This book examines the regulatory framework for untested and unapproved uses (off-label uses) of medicines in the EU, UK, and USA. Before reaching patients, medicines are extensively tested by manufacturers and approved by regulators to minimise the risk of adverse reactions. However, physicians can prescribe pharmaceuticals for off-label uses, widespread in paediatrics, oncology, rare diseases and, more recently, in treatment for Covid-19. While off-label uses may offer hope, they may also expose patients to risks and uncertainties. Clarification is therefore needed to improve the protection of patients' rights while enhancing legal certainty for health actors. To this end, this work clarifies the regulatory mechanisms and litigation trends concerning off-licence prescriptions in these jurisdictions. It assesses how traditional, prevention-driven regulatory and civil liability rules are being adapted to tackle potential risks and scientific uncertainty. The book outlines the applicable regulations, as well as considering Brexit's impact on off-label policies in the UK, and EU and national off-label policies in the context of the fight against the Covid-19 pandemic. It also explores under what conditions physicians, manufacturers, or regulators must compensate patients injured by untested prescriptions. The book will be an essential resource for researchers, academics and policy-makers working in the areas of medical law and ethics, public health law, pharmaceutical law and private comparative law.

This book systematically studies the structural characteristics of IP laws and regimes of major Asian economies, including (but not always) China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Singapore, Taiwan, and Thailand. It explores and crystallizes some worthy Asian models which could further help the development of international IP laws. This book begins with an overview of Asian modern history and IP laws. It discusses the three basic IP laws in Asia which are patent law, trademark law and copyright law. It looks at the pre-established damages for copyright infringement and trademark counterfeiting. The book also deals with problems with trade secret and its over-protection. It compares IP laws and four industries in India and China, and examines what role have IP laws played in the development in those industries and how India and China can learn from each other. Finally, it examines one medium and one small-sized Asian economy on its respective struggle (Taiwan's efforts to build a coherent IP exhaustion regime) and a success story (how Singapore has utilized IP to secure its position in global value chains). This book is a useful reference for law students, scholars, practitioners, IP professionals who are interested in knowing Asia, Asian IP laws and industries, their struggles and finding ways to better global IP laws. The case studies could provide helpful lessons for other Asian economies and beyond.

This book examines the risks to freedom of expression, particularly in relation to the internet, as a result of regulation introduced in response to terrorist threats. The work explores the challenges of maintaining security in the fight against traditional terrorism while protecting fundamental freedoms, particularly online freedom of expression. The topics discussed include the clash between freedom of speech and national security; the multijurisdictional nature of the internet and the implications for national sovereignty and transnational legal structures; how to determine legitimate and illegitimate association online; and the implications for privacy and data protection. The book presents a theoretical analysis combined with empirical research to demonstrate the difficulty of combatting internet use by terror organizations or individuals and the range of remedies that might be drawn from national and international law. The work will be essential reading for students, researchers and policy makers in the areas of Constitutional law; Criminal Law, European and International law, Information and Technology law and Security Studies.

The Encyclopedia of Transitional Justice remains the premier reference tool that presents the state of the art in the field of reckoning with the legacy of past gross human rights abuses. Almost 200 scholars and practitioners from all continents summarize country efforts to address and redress the recent past, and present key transitional justice methods, debates, institutions and concepts. Both state and non-state initiatives are concisely overviewed. Written in an accessible style but with an eye to detail and accuracy, the entries include the latest research in the field and provide suggestions for further readings. Widely consulted by academics, practitioners, government officials and civil society representatives, the Encyclopedia is unmatched in the number of countries, institutions, debates, as well as methods, programs and practices it covers.

This global primer surveys international initiatives on traditional knowledge, folklore, cultural heritage and genetic resources, and describes in a comprehensive manner regional and national principles of protection in Asia, Europe, Africa, Oceania, the Middle East, the United States and the Americas. The most innovative parts of the book discuss three key approaches. First, the book highlights the relevance of customary law, describes how it is recognized and applied in legal systems and assesses its effectiveness as an enforcement mechanism. Second, through selected cases, the book illustrates the problem of biopiracy to which the disclosure requirement has been proposed as a policy response. It traces the origins of the disclosure requirement to instruments developed jointly by WIPO and UNESCO. Third, the book proposes a novel approach to protecting traditional knowledge premised on the principle of reciprocity and the use of mutual recognition agreements (MRAs) and assesses the scope of such MRAs. Libraries and universities will find this work is an invaluable resource for scholars and researchers. The material will also be important for government officials and organizations developing policy. Furthermore, the information available in these pages can empower indigenous peoples and local communities looking to promote awareness and protect traditional knowledge.

The Routledge Handbook of Comparative Territorial Autonomies affords a comprehensive, pioneering and interdisciplinary survey of this emerging field. Moving beyond traditionally narrower engagements with the subject, it combines approaches to comparative law and comparative politics to provide an authoritative guide to the principal theoretical and empirical topics in the area. Bringing together a team of cutting-edge scholars from different disciplines and continents, the volume illuminates the latest thinking and scholarship on comparative territorial autonomies. This Handbook is an authoritative, essential reference text for students, academics and researchers in its field. It will also be of key interest to those in the fields of comparative politics, comparative law, local/regional government, federalism, decentralisation and nationalism, as well as practitioners in think tanks, NGOs and international governmental organisations.

Constitutions and their systems are increasingly under pressure from identity groups such as regional and national minorities. Presenting the first comparative analysis of the negotiation of constitutional demands by these groups, Vito Breda uses an innovative methodology to create a richer understanding of the pluralistic nature of modern states. Combining both political and constitutional analysis, Breda expertly analyses cases from the USA, Canada, UK, Spain, Italy, New Zealand and Australia, reviewing the practices of cooperation and litigation between these groups and central institutions. An evaluation of the implications of the Catalonian, Puerto Rican and Scottish referenda show how regionalists seek to negotiate with central governments, defined by what they consider acceptable engagements under constitutional law. Both the systems and the constitutions themselves are changing under the pressure of these groups, but what remains is the distinctive constitutional structure ensuring democratic agreements emerge from difficult negotiation processes. Timely and in-depth, this book is a vital contribution to discussion on constitutional law globally. It will also attract researchers interested in regional issues within law, political science and sociology, and particularly those who study the role of regional or nationalist movements inside democracies.

The criminalisation of healthcare malpractice has become a highly topical and somewhat controversial question in recent years. Studies have demonstrated that in England and Wales, the trend towards holding healthcare professionals to account for malpractice is rapidly growing, abolishing the deference doctors enjoyed decades ago. The changing attitude of judges to claims for clinical negligence has been well documented. The role of the criminal process in England and Wales has been less fully analysed with the criminal law playing a very limited role until recently in the regulation of poor healthcare practice. In contrast, in France, the criminal process has for a long time been invoked more readily to respond to cases of healthcare malpractice, which involved even mere errors. This book compares English and French criminal law responses to healthcare malpractice and considers what lessons the French model can provide for potential reform in England and elsewhere. The book takes the HIV-contaminated blood episode as a primary example of the different approaches France and England have in dealing with healthcare malpractice. Kazarian emphasises the impact of rules of substantive criminal law and criminal procedure on the way in which healthcare malpractice is criminalised in a given country. This book explores the key lessons to be drawn on whether the criminal process is an appropriate means to respond to instances of healthcare malpractice. It proposes that features of French criminal law and criminal procedure might be useful to counteract healthcare malpractice.

This book examines selected high-profile U.S. First Amendment cases occurring during the Trump era as a vehicle for exploring a possible fundamental commonality in understanding the democratic rule of law globally. In each of these cases, the adjudicating body's analytical legal strategy is discussed in terms of how it reinforces or detracts from the democratic rule of law. It was and continues to be highly internationally anticipated as to what legal examples are being set by this established democracy when confronted by legal contests between the former Trump administration and those alleging their rights were somehow violated by the executive of that time. Thus, the book is instructive for an international audience on the essential role of the courts in protecting democracy through providing, where supported by the law and the facts, a remedy for the aggrieved comparatively powerless. The book will be essential reading for academics and researchers working in the areas of constitutional law, politics and human rights.

Consumer law and policy has emerged in the last half-century as a major policy concern for all nations. This Handbook of original contributions provides an international and comparative analysis of central issues in consumer law and policy in developed and developing economies.The Handbook encompasses questions of both social policy and effective business regulation. Many of the issues are common to all countries and are becoming increasingly globalised due to the growth in international trade and technological developments such as the Internet. The authors provide a broad coverage of both substantive topics and institutional questions concerning optimal approaches to enforcement and the role of class actions in consumer policy. It also includes comparative insights into the influential EU and US models of consumer law and relates consumer law to contemporary trends in human rights law. Written by a carefully selected group of international experts, this text represents an authoritative resource for understanding contemporary and future developments in consumer law. This Handbook will provide students, researchers and policymakers with an insight to the main policy debates in each context and provide models of legal regulation to assist in the evaluation of laws and the development of consumer law and policy.

In today's legal environment, copyright licensing requires an international perspective. Licensors in both emerging and developed markets must have a detailed understanding of cross-border practices. Cross-Border Copyright Licensing provides a select guide to copyright licensing practices in a number of jurisdictions, addressing key cross-border considerations. Key features include: chapter by chapter analysis of licensing legislation in the most frequently encountered jurisdictions including: China, the EU, India, Mexico, Russia, Singapore, South Africa and the USA discussion of the inter-relation between copyright licensing and competition law clear delineation of the most relevant and critical legal issues relating to licensing practice across the named jurisdictions allowing for ease of reference contributions from expert practitioners with invaluable first hand knowledge of international licensing practices. This book will prove a valuable resource for lawyers who are implementing or enforcing a copyright licensing scheme, acting as a first point of reference on cross-border issues. Scholars of Intellectual Property will also find the text to be a useful guide on international regulations and practices. Contributors include: A. Apostolidis, H. Blignaut, K. Golish, P.G. Granados, E. Hochstadt, B. Kalra, B. Lindner, R. Lukyanov, T. Misra, L.C. Nian, D.S. Nocetti, J.B. Nordemann, T. Pattloch, S. Rab, A. Risely, W. Strong, K. Sysoeva, K. Tsuru

Concise and clear in expression, Comparative Government covers contemporary systems of government, as well as relics of the past, in an excellent introduction to the profound study of comparative constitutional law. Dragoljub Popovic has undertaken this task to display the subject in its current stage of development, concentrating on several focal points. Based on research of their characteristic features, decision-making mechanisms and lines of evolution, the author explores parliamentary, presidential, semi-presidential, power sharing and the supra-national level forms of government in an entertaining narrative and provides tools for the reader to classify and understand governments worldwide. Comparative Government will prove essential, for its comprehensive yet concise scope, to students of law, political sciences and international relations, as well as academics in the same areas, civil servants, diplomats, legislation drafters, policy makers and practicing lawyers.

Comparative Tort Law: Global Perspectives provides a framework for analyzing and understanding the current state of tort law in most of the world's legal systems. The book examines tort law theories and cultures through a comparative methodology. It looks at general issues at play throughout the globe, such as causation, economic and non-economic damages, product and professional liability, as well as the relationship between tort law and crime, insurance, and public welfare schemes. This collection of essays written by tort law experts from around the world also offers a comprehensive comparative assessment of tort law rules, and consideration for the cultural contexts in which tort laws live, covering many jurisdictions that are usually neglected by mainstream debates and literature. Insightful case studies analyze specific features of selected tort systems in Europe, USA, Latin America, East Asia, and sub-Saharan Africa. This path-breaking, though accessible book is a critical tool for students, policymakers, practitioners, scholars and academic researchers, especially tort law and comparative law specialists. Contributors: A. Basir Bin Mohamad, M. Bussani, E. Buyuksagis, D.N. Dagbanja, G. Dari-Mattiacci, M. de Morpurgo, M. Dyson, I. Ebert, E.A. Engle, J. Gordley, H. Jiang, E. Hondius, M. Infantino, D. Jutras, E. Matsumoto, V.V. Palmer, F. Parisi, M. Reimann, A.J. Sebok, S.D. Sugarman, S.C. Symeonides, F. Werro

Offers unique comparative perspective of counter-terrorism legislation in different states, including UK, Europe and North America. Accessible enough to be used at both undergraduate and postgraduate levels. Reflection points and further reading make it the perfect springboard for further study in this evolving area. The new edition offers increased coverage of issues around returning foreign fighters, links to organized crime, and electronic surveillance.

This book provides a comprehensive assessment of the effectiveness of Mobility Partnerships and their consequences for third countries. Mobility partnerships between the EU and third countries are usually viewed as reflecting asymmetric power relations where development aid, trade relations and visa policies are made conditional upon the cooperation by third countries with an EU agenda of migration control. This book argues that three main factors condition the relevance of Mobility Partnerships: the state of relations between EU Member States and a third country, and in particular, the role of postcolonial ties; the power of negotiation of a third country, which is linked to its geopolitical importance for the EU; and its administrative capacity, which is understood as the capacity of a state to define and implement policies and to legislate and enforce the law. The work combines a comparative legal analysis of the development of the legal and policy frameworks in the cases of Morocco and Cape Verde with an empirical study of the implementation of Mobility Partnerships' projects. The analysis demonstrates that Mobility Partnerships, despite their non-binding nature, have legal and policy relevance for these third countries with regard to the regulation of migration, asylum, human trafficking and even labour law. As such, this book makes a contribution to the understanding of the interplay between the interests of EU, Member State and third country actors in the implementation of the Mobility Partnerships. The book will be a key resource for academics and students focusing on Migration Law, EU Studies, Geopolitics and African Studies. The empirical approach will also appeal to policy-makers, international organisation representatives and NGOs.

African legal realities reflect an intertwining of transnational, regional, and local normative frameworks, institutions, and practices that challenge the idea of the sovereign territorial state. This book analyses the novel constellations of governance actors and conditions under which they interact and compete. The work follows a spatial approach as the emphasis on normative spaces opens avenues to better understand power relations, processes of institutionalization, and the production of legitimacy and normativities themselves. Selected case studies from thirteen African countries deliver new empirical data and grounded insights from, and into, particular normative spaces. The individual chapters explore the interrelationships between various normative orders, diverse actors, and their influences. The encounters between different normative understandings and actors open up space and multiple forums for negotiating values. The authors analyse how different doctrines, institutions, and practices are constructed, contested, negotiated, and adapted in translation processes and thereby continuously reshape Africa's multidimensional normative spaces. The volume delivers nuanced views of jurisprudence in Africa and presents an excellent resource for scholars and students of anthropology, legal geography, legal studies, sociology, political sciences, international relations, African studies, and anyone wishing to gain a better understanding of how legal constellations are shaped by unreflected assumptions about the state and the rule of law.

This book explores the legal dimension of the Islamic State, an aspect which has hitherto been neglected in the literature. ISIS' dystopian experience, intended as a short-lived territorial and political governance, has been analyzed from multiple points of view, including the geopolitical, social and religious ones. However, its legal dimension has never been properly dealt with in a comprehensive way, assuming as a point of reference both the Islamic and the Western legal tradition. This book analyzes ISIS as the expression of a potential though never fully realized legal order. The book does not describe ISIS' possible classifications according to the standards and the criteria of international law, such as its possible statehood or proto-statehood, issues that are however touched upon. Rather, it analyzes ISIS' own legal awareness, based on the group's literary materials, which show a considerable amount of juridical work. Such material, mainly propagandistic in its nature, is essential in understanding which kind of legal order ISIS aimed at establishing. The book will be of interest to students and academics in the fields of Law, International Relations, Political Sciences, Terrorism Studies, Religion and Middle Eastern Studies.

This book introduces and develops the paradigm of the organisational contract in European contract law. Suggesting that a more radical distinction should be made between contracts which regulate single or spot exchanges and contracts that organize complex economic activities without creating a new legal entity, the book argues that this distinction goes beyond that between spot and relational contracts because it focuses on the organizational dimension of contracting and its governance features. Divided into six parts, the volume brings together a group of internationally renowned experts to examine the structure of long-term contractual cooperation; networks of contracts; knowledge exchange in long-term contractual cooperation; remedies and specific governance rules in long-term relationships; and the move towards legislation. The book will be of value to academics and researchers in the areas of private law, economic theory and sociology of law, and organizational theory. It will also be a useful resource for practitioners working in international contract law and international business transaction law.

Gives the reader a wider understanding of the role judges play within the criminal justice system. Will be of interest for criminal justice and legal scholars and criminal justice and law students at both the undergraduate and graduate level on criminal justice/criminology and law degree programs. As the book contains interviews with judges from across the globe, it will have an international appeal.

This book provides a critique of current international law-making and draws on a set of principles from Persian philosophers to present an alternative to influence the development of international law-making procedure. The work conceptualizes a substantive notion of democracy in order to regulate international law-making mechanisms under a set of principles developed between the twelfth and seventeenth centuries in Persia. What the author here names 'democratic egalitarian multilateralism' is founded on: the idea of 'egalitarian law' by Suhrawardi, the account of 'substantial motion' by Mulla Sadra, and the ideal of 'intercultural dialectical democracy' developed by Rumi. Following a discussion of the conceptual flaws of the chartered and customary sources of international law, it is argued that 'democratic egalitarian multilateralism' could be a source for a set of principles to regulate the procedures through which international treaties are made as well as a criterion for customary international law-ascertainment. Presenting an alternative, drawn from a less dominant culture, to the established ideas of international law-making the book will be essential reading for researchers and academics working in public international law, history of law, legal theory, comparative legal theory, Islamic law, and history.

In our globalized era it has become impossible to deal effectively with constitutional law and related subjects such as fundamental rights, administrative law and political science without a knowledge of foreign systems. Although a wealth of literature is available, the constitutionalist faces a formidable problem: which foreign systems should I explore in order to make relevant comparisons, and how should I go about it? This book addresses the issues of comparability and appropriate comparative methodology.

The papers published in this proceedings volume are written by a selection of authors, resulting from a call for papers for the 1st International Conference on Law and Governance in a Global Context (ICLAVE) originating from Indonesia and other countries. This proceedings volume shall be a very valuable contribution to understand contemporary law issues in Indonesia which are not always taught in law schools. These proceedings will not only serve as a useful reference for law students and academicians, but also help law practitioners to understand law issues that may be encountered in Indonesia. It covers selected items such as Administrative Law, Constitutional Law, Business Law, Intellectual Property Law, Criminal Law, Human Rights Law, Adat Law, Shariah Law, Judiciary Law and International Law, which are all important for undergraduate and post-graduate law students, as well as academicians and law practitioners in the law community.

This book analyses collective punishment in the context of human rights law. Collective punishment is a concept deriving from the law of armed conflict. It describes the punishment of a group for an act allegedly committed by one of its members and is prohibited in times of armed conflict. Although the imposition of collective punishment has been witnessed in situations outside armed conflict as well, human rights instruments do not explicitly address collective punishment. Consequently, there is a genuine gap in the protection of affected groups in situations outside of or short of armed conflict. Supported by two case studies on collective punishment in the Occupied Palestinian Territories and in Chechnya, the book examines potential options to close this gap in human rights law in a way contributing to the empowerment of affected groups. This analysis centres on the European Convention on Human Rights due to its relevance to the situation in Chechnya. By questioning whether human rights instruments can encompass a prohibition of collective punishment, the book contributes to the broader academic debate on rights held by collectivities in general and on collective human rights in particular. The book will be of interest to students, academics and policy makers in the areas of International Human Rights Law, International Humanitarian Law and International Criminal Law.

This volume examines the design and impact of courts in African federal systems from a comparative perspective. Recent developments indicate that the previously stymied idea of federalism is now being revived in the constitutional arrangements of several African countries. A number of them jumped on the bandwagon of federalism in the early 1990s because it came to be seen as a means to facilitate development, to counter the concentration of power in a single governmental actor and to manage communal tensions. An important part of the move towards federalism is the establishment of courts that are empowered to umpire intergovernmental disputes. This edited volume brings together contributions that first discuss questions of design by focusing, in particular, on the organization of the judiciary and the appointment of judges in African federal systems. They then examine whether courts have had a rather centralizing or decentralizing impact on the operation of African federal systems. The book will be of interest to researchers and policy-makers in the areas of comparative constitutional law and comparative politics.

Provides a tightly structured introduction to this complex topic, supported by well chosen case studies from a variety of jurisdictions. Appropriate for law students looking to practice contract law in a transnational environment.