Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
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).
The details of the changes the White House announced for health-related transactions include:
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.”
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The pre-publication version of the Federal Register notice is at http://src.bna.com/jo1.
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