E-DRUG: Letter to USTR on TRIPS Council negotiations/Aug 30
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Letter from Reps. Waxman, Brown, Allen letter to USTR on TRIPS Council negotiations/August 30
supplied by Rachel Cohen, MSF
Rachel COHEN <rachel.cohen@newyork.msf.org>
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 access 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 provisions 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. World Trade Organization, Agreement on
Trade-Related Aspects of Intellectual Property Rights (1994)(TRIPS). The
2001 Doha Declaration states that 'the TRIPS agreement does not and should
not prevent Members from taking measures to protect public health.'
Paragraph 4,'Declaration on the TRIPS Agreement and Public Health', WTO
Ministerial Conference Fourth Session, WT/MIN(01)/DEC/2, adopted 14
November 2001. (Doha Declaration). 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.' Id. In August 2002,
the U.S. Congress passed legislation that directs adherence to the Doha
Declaration in U.S. trade negotiations. Trade Promotion Authority Act, Pub.
L. No. 107-210; 19 U.S.C. §3802(b)(4)(C).
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. Doha Declaration,
Paragraph 5. However, the Declaration did not resolve how countries could
access such generics if they lack sufficient manufacturing capacity.
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. World Trade Organization, Implementation
of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public
Health, Decision of the General Council of 30 August 2003 (WT/L/540)(Sept.
1, 2003)(online at
http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm#asterisk).
While this addressed 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. Joint
Statement by NGOS on TRIPS and Public Health: WTO Members Should Reject
Bad Deal on Medicines (Dec. 4, 2005)(online at
http://lists.essential.org/pipermail/ip-health/2005-December/008767.html).
Specifically, the protocol involves a separate process for every
country and every drug, diminishing economy of scale and reducing the
incentive of generic manufacturers to produce for other governments.
Furthermore, the procedure has not yet been employed, 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. Doctors Without Borders/Medecins Sans Frontieres (MSF)
Campaign for Access to Essential Medicines, The Second Wave of the Access
Crisis: Unaffordable AIDS Drug Prices - Again (Dec. 2005).
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. The
General Council Chairperson's statement (Aug. 30, 2003)(online at
http://www.wto.org/english/news_e/news03_e/trips_stat_28aug03_e.htm).
According to the WTO, the Statement was 'designed to provide comfort to
those who feared that the decision might be abused and undermine patent
protection.' World Trade Organization, Press Release: Decision removes
final patent obstacle to cheap drug imports (Aug. 30, 2003)(online at
http://www.wto.org/english/news_e/pres03_e/pr350_e.htm).
One problematic provision would place the responsibility of preventing diversion of drugs
on both exporting and importing countries, which may not have the
enforcement capacity. The General Council Chairperson's Statement, supra
note 9.
The United States, along with European nations, declared in the
August 2003 agreement that it would not avail itself of the importation
option. World Trade Organization, Implementation of Paragraph 6 of the Doha
Declaration on the TRIPS Agreement and Public Health, supra note 6 at
footnote 3. 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 situations, but the U.S. 'opt-out'
inexplicably rejected any such safety net. Id.
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 constraints, including procedural
requirements, relating to the export and import of generic medicines'
Sustainable Access to Treatment and Care For the Achievement of the
Millennium Development Goals, 2nd Ordinary Session of the Conference of
African Ministers of Health (CAMH2) Gaborone, Botswana, 10-14 October
2005 CAMH/Decl.1(II)(online at
http://www.phrusa.org/campaigns/aids/pdf/gabarone_declaration.pdf).
However, this proposal has not gained traction.
The Current U.S. Position
Despite the August 2003 proposal's apparently unwarranted complexity,
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 amendment. Status of TRIPS and Public Health
Negotiations (Dec. 2, 2005)(online
http://lists.essential.org/pipermail/ip-health/2005-December/008764.html).
They also reportedly urged that the Chairman's Statement from 2003 be
incorporated into the agreement. Though they appear to have relented on
this demand, they have reportedly insisted that the statement be read again
at the upcoming Hong Kong Ministerial. Id.
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 crisis. Id. 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 producer 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). Secretary of Health and Human Services Michael Leavitt
testified at a recent hearing, 'Unfortunately, current capacity for
domestic manufacture of influenza vaccine and antiviral drugs can meet only
a small fraction of the need projected for a pandemic response' Testimony
of HHS Secretary Michael O. Leavitt (Nov. 8, 2005)(online at
http://energycommerce.house.gov/108/Hearings/11082005hearing1704/Leavitt.pdf). Despite Roche's intention to issue voluntary licenses to generic
manufacturers to fulfill unmet need, an imported generic could
theoretically be necessary if, for example, another drug is found to be
more effective or the pandemic progresses more rapidly. In addition,
Roche's issuance of voluntary 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.
Governmen's position on compulsory licensing for importation.
Specifically, we would like to know why the U.S. reportedly wishes to make
permanent a system that has been criticized as overly burdensome and has
not yet been shown to be effective. In addition, we request an explanation
of why the United States should foreclose the possibility of using the
importation 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 importation system if public health
requires. If yes, we request a detailed explanation of the procedures that
would have to be employed to permit the United States to do so.
We request an immediate response.
Sincerely,
Henry A. Waxman, Sherrod Brown, Thomas H. Allen; Members of Congress