The Promise of Doha
In 1994, Members of the World Trade Organization (WTO) adopted the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). 61 The agreement ushered in a new era of intellectual property (IP) protection. Previously, countries had vastly different levels of protection for patents. 62
TRIPS changed all this. TRIPS mandated 20 years of patent protection across all fields. No longer could countries exclude medicines and food from patenting, or adjust the length of patent of protection to reflect their level of development. Countries across the world—Brazil, South Africa, Thailand—soon realised that TRIPS, despite its safeguards for public health, was restricting their ability to address the HIV epidemic. 63
The United States, along with the European Union and a handful of countries, became global IP enforcers at the request of their pharmaceutical industries. As the PMA case was developing in South Africa, the US sued Brazil in an international tribunal over its IP law. The US also warned Thailand against issuing compulsory licenses—or giving a company a license to produce a patented product without the consent of the patent owner. Activists attacked the moves as attempts to restrict access to more affordable generic medicines that threatened the HIV response. Public outrage grew.
Meanwhile, the US was itself confronted with the limits of patent law when a series of letters containing the highly toxic anthrax bacteria were mailed across the country, killing five people and infecting 17 others. Worried about the price and production capacity for the treatment, the US government suggested it would consider issuing compulsory licenses for ciprofloxacin. Bayer, the manufacturer, announced a 50% discount and guaranteed a secure supply a few days later. 64 Civil society and trade representatives from the Global South balked at the double standard.
In 2001, the Fourth WTO Ministerial Conference brought all these tensions to the fore in Doha, Qatar. Members from the Global South insisted that the public health consequences of TRIPS be addressed. Their united front helped lead to the Doha Declaration on Public Health 65 —a landmark document that affirmed the right of governments to take measures to protect public health, and pushed back on increasing IP protections. Paragraph Four read:
- We agree that the TRIPS Agreement does not and should not prevent
- Members from taking measures to protect public health. Accordingly,
- while reiterating our commitment to the TRIPS Agreement, we affirm
- that the Agreement can and should be interpreted and implemented in
- a manner supportive of WTO Members’ right to protect public health
- and, in particular, to promote access to medicines for all.
Paragraph Five noted that Members had the right to issue compulsory licenses, and import patented medicines from abroad. By clarifying the scope of TRIPS safeguards, the Doha Declaration was supposed to pave the way for bold government action to address public health challenges.
But sixteen years later, the promise of Doha has largely not been realised. The use of TRIPS safeguards to increase access to medicines remains infrequent—even if more than commonly assumed—and largely limited to HIV medicines. 66 To be sure, in recent years, India has issued a compulsory license for a cancer medicine and Malaysia for a hepatitis C cure. And yet in the most tragic of twists, South Africa, an instrumental force behind the Doha Declaration, has never really taken advantage of TRIPS safeguards. The government has yet to issue a compulsory license. Nor has it simplified its unwieldy compulsory license laws to allow third-parties to request licenses more easily.
Driving this reluctance, in part, has been immense political pressure. Although the US agreed to the Doha Declaration, US trade policy never changed. Instead, the US continues to impose significant pressure on countries to not use TRIPS flexibilities, and extend the highest levels of intellectual property protection. Governments that seek to use TRIPS flexibilities are singled out and put on the US Special 301 Watch List. Pushing new trade agreements, the US also seeks to extend IP protections beyond the level mandated by TRIPS.
By uniting around a single goal, Global South countries were remarkably effective in combatting US pressure during the Doha Round. To date, countries like South Africa, India and Brazil lead the effort to preserve TRIPS flexibilities at international forums. They have not, however, attempted to work in concert to implement TRIPS flexibilities. For example, there has never been a coordinated approach to issue compulsory licenses for a single medicine. Activists have sought to coordinate their work, such as opposing patents, across countries with some success. But governments remain isolated. Just as the US pressure was not enough to overcome the collaboration of these countries in developing the Doha Declaration, so it may not be enough to hinder compulsory licensing or parallel imports if done together.
- AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS (1994), available at https://www.wto.org/english/docs_e/legal_e/31bis_trips_01_e.htm.
- A patent is a reward that is given to a company that allows it to sell a product with no competition from other companies.
- Ellen F.M. ‘t Hoen, THE GLOBAL POLITICS OF PHARMACEUTICAL MONOPOLY POWER 19-35 (2009).
- Amy Kapczynski & Aaron Kesselheim, Government Patent Use: A Legal Approach to Reducing Drug Spending, 5 HEALTH AFFAIRS (2016).
- DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH (2001), available at https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm.
- Ellen t’Hoen et al., 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), available at http://www.who.int/bulletin/volumes/96/3/17-199364/en/