[Ip-health] MSF Open Letter to Central American Negotiators -- IP and access to meds in CAFTA

[Rachel COHEN]

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This open letter was sent to Central American negotiators of CAFTA today.=
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For a hard copy of this letter (with footnotes) and/or a copy of the letter=
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sent to USTR last week, please do not hesitate to contact me.=0D
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      Rachel=0D
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   Rachel M. Cohen=0D
   U.S. Director, Campaign for Access to Essential Medicines=0D
   Doctors Without Borders/M=C3=A9decins Sans Fronti=C3=A8res (MSF)=0D
   333 Seventh Avenue, 2nd Floor * New York, NY * 10001-5004 * USA=0D
   Tel: +1-212-655-3762=0D
   Mobile: +1-917-331-9077=0D
   Fax: +1-212-679-7016=0D
   E-mail: rachel.cohen@newyork.msf.org=0D
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   http://www.doctorswithoutborders.org/=0D
   http://www.accessmed-msf.org/=0D
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    OPEN LETTER TO CENTRAL AMERICAN NEGOTIATORS CONCERNING INTELLECTUAL=0D
  PROPERTY AND ACCESS TO MEDICINES IN THE US-CENTRAL AMERICAN FREE TRADE=0D
                             AGREEMENT (CAFTA)=0D
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October 21, 2003=0D
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Alberto Trejos                               Norman Garc=C3=ADa=0D
Minister of Trade                                  Minister of Economy=0D
Apartado 96-205                                    5ave, 4ta Calle,=0D
Edificio Salame=0D
San Jos=C3=A9, Costa Rica                         Tegucigalpa, Honduras=0D
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Miguel Lacayo                                Mario Arana=0D
Minister of Economy                          Minister of Industry and Trade=
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Alameda Juan Pablo II y Calle Guadelupe                  Km 6 Carretera a=
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Masaya =E2=80=93 Frente al Camino de Oriente=0D
Edificio C1-C2                               Managua, Nicaragua=0D
Centro de Gobierno=0D
San Salvador, El Salvador=0D
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Patricia Ramirez Ceberg=0D
Minister of Economy=0D
8va, Avenida 10-43, Zona l=0D
01001 Guatemala=0D
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Dear Sirs and Madam,=0D
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We are writing on behalf of Doctors Without Borders/M=C3=A9decins Sans=0D
Frontier=C3=A8s (MSF) on the occasion of the Houston round of negotiations =
of=0D
the US-Central America Free Trade Agreement (CAFTA) to raise our concerns=
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about the potential negative consequences of this agreement on access to=0D
essential medicines in Central American countries.  MSF has good reason to=
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believe that provisions in CAFTA related to intellectual property (IP)=0D
protection may result in needless suffering and death for our patients and=
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millions of other people in the region with HIV/AIDS and other diseases,=0D
and undermine the historic World Trade Organization (WTO) Ministerial=0D
Declaration on the TRIPS Agreement and Public Health (=E2=80=9CDoha Declara=
tion=E2=80=9D).=0D
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In an open letter to the United States Trade Representative (USTR) dated=0D
October 15, 2003 (please see attachment/enclosure), MSF called upon the US=
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to immediately make the CAFTA text available publicly; abandon efforts to=
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push TRIPS-plus proposals in CAFTA and other regional and bilateral trade=
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agreements such as the Free Trade Area of the Americas (FTAA) agreement;=0D
and uphold the Doha Declaration by explicitly supporting Central American=
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countries in fully implementing the Doha Declaration.  Today, we call upon=
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you to uphold your right and obligation to protect public health and=0D
promote access to medicines by making use of the flexibilities in the TRIPS=
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agreement, which were reaffirmed in Doha, and oppose TRIPS-plus proposals=
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in CAFTA negotiations.=0D
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SUMMARY OF CONCERNS WITH IP PROVISIONS IN CAFTA=0D
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The draft text of CAFTA has not been made public, so it is impossible to=0D
provide an informed analysis of the IP provisions proposed in the=0D
agreement.  However, IP provisions in other bilateral free trade agreement=
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(e.g. the US-Singapore agreement) are clearly TRIPS-plus, and these are=0D
consistent with proposed provisions in the Free Trade Area of the Americas=
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(FTAA) agreement.  As we have related in earlier correspondences, MSF has=
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called upon all countries in the Americas to exclude IP provisions from the=
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FTAA agreement altogether, as this will be the only way to guarantee that=
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countries in the region can uphold the commitment they made in Doha to=0D
ensure the protection of public health and the promotion of access to=0D
medicines for all.  Based on USTR=E2=80=99s negotiating objectives in numer=
ous=0D
bilateral and regional agreements, we feel it is safe to assume that=0D
similar provisions are proposed in CAFTA.=0D
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We have communicated our concerns about the draft IP Chapter of the FTAA to=
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FTAA negotiators and to the FTAA Committee of Government Representatives on=
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the Participation of Civil Society on numerous occasions over the past two=
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years.  To reiterate, MSF is concerned that the proposals would:=0D
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1. Dramatically limit the circumstances under which compulsory licenses on=
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pharmaceuticals may be issued;=0D
2. Extend patent terms on pharmaceuticals beyond the 20-year minimum in=0D
TRIPS;=0D
3. Confer abusive powers to regulatory authorities to enforce patents; and=
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4. Grant exclusive rights over pharmaceutical data (data exclusivity).=0D
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Each of these proposals would have the effect of limiting generic=0D
competition, which has been one of the most important, reliable, and=0D
powerful forces to reduce drug prices systematically in Central America and=
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other developing regions, making essential, life-saving medicines such as=
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antiretrovirals (ARVs) for the treatment of HIV/AIDS more affordable for=0D
individuals and the health systems that serve them.=0D
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WHAT IS AT STAKE: THE EXAMPLE OF AIDS IN GUATEMALA=0D
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MSF currently has projects in three of the five CAFTA countries=E2=80=94Hon=
duras,=0D
Guatemala, and Nicaragua=E2=80=94providing medical care for people living w=
ith=0D
HIV/AIDS and other sexually transmitted infections (STIs), people with=0D
Chagas=E2=80=99 disease, displaced and homeless populations, including stre=
et=0D
children, and indigenous people.  Our concerns about the effects of patents=
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on the price and availability of essential, life-saving medicines are well=
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known to USTR, and need not be reiterated here.  However, even where there=
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are no patent barriers, TRIPS-plus provisions will effectively delay=0D
generic competition and limit access to affordable medicines.  We would=0D
like to focus particular attention on one such proposal: data exclusivity.=
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Although the TRIPS Agreement only requires WTO Members to protect clinical=
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information that is generally required by drug regulatory authorities to=0D
approve the marketing of a new medicine (=E2=80=9Cundisclosed test or data=
=E2=80=9D)=0D
against =E2=80=9Cunfair commercial use=E2=80=9D and =E2=80=9Cdisclosure=E2=
=80=9D in the framework of unfair=0D
competition law, US negotiating objectives include grant of exclusive=0D
rights on these data for at least five years.  Since generic companies rely=
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on pharmaceutical test data to demonstrate that their products are safe and=
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effective, data exclusivity will significantly delay the introduction of=0D
generics even when there are no patent barriers.=0D
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In Guatemala, 67,000 people are living with HIV/AIDS.  MSF currently=0D
provides antiretroviral (ARV) therapy for over 600 people in hospitals in=
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Guatemala City and Coatepeque, and plans to double the number of patients=
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on treatment next year.  Since ARVs are not protected by patents in=0D
Guatemala, MSF is able to use generic ARVs in its programs.   Just one year=
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ago, MSF was able to pay between 75% and 99% less for generics than the=0D
government of Guatemala paid for originator drugs. For example, the price=
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of the ARV d4T (40mg) from Bristol-Myers Squibb was $5,271 per person per=
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year compared with just $53 per person per year from a generic=0D
manufacturer. Although the prices of originator ARVs have fallen=0D
dramatically in the past year due to generic competition, they are still on=
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average two to five times as expensive as quality generic equivalents, with=
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treatment from originator companies costing on average $320-800 per month.=
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Such a price differential still means less people receive treatment, as the=
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average income in Guatemala is $160 per month.=0D
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In April 2003, under pressure to adopt US standards for protection of=0D
pharmaceutical test data, the Guatemalan government modified its national=
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IP bill by passing a decree, which gives originator pharmaceutical=0D
companies five years of exclusivity on these data. This will have the=0D
effect of delaying generic competition=E2=80=94even where there are no pate=
nt=0D
barriers=E2=80=94for five years.  For thousands of Guatemalans living with=
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HIV/AIDS, five years without access to affordable ARVs can be the=0D
difference between life and death.  As it stands, Guatemala is the only=0D
country in Central America that gives five years of exclusive protection=0D
for test data, but we worry that CAFTA threatens to extend such a provision=
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to all parties to the CAFTA negotiations.=0D
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CONCLUSION=0D
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The promise of Doha is that the TRIPS Agreement can and should be=0D
interpreted and implemented in a manner =E2=80=9Csupportive of WTO members'=
 right=0D
to protect public health and, in particular, to promote access to medicines=
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for all.=E2=80=9D TRIPS-plus proposals in CAFTA threaten to make it impossi=
ble for=0D
countries in Central America to exercise the rights re-confirmed in Doha.=
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As a medical humanitarian organization, we cannot accept the subordination=
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of the health needs of our patients and millions of others to US trade=0D
interests.  The US must not hamper the ability of countries in the region=
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to fully implement the Doha Declaration, and should instead support them=0D
explicitly in doing so.  In order to ensure the protection of public health=
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and the promotion of access to medicines, the Doha Declaration must be the=
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ceiling for CAFTA and other regional and bilateral agreements.=0D
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Sincerely,=0D
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Nicolas de Torrente                                      Luis Villa, MD=0D
Executive Director, MSF USA                              Head of Mission,=
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MSF Guatemala=0D
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cc:      FTAA negotiators