E-drug: MSF Comments on Draft FTAA
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[For a copy of the original submission including footnotes, graphs,
etc. please contact rachel_cohen@newyork.msf.org]
May 1, 2002
Chair of the Committee of Government Representatives on the
Participation of Civil Society
c/o Secretaria del Area de Libre Comercio de Las Americas (ALCA)
Apartado Postal 89-10044
Zona 9, Ciudad de Panama
Republica de Panama
To Whom It May Concern:
We are pleased to submit these comments on the Draft Free Trade
Area of the Americas (FTAA) Agreement on behalf of Doctors
Without Borders/M�decins Sans Frontier�s (MSF) in response to
the Notice of Issuance by the FTAA Committee of Government
Representatives on the Participation of Civil Society of a Third Open
Invitation for Public Comment. These comments focus entirely on
the potential negative consequences of FTAA on access to
essential, life-saving medicines in developing countries in the
Americas.
MSF is an independent, international medical humanitarian
organization that delivers emergency aid to victims of armed
conflict, epidemics, natural and man-made disasters, and to others
who lack health care due to social or geographic marginalization.
MSF operates over 400 medical relief projects in nearly 90
countries throughout the world. The organization was awarded the
1999 Nobel Peace Prize. That same year, MSF launched an
international Access to Essential Medicines Campaign, which grew
directly out of the frustration of MSF doctors and nurses who were
increasingly unable to treat their patients because the medicines
they needed were too expensive, no longer effective, or simply did
not exist. 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. MSF currently has a field presence in
many countries in the Americas, including Bolivia, Brazil, Colombia,
Ecuador, El Salvador, Guatemala, Haiti, Honduras, Mexico,
Nicaragua, Panama, and Peru. Teams provide medical care for
people with HIV/AIDS, malaria, Chagas' disease, leishmaniasis,
trachoma, and other diseases, as well as primary care,
maternal/child health care, and other services for displaced and
homeless populations and for indigenous people.
UNDERMINING THE ACHIEVEMENTS OF DOHA
The 4th Ministerial Conference of the World Trade Organization
(WTO), which took place in Doha, Qatar, in November 2001, was a
breakthrough in the international debate about the impact of the
WTO Agreement on Trade-related Aspects of Intellectual Property
Rights (TRIPS) on access to medicines. One hundred and forty two
countries adopted a Declaration on the TRIPS Agreement and Public
Health, driven largely by developing countries, which firmly placed
public health needs above commercial interests and offered much
needed clarifications about key flexibilities in the TRIPS Agreement
related to public health. 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, the U.S.
negotiating position gives rise to serious questions about their true
motives in agreeing to the Doha Declaration.
The Doha Declaration must remain a ceiling for international trade
negotiations on intellectual property rights as they relate to public
health technologies, and FTAA negotiators must not renege on the
agreement reached in Doha.
PATENTS, PRICES & PATIENTS: THE EXAMPLE OF HIV/AIDS
According to the World Health Organization, 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. In several Caribbean countries, HIV/AIDS has
become a leading cause of death. The AIDS epidemic is having
major consequences for tropical infectious diseases in the region,
such as Chagas' disease (American trypanosomiasis) and
tuberculosis. Hundreds of thousands of people with HIV/AIDS in
developing countries in the Americas do not have access to
antiretroviral therapy--which, in wealthy countries such as the U.S.,
has dramatically extended and improved the lives of people living
with HIV/AIDS, reducing AIDS-related deaths by over 70%--simply
because they cannot afford it.
Price is not the only reason that people do not get the medicines
they need, but it is a major barrier. As MSF and other
non-governmental organizations have been pointing out for over
two years, the high cost of medicines is often linked to patents.
Patents give their owners a monopoly to use, manufacture, sell, and
import the patented product and therefore to sell it at the most
profitable price, which may not be the most equitable price in most
developing countries. As shown in the table below, generic
competition is crucial to ensuring downward pressure on drug
prices--as we have witnessed in countless instances in the field,
particularly with antiretrovirals for the treatment of HIV/AIDS.
[See original submission for graph on effective generic competition
on sample AIDS triple combination.]
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 as little as $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, as per the Doha Declaration, 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.
The case of AIDS drug prices helps illustrate what is to come when
all new pharmaceutical products will be patent protected in 2006,
after most WTO members have implemented the TRIPS Agreement.
For all these new medicines, generic competition will be stamped
out. As a consequence, prices of new medicines will inevitably
shoot up, far beyond the means of patients in need. The lever that
has brought the price of AIDS drugs down will be lost.
POTENTIAL IMPLICATIONS FOR ACCESS TO MEDICINES IN POOR
COUNTRIES IN THE AMERICAS
It is clear in information about the FTAA negotiating objectives of
the United States made public by the Office of the U.S. Trade
Representative (USTR) 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."
In contrast, the U.S. proposal includes several key points, which
will have a direct and negative impact on access to essential
medicines in the Americas, including, but not limited to:
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 patents 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
This refers to clinical information that is generally required by drug
regulatory authorities to approve the marketing of a new medicine.
Although the TRIPS Agreement only requires WTO Members to
protect these "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 these 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 granted.
CONCLUSION
All the proposals outlined above have been described by Carlos
Correa of the University of Buenos Aires, a leading expert on
integrating public health concerns into patent legislation in
developing countries, as "clearly TRIPS-plus." 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. If the U.S. achieves its negotiating
objectives, FTAA will annul the achievements of the Doha
Declaration on the TRIPS Agreement and Public Health and could
have devastating consequences in terms of access to medicines for
millions of people in middle- and low-income countries in the
Americas with HIV/AIDS and other neglected diseases. For them,
this is a matter of life and death.
Sincerely,
Nicolas de Torrente Olaf Valverde, MD
Executive Director Field Physician & Regional Coordinator,
MSF USA Access to Essential Medicines
Campaign
MSF Guatemala
cc:
- Ambassador Robert Zoellick, United States Trade Representative
(USTR)
- Ambassador Peter Allgeier, Deputy USTR
- Joseph Papovich, Assistant USTR for Services, Investment, and
Intellectual Property
- Claude Burcky, Deputy Assistant USTR for Intellectual Property
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