Children with cancer are being denied new drugs with the potential to save lives due to EU regulations, cancer experts have warned.
Drug companies are currently able to opt out of running clinical trials in children – but even if this loophole is closed, there are concerns young cancer patients in the UK could miss out on Europe-wide trials after Brexit.
The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust called for urgent reform to the EU Paediatric Regulation so children can access the latest cancer treatments.
They said currently nowhere near enough cancer medicines were being tested in children and recommended changes to the regulation to allow children to benefit from trials.
“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 Professor Louis Chesler, who works at both institutions.
Amanda Walker, whose six-year-old daughter died from a rare form of brain cancer in 2011, said it was “heartbreaking” to know there might be treatments being developed for rare diseases such as her daughter’s that weren’t being trialled because of the loophole.
Chief executive of the Institute of Cancer Research Paul Workman said the institutions’ advice to the European Commission represented a chance to improve an out-of date approach to clinical trials.
But he also urged the Government to recognise the importance of access to clinical trials in Brexit negotiations.
“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,” he said.
More than 600,000 patients a year in Britain take part in clinical trials, but medical research organisations have warned the UK could be bypassed by drug companies setting up trials after it leaves the EU.
The risk is particularly heightened for patients with rare diseases, including some childhood cancers, because the small number of potential trial participants makes it more efficient to run the research across Europe.
Beth Thompson, senior policy adviser at the Wellcome Trust, which funds medical research, said there is a “real risk that patients will miss out” after Brexit.
“It’s going to become more complicated to run a trial here, with our population of around 60 million, than it is to go to the whole of the EU, which has a population of 500 million,” she said. “There’s a risk that people might bypass the UK altogether and just go to Europe.”
13 ways to help prevent cancer
13 ways to help prevent cancer
Stopping smoking. This notoriously difficult habit to break sees tar build-up in the lungs and DNA alteration and causes 15,558 cancer deaths a year
Avoiding the sun, and the melanoma that comes with overexposure to harmful UV rays, could help conscientious shade-lovers dodge being one of the 7,220 people who die from it
A diet that is low in red meat can help to prevent bowel cancer, according to the research - with 30 grams a day recommended for men, and 25 a day recommended for women
Foods high in fibre, meanwhile, can further make for healthier bowels. Processed foods in developed countries appear to be causing higher rates of colon cancer than diets in continents such as Africa, which have high bean and pulse intakes
Two servings of fruit and three servings of vegetables a day were given as the magic number for good diet in the research. Overall, diet causes only slightly fewer cancer deaths than sun exposure in Australia, at 7,000 a year
Obesity and being overweight, linked to poor diet and lack of exercise, causes 3,917 deaths by cancer a year on its own
Dying of a cancer caused by infection also comes in highly, linked to 3,421 cancer deaths a year. Infections such as human papilloma virus - which can cause cervical cancer in women - and hepatitis - can be prevented by vaccinations and having regular check-ups
Cutting back on drinks could reduce the risk of cancers caused by alcohol - such as liver cancer, bowel cancer, breast cancer and mouth cancer - that are leading to 3,208 deaths a year
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Sitting around and not getting the heart pumping - less than one hour's exercise a day - is directly leading to about 1,800 people having lower immune functions and higher hormone levels, among other factors, that cause cancers
2011 Getty Images
Hormone replacement therapy, which is used to relieve symptoms of the menopause in women, caused 539 deaths from (mainly breast) cancer in Australia last year. It did, however, prevent 52 cases of colorectal cancers
2003 Getty Images
Insufficient breastfeeding, bizarrely, makes the top 10. Breastfeeding for 12 months could prevent 235 cancer cases a year, said the research
Oral contraceptives, like the Pill, caused about 105 breast cancers and 52 cervical cancers - but it also prevented about 1,440 ovarian and uterine (womb) cases of cancer last year
2006 Getty Images
Taking aspirin also prevented 232 cases in the Queensland research of colorectal and oesophagal cancers - but as it can also cause strokes, is not yet recommended as a formal treatment against the risk of cancer
The EU Paediatric Regulation, introduced in 2007, allows pharmaceutical companies to apply for a waiver from having to trial a cancer drug in children if it targets a cancer that does not affect children, such as lung cancer - even if the drug's mechanism of action means it could be effective for them.
New analysis by The ICR shows that, over the last five years, pharmaceutical companies were granted waivers from having to trial cancer drugs in children for 33 of 53 cancer treatments.
Almost two-thirds of these treatments were ultimately approved, even though some drugs targeted at adult cancers may be effective to treat childhood cancers.Reuse content