[Ip-health] Letter to Eric Goosby by Henry Waxman and Barbara Lee on the UNITAID patent pool

[Tido.von.SCHOENANGERER@geneva.msf.org]

HENRY A. WAXMAN, CALIFORNIA
CHAIRMAN
ONE HUNDRED ELEVENTH CONGRESS
COMMITTEE ON ENERGY AND COMMERCE
2125 Rayburn House Office Building
Washington, DC 20515-6115

December 11,2009

The Honorable Eric Goosby
Unites States Global AIDS Coordinator
United States Department of State
2201 C Street NW
Washington, DC 20520

Dear Dr. Goosby,

Speaking on the eve of 'World AIDS Day, Secretary Clinton described the
important role of the United States global AIDS program in creating
"sustainable health systems."1 We agree,
and believe this must include a focus on the sustainability of U.S.
treatment programs. We are therefore writing to you and to Secretary
Clinton to encourage the United States to take note of
innovative approaches to ensuring continuing global access to affordable
AIDS drugs.

As the Secretary noted in her remarks, the United States has contributed to
antiretroviral treatment for over 2 million people worldwide. This
astonishing success was possible only
because of the availability of affordable generic drugs. Earlier annual
treatment costs of $10,000 or higher for patented drugs had made broad
access to antiretrovirals in developing countries
seem impossible. Today, a year's worth of lifesaving drugs can cost as
little as $80.

Unfortunately, we cannot expect such affordable annual costs per patient to
remain available. Each year, a growing number of patients on f,rrst-line
antiretroviral treatment develop resistance or other complications and
require improved first-line regimens or second-line drugs. These often have
no generic equivalent and can be up to 17 times more expensive than those
that do. Furtherrnore, many patients are on older drug regimens that are no
longer recommended by the World Health Organization because of toxicity and
other side effects, but cannot afford to switch to second-line treatment."2

In addition, in many developing countries such as India, new or heightened
patent protections are being established, in conformance with international
agreements. As newer AIDS drugs are intr=F5duced in such countries, they ar=
e
increasingly likely to be patented. In most cases, this means that generic
manufacturers in those countries will be unable to produce generic versions
of the drugs, .ith.t for domestic use or export. As a result, the
newer-generation AIDS
drugs are unlikely to become available as affordable generics for years or
even decades.

The 2008 reauthorization of the U.S. global AIDS program funds the
development of  "mechanisms to ensure that safe and effective
pharmaceuticals, including antiretrovirals and
medicines to treat opportunistic infections, are purchased at the lowest
possible price at which such pharmaceuticals may be obtained in sufficient
quantity on the world market," provided that
they are approved as safe and effective by an uppropiiut. authority.3 The
"lowest possible price" wili only be meaningfully affordable if we find
ways to address the looming cost increase of
AIDS treatment.

We believe that innovative approaches must be developed and explored. For
example, Gilead Sciences has granted a number of nonexclusive voluntary
licenses allowing generic
manufacturers to produce and sell its AIDS medicines in developing
countries, with a royalty returned to Gilead. Since Gilead's Access Program
launched in2006, the price for its drug
Viread (tenofovir) in developing countries has fallen significantly, and
the number of patients on the drug has soared.

In a broader application of the voluntary license approach, UNITAID, an
international drug purchase facility, is currently developing the framework
for a "patent pool" through which
patentholders could voluntarily license antiretroviral drugs to generic
manufacturers for generic production and innovation in developing
countries.4 The patent pool would also allow licensees
to develop new versions of the drugs, such as new fixed-dose combinations
or much-needed pediatric formulations.

While the framework is still in its early stages, we believe it is a
promising example of a way to promote drug access and innovation while
appropriately protecting intellectual property
rights and stimulating further research and development. The United States
is not an official partner in UNITAID, but our programs and partner
countries could benefit from the expanded
availability a patent pool could provide.

In this second five-year stage of the Global AIDS Program, we must be
laying the groundwork for the future of the program and of the health
systems in the developing countries
with whom we partner. 'We urge you to lead the way in studying, encouraging
and supporting innovative ways to keep AIDS drugs affordable.

'We would appreciate a description of all efforts that your office is
undertaking to ensure an ongoing, robust pipeline of safe, affordable
drugs. We request a response by January 15.

Sincerely,

Henry A. Waxman
Chairman
Committee on Energy and Commerce

Barbara Lee
Member of Congress


cc:
The Honorable Hillary Rodham Clinton
Secretary of State

The Honorable Joe Barton
Ranking Member
Committee on Energy and Commerce

1 Secretary Hillary Rodham Clinton, Remarks on the Administration's Efforts
on
HIV/AIDS (Nov. 30,2009) (online at
www.state.gov/secretary/rm/2009a/11/132784.htm).).
2 Doctors Without Borders,"Challenges: Second Class AIDS Treatment,"
Untangling the
Web of Antiretroviral Price Reductions 12th Edition (July 2008) (online at
www.msfaccess. org/background/challenges).
3 Tom Lantos and Henry J. Hyde United States Global Leadership Against
HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 $ 301 Pub.
L.110-293 (July 30,
2008).
4 UNITAID, "The Medicines Patent Pool Initiative" (March 2009) (online at
http://www.unitaid.er-r/images/projects/PATENT_POOL_ENGLISH_15_may_REVISED.=
pdf
).