Preparing for Future Products of Biotechnology
Preparing for Future Products of Biotechnology

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-07-28

Total Pages: 231

ISBN-13: 0309452058

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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.

Animal Biotechnology
Animal Biotechnology

Author: National Research Council

Publisher: National Academies Press

Published: 2002-11-29

Total Pages: 200

ISBN-13: 030916933X

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Genetic-based animal biotechnology has produced new food and pharmaceutical products and promises many more advances to benefit humankind. These exciting prospects are accompanied by considerable unease, however, about matters such as safety and ethics. This book identifies science-based and policy-related concerns about animal biotechnologyâ€"key issues that must be resolved before the new breakthroughs can reach their potential. The book includes a short history of the field and provides understandable definitions of terms like cloning. Looking at technologies on the near horizon, the authors discuss what we know and what we fear about their effectsâ€"the inadvertent release of dangerous microorganisms, the safety of products derived from biotechnology, the impact of genetically engineered animals on their environment. In addition to these concerns, the book explores animal welfare concerns, and our societal and institutional capacity to manage and regulate the technology and its products. This accessible volume will be important to everyone interested in the implications of the use of animal biotechnology.

Biotechnology and the Law
Biotechnology and the Law

Author: Hugh B. Wellons

Publisher: American Bar Association

Published: 2007

Total Pages: 1016

ISBN-13: 9781590317617

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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.

The International Law of Biotechnology
The International Law of Biotechnology

Author: Matthias Herdegen

Publisher: Edward Elgar Publishing

Published:

Total Pages: 203

ISBN-13: 1786435969

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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.

Regulation of Genome Editing in Plant Biotechnology
Regulation of Genome Editing in Plant Biotechnology

Author: Hans-Georg Dederer

Publisher: Springer

Published: 2019-08-16

Total Pages: 379

ISBN-13: 3030171191

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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.

Economic Regulation and Its Reform
Economic Regulation and Its Reform

Author: Nancy L. Rose

Publisher: University of Chicago Press

Published: 2014-08-29

Total Pages: 619

ISBN-13: 022613816X

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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.

EU Regulation of GMOs
EU Regulation of GMOs

Author: Maria Lee

Publisher: Edward Elgar Publishing

Published: 2009-01-01

Total Pages: 297

ISBN-13: 184844396X

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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.

Understanding Biotechnology Law
Understanding Biotechnology Law

Author: Gale R. Peterson

Publisher: CRC Press

Published: 1993-05-27

Total Pages: 502

ISBN-13: 9780824789350

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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.

Biotechnology and International Law
Biotechnology and International Law

Author: Francesco Francioni

Publisher: Bloomsbury Publishing

Published: 2006-06-15

Total Pages: 486

ISBN-13: 1847312691

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As with any rapid technological development, the biotechnology revolution is putting great strains on the ability of law to adapt to new challenges and threats. Although there is general agreement on the need to regulate biotechnology in many different fields of human activity (agriculture, life sciences, forensic science) domestic law remains deeply divided over the best approach to take. This book is the first attempt at covering the most pressing legal issues raised by the impact of biotechnologies on different categories of international norms. Through the contribution of a selected group of international scholars and experts from international organizations, the book addresses 1) the international status of genetic resources, both in areas of national jurisdiction and in common spaces such as the international sea bed area and Antarctica; 2) the relevance of environmental principles in the governance of modern biotechnologies; 3) the impact of biotechnologies on trade rules, including intellectual property law; 4) the human rights implications, especially in the field of human genetics; and 5) the intersection between general international law and regional systems, especially those developed in Europe and Latin America. The overall objective of the book is to provide an up-to-date picture of international law as it stands today and to stimulate critical reflection and further research on the solutions that will be required in years to come.