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The Defining Features of the European Union’s Approach to Regulating New Health Technologies

Gordon Bache, Mark L Flear, and Tamara K Hervey

in European Law and New Health Technologies

Published in print:
2013
Published Online:
May 2013
ISBN:
9780199659210
eISBN:
9780191748165
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199659210.003.0002
Subject:
Law, EU Law, Medical Law

This chapter determines the defining features of the relationships between EU law and new health technologies. It begins by mapping out the key elements of EU regulation of new health technologies. ... More


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

Keith Syrett

in European Law and New Health Technologies

Published in print:
2013
Published Online:
May 2013
ISBN:
9780199659210
eISBN:
9780191748165
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199659210.003.0006
Subject:
Law, EU Law, Medical Law

An ‘orphan drug’ technology may be defined as one which is developed for treating a rare medical condition. This chapter analyzes how the policy problem presented by orphan drug technologies has been ... More


European Law and New Health Technologies: The Research Agenda

Mark L Flear, Anne‐Maree Farrell, Tamara K Hervey, and Thérèse Murphy

in European Law and New Health Technologies

Published in print:
2013
Published Online:
May 2013
ISBN:
9780199659210
eISBN:
9780191748165
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199659210.003.0001
Subject:
Law, EU Law, Medical Law

This chapter first sets out the book's principal objective, which is to analyzes European law and its relationships with new health technologies. The collective research agenda focuses on the ... More


Risk, Legitimacy, and EU Regulation of Health Technologies

Anne‐Maree Farrell

in European Law and New Health Technologies

Published in print:
2013
Published Online:
May 2013
ISBN:
9780199659210
eISBN:
9780191748165
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199659210.003.0009
Subject:
Law, EU Law, Medical Law

This chapter explores the relationship between risk and legitimacy in the context of the EU regulation of health technologies. It focuses on EU-wide risk regulation regimes that have been established ... More


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

R O’Connell and S Gevers

in European Law and New Health Technologies

Published in print:
2013
Published Online:
May 2013
ISBN:
9780199659210
eISBN:
9780191748165
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199659210.003.0003
Subject:
Law, EU Law, Medical Law

This chapter examines the extent of the Council of Europe's involvement in the regulation of new health technologies (NHTs) and the nature of its interventions. The chapter is organized as follows. ... More


Innovative Tissue Engineering and Its Regulation—The Search for Flexible Rules for Emerging Health Technologies

Nils Hoppe

in European Law and New Health Technologies

Published in print:
2013
Published Online:
May 2013
ISBN:
9780199659210
eISBN:
9780191748165
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199659210.003.0005
Subject:
Law, EU Law, Medical Law

Advances in tissue engineering techniques have resulted in the potential for groundbreaking new health technologies for human use. A particularly promising field of tissue engineering is that of ... More


Govering the Spaces In‐Between: Law and Legitimacy in New Health Technologies

Amanda Warren‐Jones

in European Law and New Health Technologies

Published in print:
2013
Published Online:
May 2013
ISBN:
9780199659210
eISBN:
9780191748165
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199659210.003.0020
Subject:
Law, EU Law, Medical Law

This chapter draws on the author's experience as the former chair of the Ethics and Governance Council of the UK Biobank, and focuses on the limits of law and legal intervention in the regulation of ... More


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