US Clears Way for Cuban Drugs

Regulatory NewsRegulatory News
| 14 October 2016 | By Michael Mezher 

Under the auspices of a new presidential policy directive aimed at promoting greater engagement between the US and Cuba, the US Departments of Treasury and Commerce on Friday announced changes that will clear the way for Cuban-developed drugs to gain approval by the US Food and Drug Administration (FDA).

The changes, which take effect on Monday, are being made through two amendments to the Cuban Assets Control Regulations to enable greater levels of interaction between the two countries and their people across multiple sectors, including health, travel and civil aviation.

"The Treasury Department has worked to break down economic barriers in areas such as travel, trade and commerce, banking, and telecommunications. Today's action builds on this progress by enabling more scientific collaboration, grants and scholarships, people-to-people contact, and private sector growth. These steps have the potential to accelerate constructive change and unlock greater economic opportunity for Cubans and Americans," said Treasury Secretary Jacob Lew.

The move promises to be a shot in the arm for Cuba's biotech aspirations, as the country has been looking to begin clinical trials in the US for its homemade cancer treatment and another drug to treat diabetic foot ulcers.

Under the amendments, Cuban-developed pharmaceuticals will now be allowed to file for FDA approval and be imported into the US for marketing, sale and distribution.

"Specifically, section 515.547 now authorizes transactions incident to obtaining approval from the US Food and Drug Administration (FDA) of Cuban-origin pharmaceuticals. The general license includes discovery and development, pre-clinical research, regulatory review, regulatory approval and licensing, regulatory post-market activities, and the importation into the United States of Cuban-origin pharmaceuticals."

The amendments also authorize Americans "to engage in joint medical research projects with Cuban national," which will allow both Cuban and US researchers to conduct research in the US.

In order to facilitate such efforts, the amendments allow persons subject to US jurisdiction to open Cuban bank accounts as long as those accounts are used solely for "authorized activities."

However, some restrictions that could affect joint research efforts between the two countries will continue to remain in place. In particular, the amendments note that separate authorization may be required for exporting or re-exporting certain goods or technologies to Cuba, as well as for certain types of travel to, from or within the two countries.

Office of Foreign Assets Control Final Rule

Bureau of Industry and Security Final Rule

Department of Treasury Press release

Presidential Policy Directive


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