Flawed law denies European kids life-saving cancer drugs: experts

A loophole in European law has denied life-saving cancer drugs to thousands of children, according to experts.

Under the rules, pharmaceutical companies could avoid having to test new drugs in children if the diseases they treated only affected adults.

However, the "class waiver" in the 2007 regulations meant children would forego treatment that might be effective against different cancers.

A genetic defect that triggered a particular type of cancer in adults might cause quite another disease in children.

Yet a new drug designed to hit this molecular target might not be investigated in the treatment for the childhood cancer - despite its theoretical potential.

Leading scientists from the Institute of Cancer Research (ICR) in London, a centre of pioneering work on the latest "smart" cancer drugs, are calling for changes in the law to give under-18s greater access to promising new treatments.

Professor Alan Ashworth, chief executive of the ICR, said the take home message was that potentially life-saving drugs were being denied to children because they were not being trialled properly, tvnz.co.nz reported.

He added, it was essential that ground-breaking cancer treatments were tested not only in adults but also in children, whenever the mechanism of action of the drug suggested they could be effective.

He added, that required a change to EU rules, since the current system was failing to provide children with access to new treatments that could add years to their lives.

Cancer experts said, the loophole that allowed companies to skip developing medicines for children already approved for adults.

According to European rules, pharmaceutical companies that created a licensed cancer drug for adults were supposed to submit a plan for how that treatment might work in children.

However, they could sidestep that requirement if the drug treated a cancer in adults that did not usually affect children, such as lung cancer.

Ashworth said at a press briefing yesterday, "this is out of kilter with what we believe about cancer."

He added, ''a drug developed for cancer in adults could also be effective against a cancer affecting a completely different part of the body in children.''

He said, more than half of cancer drugs developed in Europe with potential benefits for children were not tested in them.

According to Louis Chesler, a paediatric oncologist at the Institute of Cancer Research and the Royal Marsden hospital, the legislation was similar in the US, but across the Atlantic there were government-led initiatives to promote developing cancer medicines for kids.

He added, the US National Institutes of Health and others worked closely with pharmaceuticals and academics to ensure cancer treatments for children were developed.

(Read The Institute of Cancer Research note:  EU rules are denying children latest cancer drugs )