Drugs not approved for children still being used to treat them

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Science|Business reporting

Off-label and unauthorised drugs are still being prescribed, according to a European survey on use of medicines for children.


A survey of all uses of medicines for children shows that the prescription of off-label and unauthorised drugs is still widespread in Europe, more than three years after the European Union legislation that aimed to end this practice came into force.

The survey was commissioned as part of the European Paediatric regulation, which is intended to improve children’s healthcare by encouraging the development and availability of medicines for children aged 0 to 17 years, ensuring they are ethically researched and properly authorised.

The regulation, passed after long deliberation in 2007, is meant to achieve this without subjecting children to unnecessary trials, or delaying the authorisation of medicines for use in adults.

A wide range of drugs are being used off-label or without an appropriate marketing authorisation, with higher rates in very young children and children with very severe conditions, according to the survey. One of the main reasons is the lack of age-appropriate formulations.

The Paediatic regulation was intended to give drug companies an incentive to carry out safety testing in children, offering a six-month patent extension in the case of standard treatments, and a two-year extension to the patent life of orphan drugs – if safety and dosage trials are carried out on children.

In addition, there was a new designation, the Paediatric Use Marketing Authorisation, which provides 10 years’ patent protection for companies that carry out paediatric clinical trials of off-patent drugs.

The survey will inform the work of the European Medicines Agency’s Paediatric Committee, which maintains an inventory of the potential commercial opportunities for companies to develop paediatric medicines.