On February 18, 2010, 12 NGOs working on Access to Medicines submitted joint comments to the 2010 Special 301 Process
The submission is available here.
And a summary below:
SUBMISSION OF GLOBAL HEALTH ORGANIZATIONS:
OXFAM AMERICA, HEALTH GAP (GLOBAL ACCESS PROJECT), CENTER FOR POLICY ANALYSIS ON TRADE AND HEALTH, KNOWLEDGE ECOLOGY INTERNATIONAL, FORUM ON DEMOCRACY AND TRADE, UNIVERSITIES ALLIED FOR ESSENTIAL MEDICINES, IP JUSTICE, REDGE – RED PERUANA POR UNA GLOBALIZACIÓN CON EQUIDAD (PERU) (PERUVIAN NETWORK FOR GLOBALIZATION WITH EQUITY), FUNDACIÓN MISIÓN SALUD (COLOMBIA), HEALTH MISSION FOUNDATION, JUSTICE, PEACE & INTEGRITY OF CREATION MISSIONARY OBLATES, SALUD Y FARMACOS (INTERNATIONAL SOCIETY OF DRUG BULLETINS)
Summary:
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 Administration should 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. Under Special 301, USTR decides for itself what policies violate the TRIPS Agreement. And it has frequently done so under frivolous legal interpretations, such as that Article 39.3 requires data exclusivity when such a proposal was specifically amended out of the Article during TRIPS negotiations.
The U.S. government could use the Special 301 process to pursue pro-innovation policies. For example, it could encourage our trading partners to invest more in public sector R&D, including open source projects, and could highlight best practices to promote access to knowledge, such as the NIH policies to provide open access to published scholarly and scientific research when the research benefited from government funding.
At a minimum, the Special 301 program needs serious procedural reforms to provide the full and fair adjudicative process needed to ascertain relevant facts and fairly interpret and implement the statutory requirements. Full administrative justice norms should be afforded during the adjudicative process, including adequate notice and a right of reply, a neutral arbitrator and right of appeal, objective and transparent standards and interpretations of law, and a public interest representation program.