Ukraine Medical IOR | Crucial Patient Data From a Conflict Zone
Navigating trade compliance and medical IOR for a shipment of eCOA devices from Ukraine, a conflict zone. The case study examines how conflict-zone disruptions and strict dual-use regulations stranded a CRO's clinical trial devices in Poland. It details how TecEx Medical resolved the complex post-Brexit compliance hurdles to safely deliver the shipment from Ukraine to the UK.
A prominent global Contract Research Organization (CRO) engaged TecEx Medical to assist with resolving a stalled shipment of eCOA (Electronic Clinical Outcome Assessment) devices from Ukraine into the UK. Dual-use goods are increasingly more difficult to obtain trade licenses for, considering the conflict zone.
Since the implementation of Brexit, EU dual-use regulations and UK Import control requirements have become more stringent. Shipping supplies across borders, even during times of conflict, is a critical responsibility in safeguarding patient care.
Dual-use classification adds a layer of complexity, as a shipment assumed to be a standard medical device import can be delayed indefinitely if it’s later flagged as dual-use, particularly when the origin or transit point sits within an active conflict zone.
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 disruptions in trade and transportation, and limited access to raw materials and equipment. While ongoing trials face literal and figurative roadblocks, compromising duty to patients.
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 disrupted trade routes, damaged infrastructure, and higher transportation and insurance costs. Furthermore, Ukrainian authorities receive a high volume of export applications, but they naturally prioritize applications for essential goods needed in the war.
EU Trade Regulations & Dual-Use Goods
Traditionally, EU and UK dual-use regulations have stringent requirements for entry into 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 for successfully shipping clinical trial goods from Ukraine to the UK.
TecEx Medical is equipped to project-manage trade compliance and cross-border logistics for clinical trials throughout the entire lifecycle to simplify the supply chain and effectively meet SIV dates.
In this case, the TecEx Medical team was enlisted to assist with the Exporter of Record duties and the reverse logistics of trial goods destined for return to the UK for processing after a completed Ukrainian trial.
Non-Investigational Medical Products (NIMPs) Deployment
Our global CRO client first contacted us regarding the shipment of eCOA devices when it stalled in Poland. Upon entering the EU after a successful export from a Ukrainian warehouse, the shipment destined for the UK became stuck. The trial used NIMPs as data-collection devices, which are classified as complex regulatory goods.
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 as 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 Polish customs flagged several documents as incorrectly completed or missing for the shipment.
Countries in the EU, including Poland, have a complex set of trade regulations, even as transit destinations. Furthermore, the UK post-Brexit has a host of trade compliance and regulatory requirements, particularly concerning 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 start over. This posed a whole new set of concerns.
The local shipper, whose 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 in completing the trial were mounting.
Handling the Complexity of eCOA Device Exports
TecEx Medical sprang 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 took only 12 weeks to complete. This included a 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, upholding the sponsor’s duty to patients. 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 successfully retrieved a stuck shipment, reissued all necessary paperwork, and safely sent the trial eCOA devices to the CRO in the UK for processing, as initially intended.
The TecEx Medical trade compliance solution provided a complete end-to-end solution, with added layers for a conflict zone and a stuck shipment.
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.
Start the Conversation
Get in touch today, so we can better understand the details of your clinical trial import needs. We can then present a bespoke import structuring solution that suits your needs.
Let us shoulder the complexities of your global clinical trial imports so you can focus on delivering better patient outcomes. It might just be the most impactful thing you do for the long-term success of your clinical trials.
Surely that’s worth a conversation?
Ecovadis