Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to maintain competition in clinical trials after the UK leaves the EU.

The Government has made clear that a key priority through the negotiations will be to ensure that the United Kingdom remains one of the best places in the world for science and innovation, including clinical trials. Every Government department, including the Department of Health and Social Care, is planning to deliver a smooth exit under any scenario, which includes preparing the UK for the future economic partnership we hope to negotiate with the European Union, as well as the very unlikely scenario in which no mutually satisfactory agreement can be reached and the UK exits without a deal.

If the clinical trials regulation comes into force during the implementation period, as it is currently expected to do in March 2020, it will apply to the UK. The withdrawal agreement and implementation Bill will give effect to the implementation period in domestic law and will allow regulations to continue to apply in the UK for this time-limited period. If this opportunity does not come to pass, we will give priority to taking the steps necessary to bring into UK law, without delay, all relevant parts of the EU regulation that are within the UK’s control, so that those planning clinical research can do so with certainty.

The UK is already a preferred destination for EU and global clinical trials. The Government has been clear that it is in the interest of patients and the life sciences industry across Europe for the UK and EU to find a way to continue cooperation in the field of clinical trials, and for continued sharing of data and information, even if our precise relationship with the EU will by necessity change. As part of the Department’s Exiting the EU programme, officials are working to ensure appropriate coordination across a number of projects relating to research and clinical trials including workforce, regulations, funding and rare diseases.

The National Institute for Health Research (NIHR) provides the support, expertise and facilities that the National Health Service needs to undertake world-leading clinical trials funded by the NIHR, and other public, charity and life sciences industry partners, by funding a range of infrastructure facilities and the Clinical Research Network. Through NIHR and its partners, and by close collaboration with the life sciences sector and industry, the Government will ensure that the UK remains one of the best places in the world for research, science and innovation.