Clinical Trials

(asked on 13th November 2017) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, what plans he has to maintain access to new medicines from clinical trials after the UK leaves the EU.


Answered by
Steve Brine Portrait
Steve Brine
This question was answered on 16th November 2017

The Government values the strong collaborative partnerships that we have across the European Union in the areas of science, research and innovation, and as part of Exit negotiations is working to ensure that we have the best possible environment in which to support clinical trials and new medicines after we leave the EU.

On 3 November, the Government published its response to the Accelerated Access Review. It set out plans to give patients quicker access to life-changing treatments; and, make the United Kingdom the best place in the world for industry to invest and innovate. From April 2018, the new Accelerated Access Pathway will mean selected products with the greatest potential to change lives could be available up to four years earlier by reducing the time taken to negotiate the evaluation and financial approvals necessary before the National Health Service can purchase them.

In the UK, the Medicines and Healthcare products Regulatory Agency, Health Research Authority, ethics services, National Institute for Health Research and NHS have been working towards implementation of the new European Clinical Trials Regulation (CTR) since it was agreed in 2014. The application date of the CTR across the EU will be set by the European Commission. The current regulatory approval legislation will stay in place until such time as any changes are needed so there will be no interruption in UK clinical trials approval.

The UK anticipates continuing to work with EU partners on sharing of clinical data across borders where applicable under legal frameworks and with the consent of the data subject. While we cannot pre-empt the outcome of the negotiations on the UK’s exit from the EU, our aim will be to ensure that patients continue to access the best and most innovative medicines.

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