European Law and New Health Technologies

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.

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).


Therese 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.

1. Introduction, Mark Flear, Anne-Maree Farrell, Tamara Hervey, and Therese Murphy
Part I: Setting the Scene
2. Mapping Science and New Health Technologies: In Search of a Definition, Amanda Warren-Jones
3. Defining Features of the EU Law Approach to New Health Technologies, Gordon Bache, Mark Flear, and Tamara Hervey
4. The Council of Europe and the Regulation of New Health Technologies, Sjef Gevers and Rory O'Connell
A Regulator's Response, Belen Crespo Sanchez-Eznarriaga
Part II: Legal Approaches to European Law and New Health Technologies
5. Innovative Tissue Engineering and its Regulation: The Serach for Flexible Rules for Innovative Health Technologies, Nils Hoppe
6. Looking After the Orphans? Treatments for Rare Diseases, EU Law, and the Ethics of Costly Healthcare, Keith Syrett
7. Exclusions in Patent Law as an Indirect Form of Regulation For New Health Technologies in Europe, Amanda Odell-West
8. New Health Technologies and their Impact on EU Product Liability Regulations, Monica Navarro-Michel
A Regulator's Response, Jonathan Montgomery
Part III: Regulatory Theory, Regulatory Innovation, European Law and New Health Technologies
9. Risk, Legitimacy, and EU Regulation of Health Technologies, Anne-Maree Farrell
10. Something Old, Something New, Something Borrowed: Emerging Health Technologies and the Continuing Role of Existing Regulations, Elen Stokes
11. Science, Law, and the Medico-Industrial Complex in EU Pharmaceutical Regulation: The Deferiprone Controversy, John Abraham and Courtney Davis
12. The Governance of Therapeutic Nanoproducts in the European Union: A Model for New Health Technology Regulation?, Barbel Dorbeck-Jung
A Regulator's Response, Emily Jackson
Part IV: New Techniques for Researching European Law and New Health Technologies
13. Taking Technology Seriously: STS as Human Rights Method, Therese Murphy and Gearoid O'Cuinn
14. Novel Rights Approaches to Health Technologies, Richard Ashcroft
15. Sociotechnical Innovation in Mental Health: Articulating Complexity, Martyn Pickersgill
16. When Sperm Cannot Travel: Experiences of UK Patients Seeking Treatment Abroad, Ilke Turkmendag
17. Where the Wild Things Are: Xenotechnologies and European Hybrid Regulation, Nik Brown and Sian Beynon-Jones
A Regulator's Response, Graeme Laurie
Part V: Bringing It All Together
Conclusion: European Law, New Health Technologies, New Challenges, New Approaches, Mark Flear, Anne-Maree Farrell, Tamara Hervey, and Therese Murphy