Biotechnology And International Law

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.

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.

"The Intersection of International Law, Agricultural Biotechnology, and Infectious Disease" examines legal frameworks and perspectives for infectious disease and GMOs and argues for a more connective approach for future regulation.

Wer haftet, wenn sich selbst ausbreitende Gentechnik grenzüberschreitende Schäden verursacht? Mit Gene Drives und ähnlichen Verfahren wird es bald möglich sein, das Erbgut wild lebender Arten, Keime und Nutzpflanzen direkt in der Umwelt zu verändern. Dies könnte helfen, drängende Probleme in der öffentlichen Gesundheit, im Naturschutz und in der Ernährungssicherheit zu lösen. Allerdings bergen diese Verfahren auch das Risiko einer unkontrollierten Ausbreitung über Staatsgrenzen hinweg. Anhand einer grundlegenden Untersuchung der einschlägigen Verträge und des Völkergewohnheitsrechts zu Prävention und Haftung für grenzüberschreitende Schäden wird aufgezeigt, dass das derzeit geltende Völkerrecht dieser Herausforderung noch nicht gewachsen ist.

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.

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.

ÔThis book provides a clear analysis of the multi-level impacts of the existing international law regime related to genetic resources on developing countries. It does so through a cogent exposition of the different areas of the law pertaining to genetic resources that are relevant and impact on people's rights and livelihoods. Its focus on equity is a welcome addition to the literature.Õ Ð Philippe Cullet, University of London, UK ÔCamena GuneratneÕs thought-provoking book critically evaluates the clash between the private property approach to genetic resources embedded in international intellectual property conventions, and the competing values embedded in a variety of other conventions and laws. She contests key assumptions behind intellectual property regimes supporting genetic commerce, distinguishing the genetic ÒcommonsÓ from other types of resource. This book provides a comprehensive scholarly dealing with the topics noted in its title, but also should increase debate about policy failures in responding to the risks to the underprivileged of the instruments we use to pursue our economic interests of the majority.Õ Ð Paul Martin, University of New England, Australia ÔThis is a wonderful book. All too often in the quest to preserve biodiversity, we forget that the equation of equity has to be at the forefront of the debates on sustainable development. Dr Guneratne rectifies this mistake. In doing so, she shows us that in many of the most importance instances, we are not only losing large parts of the natural basis on which humanity depends, but also the ability to control the political and legal processes of which many of the world's poorest people depend. This linkage between biodiversity, politics and international law is of such a high calibre, that it is likely that this work will become a key text for students and scholars alike.Õ Ð Alexander Gillespie, University of Waikato, New Zealand This book examines current developments in international law which regulate the uses of plant genetic resources for food and agriculture, and the various property regimes which are applied to these resources by these international agreements. In the current context of the global food crisis, the development and stability of national agricultural systems is an urgent concern, particularly among developing countries. This stability, and national food security, will potentially be threatened if these countries are unable to have free access to agricultural crop plants. This book analyses a range of international agreements including the recently adopted Nagoya Protocol and demonstrates that in their current implementation they favour private ownership of these resources rather than free access. The book takes the position that this is inherently inequitable and these resources should be maintained in the public domain. This book will be of use to a wide range of readers from students and scholars to those working in the fields of trade and intellectual property, human rights, environmental conservation and advocacy on international issues. It contains a rigorous legal analysis of current international law development on the issue based on the negotiations which have taken place in the relevant forums, and will therefore be particularly useful to lawyers and legal scholars. It is also written in an uncomplicated style which makes it readily accessible to non-lawyers and the case studies and empirical data used throughout the book adds to its interest.

This casebook addresses a broad range of issues in many areas of law which are affected by recent advances in biotechnology. The book seeks to examine the law and the underlying science and policy of biotechnology in addressing these issues. This interdisciplinary book will include biotechnology issues in biologically engineered plants and foods, genetically engineered organisms, cloning, DNA, the Human Genome Project, patenting, property law, criminal law, evidence, and international aspects of law and biotechnology. The governmental management of these issues through the Executive Branch, the Legislative Branch and the Judicial Branch, as well as the private sector interaction, is examined. Several appendices are included in the casebook, which are useful reference tools for the student or the practitioner.