[Ip-health] KEI opening statement at WIPO General Assembly (2013)
thiru at keionline.org
Wed Sep 25 08:06:44 PDT 2013
KEI opening statement at WIPO General Assembly
Submitted by James Love on 24. September 2013 - 15:36
Delivered September 24, 2013, during NGO statements on agenda Item 5.
Thank you for the opportunity to speak today.
As regards the Marrakesh treaty, KEI offers its sincere and profound thanks
to Secretary Francis Gurry, Ambassador Trevor Clarke, Michelle Woods and
Geidy Lung and others members of the WIPO staff for their dedication to a
successful conclusion to this difficult negotiation.
As others have mentioned, the SCCR might want to review the technical
assistance relating to the treaty, to ensure that countries have
information about implementation strategies that are not complex or
The Marrakesh treaty began a debate on the three step test, and we hope
this debate continues, for greater sophistication about where the
three-step test applies, and where the three-step test does not apply, and
how it should be evaluated in a manner consistent with social and
One of the challenges for WIPO will be to fashion a realistic and
thoughtful strategy for addressing norm setting in the area of user rights
in copyright, and exceptions that relate to institutions like schools and
libraries that serve end users. WIPO is also being asked to resolve the
outstanding requests for new legal protections for broadcasting
organizations. KEI hopes that in all cases, WIPO will identify the problems
it is being asked to solve, and relate norm setting, if required, to those
problems, in ways to promote the public interest and expand lawful access
On the topic of medical innovations, KEI notes that WIPO Re:Search is a
program that is promoting various voluntary licensing agreements, and match
making between researchers and product developers. What is the role of
member states in supervising or reviewing the projects and activity of this
On a different topic, KEI is concerned about access to new treatments and
diagnostic tools, including for cancer.
KEI notes that WIPO has recently hired an expert in this area who has
written that people living in developing countries do not need access to
patented cancer drugs. (For example, this paper). This is profoundly
ignorant, and it is not reassuring that persons holding such views are
advising countries on patent and health issues.
According to the WHO, 7.6 million people worldwide died from cancer in 2008
and more approximately 70% of cancer deaths occur in low- and middle-income
countries -- more than 5 million deaths per year in developing countries
KEI notes that there have been attacks on India, in its efforts to expand
access to patented cancer drugs.
History will not look kindly on those who contribute to medical apartheid,
as regards cancer and other deadly illnesses.
Finally, KEI also asks WIPO to take note of discussions at the World Health
Organization the delinkage of R&D costs and prices for products. We think
that unless R&D costs and rewards for successful investments are delinked
from product prices, it will be impossible to imagine access to medicine
for all, a mandate of the 2001 Doha Declaration on TRIPS and Pubic Health.
End, KEI statement on Agenda Item 5.
I'll elaborate on the comments on the access to cancer drugs in other
agenda items at WIPO, but for some context, note that when Philip Stevens
attacks compulsory licenses on drugs, he justifies the critique in part by
saying there are not many patented drugs on the WHO essential drugs list.
Indeed, there are few patented drugs outside of those for HIV/AIDS, and
none for cancer. The WHO list comes up a lot when compulsory licenses are
attacked, including in several industry supported papers in the early 2000s
by Bruce Lehman, Tom Bombelles and Amir Attaran (who published academic
versions of papers earlier presented by Lehman and Bombelles). Among
treatment advocates, using the WHO essential medicines list as evidence
that patented drugs are not needed is infuriating. The WHO list has no
patented cancer drugs because they are expensive, and they are expensive
because of the patents. In 2011, KEI took a look at the NIH "alpha" list of
100 drugs for cancer (100 unique chemical entities, plus many combination
drugs). Among the 100 drugs, about 2/3 were protected by patents, and half
were registerd after Jan 1, 2000. (http://keionline.org/rn2011-1) In the
past 30 months, the FDA has approved 24 new drugs for cancer. The fact that
the WHO says none of the patented cancer drugs are "essential" is hardly
evidence that people living in developing countries don't need them, but
rather that patents make cancer drugs too expensive for most people in the
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