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[e-drug] MSF FTAA testimony

  • Subject: [e-drug] MSF FTAA testimony
  • From: [email protected]
  • Date: Tue, 10 Sep 2002 18:55:51 -0400 (EDT)

E-drug: MSF FTAA testimony

MSF delivered the following testimony yesterday at a USTR hearing on the
proposed Free Trade Area of the Americas (FTAA). Please feel free to
contact me with with any questions.


Rachel M. Cohen
U.S. Advocacy Liaison
Campaign for Access to Essential Medicines
Doctors Without Borders/M�decins Sans Fronti�res (MSF)
6 East 39th Street, 8th Floor * New York, NY 10016 * USA

Tel: +1-212-655-3762
Mobile: +1-917-331-9077
Fax: +1-212-679-7016
E-mail: [email protected]


Testimony of Doctors Without Borders/M�decins Sans Frontier�s (MSF) 
at the Public Hearing Concerning Market Access in the Free Trade Area 
of the
Americas Negotiations of the Office of the United States Trade Representative

Delivered by Rachel M. Cohen, U.S. Advocacy Liaison
MSF campaign for Access to Essential Medicines
September 9, 2002

I am pleased to provide this brief testimony-which focuses entirely on the
potential negative consequences of the Free Trade Area of the Americas
(FTAA) on access to essential medicines in developing countries in the
Americas-on behalf of Doctors Without Borders/M�decins Sans Frontier�s
(MSF), an international medical humanitarian organization with field
operations in nearly 90 countries.  Too often in the countries where MSF
works, we have been forced to watch our patients die because they cannot
afford the drugs that could improve, extend, or save their lives, and for
us this is simply unacceptable-it is a violation of our medical ethics.  In
the Americas, this has been particularly true for our teams providing AIDS
care and treatment in places like Guatemala, Honduras, Nicaragua, El
Salvador, and Peru, who have witnessed countless unnecessary deaths due to
the lack of access to antiretroviral (ARV) therapy and other essential AIDS

There are currently 1.8 million people living with HIV/AIDS in Latin
America and Caribbean, and 110,000 AIDS deaths were recorded in the region
in 2001. The Caribbean is the second-most affected region in the world,
after sub-Saharan Africa.  Hundreds of thousands of people with HIV/AIDS in
developing countries in the Americas do not have access to antiretroviral
therapy simply because they cannot afford it.

Just two years ago, the average cost of a triple combination of
antiretrovirals was between $10,000-$15,000 per patient per year, and 
today it is available for under $300 per patient per year. These 
price reductions were the direct result of international public 
pressure and generic
competition, particularly from Indian and Brazilian manufacturers.  Generic
competition was possible because of the lack of patent protection in those
countries.  In the coming years, such competition will not be possible due
to the filing of patents on pharmaceuticals in key developing countries
with manufacturing capacity, unless flexible conditions for granting
compulsory licenses are available and compulsory licenses are routinely
issued to address public health concerns.  Compulsory licensing of
pharmaceuticals is one of the most important policy tools for ensuring
generic competition, which will be key to improving access to HIV/AIDS
medicines in Latin America and the Caribbean.

When 142 countries adopted the Doha Declaration on the TRIPS Agreement and
Public Health in November 2001, public health needs were firmly placed
above commercial interests and much needed clarifications about key
flexibilities in the TRIPS Agreement related to public health were offered.
The very fact that public health, and in particular access to medicines,
has been singled out as an issue needing special attention in TRIPS
implementation acknowledges that health care and health care technologies
must be treated differently from other commodities and gives countries
leeway for taking measures to counter the negative effects of excessive
intellectual property protection on health.

The FTAA threatens to undermine the achievements in Doha.  In particular,
USTR's negotiating position in FTAA gives rise to serious questions about
the U.S government's true motives in agreeing to the Doha Declaration.  The
Doha Declaration must remain a ceiling for FTAA negotiations on
intellectual property rights as they relate to public health technologies,
and the U.S. government must not renege on the commitments it made in Doha.

It is clear in information about the U.S.'s FTAA negotiating objectives
that the U.S. is pushing to impose standards on pharmaceuticals that far
exceed requirements set forth in the TRIPS Agreement, and that, in some
cases, these standards directly contradict the spirit and letter of the
Doha Declaration, which clearly recognized concerns about the effects of
patents on prices and stated unambiguously that TRIPS 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."
I would like to site four examples of this:

    1. Dramatic limitations on the circumstances under which compulsory
      licenses on pharmaceuticals may be issued.  Although the Doha
      Declaration has reaffirmed the right of WTO Member countries to issue
      a compulsory license for whatever reason (not only in cases of
      emergency), the U.S. proposal explicitly provides that compulsory
      licenses shall be granted only in four limited circumstances (public
      non-commercial purposes, situations of a declared national emergency,
      other situations of extreme urgency, or declared anti-competitive
      practices) and solely for purposes of government use. Should such a
      provision be adopted, it would cancel the possibility of granting
      compulsory licenses to remedy patent abuses, such as excessive
      pricing, and to foster competition in the private sector to increase
      access to patented essential medicines.

    2. Extensions of patent terms on pharmaceuticals beyond the 20-year
      minimum in TRIPS.  The U.S. proposes to extend the term of a patent in
      exchange for "early registration of generics" and to compensate for
      unreasonable administrative or regulatory delays that occurred while
      granting the patent. This is not required by the TRIPS Agreement and a
      WTO panel expressly stated that such patent extensions do not
      constitute a "legitimate interest" of patent owners.

    3. Abusive powers to regulatory authorities to enforce patents.  The
      U.S. proposes that drug regulatory authorities notify the patent owner
      of the identity of any company that is seeking approval to market a
      generic version of the patented invention while the patent is in
      effect.  This effectively means that drug regulatory authorities will
      function as patent enforcement agencies and is likely to result in
      unjustified patent extensions.  Such a proposal can only serve to
      protect invalid patent claims, as valid claims receive adequate
      protection through normal judicial processes.

    4. Exclusive rights over pharmaceutical data.  Although the TRIPS
      Agreement only requires WTO Members to protect  "undisclosed test or
      data" against "unfair commercial use" and "disclosure" in the
      framework of unfair competition law, the U.S. is proposing to grant
      exclusive rights on pharmaceutical data for at least five years.  Such
      a proposal will result in delaying and limiting generic competition in
      cases where a patent does not exist or a compulsory license has been

The U.S. negotiating objectives for FTAA aim to strengthen patent rights
beyond what is required in TRIPS, and reduce the extent of the safeguards
to the detriment of public health-they are clearly "TRIPS-plus."  If the
U.S. achieves its negotiating objectives, FTAA will negate the achievements
of the Doha Declaration and could have devastating consequences in terms of
access to medicines for millions of people in low- and middle-income
countries in the Americas with HIV/AIDS and other neglected diseases.  For
them, this is a matter of life and death, and we therefore urge the U.S.
government in the strongest possible terms to abandon TRIPS-plus
negotiating objectives and negotiate FTAA in keeping with the spirit and
letter of the Doha Declaration.

Thank you for your attention.
Rachel M. Cohen
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