WASHINGTON - The United States welcomes the agreement reached
today in the WTO on a proposed amendment to the WTO Agreement on Trade Related
Aspects of Intellectual Property Rights (TRIPS Agreement) to enhance access to
medicines. The amendment would allow countries to override patent rights when
necessary to export life-saving drugs to developing countries that face public
health crises but cannot produce drugs for themselves. When adopted, the
amendment will make permanent an arrangement agreed to and put in place by WTO
Members in 2003. The United States played an instrumental role throughout this
"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
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.
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.