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Guidelines on Sales and Donations of Medicines and Medical Equipment to Cuba

These guidelines supplement the Export Administration Regulations (EAR) as they relate to the export of medical items to Cuba, and do not replace the relevant sections of the EAR. Exporters should consult the relevant sections of the EAR to ensure compliance with all BXA regulations. You are encouraged to follow these guidelines to assist us in processing your license applications more efficiently.

Current Procedures

On March 20, 1998, the President announced a number of steps to increase the flow of humanitarian aid to the Cuban people, including improving the procedures for sale of medicines, medical equipment and supplies. In consultation with other agencies, the Commerce Department issues licenses for the export to Cuba of medical items, either donated or sold. The Commerce Department and other agencies have developed procedures to expedite processing of humanitarian medical licenses. In addition, Commerce will work with exporters on the monitoring and on-site verification requirements for medical sales or donations to governmental entities in Cuba.

Background

Since 1992, provisions of the Cuban Democracy Act have governed the export of medicines and medical supplies and equipment to Cuba, either by sale or donation. In March 1998, the President announced that the United States would help to facilitate medical sales. This effort will build on the impact of the Pope's January 1998 visit to Cuba in supporting the role of religious groups and other elements of civil society, thereby helping prepare the Cuban people for a democratic transition.

Points of Contact

The following persons can advise you on export license procedures and policies as they relate to Cuba:

John Bolsteins
Office of Strategic Trade & Foreign Policy Controls
Bureau of Export Administration
US Commerce Department
Telephone: 202-482-3283
Telefax: 202-482-6088

Office of Cuban Affairs
Bureau of Inter-American Affairs
US State Department
Telephone: 202-647-9273
Telefax: 202-736-447

Clara David
Office of Foreign Assets Control
US Treasury Department
Telephone: 202-622-2480
Telefax: 202-622-1657

The Commerce Department licenses the export of U.S. goods and technology to Cuba. The Treasury Department authorizes the travel of groups and individuals to Cuba and family remittances. The State Department provides overall policy guidance on Cuba.

License Requirements

Because Cuba is an embargoed country, practically all U.S. goods require a Commerce export license. Export license applications for most goods are subject to a policy of denial, although some specific goods are subject to case-by-case review. The United States generally approves export applications for the sale or donation of medicines, medical equipment and supplies, and the donation of food, clothing and other designated humanitarian items. All the medicines, medical equipment and supplies discussed here require a U.S. Commerce Department export license. Commerce export licenses are valid for 24 months, during which time shipments against the license can be made.

Required Forms

Commerce Department Multipurpose Application Form BXA-748P is the standard export license application form. You may obtain the forms by calling the Department of Commerce in Washington D.C. on (202)482-4811 or our Western Regional Office at (949) 664-0144, or by contacting Commerce Department district offices located in all major U.S. cities.

Filling out the Application Forms

Form BXA-748P. This will guide you on how to fill out relevant boxes on the export license application for medical sales and donations. This will supplement the instructions on the application's cover page. Box numbers omitted below are self-explanatory; not all boxes will apply.

Box 5/Type of application: check either export or reexport.
Box 6/Documents submitted: check "letter of explanation."
Box 9/Special purpose: enter "sale (or donation) of medicines, medical equipment or supplies."
Box 14/Applicant: Your/your company name and address.
Box 16/Purchaser: The name and address of the Cuban purchaser.
Box 17/Intermediate: The name and address of intermediate parties to the transaction.
Box 18/Ultimate consignee: The name and address in Cuba.
Box 19/End-user: The names and addresses of the individuals, groups or institutions (e.g. hospital, clinic) to which the ultimate consignee will pass the goods.

Note: For boxes 16 through 19, they could all in some cases be the same party. In other transactions, not all of these boxes would apply. P.O. Box numbers are not acceptable.
Box 21/End-use: Be specific and precise in describing this. For example, don't just say that a specific medical device will be used for "medical purposes;" give its specific function (e.g. treatment of diabetes; for kidney dialysis, etc.).
Box 22a/Export Control Classification Number (ECCN): Most often this will be "EAR99," a classification which covers most humanitarian goods, including medicines, medical equipment and supplies. Most manufacturers of specialized drugs and vaccines know the classification for their products. Technically sophisticated equipment, such as those incorporating computers, may have a different classification. Inquire with the manufacturer or Commerce Department representative indicated above if you don't know.
Box 22b/CTP: This number applies to computer exports and is a determination of the computer's capability. Generally, the limit for computers that may be approved for export to Cuba is a CTP of 24.8 MTOPS, equivalent to a computer with a 486-level microprocessor. Inquire with the Commerce Department representative indicated above if you don't know.
Box 22j/Description: Be precise in describing the items to be exported. To use just "medical items" is not sufficient. Attach a product list if necessary. You may develop categories for equipment (e.g. medical devices to assist the handicapped such as crutches, wheelchairs, walkers, etc.) that cover a wide range of goods. You may use generic names of drugs versus brand names if you will be exporting more than one brand name product. For transactions extending over a longer period of time, you may estimate values and quantities. Even if an item is donated, it has a fair market value or price which you should provide.
Box 24/Information: You must describe here or in the attached letter of explanation the on-site verification/monitoring arrangements you have made to ensure that the items are routed to, and used by, those intended. This should include the name of the party doing the monitoring, the frequency of monitoring and who will retain records of monitoring. The monitoring entity options include, but are not limited to, monitoring by the applicant, religious or charitable groups, western diplomats or international nongovernmental groups. The monitor must keep records of the on-site inspections and make them available to U.S. Government authorities upon request. Records must be retained for five years from the date of export.

Applications for the export of medical donations to non-governmental entities (e.g. churches, charitable groups, international humanitarian aid organizations) will need nothing in Box 16. Be sure to write in Box 24 that this is a "medical donation."

[Please note that under the CDA, the on-site monitoring requirement applies to all sales, and also applies to all donations of medical equipment, instruments and supplies. Monitoring also applies to donations of medicines except to nongovernmental organizations for humanitarian purposes.]

You may also submit applications electronically using BIS's Simplified Network Application Process (SNAP).

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