»ÃѺ»Ãا : 7/03/2018
ʶԵԼÙéà¢éÒªÁ:6503677 ¡ÒÃà»Ô´Ë¹éÒàÇçº:9344448 Online User Last 1 hour (0 users)
MSF Oral Statement Regarding the 2011 Special 301 Review Process
02 ÁÕ¹Ò¤Á 2554
Date:
2 March 2011
Source: www.doctorswithoutborders.org
Link: http://web1.doctorswithoutborders.org/publications/article.cfm?id=5077&cat=speech
We seek increased access to
affordable lifesaving medicines, vaccines and diagnostic tools in developing
countries and to stimulate the development of urgently needed better tools for
our field teams and people in countries where MSF works. Patients 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 -like tools for neglected tropical
diseases – 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.
Through the release of the Special 301 Watch List every year, the U.S.
Government is trying to drive countries to implement intellectual property
standards above those required by international law. We urge the U.S.
Government to abstain from threatening developing countries with trade
sanctions simply for trying to respond to public health needs.
The problem of access to medicines
extends to any drug, diagnostic test or vaccine needed to treat, detect or
prevent a range of diseases affecting the people MSF treat in developing
countries. The problem of access to medicines is not limited to HIV/AIDS and
other communicable diseases. The global burden of non-communicable diseases is
increasing worldwide, with the heaviest burden falling on low- and
middle-income countries.
However the magnitude of the
HIV/AIDS pandemic has highlighted the fact that millions in the developing
world do not have access to medicines needed to treat the disease or alleviate
suffering because they or their governments cannot afford them. It has also
shown the benefits that generic competition can have on the cost of treatment.
Today, five million people are on antiretroviral therapy. This is only
possible because generic competition caused annual first-line drug prices to
reduce from over $10,000 to under $80 today. MSF could not provide treatment to
160,000 people in more than 30 countries without generic competition. The US
government also acknowledges the significance of generic competition in its
global AIDS contributions. PEPFAR has reported savings of up to 90 percent
through the purchase of Indian generic medicines.
Alongside the tremendous progress in
AIDS treatment remains tremendous need. Ten million more are in immediate need
of treatment and increasingly patients will need to switch to newer drugs to
ensure their long-term survival. But the price difference is massive
between the cheapest first-line medicines and the newest drugs because the
newer products are more often patent-protected in countries with pharmaceutical
manufacturing capacity. MSF data shows how this will impact the cost of
treatment programs – the WHO-recommended second-line treatment is around 4.4
times more expensive than the most affordable first-line regimens, and expected
third-line regimens are estimated to cost over $2,200 for one year’s treatment.
Drug costs will increasingly limit patient treatment options, unless there are
important price reductions of the kind seen through generic competition.
HIV/AIDS also serves as an example
of the persistent and increasing barriers to access to medicines imposed by
heightened IP measures. The USTR continues to undermine both PEPFAR and the
Global Fund and treatment providers such as MSF by threatening trade
repercussions against countries that use the flexibilities in international
trade law that allow for generic competition to continue.
In our 2011 submission we have
highlighted the importance of the following TRIPS flexibilities: the rights of
developing countries to define patentability criteria; issue compulsory
licenses; define data protection provisions; and define enforcement regimes. We
provided the examples of Brazil, India and Thailand as developing countries
that were included in the 2010 Special 301 report for using these
flexibilities.
The United States government has been using the Special
301 Review Process and other trade tools to force developing countries to
implement data protection provisions with a data exclusivity regime. This
is one of the most burdensome TRIPs-plus provisions because it creates a
parallel monopoly with detrimental effects on generic competition and
ethical implications to repeat clinical trials. Very recently the Obama
administration recognized the effects of data exclusivity on the cost of
healthcare and included a proposal in its 2012 budget to reduce the term
of data exclusivity for biologic products and increase competition in the
US market. The announcement reported prospective savings of 11 billion
over 10 years for the US government.
According to the WTO TRIPS Agreement, countries have an
obligation to grant patents on pharmaceutical products and processes, but
the question of what criteria to use to define what is patentable is left
for countries to determine. Yet Brazil and India, among other countries,
were named in the 2010 Special 301 report because of their use of
patentability criteria that aims to ensure that only truly novel,
inventive and innovations with industrial application are allowed to
receive a patent monopoly.
We are especially concerned with the
reference included in the 2010 Special report on “temperature-stable forms of
drugs or new means of drug delivery” in reference to India’s Section 3d. USTR
is requesting the patentability in India of known industry practices that have
benefits for use and adherence, such as heat stabilization and fixed- dose
combinations, but that are not genuine innovation with therapeutic benefits. In
our 2011 submission we have also highlighted the importance of the Brazilian
Anuencia Previa that has given a role to the National Health Surveillance
Agency (ANVISA) in the review of pharmaceutical patents applications to help
determine whether patentability criteria are met. Public health implications
and access costs demand that monopoly protection in developing countries be
reserved for only truly innovative products.
It is also important that developing countries
rights to issue compulsory licenses and to define the appropriate level of
enforcement are respected.
Today, more than 3,000 people living
with HIV/AIDs from all over Asia rallied in India alongside the United Nations
Special Rapporteur for the Right to Health to protest TRIPS plus provisions in
a trade agreement between India and the European Commission. If some of the
provisions in the agreement go forward, India’s capacity to remain “the
pharmacy of the developing world,” the place poor people rely on for their
lifesaving medicines, will be endangered. With this testimony we join in
solidarity with protestors in India and urge the US government not to ignore
their voices by pushing for similar standards.
The United States 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, they create a fundamental contradiction between U.S. trade policy and
the U.S. government commitments and priorities on global health and
development.
We urge USTR to align itself with
better access to medicines policies pursued by the U.S. government. For
example, during the January 2011 128th Executive Board of the World Health
Organization the U.S. government made a very strong statement 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 bringing down prices as robust generic competition, it urged
companies to join the recently created Medicines Patent Pool in order to
increase generic competition for newer HIV/AIDS drugs.
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. We are a humanitarian medical organization that needs and welcomes
biomedical innovation to better treat our patients. By seeking greater and
higher intellectual property norms in developing countries, however the U.S.
government through USTR is perpetuating a business model that links innovation
costs to high prices and does not address the innovation needs of developing
countries.
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 and other forums. Ways that would combine
innovation and access, by de-linking the cost of R&D from the price of
products.
The Special 301 report must no
longer be used to encourage TRIPS-plus measures not required by international
law. The Special 301 report must no longer threaten developing countries for
acting within their rights to ensure access to medicines for their populations.
Rather than using the Special 301 report to unilaterally impose a heightened IP
regime on developing countries, the US government should use its laws, policies
and financial resources to ensure that R&D is needs-driven and encourages
innovation; and to ensure sustainable access to medicines for all.
Thank you
Keywords: MSF / AIDS / TRIPS / Special 301 /
Medicines