At Doha, the United States proposed, and all WTO Members agreed, that the Doha Declaration should provide an additional ten-year transition period (until 2016) for least-developed country members to implement the pharmaceutical-related provisions of the TRIPS Agreement. This extended transition period balances the interests of intellectual property rights holders and the needs of the least-developed country members.
In addition, in paragraph 6 of the Declaration, Ministers recognized that WTO Members with "insufficient or no manufacturing capacities in the pharmaceutical sector" could have difficulty using the compulsory licensing provisions of the TRIPS Agreement and directed the TRIPS Council to find an expeditious solution to this problem. In December 2002, the United States announced a framework to ease these WTO rules for countries in need to import life-saving drugs.
On August 30, 2003, the WTO General Council adopted the "TRIPS/health solution," which is comprised of a Decision and an accompanying Chairman's Statement that sets out the shared understandings of WTO members on how the Decision should be interpreted and applied. Under the TRIPS/health solution, Members are permitted, in accordance with specified procedures, to issue compulsory licenses to export pharmaceutical products to countries that cannot produce drugs for themselves.
On December 6, 2005, the WTO General Council agreed on an amendment to make the TRIPS/health solution reached in August 2003 a permanent part of the TRIPS Agreement. U.S. efforts in working with African nations and other developing country Members were instrumental to reaching this agreement. On December 16, 2005, the United States became the first WTO Member to formally notify the WTO that it had accepted the amendment. Other WTO Members now have until December 1, 2007 to accept the amendment. It will go into effect, for those Members that accept it, once two-thirds of the membership has accepted it. The August 2003 waiver will remain in place and available until the amendment is in force.
The TRIPS/health solution is a demonstration of how the WTO can work to address the needs of poor countries. The United States strongly supports effective and appropriate use of the TRIPS/health solution to facilitate access to life-saving medicines by countries in need. The United States would be willing to discuss the need to provide technical assistance if some Members encounter difficulties in implementing or utilizing the solution. In fact, the United States has already taken steps to ensure that the solution can be implemented. For example, in July 2004, the United States reached an agreement with Canada to ensure that the provisions of the North American Free Trade Agreement (NAFTA) will not impede implementation of the TRIPS/health solution.
In recent free trade agreements with the parties to CAFTA-DR, Morocco, Bahrain, Oman, Peru and Colombia, the United States has clarified that the intellectual property provisions in the agreements do not stand in the way of measures necessary to protect public health. Specifically, the United States has confirmed that the intellectual property chapters of the FTAs do not affect the ability of the United States or our FTA partners to take necessary measures to protect public health by promoting access to medicines for all, in particular concerning cases such as HIV/AIDS, tuberculosis, malaria, and other epidemics as well as circumstances of extreme
