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Bull World Health Organ. 2018 Mar 1;96(3):185-193. doi: 10.2471/BLT.17.199364. Epub 2018 Feb 5.

Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001-2016.

Author information

1
Global Health Unit, Department of Health Sciences, University Medical Centre Groningen, University of Groningen, PO Box 30.001, Groningen, 9700 RB, the Netherlands.
2
Faculty of Law, University of Groningen, Groningen, the Netherlands.
3
Department of International Law, University of Groningen, Groningen, the Netherlands.

Abstract

in English, Arabic, Chinese, French, Russian, Spanish

Millions of people, particularly in low- and middle-income countries, lack access to effective pharmaceuticals, often because they are unaffordable. The 2001 Ministerial Conference of the World Trade Organization (WTO) adopted the Doha Declaration on the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement and Public Health. The declaration recognized the implications of intellectual property rights for both new medicine development and the price of medicines. The declaration outlined measures, known as TRIPS flexibilities, that WTO Members can take to ensure access to medicines for all. These measures include compulsory licensing of medicines patents and the least-developed countries pharmaceutical transition measure. The aim of this study was to document the use of TRIPS flexibilities to access lower-priced generic medicines between 2001 and 2016. Overall, 176 instances of the possible use of TRIPS flexibilities by 89 countries were identified: 100 (56.8%) involved compulsory licences or public noncommercial use licences and 40 (22.7%) involved the least-developed countries pharmaceutical transition measure. The remainder were: 1 case of parallel importation; 3 research exceptions; and 32 non-patent-related measures. Of the 176 instances, 152 (86.4%) were implemented. They covered products for treating 14 different diseases. However, 137 (77.8%) concerned medicines for human immunodeficiency virus infection and acquired immune deficiency syndrome or related diseases. The use of TRIPS flexibilities was found to be more frequent than is commonly assumed. Given the problems faced by countries today in procuring high-priced, patented medicines, the practical, legal pathway provided by TRIPS flexibilities for accessing lower-cost generic equivalents is increasingly important.

PMID:
29531417
PMCID:
PMC5840629
DOI:
10.2471/BLT.17.199364
[Indexed for MEDLINE]
Free PMC Article

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