Medicines research with children: Council welcomes EMA class waiver review

The Nuffield Council on Bioethics welcomes the European Medicines Agency’s revision of the class waiver list as a positive step towards further promoting research into new medicines for children.

Professor Bobbie Farsides, Chair of the Nuffield Council on Bioethics’ Working Party on children and clinical research, and Professor of Bioethics at Brighton and Sussex Medical School, says:

“Since the EU Paediatric Regulation came into force in 2007, it has made a real and welcome difference to the amount of information available to prescribers on the effects of medicines on children and young people. However, as we identified in our report, it’s clear that the waiver system has not been working as originally intended. We therefore recommended that the EMA should complete its review of the class waiver system as a matter of urgency to ensure that where a medicine may be potentially relevant for disorders affecting children and young people, research with children and young people should go ahead.

“Missed opportunities to promote research that may potentially lead to improvements in children and young people’s healthcare are a matter of ethical concern. Yesterday’s announcement by the EMA is a welcome step towards further promoting research with children.”

Since the publication of the report in May 2015, the Council has discussed its recommendations with relevant organisations, including the EMA.

About the Regulation

The 2006 EU Paediatric Regulation requires that companies must submit a plan (known as a Paediatric Investigation Plan, or PIP) that describes how a new medicine being developed should be studied in children. In cases where the medicine is likely to be ineffective or unsafe, where it does not represent a significant therapeutic benefit over existing treatments in children, or when the medicine is intended to treat a condition that only occurs in adults, companies can be granted a waiver meaning they are not required to submit a PIP.

However, as highlighted in the Council’s report, the system is not working as intended. Many adult disorders, such as some cancers, do not have direct equivalents in children, but this does not mean that the medicine being developed won’t be effective in treating related disorders in children. For instance, the Institute of Cancer Research, London notes that 26 of the 28 cancer medicines that have been authorised in Europe since 2007 have a mechanism of action that is relevant for childhood cancers; nevertheless, 14 of these medicines received waivers.

Find out more about the EMA’s announcement in this Q&A

Find out more

Further background, blogs, news and policy papers linked to the Council’s report on children and clinical research are available online.

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