The Commission is currently finalising a new legislative proposal which aims at improving the quality and effectiveness of medicines prescribed to children. The new law would promote the research and development of pharmaceuticals for this age group. The college of commissioners is expected to approve the proposal in September.
According to figures from the Commission, at least 50 per cent of the medicines given to newborn babies or to adolescents have never been tested for their impact on these age groups. As a common practice, doctors prescribe smaller or less frequent doses of medicines intended for adults. Other forms of medicine, for instance liquid instead of tablets, would often suit young patients better.
To reduce the risks of unexpected side-effects, the Commission is proposing a new piece of legislation introducing obligations for pharmaceutical companies to improve the medicines given to children. The new law would, for instance, require companies to present the results of clinical trials involving children at the time of the authorisation of drugs. The same would apply to patent-protected medicines already on the market if they wished to extend the use of the drug. Some of this information would then be made available to the public. Pharmaceutical companies would be compensated for the extra costs involved in complying with the new requirements with a six-month extension of their patent. The Commission will also propose incentives for new studies on the paediatric efficacy of generic medicines (not covered by a patent).
Ahead of the approval of the EU law, the UK's Department of Health launched a new paediatric medicines strategy on 18 August, devoting 100 million pound sterling (around 148 million euro) to encourage the development of medicines for children. Part of this budget will be spent on providing prescribers with better information about the impact of medicines on children.