E-drug: US framework to increase access
-------------------------------------------------------------------------
[Copied from Ip-Health. KM]
http://www.ustr.gov/releases/2002/06/02-56.htm
For Immediate Release
June 24, 2002
US Announces Framework to Increase Access to Drugs
to Fight HIV/AIDS and other Public Health Crises
WASHINGTON - The United States today announced a framework that would
allow poor countries unable to produce pharmaceuticals to gain greater
access to drugs needed to combat HIV/AIDS, malaria and other public
health crises. This framework would permit a mechanism for easing WTO
rules regarding production of these vital medicines. This initiative is
part of the Administration's global effort to address the serious health
problems, such as HIV/AIDS, afflicting African and other poor developing
countries.
These proposals continue the U.S. leadership provided last fall at the
World Trade Organization (WTO) Ministerial in Doha, Qatar, where WTO
members developed a landmark political declaration on public health and
international trade rules (Trade Related Intellectual Property Rights or
TRIPS). This declaration affirmed the ability of countries to use the
flexibilities in TRIPS to access disease-fighting drugs. It also
recognized that some developing countries have insufficient capacity to
manufacture pharmaceuticals to address their health crises. WTO
Ministers pledged an expeditious solution to this problem and instructed
Members to recommend a solution before the end of 2002.
"The Administration has demonstrated its commitment to address HIV/AIDS
and other major epidemic diseases," said U.S. Trade Representative
Robert B. Zoellick. "Now we are working with other WTO Members on ways
to help poorer countries that can't make pharmaceuticals. We believe our
proposal offers a way to address major public health crises faced by
those most in need."
The U.S. framework, to be formally submitted on Tuesday, June 25th in
the WTO TRIPS Council in Geneva, sets forth the fundamental aspects of a
workable, transparent, sustainable and legally certain solution that
will fulfill the Doha Declaration directive.
The U.S. proposal calls for meeting the directive of WTO Ministers in
Doha by:
� Ensuring that all poor countries can obtain needed pharmaceuticals for
public health crises�even those with insufficient pharmaceutical
manufacturing capabilities;
� Ensuring that other developing nations with pharmaceutical production
capacity can help supply these poor countries without the risk of
running afoul of WTO rules, which should help develop capacity in these
developing countries;
� Encouraging Members to establish measures to prevent the diversion of
such medicines away from intended recipients in poor countries back to
higher-income, developed markets, which would undermine the special
flexibilities afforded to poor countries.
� Being part of the growing WTO consensus in favor of using the existing
compulsory licensing flexibility under TRIPS Article 31 as the most
appropriate solution, rather than by modifying other sections of the
TRIPS agreement;
� Continuing examination with other Members to determine the most
expeditious mechanism for implementing this solution.
The United States is encouraged by the substantive contributions of
other Members toward this common goal and appreciates the communication
and cooperation from WTO Members in the development of the U.S.
proposal.
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 that the patent
rights system which promotes the continued development and creation of
new lifesaving drugs is promoted. One major part of the Doha Declaration
was agreement to provide an additional ten-year transition period (until
2016) for least developed countries, as proposed by the United States
and agreed upon by all WTO members.
Paragraph 6 of the Doha Ministerial Declaration on the TRIPS Agreement
and Public Health recognizes that WTO Members with insufficient or no
manufacturing capacities in the pharmaceutical sector could face
difficulties in making effective use of compulsory licensing under the
TRIPS Agreement in order to address these health problems. WTO Ministers
directed the TRIPS Council to find an expeditious solution to this
problem and to report to the General Council before the end of 2002.
We are pleased that several U.S. pharmaceutical companies have formed
partnerships with African countries and are working together to address
many of the problems related to providing treatment to those in need.
This includes the sale of critical medicines at very low prices, as well
as the building of an improved infrastructure for getting these
medicines to those in need.
Why is this needed? Under current WTO patent rules (Article 31 of the
TRIPS Agreement), a country is free to 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. A Member issuing a compulsory license
may give this license either to a domestic manufacturer or one in
another country under certain circumstances. However, under current WTO
rules, such licensed production by a manufacturer in another country
might nevertheless be infringing if the licensed product is already
under patent in that other country. This framework is intended to find a
solution to this and certain other problems with the provisions of the
TRIPS Agreement.
United States leadership
The United States has been a leader in efforts to harness international
trade rules to help countries gain access to life-saving drugs and
successfully fight pandemics such as HIV/AIDS.
� In February 2001, the Bush Administration stated the commitment of the
United States to a flexible approach that is sensitive to health crises
and also protective of intellectual property rights. Under this policy,
the Administration has informed WTO Members that as they take steps to
address major health crises, such as the HIV/AIDS crisis in sub-Saharan
Africa and elsewhere, the United States supports steps by Members to
Members avail themselves of the flexibility afforded by the WTO TRIPS
Agreement.
� In July 2001, the United States and Brazil agreed to transfer their
disagreement over a provision of Brazil's patent law from formal WTO
litigation to a newly created bilateral consultative mechanism. The
agreement was a positive step in the common fight against HIV/AIDS and
the constructive handling of this patent dispute. It permits more
effective and less confrontational consideration of intellectual
property issues and ensures that such discussions do not divert
attention away from the shared goal of combating the spread of HIV/AIDS.
� In Doha in November 2001, the United States provided critical
leadership in developing support for a separate, landmark political
declaration on public health and international trade rules. This
declaration helped pave the way for a successful conclusion of the
Ministerial.
� The United States remains the largest bilateral donor of HIV/AIDS
assistance, providing 45 percent of all international spending on AIDS.
In fiscal year 2003, President George Bush has requested $1.1 billion to
combat HIV/AIDS internationally and has pledged $500 million to the
Global Fund to combat the international scourge of HIV/AIDS, malaria and
tuberculosis.
--
To send a message to E-Drug, write to: e-drug@usa.healthnet.org
To subscribe or unsubscribe, write to: majordomo@usa.healthnet.org
in the body of the message type: subscribe e-drug OR unsubscribe e-drug
To contact a person, send a message to: e-drug-help@usa.healthnet.org
Information and archives: http://www.healthnet.org/programs/edrug.html