What Does Brexit Mean for Clinical Trials in Europe and the United Kingdom?
Affiliated legislation and synergetic values fortify the UK and the EU’s comprehensive collaboration on clinical trials. Now, this will alter post-Brexit, and the UK and the EU have options about whether, and how, to protract working in partnership.
Changes have already been sensed during the Brexit ambiguity. As per the current guidelines, the sponsor of a clinical trial within the EU needs to be based in the region or have a legal representative in its place, since the UK-based trials share some trial obligations and duties with the EMRN. However, after the Brexit, trials being conducted across Europe and the UK would require UK companies to appoint a legal representative within one of the EU Member States and EU sponsors to appoint a representative in the UK. The effect would be consequential, with many Pan-European trials currently in progress and could lead to clefts between several potential global research alliances. Furthermore, the necessity of embedding legal representatives in both the EU and the UK would also mean research companies lacking presence in both regions would be unfairly affected.
Options for future Regulatory cooperation in UK–EU clinical trials.
Clinical Trials – EU
- Current Clinical Trial Directive requires the Sponsor to be within EU/EEA
- European Clinical Trial Regulation 536/2014 came into force in 2019
- Brexit will affect the Sponsors’ decisions on whether to invest in future clinical trials in the UK.
- Hope that the UK implements new regulations in full, so that trials conducted in the UK will be fully recognised in the EU.
- Sponsor would only need to have a Legal Representative in EU/EEA.
- Companies should consider the location and/or the legal representative for trails being conducted in one or more of the EU27 countries. They should also assess the impact on the supply of investigational medicinal products, in particular the location where IMPs are certified by a QP.
- If clinical trial comparator product is sourced in the UK, the trial must conclude before the transition period ends to remain valid.
Clinical Trials – UK
- Companies based in the UK should consider the location of the sponsor and/or legal representative for trials being conducted in one or more of the EU27 countries, in the event that the UK is excluded from the new trial submission portal and database system that will be implemented in the EU under the Clinical Trials Regulation, probably in late 2019.
- Legally, the UK will need to transpose the EU clinical trial Regulation into English, Scottish, Welsh and Northern Irish laws or incorporate its own new legislation.
- However, if the UK were to leave the EU and then re-join the European Economic Area (EEA), little would change for clinical trials and marketing authorisations. Alongside Iceland, Liechtenstein and Norway, the UK would benefit from the harmonised Regulatory framework, although it would not have a voice in policy changes.
Freyr’s Recommendation: The most pertinent choice for UK and EU clinical trials after Brexit is complete UK participation in the EU clinical trials system on a comparable basis to Member States. If complete participation of the UK cannot be negotiated, the UK should meet its obligation to put the CTR into law and remain extremely aligned to the EU framework in the short term, to reduce disruption. The MHRA should connect firmly with academic and industry stakeholders on the options and trade-offs to agree the best alternative for the wide range of clinical trials taking place in the UK.