A Brexit deal has been agreed in principle with the EU. Both the UK and the EU need to approve and sign the withdrawal agreement.
If the withdrawal agreement is not signed by the UK and the EU, the UK could still leave with no deal.
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 on how healthcare providers can prepare for Brexit (updated September 2019) and actions for adult social care providers and local authorities to prepare for Brexit (updated October 2019).
Of particular note is the section entitled: data sharing, processing and access, which includes detail on maintaining data flow.
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 September 2019.
MHRA guidance note, September 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 NHS published new FAQs for healthcare staff on 17 September 2019. These can be read in full on the NHS England website. Of particular note is the section on clinical trials.
NHS guidance, 17 September 2019
The NHS and the government are working with organisations running clinical trials to ensure that research continues as normal in the coming months. They have encouraged these organisations to consider their supply chains for clinical trials, and to ensure appropriate supplies of trial drugs and medical products are in place.
Those responsible for recruiting patients into clinical trials should continue to do so unless they hear from a trial sponsor, from the organisation managing the trial or clinical investigation, or from formal communications.
Chief investigators, or the organisation managing the clinical trial/investigation, should liaise with trial sponsors to understand their arrangements for ensuring supply for clinical trials and investigations. Organisations should not stockpile locally and if approached to do so by a sponsor, should escalate via your organisation’s EU Exit Senior Responsible Officer (SRO).
As part of its Operational Response Centre, the Department for Health and Social Care (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.