Transgênicos - Plantas Produtoras de Fármacos (PPF) / Trangenics - Plant-Based Drugs (PBD)

Plant-Based Drugs - PBD - represent the 4th generation of genetically-modified plants and in this case the technology is used to develop and produce pharmaceuticals vaccines and/or products from transgenic seeds. This technology, like all scientific innovations, has inherent risks. However, the current knowledge available about the use of this technology means that no firm conclusions can be drawn about the nature of the risks involved, as well as their significance and the likelihood of causing serious damage or not. Risk analysis should be the starting premise prior to any implementation of techno-scientific innovations. The parameters must be evaluated and precautions taken and research must be conducted in a detailed and broad-ranging manner with respect to the potential risks of any innovation. This article analyzed the applicability of this new technology, as well as risk management and containment in order to guarantee safe use, handling and consumption by human beings.

As Plantas Produtoras de Fármacos (PPF) representam a 4ª onda de vegetais geneticamente modificados. Neste caso, com a tecnologia sendo empregada para desenvolver e produzir vacinas e/ou produtos farmacêuticos, a partir de plantas transgênicas. Esta tecnologia, como todas as inovações científicas, vem acompanhada de riscos. Porém, o conhecimento atual disponível sobre seu uso não permite ainda conclusões definitivas sobre o caráter dos riscos, sua significância e sua probabilidade de causar, ou não, sérios danos. A análise de risco deve servir de base para a implementação de inovações tecnocientíficas. Os parâmetros devem ser avaliados, precauções especiais devem ser tomadas, a pesquisa deve ser conduzida de forma detalhada e também precisa ter amplo alcance quanto aos riscos potenciais por ser uma inovação. O presente artigo revisou a aplicabilidade desta nova tecnologia com relação ao gerenciamento do risco e a uma contenção que vise a segurança de uso, a manipulação e o comércio para os seres humanos.

Intellectual property rights related to the genetically modified glyphosate tolerant soybeans in Brazil

The present work analyzes the different modalities of protection of the intellectual creations in the biotechnology agricultural field. Regarding the Brazilian legislations related to the theme (the Industrial Property Law - no. 9. 279/96 and the Plant Variety Protection Law - no. 9. 456/97), and based in the international treaties signed by Brazil, the present work points to the inclusions of each of them, as well as to their interfaces using as reference the case study of glyphosate tolerant genetically modified soybean. For this case study, Monsanto's pipelines patents were searched and used to analyze the limits of patent protection in respect to others related to the Intellectual Property (IP) laws. Thus, it was possible to elucidate the complex scenario of the Intellectual Property of the glyphosate tolerant soybeans, since for the farmer it is hard to correlate the royalties payment with the IP enterprise's rights.

O presente trabalho analisa as diferentes modalidades de proteção das criações intelectuais no campo da biotecnologia agrícola. A partir das leis Brasileiras relacionadas ao tema (Lei da Propriedade Industrial - nº 9.279/96 e Lei da Proteção de Cultivares - nº 9.456/97), e com base nos tratados internacionais assinados pelo Brasil, o presente trabalho aponta as inclusões de cada uma, assim como, suas interfaces usando como referência o estudo de caso da soja geneticamente modificada para tolerância ao glifosato. Para este caso, patentes pipelines da Monsanto foram buscadas e usadas para analisar os limites de proteção das patentes frente às outras leis de Propriedade Intelectual (PI) relacionadas. Assim, foi possível elucidar o cenário complexo da Propriedade Intelectual das sojas tolerantes ao glifosato, já que para o agricultor não é fácil correlacionar o pagamento dos royalties com os direitos de PI da empresa.

Bacillus thuringiensis (Bt) transgenic crop: an environment friendly insect-pest management strategy.

Introduction of DDT (dichloro-diphenyl-trichloroethane) and following move towards indiscriminate use of synthetic chemical insecticides led to the contamination of water and food sources, poisoning of non-target beneficial insects and development of insect-pests resistant to the chemical insecticides. Increased public concems about the adverse environmental effects of indiscriminate use of chemical insecticides prompted search of altemative methods for insect-pest control. One of the promising alternatives has been the use of biological control agents. There is well-documented history of safe application of Bt (B. thuringiensis, a gram positive soil bacterium) as effective biopesticides and a number of reports of expression of delta-endotoxin gene(s) in crop plants are available. Only a few insecticidal sprays are required on Bt transgenic crops, which not only save cost and time, but also reduce health risks. Insects exhibit remarkable ability to develop resistance to different insecticidal compounds, which raises concern about the unsystematic use of Bt transgenic technology also. Though resistance to Bt products among insect species under field conditions has been rare, laboratory studies show that insects are capable of developing high levels of resistance to one ormore Cry proteins. Now it is generally agreed that 'high-dose/refuge strategy' is the most promising and practical approach to prolong the effectiveness of Bt toxins. Although manybiosafety concerns, ethical and moral issues exist, area under Bt transgenic crops is rapidly increasing and they are cultivated on more than 32 million hectares world over Even after reservation of European Union (EU) for acceptance of geneticaly modified (GM) crops, 6 out of 25 countries have already adopted Bt crops and many otherindustrial countries will adopt Bt transgenic crops in near future. While the modem biotechnology has been recognized to have a great potential for the promotion of human well-being, adoption of biosafety protocol is necessary to protect human health and environment from the possible adverse effects of the products of genetic engineering. The debate between proponents and opponents of GM technology has created major obstacles in hamessing benefits of the technology It has now become clear that transgenics willbe accepted by the public only when doubts related with general risks and environmental safety are adequately dispelled. Thus, there is need to organize public awareness and present the benefits of Bt transgenic crops to improve social attitude for their rational deployment. In this review, an attempt has been made to discuss social and environmental safety issues of Bt transgenic crops.

Bioética, cuerpo y mercado

Antes de la formidable evolución que en tiempos recientes ha experimentado la biología y en especial las ciencias médicas, la posibilidad de realizar actos de disposición o contratos sobre el cuerpo humano y sus partes parecía una hipótesis de academia. El carácter sagrado de la persona arrastraba a su soporte material. Ahora, el panorama sufre un cambio sustancial al impactar sobre el cuerpo, sus partes y sus productos, los recientes avances científi cos y su correlativa valoración en otros campos, lo que impone la necesidad de adoptar nuevos criterios tanto en el ámbito jurídico como en el ético respecto a la disponibilidad y la comercialidad del cuerpo, sus partes –por minúsculas que fueren- y sus productos. Para introducir en el debate la nueva realidad basta con referirnos a temas tan relevantes como el trasplante de órganos y tejidos, la utilización de seres humanos en la investigación científi ca, el alquiler de úteros para concebir un ser en cuya conformación genética no interviene la “madre de alquiler”, las posibilidades abiertas con la fecundación médica asistida y el patentamiento de partes del cuerpo humano, incluyendo un gen o una secuencia parcial del mismo, embriones, células madres, líneas celulares, etc. Jamás, excepto durante el período de la esclavitud y la servidumbre se había transformado al cuerpo humano en mercancía en tan amplia escala. Estas situaciones respecto a cuya frecuencia no es necesario extenderse crean para la bioética un conjunto de problemas y dilemas de muy compleja elaboración y solución.