Children are currently receiving medicines created for adults but in smaller doses, the European Commission states that more than half of the medicines given to them have not been tested in the child population. But the new law that will come into effect next Friday, will force pharmacists to research and develop specific or adapted drugs for children.
This regulation, approved in June 2006 by the European Parliament, will prevent (with some exception, such as unnecessary or undesirable cases) that no medication is administered to the child population without first having conducted clinical trials with children, will motivate the research and development of Pediatric drugs through incentives and will improve information on the use of these medications.
The pharmaceutical industry is faithfully dedicated to adult diseases due to its profitability, but the profit margin can be compensated thanks to the extension of the patent protection in six months added to the current eight. Although the application of this regulation will begin in July 2008, they are already motivating the pharmaceutical sector to initiate research. It will be the new medicines that enjoy authorization in the specific treatment of childhood diseases after the approval of a Pediatric Committee that will be created in the next six months.
The medicines currently marketed will not have the obligation to undergo clinical trials, unless they need to change the indication, that is, add the use for the treatment of another disease, or for a new version of administration, with the exception of Homeopathic treatments or those containing active ingredients of established use.
