for pharmaceutical companies, once1 Regulation (EC) No 1901/2006 of the
authorisation has been granted for aEuropean Parliament and of the Council on
paediatric indication the new medicine ismedicinal products for paediatric use,
then eligible for a 6 month extension of itsamended by Regulation (EC) No 1902/2006.



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