Trends in compulsory licensing of pharmaceuticals since the Doha Declaration: a database analysis.

<h4>Background</h4>It is now a decade since the World Trade Organization (WTO) adopted the "Declaration on the TRIPS Agreement and Public Health" at its 4th Ministerial Conference in Doha. Many anticipated that these actions would lead nations to claim compulsory licenses (CLs)...

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Autores principales:	Reed Beall, Randall Kuhn
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2012
Materias:	Medicine R
Acceso en línea:	https://doaj.org/article/a2a511faa5784fbfa78381dc67cb3a5d
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spelling	oai:doaj.org-article:a2a511faa5784fbfa78381dc67cb3a5d2021-11-18T05:42:24ZTrends in compulsory licensing of pharmaceuticals since the Doha Declaration: a database analysis.1549-12771549-167610.1371/journal.pmed.1001154https://doaj.org/article/a2a511faa5784fbfa78381dc67cb3a5d2012-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/22253577/?tool=EBIhttps://doaj.org/toc/1549-1277https://doaj.org/toc/1549-1676<h4>Background</h4>It is now a decade since the World Trade Organization (WTO) adopted the "Declaration on the TRIPS Agreement and Public Health" at its 4th Ministerial Conference in Doha. Many anticipated that these actions would lead nations to claim compulsory licenses (CLs) for pharmaceutical products with greater regularity. A CL is the use of a patented innovation that has been licensed by a state without the permission of the patent title holder. Skeptics doubted that many CLs would occur, given political pressure against CL activity and continued health system weakness in poor countries. The subsequent decade has seen little systematic assessment of the Doha Declaration's impact.<h4>Methods and findings</h4>We assembled a database of all episodes in which a CL was publically entertained or announced by a WTO member state since 1995. Broad searches of CL activity were conducted using media, academic, and legal databases, yielding 34 potential CL episodes in 26 countries. Country- and product-specific searches were used to verify government participation, resulting in a final database of 24 verified CLs in 17 nations. We coded CL episodes in terms of outcome, national income, and disease group over three distinct periods of CL activity. Most CL episodes occurred between 2003 and 2005, involved drugs for HIV/AIDS, and occurred in upper-middle-income countries (UMICs). Aside from HIV/AIDS, few CL episodes involved communicable disease, and none occurred in least-developed or low-income countries.<h4>Conclusions</h4>Given skepticism about the Doha Declaration's likely impact, we note the relatively high occurrence of CLs, yet CL activity has diminished markedly since 2006. While UMICs have high CL activity and strong incentives to use CLs compared to other countries, we note considerable countervailing pressures against CL use even in UMICs. We conclude that there is a low probability of continued CL activity. We highlight the need for further systematic evaluation of global health governance actions. Please see later in the article for the Editors' Summary.Reed BeallRandall KuhnPublic Library of Science (PLoS)articleMedicineRENPLoS Medicine, Vol 9, Iss 1, p e1001154 (2012)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R
spellingShingle	Medicine R Reed Beall Randall Kuhn Trends in compulsory licensing of pharmaceuticals since the Doha Declaration: a database analysis.
description	<h4>Background</h4>It is now a decade since the World Trade Organization (WTO) adopted the "Declaration on the TRIPS Agreement and Public Health" at its 4th Ministerial Conference in Doha. Many anticipated that these actions would lead nations to claim compulsory licenses (CLs) for pharmaceutical products with greater regularity. A CL is the use of a patented innovation that has been licensed by a state without the permission of the patent title holder. Skeptics doubted that many CLs would occur, given political pressure against CL activity and continued health system weakness in poor countries. The subsequent decade has seen little systematic assessment of the Doha Declaration's impact.<h4>Methods and findings</h4>We assembled a database of all episodes in which a CL was publically entertained or announced by a WTO member state since 1995. Broad searches of CL activity were conducted using media, academic, and legal databases, yielding 34 potential CL episodes in 26 countries. Country- and product-specific searches were used to verify government participation, resulting in a final database of 24 verified CLs in 17 nations. We coded CL episodes in terms of outcome, national income, and disease group over three distinct periods of CL activity. Most CL episodes occurred between 2003 and 2005, involved drugs for HIV/AIDS, and occurred in upper-middle-income countries (UMICs). Aside from HIV/AIDS, few CL episodes involved communicable disease, and none occurred in least-developed or low-income countries.<h4>Conclusions</h4>Given skepticism about the Doha Declaration's likely impact, we note the relatively high occurrence of CLs, yet CL activity has diminished markedly since 2006. While UMICs have high CL activity and strong incentives to use CLs compared to other countries, we note considerable countervailing pressures against CL use even in UMICs. We conclude that there is a low probability of continued CL activity. We highlight the need for further systematic evaluation of global health governance actions. Please see later in the article for the Editors' Summary.
format	article
author	Reed Beall Randall Kuhn
author_facet	Reed Beall Randall Kuhn
author_sort	Reed Beall
title	Trends in compulsory licensing of pharmaceuticals since the Doha Declaration: a database analysis.
title_short	Trends in compulsory licensing of pharmaceuticals since the Doha Declaration: a database analysis.
title_full	Trends in compulsory licensing of pharmaceuticals since the Doha Declaration: a database analysis.
title_fullStr	Trends in compulsory licensing of pharmaceuticals since the Doha Declaration: a database analysis.
title_full_unstemmed	Trends in compulsory licensing of pharmaceuticals since the Doha Declaration: a database analysis.
title_sort	trends in compulsory licensing of pharmaceuticals since the doha declaration: a database analysis.
publisher	Public Library of Science (PLoS)
publishDate	2012
url	https://doaj.org/article/a2a511faa5784fbfa78381dc67cb3a5d
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Trends in compulsory licensing of pharmaceuticals since the Doha Declaration: a database analysis.

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