| 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.
|
