The Fundamentals: Return a shipment of eCOA devices from Ukraine to the UK for a global CRO.
The Complexities: Navigating trade compliance in a conflict zone.
Summary of Challenges:
- Increased difficulty obtaining trade licenses for dual-use goods due to trade disruption, damaged infrastructure, material shortages, and higher transport costs.
- Stricter EU dual-use regulations and UK Import control requirements post Brexit and the conflict.
The TecEx Medical IOR Solution: Retrieve the stuck shipment and resend it successfully from an active conflict zone.
Short Cuts
- Why Trade Compliance Looks Different in a Conflict Zone
- Navigating a Clinical Trial Shipment in a War Zone
- TecEx Medical Solution for Clinical Research in a Conflict Zone
Trade Amidst Turmoil
Why Trade Compliance Looks Different in a Conflict Zone
The Russian invasion of Ukraine has significantly impacted the Ukrainian supply chain, with knock-on effects rippling throughout Europe. Subsequently, Ukrainian exports have dropped by almost 40%. The country has lost access to critical markets, and the cost of doing business has increased significantly.
Many clinical trials have been suspended or delayed due to the disruption of trade, transportation, and limited access to raw materials and equipment. While ongoing trials face literal and figurative roadblocks.
Additionally, many Non-Investigational Medical Products (NIMPs), such as tablets and phones used to collect trial data, are classified as dual-use goods with civil and military applications. These goods are subject to added import and export controls.
The conflict in Ukraine has made it even more difficult to obtain trade licenses due to the disruption of trade routes, damaged infrastructure, and an increase in the cost of transportation and insurance. Furthermore, Ukrainian authorities receive a high volume of export applications, but they naturally prioritize applications for essential goods needed in the war.
Traditionally, EU and UK dual-use regulations already have stringent requirements for entering these territories. However, trade and customs authorities have heightened regulations after the conflict with Russia.
The hurdles faced by clinical trial imports and exports in Ukraine are highly nuanced. This is why a professional medical IOR, EOR, and trade compliance specialist is essential to move clinical trial goods from Ukraine to the UK successfully. TecEx Medical is equipped to project manage the trade compliance and cross-border logistics of clinical trials throughout the entire lifecycle to simplify the supply chain and effectively meet SIV dates.
In this case, the TecEx Medical IOR team was enlisted to help with the exporter of record duties and reverse logistics of trial goods destined back in the UK for processing after a completed Ukrainian trial.
Trade Compliance Under Siege
Navigating a Clinical Trial Shipment in a War Zone With a Medical IOR
The saga began when our client, a well-known global CRO, contacted us about a stuck shipment of Electronic Clinical Outcome Assessment (eCOA) devices in Poland. The trial utilized NIMPs as data collection devices. Upon entering the EU after a successful export from a Ukrainian warehouse, the shipment destined for the UK became stuck.
The shipper from the trial site attempted to use transit documentation to move the shipment from Ukraine into the UK via Poland. The goods entered the EU to a transit destination in Poland, assuming it would be reasonably easy to get them to the UK from there. However, an issue quickly arose when the Polish customs flagged several incorrectly completed or missing documents for the shipment.
Countries in the EU, including Poland, have a complex set of trade regulations even as a transit destination. Furthermore, the UK post-Brexit has a host of trade compliance and regulatory requirements, particularly about the shipment of Investigational Medical Products (IMP), NIMPs, and Dual-Use goods.
As a result of the oversight, the shipment became stuck, and the TecEx Medical team was brought on board to help. The CRO was concerned that the stuck goods containing patient records would be destroyed, so quick and efficient management was critical.
Because the transit paperwork was missing, there was no other option but to return the goods to the sender in Ukraine to begin again. This posed a whole new set of concerns. Primarily, the local shipper, who’s contract with the Clinical Research Organization(CRO), was now complete, did not want to take on the risks of storing and reshipping the goods. So, a different local entity had to take responsibility for receiving and storing the returned goods. Additionally, costs and delays for the completion of the trial were mounting.
Trade Resilience
The TecEx Medical IOR Solution for Clinical Research in a Conflict Zone
TecEx Medical sprung into action to initiate the return process, taking over the Exporter of Record (EOR), Importer of Record (IOR), and trade compliance risks and responsibilities.
Ultimately, the shipment only took 12 weeks to return to Ukraine, complete compliance checks, source the correct licenses and permits, issue a change order, add a new road freight provider, and arrive safely and without incident in the UK. This is a significant achievement for a shipment back to and out of an active conflict zone.
Thanks to the tireless efforts of the TecEx medical team and the calm determination of our client, we were able to retrieve a stuck shipment successfully, reissue all of the necessary paperwork, and safely send the trial eCOA devices for processing by the CRO in the UK as initially intended. The TecEx Medical trade compliance solution fulfilled a complete end-to-end solution with the added layer of a conflict zone and a stuck shipment to keep everyone on their toes.
Have a Stuck Shipment? Use a Medical IOR
TecEx Medical navigates complex customs regulations through medical IOR/EOR expertise, streamlines compliance, enhances supply chain efficiency, mitigates risks, and leads to cost savings fostering a seamless path to impactful clinical trial outcomes.
