Medicine Procurement and the Use of Flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001–2016

Bulletin of the World Health Organization 2018;96:185–193

University of Groningen Faculty of Law Research Paper No. 15/2019

9 Pages Posted: 30 May 2019 Last revised: 18 Jun 2019

See all articles by Ellen 't Hoen

Ellen 't Hoen

affiliation not provided to SSRN

Jacquelyn D Veraldi

Trinity College, University of Cambridge

Brigit Toebes

University of Groningen - Faculty of Law

Hans Hogerzeil

University of Groningen

Date Written: 2018

Abstract

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.

Keywords: TRIPS, access to medicines, compulsory licensing, global health

Suggested Citation

't Hoen, Ellen and Veraldi, Jacquelyn D and Toebes, Brigit and Hogerzeil, Hans, Medicine Procurement and the Use of Flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001–2016 (2018). Bulletin of the World Health Organization 2018;96:185–193, University of Groningen Faculty of Law Research Paper No. 15/2019, Available at SSRN: https://ssrn.com/abstract=3384083

Ellen 't Hoen

affiliation not provided to SSRN

Jacquelyn D Veraldi (Contact Author)

Trinity College, University of Cambridge ( email )

United Kingdom

Brigit Toebes

University of Groningen - Faculty of Law ( email )

9700 AH Groningen
Netherlands

Hans Hogerzeil

University of Groningen ( email )

P.O. Box 800
9700 AH Groningen, Groningen 9700 AV
Netherlands

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