On October 17, 2016, the U.S. Treasury Department's Office of Foreign Assets Control (OFAC) amended U.S. sanctions against Cuba to authorize certain transactions relating to Cuban pharmaceuticals and joint medical research. These changes should further normalize relations with Cuba.
Opportunities. The changes also present opportunities for the U.S. health industry, as U.S. entities and individuals may now engage in the following:
- Certain commercial and non-commercial medical research projects involving Cuban nationals.
- Transactions incident to obtaining FDA approval for Cuban-origin pharmaceuticals, including discovery and development, pre-clinical and clinical research, regulatory review, approval, licensing, and post-market activities.
- Imports of Cuban-origin pharmaceuticals into the United States.
- Marketing, sale and distribution in the United States of FDA-approved Cuban-origin pharmaceuticals.
In addition, even if a transaction is not authorized under the new amendments, it may be possible to obtain a specific license from OFAC to import Cuban-origin commodities for bona-fide research purposes.
Restrictions. Some important limitations remain. For example, a separate authorization from the U.S. Commerce Department may be needed to ship U.S.-origin goods to Cuba. And in many cases, U.S. companies still may not establish a business or physical presence in Cuba or hire Cuban nationals.
Conclusion. There are still significant challenges when pursuing business in and with Cuba. Any potential Cuba business should be reviewed on a case by case basis. While there are certainly opportunities, it is important to proceed with care.