KEI opening statement at WIPO General Assembly

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 burdensome.

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 development objectives.

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 to knowledge.

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 program?

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 from cancer.

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 Public Health.

End, KEI statement on Agenda Item 5.

Additional commentary.

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. (/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 world.