Loading
The 1994 world trade treaty that obliged every member country to grant twenty-year patents on medicines, and the 2001 declaration confirming that countries may still issue compulsory licences and protect public health; together they set the global terms on which cancer drugs are priced and copied.
International, treaty and ministerial declaration. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was concluded in the Uruguay Round in 1994 and entered into force with the World Trade Organization on 1 January 1995. The Doha Declaration on the TRIPS Agreement and Public Health was adopted by WTO ministers on 14 November 2001. Primary text: the WTO's TRIPS and Doha pages.
What TRIPS requires and allows: minimum standards for all members, including patents of at least twenty years for inventions in all fields of technology, which ended the exclusion of pharmaceuticals from patenting in India, Brazil and many other countries; transition periods to 2005 for developing countries and, for pharmaceuticals in least-developed countries, extended to 2033; protection of undisclosed test data (Article 39.3); and 'flexibilities', notably compulsory licensing (Article 31), parallel importation and the freedom to define patentability criteria. Doha confirmed that the agreement 'can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health', that each member may determine what constitutes a national emergency, and led to the 2003 waiver, made permanent as Article 31bis in 2017, allowing compulsory licences for export to countries without manufacturing capacity.
Why it matters for oncology and the arguments: the fight was first about HIV medicines, but the tools were then used for cancer, in India's Nexavar licence of 2012, Malaysia's and Colombia's actions on imatinib and other drugs, and the WHO's calls for fair pricing; the 2022 waiver for COVID-19 vaccines showed how contested the flexibilities remain. Industry argues that patents fund the drugs that later become generic everywhere; access campaigners argue that 'TRIPS-plus' terms in bilateral trade agreements, such as data exclusivity and patent term extension, have narrowed the room Doha preserved.
Shares the tags law, intl.
Shares the tags law, intl.
Shares Supplementary protection certificate (EU), EU data and market protection (8+2+1), US regulatory exclusivity periods, Prices and value and the tag law.
Shares EU data and market protection (8+2+1), US regulatory exclusivity periods, Hatch-Waxman Act 1984, Prices and value and the tag law.
Shares Novartis v. Union of India (Glivec, 2013), Nexavar compulsory licence (India, 2012), Global oncology and access in low- and middle-income countries, Most of the world has almost no cancer care and the tag law.
Shares WHO Essential Medicines List for cancer, Global oncology and access in low- and middle-income countries, Prices and value, Most of the world has almost no cancer care and the tag law.
Shares US regulatory exclusivity periods, Hatch-Waxman Act 1984, Prices and value and the tag law.
Shares US regulatory exclusivity periods, Hatch-Waxman Act 1984 and the tag law.