Hans-Georg Dederer – författare

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.

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.

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.

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 retard product approval and impede R&D. Accordingly, national regulations for therapies based on genome-edited iPS cells are an important and, as the case may be, decisive factor for both researchers and industry regarding their decision where to locate their R&D activities. Therefore, regulatory frameworks impact significantly on the competitiveness of states and their economies. This is why a comparative analysis of laws and regulations of different countries matters. Such a comparative legal analysis provides an important insight into regulatory concepts which, in turn, may inspire adjustments of, or amendments to, domestic legal regimes. For this purpose, experts present country reports on France, Germany, Japan, South Korea, Switzerland, and the USA. The reports on France and Germany also refer to the parameters and implications arising from pertinent EU law. This contributed volume is aimed at researchers, but also at, e.g., legal scholars, lawmakers, regulators, and political decision makers.

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.

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.

Die Regulierung neuartiger Technologien erfolgt typischerweise unter der Bedingung, dab Erfahrungswissen uber mogliche Schadensablaufe (noch) nicht vorhanden ist. Exemplarisch wird die Regulierung der absichtlichen Freisetzung gentechnisch veranderter Organismen in die Umwelt in Deutschland und den USA dargestellt, insbesondere ihre Steuerung durch das Verfassungsrecht.

Private Interessenorganisationen sind auf staatliche Veranlassung hin bisweilen so eng mit den Staatsfunktionen der Gesetzgebung, Vollziehung und Rechtsprechung verflochten, daß die privat organisierten Interessen bzw. deren Vertreter die Ausübung dieser staatlichen Funktionen (mit-)steuern. Hans-Georg Dederer untersucht u.a. das zentrale Problem, das sich dabei stellt: die demokratische Legitimation dieser "korporativen Staatsgewalt". Als das normativ effektivste Legitimations- und Steuerungsinstrument vermag das Parlamentsgesetz neben funktioneller, organisatorischer, prozeduraler und inhaltlicher Legitimation insbesondere auch personelle Legitimation zu vermitteln. Um ein hinreichendes Legitimationsniveau zu erreichen, bedürfen konkrete Formen korporativer Staatsgewalt regelmäßig parlamentsgesetzlicher Steuerung dessen, was im Lichte des Demokratie- und des Rechtsstaatsprinzips in Bezug auf die jeweilige konkrete Form korporativer Staatsgewalt 'wesentlich' ist. Wesentlich sind beispielsweise die Sicherung hinreichender Interessenpluralität, die tendenziell vollständige Auswahl der zu repräsentierenden Interessen und der für diese Interessen repräsentativen privaten Interessenorganisationen oder die Merkmale für Eignung und Befähigung der Interessenvertreter.