The generics industry yesterday was disappointed on a European Parliament ruling to maintain a clause in new paediatric drug legislation that encourages pharmaceutical companies to invest in clinical trials in children – in return for a six-month patent extension on branded drugs. The European generics industry had argued that the extended protection delays the entry of copycat drugs, inflating the cost to healthcare payers.

“We are disappointed by this decision as we believe our proposal was the fairest and most cost-effective form of extension,” stated Greg Perry, Director General of the European Generic Association, adding: “On a more positive note, Members of the European Parliament did pass an amendment to prevent so-called ‘double awards’ to the pharmaceutical industry for a single investment into paediatric research. MEPs also required the extension to be reviewed within six years to assess the cost implications on European healthcare.”

However, amongst the pharmaceutical industry, there is a general feeling that a six-month patent extension strikes the right balance between the need to invest in paediatric trials and the incentive for R&D innovation.

The proposal will now be sent to the Council of Ministers where it is expected to receive final approval under the UK presidency. The final legislation is expected to be published in the spring of 2006.