In 2016 the United Kingdom (UK) held a national referendum in which the country voted to leave the European Union (EU). Since then, the UK and the EU have been negotiating an agreement that outlines the terms of the UK’s withdrawal.
With uncertainty about the terms on which the UK will leave the EU, it is important to consider how Brexit will impact clinical trials. Here are 4 aspects of clinical trials that are affected by Brexit:
- Regulatory Landscape of Clinical Trials Prolonged Timelines Currently, the UK shares EU’s regulations that allow for seamless cross border clinical trial management. For this reason, 40% of UK-based clinical trials have a secondary site in the EU [1]. When Brexit negotiations began, the EU clinical trial regulations (EU CTR) were undergoing important changes & their implementation was delayed. This resulted in EU CTR being left out of Brexit negotiations, but the UK assured researchers that an alignment with EU CTR will be a priority once it takes effect [2]. Without clinical regulation alignment current trial timelines will be prolonged, slowing down the process of clinical discovery and diminishing the UK’s participation in global trials.
- Access to Testing Medicines and Medical Devices Price Hikes and Delays Many pharmaceutical and medical device companies have locations in both the UK and the EU. Some products cross international borders multiple times throughout their life cycle. If Brexit trade agreements are not properly negotiated, import and export duties can be imposed not only on approved medicines, but also testing medicines. This will result in price hikes and cause delays in delivery of important research medicines to various sites across the UK and the EU [3].
- Research Funding Will the Commitment Continue The UK and the EU will need to agree on the UK’s access to the EU’s funding programs for clinical research following Brexit [2]. This is necessary in order to promote continuous collaboration between clinical research investigators and to encourage medical innovation. If a funding deal is not reached, the UK researchers will be left to rely on the UK government’s commitment to funding for clinical research; a commitment that is volatile and dependent on the political party in charge of government operations.
- Workforce ? Who is Going to do the Work Between 2016 and 2018, the UK experienced a 95% fall in EU residents joining the UK workforce[4]. Among other professions, this drastic drop impacts talent recruitment for trained research personnel. Fear of strict immigration policies is detracting researchers from starting or joining clinical trials in the UK and is reducing international research collaboration [2]. In order to mitigate this fear, the UK will need to put forth policies that promote easy travel and immigration processes for EU researchers to conduct trials in the UK.
Bay Area Research Logistics has participated in nearly 150 clinical trials with locations in 32 countries around the globe. We ensure all of regulatory requirements are met from beginning to end, for your global clinical trial. If you’re thinking of, or are currently conducting, clinical trials in Europe and need guidance with understanding European regulations or with your domestic and international clinical trial logistics, reach out to Bay Area Research Logistics today!
References:
[1] Thompson, B. (2019, February 15). This is a pivotal moment for clinical trial regulations. Retrieved from https://wellcome.ac.uk/news/pivotal-moment-clinical-trial-regulations
[2] Future of Clinical Trials after Brexit. (n.d.). Retrieved from https://www.cancerresearchuk.org/sites/default/files/future_of_clinical_trials_after_brexit.pdf
[3] Guidance on substantial amendments to a clinical trial if the UK leaves the EU with no deal. (2019, April 3). Retrieved from https://www.gov.uk/guidance/guidance-on-substantial-amendments-to-a-clinical-trial-if-the-uk-leaves-the-eu-with-no-deal
[4] Labour Market Outlook . (2018). Retrieved from https://www.cipd.co.uk/Images/lmo-survey-summer2018_tcm18-45850.pdf
