New doors can open shortly for the Cuban pharmaceutical and biotechnological industry in very disputed as well as restrictive markets. The European Union is modifying political and commercial positions toward Cuba precisely when high-ranking officials from Washington are ratifying a special regulation for an understanding with Havana in the field of research and the production of medicines.
On the same day – December 12 – in which Cuba and the European Union signed in Brussels an agreement that officially put an end to the that bloc’s Common Position toward the largest of the Caribbean islands, a high-ranking representative of the Genetic Engineering and Biotechnology Centre (CIGB) announced the joint patent granted by the EU to one of the star products of that institution.
At the close of the 4th International Congress on Control of Diabetes and its most severe complications, held in Varadero, the deputy director of the CIGB, Ernesto López Mola, announced that a new generation of the Heberprot-P, an exclusive medicine for the treatment of diabetic foot ulcers, has been given a license in the community bloc valid up to 2036.
According to that formulation, the Heberprot-P is now presented in nanocapsules that make more effective the cicatrisation and its anti-microbial action. The drug was granted the patent by the Institute of Material Sciences of Barcelona, Spain, together with the EU.
Europe’s goodwill not only responds to the proven effectiveness of that medicine, the only one of its kind to prevent the amputation of limbs due to diabetic complications. The European understanding with Cuba coincides with visits by U.S, officials to the island. By chance?
Among the persons who in Varadero’s Plaza América Convention Centre heard the news of the European patent was U.S. Acting Assistant Secretary for Health Karen DeSalvo. The presence and the comments made by that official during the congress dedicated to diabetes confirm the interest of her country’s authorities in strengthening relations with Cuban researchers and the pharmaceutical industry.
The United States has granted licences to two Cuban biomedicines to make clinical trials in that country. Representatives of Heber Biotec, the enterprise that produces and markets the CIGB’s creations, have said they are now seeking a U.S. partner to undertake those tests with Heberprot-P.
The other drug with a license is the Cimavax-EGF, a new therapeutic lung cancer vaccine created by the Molecular Immunology Centre (CIM), a leader in the production of monoclonal antibodies. The CIM already signed an agreement with the Roswell Park Cancer Institute of New York to carry out clinical trials with the Cimavex. The New York Times featured an article on this.
Judging by the numerous visits by U.S. businesspeople to Cuban biotechnological institutions, the culmination of an agreement in the short term seems probable.
And the Europeans are in a rush, as the most recent steps indicate.
The medicine for diabetic foot ulcers has gained prestige in the world. It is registered in 23 countries, among them Russia, Argentina, Venezuela, Turkey, Colombia, Ecuador, Ukraine and Vietnam, where it has benefitted close to 250,000 persons. Other internationally renowned Cuban biotechnology medicines are the Heberferón, for skin cancer, and the meningitis and hepatitis vaccines.
The BioCubaFarma business group has registered products in more than 50 countries and exports medicines to 48. In addition to several hundreds of millions of dollars’ worth of exports every year, the group saves more than 1.7 billion dollars for import substitution.
A data can speed up the U.S. rapprochement to Heberprot-P. “In the United States, out of more than a million persons who annually develop diabetic foot ulcer, between 200,000 and 350,000 suffer from amputations,” commented Dr. Rafael Ibargollín Ulloa, a researcher from the CIGB in Sancti Spíritus.
But the North’s sights on the Cuban biotechnological and pharmaceutical industry are not only motivated by the access to a drug which received an award by the World Intellectual Property Organisation for its exclusiveness. The principal world pharmaceutical industry transnationals are based in the United States and the European Union. Now the ball is in Cuba’s court to maneuver in a field with fierce competition, without renouncing the humanist principles with which its biotechnology was born, or to the mission of the first sector that stamps a seal of high technology to exports and the Cuban economy. (2016)
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