THE 2001 World Trade Organization (WTO) Ministerial Conference in Doha reaffirmed that the TRIPS Agreement “can and should be interpreted and implemented in a manner supportive of the WTO members’ right to protect public health and, in particular, to promote access to medicines for all.” The Declaration sustained the right of developing countries like the Philippines to enforce public health safeguards so as to enable price reductions via generic competition. “Paragraph 6 Public Health Solution” of the Declaration even directed WTO member countries to facilitate access to generic medicines by poor countries with insufficient or no pharmaceutical manufacturing capacities.
In a 2005 analysis, Carlos Correa, an international expert on intellectual property law and public health, said that the Philippines’ Intellectual Property Code had not contemplated several flexibilities in the TRIPS Agreement, particularly parallel importation and the “Bolar exception.” To develop a patent regime that provides for a comprehensive set of rules consistent with the Agreement and protects and promotes public health, Correa advised the country to look into other issues such as the extent of rights conferred by a patent application and grant.
But as the global nonprofit organization Oxfam International observes, the public health safeguards allowed under TRIPS have been constantly undermined, either weakened or eliminated by higher levels of intellectual property protection — called TRIPS-plus rules — that countries like the United States have vigorously pushed through bilateral and regional trade agreements, to the benefit of the pharmaceutical industry.
Some legislators even suspect the “unseen hand” of the United States in what they say was a recent attempt to modify some of the provisions in House Bill 2844. Apparently, an unsigned position paper was circulated among members of the House of Representatives’ trade and industry committee last month.
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“Predictably, the Office of the U.S. Trade Representative echoed the position of multinational pharmaceutical companies,” says Akbayan party-list Rep. Anna Theresia Hontiveros-Baraquel of the proposals in the paper. “They don’t want a stricter definition of patentability to protect the monopoly of big pharmaceutical companies. They also want to limit the government’s use of compulsory licensing.”
Though unsigned, what purportedly gave the U.S. link away was the reference in the paper to the “modern free trade agreements (FTAs) that the U.S. negotiated (with countries) such as Morocco, Oman, Korea, just to name a few, (that) specifically provide patent protection for new uses (of known substances).” This was punctuated by a question asking if the Philippines “really want(s) to go in the opposite direction,” which Baraquel considers as a veiled warning now that the U.S.-RP Bilateral Trade and Investment Framework Agreement (TIFA) is currently under negotiations.
According to Oxfam, expanding the scope of pharmaceutical patents to include new indications — or new therapeutic uses of existing medicines — and formulations, and limiting the grounds for issuing compulsory licenses to emergencies, government non-commercial use, and competition cases are actually among the common TRIPS-plus features in FTAs negotiated by the United States with other countries.
Oxfam says that the U.S. government has close ties with pharmaceutical companies, noting that there are 20 industry representatives who sit on the advisory committees of the Office of the U.S. Trade Representative.
Oxfam also considers it an attempt to enforce TRIPS-plus rules in the Philippines when Pfizer filed a patent infringement case in 2006 against the government for importing cheaper versions of its hypertension drug, Norvasc, whose patent was set to expire in mid-2007. The court has yet to issue a ruling on the case, which seeks to prohibit the government from doing parallel importation of a patented drug, even as an exercise of the “early working” doctrine that is allowed under TRIPS (and even by the country’s current IP Code, though not as an expressed provision).