Warren-Jones, A. (2016) Regulatory justifications: regulating European medicines to maximise market potential. Law, Innovation and Technology , 8 (1). pp. 61-99. ISSN 1757-9961
Abstract
The justification for regulating is generally considered to rely on benefitting interested groups. Whereas the traditional view is that regulators act as impartial arbiters balancing competing public and private interests, modern accounts consider regulation to be dominated by single interests, such as those of industry. This article challenges these theories by arguing that regulators are substantively (not just procedurally) motivated to justify their actions according to the goals set for them by the bodies that empower them. In consequence, regulators understand their goals as market-based objectives, prompting them to focus on maximising market potential. This is demonstrated in the context of regulating medicines in Europe, through the European Patent Organisation, the CJEU, and the European Medicines Agency. The analysis identifies that regulating to achieve market benefits is a better predictor of regulatory behaviour, but this behaviour frustrates goal-achievement (relating to effective and affordable medicines) and only incidentally enables benefits to accrue to specific groups.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2016 Informa UK Limited, trading as Taylor & Francis Group. This is an author produced version of a paper subsequently published in Law, Innovation and Technology. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | Regulatory theory; Public and private interests; administrative decision-making; medicines regulation; patents; market authorisation |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Social Sciences (Sheffield) > School of Law (Sheffield) |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 28 Apr 2016 08:59 |
Last Modified: | 22 Oct 2017 15:49 |
Published Version: | http://dx.doi.org/10.1080/17579961.2016.1161890 |
Status: | Published |
Publisher: | Taylor & Francis |
Refereed: | Yes |
Identification Number: | 10.1080/17579961.2016.1161890 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:98829 |