Brian Brogan, senior logistics manager, provides guidance for clinical trial supply chain requirements post-Brexit and offers some practical solutions for affected U.K.-based life science companies.
A practical guide for IMP supply chain planning post-Brexit
The United Kingdom (U.K.) voted by referendum in June 2016 to leave the European Union (EU). Negotiations are underway between the U.K. and the EU to agree how trading, employment, regulatory and other activities will be handled leading to significant uncertainty and speculation as to what this means for the global clinical research community. Although the eventual outcome of the “Brexit” negotiations is still unknown, a “hard Brexit” could involve the U.K. trading with the EU like any other non-EU country under World Trade Organization rules with no obligation to accept free movement of people. Whereas a “soft Brexit” could involve retaining membership of the EU single market for goods and services with at least some free movement of people. Stakeholders may wish to plan for all eventualities including a “hard Brexit” and the complete exit of the U.K. from the current single market and regulatory system in March 2019.
Clinical trial logistics and Brexit
Brexit clearly presents challenges to many companies in the U.K. life sciences sector because a fundamental element in the success of these companies has been their ability to leverage themselves as an effective gateway to the EU. This ability may be greatly weakened after Brexit. From a clinical trial logistics perspective, a European clinical trial will always be more effectively managed from within a customs union. Time critical movement of investigational medicinal products (IMP) from outside a customs union will almost certainly be subject to additional complexity, such as customs clearance, delays and additional costs. Established pharma and biomedical companies within the U.K. may have to modify their existing supply chain strategy to reposition their resources within EU boundaries. Failure to do so may result in a detrimental effect on their ability to supply investigational medicines within the newly established EU boundaries after Brexit.
The EU requires for a qualified person (QP) release and distribution of investigational product to be situated in an EU member country. If a clinical trial sponsor is using the U.K. as the supply route, then that currently approved route may be at risk. Essentially, if currently located in the U.K. and a “hard Brexit” occurs, you will have to relocate your QP release and clinical trial distribution to take place within an EU country.
“Hard Brexit” partnerships
As a result, many research companies are currently seeking integral partners to support their needs for the risk mitigation provision for IMP under the “hard Brexit” conditions that will most likely prevent the mutual recognition between member states and the U.K. after March 2019. It is crucial for these companies to establish logistical partnerships to facilitate optimal performance in the clinical trial supply chain and prevent any delays in patient recruitment.
A clinical supply depot located within the EU can receive, package, QP release and distribute IMP to investigator sites across all EU states with few dependencies. Depots outside the EU will not QP release or directly distribute material to clinical sites within the EU customs boundaries.
Considerations for EU facilities
To seamlessly deal with a “hard Brexit” event, when determining a depot outside the U.K., research companies need to look for several characteristics:
- A state-of-the-art facility
- Temperature-controlled and monitored 20-25 degrees Celsius warehouse
- 2-8°C walk-in chambers
- -20°C freezers for storage of IMP
- Comparators and ancillary supplies to specific client requirements
- GMP licensed for secondary packaging and labelling activities
- Single panel and variable text label printing capabilities
- Coordinates the return and accountability of clinical trial material from clinical sites for destruction coordination
- Periodic cycle counting of all clinical trial material
- Integrated inventory management system
- 21 CFR Part 11 compliant
- Utilizes barcodes for inventory transactions
- Provides a full audit trail and reporting functions
- Product status control (from “quarantine” upon receipt to “available” following QP certification)
- Automatic release of material to approved countries for distribution
In addition to those considerations, in a post-Brexit climate, U.K.-based pharma and biomedical companies will need to find a partner with the knowledge and expertise to oversee a seamless transition of clinical trial services from any existing U.K. depot who are flexible and adapt well irrespective of the type of Brexit and potential transition agreements. Depots in Ireland, such as PPD, can provide packaging and labelling, QP release and have a global supply chain network across all regions routinely supporting shipments in and out of the EU through Ireland offer clients a significant strategic advantage in terms of communication and access to the free movement of goods within the EU.
Ensure you and your company have taken these elements into consideration before the U.K. officially leaves the EU on March 30, 2019.
Brian Brogan is a senior logistics manager with PPD.