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New EU rules make child medication safer

Guidelines requiring EU-based pharmaceutical companies to demonstrate that every new, marketed drug has been tested on children came into effect at the beginning of 2007.

Guidelines requiring EU-based pharmaceutical companies to demonstrate that every new, marketed drug has been tested on children came into effect at the beginning of 2007.

The guidelines were put into place to make drug companies conduct more paediatric testing through incentives, as well as take some of the prescribing pressures off doctors. For medicines already on the market, companies will have to list dosage information for children and adolescents.

Prescribing for children is a complex issue, as the current model is that children simply receive less of an adult drug due to lower body weight. Alternatively, children and adolescents often need greater amounts of a drug because they metabolise them more quickly.

To help enforce the guidelines, pharmaceutical companies will benefit from a six-month extension of their drug patents, which would more than meet the cost of conducting dosage testing on children. EU estimates reveal that extended patents could translate into EUR 800,000 (GBP 536,036) to EUR 9 million (GBP 6 million) in extra profits, depending on the drug.

The US put legislation in place 10 years ago to improve paediatric drugs through patent extension incentives. For example, Eli Lilly made an estimated USD 700 million in profit alone during the extra six months of marketing their anti-depressant, Prozac.

European pharmaceutical companies have traditionally avoided paediatric testing because development and testing costs for children are expensive and the market is too small to warrant the effort. Some testing for OTC products has occurred, but detailed research for more serious diseases, such as cancer and diabetes, requires much more investment and coordination.

The European Parliament reached an agreement on the Medicines for Children regulation back in June 2006. Central elements of the regulation are the introduction of a Paediatrics Committee and a Paediatric Investigation Plan. The plan states that studies should only be conducted if there is a potential therapeutic benefit to children and duplication of studies must be avoided. Also, the requirements for studies in children should not delay the authorisation of medicines for adults.

Lynn Faulds Wood, President of the European Cancer Patient Coalition, said of the regulations: "The legislation will ensure that clinical research takes place in this area and will be to the highest ethical standards to protect the vulnerability of this population group. Stringent pharmacovigilance measures are essential to meet the specific challenges of collecting safety data in this group, including data on possible long-term side-effects."

9th January 2007

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