Text of US Congressmen Waxman, Allen, Brown letter to USTR re
TRIPS in Hong Kong
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You may wish to give publicity to this in your country and to
the Trade Ministerial Team from your country that will be going
to Hong Kong
December 5, 2005
The Honorable Rob Portman
United States Trade Representative
600 17th Street, N.W.
Washington, DC 20508
Dear Ambassador Portman:
We are writing to request immediate clarification of the U.S.
Government's stance on access to generic medications at the
forthcoming World Trade Organization Ministerial in Hong Kong.
The positions reportedly taken by the United States threaten ac-
cess to affordable generics, both for developing nations and for
the United States itself.
At issue is the ability of countries to import generic versions
of a patented drug. The United States has stated that it will
not take advantage of a process that would allow it to import
generics under a compulsory license, even if the public health
requires it. In addition, it has reportedly pushed for provi-
sions that could make it harder for all countries, including the
poorest, to access generics in this manner.
Our concerns are detailed below.
Background on Intellectual Property and Importation of Generic
Drugs
The TRIPS agreement on Trade-Related Aspects of Intellectual
Property Rights took effect in 1995.[1] The 2001 Doha Declara-
tion states that "the TRIPS agreement does not and should not
prevent Members from taking measures to protect public
health."[2] According to the Declaration, "the Agreement can and
should be interpreted and implemented in a manner supportive of
WTO Members' rights to protect public health, and in particular,
to promote access to medicines for all."[3] In August 2002, the
U.S. Congress passed legislation that directs adherence to the
Doha Declaration in U.S. trade negotiations.[4]
The Doha Declaration affirmed the right of countries to issue
compulsory licenses to domestic manufacturers to make a generic
version of a patented drug when the country deems necessary.[5]
However, the Declaration did not resolve how countries could ac-
cess such generics if they lack sufficient manufacturing capac-
ity.
Compulsory Licenses for Importation of Generics
In August 2003, WTO members established a temporary mechanism by
which countries could issue compulsory licenses to manufacturers
in other nations and then import the drugs.[6] While this ad-
dressed an important gap in the Doha Declaration, the mechanism
has been criticized by public health organizations and experts
as placing undue burdens on countries' abilities to issue such
licenses.[7]
Specifically, the protocol involves a separate process for every
country and every drug, diminishing economy of scale and reduc-
ing the incentive of generic manufacturers to produce for other
governments. Furthermore, the procedure has not yet been em-
ployed, and there is therefore no evidence yet of whether it can
work to provide effective and speedy access to generic drugs.
The high prices of the current generation of HIV/AIDS drugs -
which will be on patent for years - make these concerns even
more pressing. [8]
In addition, a Statement from the General Council Chairperson
read aloud at the 2003 meeting, though of unclear legal status,
calls into further question the feasibility and usefulness of
the mechanism.[9] According to the WTO, the Statement was "de-
signed to provide comfort to those who feared that the decision
might be abused and undermine patent protection."[10] One prob-
lematic provision would place the responsibility of preventing
diversion of drugs on both exporting and importing countries,
which may not have the enforcement capacity.[11]
The United States, along with European nations, declared in the
August 2003 agreement that it would not avail itself of the im-
portation option.[12] Certain other countries, including Hong
Kong, China, Israel, and Korea, stated that they would only use
the system in cases of emergencies or extremely urgent situa-
tions, but the U.S. "opt-out" inexplicably rejected any such
safety net.[13]
In the recent Gaborone Declaration, African Health Ministers
questioned the August 2003 decision, calling for "the Ministers
of Trade to seek a more appropriate permanent solution at the
WTO that revises the TRIPS agreement and removes all con-
straints, including procedural requirements, relating to the ex-
port and import of generic medicines."[14] However, this pro-
posal has not gained traction.
The Current U.S. Position
Despite the August 2003 proposal's apparently unwarranted com-
plexity, the lack of evidence that it will be effective, and the
concern of developing nations most directly affected, United
States and European negotiators have reportedly insisted that it
be incorporated into the TRIPS agreement as a permanent amend-
ment.[15] They also reportedly urged that the Chairman's State-
ment from 2003 be incorporated into the agreement. Though they
appear to have relented on this demand, they have reportedly in-
sisted that the statement be read again at the upcoming Hong
Kong Ministerial.[16]
Furthermore, we understand that the USTR maintains the position
that the U.S. will not avail itself of the opportunity to issue
a compulsory license for importation even in the event of a cri-
sis.[17] We believe this is an untenable position, especially in
light of the current threat of an avian flu pandemic. Although
the U.S. Government has been working with Roche, the sole pro-
ducer of Tamiflu, to stockpile supplies for 2007, there remains
concern that the company will not be able to manufacture enough
of the antiviral drug to fill orders for the United States (or
other countries).[18] Despite Roche's intention to issue volun-
tary licenses to generic manufacturers to fulfill unmet need, an
imported generic could theoretically be necessary if, for exam-
ple, another drug is found to be more effective or the pandemic
progresses more rapidly. In addition, Roche's issuance of volun-
tary licenses was neither inevitable nor precedent-setting. For
this and future public health problems, the U.S. "opt-out" from
compulsory licensing for importation could leave our government
- and citizens - dangerously vulnerable.
Because of the potential threats to public health preparedness
in developing countries and at home, we request clarification of
the U.S. Government's position on compulsory licensing for im-
portation. Specifically, we would like to know why the U.S. re-
portedly wishes to make permanent a system that has been criti-
cized as overly burdensome and has not yet been shown to be ef-
fective. In addition, we request an explanation of why the
United States should foreclose the possibility of using the im-
portation mechanism. We would like to know if it is the belief
of the U.S. Trade Representative that the United States will be
able to "opt back in" to the compulsory licensing for importa-
tion system if public health requires. If yes, we request a de-
tailed explanation of the procedures that would have to be em-
ployed to permit the United States to do so.
We request an immediate response.
Sincerely,
Henry A. Waxman
Member of Congress
Sherrod Brown
Member of Congress
Thomas H. Allen
Member of Congress