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.The authors state
The extent to which countries have deployed TRIPS flexibilities, such as compulsory licences or public noncommercial use licences, for procuring medicines remains underreported. Previous studies have documented well-known and widely publicized cases of compulsory licensing, but have not examined the use of TRIPS flexibilities in procurement. Moreover, several reports in the literature perpetuate the belief that, since 2001, the use of TRIPS flexibilities has been sporadic and limited.
The aim of our study was to document the use of TRIPS flexibilities to gain access to lower-priced generic medicines. Although we recognized that the TRIPS Agreement offers a range of flexibilities relevant to national pharmaceutical and patenting policies, including the right of countries to define and apply patentability criteria and to refuse to grant patents for certain subject matter (e.g. plants and animals), we focused on measures that can be directly applied to the procurement and supply of medicines. The most relevant measures for increasing access to medicines were: (i) compulsory licensing (including public noncommercial use licensing); (ii) the least-developed countries pharmaceutical transition measure; (iii) parallel importation; and (iv) the research exception. Parallel importation is the importation and resale of a product from another country (where the same product is legitimately on sale at a lower price) without the consent of the patent holder. The research exception refers the use of a patented product or process for research or experimentation without the consent of the patent holder.