October 21, 2003
Alberto Trejos
Dear Sirs and Madam,
We are writing on behalf of Doctors Without Borders/Médecins Sans
Frontierès (MSF) on the occasion of the Houston round of negotiations of
the US-Central America Free Trade Agreement (CAFTA) to raise our concerns
about the potential negative consequences of this agreement on access to
essential medicines in Central American countries. MSF has good reason to
believe that provisions in CAFTA related to intellectual property (IP)
protection may result in needless suffering and death for our patients and
millions of other people in the region with HIV/AIDS and other diseases,
and undermine the historic World Trade Organization (WTO) Ministerial
Declaration on the TRIPS Agreement and Public Health (“Doha Declaration”).
In an open letter to the United States Trade Representative (USTR) dated
October 15, 2003 (please see attachment/enclosure), MSF called upon the US
to immediately make the CAFTA text available publicly; abandon efforts to
push TRIPS-plus proposals in CAFTA and other regional and bilateral trade
agreements such as the Free Trade Area of the Americas (FTAA) agreement;
and uphold the Doha Declaration by explicitly supporting Central American
countries in fully implementing the Doha Declaration. Today, we call upon
you to uphold your right and obligation to protect public health and
promote access to medicines by making use of the flexibilities in the TRIPS
agreement, which were reaffirmed in Doha, and oppose TRIPS-plus proposals
in CAFTA negotiations.
SUMMARY OF CONCERNS WITH IP PROVISIONS IN CAFTA
The draft text of CAFTA has not been made public, so it is impossible to
provide an informed analysis of the IP provisions proposed in the
agreement. However, IP provisions in other bilateral free trade agreement
(e.g. the US-Singapore agreement) are clearly TRIPS-plus, and these are
consistent with proposed provisions in the Free Trade Area of the Americas
(FTAA) agreement. As we have related in earlier correspondences, MSF has
called upon all countries in the Americas to exclude IP provisions from the
FTAA agreement altogether, as this will be the only way to guarantee that
countries in the region can uphold the commitment they made in Doha to
ensure the protection of public health and the promotion of access to
medicines for all. Based on USTR’s negotiating objectives in numerous
bilateral and regional agreements, we feel it is safe to assume that
similar provisions are proposed in CAFTA.
We have communicated our concerns about the draft IP Chapter of the FTAA to
FTAA negotiators and to the FTAA Committee of Government Representatives on
the Participation of Civil Society on numerous occasions over the past two
years. To reiterate, MSF is concerned that the proposals would:
Each of these proposals would have the effect of limiting generic
competition, which has been one of the most important, reliable, and
powerful forces to reduce drug prices systematically in Central America and
other developing regions, making essential, life-saving medicines such as
antiretrovirals (ARVs) for the treatment of HIV/AIDS more affordable for
individuals and the health systems that serve them.
WHAT IS AT STAKE: THE EXAMPLE OF AIDS IN GUATEMALA
MSF currently has projects in three of the five CAFTA countries—Honduras,
Guatemala, and Nicaragua—providing medical care for people living with
HIV/AIDS and other sexually transmitted infections (STIs), people with
Chagas’ disease, displaced and homeless populations, including street
children, and indigenous people. Our concerns about the effects of patents
on the price and availability of essential, life-saving medicines are well
known to USTR, and need not be reiterated here. However, even where there
are no patent barriers, TRIPS-plus provisions will effectively delay
generic competition and limit access to affordable medicines. We would
like to focus particular attention on one such proposal: data exclusivity.
Although the TRIPS Agreement only requires WTO Members to protect clinical
information that is generally required by drug regulatory authorities to
approve the marketing of a new medicine (“undisclosed test or data”)
against “unfair commercial use” and “disclosure” in the framework of unfair
competition law, US negotiating objectives include grant of exclusive
rights on these data for at least five years. Since generic companies rely
on pharmaceutical test data to demonstrate that their products are safe and
effective, data exclusivity will significantly delay the introduction of
generics even when there are no patent barriers.
In Guatemala, 67,000 people are living with HIV/AIDS. MSF currently
provides antiretroviral (ARV) therapy for over 600 people in hospitals in
Guatemala City and Coatepeque, and plans to double the number of patients
on treatment next year. Since ARVs are not protected by patents in
Guatemala, MSF is able to use generic ARVs in its programs. Just one year
ago, MSF was able to pay between 75% and 99% less for generics than the
government of Guatemala paid for originator drugs. For example, the price
of the ARV d4T (40mg) from Bristol-Myers Squibb was $5,271 per person per
year compared with just $53 per person per year from a generic
manufacturer. Although the prices of originator ARVs have fallen
dramatically in the past year due to generic competition, they are still on
average two to five times as expensive as quality generic equivalents, with
treatment from originator companies costing on average $320-800 per month.
Such a price differential still means less people receive treatment, as the
average income in Guatemala is $160 per month.
In April 2003, under pressure to adopt US standards for protection of
pharmaceutical test data, the Guatemalan government modified its national
IP bill by passing a decree, which gives originator pharmaceutical
companies five years of exclusivity on these data. This will have the
effect of delaying generic competition—even where there are no patent
barriers—for five years. For thousands of Guatemalans living with
HIV/AIDS, five years without access to affordable ARVs can be the
difference between life and death. As it stands, Guatemala is the only
country in Central America that gives five years of exclusive protection
for test data, but we worry that CAFTA threatens to extend such a provision
to all parties to the CAFTA negotiations.
CONCLUSION
The promise of Doha is that the TRIPS 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.” TRIPS-plus proposals in CAFTA threaten to make it impossible for
countries in Central America to exercise the rights re-confirmed in Doha.
As a medical humanitarian organization, we cannot accept the subordination
of the health needs of our patients and millions of others to US trade
interests. The US must not hamper the ability of countries in the region
to fully implement the Doha Declaration, and should instead support them
explicitly in doing so. In order to ensure the protection of public health
and the promotion of access to medicines, the Doha Declaration must be the
ceiling for CAFTA and other regional and bilateral agreements.
Sincerely,
Nicolas de Torrente
Luis Villa, MD
cc: FTAA negotiators
Minister of Trade
Apartado 96-205
Edificio Salame
San José, Costa Rica
Norman García
Minister of Economy
5ave, 4ta Calle,
Tegucigalpa, Honduras
Miguel Lacayo
Minister of Economy
Alameda Juan Pablo II y Calle Guadelupe
Masaya – Frente al Camino de Oriente
Edificio C1-C2
Centro de Gobierno
San Salvador, El Salvador
Mario Arana
Minister of Industry and Trade
Km 6 Carretera a
Managua, Nicaragua
Patricia Ramirez Ceberg
Minister of Economy
8va, Avenida 10-43, Zona l
01001 Guatemala
Executive Director, MSF USA
Head of Mission,
MSF Guatemala
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