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Intellectual Property: U.S. Trade Policy Guidance on WTO Declaration on Access to Medicines May Need Clarification

GAO-07-1198 Published: Sep 28, 2007. Publicly Released: Oct 30, 2007.
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The WTO Agreement on Trade-Related Intellectual Property (TRIPS) requires all 151 World Trade Organization (WTO) members to provide baseline protections, including 20-year patents for innovative pharmaceuticals. The Trade Act of 2002 granting Trade Promotion Authority (TPA) to the President outlined three negotiating objectives related to intellectual property (IP). The first two aim to strengthen IP rights and enforcement abroad. The third calls for respect of the WTO Doha Declaration on TRIPS and Public Health, which addresses access by developing countries to patented medicines, particularly in epidemic and emergency situations. This report (1) describes the Declaration and its interpretation by the United States and other nations; (2) analyzes how U. S. Trade Representative (USTR) has balanced respect for the Doha Declaration with the other two IP objectives in negotiating free trade agreements; and (3) evaluates the extent of public health input by agencies and the private sector. We reviewed official WTO and U.S. government documents, interviewed U.S. and foreign government officials, and obtained private sector views.

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Matter for Congressional Consideration

Matter Status Comments
If Congress disagrees with U.S. Trade Representative's interpretation and implementation of TPA guidance with regard to IP rights and public health, Congress may wish to specify more clearly its intentions for U.S. trade policy and public health policy input related to balancing public health concerns and the negotiation of IP rights in trade agreements.
Closed – Implemented
To assure an appropriate balance between IP rights and public health and access to medicines considerations, Congress is providing guidance to USTR in the context of consultations, such as on the Transpacific Partnership, as well as through other communications.

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Access to health careDeveloping countriesForeign aid programsForeign trade agreementsIntellectual propertyInternational agreementsInternational organizationsInternational relationsInternational tradeInternational trade regulationPatentsPharmaceutical industryPolicy evaluationProgram evaluationPublic healthTrade agreementsTrade policiesTrade regulationPolicies and procedures