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The European Paediatric Initiative its Impact on Medicines for Children

Children (particularly those 0-28 days then eligible for a 6 month extension of
old i.e. neonates) respond to drugs in a its patent protection. This patent
very different way to adults. Typically, protection is further extended for
doses in children are calculated by Orphan-designated medicines by another 18
weight and occasionally by body surface months giving a total of 12 years of
area but the dose should never exceed the exclusivity (as opposed to 10 years).
maximum adult dose. This, however, is Existing product marketing authorisations
only a guide as for some drugs children From 26 January 2009, the requirements
require a higher dose per kilogram than above will also apply to marketing
adults because of their higher metabolic authorisation variations.
rates. In addition, working out dosage Paediatric-use Marketing Authorisation
by weight should not be applied to an (PUMA)
overweight child as it could result in a This is a new marketing authorisation
much higher dose being administered than which applies to off-patent medicines
is actually necessary, safe or desirable. which have been developed specifically
In this instance, the dose has to be for paediatric use. Again, product
calculated using the ideal weight and not development must comply with the agreed
actual weight. To say that a child is PIP and provided there is compliance, a
half the size of an adult and therefore pharmaceutical company will benefit from
should receive half the adult dose is too 10 years of data protection.
simplistic and could well be dangerous. Paediatric Investigation Plans (PIPs)
The British National Formulary (BNF) for Otherwise known as a "drug
Children provides healthcare development plan" this is a
professionals with up-to-date information development plan which ensures the
on the use of medicines for treating collection of relevant data from studies
children both within the realms of the in children (when it is safe to do so).
medicine's licence (Marketing It must include details of these studies
Authorisation) and for and the ways in which the medicine has
"off-label" use i.e. the use of been adapted to make it suitable for
licensed medicines (in adults) for children. For example, children will
unlicensed uses. This resource is more readily swallow a syrup than a
invaluable for the effective and safe tablet. In some instances studies in
treatment of children. children will be deferred until the
The use of unlicensed and studies in adults have been completed.
"off-label" medicines in This ensures that studies in children are
children has caused concern, however, carried out only when it is safe, and
throughout the EU for a number of years ethical, to do so. Of course, there are
now as at least 50% of medicines used to some illnesses which do not affect
treat children have never been tested in children which means a PIP will not be
children, only adults. This lack of required and hence 'waived'.
supporting data for the treatment of For many companies the Paediatric
children was felt to have contributed to Regulation is a completely new challenge
an unacceptable number of adverse events. and, up until recently, they will not
As a result of this, and the overall have incorporated it into their business
need to improve on the information strategy. With ever decreasing
available, the European Paediatric headcount, it is becoming more and more
Initiative came into being with a new EU difficult to keep up-to-speed with all
Paediatric Regulation1 entered into force the latest legislation and the
on 26 January 2007. implications of enforcement. Regulatory
This new regulation has several Consultancies such as GRS can help
implications with the overall purpose companies by offering the services of
being to provide "better medicines senior regulatory professionals who
for children"2 and these are as already have working knowledge and
follows: experience of the Paediatric Regulation.
New product marketing authorisations With the pharmaceutical industry, the
From July 2008 any new products which Health Authorities and regulatory
were not authorised within the EU before professionals working together we can
26 January 2007 have to include results have a positive effect on the
of studies carried out in children. development, availability and safety of
These studies must comply with an agreed medicines for the treatment of children
Paediatric Investigation Plan (PIP) and improve the availability of
unless, of course, a deferral or waiver information on the use of these
has been agreed with the EMEA. A waiver medicines. This new legislation may be
may be granted, for example, when a new challenging and time consuming however it
medicine is intended to treat a condition will provide a safer future for our
which only occurs in adults (for example children.
Parkinson's disease). As an incentive 1 Regulation (EC) No 1901/2006 of the
for pharmaceutical companies, once European Parliament and of the Council on
authorisation has been granted for a medicinal products for paediatric use,
paediatric indication the new medicine is amended by Regulation (EC) No 1902/2006.




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