GBA Group Pharma updates on clinical trial risks following Brexit

- European authorities warn of imminent impact on clinical trial supply chains for companies running EU clinical trials

- QPs for batch release of Investigational Medical Products (IMPs) must be EU-based as of January 1, 2021

- Numerous ongoing and planned clinical studies are affected

- GBA Group Pharma offers solutions to the QP shortfall in post-Brexit Europe for healthcare companies worldwide

Hamburg, Germany, and Vienna, Austria, July 28, 2020: GBA Group Pharma, a leading European service provider for pharma and biotech companies, has updated industry partners and clients on the risks to their clinical trial plans caused by Brexit. As recently confirmed by a technical note from the EU commission and the European regulatory authorities, healthcare companies could meet significant business difficulties when running EU clinical trials through UK-based QPs, as of January 1, 2021. With no extension of the transition period requested by the UK as of July 1 this year, it will be treated as a "third country" by the EU regulatory authorities from January 2021 on.

The complexity of the European clinical trial supply chain means that arrangements need to be made immediately to avoid disruptions. Following Brexit, UK-based Qualified Persons (QPs), who are essential to European pharmaceutical development, manufacturing and logistics, will no longer be able to certify clinical trial batches for the European Union.

Consequently, if drug companies are using UK-based QPs they will 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 Clinical Trial Supply Management (CTSM) and QP services, will 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 severely complicated following the UK's December 2020 full exit from Europe.

In the technical notice issued by the European commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) it states: "Investigational medicinal products used in clinical trials can be imported only after their batch-release has been certified by a qualified person in the EU," and continues: "Failure to do so could in the worst-case result in discontinuation of trial treatment and thus jeopardise trial participants' safety." The note also points out that as of 1 July, 2020, there were 250 trials registered in the European Clinical Trials database (EudraCT) where the QP is established in the UK and which have been authorised in at least one Member State other than the UK within the last 3 years.

"With the UK now regarded as a "third country" from January 2021, it is vital that companies using UK-based QPs and other CTSM intermediaries must now act quickly. Companies need to establish QPs, by year-end, that know the relevant local language and regulations in the European Union. This may lead to a shortfall of QPs in the EU," said Elisabeth Lackner, CEO of GBA Group Pharma and ABF Pharmaceutical Services and continues: "Clinical trials 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. In addition to the massive impact of the corona crisis, there is another critical challenge facing the pharmaceutical industry."

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. "With the completion of Brexit, UK manufactured drug products could be subject to a value-added-tax (VAT) if shipped into the EU," Lackner added.

GBA Pharma Group has defined a one-stop solution for pharma and biotech companies looking to do business in Europe that require support in import and release activities to help solve any inconsistencies related to the UK leaving Europe and the implementation of all the EMA regulations and restrictions.

"At GBA Pharma Group, we are well set for any regulatory changes. With all our GMP sites for CTSM, QP release, import, depot, labeling/packaging, commercials and global distribution, plus our GMP testing labs for batch release testing and import testing and our Central Lab all being located in the EU 27 - we are well prepared to offer Brexit-proof services to healthcare companies", Lackner noted.

CTSM services are 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, headquartered in Hamburg/Germany, is one of the largest and most experienced service providers in the European pharmaceutical and biotechnology sector. As a unique "one stop solution", the company supports the comprehensive process of drug development and marketing, from preclinical to clinical services, including analysis services, provision of clinical trial goods, central laboratory services, QP services and support for release processes and the import & export of approved products.

GBA Group Pharma can meet all BREXIT-related service requirements of pharmaceutical and biotech companies with business activities in the EU.
GBA Group Pharma employs around 500 people in Austria, Germany and the UK and is part of GBA Group, Hamburg.

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^[2] As of 1 July, 2020, based on data registered in the European Clinical Trials database (EudraCT)