INSIGHT BLOG
Mitigating the Impact of Brexit on Your Clinical Trials
The United Kingdom has officially left the European Union. Have you considered the impact of Brexit on your clinical trial? Read on to learn about the essential implications on the pharmaceutical industry which you should be addressing.
CLINICAL TRIALS STARTED BEFORE BREXIT
Although the UK has voted in favour of Brexit, its departure from the EU wasn't immediate.
Given that clinical trials are planned well in advance and can't simply stop mid-trial, there's still a lot of uncertainty surrounding those studies that started during the lead-up to Brexit. Some questions that still remain:
What happens to clinical trials that started before December 31 2020, (end of the Brexit transition period, during which the UK continued to remain under EU pharmaceutical law) and that are running longer than the Brexit deadline?
Will you have to change your QP, packaging, and distribution vendor in the middle of the study? This would mean you would have to redo the assessments, audits, batch reviews, and contracts with a new QP.
Learn How to Brexit-Proof Your Clinical Trials
RELIANCE ON UK-BASED QUALIFED PERSONS
It is likely that UK-based Qualified Persons (QPs), who are essential to European pharmaceutical manufacturing, will no longer be able to certify clinical trial batches for the European Union. With 25% of the European Union's QPs based in the United Kingdom, there may be a shortage of QPs after December 2020.
BREXIT CURRENCY AND CUSTOMS ISSUES COULD AFFET GLOBAL CLINICAL TRIALS
The UK's transition out of the EU also has the potential to create exchange rate and customs issues that could adversely affect your business. Amid the uncertainty, the European Commission and the European Medicines Agency (EMA) published a short Q&A.
The statement addresses the impact of the UK's withdrawal from the EU with regard to medicinal products. It also confirms that the UK will become a "third country," and companies based there will no longer enjoy the privileges of EU membership.
CLINICAL TRIAL SOLUTIONS FOR BREXIT CHALLENGES
While the EMA's statement and accompanying Q&A answers some of the pressing questions about Brexit's impact on medical products, it's too early to know all of the ways that Brexit will impact global clinical trials.
That said, it is crucial to take action and transition to a provider of clinical trials services that is already positioned to operate in the post-Brexit EU. In order to avoid costly delays and disruptions to your trials, seek out the services of a provider that currently has established facilities outside of the UK.
Clinigen Clinical Supplies Management is already positioned for post-Brexit operations.