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    Rights statement: This is the peer reviewed version of the following article Brooks, E. and Geyer, R. (2016), Whatever happened to the Norwegian Medical Need Clause? Lessons for current debates in EU pharmaceutical regulation. Sociology of Health & Illness, 38: 576–591. doi: 10.1111/1467-9566.12379 which has been published in final form at http://onlinelibrary.wiley.com/doi/10.1111/1467-9566.12379/abstract This article may be used for non-commercial purposes in accordance With Wiley Terms and Conditions for self-archiving.

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Whatever happened to the Norwegian medical need clause?: lessons for current debates in EU pharmaceutical regulation

Research output: Contribution to journalJournal article

Published
<mark>Journal publication date</mark>05/2016
<mark>Journal</mark>Sociology of Health and Illness
Issue number4
Volume38
Number of pages16
Pages (from-to)576-591
Publication statusPublished
Early online date13/11/15
Original languageEnglish

Abstract

Until 1994, pharmaceutical products seeking market authorisation in Norway were required to demonstrate a fulfilment of unmet medical need. This clause enabled the national regulator to dramatically limit the number of products on the market whilst encouraging price competition to keep drug expenditure low and was credited with encouraging the development of drugs with genuine added therapeutic value and reducing the incidence of antimicrobial resistance. Norway was forced to abandon its Medical Need Clause (MNC) when it joined the European Economic Area as it was incompatible with the acquis communautaire of the European Union. This article reviews Norway's experience with its MNC in light of contemporary debates in European health policy. It discusses the potential contribution of an MNC-style regulation to improving health, reducing illness, ensuring sustainable health systems and fostering pharmaceutical innovation. It concludes by asking how these findings can inform current European Union debates over the growing cost of prescription drugs and direction of pharmaceutical development.

Bibliographic note

This is the peer reviewed version of the following article Brooks, E. and Geyer, R. (2016), Whatever happened to the Norwegian Medical Need Clause? Lessons for current debates in EU pharmaceutical regulation. Sociology of Health & Illness, 38: 576–591. doi: 10.1111/1467-9566.12379 which has been published in final form at http://onlinelibrary.wiley.com/doi/10.1111/1467-9566.12379/abstract This article may be used for non-commercial purposes in accordance With Wiley Terms and Conditions for self-archiving.