Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the effect of the UK leaving the EU (a) with and (b) without a deal on access to EU clinical trials for children with rare cancers.

The United Kingdom and the European Union have a long track record of jointly tackling global challenges with strong existing links already in place between our research and innovation communities. We look forward to continuing our relationship in research and innovation with the EU, regardless of EU exit.

As part of exit negotiations, we are working to ensure that we continue to have the best possible environment in which to support clinical trials. Our overall aim is to ensure that patients in the UK, including children with rare cancers, have access to the best and most innovative medicines.

The Department has and continues to examine the effect on clinical trials of the UK leaving the EU with and without a deal across a range of areas, including access to, and mobility of, the research leaders and the technical and research delivery workforce; access to EU research funding; the regulation of clinical trials, data and devices; rare diseases research; and clinical trials supplies.

With regards to children with rare cancers, we are fully aware that the scarcity of patients in any single country means that clinical research into rare diseases strongly benefits from international collaboration.

It is important to make clear that irrespective of whether we leave the EU with or without a deal, the UK’s ability to participate in multinational trials, in the EU or the rest of the world, will not change and UK clinical trial applications will continue to be authorised by the Medicines and Healthcare products Regulatory Agency and ethical committees as they are now.

Beyond EU Exit, the National Institute for Health Research (NIHR) cancer research expenditure has risen from £101 million in 2010/11 to £136 million in 2017/18, which constitutes the largest investment in a disease area. The NIHR Clinical Research Network has over 800 cancer trials and studies recruiting or in set-up. Through the NIHR Clinical Research Network, the proportion of patients entering cancer clinical trials and studies is more than double that in any other country for which data exists, including the United States.

The NIHR works with Cancer Research UK to fund the Paediatric Experimental Cancer Medicine Centre Network which plays a leading role in speeding up the process of cancer drug development and the search for cancer biomarkers – molecules present in blood or tissue - that can be used to diagnose cancer, predict the aggressiveness of the disease, or show whether a drug will be effective in a specific patient and at what dose.