This timely book examines the field of European and global standardisation, showing how standards give rise to a multitude of different legal questions. It explores diverse topics in regulation such as food safety, accounting, telecommunications and medical devices. Each chapter offers in-depth analysis of a number of key policy areas. These multi-disciplinary contributions go beyond the field of law, and provide cross-disciplinary comparisons.

This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.

This incisive book evaluates the legal effects of soft law, its foundations and how they behave in some of the most innovative areas of EU law. Combining theory, language and sectoral insights, this comprehensive review uses case studies to shed new light on the three core areas of soft law.

The book provides an analysis of the emergence, evolution, and transformation of transnational securities regulation and of the influences from and the interactions between global regulatory powers in the field. Combining insights from law and political science, the work employs a two-tier complementary "on-the-books" and "in-action” approach. The more classical "on-the-books" approach draws on scholarship in United States and European Union securities regulation; transnational regulation and global administrative law; regime complexity; global governance studies; and the regulatory production of the International Organisation of Securities Commissions (IOSCO). The law in-action approach leverages the author’s experience as Compliance senior professional in a multinational financial institution as well as research interviews with senior IOSCO staff. The author’s findings enable the reader to develop an original understanding of IOSCO, its standards, and its unique place in the transnational regulatory arena. They also challenge the doxa that the US are the only driving regulatory power in the securities area when in fact, other regulatory powers are emerging – for the time being, the EU. The balance has shifted and regulatory compromises are achieved at different points in the rule making process.

The relevance of contracting and self-regulation in consumer markets has increased rapidly in recent years, in particular in the platform economy. Online platforms provide opportunities for businesses and consumers to connect with strangers, often across borders, trading products, and services. In this new economy, platform operators create, apply and enforce their own rules in their contractual relationships with users. This book examines the substance of these rules and the space for private governance beyond the reach of state regulation. Vanessa Mak explores recent developments in lawmaking 'beyond the state' with case studies focusing on companies such as Airbnb and Amazon. The book asks how common values and objectives of EU law, such as consumer protection and contractual fairness, can be safeguarded when lawmaking shifts to a space outside the reach of state law.

In recent years transnational private regulators have emerged and multiplied. In this book, experts from various academic disciplines offer empirically grounded case studies and theoretical insights into the evolution and resilience of these bodies through crises. Transnational private regulators display considerable flexibility if compared to public institutions both in exercising their rule-making functions and adapting and transforming in light of endogenous or exogenous crises events calling for change. The contributors identify such events and reflect on their impact on transnational private rule-makers. This edited volume covers important areas of global production and finance that are associated with private rule-making and delves into procedural, substantive and practical elements of private rule-making processes. At a policy level, the book provides comparisons among practices of private bodies in various areas, allowing for important lessons to be drawn for all public and private stakeholders active in, or affected by, private and public rule-making. This title is Open Access.