Europe's generic drugs industry has slammed European plans to offer an additional six months of patent life to branded medicine makers who develop products for children. The proposed legislation, which is based on the current US model, could come into force early next year if it is approved by the European Parliament and ministers. Greg Perry, director general of the European Generic Medicines Association, said on Tuesday an across-the-board extension of six months to compensate big drug firms for the cost of conducting paediatric drug trials was too generous.
"We're not saying that added costs should not be compensated. We are just saying the compensation should be more proportional," he said in a telephone interview from Brussels.
Extra exclusivity for branded companies would not only keep generics off the market but would also be costly to healthcare budgets, he said.
All sides agree on the need for more research tailored to the specific needs of children, where this is ethical - but there is a gulf between the patented and unpatented sides of the drug industry as to how this should be done.
"For industry, a 6-months extension is a strict minimum requirement," said a spokesman for the European Federation of Pharmaceutical Industries and Association, which represents makers of patented drugs.
Perry, however, said three months would be a reasonable standard extension period, with six months reserved for products with very small sales or where paediatric clinical trials were especially costly.
For blockbusters, the extension should be no more than one month, he argued, since the maximum cost of a paediatric trial was 4 million euros ($5.2 million) while a top-selling drug could rake in hundreds of millions of euros from an extra six months of sales.
The United States introduced its legislation providing for a 6-months paediatric exclusivity period in 1997. This law must be re-authorised in 2007 and US generic drugmakers are already campaigning for less generous terms next time round.
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