European drug agency is exempting too many firms from testing drugs in children, cancer experts say

BMJ 2014; 348 doi: (Published 11 February 2014) Cite this as: BMJ 2014;348:g1491
  1. Nigel Hawkes
  1. 1London

Children with cancer are being denied access to new drugs because of the way European Union rules are interpreted, say UK cancer specialists.

Under regulations that came into force in 2007, drug companies are obliged to submit plans to test new products in children aged under 18, with the aim of improving the treatments available to children. But they can apply for a waiver that exempts them from this requirement. Critics, including the University of London’s Institute of Cancer Research, have said that the good intentions of the regulations were being undermined by the granting of too many waivers, even in cases where there were grounds for believing that …

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