The government has published detail on how clinical trials would be regulated if the UK leaves the EU without agreement. The guidance makes clear the government considers a ‘no deal’ scenario unlikely:
Department of Health and Social Care
"A scenario in which the UK leaves the EU without agreement (a ‘no deal’ scenario) remains unlikely given the mutual interests of the UK and the EU in securing a negotiated outcome.
"Negotiations are progressing well and both we and the EU continue to work hard to seek a positive deal. However, it’s our duty as a responsible government to prepare for all eventualities, including ‘no deal’, until we can be certain of the outcome of those negotiations."
We’ve set out the most relevant areas for researchers below.
"If there’s no deal, the UK’s participation in the European regulatory network would cease. The MHRA would take on the functions currently undertaken by the EU for medicines on the UK market. This would require changes to UK law, via the Human Medicines Regulations 2012 (HMRs). The MHRA is planning a public consultation in early autumn on some of the key proposed legislative changes.
"Detailed information on manufacturer batch testing and certification can be found in the separate technical notice on this subject."
"The 2004 Regulations will remain in force, modified using powers under the EU (Withdrawal) Act (EUWA) to make sure they still work in the UK after exit.
"The new EU Clinical Trials Regulation (CTR) 536/2014 will not be in force in the EU at the time that the UK exits the EU and so will not be incorporated into UK law on Exit day under the terms of EUWA.
"However, we’ll align where possible with the CTR without delay when it does come into force in the EU, subject to usual parliamentary approvals. This alignment will happen after 29 March 2019 so it’s not addressed in this guidance."
Implications: Clinical Trial applications
"As clinical trials are currently managed nationally, UK clinical trial applications will continue to be authorised by the MHRA and ethics committees as they are now. The UK ability to participate in multinational trials will also not change.
"MHRA will be improving processes to enable closer working with ethics bodies and allowing a single application and a single national decision in the UK. The initial pilot work has started and would continue to be developed post-exit."
Implications: Legal presence
"At present, a sponsor or their ‘legal representative’ should be based in the EU or EEA; we’re seeking to preserve this position if there’s ‘no deal’. While the legal representative will only need to be based in the EU or EEA we anticipate it will be necessary to have an individual based in the UK who has overall responsibility for the trial and can be contacted to discuss urgent issues arising in connection with a trial, for example urgent safety matters or trial suspensions. We’ll provide more information in due course."
"Our intention is to align UK transparency provisions with those currently operating in the EU. Information on how a UK system would be developed will be the subject of consultation."
Researchers may also be interested in the following guidance: