MSF is concerned about the effects
that heightened intellectual property regimes and high prices being imposed on
developing countries by the United States Trade Representative (USTR) will have
on access to affordable generic medicines for our patients and medical operations,
as well as on the lack of innovation adapted to the needs of the resource-poor
settings where we work. Populations in developing countries are denied access
to medicines, vaccines, and diagnostic tools either because they do not exist
due to inadequate incentives for the development of appropriate and effective
tools; or because they exist but are not available in their countries due in
part to intellectual property barriers and high costs.
MSF is concerned by the U.S.
Government’s continued use of trade pressures to challenge efforts by
developing countries to ensure access to medicines for their populations, and
to drive countries to implement intellectual property measures into their
domestic laws above those required by international trade law. The Special 301
mechanism is only one tool that the U.S. government has used to this end.
We urge the U.S. Government to
abstain from threatening with trade sanctions developing countries that are
trying to respond to public health needs using policies and flexibilities
allowed under international trade law.
The United States Trade
Representative (USTR) demands not only directly undermine the commitments made
by the U.S. government under the WTO Doha Declaration on the TRIPS agreement
and public health and the WHO Global Strategy and Plan of Action on Public
Health, Innovation and Intellectual Property, but also create a fundamental
contradiction between U.S. trade policy and the U.S. government commitments and
priorities on global health and development.
We further urge USTR to align itself
with the access to medicines policies pursued by the U.S. government. During
the January 2011 128th Executive Board of the World Health Organization the
U.S. government made a very powerful intervention in support of generic competition
to lower the price of HIV/AIDS treatment in developing countries. Recognizing
that pharmaceutical price discounts do not always have as much impact on bring
down prices as robust generic competition does, it urged companies to join the
recently created Medicines Patent Pool in order to increase generic competition
for newer HIV/AIDS drugs, as the U.S. National Institute of Health (NIH) has
recently done. We welcome these statements and the NIH leadership.
PEPFAR itself has reported cost
savings of up to 80 percent through the purchase of Indian generic medicines.
Other U.S. Government-funded schemes, such as the Global Fund to Fight AIDS,
Tuberculosis and Malaria, are heavily reliant on the cost savings realized
through competition between quality generic medicines. Yet the USTR continues
to undermine both PEPFAR and the Global Fund and treatment providers such as
MSF by threatening trade repercussions against countries who use the
flexibilities in international trade law that allow for generic competition to
continue.
The USTR presents the Special 301
process and its efforts to demand stronger regimes of intellectual property
protection to developing countries as a tool to protect innovation. MSF
recognizes the importance of innovation and the need to finance research and
development processes. We are a humanitarian medical organization that needs
and welcomes biomedical innovation to better treat our patients. However the
reality is that intellectual property protection in the medical field creates
access problems due to high prices and does not stimulate innovation for many
of the diseases affecting people in developing countries, where patients have
limited purchasing power. By seeking greater and higher intellectual property
norms in developing countries, the U.S. government through USTR is perpetuating
a failed business model that links innovation costs to high prices and does not
address the innovation needs of developing countries. Higher intellectual
property norms are a sledgehammer designed to protect commercial interests in
the possibility of monopolizing richer segments in developing countries, not
public health, and its weight falls on the poorest. It is too blunt an
instrument as currently applied to serve the health needs of millions of people
in the developing world.
There are better and newer ways for
the U.S. government to protect and promote innovation currently being piloted
and under discussion at the WHO. Ways that would combine innovation and access,
instead of denying access to affordable medical technologies and delaying the
adaptation and innovation of better products to allow our medical teams to
better serve the needs in the poor-resource environments where we work.
For all the reasons stated in this
submission, MSF urges USTR in its 2011 Special 301 Review Process to refrain
from:
using the Special 301 process to increase pressure on
developing countries to implement intellectual property measures into
their domestic laws beyond the requirements contained in international
law, including TRIPS Plus provisions like data exclusivity;
using the Special 301 process against developing
countries acting within their legal rights to overcome intellectual
property barriers in response to the health needs of their populations, or
against countries embracing TRIPS flexibilities to ensure access to
medicines such as compulsory licenses or patentability criteria’s; and
using the Special 301 process to impose new
intellectual property enforcement norms that would hurt access to
medicines, such as those included in the ACTA agreement.
Rather than using the Special 301
Review Process as a unilateral tool to impose a heightened intellectual
property regime on developing countries, the U.S. government should use its
laws, policies, and financial resources to ensure that developing countries
exercise the full flexibilities available to them to ensure access to medicines
for all.
This will mean:
that the Doha Declaration play a prominent role in
shaping U.S. policy on access to medicines in developing countries;
that the U.S. government encourages countries to fully
implement the WHO Global Strategy and Plan of Action on Public Health,
Innovation and Intellectual Property, including the use of incentive
mechanisms that separate research and development incentives from high
prices, for example through the use of innovation inducement prizes that
reward innovations that improve health outcomes and permit open
competition for products; and the creation of new global norms on research
and development, including a possible biomedical R&D treaty.
that the U.S. government advance an agenda supportive
of both innovation and access to affordable medicines in developing
countries, and ensure that U.S. trade policy is aligned with the U.S.
global health and development agenda;
that the U.S. government conducts impact assessments of
the effects that USTR demands would have not only on access to medicines
and innovation by patients living in developing counties but also in U.S.
supported donor efforts like PEPFAR and the Global Fund.
that the U.S. government supports a system capable of
delivering adapted and affordable drugs that respond to patients’ needs.
This should include continue with the promotion of open licensing of all
publically funded biomedical research and development for use in the
developing world, following up with NIH recent announcement of its license
on a AIDS medicines to the Medicines Patent Pool.
Finally, MSF would like to also
request that the USTR facilitate that other civil society and interested
stakeholders from around the world, especially from developing countries where
USTR policies have greater effect, are allowed to express their views in the
public hearing.
Keywords: Special 301 / AIDS / MSF /
WTO / WHO / U.S.
