At a time when the human genome has been sequenced advances in the life sciences seem to have great potential for human health, industry and the environment throughout Central and Eastern Europe (CEE). Still, for some, potential risks and ethical dilemmas remain, surrounding issues such as the appropriate use of GM crops, stem cells, genetic information, the nature of intellectual property and other challenges that come with EU accession. This book is the first of its kind to bring together experts from across Europe to explore the landscape of current life science policy and industrial development in CEE, including implications for economies, regulatory and legal frameworks, health care, ethics and human rights. It will be essential reading for researchers and students in science and technology studies, development, sociology, politics and law, and those interested in life science development in transition economies.

Biomedical patents have been the subject of heated debate. Regulatory agencies such as the European Patent Office make small decisions with big implications, which escape scrutiny and revision, when they decide who has access to expensive diagnostic tests, whether human embryonic stem cells can be traded in markets, and under what circumstances human health is more important than animal welfare. Moreover, the administration of the Trade Related Aspects of Intellectual Property Rights by the World Trade Organization has raised considerable disquiet as it has arguably created grave health inequities. Those doubting the merits of the one size fits all approach ask whether priority should be given to serving the present needs of populations in dire need of medication or to promoting global innovation. The book looks in detail into the legal issues and ethical debates to ask the following three main questions: First, what are the ideas, goals, and broader ethical visions that underpin questions of governance and the legal reasoning employed by administrative agencies? Second, how can we democratize the decision making process of technocratic institutions such as the European Patent Office? Finally, how can we make the global intellectual property system more equitable? In answering these questions the book seeks to contribute to our understanding of the role and function of regulatory agencies in the regulation of the bioeconomy, explains the process of interpretation of legal norms, and proposes ways to rethink the reform of the patent system through the lens of legitimacy.

This book gives an overview of the most salient themes in present-day bioethics. The book focuses on perspectives typical for the European context. This highlights not only particular bioethical themes such as social justice, choices in health care, and health policy (e.g., in post-communist countries), it also emphasizes specific approaches in ethical theory, in relation to Continental philosophies such as phenomenology and hermeneutics.

Controversies over issues such as genetically engineered food, foot-and-mouth disease and the failure of risk models in the global financial crisis have raised concerns about the quality of expert scientific advice. The legitimacy of experts, and of the political decision-makers and policy-makers whom they advise, essentially depends on the quality of the advice. But what does quality mean in this context, and how can it be achieved? This volume argues that the quality of scientific advice can be ensured by an appropriate institutional design of advisory organisations. Using examples from a wide range of international case studies, including think tanks, governmental research institutes, agencies and academies, the authors provide a systematic guide to the major problems and pitfalls encountered in scientific advice and the means by which organisations around the world have solved these problems.

Biotechnology is at the heart of heated debates about ethics, safety, economic development, and about the control over the biological materials and technologies used. The latter, grossly called biodiversity issues relating to the application of intellectual property, has been the subject of a wealth of literature. Yet, the situation of animal genetic resources specifically has only marginally been addressed so far. Many books and articles address ‘biotechnology and agriculture’, but have only plants and seeds in mind. Case-law and specific regulation is equally scarce. Exacerbated by the so-called ‘erosion of animal genetic resources’, climate change, the globalization of the market-place, and a strong concentration of markets, animal genetic resources however demand specific analysis and adjustments in intellectual property law. The decoupling of rights over animal genetic resources as an abstract concept, from those over the concrete animals is a fact today. The application of patents in this context became a full-fledged part of the management of animal genetic resources. This monograph analyzes against this background the impact of the patent system on ownership traditions in agriculture, on animal welfare, and on biodiversity. It looks at how those factors in turn are likely to affect the shape of patent law, and how they should affect it. The author hereby focuses on important specific issues arising, including the following: the underlying elements deciding on the shape of regulation – innovation, economic development, agriculture, human rights, animal welfare, the conservation of resources, and equal trading conditions; the continuing applicability of trademarks, geographical indications, copyright, and trade secrets; patentability rules and exclusions; the extension of patent rights over progeny; the meaning of ‘essentially biotechnological processes’; the legal definitions of ‘morality’ and ‘ordre public’ in the context of animal welfare; and the future of international patent law in the context of global governance theories. With detailed investigation of how three major jurisdictions – the European Union, the United States, and Canada – have regulated the matter, the book highlights unresolved issues in the laws dealing with animal genetic resources. How do the usual principles of patent law affect ownership over animals in agriculture? To what extent is patent law in accordance with neighbouring fields of regulation, with relation to animal welfare? How can intellectual property be used to alter, stimulate, or tackle developments in the realm of the conservation and promotion of biodiversity? Questions like these are asked, checked upon the more technical country studies; and then used to put to test the adequacy of international patent regulation in a final chapter. As a deeply informed overview of the arguments and discussion points, this is the only book of its kind. It links general discussions to the often technical and complicated patent regulations, in the specific context of animal genetic resources. It is sure to bring lawyers in the field closer to the policy debates; and decision makers closer to the precise idiosyncrasies of patent law.

In todayês 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 inve