|
|
|
|
European Law and New Health Technologies
Edited by Mark L Flear, Anne-Maree Farrell, Tamara K Hervey, and Thérèse Murphy
480 pages
|
234x156mm
978-0-19-965921-0
|
Hardback
|
14 March 2013
|
|
|
|
|
- Outlines the defining features of the European law regulation approach to new health technologies, including pharmaceuticals, stem-cell research, therapeutic nanoproducts, and reproductive technologies
- Examines the roles of risk, ethics, rights, and markets in the context of health regulation
- Includes expert reflections on the theoretical issues discussed, written by key regulators in the field
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.Readership: Scholars and students of European law, regulation, and medical health and technology
|
|
|
Edited by Mark L Flear, Lecturer in Law, Queen's University Belfast, Anne-Maree Farrell, Associate Professor at the Faculty of Law, Monash University, Australia, Tamara K Hervey, Jean Monnet Professor of European Union Law, University of Sheffield School of Law, and Thérèse Murphy, Professor of Law and Critical Theory, University of Nottingham Mark Flear is a Lecturer in Law at Queen's University of Belfast. He is also a member of the Northern Ireland DNA Database Governance Board. His works include the forthcoming title The Biopolitics of EU Public Health Governance: Cancer, HIV/AIDS and Pandemics.
Anne-Maree Farrell is Associate Professor at the Faculty of Law, Monash University, Australia. Her research expertise lies broadly within the area of health law and policy, with a particular interest in the regulatory governance of human biological materials. Recent publications include The Politics of Blood: Ethics Innovation and the Regulation of Risk (2012) and Organ Shortage: Ethics Law and Pragmatism (co-edited with D. Price and M. Quigley, 2011).
Tamara Hervey is Jean Monnet Professor of EU Law at the University of Sheffield, UK. Her research and teaching interests are in the field of European Union social and constitutional law, in particular its application in health fields, social security and welfare. She works across disciplines, and considers law in the context of broader modes of regulation. She is interested in socio-legal theory and method, and legal research methodologies in general, in particular as applied to the law of the European Union. Her recent books include Health Law and the European Union (with J McHale, 2004), Health Systems Governance in Europe: The role of EU law and policy (with E Mossialos, G Permanand, and R Baeten, 2010), andResearch Methodologies in EU and International Law (with R Cryer, B
Sokhi-Bulley, and A Bohm, 2011).
Thérèse Murphy is the Professor of Law and Critical Theory in the Faculty of Social Sciences at the University of ?Nottingham. Her work focuses on human rights law and practice, and her publications include
Civil Liberties Law: The Human Rights Act Era (2001), New Technologies and Human Rights (2009), and the forthcoming Health and Human Rights. Contributors:
John Abraham, University of Sussex
Richard Ashcroft, Queen Mary University of London
Gordon Bache, University of Sheffield
Sian Beynon-Jones, University of York
Nik Brown, University of York
Courtney Davis, University of Sussex
Bärbel Dorbeck-Jung, Unversity of Twente
Anne-Maree Farrell, Monash University
Mark Flear, Queen's University Belfast
Sjef Gevers, University of Amsterdam
Tamara Hervey, University
of Sheffield
Nils Hoppe, University of Hanover
Thérèse Murphy, University of Nottingham
Mónica Navarro-Michel, University of Barcelona
Rory O'Connell, Queen's University Belfast
Gearóid Ó'Cuinn, University of Nottingham
Amanda Odell-West, University of Manchester
Martyn Pickersgill, University of Edinburgh
Elen Stokes, Cardiff Law School
Keith Syrett, Bristol University
Ilke Turkmendag, Newcastle University
Amanda Warren-Jones, University of Sheffield
Regulators
Belen Crespo Sanchez-Eznarriaga, Director of the Spanish Medicines Agency
Emily Jackson, Human Fertilisation and Embryology
Authority
Mihalis Kritikos, formerly European Commission
Graeme Laurie, formerly chair of the UK Biobank Ethics and Governance Council
Jonathan Montgomery, Human Genetics Commission
|
|
|
1: Mark Flear, Anne-Maree Farrell, Tamara Hervey, and Thérèse Murphy: European Law and New Health Technologies: The Research Agenda
Part I: Setting the Scene
2: Gordon Bache, Mark Flear, and Tamara Hervey: The Defining Features of the European Union's Approach to Regulating New Health Technologies
3: Sjef Gevers and Rory O'Connell: Fixed Points in a Changing Age? The Council of Europe, Human Rights, and the Regulation of New Health Technologies
4: Amanda Warren-Jones: Mapping Science and New Health Technologies: In Search of a Definition
Jonathan Montgomery, Human Genetics Commission: A Regulator's Perspective
Part II: Legal Approaches to European Law and New Health Technologies
5: Nils Hoppe: Innovative Tissue Engineering and Its Regulation: The Serach for Flexible Rules for Emerging Health Technologies
6: Keith Syrett: Looking After the Orphans? Treatments for Rare Diseases, EU Law, and the Ethics of Costly Healthcare
7: Amanda Odell-West: Exclusions in Patent Law as an Indirect Form of Regulation For New Health Technologies in Europe
8: Mónica Navarro-Michel: New Health Technologies and their Impact on EU Product Liability Regulations
Graeme Laurie, formerly chair of the UK Biobank Ethics and Governance Council: A Regulator's Perspective
Belén Crespo Sánchez-Eznarriaga, Director of the Agencia Española de Medicamentos y Productos Sanitarios: A Regulator's Perspective
Part III: Regulatory Theory, Regulatory Innovation, European Law and New Health Technologies
9: Anne-Maree Farrell: Risk, Legitimacy, and EU Regulation of Health Technologies
10: Elen Stokes: Something Old, Something New, Something Borrowed: Emerging Health Technologies and the Continuing Role of Existing Regulations
11: John Abraham and Courtney Davis: Science, Law, and the Medico-Industrial Complex in EU Pharmaceutical Regulation: The Deferiprone Controversy
12: Bärbel Dorbeck-Jung: The Governance of Therapeutic Nanoproducts in the European Union: A Model for New Health Technology Regulation?
Emily Jackson, Human Fertili sation and Embryology Authority: A Regulator's Perspective
Part IV: New Techniques for Researching European Law and New Health Technologies
13: Thérèse Murphy and Gearóid Ó'Cuinn: Taking Technology Seriously: STS as Human Rights Method
14: Richard Ashcroft: Novel Rights Approaches to Health Technologies
15: Martyn Pickersgill: Sociotechnical Innovation in Mental Health: Articulating Complexity
16: Sian Beynon-Jones and Nik Brown: Where the Wild Things Are: Xenotechnologies and European Hybrid Regulation
17: Ilke Turkmendag: When Sperm Cannot Travel: Experiences of UK Fertility Patients Seeking Treatment Abroad
Mihalis Kritikos, formerly European Commission: A Regulator's Perspective
Part V: Bringing It All Together
Mark Flear, Anne-Maree Farrell, Tamara Hervey, and Thérèse Murphy: Conclusion: A European Law of New Health Technologies?
|
|
|
|
|
|
|
|
|
The specification in this catalogue, including without limitation price, format, extent, number of illustrations, and month of publication, was as accurate as possible at the time the catalogue was compiled. Occasionally, due to the nature of some contractual restrictions, we are unable to ship a specific product to a particular territory. Jacket images are provisional and liable to change before publication.
|
|
