[Ip-health] KENNEDY, WAXMAN CALL FOR INVESTIGATION OF U.S. TRADE AGREEMENTSAND INTERNATIONAL HEALTH

[James Love]

FOR IMMEDIATE RELEASE             CONTACT: Laura Capps/Melissa Wagoner
October 13, 2006                 (Kennedy) 202.224.2633
                                   Karen Lightfoot (Waxman) 202.225.5051

SEN. KENNEDY AND REP. WAXMAN CALL FOR INVESTIGATION OF U.S. TRADE
AGREEMENTS AND INTERNATIONAL HEALTH

Washington, DC- Senator Edward Kennedy and Representative Henry
Waxman have requested that the Government Accountability Office
investigate the Administration's trade negotiations and their
negative effects on developing countries' access to medicines.
According to the Trade Act of 2002, the Administration is obligated
to promote access to healthcare for all countries in their trade
practices, and Sen. Kennedy and Rep. Waxman want to ensure those
obligations are fulfilled.

Senator Kennedy said, "We've requested this investigation to help
understand how the Administration has balanced commercial drug
interests with the health needs of poor people living in developing
countries. In this era of HIV epidemics, avian flu outbreaks, and
other public health threats, it is essential that we promote good
health and access to medicines in every nation."

Rep. Waxman said "Administration trade agreements have numerous
provisions that threaten access to affordable medicine. We have to
recognize that the Bush Administration's single-minded pursuit of
intellectual property protections for drug companies can have
potentially devastating consequences for the public health in
developing countries."

Senator Kennedy and Representative Waxman have also requested the
Administration retract its demand that the World Health Organization
withdraw a report on trade and health. The report criticizes the
trade practices of some developed countries - including the U.S. - as
interfering with developing countries' rights to promote public health.

In response to the Administration's letter, Kennedy said, "The World
Health Organization's study, and others like it, suggests that our
trade policies have hampered access to life-saving medicines, such as
HIV therapies and treatments for avian flu. If this is the case, we
need to know-- and we need to change our policies."

Rep. Waxman said, "Most of our trade policy takes shape far from the
public spotlight.  We need more analysis of the implications of our
policies - not less.  The Bush Administration should assess its own
obligations to public health rather than seeking to quash any
criticism."

The letters sent from Senator Kennedy and Representative Waxman to
Comptroller General Walker on September 27, 2006, and to Sec. Leavitt
on October 13, 2006, are below. (PDF available upon request)

October 13, 2006

The Honorable Michael O. Leavitt
Secretary of Health and Human Services
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, D.C. 20201

Dear Secretary Leavitt:

              We are writing with regard to an August 18, 2006,
letter from William R. Steiger, HHS Special Assistant for
International Affairs, to the Acting Director General of the World
Health Organization. In this letter, Mr. Steiger insisted that the
World Health Organization withdraw a study critical of the impact of
U.S. trade policy on international health.

              The report Mr. Steiger found objectionable is titled
"The Use of Flexibilities in TRIPS by Developing Countries: Can They
Promote Access to Medicines?" Commissioned by WHO, it identified
barriers to public health resulting from the trade policies and free
trade negotiations of several developed nations, including the United
States.

              In his letter, Mr. Steiger demanded that WHO "withdraw"
the report and remove its emblem from the publication.  Mr. Steiger
stated that he has "raised similar concerns with the WHO Secretariat
in the past about trade agreements," and he requested that the
Executive Board of the WHO conduct a full review of WHO=92s publication
policy.

              As a signatory to the Doha Declaration, a trade
agreement recognizing the right of member countries to protect public
health, the United States is obligated to respect the public health
initiatives of other countries.  Yet in the past, we have expressed
concerns that the Administration has sought intellectual property
provisions in bilateral trade agreements that contradict our
obligations under the Doha Declaration.  These concerns have never
received a satisfactory response from the Administration, and it
seems that the problems raised by the WHO report are being similarly
dismissed rather than addressed.

              In this era of AIDS epidemics, pandemic flu threats,
and drug-resistant tuberculosis outbreaks, we need more=97not less=97
analysis of the factors affecting global public health.  Attempting
to suppress a report because it is critical of U.S. trade policy is
unacceptable. Instead, the United States should seriously assess the
impact of our trade policies on access to medicines and public health.

              We request that you forward to our offices any
additional letters or communications sent by Mr. Steiger or other
members of the Administration requesting that a World Health
Organization publication, official, or representative be recalled for
criticizing U.S. policies.  Specifically, we request that these
include copies of the past correspondence described by Mr. Steiger
and the further correspondence mentioned by Mr. Steiger when he
wrote, "I intend to address these specific issues in a subsequent
letter to you."

              We also ask that you cooperate fully with the
Government Accountability Office as it responds to our request last
week for an investigation into the effect of the U.S. Trade
Representative=92s activities on public health.  Specifically, we have
asked GAO to assess whether the formal and informal mechanisms of
U.S. trade policy conform to the Congressional directive to respect
the Doha commitment to public health.

              We would appreciate receiving these documents by
October 28, 2006. If you have any questions, please let us know, or
contact David Bowen at (202) 224-7675.

              With respect and appreciation,


Sincerely,


_______________________________       ______________________________
Senator Edward M. Kennedy             Representative Henry A. Waxman
Ranking Member                        Ranking Member
Committee on Health, Education,       Committee on Government Reform
              Labor and Pensions
U.S. Senate                           U.S. House of Representatives


September 27, 2006

The Honorable David M. Walker
Comptroller General
United States Government Accountability Office
441 G Street, NW
Washington, DC 20548

Dear Mr. Walker,

We are writing to request a study of the U.S. Trade Representative=92s
interpretation and implementation of the principle trade objectives
relating to intellectual property, as established by Congress in the
Trade Act of 2002.

The Act elaborated three objectives relating to intellectual
property: "to further promote adequate and effective protection of
intellectual property rights"; "to secure fair, equitable, and
nondiscriminatory market access opportunities for United States
persons that rely upon intellectual property protection"; and "to
respect the Declaration on the TRIPS Agreement and Public Health,
adopted by the World Trade Organization at the Fourth Ministerial
Conference at Doha, Qatar on November 14, 2001."

Taken together, these three objectives identify priorities and
articulate a clear vision for trade negotiations related to
intellectual property.  By Congressional mandate, the Administration
has an obligation to advance this vision through its formal and
informal trade promotion activities.  We are interested in how these
objectives have been interpreted, pursued, and implemented by the
Administration since Trade Promotion Authority was granted by
Congress in 2002.

In particular, we would like to learn to what extent the third
objective, to respect the Doha Declaration on TRIPS and Public
Health, has been pursued.  In relevant part, the Doha Declaration
states that no country should be prevented from exercising its rights
to protect public health and promote access to medicines for all.
Subsequent elaborations, in 2003 and 2006, have specified mechanisms
intended to facilitate such access to medicines.  We are interested
in understanding how the rights and priorities identified by the Doha
objective have been incorporated into trade-related policies,
agreements, and practices of the Administration. In your study,
please consider the following questions:

* Has the U.S.T.R., through trade agreement provisions, negotiations,
preference programs, trade-capacity building, and other efforts,
pursued objectives and principles established under the Doha
Declaration and TRIPS Agreement?  Have these efforts been successful?

* How has the U.S.T.R. balanced efforts to pursue the Doha objective
with the two other intellectual property negotiating objectives
outlined by Congress in 2002? How many, if any, provisions negotiated
since 2002 expand the Doha protections for access to medicines? How
many, if any, provisions of such agreements narrow these
protections?  What has been the relative impact of each set of
provisions?

* If any instruction included in the Trade Act of 2002 has been found
to be in conflict with the Doha objective in practice, how has the
Administration acted?

* How has the U.S.T.R. promoted the obligations of developed
countries as articulated in the Doha Declaration?  For example, the
Doha Declaration reaffirms "the commitment of developed-country
members to provide incentives to their enterprises and institutions
to promote and encourage technology transfer to least-developed
country members."  Has the U.S.T.R. facilitated such transfer through
or in connection with bilateral trade agreements or other mechanisms?

* Have demands of the U.S.T.R., through bilateral trade agreements
and other mechanisms, expanded or limited the rights of developing
countries as articulated in the Doha Declaration?  For example:

* Has the U.S.T.R. expanded or constrained developing countries=92
freedom to independently interpret the TRIPS Agreement according to
the Agreement=92s objectives and principles under Articles 7 and 8?

* Have the U.S.T.R.=92s activities affected developing nations=92 use of
compulsory licensing, Bolar provisions, and other provisions endorsed
by the World Trade Organization for the protection of public health
and the promotion of access to life-saving medicines?

* Which government agencies and private sector groups provide input
into and exert influence over the U.S.T.R.=92s policies and activities
related to intellectual property rights?  How does the U.S.T.R.
balance and incorporate the concerns of these agencies and private
sector groups in its policies and activities, and how have such
concerns, once incorporated, affected pursuit of the Doha objective?

* As GAO found in 2002, the U.S.T.R.=92s Industry Trade Advisory
Committee system has consistently failed to incorporate adequate
input from global public health interests.  To what extent has this
failure been addressed, and has the failure affected implementation
of the Doha objective?  Does the U.S.T.R. use other mechanisms to
assure that input is incorporated from groups advocating the rights
and obligations established under the Doha Declaration?

* Has the U.S.T.R. used mechanisms outside formal trade agreements to
pursue, implement, and monitor the negotiating objectives related to
intellectual property rights, and the Doha objective in particular?
Please consider the General System of Preferences, the Special 301
process, trade capacity building activities, the Industry Trade
Advisory Committee system, side letters, accessions, and diplomacy.
For example:

* Have provisions in "public health side letters" achieved or failed
to achieve the Doha policy goal of facilitating access to affordable
medicines, including the Doha right to implement compulsory
licensing?  In practice, have the authorities articulated in these
side letters been invoked?  If so, to what effect?

* How has advice offered through trade capacity building balanced
protection of intellectual property rights with preservation of
developing countries=92 rights under the Doha Declaration?

We look forward to your response to this request.  If you have any
questions, please contact David Bowen of Senator Kennedy=92s staff at
(202) 224-7675 or Naomi Seiler of Representative Waxman=92s staff at
(202) 225-5420.

With great respect and appreciation, and we look forward to the study.


Sincerely,



Senator Edward M. Kennedy            Representative Henry A. Waxman
Ranking Member                       Ranking Member
Committee on Health,                 Committee on Government Reform
    Education, Labor, and Pensions


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