The UK is due to leave the EU on 31 October 2019.
The government has been clear that delivering a deal negotiated with the EU remains its top priority. If this is not possible, we will leave without a deal and make all necessary preparations to do so.
On this page, the HRA will highlight guidance to help the health and social care research community to prepare for a no-deal EU Exit, as well as our own guidance on aspects of planning which are within our regulatory remit.
Handling amendments in the case of a no-deal Brexit
The HRA published new guidance in 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.
The MHRA has also published guidance on substantial amendments to a clinical trial if the UK leaves the EU with no deal. This guidance was updated in August 2019.
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 (updated August 2019). 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
The Medicine and Healthcare products Regulatory Agency (MHRA) published updated guidance on the regulation of medicines, medical devices and clinical trials in the event of a no deal EU Exit in August 2019.
MHRA guidance note, August 2019
2.3 Clinical Investigations
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.
3.1 How we propose to regulate clinical trials if there’s no deal
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. This section provides further detail on how we propose the UK system would operate.
3.2 Existing approvals
The UK will continue to recognise existing approvals - both for regulatory and ethics approvals – and there will be no need to re-apply.
3.8 Publishing trial results
The UK’s overall intention is to align transparency provisions with those currently operating in the EU, in order to eliminate the need for companies to duplicate efforts.
In the short term, those running trials should continue to use existing and established international registries such as EudraCT (EU), ISRCTN (International Standard Randomised Controlled Trial Number) registry, ISRCTN (UK), and ClinicalTrials.gov (USA) to ensure that UK patients are aware of your trial. The UK will continue to make information about trials being conducted in the UK available to patients and clinicians via the UK Clinical Trials Gateway.
By the time the EU’s new portal goes live (as part of the new CTR), the UK will have its own specific hub that would give both the UK patients and researchers a single reference point for all UK trials.
The Department of Health and Social Care (DHSC) released operational readiness guidance, actions the health and care system in England should take to prepare for a no deal scenario, in December 2018. It can be read in full on the gov.uk website. Of particular note are pages 12 and 13.
Department of Health and Social Care, 21 December 2018
Clinical trials and clinical investigations:
Organisations should […] continue to participate in and/or recruit patients to clinical trials and clinical investigations from the EU exit date, 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.
As part of its Operational Response Centre, DHSC has set up a National Supply Disruption Response (NSDR). The NSDR processes will monitor the supply situation and co-ordinate actions to address supply disruption incidents that occur after the UK has exited the EU where normal procedures are unable to provide a resolution.
Department of Health and Social Care, 27 March 2019
Clinical trials and clinical investigations:
The Department of Health and Social Care (DHSC) has communicated widely with industry (via trade associations), the NHS and charities (via Association of Medical Research Charities), and Universities, and has emphasised that organisations running clinical trials and clinical investigations in the UK should consider their supply chains for supplies (including Investigational Medicinal Products, devices/in-vitro diagnostics devices, advanced therapy medicinal products, radioisotopes and other clinical consumables) to ensure appropriate arrangements are in place to assure supplies in the event of any possible border delays.
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.