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Children need access to cancer drug ‘goldmine’

EU regulations deny children access to life-saving treatments, say experts

Louise Prime

Tuesday, 11 February 2014

Children with cancer are being denied access to a potential ‘goldmine’ of life-saving medicines because of how EU regulations are being implemented, say cancer experts. They insist that more must urgently be done to make drugs available to children where there is evidence that they could be beneficial.

The ICR explains that a drug developed for a specific adult cancer that doesn’t occur in children may still be able to treat a different cancer in children. But the charity complains that too often, pharmaceutical companies are granted waivers and exemptions so that they do not have to carry out expensive testing of a drug in under-18s, on the basis that the adult cancer targeted does not occur in children – even when there is evidence that the drug has a mechanism of action that could also treat childhood cancers. It says such ‘class waivers’ result in significant delays in the medicines becoming available to children; or they might never be formally licensed for paediatric use.

The ICR has collaborated with the European Consortium for Innovative Therapies for Children with Cancer on an analysis of the impact of the current EU regulations. They are pushing for ‘urgent modifications’ of the 2007 European Union Regulation on Paediatric Medicine – which, ironically, was originally designed to improve children’s access to new treatments – to ensure that pharmaceutical companies test more of their medicines in children. The ICR is also calling for stronger financial incentives to compensate pharmaceutical companies for the financial challenge of developing drugs for small patient populations.

Dr Louis Chesler, reader in paediatric solid tumour biology and therapeutics at the ICR and honorary consultant at The Royal Marsden NHS Foundation Trust, said: “Increasing the number of paediatric cancer trials can have enormous benefits for children with cancer, by increasing the number of drugs available to them, improving doctors’ knowledge about how best to use drugs in children, and providing treatment in a best-practice clinical trial environment.

“Many cancer drugs developed for adults could be effective in children if we were able to test them in clinical trials. But the current system allows drug manufacturers to avoid testing their products in children, on the flawed grounds that adult cancers don’t have direct children’s equivalents – even where there is a common mechanism of action.”

Sutton and Cheam MP Paul Burstow, a former health minister, said: “It makes no sense to restrict research into potentially life-saving new treatments.

“It is important that we have rules to govern the ethical pursuit of new medicines, but these rules must be grounded in scientific reality and human need.”

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