Juvenile medicine: Medicines developed and tested specifically for children in Europe have moved one step closer, following the acceptance of an EU regulation on children's medicines.
The Irish Medicines Board (IMB) and the Irish Pharmaceutical Healthcare Association (IPHA) welcomed the ruling on children's medicines adopted by the European Parliament last Thursday.
The regulation, which now awaits only the formal acceptance by the European Council of Ministers, will increase the availability of researched and authorised medicines for children. Currently, more than 50 per cent of the medicines used to treat sick children have been tested only on adults.
The IMB said the new laws were a positive development.
"The objective of this legislation is to facilitate paediatric clinical trials in order that medicines will be 'children-specific' and available in appropriate formulations," said an IMB spokeswoman.
Currently, most doctors use drugs "off-label" for children, relying on clinical experience to adapt dosage and frequency of usage. Inaccuracies sometimes occur with dosage calculations and when risks of side effects aren't fully known. Some of the impetus for the development of children-specific clinical trials comes from the acceptance that drugs act differently in children than in adults. Children respond differently and this has consequences in terms of effectiveness and side effects.
The IPHA, which is the representative body for the pharmaceutical industry in Ireland, said that - together with health professionals, patient and parent organisations and the EU institutions - the pharmaceutical industry had consistently supported the regulation on children's medicines.
"All going well, the regulation will come into force in the coming months and pharmaceutical companies will be obligated to carry out paediatric investigations within 18 months on new products or 24 months on existing products in new indications or strengths," an IPHA spokesman said.
To monitor future paediatric clinical trials, the EU regulation on children's medicines includes measures to set up a paediatrics committee within the European Medicines Agency.
There will also be measures to monitor the safety of medicines used for children, an EU inventory of the therapeutic needs of children, and an EU network of investigators and trial centres to conduct paediatric clinical trials.
The regulation on children's medicine now awaits its final stage which is the acceptance by the European Council of Ministers. This decision is expected in the near future and the regulation is expected to become law in member states towards the end of this year.
