European law and new health technologies / edited by Mark L. Flear [and three others].

Format:

Book

Author/Creator:

Flear, Mark L., Editor.

Contributor:

Flear, Mark L., editor.

Series:

Oxford studies in European law.

Oxford Studies in European Law

Language:

English

Subjects (All):

Medical technology--Law and legislation--Europe.

Medical technology.

Medical technology--Law and legislation--European Union countries.

Physical Description:

1 online resource (480 pages) : illustrations.

Edition:

First edition.

Place of Publication:

Oxford : Oxford University Press, 2013.

Language Note:

English

Summary:

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.

Contents:

1. European Law and New Health Technologies: The Research Agenda

Part I. Setting the Scene

2. The Defining Features of the European Union's Approach to Regulating New Health Technologies

3. Fixed Points in a Changing Age? The Council of Europe, Human Rights, and the Regulation of New Health Technologies

4. Mapping Science and New Health Technologies: In Search of a Definition

Part II. Legal Approaches to European Law and New Health Technologies

5. Innovative Tissue Engineering and Its Regulation -The Search for Flexible Rules for Emerging Health Technologies

6. Looking After the Orphans? Treatments for Rare Diseases, EU Law, and the Ethics of Costly Health Care

7. Exclusions in Patent Law as an Indirect Form of Regulation for New Health Technologies in Europe

8. New Health Technologies and Their Impact on EU Product Liability Regulations

Part III. Regulatory Theory, Regulatory Innovation, European Law, and New Health Technologies

9. Risk, Legitimacy, and EU Regulation of Health Technologies

10. Something Old, Something New, Something Borrowed: Emerging Health Technologies and the Continuing Role of Existing Regulations

11. Science, Law, and the Medical-Industrial Complex in EU Pharmaceutical Regulation: The Deferiprone Controversy

12. The Governance of Therapeutic Nanoproducts in the European Union - A Model for New Health Technology Regulation?

Part IV. New Techniques for Researching European Law and New Health Technologies

13. Taking Technology Seriously: STS as a Human Rights Method

14. Novel Rights-Based Approaches to Health Technologies

15. Sociotechnical Innovation in Mental Health: Articulating Complexity

16. Where the Wild Things Are: Xenotechnologies and European Hybrid Regulation

17. When Sperm Cannot Travel: Experiences of UK Fertility Patients Seeking Treatment Abroad

Part V. Bringing it All Together

18. A European Law of New Health Technologies?

Notes:

Includes bibliographical references and index.

CC BY-NC-ND

Description based on print version record.

Description based on publisher supplied metadata and other sources.

ISBN:

9780191748165

0191748161

9781299559189

1299559182

9780191634857

0191634859

9780191634840

0191634840

OCLC:

84288154