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Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309452058
Category : Science
Languages : en
Pages : 231
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Book Description
Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309452058
Category : Science
Languages : en
Pages : 231
Get Book Here
Book Description
Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Author: Hugh B. Wellons
Publisher: American Bar Association
ISBN: 9781590317617
Category : Law
Languages : en
Pages : 1016
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Book Description
The book is written to help lawyers faced with the challenge of identifying the legal issues and processes that must be faced by their clients in building, marketing, and protecting a biotech business. The contributors are experts in this specialized area and provide thorough, yet accessible, overviews of biotech subspecialties with an eye to practical application. A biotech legal practice involves specialized subject matter and regulatory schemes that, generally, are not part of the business lawyer's repertoire and which can present many hazards for the uninitiated. Because of the expansion in biotech practice beyond the traditional organizations and their representatives, this guide was written to help lawyers find their way through the biotech maze.
Author: Hans-Georg Dederer
Publisher: Springer
ISBN: 3030171191
Category : Law
Languages : en
Pages : 379
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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: Matthias Herdegen
Publisher: Edward Elgar Publishing
ISBN: 1786435969
Category : Biotechnology
Languages : en
Pages : 203
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Book Description
Biotechnology is a field that inspires complex legal and ethical debates on an international scale. Taking a fresh approach to the subject, Matthias Herdegen provides a comprehensive assessment of the regulation of biotechnology processes and products from an international and comparative perspective.
Author: Nancy L. Rose
Publisher: University of Chicago Press
ISBN: 022613816X
Category : Business & Economics
Languages : en
Pages : 619
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Book Description
The past thirty years have witnessed a transformation of government economic intervention in broad segments of industry throughout the world. Many industries historically subject to economic price and entry controls have been largely deregulated, including natural gas, trucking, airlines, and commercial banking. However, recent concerns about market power in restructured electricity markets, airline industry instability amid chronic financial stress, and the challenges created by the repeal of the Glass-Steagall Act, which allowed commercial banks to participate in investment banking, have led to calls for renewed market intervention. Economic Regulation and Its Reform collects research by a group of distinguished scholars who explore these and other issues surrounding government economic intervention. Determining the consequences of such intervention requires a careful assessment of the costs and benefits of imperfect regulation. Moreover, government interventions may take a variety of forms, from relatively nonintrusive performance-based regulations to more aggressive antitrust and competition policies and barriers to entry. This volume introduces the key issues surrounding economic regulation, provides an assessment of the economic effects of regulatory reforms over the past three decades, and examines how these insights bear on some of today’s most significant concerns in regulatory policy.
Author: Michele Goodwin
Publisher:
ISBN: 9780820559858
Category : Bioethics
Languages : en
Pages : 0
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Book Description
With every new advancement in biotechnology, ethical and legal questions arise. Sometimes, those questions are easily addressed and settled. However, more often, these issues are not easily resolved and at times are left to the democratic process or markets to establish the boundaries of technological pioneering. In Biotechnology, Bioethics, and the Law, the authors canvass the broader fields, valleys, and pastures of biotechnology, providing mostly cases, but at times law review and medical journal articles to provide a comprehensive look at a given technology. Their goal is to encourage a critical engagement on the topics shared in the book, whether on cloning animals and plants for human consumption, drug regulation, or human reproduction and eugenics. Many of the cases contained in the book provide novel questions for judges. Some of these cases are the first impression for the courts, meaning that judges are attempting to learn the law in these new areas and develop its jurisprudence at the same time that the public -- or the reader -- are doing the same. As students read the cases, they are asked to consider whether they would reach the same conclusions as the courts. Are these issues better left to legislatures? Are markets the best forum for efficiently resolving biotechnological conundrums?
Author: Alison McLennan
Publisher: Edward Elgar Publishing
ISBN: 178536944X
Category : Business & Economics
Languages : en
Pages : 283
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Book Description
This book explores the interplay between regulation and emerging technologies in the context of synthetic biology, a developing field that promises great benefits, and has already yielded fuels and medicines made with designer micro-organisms. For all its promise, however, it also poses various risks. Investigating the distinctiveness of synthetic biology and the regulatory issues that arise, Alison McLennan questions whether synthetic biology can be regulated within existing structures or whether new mechanisms are needed.
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: Gale R. Peterson
Publisher: CRC Press
ISBN: 9780824789350
Category : Science
Languages : en
Pages : 502
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Book Description
Detailing the intellectual-property aspects of biotechnology law - from initial identification and reporting through licensing - this comprehensive reference explains the rules, regulations and procedures typically encountered by researchers in the development of their innovations.;Focusing on the fundamental legal concepts that should be understood by scientists, academicians and technicians working in the field, Understanding Biotechnology Law: considers the role of the inventor in the preparation of a patent application; describes the patent application process from discovery of an invention to issuance of a patent; discusses the law governing ownership of laboratory discoveries and products; examines intellectual-property policies, research agreements, consulting agreements, and conflicts of interest; presents the rules for determining inventorship; reviews patent infringement laws, including claim interpretation, literal infringement, and infringement under the doctrine of equivalents; and outlines modern license agreements, providing the principal terms encountered in biotechnology licenses.;Written by authorities in the field, Understanding Biotechnology Law is a reference for molecular and cell biologists, microbiologists, virologists, bioprocess technologists, biochemists, food scientists and technologists, pharmacologists, and pharmacists.
Author: Maria Lee
Publisher: Edward Elgar Publishing
ISBN: 184844396X
Category : Science
Languages : en
Pages : 297
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Book Description
Lee s book is a valuable addition to the literature for those wishing to broaden their understanding of the range of legal disciplines involved in GMO regulation. Tracey Epps, European Review of Agricultural Economics Maria Lee s work is a successful attempt to illustrate the big legal issues behind the regulation of genetically modified organisms (GMOs). This study, which is thorough and well documented, is particularly welcomed in view of the need for a dialogue between different legal specialisms for which GMOs are a relevant area of research. . . [The] book provides a very interesting and insightful examination of the legal problems raised by GMOs. I would warmly recommend its reading to academics and practitioners who are interested in European risk regulation law, environmental law, biotechnology and trade law. Sara Poli, European Law Review Genetically modified organisms (GMOs) are an extraordinary innovation. They raise great expectations of economic prosperity and improved capacity to address pressing problems of poverty and environmental degradation, whilst simultaneously raising great concerns about the type of social and physical world they promise. Finding space in regulation to consider the full range of issues provoked by GMOs is a huge challenge. This book explores the EU s elaborate regulatory framework for GMOs, which extends far beyond the process of their authorisation (or not) for the EU market, embracing disparate legal disciplines including intellectual property, consumer protection and civil liability. The regulation of GMOs also highlights questions of EU legitimacy in a context of multi-level governance, both internally towards national and local government, and externally in a world where technologies and their regulation have global impacts. This book will be of interest to academics and students in both law and social sciences, as well as practising lawyers and policy makers. It addresses questions that are significant for those involved in environmental or food issues, as well as specialists in GMOs.
