Comment from the Nuffield Council on Bioethics on the Paediatric Regulation

In 2015 the Nuffield Council on Bioethics published a report on children in clinical research: ethical issues, following a two year enquiry, chaired by Professor Bobbie Farsides. One of its key messages was that the evidence base for children’s healthcare can only be improved through research – and that children are more vulnerable, not less, if they are not able to access clinical trials.

Hugh Whittall, Director of the Council said: "In our recent response to the EU consultation on Paediatric Regulation, we welcomed the significant benefits that the Regulation has brought by increasing the focus on medicines research with children in a European context. We also recognised in particular the positive and proactive approach the European Medicines Agency and its Paediatric Committee (PDCO) have taken to their regulatory role, using it not only to police the system established by the Regulation, but also to promote effective and collaborative research with children and young people. We encouraged them to continue to build on these successes, and to use the opportunity of the ten-year review to identify need for legislative change."

Brexit obviously threatens this – and we therefore believe it is critical for government to aim to maintain harmonisation of requirements for clinical trials with those in the EU to ensure that it is practical for international and cross-European trials to include children from the UK."

Notes to Editors:

We have previously welcomed the EMA’s 2015 review of class waiver decisions and its encouragement of a voluntary approach to carrying out research with children. We note and encourage the PDCO’s commitment to continue to revise the class waiver list as more information on medicines and diseases become available.

See also:

The Guardian: UK children with cancer could miss out on drug trials after Brexit, doctors warn and http://www.bbc.co.uk/news/health-39207326

BBC Online: Cancer treatments 'not being trialled in children'