The steady expansion of the European Union's involvement in health over the past 20 years has been accelerated by recent events. This Handbook offers an up-to-date analytical overview of the most important topics in EU health law and policy. It outlines, as far as possible, the direction of travel for each topic and suggests research agendas for the future. Split into five parts, this book brings together international, interdisciplinary contributions to consider the past, present and future of EU health law and policy. The changing membership of the EU could see dramatic changes for EU health law and policy: the contributors consider current developments in the light of past trajectories. The book covers key institutions; policies on people and products; health systems; public health; and the health implications of the EU's external trade policies and laws. Wide-ranging and accessible, this Handbook will appeal to academics and students focussing on EU health law or policy. It will also be of interest to lawyers and policy makers working in or with the EU as well as health managers and NGOs. Contributors include: A. Alemanno, O. Bartlett, L.E. Bishop, E. Brosset, A. de Ruijter, A. den Exter, G. Dussault, M.L. Flear, M. Frischhut, A. Garde, I. Goldner Lang, S.L Greer, M. Guy, T.K. Hervey, H. Jarman, M. Koivusalo, E. Kuhlmann, C. Larsen, A. Mahalatchimy, C.B. Maier, D.S Martinsen, J.V. McHale, N. Mijatovic, E. Pavolini, M. Pilgerstorfer, C. Rieder, C.S. Rusu, W. Sauter, T. Sokol, M.-I. Ungureanu, J.W. van de Gronden, C.A. Young

There is a fundamental contradiction at the core of health policy in the EU that makes it difficult to draw a line between EU and Member State responsibilities. This raises a number of difficult questions for policy makers and practitioners as they struggle to interpret both 'hard' and 'soft' laws at EU and Member State level and to reconcile tensions between economic and social imperatives in health care. The book addresses these complex questions by combining analysis of the underlying issues with carefully chosen case studies that illustrate how broader principles are played out in practice. Each chapter addresses a topical area in which there is considerable debate and potential uncertainty. The book thus offers a comprehensive discussion of a number of current and emerging governance issues in EU health policy, including regulatory, legal, 'new governance' and policy-making dynamics, and the application of the legal framework in these areas.

There is a fundamental contradiction at the core of health policy in the EU that makes it difficult to draw a line between EU and Member State responsibilities. This raises a number of difficult questions for policy makers and practitioners as they struggle to interpret both 'hard' and 'soft' laws at EU and Member State level and to reconcile tensions between economic and social imperatives in health care. The book addresses these complex questions by combining analysis of the underlying issues with carefully chosen case studies that illustrate how broader principles are played out in practice. Each chapter addresses a topical area in which there is considerable debate and potential uncertainty. The book thus offers a comprehensive discussion of a number of current and emerging governance issues in EU health policy, including regulatory, legal, 'new governance' and policy-making dynamics, and the application of the legal framework in these areas.

How does the law of the European Union affect health law and policy? At first sight, it seems limited. However, despite its restricted formal competence, the EU has recently become increasingly involved in the health field. Litigation based on EU law has resulted in a 'right to receive health care services' across national boundaries which may have huge practical implications for national health systems. The EU has promulgated legislation regulating clinical research, and the marketing of pharmaceuticals; patients' rights are affected by EU legislation on data protection and product liability; the qualifications of health care professionals are legally recognised across the EU; and the EU has acted to promote public health. This book explores the various impacts of measures of EU law on national health law and policy. Through elaboration of selected examples, the authors show that, within the EU, health law cannot be regarded as a purely national affair.

Health is a matter of fundamental importance in European societies, both as a human right in itself, and as a factor in a productive workforce and therefore a healthy economy. New health technologies promise improved quality of life for patients suffering from a range of diseases, and the potential for the prevention of incidence of disease in the future. At the same time, new health technologies pose significant challenges for governments, particularly in relation to ensuring the technologies are safe, effective, and provide appropriate value for (public) money. To guard against the possible dangers arising from new health technologies, and to maximize the benefits, all European governments regulate their development, marketing, and public financing. In addition, several international institutions operating at European level, in particular the European Union, the Council of Europe, and the European Patent Office, have become involved in the regulation of new health technologies. They have done so both through traditional 'command and control' legal measures, and through other regulatory mechanisms, including guidelines, soft law, 'steering' through redistribution of resources, and private or quasi-private regulation. This collection analyses European law and its relationships with new health technologies. It uses interdisciplinary insights, particularly from law but also drawing on regulation theory, and science and technology studies, to shed new light on some of the key defining features of the relationships and especially the roles of risk, rights, ethics, and markets. The collection explores the way in which European law's engagement with new health technologies is to be legitimized, and discusses the implications for biological or biomedical citizenship.

'European Union Health Law and Policy' is now a meaningful field of study. This monograph elaborates that field through the lens of five important themes. The themes (or orientations) of European Union health law and policy are consumerism; protection of (human) rights; risk regulation; interactions between equality, solidarity and competition; and globalism. The book explores interactions between law, policy and 'governance' in the creation, elaboration, application and development of European Union health law and policy through case studies in key substantive areas, such as the regulation of health research, access of patients to high quality care, health care professional regulation, organisation and funding of health care services, and public health. As European Union health law and policy forms a crucial context within which national health law and policy is developed, the book is essential reading for anyone interested in health law or policy in any EU Member State.

The Oxford Handbook of Comparative Health Law addresses some of the most critical issues facing scholars, legislators, and judges today: how to protect against threats to public health that can quickly cross national borders, how to ensure access to affordable health care, and how to regulate the pharmaceutical industry, among many others. When matters of life and death literally hang in the balance, it is especially important for policymakers to get things right, and the making of policy can be greatly enhanced by learning from the successes and failures of approaches taken in other countries. Where there are "common challenges" in law and health, there is much to be gained from experiences elsewhere. Thus, for example, countries that suffered early from the COVID-19 pandemic provided valuable lessons about public health interventions for countries that were hit later. Accordingly, the Handbook considers key health law questions from a comparative perspective. In health law, common challenges are frequent. In addition to ones already mentioned, there are questions about addressing the social determinants of health (e.g., poverty and pollution), organizing health systems to optimize use of available resources, ensuring that physicians provide care of the highest quality, protecting patient privacy in a data-driven world, and properly balancing patient autonomy with the interest in preserving life when reproductive and end-of-life decisions are made. This Handbook's wide scope and comparative take on health law are particularly timely. Economic globalization has made it increasingly important for different countries to harmonize their legal rules. Students, practitioners, scholars, and policymakers need to understand how health laws vary across national boundaries and how reforms can ensure a convergence toward an optimal set of legal rules, or ensure that specific legal arrangements are needed in particular contexts. Indeed, comparative analysis has become essential for legal scholars, and The Oxford Handbook of Comparative Health Law is the only resource that provides such an analysis in health law.