The UK government earlier this year provided the “strongest possible reassurance” that it will implement the incoming European Union Clinical Trials Regulation, regardless of happens in the Brexit negotiations, during a discussion in the House of Lords.
Recently, the Medicines and Healthcare products Regulatory Agency (MHRA) published an update, detailing how the implementation period affects the regulation.
The new regulation is expected to be implemented during 2020, and as such would apply to the UK under the terms of the implementation period – from March 30, 2019, to December 31, 2020 – during which the UK will no longer be an EU member state.
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Involved in development of the new regulation, the UK and EU agreed that EU rules and regulations will remain in place “in order to provide continuity and certainty to businesses and citizens.”
The new regulation aims to streamline application and assessment procedures, and would provide a single portal for all EU clinical trials. It also looks to simplify reporting procedures, including for multi-member state trials.
“As part of exit negotiations, MHRA is working to ensure that we continue to have the best possible environment in which to support clinical trials,” according to the agency.
However, if the new regulation – which replaces the EU Clinical Trial Directive (EC) No. 2001/20/EC –does not come into effect during the implementation period, the UK government confirmed that its law will “remain aligned with parts of the EU’s CTR legislation that are within the UK’s control.”
Not within the UK’s control would be the use of a shared central IT portal and participation in the single assessment model. As the agency noted, both of these would require a negotiated agreement for UK involvement. In the meantime, access to the networks and information systems will continue during the implementation period.
“We cannot pre-empt the outcome of these negotiations, but the Government has always been clear on its preference for close cooperation with the EU across all aspects of medicines regulations,” MHRA said.
“It is in the interest of patients and the Life Sciences industry internationally for the UK and EU to find a way to continue cooperation in the field of clinical trials, and for continued sharing of data, even if our precise relationship with the EU will by necessity change.
No matter what the outcome of negotiations, the UK is committed to offering a competitive service for clinical trial assessment.”
The final Withdrawal Agreement is expected to be finalized in October.
“The Government has always been confident that we will get a good deal – and now that good deal is clearer and closer than ever,” MHRA added – though planning for all scenarios.
The agency said it has “increased confidence” that the UK will exit the EU with a deal and that a “no deal” scenario in March 2019 “is significantly less likely.”
Following what is described as an “unlikely scenario” of no-deal, the government said it recognizes the importance of reaching a resolution to supply chain questions, particularly regarding Investigational Medicinal Products.
“The Life Science Industrial Strategy set out a clear ambition to remain at the forefront of innovation,” according to the agency. This includes “a commitment to increase the number of clinical trials and to ensure the UK remains an attractive location for trials to take place, with a view to getting medicinal products licensed in the UK and elsewhere.”
If outside the EU network after the implementation period, MHRA explained that it would still be possible for sponsors to run multistate trials involving the UK.
In this scenario, sponsors would need to apply to MHRA in addition to the necessary EU states. According to the agency, the UK would provide an assessment outcome “no later than the European timeframe.”
“The current regulatory approval legislation will stay in place until such time as any changes are needed, so there will be no interruption in UK clinical trials approval,” MHRA said.
