European Law and New Health Technologies

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

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?