Drug development companies could face Investigational Medical Products (IMP) and Investigational New Drug (IND) clinical supply chain and commercial product supply issues created by the UK’s departure from the EU. New rules, especially in terms of CTSM and QP services, could cost healthcare companies millions in clinical trial hold ups and potential trial failure if they are not prepared in time. Furthermore, approved drug supply and delivery will be complicated following the UK’s December 2020 full exit from Europe.“Following ratification of the UK’s “Withdrawal Agreement” there is clarity on all the forced changes the UK’s departure from Europe will involve for healthcare companies worldwide running clinical trials in the EU.
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The impact on the clinical trials supply chain could disrupt new drug development, with significant financial and economic losses,” said Elisabeth Lackner, CEO of GBA Group Pharma and ABF Pharmaceutical Services. “Clinical trials are planned years in advance and cannot simply be stopped mid-trial. Any disruption can cause imperative reorganizations to existing qualified and audited supply chains for ongoing and planned clinical studies. Should a company need to switch QPs mid-trial, it might well be necessary for a new QP to requalify the entire supply chain, for instance,” she added.The complexity of the European clinical trial supply chain means that arrangements need to be made now to avoid disruptions mid-trial.
Following Brexit and the 11 months transition period, UK-based QPs, who are essential to European pharmaceutical manufacturing, will no longer be able to certify clinical trial batches for the European Union.“A further issue facing non-EU companies is the movement of drug products within the Union. Today, these products can be transported and distributed without import or export duties. Following the Brexit transition period, UK manufactured drug products will be subject to a value-added-tax (VAT) if shipped into the EU. It is therefore vital that drug products currently stored in the UK need to be transferred to an EU country to avoid the future import VAT on existing inventories,” Lackner noted.