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The European Paediatric Initiative its Impact on Medicines for Children

Children (particularly those 0-28 daysmonth extension of its patent
old i.e. neonates) respond to drugs in aprotection. This patent protection is
very different way to adults.further extended for Orphan-designated
Typically, doses in children aremedicines by another 18 months giving a
calculated by weight and occasionally bytotal of 12 years of exclusivity (as
body surface area but the dose shouldopposed to 10 years).
never exceed the maximum adult dose.Existing product marketing
This, however, is only a guide as forauthorisations
some drugs children require a higherFrom 26 January 2009, the requirements
dose per kilogram than adults because ofabove will also apply to marketing
their higher metabolic rates. Inauthorisation variations.
addition, working out dosage by weightPaediatric-use Marketing Authorisation
should not be applied to an overweight(PUMA)
child as it could result in a muchThis is a new marketing authorisation
higher dose being administered than iswhich applies to off-patent medicines
actually necessary, safe or desirable.which have been developed specifically
In this instance, the dose has to befor paediatric use. Again, product
calculated using the ideal weight anddevelopment must comply with the agreed
not actual weight. To say that a childPIP and provided there is compliance, a
is half the size of an adult andpharmaceutical company will benefit from
therefore should receive half the adult10 years of data protection.
dose is too simplistic and could well bePaediatric Investigation Plans (PIPs)
dangerous.Otherwise known as a "drug
The British National Formulary (BNF) fordevelopment plan" this is a
Children provides healthcaredevelopment plan which ensures the
professionals with up-to-datecollection of relevant data from studies
information on the use of medicines forin children (when it is safe to do so).
treating children both within the realmsIt must include details of these
of the medicine's licence (Marketingstudies and the ways in which the
Authorisation) and formedicine has been adapted to make it
"off-label" use i.e. the usesuitable for children. For example,
of licensed medicines (in adults) forchildren will more readily swallow a
unlicensed uses. This resource issyrup than a tablet. In some instances
invaluable for the effective and safestudies in children will be deferred
treatment of children.until the studies in adults have been
The use of unlicensed andcompleted. This ensures that studies in
"off-label" medicines inchildren are carried out only when it is
children has caused concern, however,safe, and ethical, to do so. Of course,
throughout the EU for a number of yearsthere are some illnesses which do not
now as at least 50% of medicines used toaffect children which means a PIP will
treat children have never been tested innot be required and hence 'waived'.
children, only adults. This lack ofFor many companies the Paediatric
supporting data for the treatment ofRegulation is a completely new challenge
children was felt to have contributed toand, up until recently, they will not
an unacceptable number of adversehave incorporated it into their business
events. As a result of this, and thestrategy. With ever decreasing
overall need to improve on theheadcount, it is becoming more and more
information available, the Europeandifficult to keep up-to-speed with all
Paediatric Initiative came into beingthe latest legislation and the
with a new EU Paediatric Regulation1implications of enforcement. Regulatory
entered into force on 26 January 2007.Consultancies such as GRS can help
This new regulation has severalcompanies by offering the services of
implications with the overall purposesenior regulatory professionals who
being to provide "better medicinesalready have working knowledge and
for children"2 and these are asexperience of the Paediatric Regulation.
follows:With the pharmaceutical industry, the
New product marketing authorisationsHealth Authorities and regulatory
From July 2008 any new products whichprofessionals working together we can
were not authorised within the EU beforehave a positive effect on the
26 January 2007 have to include resultsdevelopment, availability and safety of
of studies carried out in children.medicines for the treatment of children
These studies must comply with an agreedand improve the availability of
Paediatric Investigation Plan (PIP)information on the use of these
unless, of course, a deferral or waivermedicines. This new legislation may be
has been agreed with the EMEA. A waiverchallenging and time consuming however
may be granted, for example, when a newit will provide a safer future for our
medicine is intended to treat achildren.
condition which only occurs in adults1 Regulation (EC) No 1901/2006 of the
(for example Parkinson's disease). AsEuropean Parliament and of the Council
an incentive for pharmaceuticalon medicinal products for paediatric
companies, once authorisation has beenuse, amended by Regulation (EC) No 1902
granted for a paediatric indication the2006.
new medicine is then eligible for a 6



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