Informed consent is the legal instrument that purports to protect an individual’s autonomy and defends against medical arbitrariness. This illuminating book investigates our evolving understanding of informed consent from a range of comparative and international perspectives, demonstrating the diversity of its interpretations around the world. Chapters offer a nuanced analysis of the problems that impede the understanding and implementation of the concept of informed consent and explore the contemporary challenges that continue to hinder both the patient and the medical community. Learn More

With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking. Addressing pressing questions such as how do national biobanks best contribute to translational research and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research. Learn More

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. Learn More

This book explores the interplay between regulation and emerging technologies in the context of synthetic biology, a developing field that promises great benefits, and has already yielded fuels and medicines made with designer micro-organisms. For all its promise, however, it also poses various risks. Investigating the distinctiveness of synthetic biology and the regulatory issues that arise, Alison McLennan questions whether synthetic biology can be regulated within existing structures or whether new mechanisms are needed. Learn More

Intellectual property (IP) is a key component of the life sciences, one of the most dynamic and innovative fields of technology today. At the same time, the relationship between IP and the life sciences raises new public policy dilemmas. The Research Handbook on Intellectual Property and the Life Sciences comprises contributions by leading experts from academia and industry to provide in-depth analyses of key topics including pharmaceuticals, diagnostics and genes, plant innovations, stem cells, the role of competition law and access to medicines. The Research Handbook focuses on the relationship between IP and the life sciences in Europe and the United States, complemented by country-specific case studies on Australia, Brazil, China, India, Japan, Kenya, South Africa and Thailand to provide a truly international perspective. Learn More

This book constitutes a fascinating and in-depth analysis of the significance of the requirement of industrial application within gene patenting and how this influences innovation in Europe and the US. The author addresses an area normally overlooked in biotechnology patenting due to the predominance of the ethical debate, and in doing so produces a unique approach to dealing with concerns in this field. Learn More

One of the major shortcomings of the current drug discovery and development process is the inability to bridge the gap between early stage discoveries and pre-clinical research in order to advance innovations beyond the discovery phase. This book examines a drug discovery and development model, where the respective expertise of academia and industry are brought together to take promising discoveries through to proof of concept, providing a means to de-risk the drug discovery and development process. Learn More

As our understanding of genetics increases, its use in criminal justice becomes more attractive. This timely book examines the use of genetic information both in criminal investigations and during the trial process. It discusses current scientific understanding and considers some potential legal, ethical and sociological issues with the use of genetic information. Topics include rights of privacy and consent in obtaining DNA samples, evidentiary issues in court, the impact of genetic evidence on punishment theory and sentencing, and genetic discrimination. Learn More

In today’s technological world, biotechnology is one of the most innovative and highly invested-in industries for research, in the field of science. This book analyses the forms and limitations of patent protection recognition for biotechnological inventions, with particular regard to patentability of life. Learn More

This timely book investigates the concept of innovation and illustrates the crucial role that patent strategies play within processes of pharmaceutical innovation. Drawing on extensive country and company case studies, it identifies the key issues relevant to the revival of local pharmaceutical industries. Based on an understanding of the post-TRIPS environment and case studies of national innovation strategies, it specifically addresses an important question – to what extent can lessons from national experiences be transferred to current policy developments for innovation in the pharmaceutical industry in a developing country context? Learn More

The pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the problems, ranging from false advertising and counterfeiting to corruption waste and overpricing, with unacceptable pressures on doctors, politicians, patients and the media. Uniquely, the book goes on to present a realistic and worldwide solution for the future, with positive policies encouraging honest dealing as well as partial privatization of enforcement and greater emphasis on creative research to develop the medicines that society needs most. Learn More

This book examines the EU regulatory framework in the Genetic Modification of agriculture and food to see how adequately EU law treats serious contestations about the development and use of GMOs. Since linkages between law, technology and public contestations could have a crucial dimension in the shaping of democratic societies, the space EU law provides for publics outside of the scientific experts to shape the regulation of GMOs becomes significant. By examining the employment of the precautionary principle and (the advices from) public bioethics committees in GMO regulation, this book examines the policy claim of public participation as a mechanism to represent and mediate public contestations about the use and regulation of GMOs. Learn More

Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Learn More

The new millennium has carried several challenges for patent law. This up-to-date book provides readers with an important overview of the most critical issues patent law is still facing today at the beginning of the twenty first century, on both sides of the Atlantic. Learn More

This book provides a detailed and comparative examination of medical patent law and the issues at the heart of the medical treatment exclusion for therapeutic treatments, surgical treatments and diagnostic methods. Learn More

The book engages with a broad range of new case studies, providing a detailed examination of options for the resolution of access-to-medicine issues at global, national and local levels. In addition, the book reflects the significant progress in international and national patent law and in international policymaking in this area. Learn More

Innovation and Liability in Biotechnology introduces and articulates an innovative framework, the Liability Analysis Framework (LAF), which offers a new perspective from which stakeholders and society can assess, manage and communicate about liability in relation to innovation. This path-breaking book provides a detailed description of the relationship between risk and liability. Risk and liability are not synonymous and the fact that, at times, the terms have been used in very close proximity has resulted in confusion and misunderstandings. Learn More

Intellectual property rights (IPRs), particularly patents, occupy a prominent position in innovation systems, but to what extent they support or hinder innovation is widely disputed. Through the lens of biotechnology, this book delves deeply into the main issues at the crossroads of innovation and IPRs to evaluate claims of the positive and negative impacts of IPRs on innovation. Learn More

Pharmaceuticals play a central role in health care throughout the world. The pharmaceutical industry is beset with difficulties as increasing research and development expenditure yields fewer new treatments. Public and private budgets strain under the weight of high prices and limited access. The world’s poor see little effort to address diseases prevalent in less affluent societies, while the world’s wealthy are overusing prescription drugs, risking their health and wasting resources. Learn More