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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.
This book follows and complements the previous volume Biotechnology and International Law (Hart 2006) bringing a specific focus on human rights. It is the result of a collaborative effort which brings together the contributions of a select group of experts from academia and from international organisations with the purpose of discussing the extent to which current activities in the field of biotechnology can be regulated by existing human rights principles and standards, and what gaps, if any, need to be identified and filled with new legislative initiatives. Instruments such as the UNESCO Declaration on the Human Genome (1997) and on Bioethics and Human Rights (2005) are having an impact on customary international law. But what is the relevance of these instruments with respect to traditional concepts of state responsibility and the functioning of domestic remedies against misuse of biotechnologies? Are new legislative initiatives needed, and what are the pros and cons of a race toward the adoption of new ad hoc instruments in an area of such rapid technological development? Are there risks of normative and institutional fragmentation as a consequence of the proliferation of different regulatory regimes? Can we identify a core of human rights principles that define the boundaries of legitimate uses of biotechnology, the legal status of human genetic material, as well as the implications of the definition of the human genome as 'common heritage of humanity' for the purpose of patenting of genetic inventions? These and other questions are the focus of a fascinating collection of essays which, together, help to map this emerging field of inquiry.
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.
An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology provides a comprehensive look at the biggest technologies that have revolutionized biology since the early 20th century, also discussing their impact on society. The book focuses on issues related to bioethics, biosafety and intellectual property rights, and is written in an easy-to-understand manner for graduate students and early career researchers interested in the opportunities and challenges associated with advances in biotechnology. Important topics covered include the Human Genome Project, human cloning, rDNA technology, the 3Rs and animal welfare, bioterrorism, human rights and genetic discrimination, good laboratory practices, good manufacturing practices, the protection of biological material and much more. Full of relevant case studies, practical examples, weblinks and resources for further reading, this book offers an essential and holistic look at the ways in which biotechnology has affected our global society. - Provides a comprehensive look at the ethical, legal and social implications of biotechnology - Discusses the global efforts made to resolve issues - Incorporates numerous case studies to more clearly convey concepts and chart the development of guidelines and legislation regulating issues in biotechnology - Takes a straightforward approach to highlight and discuss both the benefits and risks associated with the latest biotechnologies
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.
This book offers a valuable contribution to contemporary legal literature, providing deep insights into the interface between law and genetics, highlighting emerging issues and providing meaningful solutions to current problems. It will be of interest to a broad readership, including academics, lawyers, policy makers and scholars engaged in interdisciplinary research. In the context of examining and analyzing the legal and social implications arising from the recent conjunction of biotechnology and intellectual property rights, the book particularly focuses on human genes and gene variations. Emphasis is placed on “patent law,” as a considerable percentage of genetic inventions are covered by patents. The book presents a comparative and critical examination of patent laws and practices related to biotechnology patents in the United States, Canada, European Union and India, in order to gather the common issues and the differences between them. The international patent approach regarding biotechnology is also analyzed in light of the constant conflict between differentiation and harmonization of patent laws. The book highlights the potential gaps and uncertainties as to the scope of numerous terms such as invention, microorganisms, microbiological processes, and essential biological processes under TRIPS. Also analyzed are the social and policy implications of patents relating to genetic research tools and genetic testing. The intricacies involved in providing effective intellectual property protection to bioinformatics and genomic databases are also examined. Bearing in mind the collaborative nature of bioinformatics and genomic databases, the book evaluates the pros and cons of open biotechnology and assesses the implications of extending intellectual property rights to human genetic resources, before explaining the ownership puzzle concerning human genetic material used in genetic research.
Biotechnology, Weapons and Humanity traces the historical development of biological weapons and considers the role of health care professionals, scientists, governments, and international agencies in limiting and managing the effects of new biological weapons. In particular, the strengths and weaknesses of the Biological and Toxin Weapons Convention are examined, and steps that can be taken to minimize the risk of the proliferation of weapons. This report considers whether new biological weapons, made possible by the mapping of the human genome, could be incorporated into the arsenals of states and terrorist organizations. How might the revolution in biotechnology be used to attack the genetic constitution of a national or ethnic group, or enhance the virulence of organizations hostile to human health?
The principal message of this book is that thermodynamics and statistical mechanics will benefit from replacing the unfortunate, misleading and mysterious term "entropy" with a more familiar, meaningful and appropriate term such as information, missing information or uncertainty. This replacement would facilitate the interpretation of the "driving force" of many processes in terms of informational changes and dispel the mystery that has always enshrouded entropy. It has been 140 years since Clausius coined the term "entropy"; almost 50 years since Shannon developed the mathematical theory of "information"--Subsequently renamed "entropy." In this book, the author advocates replacing "entropy" by "information," a term that has become widely used in many branches of science. The author also takes a new and bold approach to thermodynamics and statistical mechanics. Information is used not only as a tool for predicting distributions but as the fundamental cornerstone concept of thermodynamics, held until now by the term "entropy." The topics covered include the fundamentals of probability and information theory; the general concept of information as well as the particular concept of information as applied in thermodynamics; the re-derivation of the Sackur-Tetrode equation for the entropy of an ideal gas from purely informational arguments; the fundamental formalism of statistical mechanics; and many examples of simple processes the "driving force" for which is analyzed in terms of information.
Providing the first overview of Asia’s emerging biosciences landscape, this timely and important collection brings together ethnographic case studies on biotech endeavors such as genetically modified foods in China, clinical trials in India, blood collection in Singapore and China, and stem-cell research in Singapore, South Korea, and Taiwan. While biotech policies and projects vary by country, the contributors identify a significant trend toward state entrepreneurialism in biotechnology, and they highlight the ways that political thinking and ethical reasoning are converging around the biosciences. As ascendant nations in a region of postcolonial emergence, with an “uncanny surplus” in population and pandemics, Asian countries treat their populations as sources of opportunity and risk. Biotech enterprises are allied to efforts to overcome past humiliations and restore national identity and political ambition, and they are legitimized as solutions to national anxieties about food supplies, diseases, epidemics, and unknown biological crises in the future. Biotechnological responses to perceived risks stir deep feelings about shared fate, and they crystallize new ethical configurations, often re-inscribing traditional beliefs about ethnicity, nation, and race. As many of the essays in this collection illustrate, state involvement in biotech initiatives is driving the emergence of “biosovereignty,” an increasing pressure for state control over biological resources, commercial health products, corporate behavior, and genetic based-identities. Asian Biotech offers much-needed analysis of the interplay among biotechnologies, economic growth, biosecurity, and ethical practices in Asia. Contributors Vincanne Adams Nancy N. Chen Stefan Ecks Kathleen Erwin Phuoc V. Le Jennifer Liu Aihwa Ong Margaret Sleeboom-Faulkner Kaushik Sunder Rajan Wen-Ching Sung Charis Thompson Ara Wilson
As technological developments multiply around the globeâ€"even as the patenting of human genes comes under serious discussionâ€"nations, companies, and researchers find themselves in conflict over intellectual property rights (IPRs). Now, an international group of experts presents the first multidisciplinary look at IPRs in an age of explosive growth in science and technology. This thought-provoking volume offers an update on current international IPR negotiations and includes case studies on software, computer chips, optoelectronics, and biotechnologyâ€"areas characterized by high development cost and easy reproducibility. The volume covers these and other issues: Modern economic theory as a basis for approaching international IPRs. U.S. intellectual property practices versus those in Japan, India, the European Community, and the developing and newly industrializing countries. Trends in science and technology and how they affect IPRs. Pros and cons of a uniform international IPRs regime versus a system reflecting national differences.