Emergence and development of the biotechnological sector in Cuba

Biotechnology has a promising development in Cuba, where this sector started being strengthened since the 1980s and today is among the Caribbean nation’s principal economic and scientific areas, which is attracting the attention and interest of the first world. From the production of vaccines to that of transgenic animals, of diagnosis systems to a wide gamut of cutting-edge pharmaceutical and biotechnological products, together with other results in the field of human health, that high-tech industry today represents one of the most important export lines for the country.

Foto: Tomada de la web de biotecnología.

Biotechnology, as a high-tech industry, is characteristic of companies from industrialised countries and, though in reality the sector is dominated by the most developed nations, some developing countries like Cuba are showing relevant results in this field. Starting in the 1980s, the Cuban government decided to speed up the biotechnological advance to guarantee the incorporation of the country to the world tendency of promoting an industry of high added value products. Viewed in comparison with other experiences of investment in biotechnology and technological parks, Cuba exhibits a group of traits that make it unique.

Though on the island in the 19th century there already existed an advanced scientific thinking, with world-level figures like Carlos J. Finlay, Tomás Romay and Álvaro Reynoso, it is not until the Revolution arrived that a real strategy for the development of science started to be formed in Cuba.

With the triumph of the Cuban Revolution multiple education programmes were introduced that made it possible to establish the necessary professional base. Already in 1960, Fidel Castro said in a speech given in the ceremony held by the Speleological Society of Cuba, in the Academy of Sciences, that “the future of our nation necessarily has to be a future of men of science, it has to be a future of men of thinking, because it is precisely what we are planting the most; what we are most planting are opportunities for the intelligentsia.…”

Since the 1980s, Cuba considered a strategy for the development of biotechnology. In 1981 the Biological Front was created (which later was the country’s first productive scientific centre: the Scientific Cluster of West of Havana), for the coordination and the organisation into a hierarchy of the activities in the sphere of biosciences, with the aim of boosting the development and the application of biotechnology, as well as the country’s incorporation to the world tendency to promote an industry of high added value products. That was the first time in the history of the Cuban economy that the Caribbean nation formed part of an activity at the same time as it was conceived in the world.

At that time, the strategy for the development of the sector was based on:

– the impact of health in Cuba, through the application of the research results in meeting the country’s needs,

– the impact in food production,

– fast access, at the highest level, to science and technology in this field,

– its own scientific potential and economic resources,

– the integration of the institutions, which implies that they do not compete among themselves but rather that they support each other so that resources are centralised in the enterprise specialising in a certain field (e.g.: an institution makes a discovery and contributes its findings to the enterprise within the sector which can benefit the most, or the one that specialises in the area of the discovery),

– the complete cycle (or closed cycle) system: research, production and marketing centres under one same administration.

 

Source: Taken from Lage, Agustín: “Tendencias actuales del mercado mundial de la biotecnología” (Current Tendencies of the Biotechnological World Market), joint presentation by CIM and CIGB, 2010.

 

Ciclo – Cycle: from the idea to the product

Cooperación – Cooperation between Cuban institutions

Investigación – Research and Development

Producción – Production

Actividades – Marketing

Patentes – Patents

Peoductos – Products

Economia – Economy

I/D alianzas – R/D alliances with foreign companies

Acuerdos – Marketing agreements with foreign companies

Contratos – Production Contracts

 

These characteristics are still valid at present and the last three classify as the most distinctive of Cuban biotechnology, since in addition to sustaining the sector’s success, they have not been repeated in any of the international experiences.

The principal centres linked to the Biological Front between 1982 and 1990 were the Lab Animal Production Centre (CENPALAB), the Biological Research Centre (CIB), the Genetic and Biotechnological Engineering Centre (CIGB), the Immunoassay Centre (CIE), the Meningitis Vaccine National Centre, the Scientific Research Centre (CNIC), the Pedro Kourí Institute of Tropical Medicine (IPK) and the National Institute of Oncology and Radiobiology (INOR)1.

The production of Human Leukocyte Alpha Interferon which had started in the country in early 1981 contributed to a great extent to the creation of the CIB, the first Cuban scientific-productive biotechnological institution. As a concrete result of the application of genetic engineering, the recombinant interferon started being produced a while later.

The first results of the effort started being obtained in that decade. The first monoclonal antibodies are achieved; the meningitis type B vaccine (the only one in the world) is produced; the alpha 2b Interferon is produced in large amounts; the network of SUMA labs is created; the first Cuban recombinant vaccine is achieved, the Hepatitis B vaccine; and the first transgenic animals are obtained.

During the first years of the 1990s, in the midst of the country’s economic crisis, the government’s political will persists in continuing advancing in the biotechnological development and the pharmaceutical industry, with the aim of minimising the effects on the health programmes based on the production of medicines, reagents and equipment, to substitute imports as well as to generate export incomes.

Exporting then became the inevitable condition to obtain the expected economic viability, though the first priority has always been meeting the needs of the National Health System.

In this context, three new centres were created: the Carlos J. Finlay Institute in 1991, for the development of vaccine compounds; the National Biopreparations Centre (BIOCEN) in 1992, with the fundamental aim of selling the products of other biotechnological institutions; and the Molecular Immunology Centre (CIM) in 1994, for the R+D (research and development) and production of monoclonal antibodies.

Moreover, biotechnology was extended to several provinces with the inauguration of the Genetic and Biotechnological Engineering Centre (CIGB) of Camagüey in 1989, of Sancti Spíritus in 1990, the Biotechnology Centre of Ciego de Ávila in 1991 and the Plant Biotechnology Centre of the Central University of Villa Clara in 1992, as well as similar institutions in Holguín and Santiago de Cuba.

This stage was characterised by the creation of a productive infrastructure made up by complex and modern installations, despite the fact that it coincided with the most difficult years, as a consequence of the disappearance of the USSR and the European socialist countries, and the strengthened economic hostility of the United States.

The Scientific Cluster of the West of Havana was created in 1992 and it consisted of more than 50 institutions and 10,000 workers. That structure allowed all the producing enterprises that comprised it to have their own marketing enterprise to facilitate the export process.

Biotechnology’s scope throughout the country, through an extensive network of institutions, guaranteed that its achievements and advances benefitted numerous sectors of the economy. The construction of biofactories for the production of in vitro plants to improve the agricultural sector made it possible to obtain new varieties more resistant to diseases and plagues in crops such as sugar cane, potato, garden vegetables and citrus fruit.

In the same way, advances were confirmed in animal biotechnology with the obtaining of new generation animal vaccines and the production of transgenic animals, in addition to exporting, in the field of human health, a wide gamut of pharmaceutical and biotechnological products that today represent one of the country’s most important export lines.

During this stage, to the extent that exports grew, the meningitis epidemic is controlled, infant mortality decreases through the programme of alpha-fetoprotein testing, the incidence of hepatitis B decreases because of the vaccination, the production of antiretroviral products is established and mortality because of AIDS decreases.

Since 2005 it is said that biotechnology in Cuba reached a superior state, since without stopping to grow as a sector and continuing to expand its exports, the new investments are made with the results of the institutions themselves and with less State funds, compared to the preceding stage. To the extent that the sector becomes profitable, the strategy is centred on:

– Increasing the economic impact.

– Increasing the integration with the National Health System.

– Diversifying markets, fundamentally in the developed countries.

– Increasing the participation of the Cuban biotechnological industry in Third World countries.

– Seeking new applications and combined formulations of current biotechnological products.

At present, Cuba can show advances in the biotechnology sector comparable to first world countries and its results are shown in areas like animal health, agriculture and, fundamentally, in human health. Some of the most relevant results in this last stage have been:

  • Reduction of the incidence of hepatitis B.

 

Source: Taken from Romero, I.: “Aportes de la biotecnología al pensamiento estratégico cubano” (Contributions of Biotechnology to Cuban Strategic Thinking), paper presented at the annual event of the Faculty of Economy, University of Havana, 2010.

 

Incidencia – Incidence of Hepatitis B in Cuba, 1991-2006

Casos: Cases

Años – Years

Poblacion – General population

Niños – Children <15 years

Children <5 years

 

 

 

  • The haemophilus influenzae type B vaccine, produced based on a synthetic antigen that immunises against the bacteria that causes meningitis and pneumonia in children less than a year old.
  • Control of meningitis and leptospirosis.

 

Source: Taken from Romero, I., ob cit.

 

Incidencia meningococcica – Incidence of meningitis in Cuba 1989-2008

Casos – Cases

Años – Years

 

Incidencia leptospirosis – Incidence of leptospirosis in Cuba 1976-2008

Incidencia (x 10 000 hab) – Incidence per 10,000 inhab.

Años – Years

 

 

  • Mass vaccination campaigns in the community and schools against 13 diseases (polio, tetanus, diphtheria, measles, whooping cough, rubella, among others).
  • Reduction of mortality due to heart attack because of the treatment with recombinant streptokinase. The use of this medicine was extended nationwide since 1993 for the treatment of severe myocardial infarction. A total of 11,540 patients were treated since 2001, with a 28 per cent reduction in mortality. More than 200 lives per year have been saved.
  • Early diagnosis of congenital malformations and decrease of infant mortality. Its application in the Cuban alpha fetoprotein programme, since 1982 to date, has made it possible to study 3,357,619 (99.6%) of the pregnant women and detected some 7,529 malformations.
  • Perinatal diagnosis of congenital hyperthyroidism. A total of 2,910,387 (99%) newborns have been studied from 1986 to date and 754 cases have come out positive; the early treatment has avoided hundreds of cases of cretinism.
  • Safety of blood transfusions.
  • System of epidemiological watch.
  • Systems for the diagnosis of diseases like HIV/AIDS, helping to maintain the prevalence rates among the lowest in the world.
  • Total coverage of AIDS patients with antiretroviral treatment.
  • National production of 560 of the 881 medicines administered in Cuba, including eight of the 13 vaccines used in the expanded immunisation programme.
  • The availability in the hospitals of cutting-edge medicines, like erythropoietin (EPO), interferon (IFN), the epidermal growth factor (GSCF), the monoclonal antibodies, the lung cancer vaccines, heberprot-P, among others.

Finally, this industry underwent a new transformation in December 2012, when the Cuban biotechnological enterprises went on to form part of the BioCubaFarma business group, which was constituted by Decree No. 307. The entities of the biotechnological sectors that previously belonged to the Science, Technology and Environment Ministry (CITMA) and entities of the QUIMEFA Business Group (in charge of the production of medicines in the country) joined the group. The group has establishments in the country’s 15 provinces and is made up by 16 large production enterprises, eight marketing enterprises and 11 based abroad and three that offer services.

The new organisation functions integrally under business principles, which is why the budgeted units that used to make up the scientific cluster are transformed into business entities and are no longer financed by the State.

This step, which forms part of the business reorganisation process being put into practice in the country in recent years, has the aim of achieving greater levels of integration in the biotechnological and pharmaceutical sector. The BioCubaFarma Higher Management Organisation (OSDE) falls within the world tendency of merging the biotechnological and pharmaceutical industries, a business reorganisation seeking to raise the quality standards and export levels; use with greater efficiency of the installations and equipment and, fundamentally, the human capital it has. Its materialisation must generate for the country, in general, a higher scientific technical development, with a view to improving different aspects such as:

– positioning in the market,

– taking optimum advantage of the capacities,

– efficiency in the balance of materials in the sense of greater saving,

– access to markets.

The integration of the biotechnological and pharmaceutical industry could report benefits for both; however, the experience is still very incipient to venture into conclusions. Supposedly, on the one hand the pharmaceutical sector could raise its quality standards based on the experience of the cluster’s centres in the research, production and marketing of products. While, on the other hand, biotechnology, which lacked the central organisational structure, would gain from the business experience contributed by the entities of the pharmaceutical industry.

Among many other challenges, this transformation highlights the country’s need to demonstrate how efficient the socialist state enterprise can be. A policy for economic development with prerogatives to achieve autonomy and decision making to revitalise the industry was approved for BioCubaFarma. These include “approving the amount of the year’s gross added value devoted to the creation of the wage fund,” according to the Gaceta Oficial of December 7, 2012; that is to say, the wage incentive according to results: to the extent that they contribute more, workers will be better paid.

To conclude, the new BioCubaFarma OSDE is a national business entity that includes for the first time in Cuba the concept of high-tech enterprises and it is relevant to highlight that, though the integration of both industries is certainly a factor of success in time, one has to differentiate the “enterprise” from the “high-tech enterprise” since it is clear that the world is directed toward the last type of enterprise. The BioCubaFarma group must take on the promotion, development and protection of this type of enterprise, since in the end it is the one that generates differentiated exports of high added value, which constitute one of the country’s principal lines and for which one must continue betting in the future. (2015).

 

Bibliography:

 

Lage, A.: “La organización productiva en la economía del conocimiento: Experiencias a partir de la Biotecnología Cubana” (Productive Organisation in the Economy of Knowledge: Experiences based on Cuban Biotechnology), lecture, Faculty of Economy, University of Havana, Cuba, 2013.

 

 

1 Somoza, J.: “Industria biotecnológica y médico-farmacéutica” (Biotechnological and Medical Pharmaceutical Industry), in Estructura Económica de Cuba (Economic Structure of Cuba), Tome 1, p.: 236, 2001.

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