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Regulation of Genome Editing in Human iPS Cells
The book provides a concise overview of currently applicable regulatory frameworks of states which are among the world leaders in research and development (R&D) of cell and gene therapies. Developments in genome editing are expected to lead to new possibilities for the treatment of hereditary diseases in humans. The treatment of such often severe but hitherto uncurable diseases can be based on genome-edited induced pluripotent stem cells (iPS cells). Such treatments constitute combined cell/gene therapies. These therapies need to be governed by a regulatory framework which ensures quality, safety, and efficacy of the relevant therapeutic products. On the other hand, such regulations may reta...
Brain Organoids in Research and Therapy
This volume elucidates the pivotal ethical and legal issues arising from the use of brain organoids for research, therapeutic and enhancement purposes. The function of the human brain is still a mystery. Until recently, only post-mortem tissue was available for a structural examination of the brain. Consequently, the examination results could only reflect the state at the end of life. However, in order to better understand the development and function of the human brain, dynamic and functional investigations of different human brain cells are necessary. This is where brain organoids, artificially grown in vitro miniature brains, provide the opportunity for more flexible research scenarios. A...
Regulation of Genome Editing in Plant Biotechnology
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.
Contemporary Issues in Environmental Law
This book presents a variety of articles on contemporary issues in environmental law by eminent university professors of environmental law, international public law, European Union law, and comparative law in Europe and Japan. It is the first book in the field of environmental law based on the results of international conferences and research activities supported by the European Union delegation in Japan. Current essential and global topics such as principles of environmental law, climate change, biodiversity, ethics pertaining to animal rights , nuclear safety regime after Fukushima, environmental impact assessments, protecting international waters, genetically-modified organisms, and imple...
European Yearbook of International Economic Law 2011
Part one of Vol. 2 (2011) of the European Yearbook of International Economic Law adresses two major topics of current academic debate and public interest: firstly, it focuses on the State and the Global Economy, secondly, on Climate Change and International Economic Law. Part two contains treatises of recent regional integration developments taking place in the major regions of the world. Part three covers the legal and political developments in the major international organizations and fora dealing with international economic policy making. Part four contains book reviews of recent works in the field of International Economic Law.
Common Commercial Policy after Lisbon
Since the beginning of the process of European integration the EU Common Commercial Policy (CCP) has been one of the most dynamic political fields. The EU has achieved a leading role among the economic superpowers and is regarded as a single economic area in which the EU speaks also on behalf of its Member States for most aspects of external economic politics. This volume analyzes the implications of the Treaty of Lisbon for the Common Commercial Policy of the EU. The Lisbon Treaty has declared all matters concerning external commercial policy as exclusive competences of the EU. Which consequences does this have for the Member States of the EU? With regard to institutional modifications, the Lisbon Treaty has significantly strengthened the role of the European Parliament and has substantially changed the role of the ‘High Representative of the Union for Foreign Affairs and Security Policy’ (HR). Further topics of this volume are the new normative framework of the CCP, inter alia the linkage of the CCP to the general objectives for the EU’s external actions and its dependence on secondary legislation, as well as investment policy now being part of the CCP.
Genetic Technology and Food Safety
The volume gives an overview on how legislators all over the world have come up with different legal solutions for governing genetically modified organisms (GMOs) and food security and provides a compact summary of the existing regulations in this field. In a comparative legal approach, a general report analyses and compares these various national and supranational legal systems. It closely follows the newest developments at the interface between genetic engineering law and food law. The emergence of a new technology usually leads to fundamental questions as to how the law should respond to it. The regulation of genetically modified organisms is a prime example, they have been discussed cont...
Permanent Sovereignty over Natural Resources
Fifty years after the adoption of the Declaration on Permanent Sovereignty over Natural Resources by the General Assembly of the United Nations in December 1962, this volume assesses the evolution of the principle of permanent sovereignty over natural resources into a principle of customary international law as well as related developments. International environmental and human rights law leave unresolved questions regarding the limitations of this principle, e.g. extraterritorial and international influences such as the applicable criminal and tort law, as well as the extraterritorial and international promotion of good governance, including transparency obligations.
