Beginning in the early 1960s, biotechnology and medical research became a top priority of the Cuban government, which invested over one billion dollars in biotech research and development (R&D) in the 1990s alone. Cuba’s national Center for Scientific Investigation was founded in 1965, leading the way for the opening of numerous other research facilities. Today, there are 38 biotech centers, grouped together in a science park to the west of Havana, which integrate R&D, production and marketing.
Cuba’s biotech research effort has produced a variety of products ranging from vaccines and cancer therapy drugs to fetal monitoring equipment, and it now holds 400 patents in the biotech field. Cuba also has a number of biotech products in the pipeline and undergoing clinical trials, including vaccines for AIDS, cholera and cancer. At present, Cuba exports its biotech products to over 20 countries, including the United Kingdom and Canada. The quality of these exports is therefore subject to the scrutiny of these countries’ regulatory authorities as well as those of the World Health Organization (WHO). Cuba’s hepatitis B vaccine is on the WHO list of vaccines purchased by UN agencies.
But Cuba’s biotech program does not aim simply at producing patentable drugs; instead it is integrated into the state-funded health system, which provides free medical care for all Cubans and emphasizes preventive care and public health measures. A highly focused biotech research strategy has enabled the country to eradicate numerous diseases and to control epidemics in remarkably short periods of time. For example, in the early 1980s Cuba experienced an epidemic of dengue fever, a serious mosquito-transmitted disease characterized by high fever that has no specific treatment. Cuban scientists discovered that their own interferon, which had been perfected in under two months, was effective against the internal bleeding which results from dengue. (Interferons, now widely used in cancer treatment, were among the first substances to be made using recombinant gene technology.)
A vaccine for meningitis B—an inflammation of the membranes covering the brain or spinal cord which can be fatal—was developed at Cuba’s Carlos Finlay Institute in the 1980s and is now administered to all Cuban infants over three months. This has contributed to a 93% reduction in cases of meningococcal disease on the island. The anti-meningitis B vaccine, unique in the world, caught the attention of the pharmaceutical company SmithKline Beecham (now Glaxo SmithKline), which subsequently reached an agreement with the Finlay Institute to market the vaccine globally. The Finlay Institute retains the vaccine patent and control over R&D, production and quality assessment capacities in Cuba.
Given the size of the U.S. market, SmithKline was obviously interested in being able to market the vaccine in the United States, a suggestion that Cuba welcomed. Currently in the United States there are some 3,000 cases of meningitis a year, 300 of them fatal, many of which could be prevented by immunizing children and teenagers, particularly in high risk areas. But export to the United States was initially blocked by the U.S. embargo against Cuba. In 1996, passage of the Helms-Burton Act had further tightened the embargo. U.S.-owned pharmaceutical companies anywhere in the world are prohibited from trading with Cuba, a measure which specifically affects Cuba’s biotechnology sector.
SmithKline Beecham, however, managed to galvanize enough scientific and medical support to demonstrate that the Finlay vaccine was the only option available on the market. After two years of negotiations, SmithKline Beecham received a license from the U.S. Treasury Department allowing them to finalize a deal with Finlay and bring the vaccine to the U.S. market, providing these vaccines were produced in SmithKline Beecham facilities. Other conditions were imposed by the U.S. government as well, including minimizing the hard currency that the Finlay Institute could receive: Part of the royalties must be paid in kind, through delivery of medicines and other materials to Cuba. The potential for use of the Cuban meningitis B vaccine outside Cuba is, to date, still being investigated.
With the fall of the U.S.S.R., Cuba’s public health financing experienced a dramatic reduction, from over $250 million a year in the late 1980s to $65 million in 1993, only rising slowly to around $160 million in late 1990s. The problems caused by the decreased national health budget were aggravated by increased pressures on the health system, including an aging population, increasing numbers of doctors and health practitioners, and increasing numbers of surgical procedures. The situation was further exacerbated by the U.S. embargo; Cuba could not purchase medicines from the United States and it was increasingly difficult to acquire them elsewhere. Prior to the 1990s, Cuba was able to minimize the impact of the U.S. blockade by purchasing drugs in both Western and Eastern Europe. Following the collapse of the Soviet Union, East European supplies, as well as the hard currency to purchase drugs in Western Europe, dried up. Now Cuba pays substantial shipping costs for all imported materials because the U.S. embargo requires that no freighters docking in Cuba may visit a U.S. port within six months. As a consequence, imported pharmaceuticals soak up around 52% of Cuba’s public health expenditure. Moreover, the 1990s witnessed a period of smaller European pharmaceutical companies being bought out by U.S. companies and thus coming directly under the terms of the embargo.
But one of the unintended "benefits" of the embargo for Cuba is that it has developed a remarkable self-reliance in terms of both healthcare and biotechnology. Cuba implemented a program of import substitution and domestic production of drugs, encompassing a total of 422 pharmaceuticals at a cost of $75 million. Besides the increased emphasis on biotech research, Cuba also designed and developed a Natural and Traditional Medicine Program which covers acupuncture, homeopathy, herbal medicines and water therapy. Although import substitution tactics have saved millions of dollars, Cuba nonetheless has had to more tightly control distribution of medicines; such basic drugs as Ibuprofen, Vitamin E and the antibiotic Erythromycin are not available in the country.
In 1995, the American Association for World Health did a year-long study of the impact of the embargo—which unlike any other embargo explicitly bans sales of both food and medicine to Cuba—on the health of the Cuban people. The study concluded that the embargo had contributed to serious nutritional deficits and a degradation of Cuba’s water supply, due to the unavailability of purifying chemicals, as well as widespread shortages of pharmaceuticals. Nevertheless, Cuba’s success in dealing with infectious diseases is such that the country’s leading causes of mortality are heart disease and cancer. Many of Cuba’s health indicators match those of a developed country, and in a 2000 World Health Organization report, Cuba’s public health system ranked 39th out of 191 countries.
Despite the twin constraints of a developing country economy and the U.S. embargo, the Cuban medical research community and public healthcare system have much to offer both their immediate neighbors and the wider international community. Cuba boasts a ratio of 1.8 scientists per 1000 inhabitants, a level comparable to the European Union (though with a far smaller GDP). At a meeting in Havana last year sponsored by the Pugwash Conferences on Science and World Affairs, international participants asked how the Cuban experience in biotech could be replicated in other developing countries. It was noted that, despite its scarce resources, Cuba has achieved success by focusing on specific goals and investing in a variety of projects, both short-term (with low risk of failure but low probable reward) and long-term (with high risk but high rewards). An example of the latter is the meningitis B vaccine program. The result was both a resolution of a domestic health problem and the development of a product that can be marketed on a global level, generating a positive cash flow for the country. Export of both the meningitis B vaccine and the hepatitis B vaccine provide income which is both reinvested in research and used to develop local vaccination programs.
ABOUT THE AUTHOR:
Amina Aitsiselmi is a final year medical student at Cambridge University. This article updates her report on the Pugwash Conference "Medical Research in Cuba: Strengthening International Cooperation" held in February, 2001 in Havana. The entire report is available at
http://www.pugwash.org/reports/ees/ees8e.htm
