MEPs back law favouring child medicines
08.09.05 @ 10:47
The European Parliament on Wednesday (7 September) voted in favour of a new regulation on medicine, obliging pharmaceutical companies producing a drug for adults in the EU to test whether it can also be used for children.
Named the "Regulation on Medicinal Products for Paediatric Use" the law is aimed at stemming criticism that drugs are generally only tested on adults.
"For far too long Europe's children have been waiting, and parents' and patients' organisations have been calling, for special paediatric medicines. Let's not disappoint them," centre-right French MEP Francoise Grossetête wrote in a report ahead of Wednesday's vote.
As medicine is generally only tested on adults, doctors can often only estimate the dose of medicine that should be given to children.
There is also a lack of knowledge about the possible side-effects from the medicine.
Fifty per cent of drugs prescribed to children are not tested on children.
One obstacle for enhanced testing on children has been incentives to pharmaceutical companies to invest more in testing.
Medicine for children's use makes up for a minor part of the medicine market, and pharmaceutical companies have shown little interest in investing in additional tests.
In order to boost research incentives, the newly adopted law says that companies should have an extra six months of protection under existing patents.
Brian Ager, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) said he was pleased with the outcome of Wednesday's vote:
"This week's Strasbourg plenary vote is a key opportunity for Europe's children and for Europe's pharmaceutical science base", he said in a press.
But manufacturers of generic low-cost alternatives to patented medicines have protested saying high-cost companies will make too much of a profit on prolonged patents.
The regulation now has to be approved by member states before it can go into force.