The UK Government has confirmed that it is committed to implementing the new EU Clinical Trials Regulation (EU) 534/2014 (“EU CTR”) into UK law post-Brexit.
The EU CTR entered into force in 2014 but will not apply until 6 months after the European Commission issues a notice confirming that the new EU clinical trials portal and database are fully functioning. The development of the portal and database is taking longer than anticipated and the date of application of the EU CTR is currently expected be March 2020. This means that, as drafted, the EU CTR will not be caught by the EU (Withdrawal) Bill (which will implement EU law into UK national law when the UK leaves the EU on 29 March 2019 as far as possible), leading to uncertainty as to the status of EU CTR in the UK.
During a recent debate in the House of Lords, the Government’s representative for life sciences, Baroness Goldie, confirmed that the Government is committed to implementing the EU CTR into UK law to the extent possible.
If, as currently expected, the date of application of the EU CTR occurs during the anticipated transition period (from 30 March 2019 until the end of 2020), the UK would be able to participate in the database and portal for the remainder of that period. However, Baroness Goldie acknowledged that participation in the database and portal beyond the transition period will require agreement with the EU as part of the wider Brexit negotiations.
The EU CTR harmonises the rules for conducting clinical trials throughout the EU and streamlines the application process. The new online EU clinical trial portal will enable sponsors of trials involving multiple sites to submit a single application to the authorities of all EU Member States concerned. Applications will initially be assessed by a single reporting EU Member State and then validated by the remaining concerned Member States and undergo national ethics reviews. The new procedure is expected to accelerate the authorisation procedure for conducting trials in the EU.
Consistent with the Government’s position, the UK Medicines and Healthcare products Agency’s (MHRA) recently published its Five Year Plan for 2018-2023, which refers to the MHRA’s progress in working towards implementation of the EU CTR as part of the UK’s strategy to continue to attract research following Brexit.