Governing, Protecting, and Regulating the Future of Genome Editing PDF Download
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Author: Santa Slokenberga
Publisher: BRILL
ISBN: 9004526137
Category : Law
Languages : en
Pages : 319
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Book Description
This edited collection examines the ethical, legal, social and policy implications of genome editing technologies. Moreover, it offers a broad spectrum of timely legal analysis related to bringing genome editing to the market and making it available to patients, including addressing genome editing technology regulation through procedures for regulatory approval, patent law and competition law. In twelve chapters, this volume offers persuasive arguments for justifying transformative regulatory interventions regarding human genome editing, as well as the various legal venues for introducing necessary or desirable changes needed to create an environment for realizing the potential of genome editing technology for the benefit of patients and society.
Author: Santa Slokenberga
Publisher: BRILL
ISBN: 9004526137
Category : Law
Languages : en
Pages : 319
Get Book Here
Book Description
This edited collection examines the ethical, legal, social and policy implications of genome editing technologies. Moreover, it offers a broad spectrum of timely legal analysis related to bringing genome editing to the market and making it available to patients, including addressing genome editing technology regulation through procedures for regulatory approval, patent law and competition law. In twelve chapters, this volume offers persuasive arguments for justifying transformative regulatory interventions regarding human genome editing, as well as the various legal venues for introducing necessary or desirable changes needed to create an environment for realizing the potential of genome editing technology for the benefit of patients and society.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309452880
Category : Medical
Languages : en
Pages : 329
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Book Description
Genome editing is a powerful new tool for making precise alterations to an organism's genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions. Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.
Author: Alberto Asquer
Publisher: Frontiers Media SA
ISBN: 2832503918
Category : Social Science
Languages : en
Pages : 113
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Book Description
Author: The Royal Society
Publisher: National Academies Press
ISBN: 0309671132
Category : Medical
Languages : en
Pages : 239
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Book Description
Heritable human genome editing - making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy - raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues. Human embryos whose genomes have been edited should not be used to create a pregnancy until it is established that precise genomic changes can be made reliably and without introducing undesired changes - criteria that have not yet been met, says Heritable Human Genome Editing. From an international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.'s Royal Society, the report considers potential benefits, harms, and uncertainties associated with genome editing technologies and defines a translational pathway from rigorous preclinical research to initial clinical uses, should a country decide to permit such uses. The report specifies stringent preclinical and clinical requirements for establishing safety and efficacy, and for undertaking long-term monitoring of outcomes. Extensive national and international dialogue is needed before any country decides whether to permit clinical use of this technology, according to the report, which identifies essential elements of national and international scientific governance and oversight.
Author: Paul Enríquez
Publisher: Cambridge University Press
ISBN: 1108613624
Category : Law
Languages : en
Pages : 441
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Book Description
History will mark the twenty-first century as the dawn of the age of precise genetic manipulation. Breakthroughs in genome editing are poised to enable humankind to fundamentally transform life on Earth. Those familiar with genome editing understand its potential to revolutionize civilization in ways that surpass the impact of the discovery of electricity and the development of gunpowder, the atomic bomb, or the Internet. Significant questions regarding how society should promote or hinder genome editing loom large in the horizon. And it is up to humans to decide the fate of this powerful technology. Rewriting Nature is a compelling, thought-provoking interdisciplinary exploration of the law, science, and policy of genome editing. The book guides readers through complex legal, scientific, ethical, political, economic, and social issues concerning this emerging technology, and challenges the conventional false dichotomy often associated with science and law, which contributes to a growing divide between both fields.
Author: Lisa F. Clark
Publisher: Springer Nature
ISBN: 3031639170
Category :
Languages : en
Pages : 127
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Book Description
Author: Andrea Boggio
Publisher: Cambridge University Press
ISBN: 9781108718448
Category : Law
Languages : en
Pages : 0
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Book Description
The advent of the CRISPR/Cas9 class of genome editing tools is transforming not just science and medicine, but also law. When the genome of germline cells is modified, the modifications could be inherited, with far-reaching effects in time and scale. Legal systems are struggling with keeping up with the CRISPR revolution and both lawyers and scientists are often confused about existing regulations. This book contains an analysis of the national regulatory framework in eighteen selected countries. Written by national legal experts, it includes all major players in bioengineering, plus an analysis of the emerging international standards and a discussion of how international human rights standards should inform national and international regulatory frameworks. The authors propose a set of principles for the regulation of germline engineering, based on international human rights law, that can be the foundation for regulating heritable gene editing both at the level of countries as well as globally.
Author: Hans-Georg Dederer
Publisher: Springer
ISBN: 3030171191
Category : Law
Languages : en
Pages : 372
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Book Description
This book provides in-depth insights into the regulatory frameworks of five countries and the EU concerning the regulation of genome edited plants. The country reports form the basis for a comparative analysis of the various national regulations governing genetically modified organisms (GMOs) in general and genome edited plants in particular, as well as the underlying regulatory approaches.The reports, which focus on the regulatory status quo of genome edited plants in Argentina, Australia, Canada, the EU, Japan and the USA, were written by distinguished experts following a uniform structure. On this basis, the legal frameworks are compared in order to foster a rational assessment of which approaches could be drawn upon to adjust, or to completely realign, the current EU regime for GMOs. In addition, a separate chapter identifies potential best practices for the regulation of plants derived from genome editing.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309437385
Category : Science
Languages : en
Pages : 607
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Book Description
Genetically engineered (GE) crops were first introduced commercially in the 1990s. After two decades of production, some groups and individuals remain critical of the technology based on their concerns about possible adverse effects on human health, the environment, and ethical considerations. At the same time, others are concerned that the technology is not reaching its potential to improve human health and the environment because of stringent regulations and reduced public funding to develop products offering more benefits to society. While the debate about these and other questions related to the genetic engineering techniques of the first 20 years goes on, emerging genetic-engineering technologies are adding new complexities to the conversation. Genetically Engineered Crops builds on previous related Academies reports published between 1987 and 2010 by undertaking a retrospective examination of the purported positive and adverse effects of GE crops and to anticipate what emerging genetic-engineering technologies hold for the future. This report indicates where there are uncertainties about the economic, agronomic, health, safety, or other impacts of GE crops and food, and makes recommendations to fill gaps in safety assessments, increase regulatory clarity, and improve innovations in and access to GE technology.
Author: Kamel A Abd-Elsalam
Publisher: Elsevier
ISBN: 0443184453
Category : Technology & Engineering
Languages : en
Pages : 571
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Book Description
Global Regulatory Outlook of CRISPRized Plants summarizes CRISPR/Cas systems and applications for precise editing of plant genomes and discusses the global regulatory framework for CRISPR edited crops. While CRISPR technology has become a routine, cheap and an efficient method to generate edited crops with superior traits, how these crops will be regulated, will determine the future of this technology. Understanding the current state of regulation, the concerns, issues and foundations for decisions will be key in determining how this technology is used going forward. Global Regulatory Outlook of CRISPRized Plants highlights regulatory classification of CRISPR modifications such as SDN1, SDN2 and SDN3 and their global regulation. and discusses the social, ethical, governance, and policy issues related to CRISPR edited crops. This important summary will be vital to the successful commercialization of CRISPR technology and biosafety concerns associated with this technology. - Presents regulatory frameworks for CRISPR edited crops in the USA, Canada, Australia and New Zealand, Japan, EU, Africa, and Asia - Includes a specific chapter on global regulation of genetically engineered crops - Addresses public perception, social aspects, and ethical concerns that are impacting the commercialization of CRISPR edited crops
