Biotechnology Regulation series – serie

Biotechnology has prompted a revolution in science and society in the truest sense of the word. For what superficially appears to be a revolution in biotechnology, in effect touches upon the fundamentals of life and the way in which humans relate to it. This book will make a significant contribution to the debate surrounding the effective regulation of biotechnology. The contributing authors assess how regulatory regimes can accommodate the many different and often conflicting issues to which biotechnology is giving rise to (including a very tainted public image). The book's ultimate aim is to explore ways of designing a regulatory regime that takes heed of these different demands whilst, at the same time, answering to the imperatives of effectiveness and efficiency.The book synthesizes three fields of legal analysis; the first focuses on the risk-dominated regulation of GM food and bio-agriculture; the second involves human genetics as a field dominated by considerations of ethics. Finally, patent law has been chosen as an area captured by notions of property.With its holistic approach, The Regulatory Challenge of Biotechnology will be of great interest to academics, policymakers and regulators as well as biotechnology and law students.

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.

This thoughtful book explores how EU law treats serious disagreements about the development and use of a radically new technology like genetic modification. Relevant EU laws are examined to analyze the room available, or possible, for public participation in the EU regulation of GMOs.Since linkages between law, technology and public contestations could have a crucial dimension in the shaping of democratic societies, the space that EU law provides for publics (outside of the scientific experts who shape the regulation of GMOs) becomes significant. By examining the employment of the precautionary principle and (advice from) public bioethics committees in GMO regulation, this book examines the policy claim that public participation as a regulatory mechanism represents and mediates public contestations about the use and regulation of GMOs.Biotechnology Regulation and GMOs will be of great interest to researchers, academics, students, policy advisors, decision-makers and other professionals involved in the fields of law, biotechnology, innovation systems, science and technology policy, as well as development. Federal regulators and industry representatives will also find much to interest them in this detailed study.Contents: 1. Introduction 2. The EU Legal Framework for GMO Regulation 3. Risk, Science and Society 4. Precaution, Public Participation and Technocratic Responses 5. Participation in Safety and Public Morals Regulation Ambit in Global Rules 6. Public Contestations and Pursuit of Public Values Index