[Ip-health] MSF Oral Statement regarding the 2011 Special 301 Review Process

Judit Rius juditrius at yahoo.com
Wed Mar 2 21:54:13 PST 2011

Dear all,
Today, Medecins Sans Frontieres/Doctors without Borders (MSF) delivered an Oral 
Statement at the public hearing organized by USTR regarding the 2011 Special 301 
Review Process. 

The oral statement is available here (and copied below): 

Our 2011 written submission is available here: 

2 MARCH 2011he 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 the low- and 
middle-income countries. · 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 

We are especially concerned with the reference included in the 2010 Special 
report to “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 industry known practices that have undoubtedly benefits for use and adherence 
such as heat stabilization and fix 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 demands that 
monopoly protection in developing countries be reserved to only truly innovative 
products. 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. · It is also important that developing 
countries rights to issue compulsory licenses and to define the appropriate 
level of enforcement are respected. 
Judit Rius Sanjuan
US Manager
Campaign for Access to Essential Medicines
Doctors Without Borders/Médecins Sans Frontières (MSF)
333 7th Ave., 2nd Floor
New York, NY 10001
Thank you for this opportunity to speak about the 2011 Special 301 Review 
Medecins Sans Frontieres/Doctors Without Borders (MSF) is an independent, 
international medical humanitarian organization that delivers medical care to 
patients in over 60 countries. Our projects focus on the medical needs of poor 
people living in developing countries where medical needs are often the most 

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. T
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 up to 
90% 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 these 
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 
medicine access 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. 

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 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


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