Framework conditions facilitating paediatric clinical research

The Coordination of Research on Priority Medicines for Children (ERA-NET PRIOMEDCHILD) is a network of research funding organisations from eleven different European Union (EU)-member-states, initially founded on January 1st, 2007 for a period of three years extended to four due to an official extension by the European Community (EC). The network's primary goal is to contribute to the European Research Area on priority medicines for children by implementing a European joint research programme including development and innovation themes [1]. ERA-NET PRIOMEDCHILD's concern is also to bring coherence and cooperation to national research programmes and to establish policies on priority medicines for children research.Between 2007 and 2010, key national and international organisations including the European Medicine Agency (EMA) and its Paediatric Committee (PDCO) representative members have been consulted to address research, research funding, public-private research cooperation, ethical and regulatory issues. A set of workshops and meetings involving stakeholders, i.e., academic experts from public hospitals, pharmaceutical industry's, insurance company's, parent associations' and health authorities representatives were held. Based on expert consultations, questionnaires sent to stakeholders and a literature review on that topic, ERA-NET PRIOMEDCHILD identified legal and ethical issues arising from the European Regulation of Paediatric Medicines and made recommendations for facilitating clinical research with children.The three legal pillars of the new Regulation [2] are i) the adoption of incentives for industry; ii) the implementation of a mandatory Paediatric Investigation Plan (PIP) considering all age ranges and iii) the creation of a Paediatric Committee (PDCO). The Regulation provides therefore strong obligations for the pharmaceutical industry together with some rewards and incentives in order to facilitate the development and accessibility of medicinal products