Developing a European framework for research on children’s medicines: an examination of the proposed EU regulation on medicinal products for paediatric use

Abstract

Leading figures from research, industry, regulators and parents’ organisations met in Brussels in January at the annual conference of the European Forum for Good Clinical Practice to discuss one of the most urgent topics in health today: the shortage of medicines tested for use in children. The focus for the conference was the European Commission’s proposed new Regulation on Medicinal Products for Paediatric Use. The spirit of the meeting was captured by James Appleyard, past-president of the World Medical Association, in his keynote Joseph J. Hoet Lecture on ethics in clinical research. “There is a moral imperative for all governments, rich and poor, to promote the health of their children,” he said, adding: “There is also a moral imperative for all governments to create child health research to implement the aim—and to implement the research.”