By Henrietta Billings - 6th September 2005
MEPs have given the go-ahead to new EU rules designed to boost industry research into medicines specifically designed for children.
Under draft European Commission rules, pharmaceutical companies will be given incentives to perform studies and trials on medicines for the under 18 year old market.
Difficulty in conducting clinical research and the small size of the market has hampered research into childrens medicines - with babies, children and adolescents just prescribed lower doses of drugs designed for adults.
Most controversial in the draft EU plan was a six month extension for patent products to allow industry to develop children's medicines - proposals that were passed by the European Parliament on Wednesday.
The French centre-right MEP Francoise, responsible for guiding the legislation through parliament, Grossetete welcomed the result of the vote.
"I am very satisfied with the result. This new regulation will affect the 100 million under 18 year olds in the EU. That's a large chunk of the population,” she said.
Grossetete also said she campaigned hard for the six month patent extension, despite pressure from the pharmaceutical industry for a longer period of up to one year.
"I fought very hard for a fixed period - that was a very important point."
The European Commission which backed the extension, said it would provide the necessary incentives to pharmaceutical companies to invest in research in drugs for children.
The result was also welcomed by the pharmaceutical industry.
"This week's Strasbourg plenary vote is a key opportunity for Europe's children and for Europe's pharmaceutical science base", said the European Federation of Pharmaceutical Industries and Associations (EFPIA) in a statement.
"By casting their vote, MEPs showed broad support for a balance between the obligations for pharmaceutical companies to conduct often complex, costly and lengthy paediatric research and the need to stimulate paediatric research in Europe."
Brussels estimates that a further six months could produce extra profits for industry to the tune of €800,00 to €9 million - compared to the cost of a trial which can cost as much as €4m.
Critics however argue that a six month patent extension would add billions of euros to European healthcare budgets - limiting access to cheaper generic medicines.
The parliament's report will now go to member states for discussion, where Grossetete is confident it will be broadly approved. She said her report already had the support of 20 out of 25 member states, and may not need to go to second reading.
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