OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE
Executive Office of the President
Washington, D.C.
20508
For Immediate Release:
December 6, 2005
United States Welcomes Negotiations Leading to Positive Outcome on
Enhancing Access to Medicines
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 process.
"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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