Paediatric drug policy in Australia

International Changes to Paediatric Drug Policies
Providing children with better access to safe and effective medicines to address their therapeutic needs is a global issue. Therapeutic mishaps affecting children have historically led to major reforms designed to ensure the efficacy and safety of medicines.1 Over the past 15 years, legislation in the United States and developments in Europe and the World Health Organization have been implemented to address the gap in licensing and labelling needs for medicines for children2 (Fig. 1). While it is clear that legislative changes including the 2003 Pediatric Research Equity Act and European Pediatric Regulation 1901/2006 have stimulated the conduct of paediatric studies and increased the knowledge of pharmacokinetics, dosing and safety in children,4, 5 substantial concern remains that many of the applications and studies reflect the adult market rather than a specific paediatric research agenda.6 It is also apparent that voluntary incentives including the European Paediatric Use Marketing Authorisation for the study of off‐patent medicines have been less productive and that additional measures such as public funding may be needed.3