Looming Brexit sparks fears for child cancer trials, experts warn
pharmafile | March 9, 2017 | News story | Medical Communications, Research and Development | EU, ICR, brexit
The trials of cancer treatments in the EU are already at a low level and Brexit has experts worried that children in the UK may lose out even further. The Institute for Cancer Research (ICR) has raised the alarm that many companies do not currently trial their drugs in children due to a loophole in EU law, it’s rallying for changes to be made before the UK’s influence wanes.
The loophole relates to the EU Paediatric Regulation, set up in 2007, that allows pharmaceutical companies to be granted a waiver from being forced to trial their drugs in children. The condition for receiving the waiver relates to whether the treatment would be used in children. For example, lung cancer very rarely affects children and therefore a treatment designed to treat it would be unlikely to have to go through clinical trials in children.
However, as new treatments have arrived on the market, initial indications for treatment have often been expanded and new uses have been found for drugs – potentially indicating that children could benefit. The ICR stated that 33 out of 53 approved cancer treatments (62%), of the past five years, were granted waivers not to be tested in children.
The difficulty lies in the rarity of children suffering from cancer and therefore the difficulty the pharmaceutical companies have in making back any investment they commit to the project. Clinical trials are notoriously expensive to run and the potential treatment pool too small to justify such costs, from a business perspective.
Professor Paul Workman, Chief Executive of the ICR, said: “This is a real chance for reform to prevent the current out-of-date approach from being cemented for a decade.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.”
This is a key issue within the wider argument on children’s access to cancer trials – with Brexit potentially making the process of involving UK children more complicated, there is a danger that the UK children will be bypassed in favour of children within the EU. The ICR want to see the loophole closed up, forcing pharmaceutical companies to trial their drugs in children to determine whether they can be helpful, using the generous profits the bigger companies make to finance these trials.
Ben Hargreaves
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