European Law and New Health Technologies

Hardcover | April 14, 2013

EditorMark L. Flear, Anne-Maree Farrell, Tamara K. Hervey

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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 thepotential 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 EuropeanUnion, 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 relationshipsand 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.

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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 thepotential for the prevention of incidence of dis...

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 Uni...

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Format:HardcoverDimensions:450 pages, 9.21 × 6.14 × 0.01 inPublished:April 14, 2013Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0199659214

ISBN - 13:9780199659210

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Table of Contents

1. Mark Flear, Anne-Maree Farrell, Tamara Hervey, and Therese Murphy: IntroductionPart I: Setting the Scene2. Amanda Warren-Jones: Mapping Science and New Health Technologies: In Search of a Definition3. Gordon Bache, Mark Flear, and Tamara Hervey: Defining Features of the EU Law Approach to New Health Technologies4. Sjef Gevers and Rory O'Connell: The Council of Europe and the Regulation of New Health TechnologiesBelen Crespo Sanchez-Eznarriaga: A Regulator's ResponsePart II: Legal Approaches to European Law and New Health Technologies5. Nils Hoppe: Innovative Tissue Engineering and its Regulation: The Serach for Flexible Rules for Innovative Health Technologies6. Keith Syrett: Looking After the Orphans? Treatments for Rare Diseases, EU Law, and the Ethics of Costly Healthcare7. Amanda Odell-West: Exclusions in Patent Law as an Indirect Form of Regulation For New Health Technologies in Europe8. Monica Navarro-Michel: New Health Technologies and their Impact on EU Product Liability RegulationsJonathan Montgomery: A Regulator's ResponsePart III: Regulatory Theory, Regulatory Innovation, European Law and New Health Technologies9. Anne-Maree Farrell: Risk, Legitimacy, and EU Regulation of Health Technologies10. Elen Stokes: Something Old, Something New, Something Borrowed: Emerging Health Technologies and the Continuing Role of Existing Regulations11. John Abraham and Courtney Davis: Science, Law, and the Medico-Industrial Complex in EU Pharmaceutical Regulation: The Deferiprone Controversy12. Barbel Dorbeck-Jung: The Governance of Therapeutic Nanoproducts in the European Union: A Model for New Health Technology Regulation?Emily Jackson: A Regulator's ResponsePart IV: New Techniques for Researching European Law and New Health Technologies13. Therese Murphy and Gearoid O'Cuinn: Taking Technology Seriously: STS as Human Rights Method14. Richard Ashcroft: Novel Rights Approaches to Health Technologies15. Martyn Pickersgill: Sociotechnical Innovation in Mental Health: Articulating Complexity16. Ilke Turkmendag: When Sperm Cannot Travel: Experiences of UK Patients Seeking Treatment Abroad17. Nik Brown and Sian Beynon-Jones: Where the Wild Things Are: Xenotechnologies and European Hybrid RegulationGraeme Laurie: A Regulator's ResponsePart V: Bringing It All TogetherMark Flear, Anne-Maree Farrell, Tamara Hervey, and Therese Murphy: Conclusion: European Law, New Health Technologies, New Challenges, New Approaches