RESUMO
Background: The first live birth following the use of a new reproductive technique, maternal spindle transfer (MST), which is a mitochondrial replacement technique (MRT), was accomplished by dividing the execution of the MST procedure between two countries, the USA and Mexico. This was done in order to avoid US legal restrictions on this technique. Sources of data: Academic articles, news articles, documents obtained through freedom of information requests, laws, regulations and national reports. Areas of agreement: MRTs are new reproductive techniques that present novel ethical and legal challenges, since genetic material from three people is employed to create a child. Areas of controversy: Could the first MST procedure that culminated in a live birth negatively impact reproductive medicine in Mexico? Growing points: The USA and Mexico need specific and clear legislation on MRTs, in order for such techniques not to be governed by prior existing legislation on assisted reproduction that is inadequate for dealing with the new challenges that these techniques present. Areas timely for developing research: There is a pressing need for work to be done on the international governance of new reproductive techniques.
Assuntos
Engenharia Genética/ética , Doenças Mitocondriais/terapia , Terapia de Substituição Mitocondrial/ética , Temas Bioéticos , Ética Médica , Feminino , Engenharia Genética/legislação & jurisprudência , Humanos , México , Doenças Mitocondriais/genética , Terapia de Substituição Mitocondrial/legislação & jurisprudência , Pessoalidade , GravidezRESUMO
In the last few decades, genomic manipulation has made significant progress as a result of the development of recombinant DNA technologies; however, more often than not, these techniques have been costly and labor intensive. In contrast, recently developed next-generation sequencing (NGS) technologies have provided a cheaper, faster, and easier process to study genomics. In particular, an NGS technique emerged from bacterial CRISPR-associated protein-9 nuclease (Cas9) as a revolutionary method to modify, regulate, or mark specific genomic sequences on virtually any organism. A later adaptation of this bacterial defense mechanism that successfully and permanently edits dysfunctional genes and corrects missing proteins has resulted in a new era for disease genetic engineering. Clinical trials using this technique are already being performed, and the applicability of CRISPR-Cas9 techniques is actively being investigated using in vivo studies. However, the concept of genome correction poses great concerns from a regulatory perspective, especially in terms of security, so principles for the regulation of these methodologies are being established. We delved into CRISPR-Cas9 from its natural and ortholog origins to its engineered variants and behaviors to present its notable and diverse applications in the fields of biotechnology and human therapeutics.
Assuntos
Proteína 9 Associada à CRISPR/metabolismo , Engenharia Genética/legislação & jurisprudência , Proteínas de Bactérias/metabolismo , Sistemas CRISPR-Cas , Ensaios Clínicos como Assunto/legislação & jurisprudência , Engenharia Genética/métodos , Genoma Humano , Sequenciamento de Nucleotídeos em Larga Escala , Humanos , Mutação , Análise de Sequência de DNARESUMO
The UK was the first country to legalise mitochondrial donation in October 2015 (1). In 2016, the first three-parent baby was born in Mexico (2) and the US Food and Drug Administration declared that further research on mitochondrial donation is ethically permissible (3). It has now become an important issue, raising as it does, the spectre of "genetically modified designer babies".
Assuntos
Engenharia Genética/ética , Pesquisa em Genética/ética , Regulamentação Governamental , Doenças Mitocondriais , Terapia de Substituição Mitocondrial , Pais , Complicações na Gravidez , DNA Mitocondrial , Ética em Pesquisa , Feminino , Engenharia Genética/legislação & jurisprudência , Pesquisa em Genética/legislação & jurisprudência , Humanos , Índia , Lactente , México , Mitocôndrias , Princípios Morais , Gravidez , Reino Unido , Estados UnidosRESUMO
Gene editing technologies are a group of recent innovations in plant breeding using molecular biology, which have in common the capability of introducing a site-directed mutation or deletion in the genome. The first cases of crops improved with these technologies are approaching the market; this has raised an international debate regarding if they should be regulated as genetically modified crops or just as another form of mutagenesis under conventional breeding. This dilemma for policymakers not only entails issues pertaining safety information and legal/regulatory definitions. It also demands borrowing tools developed in the field of social studies of science and technology, as an additional basis for sound decision making.
Assuntos
Produtos Agrícolas/genética , Edição de Genes/métodos , Genoma de Planta/genética , Regulamentação Governamental , Melhoramento Vegetal/métodos , Biotecnologia/legislação & jurisprudência , Biotecnologia/métodos , Inocuidade dos Alimentos , Alimentos Geneticamente Modificados/normas , Edição de Genes/legislação & jurisprudência , Engenharia Genética/legislação & jurisprudência , Engenharia Genética/métodos , Melhoramento Vegetal/legislação & jurisprudência , Plantas Geneticamente Modificadas , Pesquisa , Fatores SocioeconômicosRESUMO
Soybean event DAS-444Ø6-6 is tolerant to the herbicides 2,4-D, glyphosate, and glufosinate. An investigation of potential unintended adverse compositional changes in a genetically modified crop is required to meet government regulatory requirements in various geographies. A study to meet these requirements in Brazil was completed demonstrating compositional equivalency between DAS-444Ø6-6 and non-transgenic soybean. This study supplements the extensive literature supporting transgenesis as less disruptive of crop composition compared with traditional breeding methods.
Assuntos
Biotecnologia/legislação & jurisprudência , Engenharia Genética/legislação & jurisprudência , Glycine max/efeitos dos fármacos , Resistência a Herbicidas , Herbicidas/farmacologia , Plantas Geneticamente Modificadas/efeitos dos fármacos , Ácido 2,4-Diclorofenoxiacético/farmacologia , Ácido 4-Acetamido-4'-isotiocianatostilbeno-2,2'-dissulfônico/análogos & derivados , Ácido 4-Acetamido-4'-isotiocianatostilbeno-2,2'-dissulfônico/farmacologia , Agricultura/legislação & jurisprudência , Aminobutiratos/farmacologia , Brasil , Cruzamento , Produtos Agrícolas , Glicina/análogos & derivados , Glicina/farmacologia , Glycine max/genética , GlifosatoRESUMO
"New Breeding Techniques" (NBTs) are a group of recent innovations in plant breeding using molecular biology tools. It is becoming evident that NBTs can introduce advantageous traits for agriculture that could be commercially available very soon However, there is still a need of clarifying its regulatory status, particularly in regards to worldwide regulations on Genetically Modified Organisms (GMOs). This article reviews the meaning of the NBTs concept, performs an overall regulatory analysis of these technologies and reports the first regulation in the world that is applied to these technologies, which was issued by the Argentine Government.
Assuntos
Agricultura/legislação & jurisprudência , Cruzamento/legislação & jurisprudência , Engenharia Genética/legislação & jurisprudência , Organismos Geneticamente Modificados , Agricultura/métodos , Agricultura/tendências , Argentina , Cruzamento/métodos , Engenharia Genética/métodos , Variação Genética , Regulamentação Governamental , SegurançaAssuntos
Animais Geneticamente Modificados/genética , Culicidae/genética , Engenharia Genética/legislação & jurisprudência , Controle de Mosquitos/métodos , Controle Biológico de Vetores/legislação & jurisprudência , Controle Biológico de Vetores/métodos , Animais , Vírus Chikungunya/genética , Ensaios Clínicos como Assunto , Dengue/prevenção & controle , Dengue/transmissão , Aprovação de Drogas , Florida , Política de Saúde , Humanos , Panamá , Estados Unidos , United States Food and Drug AdministrationRESUMO
The genetically modified (GM) common bean Embrapa 5.1 was recently approved for commercialization. The reliable detection and quantification of GM organisms is strongly dependent on validated methods as well as calibration systems. This work presents the development of a calibrant plasmid for Embrapa 5.1 common bean detection. The reaction parameters were determined and compared for both the plasmid DNA (pDNA) and the genomic DNA (gDNA). PCR efficiencies for pDNA were 81% for the construction-specific assays and 76% for the taxon-specific assay, whereas for gDNA efficiencies were 94 and 93%, respectively. The limits of detection (LOD) in both qPCR assays were 10(2) and 10(3) copies of gDNA and pDNA per PCR reaction, respectively. This is sufficient to detect 0.067 and 0.67% of GM common bean in 100 ng of DNA, respectively, which is in agreement with detecting the 1% GM content required by the Brazilian legislation.
Assuntos
DNA de Plantas/análise , DNA de Plantas/genética , Phaseolus/genética , Plantas Geneticamente Modificadas/genética , Plasmídeos/genética , Brasil , Calibragem , Engenharia Genética/legislação & jurisprudência , Limite de Detecção , Reação em Cadeia da Polimerase em Tempo Real/normasRESUMO
Plant-Based Drugs - PBD - represent the 4(th) 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.
Assuntos
Plantas Geneticamente Modificadas , Brasil , Indústria Farmacêutica , Engenharia Genética/legislação & jurisprudência , Plantas Geneticamente Modificadas/metabolismo , Proteínas Recombinantes/biossíntese , Gestão de RiscosRESUMO
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.
Assuntos
Plantas Geneticamente Modificadas , Brasil , Indústria Farmacêutica , Engenharia Genética/legislação & jurisprudência , Plantas Geneticamente Modificadas/metabolismo , Proteínas Recombinantes/biossíntese , Gestão de RiscosRESUMO
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.
Assuntos
Engenharia Genética/legislação & jurisprudência , Glycine max/genética , Glicina/análogos & derivados , Herbicidas/farmacologia , Propriedade Intelectual , Plantas Geneticamente Modificadas/genética , Brasil , Engenharia Genética/economia , Glicina/farmacologia , Resistência a Herbicidas/genética , Patentes como Assunto/legislação & jurisprudência , Plantas Geneticamente Modificadas/efeitos dos fármacos , Glycine max/efeitos dos fármacos , GlifosatoRESUMO
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.
Assuntos
Engenharia Genética/legislação & jurisprudência , Glicina/análogos & derivados , Herbicidas/farmacologia , Propriedade Intelectual , Plantas Geneticamente Modificadas/genética , Glycine max/genética , Brasil , Engenharia Genética/economia , Glicina/farmacologia , Resistência a Herbicidas/genética , Patentes como Assunto/legislação & jurisprudência , Plantas Geneticamente Modificadas/efeitos dos fármacos , Glycine max/efeitos dos fármacosAssuntos
Biotecnologia/tendências , Engenharia Genética/tendências , Segurança/legislação & jurisprudência , Agricultura/legislação & jurisprudência , Agricultura/tendências , Biotecnologia/legislação & jurisprudência , Brasil , Conservação dos Recursos Naturais , Engenharia Genética/legislação & jurisprudência , Humanos , Organismos Geneticamente ModificadosRESUMO
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.
Assuntos
Bioética , Bancos de Espécimes Biológicos , Biotecnologia/legislação & jurisprudência , Comércio , Corpo Humano , Experimentação Humana , Engenharia Genética/legislação & jurisprudênciaRESUMO
The autor analyses in detail the criminal regulation related to genetic manipulation with human cloning purposes in Perú.
Assuntos
Clonagem de Organismos/legislação & jurisprudência , Direito Penal , Engenharia Genética/legislação & jurisprudência , Humanos , PeruRESUMO
The article that one presents has for purpose outline and comment on the recent modifications to the Penal Code for the Federal District of México which establish, for the first time, crimes related to the artificial procreation and to the genetic manipulation. Also one refers to the interaction of the new legal texts with the sanitary legislation of the country. Since it will be stated in some cases they present confrontations between the penal and the sanitary reglamentation and some points related to the legality or unlawfulness of a conduct that stayed without the enough development. These lacks will complicate the application of the new rules of the Penal Code of the Federal District.