The European Parliament today voted to accept a compromise agreement that should hasten new rules on the testing of drugs for use in children through the legislature.
The regulation is intended to encourage the research, development and authorisation of medicines for paediatric use, through the use of inventive measures that reward groups carrying out clinical testing on new and established drugs, as well as create a paediatric R&D infrastructure across Europe.
Companies will be rewarded with an extra six months patent protection in return for carrying out the paediatric research, and once the paediatric data has been collected and verified, those marketing the drug to health professionals will be able to point to a "P" for paediatric logo which the product will display. The extended patent life follows a model already widely used in the USA to encourage testing of drugs in children.
The news will disappoint the European generics industry, which has argued that the extended protection delays the entry of copycat drugs, inflating the cost to healthcare payers.
Previously, many firms have considered that the economics of expensive and lengthy research into a new product's suitability for children do not add up - obviously there are fewer children than adults and therefore fewer potential customers. More than half the medicines taken by children in Europe have never been clinically tested or specifically approved for use in that age group.
The vote was welcomed by the European Federation of Pharmaceutical Industries and Associations, whose director general, Brian Ager, said: “our children must be able to benefit from medicines tailored to their special needs.”
“This must be achieved by restoring a strong pharmaceutical research and development presence for Europe.”
Worldwide sales of prescription drugs intended for use by children are expected to grow more than 6% a year to more than $46 billion in 2009, according to market research from Kalorama Information.