Tamara K Hervey – författare

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.

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.

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.

A contextual analysis of the internal logics of EU health law through four themes: consumerism; (human) rights; interactions between equality, solidarity and competition; and risk. Leading authors in the emergent field explain the interactions and implications of EU health law through thematic reinterpretation of the law in context 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. This book offers a fresh perspective and thorough understanding of EU health law through individual and collective or systemic perspectives, and covers health law both within the EU and globally. Essential reading for anyone interested in health law in any EU Member State or in global health law.