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The U.S. government has an unfortunate history of pressuring low- and middle-income countries to observe strong intellectual property protection on medicines. This blocks access to generics in countries unable to afford expensive brand name drugs sold by American drug companies.   The Bush and Obama Administrations both promised to stop doing this, yet the pressures continue.  Tomorrow, trade officials will hear from public health advocates at an open hearing that their policies on intellectual property enforcement impede access to medicines around the world. In late April, it will publish its annual “Special 301” report, which blacklists countries allegedly lacking strong intellectual property protection.

The WTO’s Agreement on Trade Related Intellectual Property Rights (TRIPS) requires countries to enact enforceable minimum requirements for patents and other forms of IP, but it also contains flexibilities that give countries a lot of latitude to ensure access to medicines.

The U.S. has pledged to respect the TRIPS flexibilities in various multilateral forums.

In 2001, it signed the Doha Declaration on TRIPS and Public Health, affirming “the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility [to promote access to medicines for all].”

In 2008, it signed the World Health Assembly Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, promising “to take into account in trade agreements the flexibilities contained in the [TRIPS] and including those recognized by the Declaration on the TRIPS Agreement and Public Health.”

Nonetheless, the U.S. has engaged in trade disputes, and has cited countries in the Special 301 Report for using the flexibilities built into the TRIPS Agreement.  For instance, USTR cited Thailand for its use of TRIPS-compliant compulsory licenses on medicines, despite the fact that 27 Members of Congress urged them not to, stating that “countries should not be cited for the use of compulsory licenses or other flexibilities in accordance with international trade rules.”  In the 2011 Special 301 Report, USTR objected to the compulsory licensing regimes in China and Ecuador.

USTR often uses the Special 301 Report to pressure countries to adopt levels of intellectual property protection that exceed those required by TRIPS.  In these cases, countries are not in violation of multilateral IP norms, but the U.S. is unilaterally accusing them of denying “adequate and effective” IP protection anyway.  Countries are frequently cited for:

• Not providing new patents for new uses of known, patented subject matter.
• Not extending patents beyond the 20 year term required by the TRIPS Agreement to compensate for the time it takes to win patent or regulatory approval.
• Lacking data exclusivity, a form of intellectual property protection that prevents generic producers from winning regulatory approval for their products based on the originator’s safety and efficacy data for a period of time.
• Lacking enforcement measures that exceed those required by the TRIPS Agreement.

There are a number of Congressional documents opposing USTR’s efforts to advance TRIPS-Plus intellectual property protection that harms access to medicines, including:

• The Kennedy Amendment to the 2002 Trade Promotion Authority legislation, which was intended to block TRIPS-plus trade pressure by requiring that trade authority respect the Doha Declaration.
• The 2005 Committee on Government Reform report which argued that promoting TRIPS-plus provisions on pharmaceuticals was “[c]ontrary to the principles of the Doha Declaration” because they “will significantly impede the ability of developing countries to obtain access to inexpensive, lifesaving medications.”
• The May 10, 2007 “New Trade Policy for America,” a bipartisan policy agreement between congressional leaders and the Bush Administration, which agreed to a limit pending trade agreement provisions on data exclusivity, and excluded requirements for linkage and patent extensions.

Finally, the Obama administration has pledged its support of the use TRIPS flexibilities to access generic medicines.

• In 2008, the Candidate Obama’s campaign platform pledged to “break the stranglehold that a few big drug and insurance companies have on these life-saving drugs. They support the rights of sovereign nations to access quality-assured, low-cost generic medication to meet their pressing public health needs under the WTO’s Declaration on Trade Related Aspects of Intellectual Property Rights (TRIPS).”
• In 2009 a PEPFAR press release claimed that “The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) supports the increased availability of safe, effective, low-cost, and generic antiretroviral drugs (ARVs) in the developing world, extending its impact on treatment access beyond PEPFAR-supported programs.”

Earlier this month, USTR accepted written comments from civil society that addressed the issue of IP and access to medicines – see for instance comments from the NGOs Médecins Sans Frontières, Knowledge Ecology International, Essential Inventions, and the Brazilian Network for the Integration of Peoples Working Group on Intellectual Property, as well as a comment submitted by Sean Flynn and I, and another from Brooks Tueting of the University of Wyoming College of Law Center for International Human Rights Law and Advocacy.

The witnesses that USTR will testify at tomorrow’s hearing will include civil society groups which have long argued against the U.S. government’s use of trade policy to promote TRIPS-Plus IP policies that harm access to medicines.  In the past, USTR has taken comments from these groups and others, then proceeded to publish Special 301 Reports that still target countries for pro-health intellectual property policies aimed at promoting access to medicines.  This year the U.S. government may do the same, but it has (yet another) opportunity to stop using IP policy to bully countries on access to medicines – as it has promised to do in the past.