Without autonomy in biotechnology, Brazil becomes hostage for vaccine acquisition

We are totally dependent on imports, even if companies are on Brazilian soil, they need to use active products that are imported

Amid the pandemic of the new coronavirus, biotechnology proved to be an essential tool to face COVID-19. Thanks to it and the researchers efforts, it only took 42 days for a vaccine based on modern biotechnology to reach the first clinical phase. With the help of this technology, not only the mRNA-1273 vaccine was developed, but also others that use DNA or recombinant protein. The potential for the application of biotechnology in the health area is very wide and, in addition to helping to detect diseases in people, animals and crops, its advances have contributed to the development of safer and more effective formulations.

In Brazil, since the 1970s, there has been a great investment in the training of qualified researchers in the field of biotechnology. However, only in 2005, the Technological Innovation Law was regulated, which establishes measures to encourage innovation and scientific and technological research in the productive environment, aiming at achieving technological autonomy and industrial development in the country.

However, Brazil was late in the race to master the knowledge of biotechnological processes and their application in industrial production. The director of the Oswaldo Cruz Foundation (Fiocruz), a researcher specialized in public health in the biotechnology area, Dr. Rodrigo Stabeli, recalls that the lack of technology for this area in Brazil is structural. “The advent of technologies for the production of medicines, especially bio-inputs, makes us totally dependent on imports. Even if the companies are on Brazilian soil, they need to use active products that are imported, because we do not have a technology park that can supply the technological deficiency that Brazil has, and this is structural”, he points out. To better understand the gap when comparing Brazil to other countries that have invested in this technology, the researcher cites the first prototyping center for bio-inputs that was opened in Latin America just three years ago. For him, biotechnology did not receive the same incentive that scientific development had when the São Paulo State Research Support Foundation (Fapesp) and the National Council for Scientific and Technological Development (CNPq), for example, were created. Professor Stabeli clarifies that there was investment in science and technology, but investment in industrial technology is insipient.

Investments in biotechnology can improve science in Brazil. Dr. Luciana Cezar de Cerqueira, who has extensive experience in the field of molecular biotechnology, with an emphasis on vaccine development, explains that science involves basic research and applied research, the latter containing biotechnology, which helps translate knowledge into products with population interest. For the researcher, the acquisition of competence in biotechnology is a continuous process due to the dynamics of the area, so the investment must be continuous. You cannot acquire this competence overnight, if it is not established, the investment will not resolve, she adds.

Professor at the Department of Cellular Biology and Genetics at the Federal University of Rio Grande do Norte (UFRN) Lucymara Fassarella, who is also the general coordinator of the Northeast Biotechnology Network (Renorbio), notes that Brazil has a strong academic base, excellent researchers, well-established graduate programs, that is, in terms of human resources, the country has a reasonable critical mass. “We have good scientific production, we are the main producer of scientific knowledge in Latin America, although we are still distant from countries like the United States, some countries in Europe or Asia, but I see that the greatest deficiency occurs between academia and the private sector”, she stresses.

For the general coordinator of Renorbio, there is a lack of dialogue instruments, strategies of approximation, so that the demands of the private sector reach universities so that they can also participate in the development of new products and inputs. “But there is also a lack of a private sector insight on the importance of investment in research, which starts with basic research. The private sector still provides few resources for the basic development of research”, laments Dr. Fassarella. The teacher recalls the difference in investment in Science and Technology practiced in Brazil when mentioning that we are far behind, in terms of Gross Domestic Product (GDP), of countries like Korea, China, United States. “This is undoubtedly one of the main reasons why we are not so competitive. Investment is fundamental and we have been going through a period of decreased investments, which is extremely harmful to Brazilian research institutions. Many researchers are without resources to work due to the contingencies that have occurred”, she concludes.

Brazil without autonomy

The companies that grew the most in the last ten years were those that invested in recombinant DNA technology and bio inputs for the production of antibodies. Unfortunately, we did not have this investment in Brazil. According to Stabeli, we have great scientists who can manipulate the workbench, but we dont have enough equipment to transform it into production, which is also reflected in vaccines. And at this point, the researcher is categorical when stating that vaccine resources are investments and not expenditures. A country that thinks about health technology is a country that seeks the social well-being of its citizens and that is an investment, not an expense. For him, a strong Brazilian industry, with sufficient health technology, will also bring the countrys enrichment. If we want to have a sovereign and developed nation, we need to invest in technologies that make our research leave the bench and reach the industrial sector, she emphasizes.

Dr. Fassarella admits the existing bottlenecks in the development of medicines, research for new drugs and the great dependence on inputs that are often imported. According to her, this problem is not restricted only to vaccine production, but for everyone who works with molecular biology or biotechnology. The professor reinforces that the lack of production of inputs in Brazil makes the research dependent on other centers that produce reagents for molecular biology. We have institutes such as Butantã and Fiocruz with a long tradition in the production of vaccines, that is, technical and production capacity exists in the country, she says.

To get an idea, Brazil is so dependent on the technological production of vaccines or monoclonal antibodies that it often needs to buy water at an injectable level. Ninety percent of what is used in medical technology is now imported, that is, it is a deficit in the trade balance of 20 billion dollars. For Dr. Stabeli,Brazil must look at health as an economic and industrial complex. The health industrial economic complex is one of the most profitable industries in the world. Profitable in the sense of developing a nation, she adds. And the pandemic has shown this importance to the world. Countries that have technologies have managed to provide an answer both in the packaging and in the production of vaccines and are reducing the number of hospitalizations and deaths due to COVID-19. This shows how important it is to have health technology available.

Dr. Cerqueira Leite, who was once deputy director of Fundação Butantã, director of the Biotechnology Center and director of the Institutes vaccine development laboratory, recognizes that Brazil has a high established competence in basic science and some phases of vaccine development, such as phase of clinical trials and production of some immunobiologicals. However, there is a gap in the development phases involving biotechnology, where the competence to carry out the research necessary for scheduling processes and obtaining products with the quality control necessary to start clinical trials is still incipient. Also according to Dr. Cerqueira Leite, biotechnology in Brazil is restricted and certainly not enough to support the basic and applied research carried out. “Many inventions are lost because there is no way to proceed to the next steps. Brazil has some competence in biotechnology, but the investment required in this area is greater than in the basic areas. The phases of low investment mean the loss of the established competence and the previous investment”, she highlights when saying that the technology development process involves countless skills, some of which are lacking in Brazil.

Brazil currently does not have a clear policy in strategic sectors. In the past, the National Plan for Self-Reliance in Immunobiologicals has boosted the entire area of biotechnology and drug production, including the field of vaccine development. “But currently, all investment in the area of research and development has been reduced. This goes against the grain of most countries, which have already realized that without a strong innovation sector, an economy cannot be sustained, points out the researcher. The countries that are managing to produce the vaccines, including the developing countries of the BRICS, China, India and Russia, are those that have an investment policy in these strategic sectors, including in Biotechnology.

Biotechnology in Health

Opening in 2023, the Industrial Biotechnology in Health Complex of the Institute of Technology in Immunobiologicals (Bio-Manguinhos) will be the largest center for the manufacturing of biological products in Latin America and one of the most modern in the world. The site will have a production capacity of 120 million vials of vaccines and biopharmaceuticals per year. It will be responsible for all vaccine production at Fiocruz, including thd vaccine against COVID-19. Vaccines against meningitis, hepatitis and bacterial triple, which are currently imported, will also be produced in the complex.

Currently, Brazil has 574 biotechnology companies, among startups and mature, national and multinational, according to the Biotec Map, released by the open platform Profissão Biotec. The data reveal the disproportionate concentration of research centers, the basis for the implantation of biotechnology companies, in relation to the regions: There are 381 in the Southeast; 113 in the South; 45 in the Midwest; 27 in the Northeast; 8 in the North. Established companies range from the environmental area to bioenergy, from inputs to animal health, in addition to the broad sectors of agriculture and the food industry. The sector of activity “Human Health and Wellness”, for example, includes companies that develop technologies, produce and market biological medicines, diagnostic kits, recombinant proteins, prostheses, specialized medical devices and equipment, cell therapies, dressings and artificial skins and/or vaccines to treat humans. Analysis laboratories that have molecular techniques are contemplated, in addition to companies with Research and Development in the area, such as identification of new molecules and drugs, validation of new drugs (pre-clinical and clinical trials). Also contemplated are companies in the cosmetic or personal hygiene area that obtain/modify potential molecules from bioprocesses through the use of live microorganisms or part of them and that have research centers in the area of Biotechnology.

Biotechnology is extremely present in the development of instruments for diagnosis, prognosis and often even treatment of diseases. It is a revolutionary technique, a powerful tool that enabled technological discoveries in various industrial areas and in sectors of science with improvements and innovations. One of the impacts caused by the modern biotechnological revolution represented a significant change in the way modern vaccines are developed. In addition, research into the use of biotechnology in several areas, from vaccine production to drugs with fewer side effects, can provide more personalized medicine and more effective disease prevention.

The COVID-19 pandemic that led the rush of the pharmaceutical industries to new discoveries, clinical research, medicines and services, showed that Brazil needs to expand the biotechnology sector, because without autonomy, it has become a hostage to other countries. Without investment in science and technology, we will not reduce inequality. It will only decrease when we understand that the pillars for the development of a nation are based on education, science and technology. A country that does not invest in them is bound to be colonized by those who have the technology. This is what we see in Brazil until today: before, we exchanged our fruits, our gold, mirrors. Today we exchange our soy for vaccines. And this is very expensive for Brazil.