Last updated 11 March 2019
The government has been clear that delivering the deal negotiated with the EU remains its top priority. This has not changed.
However, the government is clear that it must prepare for every eventuality, including a no deal scenario. For two years, it has been implementing a significant programme of work to ensure that the UK is prepared to leave the EU on March 29 2019.
In the summer, the government published a series of 106 technical notices setting out information to allow businesses and citizens to understand what they would need to do in a no deal scenario so they can make informed plans and preparations. At that time, the HRA highlighted the aspects most relevant to health and social care research.
On this page, we will highlight updates and additional guidance published more recently to help organisations prepare for a no-deal EU Exit, as well as our own guidance on aspects of planning which are within our regulatory remit.
Handing amendments in the case of a no-deal Brexit
The HRA published new guidance on 6 March 2019. The guidance sets out some of the changes which may need to be made to studies in the event of a no-deal scenario, and whether they constitute substantial amendments.
Transferring research data between countries in the event of a no-deal Brexit
NHS England has published a set of questions and answers for the health and social care community on ensuring continued access to, processing and sharing of data after EU Exit. It has confirmed that this guidance applies to personal data flows for the purpose of health and social care research (please see the final question).
This guidance complements DHSC guidance which can be read in full on the gov.uk website. Of particular note is page 13, which includes more detail on maintaining data flows.
Clinical trials of medicinal products and clinical investigations of medical devices
Stephen Hammond, Minister of State for Health, 25 February 2019
Supplies for clinical trials:
"We are working with organisations running clinical trials and have requested these organisations to consider their supply chains for clinical trials ahead of 29 March. We have requested that they ensure contingency arrangements are in place for their supplies. Supplies for clinical trials are transported in small quantities and usually via airfreight."
Department of Health and Social Care, 21 December 2018
Clinical trials and clinical investigations:
"The Department continues to engage with the life sciences industry regarding contract research and clinical trials of investigational medicinal products (IMPs) and medical devices. The Department is working closely with the NHS and is undertaking a comprehensive assessment of the potential impact of ‘no deal’ exit on clinical trials and investigations, to gain a greater understanding of those which might be affected by supply issues. This includes examining supply chains for IMPs, medical devices, in vitro diagnostic devices, advanced therapy medicinal products, radioisotopes and other clinical consumables, used in clinical trials and investigations, which originate from, or travel through, the EU and EEA. This assessment aims to conclude in January 2019 and, if necessary, further guidance will be issued thereafter.
"All organisations participating in and/or recruiting patients to clinical trials or clinical investigations in the UK should contact their relevant trial sponsors for confirmation of plans for supply chains for IMPs and medical devices as soon as possible.
“Organisations should […] continue to participate in and/or recruit patients to clinical trials and clinical investigations from 29 March 2019, unless they receive information to the contrary from a trial sponsor, organisation managing the trial or investigation, or from formal communications.”
Clinical Trial Regulation:
"For EU-wide trials, the new EU Clinical Trial Regulation (CTR) will not be in force in the EU on 29 March 2019 and so will not be incorporated into UK law. However, the Government has stated the UK will align where possible with the CTR without delay when it does come into force in the EU, subject to usual parliamentary approvals. This will provide certainty for organisations conducting trials in the UK."
The Minister's full statement to the House of Commons on plans for the continuity of medicines and medical products in the event of a no-deal Brexit can be read on the gov.uk website.
The DHSC guidance can be read in full on the gov.uk website. Of particular note are pages 12 and 13.
MHRA, 3 January 2019
"The UK will continue to recognise existing clinical investigation approvals – both for regulatory and ethics approvals – and there will be no need to re-apply. UK clinical investigation applications will continue to be authorised by the MHRA and ethics committees as they are presently."
Clinical Trials of investigational medicinal products:
"If there’s no deal, the UK’s current participation in the European regulatory network for clinical trials would end, and the MHRA would take on the responsibilities for the UK that are currently undertaken through the EU system. The UK will continue to recognise existing approvals – both for regulatory and ethics approvals – and there will be no need to re-apply."
New EU regulations:
"Through the no deal statutory instrument, which will amend the Medical Devices Regulations 2002, the UK will have a regulatory system in place on 30 March 2019, which will mirror all the key elements contained in Regulations 2017/745 on medical devices (MDR) and 2017/746 on in vitro diagnostic medical devices (IVDR) and which will be brought into force in line with the transitional timetable being followed by the EU for the full application of those two Regulations."
The MHRA guidance can be read in full on the gov.uk website. Of particular note are sections 2.4, 2.6 and 3.
EU research and innovation funding schemes
Department of Health and Social Care, 21 December 2018
"The Government has guaranteed funding committed to UK organisations for certain EU funded projects in the event of a ‘no deal’ scenario. This includes the payment of awards where UK organisations successfully bid directly to the EU while we remain in the EU, and the payment of awards where UK organisations are able to successfully bid to participate as a third country after EU Exit, until the end of 2020.
"This means that successful bids for EU programme funding until the end of 2020 will receive their full financial allocation for the lifetime of the project"
The DHSC guidance can be read in full on the gov.uk website. Of particular note is page 11.
This page has been produced to flag the most relevant sections of the most recent guidance for health and social care researchers, sponsors and funders, but the HRA cannot replicate the whole of these documents here. We recommend that you follow the links above to read the guidance in full.