Special 301 is an annual report by the Office of the US Trade Representative (USTR) which places countries on a “watch list” if USTR would like to see greater changes in their intellectual property rules or enforcement practice. This year’s report came out May 1st. We pay attention because USTR relies heavily on comments from big business, and USTR’s opaque standards and criticism of other countries could stymie the development of public interest policies in areas including health. For example, countries have sovereign rights to issue “compulsory licenses” on pharmaceutical patents. Compulsory licensing authorizes price-lowering generic competition with patented drugs in exchange for royalty payments to the patent holder. It’s a key strategy for improving access to affordable medicines, especially in developing countries. But the US has often criticized compulsory licensing, and sometimes sought to stop it (see eg: www.citizen.org/leaked-cables-show-US-tried-failed-to-organize-against-ecuador-compulsory-licensing).
This year’s Special 301 Report, and past 301 Reports, have included language to the effect, “the United States respects a trading partner’s right to protect public health and, in particular, to promote access to medicines for all,” and “the United States respects its trading partners’ rights to grant compulsory licenses in a manner consistent with the provisions of the TRIPS Agreement [the World Trade Organization agreement on intellectual property rules].” (See pages 22 and 23 of this year’s 301 report.)
Nevertheless, in recent years, USTR has typically cited countries for issuing compulsory licenses or developing compulsory licensing plans, and expressed concern on behalf of the US government. With the exception of Canada’s 2007 export arrangement with Rwanda, every recent pharmaceutical compulsory license or major compulsory licensing policy – at least, of which USTR is aware, and so far as I can tell — has been referenced in the 301 Report. (I had to go back to 2004/2005 to find exceptions, in the case of Indonesian and Malaysian government use licenses for AIDS.) Sometimes the criticism is direct; other times the references are oblique or pledges to monitor the situation. But in each case the mere reference is important; a bullying tactic that tends to serve as a warning to all countries against using health rights.
At USTR’s hearing earlier this year informing the Special 301 review, I stated that it is becoming difficult to maintain faith in the US government’s general assurances that it respects countries’ use of these health rights, since USTR appears to cite any given use of compulsory licensing in the 301 Report. I asked USTR and the other federal agencies present to lend meaning to US Government commitments by excluding any reference to TRIPS-compliant compulsory licenses in this year’s report. (I’ve repeated the ask in various private meetings.)
This year’s 301 Report is, as always, an embarrassing application of US power on behalf of Big Pharma and the content industry, and against a number of public interests. The report criticizes compulsory licensing in India and Indonesia, among other pharmaceuticals-related policies.