Why children still wait years for medicines adults already have
Two decades of incentives and mandates on both sides of the Atlantic have transformed paediatric drug development. They have not closed the gap.
Regulation, incentives, pricing and access across the US, UK and EU.
Two decades of incentives and mandates on both sides of the Atlantic have transformed paediatric drug development. They have not closed the gap.
Policy
Brussels’ overhaul of its medicines legislation folds the Paediatric Regulation into a single framework. The details will decide whether plans for children start earlier.
Policy
Since 2021 the MHRA has run its own paediatric regime for Great Britain. For most companies it means one more plan to agree, not a different philosophy.
Policy
A tradable right to faster FDA review has become one of the more valuable prizes in paediatric drug development. Whether it creates new medicines is still debated.
Policy
Health technology assessment was built around adult trials and adult lives. Children’s medicines strain almost every assumption it relies on.
Policy
Doctors routinely give children medicines that were never licensed for them. It is often the best option available, and that is precisely the problem.