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The Joint Research Office has this week written to all Principal Investigators (PIs) for studies happening at ¹û¶³Ó°ÔºH to advise them on preparations being made at ¹û¶³Ó°ÔºH for a possible ‘no deal’ Brexit, and to advise PIs on actions they need to take now, and actions they may need to take in the event of a ‘no deal’ Brexit.

The communication to PIs is reproduced in full below. The JRO will continue to provide updates to investigators on Brexit as negotiations between the UK and EU progress.

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The JRO and ¹û¶³Ó°ÔºH Pharmacy have been working closely with the ¹û¶³Ó°ÔºH Brexit Committee to plan for a no-deal Brexit.

The Department of Health has released guidance on planning for the supply of drugs, including Investigational Medicinal Products for clinical trials – in the event that Brexit negotiations conclude in a ‘no-deal’.

The JRO and ¹û¶³Ó°ÔºH wrote to all researchers in December to share this information and advised that Principal Investigators (PIs) make contact with Sponsors as soon as possible to request IMP supply strategies.

Where IMP supply is managed by the study sponsor, it is the sponsor who takes responsibility for ensuring the continuation of this supply in the event there is a no-deal.

• Since December 2018, ¹û¶³Ó°ÔºH Pharmacy have been making contact with all Commercial Sponsors (for research studies) requesting they share their IMP mitigation plans in the event of a nodeal
• ¹û¶³Ó°ÔºH Pharmacy and the JRO will make contact with noncommercial sponsors in the coming week
• In addition, it is vital that all PIs request confirmation that supplies for their specific study will continue   for those patients who are currently receiving treatment as part of the trial and for those likely to be recruited in the weeks following Brexit 
• Where ¹û¶³Ó°ÔºH pharmacy have contractually agreed to source the supportive / standard of care medicines on behalf of a sponsor: ¹û¶³Ó°ÔºH Pharmacy will work with the DHSC to ensure continuity of supply.

You should contact the JRO immediately if:

• The sponsor has no mitigation strategy and cannot continue supply – for current patients and for those planned to be recruited in the months following Brexit.
• The sponsor has a mitigation strategy but continued supply runs out as an emergency

Should you have any queries please do email ¹û¶³Ó°ÔºH Pharmacy (Chi Chung – Principal Pharmacist for R&D: chiyee.chung@nhs.net) or the JRO at uclh.JRO-Communications@nhs.net.