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The Nordic Contribution to Delivering Better Medicines for Europe’s Children

The paediatric population is primarily healthy, rendering paediatric drug development research challenging due to the limited number of children typically impacted by a medical condition. Traditional drug development approaches using large randomized controlled trials to evaluate a drug’s benefit and risk profile are rarely an option. This challenge is further complicated by the additional need for developmentally-appropriate outcome measures for children across the age spectrum, adaptations required in research procedures and settings to accommodate children's physical, cognitive, and emotional development, as well the need to comply with ethico-legal protections due to their vulnerability. These complexities, in addition to the lack of commercial drivers, have led paediatric drug evaluation to be neglected historically, leading to inadequate efficacy and safety information for drugs frequently used to treat childhood diseases. Over the past two decades, governments have been addressing the inadequacy of drug testing and insufficient information for use in product labels for children through the introduction of policies intended to stimulate investment in pediatric drug development. In the United States and Europe, these laws have been impactful tools to enhance both the quantity and quality of medicines development for children.