Comments to USTR on the Special 301 Out of Cycle Reivew of Thai Intellectual Property

December 7, 2010

Ambassador Ron Kirk
United States Trade Representative
600 17th Street NW
Washington, DC 20508

RE: 2010 Special 301 Out-of-Cycle Review - Docket # USTR-2010-0035

Last February, faculty and staff from American University’s Program on Information Justice and Intellectual Property acted as counsel for a coalition of public health NGOs that submitted detailed comments for the Special 301 Report.[1]   We argued that USTR should not identify nations in the Special 301 Report for the use of TRIPS-compliant intellectual property laws and/or practices that promote access to medicines.  Use of Special 301 to promote TRIPS-plus restrictions on access to medicines violates a number of American obligations and interests, including:

  • The TRIPS Agreement Article 8, guaranteeing that all Members may “adopt measures necessary to protect public health.” [2]
  • The 2001 Doha Declaration on TRIPS and Public Health, upholding “the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility” to “promote access to medicines for all.”  [emphasis added] [3]
  • President Obama's expressed policy to “support the rights of sovereign nations to access quality-assured, low-cost generic medication to meet their pressing public health needs under the WTO’s Declaration on Trade Related Aspects of Intellectual Property Right." [4]
  • The 110th Congress’s “New Trade Policy for America” which removed the requirement for linkage provisions and mandatory patent extensions from pending agreements. [5] 
  • The WTO Understanding on Dispute Settlement, which states that “Members shall not make a determination to the effect that a violation has occurred, that benefits have been nullified or impaired or that the attainment of any objective of the covered agreements has been impeded, except through recourse to dispute settlement in accordance with the rules and procedures of this understanding.”[6]
  • Human rights obligations to support the right to the health, including the obligation of developed countries to “take steps towards the full realization of the right to health through international assistance and cooperation.”[7]
  • The Declaration of Helsinki that prohibits the repetition of experiments on humans "when there is conclusive proof of positive and beneficial results.” (Data exclusivity would require generic firms to repeat clinical trials in order to bring a product to market before the expiration of the period of exclusivity.) [8]

For the same reasons, the Out-of-Cycle Review of Thailand should not sanction that country for any policies or practices that address health needs and comply with the TRIPS agreement.  It is improper for the U.S. to object to Thailand’s use of compulsory licenses, to press for data exclusivity or linkage provisions, or to interfere with any efforts to amend the local patent law to promote public health.  


Sean Flynn, Associate Director
Mike Palmedo, Assistant Director
Program on Information Justice and Intellectual Property





1.  Submission of Global Health Organizations to USTR for the 2010 Special 301 Report. Available at
2.  Agreement on the Trade Related Aspects of Intellectual Property Rights. Available at
3.  Doha Declaration on the TRIPS Agreement and Public Health. Available at
4.  Press Release, The Obama-Biden Plan to Combat Global HIV/AIDS.  Available at 
5.  House Committee on Ways and Means. “New Trade Policy for America.”  May 2007. Available at: 
6.  Understanding on Rules and Procedures Governing the Settlement of Disputes, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 2, art. 23.2 Available at
7.  Report of the UN Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, U.N. doc. A/HRC/11/12 (Mar. 31, 2009). Available at:
8.  World Medical Association, Declaration of Helsinki - Ethical Principles for Medical Research Involving
Human Subjects, 18th WMA General Assemb. Art. 20 (Jun. 1964) Available at


 Image of pills (cc) Daren Hester.



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