EU paediatric regulations earn companies, cost Europe billions: Generics industry
This article was originally published in SRA
Executive Summary
Originator companies complain that the EU Paediatric Regulation offers heavy burden for scant reward, but number crunching by the British Generic Manufacturers Association reveals that firms in the UK have raked in at least £379.7 million (approximately $616) thanks to the six-month supplementary protection certificate extensions awarded under the regulation1,2.