European Medicines Agency

Department of Health and Social Care written question – answered on 26th June 2018.

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Photo of Stephen Timms Stephen Timms Labour, East Ham

To ask the Secretary of State for Health and Social Care, whether he has plans for UK companies to have full access to European Medicines Agency (a) clinical trials portal and database after the UK leaves the EU; and if he will make a statement.

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary for Health and Social Care

The Government values the strong collaborative partnerships that we have across the European Union in the areas of science, research and innovation, and as part of Exit negotiations is working to ensure that we have the best possible environment in which to support clinical trials and new medicines after we leave the EU.

In March, the United Kingdom and EU negotiating teams reached agreement on the terms of a time-limited implementation period, that will start on 30 March 2019 and last until 31 December 2020. One benefit of this agreement is that the UK’s access to networks, information systems and databases will continue as now during this time.

Regarding the EU’s new Clinical Trials Regulation (CTR), the CTR is expected to be implemented during 2020 and would therefore apply to the UK under the terms of the time-limited implementation period. If the new regulation does not come into force during the implementation period, the Government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, in order that researchers conducting clinical trials can plan with greater certainty.

The two key elements of the regulation that the UK would not be able to implement on its own after this time are the use of a shared central IT portal and participation in the single assessment model, both of which would require a negotiated UK/EU agreement regarding UK involvement following the end of 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. No matter what the outcome of negotiations, the UK is committed to offering a competitive service for clinical trial assessment.

If the UK is outside of the EU network following the end of the Implementation Period, it will still be possible for sponsors to run multistate trials involving the UK. Sponsors would have to apply to the UK, as well as to the EU concerned states; but the UK would take every effort to ensure this parallel submission is as streamlined and efficient as possible (for example by using the same application dossier), and 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 (whether for academic or industry-led clinical trials).

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