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Rev. bioét. derecho ; (47): 5-15, nov. 2019. ilus
Artigo em Inglês | IBECS | ID: ibc-184862


DNA read and write technologies have accelerated biotechnology at an unprecedented pace. This enhanced capacity to engineer living beings has accelerated not only scientific research, but also the translation into novel therapies. New approved medicinal products include the correction of the diseased genome and synthetic enhancement to fight diseases. These practices are widely supported socially and scientifically. Applications beyond therapy have also be attempted. In 2018, researcher He Jiankui reported on the edition of human germline during the Second International Summit on Human Genome Editing. On the other hand, during the last years, there have also been attempts at somatic genetic enhancement without the provision of detailed outcomes. Reading and writing DNA empowers us to change our world, even ourselves. The social benefits may be enormous. We need to accelerate the debate, including the stakeholders, to foster a responsible use of these technologies and maximize the positive impact on society

Las tecnologías de lectura y escritura de ADN han acelerado la biotecnología a un ritmo sin precedentes. Esta capacidad mejora para diseñar seres vivos no solo ha acelerado la investigación científica, sino también la translación a terapias novedosas. Nuevos medicamentos aprobados incluyen la corrección del genoma enfermo y la mejora sintética para combatir las enfermedades. Estas prácticas son ampliamente apoyadas social y científicamente. También se han intentado aplicaciones más allá de la terapia. En 2018, el investigador He Jiankui informó sobre la edición de la línea germinal humana durante la Segunda Cumbre Internacional sobre la Edición del Genoma Humano. Por otro lado, en los últimos años también se han producido intentos de mejora genética somática. Leer y escribir ADN nos permite cambiar nuestro planeta, incluso cambiarnos a nosotros mismos. Los beneficios sociales

Les tecnologies de lectura i escriptura d'ADN han accelerat la biotecnologia a un ritme sense precedents. Aquesta capacitat millorada per dissenyar éssers vius no només ha accelerat la recerca científica, sinó també la translació a teràpies noves. Nous medicaments aprovats inclouen la correcció del genoma malalt i la millora sintètica per a combatre les malalties. Aquestes pràctiques són àmpliament recolzades social i científicament. També s'han intentat aplicacions més enllà de la teràpia. El 2018, l'investigador He Jiankui va informar sobre l'edició de la línia germinal humana durant la Segona Cimera Internacional sobre l'Edició del Genoma Humà. D'altra banda, en els últims anys també s'han produït intents de millora genètica somàtica. Llegir i escriure ADN ens permet canviar el nostre planeta, fins i tot canviar-nos a nosaltres mateixos. Els beneficis socials poden ser enormes. Necessitem accelerar el debat, incloent-hi les parts interessades a fi de fomentar un ús responsable d'aquestes tecnologies i maximitzar-ne l'impacte positiu en la societat

Humanos , Edição de Genes , Pesquisa Médica Translacional , Biologia Sintética/ética , Biotecnologia/ética , Biotecnologia/instrumentação , Biotecnologia/legislação & jurisprudência , Avaliação da Tecnologia Biomédica/legislação & jurisprudência
Health Secur ; 17(2): 83-99, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30942632


Understanding the overall biosecurity and biodefense policy landscape, the relationships between policies and their effects on each other, and the mechanisms for leveraging advances in science and technology to enhance defensive capabilities is crucial for ensuring that policy strategies address long-standing gaps and challenges. To date, policy analyses have been conducted primarily on single issues, which limits analyses of broader effects of policies, particularly after implementation. Here we describe the first-ever systems-based analysis of the US biosecurity and biodefense policy landscape to analyze functional relationships between policies, including examination of the unintended positive or negative consequences of policy actions. This analysis revealed a striking bifurcation of the US policy landscape for countering biological threats, with one grouping of policies focused on prevention of theft, diversion, or deliberate malicious use of biological sciences knowledge, skills, materials, and technologies (ie, biosecurity) and a second grouping on development of capabilities and knowledge to assess, detect, monitor, respond to, and attribute biological threats (ie, biodefense). An analysis of indirect effects demonstrated that policies within groups may result in mutual benefit, but policies in different groups may counteract each other, limiting achievement of the policy objectives in either group. The current policy landscape predominantly focuses on pathogens and toxins, having limited focus on rapidly changing biotechnologies with potential to positively contribute to biodefense capabilities or introduce unknown and/or unacceptable security risk. Based on our analyses, we present actions for implementing biosecurity and biodefense policy in the United States that intends to harness the benefits of science and technology while also minimizing potential risks. This article synthesizes and highlights the major findings and conclusions from the detailed analyses, which can be found in the full report ( ).

Bioterrorismo/prevenção & controle , Formulação de Políticas , Medidas de Segurança/legislação & jurisprudência , Biotecnologia/legislação & jurisprudência , Bioterrorismo/legislação & jurisprudência , Humanos , Análise de Sistemas , Estados Unidos
N Biotechnol ; 51: 49-56, 2019 Jul 25.
Artigo em Inglês | MEDLINE | ID: mdl-30779963


The comparatively low adoption rate of GMO products in the European Union (EU) market seems to be connected with the strictness of authorization regulations and inefficiency of the authorization process itself. These problems will apply to any product deemed to be a GMO that could potentially be marketable in the EU. Since modern methods of plant breeding involving oligonucleotide-directed mutagenesis (ODMs) or site-directed nucleases (SDNs), including Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), are becoming ever more popular, it is crucial to establish whether the products of such new breeding techniques (NBTs), in particular those which involve precise methods of mutagenesis, are exempted from the EU legislation on GMOs or not. Legal uncertainty as to their status may result in reluctance to invest in such methods and develop them further. Here, developments are presented in the legal classification of certain NBTs products in the context of recent decisions and jurisprudence. The socioeconomic aspects of GMO adoption in both global and European contexts are discussed. The legal and practical landscape of GMO regulation in the EU is presented and how it may pose an obstacle to investment and the development of new products. The latest jurisprudence (e.g., Case C-528/16) [1] on the interpretation of the legal concept of GMOs and the scope of the legislation are analyzed, with the conclusion that the strict regulations will probably also apply to products of the NBTs involving precise methods of mutagenesis. This in turn will probably result in the restriction of their application in the development of new plant varieties in the EU.

Biotecnologia/legislação & jurisprudência , Organismos Geneticamente Modificados/genética , Melhoramento Vegetal/legislação & jurisprudência , União Europeia
Nat Biotechnol ; 36(11): 1043-1047, 2018 11 09.
Artigo em Inglês | MEDLINE | ID: mdl-30412195


The reporting quality of patent landscapes is inadequate. The Reporting Items for Patent Landscapes (RIPL) checklist can improve reporting quality.

Biotecnologia/legislação & jurisprudência , Patentes como Assunto , Guias como Assunto/normas , Editoração/normas
Fordham Law Rev ; 87(1): 437-83, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30296034


Recent developments in gene-editing technology have enabled scientists to manipulate the human genome in unprecedented ways. One technology in particular, Clustered Regularly Interspaced Short Pallindromic Repeat (CRISPR), has made gene editing more precise and cost-effective than ever before. Indeed, scientists have already shown that CRISPR can eliminate genes linked to life-threatening diseases from an individual's genetic makeup and, when used on human embryos, CRISPR has the potential to permanently eliminate hereditary diseases from the human genome in its entirety. These developments have brought great hope to individuals and their families, who suffer from genetically linked diseases. But there is a dark side: in the wrong hands, CRISPR could negatively impact the course of human evolution or be used to create biological weaponry. Despite these possible consequences, CRISPR remains largely unregulated due to the United States's outdated regulatory scheme for biotechnology. Moreover, human embryo research, which is likely critical to maximizing the therapeutic applications of CRISPR, is not easily undertaken by scientists due to a number of federal and state restrictions aimed at preventing such research. This Note examines the possible benefits and consequences of CRISPR and discusses the current regulations in both the fields of biotechnology and human embryo research that hamper the government's ability to effectively regulate this technology. Ultimately, this Note proposes a new regulatory scheme for biotechnology that focuses on the processes used to create products using CRISPR, rather than the products themselves, with a focus on enabling ethical research using human embryos to maximize the potential benefits of CRISPR.

Biotecnologia/ética , Biotecnologia/normas , Sistemas CRISPR-Cas , Pesquisas com Embriões/ética , Edição de Genes/ética , Edição de Genes/normas , Regulamentação Governamental , Biotecnologia/legislação & jurisprudência , Pesquisas com Embriões/história , Pesquisas com Embriões/legislação & jurisprudência , Edição de Genes/legislação & jurisprudência , Regulamentação Governamental/história , História do Século XX , Humanos , Pesquisa com Células-Tronco/ética , Pesquisa com Células-Tronco/história , Pesquisa com Células-Tronco/legislação & jurisprudência , Estados Unidos