BIS Issues Best Practices for Russia-Related License Applications Involving Medical Goods

The Bureau of Industry and Society last week issued guidance for license applicants seeking to export medical-related items to Russia, Belarus or certain occupied regions of Ukraine, outlining best practices for submitting applications and what information should be included. BIS urged exporters to “provide all the necessary information when the application is first submitted” so the agency can “promptly analyze the proposed scope of the transactions” before submitting it for interagency review, and the agency detailed what types of applications may lead to delays.

The guidance said applications should include end-use or end-user statements that certify due diligence “has been exercised to ensure the medical facilities listed as ultimate consignees or end-users on the application are civilian facilities providing direct patient care” and will not aid the Russian military or government. Because the Russian and Belarusian defense ministries and their armed services are military end-users under the Export Administration Regulations, any exports to hospitals operated by them will be reviewed under a policy of denial, except for certain food and medicine designated as EAR99, which will be reviewed on a case-by-case basis.

BIS said it can “more quickly” evaluate applications with a “relatively narrow transaction scope” as opposed to applications with “many parties and large quantities of items.” Exporters should consider narrowing the scope to a single consignee or distributor, no more than 100 end-users or “preferably fewer,” and a one-year supply of item quantities. BIS said it’s typically approving these license applications under a one-year validity period to “limit the risk of diversion in a dynamic and fluid wartime environment.”

Export applications with “varying categories of items,” such as different items that could all be categorized as “consumables,” should list those items “individually but group them into like categories which clearly describe to interagency reviewers what items are being exported,” the guidance said. BIS said applications that are often delayed include only “general item descriptions without specifics,” such as “‘consumables’ with no further description,” or “applications that only refer to an attachment.” Exporters can help speed up the process by referencing specific Harmonized System Codes or by citing “relevant regulatory provisions in the EAR, which may help “reduce classification confusion and facilitate timely review.”

BIS also said license applications for medicine, medical devices, medical equipment and other similar items will move through interagency review “more efficiently” if they “clearly demonstrate that the end users will use the items to provide direct patient care to civilian patients in a civilian treatment facility.” The agency may remove certain parties from the scope of the application if they don’t “clearly” give “direct patient care to civilians” so BIS can “facilitate the processing of applications that focus on providing direct patient care to the Russian or Belarusian people.”

The agency listed several questions exporters should consider before submitting an application:

• 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 one 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?