The United Kingdom (UK) has committed to adopting the European Union (EU) Clinical Trial Regulation despite Brexit. In the House of Lords, a government representative has made a promise to prevent a potential rebellion that would have pushed for a legislative guarantee that the UK will adopt the regulation.
Provided all goes to plan with the roll-out of the legislation and EU exit negotiations, the trial regulation will come into force sometime during the planned Brexit transition period. However, there is still uncertainty due to the potential for this not to happen. The European Medicines Agency (EMA) has already delayed adoption of regulations and this could push the date out past the end of the transition. Furthermore, there is a chance Brexit negotiations could fall apart.
The House of Lords will seek to modify the UK’s EU withdrawal bill to help ensure that the trial regulation will come into force before Brexit day and is therefore transposed into national law. If the regulation does not come into force during the transition period, the government has stated that they will seek to bring into UK law all relevant parts of the EU regulation that are within the UK’s control. The aim is to create a predictable regulatory environment for sponsors planning to run clinical trials.
It is important to note that some aspects of the implementation of the regulation are outside the UK’s control. For example, the UK will only be able to use the shared information technology (IT) portal that is key to the regulation and participation in single assessments if the EU agrees.
Notably, negotiating guidelines adopted by the European Council last month preclude “participation of the UK as a third-country in the Union Institutions and participation in the decision-making of the Union bodies, offices and agencies.”
To view the debate transcript from Baroness Goldie, regarding the EU Clinical Trial Regulation, please click here.