A difficult first five years with the EU Paediatric Regulation

摘要

What has been the experience with the EU Paediatric Regulation since it came into force over five years ago?The agencies involved are reviewing the legislation and reflecting on how it has been working in practice. On 8 July 2012, the European Medicines Agency with its paediatric committee (PDCO) prepared a five-year report for the European Commission on experience of the regulation since its entry into force on 26 January 2007.Then, on 19 September last yean the commission launched a public consultation in order to report to the European Parliament and Council in 2013.This consultation closed on 28 November the summary of replies has been published and a report is due this spring or summer This 5-year report however will not bring about amendments to the Paediatric Regulation, changes to this legislation will have to wait until a more comprehensive report which is due in 2017.This article examines the past five years of experience with the regulation with particular focus on the UK. It also attempts to answer the question of whether the incentives available under the regulation are sufficient reward to the pharmaceutical industry in return for the investment made in developing products and conducting clinical studies relevant to the pediatric population.The short answer is "no".