Why we exist

Most medicines were developed for adults because:

There are many more adults than children in the world, so medicines designed for adults are used in much larger quantities, and so they are more economical for manufacturers to make and sell.

In many cases, manufacturers who want to develop new medicines can try them out on adult volunteers, to make sure that they are safe and effective. They can advertise in newspapers, on buses, and elsewhere, for adult volunteers. Testing on children raises greater ethical issues, which has hindered development.

Consequently:

Sometimes in the past, doctors who needed to treat sick children faced a dilemma.

They might have used a medicine off-label; for example, where the dose of a medicine had been scientifically tested, but only for adults, when the doctors might have prescribed lower doses for children, by using their professional skill. Or, the doctors might have prescribed a medicine to treat a childhood illness for which it had not been scientifically tested, but it was well-known to be safe and effective.

They might have used a medicine in an unlicensed way; for example, by grinding tablets into a powder and mixing it with a liquid, to make it easier for children to swallow.

You can read more about off-label and unlicensed medicines by clicking here. 

But now:

There is a new European legal requirement to test medicines on children before they can be licensed for children. This raises questions of costs and ethics.

As an incentive for manufacturers to fund the scientific research into medicines for children, they are allowed extended patent protection to help them recover their research costs.

Our role as part of the UK National Institute for Health Research includes helping manufacturers and NHS researchers carry out research ethically, introducing them to young patients.

Please click here to find more about what we do.