PIJIP Represents Public Health and States in Submissions to the United States Trade Representative

Submissions Call for Obama Administration to Change U.S. Trade Policy to Promote Access to Medicines in the U.S. and Abroad

For Immediate Release
February 19, 2010


SEAN FLYNN, Counsel of Record
202-294-5749; sflynn@wcl.american.edu

Contact Information for (US-based) Global Public Health Groups:

    Stephanie Burgos: 202-496-1088; sBurgos@oxfamamerica.org
    Brook Baker: 617-373-3217; b.baker@neu.edu
    Ellen Shaffer: 415-922-6204; ershaffer@gmail.com
    James Love: 202-202.332.2670; james.love@keionline.org
    Ethan Guillen: ethan.guillen@essentialmedicine.org
    Robin Gross: robin@ipjustice.org

Contact Information for Groups Representing US State Governments:

    Dana Eidsness: 202-609-7339; dana@forumdemocracy.net
    Sharon Treat: 207-622-5597; streat@reducedrugprices.org

Submissions to US Trade Representative

In two submissions to the United States Trade Representative for its “Special 301” trade hearings, public interest advocates called on the Obama Administration to end past trade policies that have threatened access to medicine at home and abroad. The public interest groups were represented by American University Washington College of Law’s Program on Information Justice and Intellectual Property (PIJIP).

A submission by 11 global health organizations  called on the United States Trade Representative to end the practice of using trade pressure to promote intellectual property standards on medicines in developing countries that exceed the minimum standards in the World Trade Organization Agreement on Trade Related Aspects of Intellectual Property. The submission states:

This year will be the first Special 301 report written by a United States Trade Representative office overseen by a political appointee of the Obama Administration. We call on the Administration to stop using this process to promote TRIPS-plus policies that endanger access to medicines for millions of people around the world. 

USTR’s past policy of using the Special 301 Report to promote TRIPS-plus restrictions on access to medicines violates U.S. commitments under the 2001 WTO Doha Declaration on the TRIPS Agreement and Public Health, the multilateral commitments in the World Trade Organization and World Health Organization, ethical guidelines of the Declaration of Helsinki, express Congressional policy, Obama campaign pledges, the best interests of the PEPFAR program, the interests of global health and international human rights obligations.

We call on the administration to extend the policy guidelines of President Clinton’s Executive Order 13155 to all developing countries. Specifically, it should be the policy of the United States that:
(a) The United States shall not seek -- through Special 301, negotiation, sanction, trade preference, or otherwise -- the revocation or revision of any intellectual property or pharmaceutical market regulation of any developing country that
(1) promotes access to affordable pharmaceuticals or medical technologies; and
(2) provides adequate and effective intellectual property protection consistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) referred to in section 101(d)(15) of the Uruguay Round Agreements Act (19 U.S.C.  511(d)(15)), the Doha Declaration on the TRIPS Agreement and Public Health, and the August 30 Decision system promoting access to generics for countries with inadequate local capacity to manufacture medicines and the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.
The global health submission further calls on the Obama Administration to “undertake an urgent review of legislative and policy changes necessary to bring Special 301 into compliance with the WTO’s ban on unilateral adjudication of trade disputes.”

The Special 301 program is an agency adjudication in which USTR decides for itself what foreign policies violate international trade agreements or otherwise burden U.S. commerce and places offending countries on watch lists. USTR is authorized to unilaterally sanction countries that reach the highest level of the watch lists, known as Priority Foreign Countries. The program was put in place by Congress in the 1980s, a decade before the World Trade Organization, and has not been amended in response to the WTO’s ban on unilateral adjudication of Trade disputes.

Sean Flynn, the Associate Director of PIJIP and expert in international intellectual property law, explained:

Unilaterally adjudicating trade disputes is a blatant violation of the WTO dispute resolution understanding. It offends foreign countries and the multilateral commitments of the U.S. The past administration treated commitments to multilateralism as quaint. With the new administration, it can be hoped that these commitments will be taken more seriously. The U.S. will be better off if it adheres to both the letter and spirit of multilateral commitments in international trade forums.

A second submission was filed yesterday in the Special 301 process on behalf of organizations representing U.S. state officials concerned about the rising costs of pharmaceuticals in this country.  In the submission, states “oppose the recent and disturbing use” of trade pressure and agreements by the USTR to create new international restrictions on pharmaceutical reimbursement programs that restrain excessive pricing by drug companies. The submission states:

This agenda is not authorized by any statute or administrative directive. And the agenda is incredibly unwise at a time when the U.S. is struggling to find ways to restrain its own health costs. To the extent there are best practices in the U.S., they are at the state governmental level and they follow the same basic policies and principles of foreign countries that USTR seeks to discipline. Reciprocal enforcement of USTR standards to state programs would obliterate the effectiveness of Medicaid pricing programs and threaten the administration’s policy goal of reducing the cost of healthcare in this country.    

According to the submission,

States have repeatedly contacted federal officials [in the previous administration] opposing this radical agenda. . .  State representatives appeal to the Obama administration to change course and halt the use of trade pressure or negotiations to internationally regulate domestic drug pricing programs that do not violate any World Trade Organization rule.

The two submissions were filed by PIJIP as part of its effort to support raising the voices of traditionally excluded groups from intellectual property policy making forums. In the recent past, only one non-profit public interest organization had participated in the annual Special 301 process. This year, there have been over 250 submissions to the process, many of which are from organizations and individuals concerned with the public interest impacts of the Special 301 unilateral adjudication of intellectual property issues.

The Program on Information Justice and Intellectual Property (PIJIP) at the Washington College of Law promotes public interest approaches to domestic and international intellectual property law through advocacy, events and the provision of legal and consulting services.  PIJIP’s activities focus on a balanced approach to intellectual property and other legal regimes that reward creators while ensuring broad public access to information and its products. This submission is part of PIJIP’s project examining public interest impacts of the international intellectual property enforcement agenda, funded in part by a gift from Google, Inc.

For more information on PIJIP’s enforcement project, see  http://www.wcl.american.edu/pijip/go/enforcement


Image of pills (cc) by rodrigo senna.


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