The Agreement on Trade-Related Aspects of Intellectual Property Rights, TRIPS, took effect with the WTO in 1995. For the first time it obliged every member to grant patents in all fields of technology, including pharmaceuticals, for at least twenty years. Countries such as India and Brazil, which had built generic drug industries under laws that excluded medicines from patenting, had to change course, with transition periods that ran until 2005.
The AIDS crisis and Doha
By the late 1990s antiretroviral therapy cost more than ten thousand dollars per patient per year, far out of reach for African health systems, while Indian generics could be made for a few hundred. When South Africa passed a law to import cheaper medicines, 39 pharmaceutical companies sued and withdrew only under public pressure in 2001. Later that year the Doha Ministerial Declaration on TRIPS and Public Health affirmed that the agreement “can and should be interpreted” to protect public health and that members are free to grant compulsory licences. A 2003 decision, made permanent as a TRIPS amendment in 2017, allowed countries without manufacturing capacity to import under such licences.
The flexibilities
The main tools are compulsory licensing (a government authorises production without the patent holder’s consent, against a royalty), parallel importation (buying the patented product where it is cheapest), strict patentability criteria such as India’s rule against patents on minor modifications, and the least-developed-country exemption for pharmaceutical patents, which has been extended to 2033. Regional trade agreements have often demanded “TRIPS-plus” rules that limit these flexibilities, which is why the topic never left the negotiating table.
Biodiversity and traditional knowledge
TRIPS also clashed with the Convention on Biological Diversity over patents on plant varieties and genetic resources. After two decades of talks, WIPO members adopted a treaty in May 2024 that requires patent applicants to disclose the origin of genetic resources and associated traditional knowledge.
COVID-19
In 2020 India and South Africa proposed a broad TRIPS waiver for COVID-19 products. The WTO agreed a much narrower compromise on vaccine patents in June 2022; its extension to treatments and diagnostics was not agreed. The debate over whether patents or manufacturing capacity were the real bottleneck continues.
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