[e-drug] Open letter MSF to USTR on IP and access

[Rachel Cohen <rachel.cohen@newyork.msf.org>]

E-drug: Open letter MSF to USTR on IP and access
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This open letter was sent to USTR this afternoon. The penultimate
round of negotiations of the US-Central American Free Trade
Agreement (CAFTA)   concerning Costa Rica, El Salvador,
Guatemala, Honduras, and Nicaragua   begins in Houston, Texas,
this coming Monday, October 20. CAFTA is scheduled to enter into
force January 1, 2004. For a Word version of this letter, please do not
hesitate to contact me.

Regards,

Rachel

Rachel M. Cohen
U.S. Director, Campaign for Access to Essential Medicines
Doctors Without Borders / M?decins Sans Fronti?res (MSF)
333 Seventh Avenue, 2nd Floor * New York, NY * 10001-5004 * USA
Tel: +1-212-655-3762
Mobile: +1-917-331-9077
Fax: +1-212-679-7016
E-mail: rachel.cohen@newyork.msf.org

http://www.doctorswithoutborders.org/
http://www.accessmed-msf.org/
___________________________

Open Letter Concerning Intellectual Property and Access to
Medicines in the US-Central American Free Trade Agreement
(CAFTA)

October 15, 2003

Ambassador Robert Zoellick
U.S. Trade Representative
Office of the U.S. Trade Representative
Washington, DC 20508

Sent Via E-mail to FR0060@ustr.gov and via Facsimile Transmission
to 202-395-4549

Dear Ambassador Zoellick,

We are writing on behalf of Doctors Without Borders / M?decins Sans
Frontier?s (MSF) in advance 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").

We call upon USTR to immediately make the CAFTA text available
publicly, abandon efforts to push TRIPS-plus proposals in CAFTA
and other regional and bilateral trade agreements, and uphold the
Doha Declaration, which the US adopted along with all other WTO
members just two years ago, by explicitly supporting Central
American countries in fully implementing the Doha Declaration.

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 CAFTA, which, out of
necessity, are based on our analysis of the draft IP Chapter of the
FTAA, to you 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:

1. Dramatically limit the circumstances under which compulsory
licenses on pharmaceuticals may be issued;
2. Extend patent terms on pharmaceuticals beyond the 20-year
minimum in TRIPS;
3. Confer abusive powers to regulatory authorities to enforce patents;
and
4. Grant exclusive rights over pharmaceutical data (data exclusivity).

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.(1) 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.(2)

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."(3) 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  and Luis Villa, MD
Executive Director, MSF USA
Head of Mission, MSF Guatemala

cc:       Amb. Peter Allgeier, Deputy USTR
  Amb. Ross Wilson, Senior Negotiator for the Free Trade Area of
  the Americas
  James Mendenhall, Assistant USTR for Services, Investment,
  and Intellectual Property
  Claude Burcky, Deputy Assistant USTR for Intellectual Property
  Kira Alvarez, FTAA Intellectual Property Group
  Christina Sevilla, Director for Intergovernmental Affairs
  Mirta Peragio, MD, Executive Director, Pan-American Health
  Organization (PAHO)
  Daniel Lopez Acuña, Director of Program Management,
  Pan-American Health Organization (PAHO)
  Cesar Vieira, MD, Area Manager, Governance and Policy,
  Pan-American Health Organization (PAHO) 
_____________________

Footnotes:

(1) MSF is providing ARV treatment for 600 patients, out of a total of
1,600 Guatemalans currently receiving ARV treatment throughout the
country. It is estimated that approximately 7,000 Guatemalans with
HIV/AIDS are in urgent clinical need of ARV treatment.
(2) Moreover, FTAA threatens to extend data exclusivity provisions to
all countries in the Americas, except Cuba.
(3) See
http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_
e.htm

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