"This is a landmark achievement that we hope will help developing countries devastated by HIV/AIDS and other public health crises," said Ambassador Portman. "The Africa Group, and other developing countries, made clear that the amendment was something they saw as essential to accomplish before Hong Kong and we were pleased to work with them to make it happen. The United States applauds the leadership demonstrated by Ambassador Choi, Chair of the TRIPS Council and Ambassador Mohammed, Chair of the General Council, in creating a consensus." Ambassador Portman highlighted the work done by the Africa Group, saying "I also want to acknowledge the critical work done by members of the Africa Group and congratulate them on this success."

Agreement on the proposed amendment is the latest in a series of moves supported by the United States to ensure that intellectual property rules in the WTO complement efforts to enhance access to medicines. At the WTO Ministerial in Doha, Qatar, in 2001, WTO members issued a landmark political declaration: the Doha Declaration on the TRIPS Agreement and Public Health (the Doha Declaration).

One major part of the Doha Declaration was agreement to provide an additional ten year transition period for pharmaceutical products (until 2016) for least developed countries, as proposed by the United States. Today’s announcement follows an earlier announcement on November 29th that the WTO would extend the remaining TRIPS provisions for least developed countries from January 2006 until July 2013. The United States worked closely with the least developed countries and the other WTO members to extend this date.

Under the rules of the WTO, the amendment will now be circulated to WTO Members for adoption. WTO Members have until December 1, 2007 to accept the amendment. The amendment will go into effect, for those Members that adopt it, once 2/3 of the membership has adopted it. The waiver solution will remain in place until the amendment is in force.

Background

At the Doha Ministerial, Ministers acknowledged the serious public health problems afflicting Africa and other developing and least developed countries, especially those resulting from HIV/AIDS, malaria, tuberculosis, and other epidemics. Ministers agreed on the need for a balance between the needs of poor countries without the resources to pay for cutting edge pharmaceuticals and the need to ensure a patent rights system which promotes the continued innovation, development and creation of new lifesaving drugs.

Under the TRIPS Agreement, a country may compel a patent owner, under certain conditions, to license another producer to manufacture generic versions of the patented product. This is called compulsory licensing. The Doha Declaration affirmed that Members may use compulsory licensing to address public health crises. However, the TRIPS Agreement states that compulsory licenses should be used predominantly for the domestic market. As a result, some felt that countries that could not produce drugs for themselves would have difficulty importing them from abroad under a compulsory license. Paragraph 6 of the Doha Declaration recognized this problem and urged WTO Members to find a solution.

In August 2003, Members agreed to waive the provisions in the TRIPS Agreement that would have restricted the ability of countries to issue compulsory licenses to produce and export drugs to countries in need that could not produce drugs for themselves. The waiver was effective immediately and remains in effect today. Some Members, however, wanted to have the waiver become a permanent part of the TRIPS Agreement through an amendment. The United States has always strongly supported the amendment process and is pleased that an agreement has been reached. This amendment would make that solution permanent.

A fact sheet on the leadership role played by the United States throughout the history of this issue is available on the USTR website.

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