Europe follows U.S. lead on child medicine testing
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Europe is following the U.S. lead with proposals requiring medicine testing on children, in a move welcomed by many doctors, patients and research-based companies but criticised by makers of cheap generic drugs.
More than half of medicines currently used to treat children in the European Union have not been specifically tested in youngsters.
As a result, clinicians lack clear guidelines on the best drug to use and often have to guess at the correct dose, since many products are not formulated properly for younger patients.
In a bid to address the issue, the European Commission has drawn up draft legislation, which would require testing in children, and, in exchange, give drug companies six months extra patent protection from generics.
The package is expected to receive a boost when Britain takes over the rotating presidency of the EU in July, since health minister Lord Warner has already said paediatric medicine is a priority issue. The law could apply in 2006.
Alistair Kent, director of the Genetics Interest Group, which represents families affected by genetic disorders, said regulation of paediatric medicine would protect children’s health and could save many lives.
“Children are not simply small adults; they are physiologically different in many highly significant ways,” he told reporters at a briefing on Wednesday.
“No parent wants to see their child treated as a guinea pig ... but without appropriate high quality medical research, it is clear that children will continue to suffer.”
CANCER DRUGS
Dr. Bruce Morland, a specialist in childhood cancers at Birmingham Children’s Hospital, also welcomed the move, which he said should lead to more tailored treatments, although he warned that the new system should not become bureaucratic.
At present, many cancer drugs, such as carboplatin, are widely used to treat children on an “off-label”, or unlicensed, basis.
Dr. Richard Tiner, medical director of the Association of the British Pharmaceutical Industry, said the proposed new law was a “win-win” situation for patients and industry.
In the United States, the introduction of paediatric legislation in 1997 led to a flood of important new prescribing information and label changes on 44 drugs, he said.
But generic drug manufacturers, who 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.
The European Generic Medicines Association has launched a campaign to get the extension reduced to a standard three months.
Tiner countered that six months was the minimum required if Europe wanted to remain a centre for medicines research, since otherwise more and more drug research would simply shift to the United States and Asia.
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