[Ip-health] letter sent to Secretary Rice&Ambassador Schwab on Thai CL
Benjamin Krohmal
ben.krohmal@cptech.org
Thu Dec 21 13:49:03 2006
--
[ Picked text/plain from multipart/alternative ]
Today more than 140 organizations and individuals wrote to US
Secretary of State Condoleeza Rice and USTR head Susan Schwab, asking
that the United States government not interfer with Thai efforts to
issue compulsory licenses on AIDS drugs. The letter follows
disclosures that the US embassy in Bangkok and the USTR offices in
Washington, DC have asked the Thailand government to enter into
negotiations with Merck before they execute a compulsory license on
the patents for the AIDS drug efavirenz. The letter follows:
http://www.cptech.org/ip/health/c/thailand/riceschwabthailand21dec06.pdf
http://www.cptech.org/ip/health/c/thailand/
riceschwabthailand21dec06.html
21 December 2006
Secretary of State Condoleeza 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."
Page169 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$3.2 billion discounted through 2025."
2004 Prices of Active Pharmaceutical Ingredients
Comparison of prices when products are purchased as generics in Brazil
=09 Lowest ($) =09 Highest($)
Products Brazil buys as generics
Didanosine (ddI)=09 450 =09 850
Indinavir (IDV)=09 285 =09 400
Lamivudine (3TC)=09 295 =09 480
Nevirapine (NVP)=09 320 =09 475
Stavudine (d4T)=09 580 =09 775
Zidovudine (AZT)=09 360 =09 510
average=09 $ 382 =09 $ 582
Products Brazil does not buy as generics
Abacavir (ABC)=09 1,500 =09 3,500
Efavirenz (EFV)=09 1,200 =09 1,600
Lopinavir (LPV)=09 2,900 =09 4,000
Nelfinavir (NFV)=09 900 =09 1,400
Ritonavir (RTV)=09 2,600 =09 4,320
Saquinavir (SQV)=09 1,200 =09 3,300
average=09 $ 1,717 =09 $ 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=92s Alliance (MECA)
Missionary Oblates of Mary Immaculate
National Action Network, Kansas Chapter
Oxfam America
Peoples=92 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
S=E9amus 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=92s 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, Washington, DC
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
Linda Pang, Thomas Jefferson University MD program, Philadelphia, PA
Nina Yamanis, MPH, Graduate Student of Public Health University of
North Carolina at Chapel Hill, Chapal Hill, NC
Lea Zeldin, 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
Fundaci=F3n 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
V=E9ronique Dor=E9, 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 M=E9diterran=E9e, 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
Benjamin Krohmal
Consumer Project on Technology
Tel: +1-202-332-2670 ex. 14
Fax: +1-202-332-2673
ben.krohmal@cptech.org