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21 December
2006
Secretary
of State Condoleezza Rice
U.S.
Department of State
2201 C
Street NW
Washington,
DC 20520
Ambassador
Susan Schwab
United
States Trade Representative
600 17th
Street, N.W.
Washington,
DC 20508
Dear
Secretary Rice and Ambassador Schwab:
We are
writing to express our concern that the United States Department of
State and the United States Trade Representative have intervened in the
decision by the government of Thailand to issue a compulsory license on
patents for the AIDS drug efavirenz, and to explain why the US
government should refrain from such actions.
The US
government is reportedly asking the Thai government to engage in prior
negotiation with patent owners before issuing compulsory licenses. Not
only is this not required under the World Trade
Organization (WTO) rules when the compulsory license is for government
use, it is not required under US law. What the WTO does require is that
Thailand "promptly" notify the patent owner when it issues a compulsory
license. Thailand has clearly done this. The US government should not
be in the business of micro-managing Thailand's dealing with the patent
owners, as long as Thailand abides by its WTO TRIPS obligations.
In 2001 the
United States government and every other member of the World Trade
Organization (WTO) announced the signing of the Doha Declaration on
TRIPS and Public Health. This historic agreement said:
<begin
quote>
We
agree that the TRIPS Agreement does not and should not prevent members
from taking measures to protect public health. Accordingly, while
reiterating our commitment to the TRIPS Agreement, we affirm that the
Agreement can and should be interpreted and implemented in a manner
supportive of WTO members' right to protect public health and, in
particular, to promote access to medicines for all.
In this
connection, we reaffirm the right of WTO members to use, to the full,
the provisions in the TRIPS Agreement, which provide flexibility for
this purpose.
</end
quote>
Thailand is
obviously trying to do exactly what the Doha Declaration promised it
could. Respecting Thailand's decision to exercise its right under the
Doha declaration is not only a matter of concern for Thai patients in
need of affordable AIDS treatment, but also a matter of good faith in
honoring America's international commitments.[1]
Patient
advocates and others who are concerned about the AIDS crisis have
welcomed the compulsory license on efavirenz as a major step forward for
access to AIDS drugs in Thailand. Thailand has stood out among
developing countries for its efforts to expand treatment opportunities
for AIDS patients, but the high price of newer drugs like efavirenz is a
significant hurdle for the long term sustainability of AIDS treatment
programs in Thailand and other developing countries.
Experts who
are struggling to implement treatment programs in developing countries
have concluded that it is essential to create a competitive generics
market for efavirenz and other newer AIDS drugs that are patented in
Brazil and other markets.[2]
Brazil did
not have patents on medicines until 1996. For those AIDS drugs invented
before 1996, Brazil continues to purchase generic versions. This has
stimulated entry by generic manufacturers, driving the prices of active
pharmaceuticals ingredients (APIs) down over time. For example, the
global prices of APIs (per kilo) for lamivudine (3TC) fell from more
than $25 thousand dollars in 1996 to $5 thousand by 1999, to less than
$300 by 2004, illustrating the dynamic nature of cost savings from
generic competition.
In
contrast, the global prices for products invented after 1996, and
protected by patent in Brazil, are much more expensive. This is
because, contrary to popular misconception, Brazil has not issued
compulsory licenses, and for AIDS drugs invented after 1996, only buys
from patent owners at negotiated prices. In a 2004 study by the World
Health Organization (WHO), the average API prices for six AIDS drugs
purchased as generics by Brazil were $382 to $582 per kilo. For another
six AIDS drugs that were patented in Brazil, the average prices for
generic APIs were $1,717 to $3,020. (See table below). This
illustrates the important role of economies of scale, and the global
impact of decisions by large purchasers to buy (or not buy) from generic
suppliers.
Thailand's
decision will have important consequences, not only for Thailand, but
for any developing country that needs to obtain low cost generic
products. If Thailand follows through and begins to buy from generic
suppliers, it will create a larger global market for generic products,
stimulate competition, and lower prices everywhere for the newer
products.
While the
benefits of expanded generic competition are widely appreciated among
experts, many developing countries have been reluctant to issue
compulsory licenses because of fears that the United States government
will oppose such actions and exert pressure.
We note
also that the United States is itself a major purchaser of AIDS drugs in
developing countries, through our contributions to PEPFAR and the Global
Fund for AIDS, TB and Malaria. Thus, any action by Thailand to create
more generic competition for the new AIDS drugs will benefit the US
taxpayers who are shouldering the burden of these outlays.
Finally, we
note that Thailand is among the countries that are supporting proposals
for a treaty on R&D in the World Health Organization (WHO) new
Intergovernmental Working Group on Public Health and Innovation. We
agree with those who suggest this is a more appropriate way to address
the US interest of sharing the global costs of medical R&D than policies
that raise prices for AIDS drugs and other essential medicines.
We ask that
the United States government refrain from any opposition or interference
with the Thai efforts to use WTO flexibilities to buy generic AIDS
medicines -- including pressuring or otherwise seeking to persuade
Thailand to engage in negotiations with Merck rather than proceed to
execute the compulsory license it has issued - and consider more
constructive ways to promote our national interest in matters concerning
innovation and access to medicines.
NOTES
[1] The
USTR has publicly stated that its side letters in some Free Trade
Agreements (FTAs) give countries flexibility to issue TRIPS-
compliant/Doha-fulfilling compulsory licenses. Efforts by the U.S. to
prevent or reverse the actual granting of such licenses raises doubts
about the credibility of the United States, making it more difficult for
the United States to achieve other objectives in our FTA negotiations.
[2] See the
August 2006, World Bank Report, "The Economics of Effective AIDS
Treatment: Evaluating Policy Options for Thailand." Page 169 states "by
exercising compulsory licensing to reduce the cost of second line
therapy by 90 percent, the government would reduce its future budgetary
obligations by US$3.2 billion discounted through 2025."
2004 Prices
of Active Pharmaceutical Ingredients Comparison of prices when products
are purchased as generics in Brazil
Lowest ($) Highest ($)
Products Brazil buys as generics
Didanosine
(ddI) 450 850
Indinavir
(IDV) 285 400
Lamivudine
(3TC) 295 480
Nevirapine
(NVP) 320 475
Stavudine
(d4T) 580 775
Zidovudine
(AZT) 360 510
Average $ 382 $ 582
Products Brazil does not buy as generics
Abacavir
(ABC) 1,500 3,500
Efavirenz
(EFV) 1,200 1,600
Lopinavir
(LPV) 2,900 4,000
Nelfinavir
(NFV) 900 1,400
Ritonavir
(RTV) 2,600 4,320
Saquinavir
(SQV) 1,200 3,300
Average $ 1,717 $ 3,020
Source:
WHO, Sources and Prices of Active Pharmaceutical Ingredients,
2004.
http://www.who.int/entity/3by5/amds/en/API.pdf
Sincerely,
ACT UP East
Bay, Oakland, CA
AIDS Policy
Project, Philadelphia
American
Jewish World Service
American
Medical Student Association
Center for
Health and Gender Equity (CHANGE)
Center for
Policy Analysis on Trade and Health (CPATH)
Church
World Service
Community
HIV/AIDS Mobilization Project (CHAMP), Los Angeles, CA
Consumer
Project on Technology (CPTech)
Corporate
Responsibility Program, Province of St. Joseph of the Capuchin Order
Edmonds
Institute
Essential
Action
Global AIDS
Alliance
Harm
Reduction Coalition
Health Gap
International AIDS Empowerment
Maryknoll
Office for Global Concerns
Middle East
Children’s Alliance (MECA)
Missionary
Oblates of Mary Immaculate
National
Action Network, Kansas Chapter
Oxfam
America
Peoples’
Health Movement
Progressive
Intellectual Property Law Association (PIPLA) Results USA
Stop
HIV/AIDS in India Initiative (SHAII)
Student
Global AIDS Campaign
Treatment
Action Group (TAG), New York, NY
Universities Allied for Essential Medicine (UAEM)
Malini
Aisola, CPTech, Washington DC
Tali
Averbuch, Boston University Medical Center, Boston, MA
Professor
Brook K. Baker, Program on Human Rights and the Global Economy,
Northeastern University School of Law, Boston, MA
Dean Baker,
Co-Director, Center for Economic and Policy Research, Washington, DC
Jon
Beckler, paralegal, Stockton, CA
Anand Bhat,
University of Texas Medical Branch MD program, Galveston, TX
Timothy
Boyd, Policy Research Assistant, AIDS Healthcare Foundation Los Angeles,
CA
Garrett
Brown, Coordinator, Maquiladora Health & Safety Support Network,
Berkeley, CA
Sister Judy
Byron, OP, Northwest Coalition for Responsible Investment, Seattle, WA
John
Celichowski, OFM Cap, Corporate Responsibility Program Province of St.
Joseph of the Capuchin Order, Milwaukee, WI
Jennifer
Chase, MS, Epidemiologist, Fort Collins, CO
Sae-Rom
Chae, University of Illinois at Chicago College of Medicine MD program,
Chicago, IL
Mardge
Cohen MD, Medical Director of WE-ACTx and Director of Women's HIV
Research, CORE Center, Chicago, IL
Andee
Cooper, Uganda Program Manager, Foundation for International Medical
Relief of Children, Washington, DC
Christine
Curry, Loyola University MD/PhD Program, Chicago, IL
Jim
Daidson, Bellingham, WA
Michael H.
Davis, Professor of Law, Cleveland State Univ. College of Law and
Director of PIPLA, the Progressive Intellectual Property Law
Association, Cleveland, OH
Marquita
Decker, University of Texas Health Science Center MD/MPH program,
Houston, TX
Daniel A.
del Portal, University of Pennsylvania School of Medicine MD program,
Philadelphia, PA
Iuliana
Dit, Wayne State University School of Medicine MD program, Detroit, MI
Séamus
Finn, OMI, Director, Justice Peace/Integrity of Creation Office,
Missionary Oblates of Mary Immaculate
Anna
Fiskin, Case Western Reserve University School of Medicine MD program,
Cleveland, OH
Sean Flynn,
Associate Director, Program on Information Justice and Intellectual
Property, American University, Washington College of Law, Washington, DC
Alyson D.
Follenius, MPH Candidate, The George Washington University School of
Public Health and Health Services Department of Environmental &
Occupational Health, Washington, DC
Mena Gorre,
Public Affairs Manager, AIDS Healthcare Foundation, Los Angeles, CA
Dr. Vineeta
Gupta, Director, Stop HIV/AIDS in India Initiative, Washington, DC
Kimberly
Hadley, University of Kansas School of Medicine MD program, Kansas City,
KS
Hillary
Hai, Peace Corps Volunteer Thailand, Los Angeles, CA
Nathan
Heckerson, University of Kansas School of Medicine MD program, Kansas
City, KS
Ben
Herbstman, Weill Medical College of Cornell University MD program, New
York, NY
Liza
Goldman Huertas, Yale School of Medicine MD program, New Haven, CT
Amit Khera,
University of Pennsylvania School of Medicine, Philadelphia, PA
Jeremy
Kirchoff, University of Kansas MD program, Lenexa, KS
Sathia
Krishnamoorthy, Boston, MA
John
Iversen, co-founder of the Berkeley Syringe Exchange, Oakland , CA
Emily
Lawson, United States Peace Corps volunteer Thailand, Houston, TX
QuyChi Le,
University of Kansas Medical School MD program, Olathe, KS
Roberta J.
Lee, RN,MSN,MPH, Cincinnati, OH
Alexandra
Liggatt, University of Kansas Medical School MD program, Kansas City, KS
Jamison
Litten, Peace Corps Volunteer, Peace Corps Thailand, Orinda, CA
Jing Luo,
University of Illinois at Chicago College of Medicine MD program,
Chicago, IL
Mary
Manivong, University of Kansas School of Medicine MD program, Kansas
City, KS
John May,
University of Kansas, School of Medicine MD program, Kansas City, KS
Dr David
McCoy, B.Med, DrPH, Co-managing Editor Global Health Watch
Aimee
McHale, JD, Graduate Student, University of North Carolina School of
Public Health, Chapel Hill, NC
Bridget
McHenry Ali, Program Manager, The White Ribbon Alliance for Safe
Motherhood, Washington, DC
Ann Mead,
Graduate Student, George Washington University School of Public Health,
Washington, DC
Jon F.
Merz, MBA, JD, PhD, Associate Professor, Department of Medical Ethics
University of Pennsylvania, Philadelphia, PA
Suerie
Moon, Pre-Doctoral Candidate, Harvard University’s John F.
Kennedy
School of Government, Cambridge, MA
James M
Nordlund, Communications Director, Kansas Chapter of the National Action
Network, Stockton, KS
Amy Nunn,
Doctoral Candidate, Population and International Health Department,
Harvard University, Cambridge, MA
Jeremy
Ogusky, Metropolitan Washington Public Health Association, Washington DC
Delane
Olsen, University of Kansas School of Medicine MD program, Wichita, KS
Kayla
Oursler, MPH student, Boston University School of Public Health, Boston,
MA
Kevin
Outterson, Professor of Law, West Virginia University, Hershey, PA
Giao Pham,
University of Kansas School of Medicine MD program, Kansas City, KS
Thomas
Pogge, Professor of Political Science, Columbia University, New York, NY
Christin N.
Price, Weill Medical College of Cornell University MD program, New York,
NY
Mary M.
Puttmann, MSc, Georgetown University MD program, Washington, DC
Amit V.
Raghavan, University of Kansas School of Medicine MD Program, Wichita,
KS
Srividhya
Ragavan, Associate Professor of Law, University of Oklahoma Law Center,
Norman, OK
Joana
Ramos, MSW, Cancer Resources & Advocacy, Seattle, WA
Bridget
Reutener, Graduate student, GW School of Public Health and Health
Services, Arlington, VA
Daniela
Resh, Graduate student, GWU School of Public Health and Health Services,
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Maria
Rishoi, Program Assistant, National Association of County and City
Health Officials, Washington, DC
Rosemary
Ryan MMS, MD, Medical Mission Sisters Sector North America Coordinator
for Mission, Philadelphia, PA
Cathy
Rowan, Corporate Responsibility Coordinator, Maryknoll Sisters, Bronx,
NY
Emily E.
Sanders, Legislative Assistant, US House of Representatives, Washington,
DC
Helena M.
Sause, OP, Member of the Dominican Sisters' Leadership Team, Columbus,
OH
Christie
Shrestha, MPH, Clinical Research Coordinator, University of Kentucky
Department of Neurology, Lexington, KY
S. Kendall
Smith, University of Kansas School of Medicine MD program, Kansas City,
MO
Susan K.
Sell, Professor of Political Science and International Affairs, the
George Washington University, Washington, DC
Sural Shah,
Pennsylvania State University College of Medicine MD program, Hershey,
PA
David
Sturza, Peace Corps Volunteer, Project Specialst, Don Jan District
People Living with HIV/AIDS (PHA) Group
Mary
Sullivan, Texas Tech University Health Sciences Center MD program, El
Paso, TX
Chong Kee
Tan, CBA Specialist, Asian & Pacfific Islander Wellness Center, San
Francisco, CA
Sophia
Tcheung, Texas Tech University Health Sciences Center MD program,
Lubbock, Texas
Blair
Thedinger, University of Kansas School of Medicine MD program, Kansas
City, KS
Sharon
Treat, Executive Director, National Legislative Association on
Prescription Drug Prices, Hallowell, ME
Laura
Turiano, MS, PA-C, Right to Health Care Campaign, People's Health
Movement, Oakland, CA
Robert
Ullom, University of Kansas School of Medicine MD program, Kansas City,
Kansas
Ashwin
Vasan, Program Associate, Partners in Health, Ann Arbor, MI
Daniel
Warren, Kansas University School of Medicine, Kansas City, KS
Margaret
Weber, Coordinator of Corporate Responsibility, Adrian Dominican
Sisters, Adrian, MI
Kristin
Wilson, University of Kansas School of Medicine MD program, Kansas City,
KS
Anne
Woodruff, MPH Candidate, The George Washington University, Washington,
DC
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Thomas Jefferson University MD program, Philadelphia, PA
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Editor, Health Writers, Madison, WI
Non-US
groups and individuals
Actions
Traitements, Paris, France
ACT UP
Paris, France
Asia
Pacific Network of People Living with HIV/AIDS (APN+), Bangkok,
Thailand.
Association
de Lutte Contre le SIDA (ALCS), Morocco
Association
SunAids, Douala, Cameroon
European
AIDS Treatment Group (EATG), Brussels, Belgium
Fundación
Apoyo y Solidaridad, Cali, Colombia
Japanese
Network of People Living with HIV/AIDS (JaNP+), Tokyo, Japan
Latin
American Network of PLWHA - RedLa+
Tuberculosis Television (TBTV), Laval, France
Thai AIDS
Treatment Action Group (TTAG), Bangkok, Thailand
World AIDS
Campaign, Amsterdam
Jorge
Bermudez, ENSP/Fiocruz, Rio de Janeiro, Brazil
Maurice
Cassier, CNRS, Paris, France
Julien
Chauveau, researcher/ORS-Inserm, Marseille, France
Benjamin
Coriat, University Paris XIII, Paris, France
Bernard
Couttolenc, PhD / USP, Sao Paulo, Brazil
D. Cyrillo,
Dr/USP, Sao Paul, Brazil
Elize
Massard da Fonseca, Ministry of Public Health and PHD Candidate, Oswaldo
Cruz Foundation, Rio de Janeiro, Brazil
Daniel de
Beer, Lawyer, Vrij Universiteit Brussel, Belgium
Katy De
Clercq, staff member, Sensoa, Antwerp, Belgium
Marcio De
Sa, PNDST/AIDS, Brasilia, Brazil
Véronique
Doré, Head Social Sciences/ANRS, Paris, France
Lia
Hasenclever, IE-UFRT, Rio de janeiro, Brazil
Naoko
Kawana, Advocacy Coordinator, Japanese Network of People Living with
HIV/AIDS
Gaelle
Krikorian, CRESP, University Paris XIII/EHESS/inserm, Paris, France
Bernard
Larouze, Inserm, Paris, France
Constance
Meiners, MS/SAS, Brasilia, Brazil
Jean-Paul
Moatti, University de la Méditerranée, Inserm, Marseille, France
Mulumba
Moses, The Law Development Centre, Kampala Uganda
Heeseob
Nam, Chairperson, Patent Attorney / Intellectual Property Left, Horizon
Law Group, Seoul, Republic of Korea
Fabienne
Orsi, University Paris XIII, Paris, France
Ethel
Pengel, Chair-Person, STG Mamio Namens Projekt, Suriname
Christina
Possas, PN-DST-AIDS, Ministry of Health, Brasilia, Brazil
Paulo R.
Teixeira, Dr/SES, Sao Paulo, Brazil
Armand
Totouom, Programmes Officer/Coordinator, Association SunAids, Douala,
Cameroon
Luc Van
Leemput, Doctors Without Borders, Brussels, Belgium
Peter
Wiessner, Aids Hilfe Munich, Germany
Moacir Wuo,
Dr UMC, Mogi Das Cruz, Brazil
Yazdanpanah
Yazdan, CNRS, Lille, France |
