On July 19, 2023, the Bureau of Industry and Security (“BIS”) in the US Commerce Department published much-anticipated guidance for license applications involving medical-related items destined to Russia, Belarus, and the Occupied/Covered Regions of Ukraine (Crimea, Donetsk People’s Republic, and Luhansk People’s Republic).
The guidance is just over three pages long, and we recommend that companies submitting applications for medical-related items to these destinations review the document in full. While BIS has been communicating many of the points made in this guidance informally or in the context of live license applications, this public, more formalized guidance is a welcome development.
The guidance comes on the heels of a significant expansion of licensing requirements under the Export Administration Regulations (“EAR”) on May 19, which targeted exports, reexports, or in-country transfers of broad categories of items to or within Russia or Belarus, including various types of medical devices and other medical-related products (see our blog post here). This was in addition to pre-existing licensing requirements under the EAR applicable to the supply of certain other types of medical-related items to or within the above-listed destinations.
The guidance is styled as “best practices” that applicants are “encouraged” to follow, not as instructions or requirements for applications. That said, BIS states that following the guidance will assist the agencies (BIS and the other agencies involved in the interagency review process) in processing applications more efficiently and expeditiously.
On the other hand, the realities of commercial transactions and medical supply chains may not always lend themselves to easily following this guidance. This underscores the importance of clearly explaining those realities in license applications, often in an accompanying letter of explanation.
