The United Kingdom officially withdrew from the European Union (EU) on Jan 31, 2020. They have until Dec 31, 2020 to complete all plans relating to the transition or exit. How does this impact the clinical trial landscape of research conducted within the United Kingdom? Well, it means there is an environment to navigate today and an environment to navigate after Dec 31, 2020. In this article, Pharm-Olam interviewed one of our Regulatory Affairs Directors, Sunera Awan, to understand the current and future clinical trial regulatory environment for the United Kingdom.
How is Brexit Changing the Clinical Trial Regulatory Process?
Clinical research studies are undoubtedly going to be impacted by Brexit. That does not automatically mean that the effects will be negative or damaging, but researchers should expect to see some changes, particularly concerning protocol submission, the use of a submission platform, and the involvement of Qualified Persons (QPs).
Study Submission Process
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has already started getting ready for the United Kingdom to leave the European Union. As of Jan 31, 2020, the UK is not part of the EU, but the two are still in the process of untangling some functions. The UK MHRA has developed a study submission system (MHRA Submissions Portal) that mirrors the Common European Submission Platform (CESP) system so that the impact on researchers is minimized. Guidance around the submission platform has been withdrawn because it was centered on a no-deal Brexit. Right now, CROs are using the CESP system, but once the deal is finalized, we can seamlessly transition to the UK’s version of the same. A new submission portal will likely not come into effect until after the deal is completed.
That said, there is also the matter of a new portal for study protocol submissions. The EU is developing a single platform that acts as a single point of reference for submissions, assessments, and supervision. It is called the Clinical Trials Information System (CTIS), and it is maintained by the European Medicines Agency (EMA). The goal of this platform is to improve efficiency, transparency, and patient safety by leveraging consistent trial rules throughout the European Union. The UK will not have this platform. Researchers in the United Kingdom will make submissions via MHRA Submissions. However, that was the expectation in a no-deal scenario. That guidance has since been withdrawn (May 18, 2020). As of the date of this article, new guidance has not been issued yet.
Impact on Qualified Persons
One issue that we do anticipate is the evolution of Qualified Persons. QPs approve and certify trial batches in the EU system. Roughly 25% of the current QPs are based in the UK. That’s okay for now, but after Brexit comes through, those individuals will no longer be able to act as QPs in EU clinical trials. This is causing somewhat of a hiring spree as companies look to establish an EU depot if they only had a UK one and vice versa.
What Do We Not Know About Research in the UK Post Brexit?
We do not know whether there will be any customs issues or the extent of those challenges. The UK and the EU will need to decide how to handle imports and exports of medical supplies and biosamples. If one or the other chooses to be very strict, that could complicate matters. There is a chance that the EU will treat the UK like it does Norway or Switzerland, but there are no guarantees. As a CRO that is experienced working internationally, Pharm-Olam will be able to manage those issues however they manifest, but there is uncertainty surrounding imports and exports post-Brexit.
What Will Brexit Mean for Clinical Research and Study Trials?
The United Kingdom is a popular location for clinical studies, and it will still be highly sought after, post-Brexit. MHRA is well-respected and often sought after for advice on regulatory standards. Pharm-Olam will continue to have a strong presence in the UK and the EU. While there may be some changes in the way we do things, the impact of conducting a study in the UK during and post-Brexit on our sponsors will be minimal. If you have questions relating to Brexit and clinical trial start-up, speak with our Regulatory Affairs team.
Sunera Awan,Director, Regulatory Affairs
John Colby, Exec. Director, Global Marketing & Communications
Renee Breiten, Marketing Content Manager