Public Health Responses to the Release of the Special 301 Report
The following quotes are excerpts from the organizations' full press releases. For more information on Special 301, please see PIJIP's page at wcl.american.edu/pijip/go/301.
Sean Flynn,Associate Director
The 2010 report indicates there has been a major policy change in the Obama adminstration on the issue of linkage. "Linkage" refers to requirements that FDA-like marketing authorities not register generic copies of medicines for which there is a patent claimed by a supplier. The rule in the US has led to "ever-greening" - where marketing monopolies are continually extended with new (often baseless) applications for patents that prohibit FDA approval of generics until the patent dispute is litigated. The WTO TRIPS agreement does not require countries to implement linkage rules.
In 2009, a lack of linkage was the second most cited medicines-related complaint in Special 301 (after data exclusivity). This year, the only countries cited for lacking linkage in the report are those that agreed to linkage requirements in FTAs signed before the New Trade Deal with Peru and other countries. For example Chile and Dominican Republic are cited for lack of linkage, but both signed trade agreements with the U.S. containing a linkage requirement. At least on the issue of linkage, the new administration has embraced a more progressive rule that countries will not be cited in 301 for lacking a policy not clearly required by TRIPS or an FTA obligation with the U.S.
Unfortunately, this new rule is not applied to other areas. The US still cites countries for lacking data exclusivity, even though the U.S. proposal that TRIPS include a data exclusivity requirement was rejected in the WTO negotiations.This and other uses of Special 301 to promote controversial interpretations of TRIPS on other countries violates the multilateral dispute mechanism of the WTO. The U.S. violats international law when it unilaterally sanctions and threatens to sanction countries for policies that are not required by any trade agreement that both parties have signed.
Emi MacLean, U.S. director of the MSF Access to Essential Medicines Campaign:
It is unacceptable that the U.S. is continuing to threaten developing countries aiming to provide medicines to their populations, and disregarding international commitments to ensure access to medicines. The U.S. is using its trade laws to bully developing countries into applying arbitrary pharmaceutical industry requests at the expense of millions of people who depend on generic medicines in developing countries.
The terribly irony is that these pressure tactics would, if successful, limit the scope of actions countries can take to promote access to generic medicines, and undermine even the U.S. government’s own global health efforts.
Rohit Malpani, Senior Policy Advisor
This year’s Special 301 Report reflects some positive efforts by the Obama administration to introduce a more inclusive public consultation process, take into account public health concerns, and acknowledge the right of countries to use some of the available safeguards under the TRIPS Agreement to promote and protect public health. However, Oxfam is disappointed that once again, the report continues to insist that poor countries adopt other US-style intellectual property standards that are aggressively promoted by the multinational pharmaceutical industry.
Oxfam hopes the Administration will continue to work with public health groups constructively to ensure that US policy and practice fully respects the Doha Declaration on TRIPS and Public Health. The US should not punish developing countries seeking to use legal safeguards and flexibilities under the TRIPS Agreement to ensure access to affordable medicines. More expensive medicines in poor countries does not lead to more innovation to their benefit, it just means poor people don’t get medicines.
James Love, Director
Pharmaceutical test data and some type of linkage between patent status and drug registration are common asks in the 301 report. The language on linkage is somewhat weaker than in past reports, which is a good thing. The language on pharmaceutical test data is also weaker, focusing on "effective protection," which is also an improvement. Overall, I expected a worse report.
Brook Baker, Professor of Law
Although it has increased its verbal support for the Doha Declaration on the TRIPS Agreement and Public Health, the 2010 Special 301 Report continues to punish countries for their lawful refusals to adopt TRIPS-plus intellectual property protections and for using TRIPS-compliant flexibilities that positively impact access to medicine. Three “complaints” by the USTR stand out: alleged lack of data exclusivity for pharmaceutical products, adoption of patent standards that decrease opportunities for obtaining patents on medicines, and use of compulsory licenses......In addition to these very direct violations of the Doha Declaration, the USTR has continued to pursue draconian border and enforcement measures that will inevitably restrict legitimate trade in lawful generic medicines. With 10 million people waiting in line for AIDS medicines, US trade policies, including the Special 301 list, that threaten access to medicines must be condemned in the strongest terms.
Photo of medicines (cc) Darren Hester.