Europe's Pediatric Rules Come Under Fire

Children with cancer are being denied new drugs because European Union rules are allowing companies to conduct trials on certain drugs only in adults, according to experts from The Institute of Cancer Research (ICR) in London.

“Increasing the number of pediatric cancer trials can have enormous benefits for children with cancer, by increasing the number of drugs available to them, improving doctors’ knowledge about how best to use drugs in children, and providing treatment in a best-practice clinical trial environment,” noted Dr. Louis Chesler, Reader in Pediatric Solid Tumor Biology and Therapeutics at the ICR and Honorary Consultant at The Royal Marsden NHS Foundation Trust. “Many cancer drugs developed for adults could be effective in children if we were able to test them in clinical trials. But the current system allows drug manufacturers to avoid testing their products in children, on the flawed grounds that adult cancers don’t have direct children’s equivalents – even where there is a common mechanism of action.”

Representatives from the ICR have asked the European Commission to make changes to the implementation of the EU Regulation on Pediatric Medicine, and now plan to speak to key partners in the U.K. and globally. They also believe in the need for stronger financial incentives to compensate pharmaceutical companies for the financial challenge of developing drugs for small patient populations. Some pharmaceutical companies already voluntarily submit Pediatric Investigation Plans (PIPs) based on mechanism of drug action, but others do not.

“It’s essential that ground-breaking cancer treatments are tested not only in adults but also in children, whenever the mechanism of action of the drug suggests they could be effective. That requires a change to EU rules, since the current system is failing to provide children with access to new treatments that could add years to their lives,” said Prof. Alan Ashworth, Chief Executive of the ICR.

The European Pediatric Medicine regulation significantly changed the landscape of drug development in children, there is an urgent need to change its implementation in order to meet the need for new innovative medicines to cure children and adolescents suffering life-threatening malignancies, according to Prof. Gilles Vassal, Head of Clinical Research at Institut Gustave Roussy, Villejuif, France, and Chair of the European Consortium for Innovative Therapies for Children with Cancer.