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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

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Whatever happened to the Norwegian medical need clause? lessons for current debates in EU pharmaceutical regulation. / Brooks, Ellie; Geyer, Robert.

In: Sociology of Health and Illness, Vol. 38, No. 4, 05.2016, p. 576-591.

Research output: Contribution to Journal/MagazineJournal articlepeer-review

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Brooks E, Geyer R. Whatever happened to the Norwegian medical need clause? lessons for current debates in EU pharmaceutical regulation. Sociology of Health and Illness. 2016 May;38(4):576-591. Epub 2015 Nov 13. doi: 10.1111/1467-9566.12379

Author

Brooks, Ellie ; Geyer, Robert. / Whatever happened to the Norwegian medical need clause? lessons for current debates in EU pharmaceutical regulation. In: Sociology of Health and Illness. 2016 ; Vol. 38, No. 4. pp. 576-591.

Bibtex

@article{aaa126dc6e024a0a9b50b2978db17a09,
title = "Whatever happened to the Norwegian medical need clause?: lessons for current debates in EU pharmaceutical regulation",
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.",
keywords = "European Union, pharmaceuticals, health, innovation, regulation, added therapeutic value, drug market, medical need clause",
author = "Ellie Brooks and Robert Geyer",
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.",
year = "2016",
month = may,
doi = "10.1111/1467-9566.12379",
language = "English",
volume = "38",
pages = "576--591",
journal = "Sociology of Health and Illness",
issn = "0141-9889",
publisher = "Blackwell Publishing Ltd",
number = "4",

}

RIS

TY - JOUR

T1 - Whatever happened to the Norwegian medical need clause?

T2 - lessons for current debates in EU pharmaceutical regulation

AU - Brooks, Ellie

AU - Geyer, Robert

N1 - 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.

PY - 2016/5

Y1 - 2016/5

N2 - 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.

AB - 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.

KW - European Union

KW - pharmaceuticals

KW - health

KW - innovation

KW - regulation

KW - added therapeutic value

KW - drug market

KW - medical need clause

U2 - 10.1111/1467-9566.12379

DO - 10.1111/1467-9566.12379

M3 - Journal article

VL - 38

SP - 576

EP - 591

JO - Sociology of Health and Illness

JF - Sociology of Health and Illness

SN - 0141-9889

IS - 4

ER -