European Law and New Health Technologies by Flear, Mark L; Farrell, Anne-Maree; Hervey, Tamara K;

Sorozatcím: Oxford Studies in European Law;

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A termék adatai:

Kiadó OUP Oxford
Megjelenés dátuma 2013. március 14.

ISBN 9780199659210
Kötéstípus Keménykötés
Terjedelem478 oldal
Méret 240x162x36 mm
Súly 860 g
Nyelv angol

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Rövid leírás:

New health technologies promise great things but they also pose significant challenges for governments, particularly around safety concerns, effectiveness, and value for money. This collection analyses the defining features of the relationship between EU law and new technologies, and the roles of risk, rights, ethics, and markets.

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Hosszú leírás:

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.

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.

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Tartalomjegyzék:

European Law and New Health Technologies: The Research Agenda
Part I: Setting the Scene
The Defining Features of the European Union's Approach to Regulating New Health Technologies
Fixed Points in a Changing Age? The Council of Europe, Human Rights, and the Regulation of New Health Technologies
Mapping Science and New Health Technologies: In Search of a Definition
A Regulator's Perspective
Part II: Legal Approaches to European Law and New Health Technologies
Innovative Tissue Engineering and Its Regulation: The Serach for Flexible Rules for Emerging Health Technologies
Looking After the Orphans? Treatments for Rare Diseases, EU Law, and the Ethics of Costly Healthcare
Exclusions in Patent Law as an Indirect Form of Regulation For New Health Technologies in Europe
New Health Technologies and their Impact on EU Product Liability Regulations
A Regulator's Perspective
A Regulator's Perspective
Part III: Regulatory Theory, Regulatory Innovation, European Law and New Health Technologies
Risk, Legitimacy, and EU Regulation of Health Technologies
Something Old, Something New, Something Borrowed: Emerging Health Technologies and the Continuing Role of Existing Regulations
Science, Law, and the Medico-Industrial Complex in EU Pharmaceutical Regulation: The Deferiprone Controversy
The Governance of Therapeutic Nanoproducts in the European Union: A Model for New Health Technology Regulation?
A Regulator's Perspective
Part IV: New Techniques for Researching European Law and New Health Technologies
Taking Technology Seriously: STS as Human Rights Method
Novel Rights Approaches to Health Technologies
Sociotechnical Innovation in Mental Health: Articulating Complexity
Where the Wild Things Are: Xenotechnologies and European Hybrid Regulation
When Sperm Cannot Travel: Experiences of UK Fertility Patients Seeking Treatment Abroad
A Regulator's Perspective
Part V: Bringing It All Together
Conclusion: A European Law of New Health Technologies?