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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


A European Law of New Health Technologies?

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/9780199659210.003.0018
Subject:
Law, EU Law, Medical Law

This chapter reflects on the relationships between European law and new health technologies. In so doing, it asks a further question: To what extent does the current investigation define a new field ... 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


The Promise of European Regulation of New Health Technologies in a Time of Ageing Populations

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/9780199659210.003.0021
Subject:
Law, EU Law, Medical Law

This chapter emphasizes two aspects for discussions of health technologies: their contribution to the improvement of personal and public health and their growing importance in the cost determination ... More


Sociotechnical Innovation in Mental Health: Articulating Complexity

Martyn Pickersgill

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/9780199659210.003.0015
Subject:
Law, EU Law, Medical Law

This chapter examines the ways in which, in an era of costly, high-tech biomedical apparatuses and treatments, a simple book has acted — and continues to act — as an innovative health technology: the ... More


Regulating New Technologies: EU Internal Market Law, Risk, and Socio-Technical Order

Mark L. Flear

in New Technologies and EU Law

Published in print:
2017
Published Online:
July 2017
ISBN:
9780198807216
eISBN:
9780191844935
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780198807216.003.0004
Subject:
Law, EU Law

The chapter argues that, more than playing catch up with and being determined by technoscientific innovation, law also plays a leading role in the regulation of new technologies by shaping and ... More


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

Amanda Odell‐West

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/9780199659210.003.0007
Subject:
Law, EU Law, Medical Law

This chapter considers the effects of the ‘medical’ and ‘morality’ exclusions in patent law on new health technologies. It begins by outlining the legal framework for patents in Europe and describing ... More


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

Bärbel Dorbeck‐Jung

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/9780199659210.003.0012
Subject:
Law, EU Law, Medical Law

This chapter examines the EU's regulation of therapeutic nanoproducts. The first section discusses the potential benefits and risks of therapeutic nanoproducts. The second section explores regulatory ... 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


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

Elen Stokes

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/9780199659210.003.0010
Subject:
Law, EU Law, Medical Law

This chapter examines the role and interpretation of ‘newness’ in EU regulatory and policy debates. It begins by looking at the debate on nanotechnologies. It shows that while the contours of ... More


New Health Technologies and Their Impact on EU Product Liability Regulations

Monica Navarro‐Michel

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/9780199659210.003.0008
Subject:
Law, EU Law, Medical Law

This chapter examines the impact of new health technologies on EU product liability law, with particular reference to risks, markets, and rights. It reveals a lack of uniformity at the Member State ... 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


Taking Technology Seriously: STS as a Human Rights Method

Thérèse Murphy and Gearóid Ó Cuinn

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/9780199659210.003.0013
Subject:
Law, EU Law, Medical Law

Science and technology studies (STS) is a relatively young academic field that has developed from the 1970s onwards. Today it encompasses a range of scholarly perspectives and, as a result, a range ... 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


Novel Rights‐Based Approaches to Health Technologies

Richard Ashcroft

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/9780199659210.003.0014
Subject:
Law, EU Law, Medical Law

This chapter discusses the development of a normative framework for European governance of biomedicine, and the institutionalization of a human rights approach. It begins with a brief description of ... More


Where the Wild Things Are: Xenotechnologies and European Hybrid Regulation

Siân Beynon‐Jones and Nik Brown

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/9780199659210.003.0016
Subject:
Law, EU Law, Medical Law

This chapter analyzes the regulation of xenotechnologies in Europe, focusing on the implications of this process for humans and other animals. It argues that, although processes of purification and ... More


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

Ilke Turkmendag

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/9780199659210.003.0017
Subject:
Law, EU Law, Medical Law

Assisted reproduction technology (ART) is a term referring to any technique or medical intervention that enables individuals to procreate, where such procreation would be unlikely to occur otherwise. ... More


Regulating Embryo Research

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/9780199659210.003.0022
Subject:
Law, EU Law, Medical Law

This chapter by the former deputy chair of the UK's Human Fertilisation and Embryology Authority (HFEA), provides a brief personal overview of some of the challenges faced by the HFEA in recent ... More


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