U.S. to Allow Research Collaborations, Drug Imports From Cuba

Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...

By John T. Aquino

Oct. 14 — The U.S. will allow individuals subject to U.S. jurisdictions to engage in joint medical research projects with Cuban nationals, the White House announced Oct. 14.

The White House also announced that the Treasury Department's Office of Foreign Assets Control (OFAC) will permit approval of Cuban-created pharmaceuticals by the Food and Drug Administration and will allow them to be imported for marketing, sale and distribution.

An OFAC final rule implementing the changes is set to be published in an Oct. 17 Federal Register notice.

The announcement expands the thawing of Cuban-U.S. relations. As a result of the 54-year-old U.S. blockade of the country, Cuba developed its own biopharmaceutical industry, including drugs and vaccines that have attracted the interest of U.S. biopharmas and prompted U.S. citizens to participate in medical tourism in Cuba (10 LSLR 18, 9/16/16).

Major Changes

The details of the changes the White House announced for health-related transactions include:

  •  OFAC is amending 31 C.F.R. §515.547 to authorize persons subject to U.S. jurisdiction to engage in joint medical research projects with Cuban nationals; authorized projects now include both non-commercial and commercial medical research.
  •  OFAC also is amending Section 515.547 to add new authorizations related to Cuban-origin pharmaceuticals. The general license includes discovery and development, preclinical research, clinical research, regulatory review, regulatory approval and licensing, regulatory postmarket activities and the importation into the U.S. of Cuban-created pharmaceuticals.
  •  Section 515.547 also now authorizes the importation and the marketing, sale or other distribution in the U.S. of FDA-approved Cuban-origin pharmaceuticals.
  •  In addition, revised Section 515.547 authorizes persons subject to U.S. jurisdiction who are engaging in such authorized activities to open, maintain and close bank accounts at Cuban financial institutions as long as such accounts are used solely for the activities.

More Collaboration Opportunities

These are among a number of changes that will be included in Treasury and Commerce department regulations.

The U.S. Treasury Department says on its website: “These changes are intended to expand opportunities for scientific collaboration by authorizing certain transactions related to Cuban-origin pharmaceuticals and joint medical research; improve living conditions for Cubans by expanding existing authorizations for grants and humanitarian-related services; increase people-to-people contact in Cuba by facilitating authorized travel and commerce; facilitate safe travel between the United States and Cuba by authorizing civil aviation safety-related services; and bolster trade and commercial opportunities by expanding and streamlining authorizations relating to trade and commerce.”

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bna.com

For More Information

The pre-publication version of the Federal Register notice is at http://src.bna.com/jo1.

Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.