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UNAIDS Policy Brief: Using TRIPS flexibility to improve access to HIV treatment

The right of every human being to access the highest attainable standards of health is now fully recognized by numerous national constitutions and legally binding international human rights treaties. Access to essential medicines is now established as a part of the right to health. In the context of HIV, this includes access to antiretroviral drugs and other medicines essential for HIV care, including medicines for the treatment of opportunistic infections such as tuberculosis.

This paper reviews how countries can successfully use the flexibilities of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to increase access to HIV treatment. The Millennium Declaration set in 2001 the goal to achieve, by 2010, universal access to treatment for HIV/AIDS for all those who need it (Goal 6, Target 2).

This was reaffirmed in the Political Declaration on HIV/AIDS highlighting the flexibilities of the TRIPS Agreement to improve access to treatment. The World Health Organization (WHO) Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property urges governments to “consider, whenever necessary, adapting national legislation in order to use to the full the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights, including those recognized by the Doha Declaration on TRIPS Agreement and Public Health and the WTO decision of 30 August 2003” (WHO 2008b).

Antiretroviral therapy significantly reduces morbidity and mortality among people living with HIV (Braitstein et al. 2006). As of December 2009, an estimated 5.2 million people living with HIV in low- and middle-income countries were receiving antiretroviral therapy, a 12-fold increase since 2003 (WHO 2010). The new 2010 WHO HIV treatment guidelines for adults and adolescents recommend starting HIV treatment at a CD4 count of 350 cells/mm to reduce HIVrelated mortality and to prevent opportunistic infections such as tuberculosis (WHO 2009).

This change has increased the number of people estimated to be in need of antiretroviral therapy at the end of 2009, from 10.1 million to nearly 15 million. The situation is even more urgent among children living with HIV: in December 2009, it was estimated that only 355 000 children under the age of 15 years living with HIV were receiving antiretroviral therapy. Despite progress, nearly 10 million of the estimated 15 million people needing antiretroviral therapy are without access to treatment, making it absolutely critical to accelerate programme delivery to reach universal access goals. In July 2010, UNAIDS and WHO launched the Treatment 2.0 platform, which aims to accelerate access to more effective and less toxic drug combinations and diagnostics and to start antiretroviral therapy earlier. Treatment 2.0 acknowledges the positive consequences of treatment on reduced HIV transmission and aims to remove cost as a barrier to treatment.

What is TRIPS and why does it matter?
In January 1995, when WTO was created, the TRIPS Agreement, building on the existing multilateral treaties administered by the World Intellectual Property Organization (WIPO), introduced minimum standards for protecting and enforcing intellectual property rights to an extent previously unseen at the global level, including new monitoring and dispute settlement mechanisms. Article 27.1 of the Agreement requires WTO Members to make patents “available for any inventions, whether products or processes, in all fields of technology”, which includes patents for pharmaceutical processes and products. The minimum term of protection that a country must make available under the TRIPS Agreement is 20 years from the filing date of a patent application. In 1986, at the start of the Uruguay Round, the eighth round of multilateral trade negotiations, countries were free to determine the duration of patents; about 50 countries did not grant patent protection for pharmaceutical products at all, while some also excluded pharmaceutical processes. When TRIPS was introduced in 1994, it reduced the discretionary powers of WTO Members to customize key elements of their national intellectual property regimes. (March 2011)

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