The focus of this book is on regulatory agencies, such as the European Patent Office and the World Trade Organisation, and their role and function in the regulation of the bioeconomy.

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.