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European Medicines Agency acknowledges limitations of paediatric licensing rules

The European Medicines Agency has acknowledged that there is a lack of development of medicines for paediatric cancers after the Institute for Cancer Research claimed that children with cancer are missing out on new medicines because of EU rules.

In a statement issued earlier this week (10 February 2014), the ICR explained that currently medicines for adult diseases are only required to be tested in the paediatric population if the same disease also affects children. It points out that many cancer medicines licensed for adults are exempt even though there are childhood cancers with common genetic features. To illustrate the point, the ICR says that out of the 28 cancer medicines that have gained EU approval since 2007, 26 have a mechanism of action that suggests they could be effective in childhood cancers. However, 14 of these have had the requirement for paediatric testing waived.

In response to the claims, the EMA — which is responsible for evaluating medicines put forward for an EU licence — conceded that there is a lack of development of childhood cancer medicines. “[The EMA] is working actively with its partners across the EU to address this unmet medical need,” said a spokeswoman. She explained that the EU Paediatric Regulation was designed to increase the number of medicines for children and she claimed that overall this Regulation has been a success. However, she added that the Regulation does not give regulatory authorities the legal right to compel companies to develop a particular medicine for a different condition from the adult one.

But the ICR, in partnership with the European Consortium for Innovative Therapies for Children with Cancer (ITCC), is calling for the EU to scrap the current system of waivers and exemptions. “Specifically, the ICR wants the European Commission to refuse to grant waivers to pharmaceutical companies exempting them from testing cancer drugs in children on the basis that the adult cancer targeted does not occur in children.”

The EMA spokeswoman said that the lack of availability of medicines for paediatric cancers has been highlighted in the European Commission’s five-year progress report on the impact of the EU Paediatric Regulation and identified as an area for future work.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11134267

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