Biology has been introducing techniques called biotechnologies or technologies of life for quite some time, as the result of detailed studies, manipulations and experimentations.
We must however keep in mind the official dates which mark the birth of this subject: 1857, when Louis Pasteur published his studies on the mechanisms of leavening and fermentation; 1878, when enzymes which cause leavening were discovered; and, 1929, when enzymes were recognized to be proteins. Already in the late 19th and early 20th centuries, when Mendel discovered the laws behind the heredity of characters (1865), human skill in manipulating plants and animals had greatly increased, though it could still be considered a normal evolutionary process. The main achievement in the early 20th century was the demonstration of the bacterial transformation process (1928). Later, our power to act on and even alter the processes on which life is based increased together with our knowledge of genetics. Probably the most important step in this direction was made between 1940 and 1950 with the discovery that the information required to build and operate a living organsim is contained in the genes present in the double stranded molecule of deoxyribonucleic acid, the DNA (1953). Since then progress has moved at an extremely fast pace and twenty years later, the first patent (1973) for the recombinant DNA technology was reached with the first recombination process.

This technology enables scientists to modify the DNA of an organism by adding the genes of another organism to its genetic heritage. The first biotechnological company was formed only two years later, in 1975, and 1977 marked the beginning of the production of human insulin. In 1983 the biochemist Kary Mullis perfected the PCR technique (polymerase chain reaction), which enables us to multiply DNA fragments unlimitedly. The use of the first drugs such as Synthetic Insulin (1982) and the Growth Hormone (1985) has spread since in medical practice. The first blood proteins and the first modulators of the immune system were obtained always in the ’80s, not to mention the production of vaccines (1986) and the first experiment with genic treatment (1990). It has thus become possible to act directly on the code of life by manipulating it. That specified, we can hence state that: “biotechnology consists in the use of living organisms to produce commercial quantities of useful products, or to improve the characteristics of plants and animals”. Real sophisticated “factories” can be created by applying genetic engineering techniques, which enable man to modify the genetic features of organisms. Bacteria in particular, and other microorganisms too, receive the information supplied by other animal or vegetable species in their genetic code, and they use it to produce, at a low cost, drugs or other substances useful to man. At times certain genetically modified retroviruses are used to feed the information received to plants or animals which thus acquire new properties - they can, for example, become more productive or more resistant. The progress of biotechnological studies is the result of a close interdisciplinary cooperation between the different sciences (chemistry, physics, medicine, pharmacy and biology) which also work in synergy with the industrial sector, and biotechnology can now be applied on a large scale, remarkably altering international approach to environmental, health, and nutritional problems. Encouraged by the global increase in investments, the biotechnological firms are experiencing a moment of development and expansion. Today the United States are the first in the world, with 72% of the total turnover. According to Beyond Borders, today the biotechnology sector counts 4,284 firms in 25 countries - 622 are public and 3,662 are private. In 2001 public firms recorded a turnover of 35 billion dollars - they have invested 16 billion dollars in research and development and have employed over 188,000 people. In Europe, Great Britain boasts the largest concentration of biotechnological firms, followed by Germany and France. Italy ranks only eleventh with just 46 companies - only one of them is large; 40% of these companies operates in the biomedical sector, 30% in equipment, 16% in environment and 14 % in agriculture. In 2001 investments made in this sector amounted to about 8 billion dollars, while the European firms made over 2 billion dollars and the Canadian ones about 900 million dollars. “Talents, knowledge and investments seem destined to grow and circulate with increasing freedom worldwide and the companies that operate in the field of biotechnology must be ready to implement developmental strategies which can exploit these opportunities“ - thus stated Donn Szaro (Global Health Sciences Director of Ernst & Young). By 2005 the biotechnology market in Europe will double its current numbers, surpassing the top limit of 100 billion dollars. But the race is slowed down by the high prices of drugs and the matter of defending patents. The debate is still open, also due to the likelihood of having to patent new forms of life (microorganisms, plants and even animals) or their parts. This would enable institutes and industries to create modified forms of life and, after spending considerable amounts on research, they would be guaranteed the ownership and economic development of the invention at least for a certain number of years.

This possibility encourages experimentation and helps science to progress, but it opens an ethical question on life, which in itself cannot be patented. Today patents are given, and here too a debate is open, to certain modifications genetic engineering performs on human cells, as long as these alterations are an invention, a novelty and not something obvious; they must also offer a potential productive use. Uncertain public policies and the lack of regulations are signs of the heated debate going on in many countries - a debate raised by the use of biotechnology in agriculture, by studies on stem cells and by cloning. Bioethical matters too must be studied and they need the considerations of bioethical committees - philosophers, scientists and jurists who have been drawn into the matter. In Italy too, a National Bioethics Committee was formed already in 1990 and the theoreticians handling the problem (scientists, philosophers, etc.) agreed in consenting to the production of transgenic animals to be used as guinea pigs for studies and experiments on cures against serious human diseases; they also agreed to the use of parts of the genetic heritage or of live cells to cure the same diseases or to produce drugs, diagnostic reagents and vaccines, but they absolutely forbid the creation of human embryos with in vitro fertilization methods for research purposes, during their life or after their death. In the same manner the Committee forbids the creation of identical human beings, produced with cloning methods or any other technique for any purpose whatsoever, including that of selecting the human race. Not last and probably most important of all - the implantation of the human embryo in the uterus of another animal and the opposite is forbidden, that is the fusion of gametes (human reproduction cells) with those of other animals. ITALIANS AND BIOTECHNOLOGY It is very important to understand whether public opinion, in this case that of Italians, trusts science and its usefulness in improving the quality of their life. This is why studies and large scale opinion surveys are conducted so frequently. Over one thousand people were asked this question by a well known company that handles market surveys and statistical investigations, with a surprising result - six Italians on seven said “Yes, we trust science”. This shows that Italians consider Medicine and its efforts to remove certain important diseases with gratitude and it shows they know that it is thanks to medicine, experimentation and scientific research that the average life span has doubled in the last century. Over 50% of Italians also ask for clear and more extensive information from those who work in the most modern fields of science, while 70% believe that it is a mistake to “block scientific experiments in order to prevent every possible risk”. On the other hand, a considerable amount of Italians fears that biotechnological experimentation could prove to be dangerous both to man and the ecosystem. Even though biotechnology has greatly improved the quality of life in recent years, most people are not aware of its applications in the medical field. A survey conducted on this topic in 1999 revealed that 48% of the people interviewed did not know about it; this percentage rose to 60% for people with an average/low standard of education. But a survey conducted in 2001 showed that, thanks to mass information, the situation seems to have improved in recent years - 62% of the people interviewed believes that in the future biotechnology will lead to the discovery of new cures for serious diseases (AIDS, Alzheimer); 55.2% also believes that biotechnology will defeat genetic diseases and other serious pathologies. But unfortunately, even mass information has a disadvantage - it is often inaccurate and at times even wrong; this creates false expectations and fears that could be avoided with a more accurate and scientific assessment of the information published and broadcasted by the media. In short, ‘yes’ to scientific progress, but with reserve and greater economic investments, besides clearer policies. This is the request of a civil and modern nation. BIOTECHNOLOGY AND MEDICINE Medicine is particularly interested in the applications of biotechnology which can benefit the fields of prevention, diagnosis and treatment. The discovery of monoclonal antibodies has brought important innovations to diagnostics. Thanks to their purity, specificity and unlimited number they are greatly appreciated in oncology, because they specifically distinguish the structures produced by tumour cells. These very properties enable the use of monoclonal antibodies as vectors of anti-tumour drugs for therapeutic purposes. In this manner the immune drugs reach only the malignant cells and their toxicity does not cause further consequences to the others. So far this has been applied to tumours in the ovaries, the gastro-intestinal tract, the lungs and the liver. Monoclonal antibodies are also used in the study of infective diseases to recognize infective germs; this has in fact helped scientists understand epidemiology, that is the reasons for certain widespread diseases such as viral hepatitis A and B, infections caused by the Herpes virus type I and by the Chlamydia, and mononucleosis. Monoclonal antibodies are also used in immunology, which studies the effects of the antigen-antibody reaction. These antibodies have enabled scientists to study the various subpopulations of lymphocytes, white blood cells present in the blood and which produce antibodies, and the mechanism of the immune response. This is how the causes of certain pathologies and of certain diseases such as immunodeficiencies, both acquired and hereditary, and auto-immune diseases in which the defence system attacks one’s own organism have been discovered. The use of monoclonal antibodies has also helped improve the methods of analysis of various substances present in biological liquids. The recombinant DNA technology is applied especially in the diagnostic field. Genetic probes are also used to recognize the special sequences in nucleic acids which assure the complementarity of nitrogenous bases, in order to study neuroblastomas, malignant tumours which affect the ganglia – they are small, round or fusiform swellings located along nerves, and again, to diagnose genetic diseases before birth. The use of molecular probes also enables scientists to identify genetic mutations even when they do not lead to clinically evident diseases. The drugs and vaccines produced by biotechnological methods are also particularly important. Translated by Interpres sas