BIS Guidance - Best Practices for License Applications for Medical-related Items

BIS  published best practices for submitting export license applications for medical-related items destined for Russia, Belarus, and the occupied/covered regions of Ukraine.

It reflects the U.S. Government's position that the Russian and Belarusian people are not the target of export controls imposed on Russia and Belarus due to their activities in Ukraine.

Key takeaways are:

1. End-Use/User Statements: Exporters must certify they have carried out due diligence to ensure the medical facilities listed as ultimate consignees or end-users are civilian facilities providing direct patient care.

2. License Scope: It is generally advised to limit licenses to a one-year validity period due to the potential risk of diversion in a dynamic wartime environment. Applications with a relatively narrow transaction scope can be evaluated faster by the reviewing agencies.

3. Export Item Grouping: When listing varying categories of items, it's recommended to group them into like categories for easier evaluation by reviewing agencies. Clear and specific item descriptions, including the use of Harmonized System (HS) codes, can expedite the review process.

4. Direct Patient Care: Applications that clearly demonstrate the end users will use the items to provide direct patient care to civilian patients in a civilian treatment facility are processed more efficiently.

5. HS Codes: The use of correct HS codes in license applications is important to avoid potential misclassification of items.

6. Best Practices Checklist: The document provides a checklist for exporters to follow when preparing their license applications, with considerations such as whether the exporter has provided a statement certifying the medical facilities on the application are civilian facilities providing direct patient care, and whether they have provided an accurate description of how the items would be used for direct patient care.

   Best Practices Checklist

7.  
   • Have you provided a statement certifying that the medical facilities on the application are civilian facilities providing direct patient care only to civilian patients?
   • Are the item quantities scoped to what would be used over the period of 1 year?
   • Do the items for export have an identifying description in the Technical Description Block?
   • Did you scope the license to minimize the risk of diversion to unauthorized end users/end uses?
   • For items controlled by HS code, have you included the HS code that covers your items and the section of the EAR where that HS code is referenced?
   • Did you provide a description of how the items would be used for direct patient care?
   • Have you explained the role of any parties that do not provide direct patient care?

This guidance is intended to help draft applications that can be reviewed efficiently, but does not impose or create additional requirements for license applications. All applications received by BIS will be reviewed consistent with the provisions of Executive Order 12981 and the relevant provisions of the EAR.

[BIS Document]