It is easy to get caught up in the head-spinning politics of Brexit and its impact on the clinical supply chain, debating the various outcomes that may or may not happen. But when it comes to supply chain planning, we must set politics aside and approach this as a business continuity issue. After all, at the end of the day, that is what’s required. Evaluate the ‘worst case’ scenario and design a supply chain that assures continuity of supply.
In the event of a ‘Hard Brexit’, the most extreme outcome, pharmaceutical companies with clinical trial patients in both the UK and Europe will require storage and distribution capacity in the UK and in Europe with Qualified Person (QP) release capability. In the context of business continuity, it is no different than what we’d recommend to provide back-up in the event of a disaster at one location.
What steps are required to ensure readiness in case of a ‘Hard Brexit’?
- The Investigational Medicinal Product Dossier (IMPD) and Clinical Trial Application should state the UK and EU locations as batch release sites (QP release sites). The QP declaration submitted should also be reviewed and amended to include any UK Manufacturing/packaging/testing sites which will now be deemed to be outside the EU/EEA.
- Any additional sites in the supply chain need to be qualified according to individual Quality Management System (QMS) expectations.
- Quality Agreements should be reviewed in the context of any required changes and, ideally, these should be harmonized across sites.
- QP agreements that are in place between the manufacturer’s QPs and their supplier may need updating. If working with a new supplier, QP agreements may need to be established.
- Technology systems (IVR / IRT) that support automatic ordering across the distribution network will need to be updated. There will be an associated lead time to allow the technology supplier to implement and test these changes.
- Current and upcoming shipment activity should be analyzed to ensure supplies are available to transfer. This analysis must be far enough in advance to accommodate any further packaging that may be required.
As a long-time provider of clinical supply chain solutions, we understand this kind of change can seem overwhelming. In our experience, these are some ‘best practices’ that can streamline and simplify the process.
- Comprehensive project plans should be in place that walk through each step in the supply chain that is impacted by Brexit, allowing you to define a path forward.
- Work with a clinical supply chain provider that has a global footprint with standardized procedures across their network.
- Automated analysis tools should be available to assess current stock holdings and distribution patterns in order to identify required transfers between facilities.
- Where required providers should have QP to QP agreements in place between their facilities to enable a smooth flow of information.
- In-depth regulatory knowledge and expertise with the import / export process is essential. Ideally your provider can serve as Importer of Record and, where possible, they can minimize tax and duty liability.
Given the current March 29, 2019 exit date, planning for the worst case scenario should be well underway. The good news is there are solutions already in place, and clinical supply chain providers that can help you mitigate risk so that, at the end of the day, patients are not impacted by Brexit.