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Clinical Trials: EU Law

Answer

If the Clinical Trials Regulation comes into force during the Implementation Period, as it is currently expected to in March 2020, it will apply to the United Kingdom. The Withdrawal Agreement and Implementation Bill will give effect to the implementation period in domestic law and will allow regulations to continue to apply in the UK for this time-limited period.

If this opportunity does not come to pass, we will give priority to taking the steps necessary to bring into UK law, without delay, all relevant parts of the European Union regulation that are within the UK’s control, so that those planning clinical research can do so with certainty.

The two key elements of the Regulation that are outside of the UK’s control, and this guarantee does not therefore cover, are the use of a shared central IT portal and database and participation in the single assessment model, both of which require a negotiated UK/EU agreement regarding UK involvement post-Brexit. We cannot pre-empt these negotiations, nor can we disadvantage the UK’s position in these negotiations by giving any further guarantees at this time.

Regardless of the outcome of a Brexit deal and the application date of the Regulation, the UK is committed to offering a competitive service for clinical trial assessment. This covers regulatory approval from the Medicines and Health products Regulatory Agency (MHRA) as well as services from the Health Research Authority, ethics services, the National Institute for Health Research and the National Health Service. 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.

In the event that the UK is not part of the EU shared central IT portal and database and therefore trials to be run wholly or in part in the UK are not submitted through the EU portal, it will still be perfectly possible for sponsors to run multistate trials involving the UK. Sponsors would have to apply to the MHRA as well as to the EU concerned states. However, MHRA would take every effort to ensure that a parallel submission to the MHRA was as streamlined and efficient as possible and that we were able to match or better the European timeline for assessment. MHRA and UK ethics committees are already internationally recognised for their robust yet timely assessment of trial applications and the UK is currently one of the most competitive Member States for timelines.

Secondary information

Type

Written question

Reference

137169

Session

2017-19

Transferred

Yes

Subjects

Databases EU law Clinical trials Brexit

Link

View this Written question on www.parliament.uk