UK commits to post-Brexit clinical trial rule harmonization but uncertainties remain

By Nick Taylor

- Last updated on GMT

(Image: Getty/MarianVejcik)
(Image: Getty/MarianVejcik)
The UK government has provided the “strongest possible reassurance” that it will implement the incoming European Union Clinical Trial Regulation, whatever happens in the Brexit negotiations.

People and organizations involved in clinical trials in the EU and UK are worried Brexit ​will drive the divergence of the regulatory regimes in the two regions. This would make it harder to set up clinical trials that activate sites in the EU and UK.

Facing a rebellion on the topic in the House of Lords, the UK government has emphasized its commitment​ to implementing EU clinical trial rules that are due to come into force in 2020.

Baroness Goldie, the government’s representative in the Lords, said ​the UK will do everything it can to implement the regulations and maintain the harmonized clinical trial regulatory environment. 

As it stands, the regulation is due to come into force after the UK officially leaves the EU in March​ but before the end of the planned transition period. If that happens, the regulation should automatically become part of British law.

However, as with much to do with Brexit, little of this is set in stone. The failure to agree a transition period or delay to the implementation of the regulation could make the envisaged UK adoption of the rules more difficult. 

Acknowledging that, Goldie said the government will implement as much of the regulation as it can even if the rules come into force outside of the transition period.

There are limits to what the UK can promise unilaterally, though. The UK will only have access to the shared IT portal and participate in single assessments if the EU agrees. 

Potential risks

The ultimate significance of these limitations depends on what happens in the coming months and years. For now, the lack of common ground between EU and UK negotiators on key topics such as the Irish border means the preferred, simple transfer of the regulations in national law is not guaranteed.

Notably, the final terms of the transition period are yet to be agreed, meaning the UK could make a hard split from the EU in 10 months. In that scenario, the UK would sever its ties to the EU before the regulation comes into force, raising doubts about how the rules would apply to its clinical trial sector.

There is also a risk the European Medicines Agency (EMA) will further delay the implementation of the regulation. Technical challenges have already forced the EMA to push back the start date once.

With the relocation to Amsterdam​, the Netherlands stretching its resources, the EMA could delay the implementation date again. If the new date is set for later than the end of 2020, the UK will likely have left the EU even if a transition period is agreed.

The likelihood of these scenarios occurring may be small but the potential for them to disrupt clinical research means they are a cause for concern in the industry.

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