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ICR co-ordinates sector-wide Telegraph letter on childhood cancer drugs rules

A letter written by The Institute of Cancer Research, London, and co-signed by more than 10 charities has been published in The Telegraph. 

The letter calls for a change to EU rules that currently deny children promising cancer drugs. 

It calls for urgent reform to close a regulatory loophole that allows drug companies to be exempted from testing promising drugs in children and young people. 

We had hoped the European Commission would revise its guidelines following a consultation earlier this year on paediatric investigation plans (PIPs). These plans set out how companies will test their drugs in children – and companies legally have to prepare them if seeking authorisation for an adult cancer drug. 

However, companies can be given a waiver from producing a PIP if the drug they are trialling is being tested against cancers that only occur in adults. They can be granted a waiver even if there is evidence the drug could also work in childhood cancers. 

We and several other organisations, including the Teenage Cancer Trust, responded to the European Commission consultation – calling for this loophole to be closed. But the Commission deemed this out of the scope of the consultation. 

The letter responds to this by calling for the relevant European Regulation – called the Paediatric Regulation – to be changed at the earliest possible opportunity to close the loophole. 

It is co-signed by organisations including the Teenage Cancer Trust, Children with Cancer UK and Genetic Alliance UK. 

Commenting on the letter, Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, said: “Children with cancer are being denied access to new cancer drugs because of a failure of EU regulations to ensure that the latest treatments are tested in clinical trials. The rules need to be revised to provide children with the same access to new cancer drugs that is already afforded to adults. 

“The European Commission has missed a golden opportunity to make changes which could have significantly improved access to new treatments for children with cancer. 

“It is very disappointing that a technicality in EU process should be allowed to block a change that could have transformed access to new cancer drugs for the 15,000 children and adolescents diagnosed with cancer across Europe each year.” 

You can read more about this issue in this blog from our Science Information and Policy Manager, Dr Eva Sharpe. 

The full list of the signatories to the letter is: 

Professor Paul Workman, Chief Executive, The Institute of Cancer Research, London

Siobhan Dunn, CEO, Teenage Cancer Trust

Alistair Kent, Chief Executive, Genetic Alliance UK

Caroline Blakely, Chief Executive, Children with Cancer UK

Sarah Lindsell, CEO, The Brain Tumour Charity

Sue Farrington Smith, Chief Executive, Brain Tumour Research

Lindsey Bennister, Chief Executive, Sarcoma UK

Jane Lyons, CEO, Cancer52

Karen and Kevin Capel, Founders, Christopher’s Smile

Mike Shaw, co-Founder, and Claire Attard, Chairperson, Abbie’s Fund

Amanda Walker, Founder, Abbie’s Army

Lynn Lucas, Founder, Chris Lucas Trust
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