Access to medicines in poor and developing countries remains a hot issue and the outcome can often be influenced by trade policies. For this reason, the annual report from the US Trade Representative is closely watched for signs that public policy strikes an even balance between basic human needs and the economic interests, notably patents, of key US industries, including the pharmaceutical industry.

This time around, the US Trade Rep’s annual report (which you can read here) notes that the US affirms the conclusions of the Doha declaration of TRIPS, the trade-related aspects of intellectual property rights (see this primer), and “respects a country’s right to protect public health and, in particular, to promote access to medicines for all, and supports the vital role of the patent system in promoting the development and creation of new and innovative lifesaving medicines.”

Interestingly, Sean Flynn, the associate director of the Program on Information Justice and Intellectual Property at the American University Washington College of Law, notes that this year’s language removes a qualification the US used in earlier reports for its support for the TRIPS agreement by writing about flexibilities in a “crisis” or “emergency.”

Just the same, the USTR 301 report was criticized by various groups, including Doctors Without Borders, for pressuring various countries to adopt intellectual property protections, such as data exclusivity. And such concerns were expressed on the eve of the release of the report by Henry Waxman (see his letter) and Maine Governor John Balducci, who wrote the Department of Health and Human Services that the US should not “press countries to restrict pharmaceutical pricing programs that are substantially identical to those used by states such as Maine” (see the letter).

Doctors Without Borders criticized the US Trade Rep for placing countries on its “Watch List” for taking action against countries considered to be inadequately protecting intellectual pproperty, even though they are complying with international agreements. Thailand, Brazil and India, which makes many generic meds, “were singled out for insufficient enforcement of intellectual property. However, the countries challenged are acting within their legal rights when they limit the issuance of patents - such as in India and Brazil—or when they override existing medicine patents through the use of compulsory licenses, as Thailand has done in the past.

“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,” Emi MacLean, US director of the Access to Essential Medicines Campaign, says in a statement. “The US 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.”

And Flynn also released a statement, saying “the Special 301 program continues to be used to pressure developing countries to adopt heightened intellectual property protection and reduced price regulation of medicines in developing countries. USTR expresses concern about compulsory licenses in Thailand and Ecuador and about TRIPS compliant patentability criteria in India and Brazil. The most frequently asserted complaint on medicines issues continues to be a lack of US or EU-style ‘data exclusivity’ rules, despite the removal of a data exclusivity requirement from TRIPS in the negotiation.”

And Jamie Love of Knowledge Ecology International, which has pushed for the use of compulsory licensing, wrote that “As usual, the list is highly political. It is not as if Canada doesn’t protect IP more than countless countries not on the Priority list. China is probably hard wired to the list for domestic political reasons. Compulsory licensing was mentioned in connection with China and Ecuador, in a report that declared that compulsory licensing of patents was a ‘right’ of countries, but also something that the US would monitor. No mention of the growing number of compulsory licenses issued in the US as part of the post eBay standards for injunctions on patent infringement cases.

“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.”