Leading doctors are warning that British children with cancer could suffer if they are no longer able to join Europe-wide trials of innovative new medicines as a result of the Brexit deal.
The Institute of Cancer Research (ICR) and the Royal Marsden NHS Foundation Trust say the best hope for some children with cancer is a clinical trial where a new drug is being tested. But because of the small number of children with the same cancers, the trials have to be run in many hospitals, often across Europe.
If the UK leaves the European Union and withdraws from the currently London-based European Medicines Agency which licenses new drugs, as expected, then pharmaceutical companies may choose to trial drugs just for children from countries in the EU. Children in the UK would lose out, and it could take years before they could get access to the newest treatments.
The ICR and the Marsden say EU regulations governing the way medicines are tested in children badly need reform to make companies trial more drugs in children, but the UK would be worse off without them.
“It is imperfect but it is all we have,” said Prof Louis Chesler, a consultant in paediatric oncology at the Marsden.
Children’s cancer is a very small field, he said. “The most effective way to run a clinical trial is to run a big one. If the regulations change and stop us working across European sites, that is a big problem for us,” he said.
The ICR and the Marsden, in their response to a European commission consultation on the future of drug regulation for children, are calling for changes so that drug companies cannot so easily obtain a waiver and duck the obligation to do trials in children once they have shown a drug works in adults.
A new analysis by the ICR shows that over the past five years (2012-2016) pharmaceutical companies were granted waivers from having to trial cancer drugs in children for 33 of 53 approved cancer treatments.
“By allowing pharmaceutical companies to use waivers to avoid trials in children so they can focus on adult treatments, the regulation is stifling progress and could be stopping children receiving a treatment that could save their lives,” said Chesler.
Prof Paul Workman, the chief executive of the ICR, said: “Children with cancer are currently missing out on the kind of innovative cancer treatments that are becoming increasingly common in adults because of outdated European rules that have failed to keep up with advances in science.
“We’ve been urging decision-makers to change the regulation for several years now, so that adult cancer drugs are tested in children whenever their mechanism of action suggests they could be effective.
“This is a real chance for reform to prevent the current out-of-date approach from being cemented for a decade. It could also be the last chance to make meaningful changes that apply across Europe, including the UK, before we leave the EU. It’s vital that whatever deal the UK does preserves access to Europe-wide clinical trials for children with cancer and avoids creating even longer delays in children accessing the latest cancer medicines.”
Dr Lynley Marshall, a consultant in child and adult cancer drug development at the Marsden, said families who are going through the trauma of caring for a child with cancer should not be alarmed. She pointed out that children with cancer in countries outside the EU, as far away as Israel and Australia, participate in some of the big treatment trials because of the difficulties of getting enough children with the same condition in one place.
She did not think fewer children in the UK with cancer would be included in trials. “I think it would be difficult to be categorical about it, but we will all be working very hard to ensure that there wouldn’t be,” she said.
UK children with cancer could miss out on drug trials after Brexit, doctors warn
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