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An antibiotic’s journey from marketing authorization to use, Norway

Here we describe in detail marketing authorization and reimbursement procedures for medicinal products in Norway, with particular reference to nine novel antibiotics that received marketing authorization between 2005 and 2015. The description illustrates that, in places like Norway, with effective a...

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Autores principales: Årdal, Christine, Blix, Hege Salvesen, Plahte, Jens, Røttingen, John-Arne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: World Health Organization 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5328106/
https://www.ncbi.nlm.nih.gov/pubmed/28250535
http://dx.doi.org/10.2471/BLT.16.172874
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author Årdal, Christine
Blix, Hege Salvesen
Plahte, Jens
Røttingen, John-Arne
author_facet Årdal, Christine
Blix, Hege Salvesen
Plahte, Jens
Røttingen, John-Arne
author_sort Årdal, Christine
collection PubMed
description Here we describe in detail marketing authorization and reimbursement procedures for medicinal products in Norway, with particular reference to nine novel antibiotics that received marketing authorization between 2005 and 2015. The description illustrates that, in places like Norway, with effective antibiotic stewardship policies and an associated low prevalence of antibiotic-resistant bacterial infection, there is little need for newer, more expensive antibiotics whose therapeutic superiority to existing compounds has not been demonstrated. Since resistance begins to emerge as soon as an antibiotic is used, Norway’s practice of leaving newer antibiotics on the shelf is consistent with the goal of prolonging the effectiveness of newer antibiotics. An unintended consequence is that the country has signalled to the private sector that there is little commercial value in novel antibiotics, which may nevertheless still be needed to treat rare or emerging infections. Every country aims to improve infection control and to promote responsible antibiotic use. However, as progress is made, antibiotic-resistant bacteria should become less common and, consequently, the need for, and the commercial value of, novel antibiotics will probably be reduced. Nevertheless, antibiotic innovation continues to be essential. This dilemma will have to be resolved through the introduction of alternative reward systems for antibiotic innovation. The DRIVE-AB (Driving re-investment in research and development and responsible antibiotic use) research consortium in Europe has been tasked with identifying ways of meeting this challenge.
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spelling pubmed-53281062017-03-02 An antibiotic’s journey from marketing authorization to use, Norway Årdal, Christine Blix, Hege Salvesen Plahte, Jens Røttingen, John-Arne Bull World Health Organ Policy & Practice Here we describe in detail marketing authorization and reimbursement procedures for medicinal products in Norway, with particular reference to nine novel antibiotics that received marketing authorization between 2005 and 2015. The description illustrates that, in places like Norway, with effective antibiotic stewardship policies and an associated low prevalence of antibiotic-resistant bacterial infection, there is little need for newer, more expensive antibiotics whose therapeutic superiority to existing compounds has not been demonstrated. Since resistance begins to emerge as soon as an antibiotic is used, Norway’s practice of leaving newer antibiotics on the shelf is consistent with the goal of prolonging the effectiveness of newer antibiotics. An unintended consequence is that the country has signalled to the private sector that there is little commercial value in novel antibiotics, which may nevertheless still be needed to treat rare or emerging infections. Every country aims to improve infection control and to promote responsible antibiotic use. However, as progress is made, antibiotic-resistant bacteria should become less common and, consequently, the need for, and the commercial value of, novel antibiotics will probably be reduced. Nevertheless, antibiotic innovation continues to be essential. This dilemma will have to be resolved through the introduction of alternative reward systems for antibiotic innovation. The DRIVE-AB (Driving re-investment in research and development and responsible antibiotic use) research consortium in Europe has been tasked with identifying ways of meeting this challenge. World Health Organization 2017-03-01 2017-01-19 /pmc/articles/PMC5328106/ /pubmed/28250535 http://dx.doi.org/10.2471/BLT.16.172874 Text en (c) 2017 The authors; licensee World Health Organization. This is an open access article distributed under the terms of the Creative Commons Attribution IGO License (http://creativecommons.org/licenses/by/3.0/igo/legalcode), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any reproduction of this article there should not be any suggestion that WHO or this article endorse any specific organization or products. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL.
spellingShingle Policy & Practice
Årdal, Christine
Blix, Hege Salvesen
Plahte, Jens
Røttingen, John-Arne
An antibiotic’s journey from marketing authorization to use, Norway
title An antibiotic’s journey from marketing authorization to use, Norway
title_full An antibiotic’s journey from marketing authorization to use, Norway
title_fullStr An antibiotic’s journey from marketing authorization to use, Norway
title_full_unstemmed An antibiotic’s journey from marketing authorization to use, Norway
title_short An antibiotic’s journey from marketing authorization to use, Norway
title_sort antibiotic’s journey from marketing authorization to use, norway
topic Policy & Practice
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5328106/
https://www.ncbi.nlm.nih.gov/pubmed/28250535
http://dx.doi.org/10.2471/BLT.16.172874
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