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.
"This book is novel in focusing on the European regulatory environment pertaining to NHTs...The aim [of the 1st part of the book] appears to be rather to broaden the reader's horizons so as to be able to see the wider picture. Chapter 2 for example does this brilliantly, providing a sound overview of the potential influences of EU law on NHTs... Present[s] a number of well-selected examples of contemporary problems with European regulation of NHTs. Such examples are thought-provoking and serve to highlight the need for constant regulatory vigilance and willingness to reform in this area...Even a reader with familiarity of some or many aspects of NHT
regulation will find something new and instructive in the various topics that have been chosen. The central topic of this book extremely relevant given the upcoming revision of the data protection directive and the medical device directives proposed by the European Commission." - Quinn, Common Market Law Review
"This is an excellent collection that provides a rich overview of the ways in which European law shapes, and is shaped by, new health technologies and, arguably, offers a first step towards the constitution of the European Law of new health technologies as an emerging field of inquiry. Bringing together a vast range of technological developments, of
disciplinary insights, and of conceptual questions, this will become a key resource for any scholar seeking to explore the relationship between health technologies and European law and policy, but also for those more broadly interested in the interface between law and technoscience." - E. Cloatre, Kent Law School
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?