GBA Group Pharma has informed its industry partners and clients on risks to their clinical trial plans caused by Brexit by highlighting the significant business difficulties for healthcare companies running clinical trials through UK-based organisations. 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. 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.
GBA Pharma Group has defined a one-stop solution for pharma and biotech companies looking to do business in Europe and requiring support in import and release activities is in part to help solve any inconsistencies related to the UK leaving Europe and the implementation of all the EMA regulations and restrictions.
“We are well set for any regulatory changes. With all our GMP sites for CTSM, commercials, import, QP release, depot, labeling/packaging, global distribution, plus our GMP testing labs for batch release testing and import testing and our Central Lab are all being located in the EU 27 - we are well prepared to offer Brexit-proof services to healthcare companies”, Lackner noted.
“Recently, to ensure continuity of our services through these confusing times, we announced the completion of our expansion and scale-up of facilities in Vienna to meet the necessary increased demands from our clients,” Lackner said. For example, GBA has doubled the size and increased the capacity in its facilities and are now able to run over 250 clinical studies a day, offer increased storage space for both IMP and IND products, plus a GMP warehouse and five packaging suites.
Additionally, CTSM services are now coordinated through GBA Group Pharma’s ABF Pharmaceutical Services, which works closely with other members of the GBA Group Pharma, such as: Germany-based Pharmacelsus for preclinical CRO work; LKF Laboratory for Clinical Trials; and GBA Pharma Labs, plus a partner depot in the UK.
About GBA Group Pharma:
GBA Group Pharma (Vienna, Austria) ranks among the largest and most experienced service groups in the European pharmaceutical and biotech sector. It’s group member ABF Pharmaceutical Services (Vienna, Austria) is one of the largest international full-service provider for the import, export and CTSM (clinical trial supply management) in Europe. GBA Group Pharma is part of the GBA Group (Hamburg, Germany).