LONDON (AP) — Leading cancer experts say Europe's antiquated drug regulatory system is stopping children from getting life-saving medicines and are calling for changes that would remove a loophole that allows companies to skip developing medicines for children already approved for adults.
According to European rules, pharmaceutical companies that create a licensed cancer drug for adults are supposed to submit a plan for how that treatment might work in children. But they can sidestep that requirement if the drug treats a cancer in adults that doesn't usually affect children, such as lung cancer.
"This is out of kilter with what we believe about cancer," said Alan Ashworth, director of Britain's Institute of Cancer Research at a press briefing on Monday. "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. Ashworth said that more than half of cancer drugs developed in Europe with potential benefits for children are not tested in them.
Because cancer doesn't affect many children — there are about 15,000 new cases in Europe every year — drug companies don't often prioritize developing new therapies for them.
Dr. Louis Chesler, a pediatric oncologist at the Institute of Cancer Research and the Royal Marsden hospital, said the legislation is similar in the U.S. but that across the Atlantic there are government-led initiatives to promote developing cancer medicines for kids. Chesler said the U.S. National Institutes of Health and others work closely with pharmaceuticals and academics to ensure cancer treatments for children are developed.
"A company in the U.S. can just decide to farm out their drug to the NIH and they will take the lead on seeing if it is effective for children," Chesler said. "Nothing like that exists in Europe." He said the regulatory roadblocks in Europe mean there are delays for children who need certain cancer medicines or that it's difficult for them to get the drugs.
The European Commission recently held a consultation on its guidelines for the development of cancer drugs for children; it's unclear when there will be a final decision.