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Biotechnology is neither a scientific discipline nor an industry, but a rapidly developing and still diffusing field of activity that cannot be adequately described by a short definition. In a report prepared for the OECD, Bull et al. [5] propose the following "working definition'' of biotechnology: "Biotechnology is the application of scientific and engineering principles to the processing of materials by biological agents to provide goods and services." This definition attempts to avoid both too narrow or too wide a view, seeing biotechnology neither as essentially genetic manipulation nor as all activities involving living materials. Thus, "scientific and engineering principles" are taken to cover a variety of disciplines, but in particular microbiology, biochemistry, genetics, and biochemical and chemical engineering; "biological agents" refer to a wide range of biological catalysts but particularly to micro-organisms, enzymes, and animal and plant cells; "materials" are taken in a broad sense to include both organic and inorganic compounds; and the essential link of scientific activity with industry is considered in the "application... to provide goods and services," covering a variety of products such as pharmaceuticals, biochemicals, and foodstuffs, as well as services such as water purification and waste management.
Essentially, biotechnology harnesses the catalytic power of biological systems, whether by direct use of enzymes or through the use of the intricate biochemistry of whole cells and micro-organisms. Defined in this way, biotechnology encompasses everything from the technology of bread-making to that involved in the production of human insulin from a bacterium induced to take up a non-bacterial gene and produce the protein coded by that gene Its history goes back centuries in such activities as fermentation and brewing of alcohol or bread- and cheese-making. New scientific and technological advances in genetic engineering and other ways of transforming biological organisms in the 1970s revolutionized commercial possibilities, giving rise to a large number of applications with the development of new products and new techniques. The recent technological developments in genetic engineering, enzyme technology, and fermentation technology are often called "the second biotechnological revolution" (or the "new biotechnology"), the first being generally recognized as Pasteur's revolutionary treatment and prevention of human and animal infectious diseases through immunization in the late 1880s.
New biotechnology is typically a science-led technology, in the sense that most of the inventions and process and product innovations have emerged from breakthroughs in scientific and technological research undertaken in universities, research institutes, and industrial R&D departments. It denotes a broad and heterogeneous field of applied sciences and related strategic research, encompassing several distinct technologies utilized in a wide range of industries: agriculture, pharmaceuticals, chemicals, and even weaponry are all potential beneficiaries of the advances being made.
Industries are increasingly using biotechnology to produce industrial substitutes for natural agriculture products manufactured in large quantities (and mainly exported by developing countries). Many new substances are competing with each other as viable substitutes for a particular product (foodstuffs, flavours, additives, fragrances), a trend very similar to the one encountered in new materials. The demand for new foodstuffs and pharmaceutical products (e.g. vaccines) is becoming increasingly diversified, and biotechnology is providing industry with the opportunity to abandon commodity chemicals and move into more lucrative specialty and agricultural chemicals. Older biotechnological techniques (e.g. fermentation) are themselves benefiting from additional inputs from genetic engineering and new enzymatic processes.
Bio-industry is reorganizing itself to respond to these trends: conscious of the economic stakes involved in the enormous potential markets for the new biotechnological products, many chemical, pharmaceutical, petrochemical, and industrial food corporations are creating their own research laboratories in plant biology and physiology and are investing in small venture-capital companies engaged in advanced research as well as in larger companies with R&D experience. As new products depend heavily on new and more productive processes and call for rigorous quality standards and safety tests, bio-industry is typically science- and capital-intensive and requires highly qualified staff and skilled labour.
A number of biotechnology developments are having profound technical impacts on processes and products. As with new materials, these technical changes are inducing important structural changes in the economy [35]:
The bulk of biotechnology sales in terms of volume and value can be grouped in three main groups of products [21]:
Some applications
Biotechnology inventions and innovations have already been applied in numerous industrial sectors.
FOOD AND AGRICULTURAL PRODUCTION. The potential of biotechnology for increasing agricultural productivity is high, in terms of both increasing the yields of cultivated plants and of obtaining foodstuffs with higher nutritional value. Many foodstuffs are produced by fermentation, and enzymes are now widely used as processing aids in food manufacturing. Acetone, citric acid, ethanol, and other chemicals are, or have been, produced industrially by fermentation. The digestion of wastes anaerobically is not only part of sewage treatment but also a way of generating methane gas as a source of energy. Biotechnology offers ways of improving even traditional fermentations like the production of silage, a fermented gas product used as cattle feed: microbial cultures are available that ensure that the correct sort of fermentation takes place. It is expected that by the year 2000, five-sixths of the annual increase in agricultural production in the world will be due to new biotechnology and other yield increases, while only one sixth will result from the increase in the area of land used in production [37]. In the next century, about 75 per cent of all major seeds may be developed by genetic engineering or tissue culture.
Many developing countries have established programmes to incorporate biotechnology into agricultural and agro-industrial activities. Some have already successfully applied biotechnology to their production of palm coconut oil, eliminating major disease traits and thereby increasing productivity by about 30 per cent. A marked increase in production, using cloning techniques to enable the propagation of high-yielding varieties of oil-palms and cocos, would make it possible to improve the fat content of diets and thus cover the additional nutritional needs of growing populations. But the production of oil-palm and coca clones using tissue culture techniques, where the applications could benefit millions of small landholders in developing countries whose standard of living depends entirely on the productivity of their holdings and whose cultivation techniques would have to be adapted to the properties of the new clones, constitutes a break through that cannot be fully exploited before the end of the century [48].
Wood exports play an important role in the economy of many tropical developing countries. The in vitro micropropagation of forest tree species for their wood or paper pulp is therefore of great economic interest; this technique is for instance being studied for the large-scale production of clones of several eucalyptus species with better resistance to cold weather and greater wood yield. Similarly, the multiplication and exploitation of drought-resistant plant species of commercial interest could afford useful outlets for a number of developing countries located in arid or semi-arid zones. For instance the jojoba, cultivated today in all five continents, can tolerate temperatures up to 50°C and its roots can search for water at a depth of 30 metros. It offers the possibility of controlling desertification by fixing soils and of earning a good income from a valuable oil extracted from its seeds, thus bringing employment to the rural areas and the chance to export a multi-purpose product with a high potential demand on the world market. Jojoba oil can be used industrially as an excellent transmission fluid or lubricant for fast rotating machines under high pressures and high temperatures (replacing the strategic sperm whale oil and thus limiting the massacre of sperm whale and other cetacean populations), as a shampoo and a sun cream in the cosmetics industry, as a treatment for skin diseases and burns in the pharmaceutical industry, as a wax to replace other plant or animal waxes, and meal proteins could be extracted from it for use in animal feed [48].
Tissue culture techniques have been applied to rice, maize, wheat, barley, cabbage, lettuce, tomatoes, peas, onions, potatoes, rapeseed, tobacco, sugar cane, and cotton for such purposes as gene transfer for disease resistance and salinity tolerance, selection of plants resistant to pathogens, and recovery of immature embryos from defective seeds. Substantial research in biotechnology and genetic resources has led to the adoption of genetic selection and breeding techniques by several countries, as well as to the improvement and production of local varieties of crops with higher yields, greater pest resistance, and earlier maturation. Progress in fermentation technology for the production of feed components, single-cell protein and industrial chemicals, as well as recent developments in enzyme technology for the production of antibiotics are expected to have a large impact on industry and agriculture in several developing countries. Nitrogen-fixing biotechnology, which enables non-leguminous crop plants to fix atmospheric nitrogen should permit a two to fourfold increase in corn yields.
LIVESTOCK HUSBANDRY AND ANIMAL HEALTH. Genetic engineering is already being applied in animal husbandry. Bovine embryo transfer techniques can have great zootechnical and economic advantages. Besides helping to speed up the improvement process or the preservation of superior breeds showing special characteristics (for instance, better resistance to tropical bovine diseases), embryo transfer can increase the production of meat and milk, each inseminated cow being able to give birth to up to 20 calves per year. The development of DNA probes can permit the sexing of the bovine embryos to be transplanted, thus selecting male embryos for meat production and female embryos for milk production. In some developing countries this technique could help overcome chronic milk shortages.
Genetic engineering also provides the possibility of developing and producing large quantities of new vaccines against many cattle, swine, and poultry infectious diseases that plague developing countries, like aphthous fever, theileriasis, hog cholera, colibacillus and viral diarrhoea, pseudo-rabies, coccidiosis, fowl pest, etc. Traditional vaccines against the aphthous fever virus, which is endemic in large areas in developing countries, are prepared by inactivation or attenuation of virus strains obtained from material collected from the lesions themselves, and imply the manipulation of very large quantities of virulent virus; in addition, these vaccines are unstable and must be stored under refrigeration, which is not always easy in tropical countries. The production by rDNA techniques of an effective, safe, and heat-stable vaccine against this disease will have a great economic impact in developing countries, which will be able to vaccinate their herds systematically and to increase the export of their livestock products to disease-free industrialized countries.
Fowl pest is the principal virus disease of poultry in the world, and it has devastating economic effects in several developing countries, where poultry meat and eggs form a major contribution to the human diet; most of the commonly used vaccines are relatively ineffective and must be administered on several occasions in high doses, a task rendered very difficult, particularly in countries where village poultry and small flocks predominate. A new, simple, and cheap vaccine is needed; research in genetic engineering may permit the production of massive quantities of antigen to be used for the preparation of an improved vaccine, in terms of potency and geographical utility [48].
PHARMACEUTICAL AND CHEMICAL PROCESSING. Biotechnology has been efficiently used to produce new pharmaceutical products, such as interferon, growth hormone, lymphokines, and tissue plasminogen activators. Biosynthesis of growth hormones of the main livestock species by genetically engineered micro-organisms can markedly improve their productivity and would have significant effects in intensive livestock husbandry [48]. Bovine growth hormone can increase milk production by 20 per cent at the same feed costs.
MEDICAL TREATMENT. The health care sector has attracted the most early interest for various reasons. Health care covers a large number of human activities, ranging from "formal" care provided by organized health services (clinics, hospitals, and other organizations for care, cure, or preventive medicine), "alternative" medical practitioners and self-medication or self-diagnosis products, to unpaid care of the sick and infirm. Biotechnology is particularly applicable to health care products in all these activities, including pharmaceuticals, vaccines, and diagnostic kits. It also provides ways of more rapidly screening potential pharmaceuticals, speeding up and lowering the high cost of pharmaceutical innovation.
Genetic engineering offers a way of producing on a larger scale biological molecules with therapeutic value that were formerly very scarce and therefore expensive, if available at all. Examples of these substances would include the first product of rDNA organisms for human therapy, human insulin, as well as human growth hormone, the interferons, interleukin, and other bioactive proteins. Many higher plants possess active compounds that form the starting material for a large range of drugs. The 1986 market for plant-derived pharmaceuticals was estimated at US$9 billion in the United States alone [13]. Tropical developing countries, whose pharmacopoeia is very rich and which constitute the main exporters of plant medicinal raw materials, could start from naturally occurring compounds and resort to biotechnology to isolate them and produce novel pharmaceuticals, thus reducing current imports. In addition, the amount of active product required for pharmaceutical uses of these substances is usually low and the pay-off potentially huge in many instances; however, the regulations concerning the commercialization of medicines apply equally to plant medicinal products, and since most therapeutic substances require painstaking testing, development may often be a lengthy and expensive process.
By contrast, a large number of new methods of testing human fluids and infections have been developed, based on monoclonal antibody technology. The fastest growing diagnostics markets are in immunology and microbiology. Monoclonal antibodies used in diagnostic kits offer products that, because they are not ingested by or applied to people, could be brought quickly to market and for which there is growing demand. Already, monoclonal antibody-based tests sold in pharmacies for confirming pregnancy are being established as a do-it-yourself market, and other over the-counter products are being introduced for monitoring fertility. Monoclonal antibody products are also becoming a vital part of the growth of new types of imaging techniques, and accurate, rapid, and cheap tests based on DNA probes and biosensors are promising future developments [21].
The cost of the techniques involved are falling sharply [48], so that they are likely to become, with the improvement of current vaccines and the development of effective, safer, and cheaper new vaccines, the major instruments of public health policy in developing countries.
Recombinant DNA techniques can be used to produce large quantities of immunogenic proteins synthesized by genetically engineered microorganisms, which are the basis for effective new vaccines. A genetically engineered vaccine requires no inactivation procedure as conventional vaccines do, facilitating its administration and reducing cost; additional economies may arise from the replacement of expensive embryo culture systems by relatively simple conventional bacterial media, from savings on high-security plants usually required in the production of conventional infectious disease vaccines, from reduced transport and storage costs, and from reduced testing, since the vaccines do not contain the disease-producing pathogen. Recombinant DNA techniques are being developed for the production of vaccines against viral hepatitis B (highly endemic in regions of Africa, Asia, and South America), rabies (a serious health problem in developing countries and still a cause of high mortality in domestic livestock), herpes, cholera, leprosy, malaria (the most widespread human infectious disease), schistosomiasis (chronic throughout tropical countries), onchocerciasis, sleeping sickness, and Chagas' disease [48].
Advantages and disadvantages
One of the main advantages of these innovations in biotechnology has been the possibility of their economic use on a small scale, without large infrastructure requirements, and their application at different levels of complexity, investment, and effort. It is in fact possible to adapt sophisticated biotechnical technologies to low-cost operations without eliminating the chances of success. This characteristic may facilitate the use of biotechnology in developing countries, provided that the promises brought to them are accurately identified, as well as the positive or negative impacts on their economy, their way of life, and their social structure. For instance, the expected growth in the market for gene synthesizers, protein fractionation equipment, or gene-splicing enzymes requires the provision of adequate infrastructure in terms of these enabling technologies, as well as culture collections and information systems. These requirements present an increasing concern to developing countries wishing to establish a sound base in biotechnology, which must therefore reconcile the spectacular progress of biotechnology with the lack of funding resources and qualified personnel needed by most sectors of bio-industry.
However, plant and animal biotechnologies may also have negative impacts in the developing countries.
Developing countries can be considered as "natural reservoirs" of wild and semi-domesticated species used to improve the crop potential [4], since the major centres of plant biological diversity are found in the tropical regions, where two-thirds of the world's plant genetic resources lie. Developing countries are therefore, directly or indirectly, the suppliers of plant genetic resources used in improving food production, in increasing yields of fibre or woody plants, and in finding new plant raw materials or pharmaceutical substances [48].
Stewart [53] has pointed to some of the major implications of the new biotechnologies for developing countries, which are much in line with the analysis presented above:
Table 2 Impact of selected aspects of plant biotechnology
| Aspects | Positive impact | Negative impact |
| Genetic diversity | Quick means of germ plasm transfer; broader breeding base; genetic base for new production; reduction in losses | Increase in uniformity and vulnerability; "genetic erosion" |
| Germ plasm identification | Elimination of undesirable characteristics; acceleration in new cultivar development | Ignorance of local conditions, such as local pests |
| Cultivar dissemination | Production of a broad variety of new plants; replanting of crops feasible within a growing season | Reduced long-term biological potentials of crops |
| Production | Significant increase in yield | Overproduction: market instability; reduced export income |
| Pest problems | New and fast ways to combat pest epidemics | Alteration of natural com position of organisms with unknown consequences |
| Mechanization | Amenability to harvest, processing, and packaging | Unemployment; fewer product varieties |
| Germ plasm | Viable means for long-term storage | Storage concentrated in a few countries, with potential for discriminatory exploitation |
| Land use | Reduction in land area needed for production, giving room for other national purposes and redistribution of land to smaller farmers | Global overproduction; de pressed economies unable to take advantage of potential benefits |
| Environment | Development of organisms likely to survive in difficult natural environments | Upsetting balance of Nature through release of genetically altered micro-organisms |
Source: Ref. 56.
The opportunities offered by biotechnology to developing countries should therefore be weighed against its environmental risks and the interrelated social and economic implications. Table 2 attempts to summarize the main issues discussed above.
It seems probable, therefore, that developing countries that are mainly primary producers, that lack flexibility in terms of diversification potential, and that do not have a sufficient degree of indigenous scientific, technological, and industrial capacity to enter the field themselves, may suffer some major losses as a result of the new biotechnology, and will have to pay heavily for its use; their net gains are likely to be small. By contrast, developing countries capable of diversifying out of primary products and establishing some local R&D capacity will be able to use new biotechnology to raise productivity and employment.
There are also enduring regulatory uncertainties, and the whole area of intellectual property rights is one of permanent controversy, making investment in some areas extremely risky. For instance, the rules that apply to the award of patents do not apply, in most cases, to new plant varieties, and the initial national regulations in industrialized countries did not grant breeders the protection of their "inventions." But recently, important changes in the legislation regarding the protection of plant varieties, brought by the development of plant biotechnologies, have been adopted by industrialized countries under pressure from industrial companies willing to make research in plant genetics and breeding more attractive. Following a decision by the Supreme Court of the United States in 1980 (the "Chakrabarty decision"), ruling that "the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and man-made inventions," the number of patents in genetic engineering increased twice as fast as those in other technologies. New attitudes regarding the extension of property rights to all biotechnological inventions, even those concerning genetically modified living things, are being adopted by many private organizations and even by public research institutions, including the extension, to the whole transformed plant, of an inventor's natural right over a new gene permitting the breeding of a new plant variety.
These attitudes, intended to protect the products of increasingly expensive plant genetic research and to make this research more profitable, together with the increasing role of the private sector in the collection, conservation, and utilization of germ plasm for commercial purposes, inevitably entail, for the developing countries, the payment of ever higher fees for the seeds of new and more productive crop varieties, often derived from species grown and improved in their own regions as the result of the efforts of many generations of farmers. As Sasson [48] puts it: "for the first time in agricultural history, there is a confrontation between the breeder's and the farmer's rights." Consequently, in the third world technological dependence is highly likely to increase. As with information technology, the impact of biotechnology on developing countries will depend largely on which political and industrial strategies are adopted, and on the appropriate choice of targets or objectives to be reached.