The Regulation of Medical Products

Dope, Drugs and Devices

Penny Gleeson (Deakin University, Australia.)

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Hardback

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English

Routledge
31 December 2024

Public administration; Systems of law; Medical & healthcare law; Personal & public health; Medicolegal issues

Series: Law, Science and Society

This book develops a theoretical framework for examining and assessing the regulatory arrangements for medical products.

Since the first half of the 20th century, the regulation of pharmaceuticals, medical devices and, more recently, biologicals have been controlled in many jurisdictions by specific regulatory regimes and agencies. Their regulatory mandates are similar – to ensure the quality, safety and efficacy of medical products. This book provides a timely and relevant assessment of the complexities of medical regulatory regimes, by drawing on a particular theory of political legitimacy. In this respect, the book adopts a ‘dialogic’ approach – according to which a shared set of normative beliefs and values are formulated – as a theoretical ‘tool’ to identify deficiencies in the regulatory arrangements for medical products. Drawing on several Australian cases studies, characterised by divergent normative perspectives, the book develops its dialogic approach in order to challenge the usual legitimation of regulatory regimes from the perspective of science alone. Specifically, it maintains that such regimes need to embrace a normative pluralism that admits a diversity of types and sources of knowledge.

This evaluation of the increasingly influential domain of medical regulation will appeal to a range of scholars and practitioners working in law, public health, politics and science and technology studies.

By: Penny Gleeson (Deakin University Australia.)
Imprint: Routledge
Country of Publication: United Kingdom
Dimensions: Height: 234mm, Width: 156mm,
Weight: 453g
ISBN: 9781032277127
ISBN 10: 1032277122
Series: Law, Science and Society
Pages: 276
Publication Date: 31 December 2024
Audience: College/higher education , Professional and scholarly , Further / Higher Education , Undergraduate
Format: Hardback
Publisher's Status: Active

1. Introduction 2. The Foundations of the Regulation of Medical Products 3. A Constant Dialogic Approach to Political Legitimacy 4. Voices of Change: Regulatory Reform of Medicinal Cannabis in Australia 5. A Normative Void: The Regulation of Medical Abortion in Australia 6. The Regulation of Urogynaecological Mesh Devices in Australia: Shouting to be Heard 7. Regulatory Challenges, Courage and Evolution 8. Conclusion

Penny Gleeson is Lecturer at Deakin Law School, Melbourne, Australia.