QPS is a global contract research organization (CRO) with offices in The Netherlands, home of the new European Medicines Agency (EMA) headquarters.
The company’s president and general manager of QPS in the Netherlands Marc Thouin said the main reason for the decrease in UK-based clinical trials can be attributed to uncertainty about the regulatory process and mutual recognition.
“With uncertainty comes delays, which are critical for biotech companies as funding is tight so timing is of the essence,” he told us.
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According to several sources, the number of new clinical trials taking place in the UK has reportedly declined by approximately 25% after the UK voted to leave the EU in 2016.
As for how is Brexit affects the UK’s clinical trials environment, Thouin said a loss of funding will be an issue, as pharmaceutical research projects have been a priority for the European Union’s Horizon 2020 project, a research and innovation program with nearly €80bn of funding available over 7 years.
Horizon Europe currently has €8.2bn ($9.23bn) earmarked for health research, though Thouin said Britain’s departure from the EU puts UK-based preclinical and clinical research projects at risk of losing this funding.
Despite the biggest challenges, Thouin said EU and UK authorities are likely to cooperate, with the UK government stating its commitment to harmonizing clinical trial regulations post-Brexit.
“So, in a couple of years looking back under the Brexit scenario one will conclude that much is as it was. But, until this is actually known, companies running trials in the UK will face open questions as to acceptance of results in the EU,” he added.
Without a deal, however, EU-based companies “will also face challenges as to the accessibility of a substantial UK drug market and may conclude that repeating studies in the UK will be the easier, yet pricier way forward,” Thouin explained.
Yet, clinical trials are not the only concern for pharmaceutical research projects, noted Zamas Lam, PhD, QPS senior vice president and global head of preclinical development.
“Brexit’s disruption of the supply chain and logistics will make access to the most common preclinical and bioanalytical research materials problematic, endangering the continuation of testing facilities located in the UK,” Lam told us.
As one example, Lam said importing non-human primates (NHPs) could be a problem for UK-based preclinical and bioanalysis research projects, particularly in the areas of gene therapy and biosimilars.
“This research requires a steady supply of NHPs because they are similar to humans in terms of physiological functions and drug metabolism, which is important for assessing the safety and efficacy of these advanced therapeutics,” explained Lam.
In the US, the National Association for Biomedical Research (NABR) filed a complaint on August 21, 2018 with the US Department of Transportation (DOT), alleging illegal discrimination by airlines refusing to transport lab animals. While there has been no resolution, researchers’ responses – of which there were more than 20,000 – stress the importance of animal research.
NABR President Matthew R. Bailey told us at the time that if the DOT choose not to pursue the complaint “it will become increasingly challenging to ensure the appropriate models are available for medical research which federal agencies require before drugs and treatments can proceed to human clinical trials.”
As Lam explained, most facilities do not breed their own animals for preclinical research, but rather important them from the EU of Asia. Brexit presents and unclear path for import and export licenses, he said, adding that acquiring “adequate colonies of NHPs will likely be an issue.”
“Without a steady supply of research animals, it will be difficult, if not impossible, to carry out pharmacology, DMPK and toxicology studies for biosimilars, as well as gene and cell therapy research projects, in the UK,” said Lam.
“The net result is the UK may no longer be a country where bioanalytical innovation is feasible.”