However, experts have warned the medicines most needed by children maynot be developed if funding is only made available throughpharmaceutical companies.
Drug companies focus on making medicines for adults because the marketis larger and more profitable. Developing medicines for children iscostly and difficult, as children's requirements change as they grow. Asa result, more than 50 per cent of medicines used to treat children areunlicensed, or "off-label", because they have not been adequately testedor authorised for use by children.
The regulations will require all companies creating new medicines foradults to test whether they can also be used for children, unless theycan show there is no demand for them.
A European paediatric committee will be created to assess companies'plans, and organisations that develop children's medicines will be givena six-month patent to help cover costs and act as an incentive.
The plans also include a fund to finance research into adapting existingdrugs for use by children, available to academics and healthprofessionals as well as pharmaceutical companies.
However, Professor Imtiaz Choonara, a paediatric clinical pharmacologistat the University of Nottingham, said there was mounting concern thatno-one had identified where the money for the fund would come from.
He warned the fund was vital as pharmaceutical companies were unlikelyto develop medicines that were the most useful for children. And he saidthat in America, which has already adopted similar legislation,companies were taking advantage of the patent to redevelop lucrative"blockbuster" drugs for illnesses that few children suffered from.
"We can't wait for pharmaceutical companies to initiate research," hesaid. "We need a pot of money open to anyone who thinks there's a needfor a particular medicine, or it won't allow some of the less popularmedicines to be developed."
However, Sharon Conroy, a lecturer at the University of Nottingham wholed a review on adverse reactions suffered by children to off-labelmedicines, said the laws would have a "high impact" on the lack ofchildren's medicines.
The news follows the launch by the European Medicines Agency of asix-month consultation on the first guidelines to focus specifically onthe safety of medicines for children.
- www.emea.eu.int/pdfs/human/phvwp/23591005en.pdf.
