The Global Politics of Pharmaceutical Monopoly Power. Drug Patents, Access, Innovation and the Application of the WTO Doha Declaration on TRIPS and Public Health
(2009; 160 pages) [Russian]


The magnitude of the AIDS crisis has drawn attention to the fact that millions of people in the developing world do not have access to the medicines they need to treat disease or alleviate suffering. The high cost of AIDS medicines has focused attention on the relationship between patent protection and high drug prices. The difficulties developing countries experience in paying for new essential medicines has raised concerns about the effects of the 1994 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which mandates global minimum standards for the protection of intellectual property (IP).

Most significantly, the TRIPS Agreement harmonized patent terms for a minimum of 20 years and mandated the granting of patents in all fields of technology; this requirement made it no longer possible to exclude medicines and food from patenting. The full implications of the TRIPS Agreement for health are just beginning to emerge, but will only become fully apparent in the years to come. All new health products, including drugs, vaccines and diagnostics, are likely to be affected by the new TRIPS-based patent regime.

The Fourth WTO Ministerial Conference, held in 2001 in Doha, Qatar, responded to these concerns by adopting the Declaration on TRIPS and Public Health. The Doha Declaration, as it is widely known, affirmed the sovereign right of governments to take measures to protect public health, including the use of compulsory licensing and parallel importation. It also allowed least developed countries (LDCs) not to grant or enforce pharmaceutical product patents until at least 2016. These measures have become known as the "TRIPS flexibilities."

A key issue that remained unresolved in Doha was how to ensure that products manufactured under a compulsory license could be exported to countries without domestic production capacity. It took two years of difficult negotiations at the WTO to arrive at the "August 30th" decision, which established a cumbersome process to allow such export; to date, it has been used by only one country. The Doha Declaration also did not address the as-yet-unfulfilled promises of increased R&D in exchange for higher levels of IP protection, an expectation that was part of the bargain when countries were negotiating the TRIPS Agreement.

Nevertheless, the Doha Declaration is one of the most significant developments of the last decade in trade and health. It signalled a sea change in thinking about patents and medicines, and is at the root of a cascade of activities aimed at reformulating IP protection as a social policy tool for the benefit of society as a whole, rather than a mechanism to protect only limited commercial interests...

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