EU paves way for drugs modified for children
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Drugs specifically adapted for pediatric use will become more widely available in the European Union starting next year, following the adoption of new rules released by the European Parliament on Thursday.
More than half the medicines currently used to treat children have only been tested on adults and are not authorized for use specifically on infants, making it difficult for doctors to estimate the right dosage or predict side effects.
Many cancer drugs, such as carboplatin, are widely used to treat children on an “off-label” or unlicensed basis, cancer specialists say.
To tackle this, the European Commission drew up draft legislation that would require testing on children and, in exchange, drug companies would receive an extra six months of patent protection.
The new rules will cover medicines still in the development stage and not yet authorized as well as those already in use. Drug firms will have to submit a “pediatric investigation plan” to show how the treatment should be used for children.
Parliament adopted the legislation at second reading and the new rules will come into effect next January.
Medical experts said the rules were needed because children were physiologically different to adults.
“A member state on its own does not have the means to promote such a policy in favor of all our children,” said Francoise Grossetete, the French center-right MEP who steered the legislation through parliament.
The EU is following in the footsteps of the United States, which introduced pediatric legislation in 1997 that led to new prescribing information and label changes on 44 drugs.
Generic drug makers, which stand to lose out from the extra exclusivity granted to branded medicine firms, fear the plan for six months of additional patent life is too generous.
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