Last week, President Obama expanding opportunities for scientific collaboration and access to medical innovations as part of a series of executive actions designed to dismantle the U.S. embargo against Cuba.
The move grants legal status to the following health-related transactions:
Joint medical research
U.S. Treasury’s Office of Foreign Assets Control (OFAC) is issuing a new authorization that will allow persons subject to U.S. jurisdiction to engage in joint medical research projects with Cuban nationals. This authorization will encompass both non-commercial and commercial research.
OFAC is issuing a new authorization that will allow transactions incident to obtaining U.S. Food and Drug Administration (FDA) approval of Cuban-origin pharmaceuticals. An additional authorization will allow the importation into the U.S., and the marketing, sale, or other distribution in the U.S., of FDA-approved Cuban-origin pharmaceuticals.
Persons subject to U.S. jurisdiction engaging in the aforementioned health-related activities will also be authorized to open and maintain bank accounts in Cuba for use in conducting the authorized business.
Here is some history about Cuba’s Cimavax
In 2011, Cuban scientists contacted Roswell Park Cancer Institute to discuss a vaccine CIM had developed for potential use in treating advanced stage lung cancer and other cancers.
After discussions that focused on the science as well as building trust, CIM and Roswell Park entered into an R&D partnership to test the Cuban vaccine, Cimavax.
Cimavax reportedly works by stimulating the body’s own immune system to attack epidermal growth factor, a naturally occurring protein that can feed cancerous tumors. Since 2011, the vaccine has been available for free to the public in Cuba. It also has been approved for use in Peru. Reportedly, experience to date with the vaccine is promising. CIM and Roswell Park seek to replicate research and development carried out in Cuba under US gold standards for medical R&D.
Roswell Park applied to the US Office of Foreign Assets Control, received a license, and has begun its R&D collaboration. The collaboration includes importing research samples; applying for US Food and Drug Administration approval for US clinical trials for the vaccine; carrying out early-phase clinical trials at Roswell Park to assess safety and efficacy; and, if all goes well, fostering future partnerships between CIM and US firms interested in further development and commercialization of the vaccine. Other anti-cancer immunotherapies developed by CIM also are being studied at Roswell Park.
According to Roswell Park, CimaVax has been administered to 5,000 patients across the world, including 1,000 Cubans – as of last year. Expansive clinical trials have been underway for some time now, with published data showing prolonged life (especially in patients <60 yrs old, with a mean overall survival of 18.53 months in the vaccinated patients compared to 7.55 months for the unvaccinated patients) when compared to standard care, with minimal vaccine-related toxicity.
Roswell Park scientists attribute the success of the partnership to date to several factors. First, both sides have a shared mission in advancing cancer treatment to benefit the public good. Cuba’s biotech sector places a priority on delivering high-quality, affordable products, a priority shared by Roswell Park. Moreover, CIM has a commercial arm in Cuba and experienced legal counsel in the United States that have worked cooperatively with Roswell Park to facilitate the collaboration. While IPR-related questions may arise down the road, Roswell Park’s experience to date suggests that they may be manageable.
Normalizing relations between the two countries reportedly may open doors for collaborations in other areas, including vaccines against childhood meningitis, brain mapping, advanced wound care, alternative medicines, and best practices in delivering cost-effective care and preventive medicine for poor populations. According to a recent article in the American Journal of Public Health, one of the single biggest gains in public health from normalizing trade and travel with Cuba could be improved opportunities for medical research collaborations.
Sources: Lee, “Over the Straits,” October 8, 2015; Drain, “Implications of Repealing,” 2015; Medscape, “As Cuba-US Relations Thaw,” July 7, 2015.