[Ip-health] Access to Medicines Submission to USTR Special 301

[Sean Flynn]

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SUBMISSION OF GLOBAL HEALTH ORGANIZATIONS:

OXFAM AMERICA, HEALTH GAP (GLOBAL ACCESS PROJECT), CENTER FOR POLICY ANALYS=
IS ON TRADE AND HEALTH, KNOWLEDGE ECOLOGY INTERNATIONAL, FORUM ON DEMOCRACY=
 AND TRADE, UNIVERSITIES ALLIED FOR ESSENTIAL MEDICINES, IP JUSTICE, REDGE =
- RED PERUANA POR UNA GLOBALIZACI=D3N CON EQUIDAD (PERU) (PERUVIAN NETWORK =
FOR GLOBALIZATION WITH EQUITY), FUNDACI=D3N MISI=D3N SALUD (COLOMBIA), HEAL=
TH MISSION FOUNDATION, JUSTICE, PEACE & INTEGRITY OF CREATION MISSIONARY OB=
LATES, SALUD Y FARMACOS (INTERNATIONAL SOCIETY OF DRUG BULLETINS)



Summary:

This year will be the first Special 301 report written by a United States T=
rade Representative office overseen by a political appointee of the Obama A=
dministration. 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 re=
strictions on access to medicines violates U.S. commitments under the 2001 =
WTO Doha Declaration on the TRIPS Agreement and Public Health, the multilat=
eral commitments in the World Trade Organization and World Health Organizat=
ion, ethical guidelines of the Declaration of Helsinki, express Congression=
al 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, s=
anction, trade preference, or otherwise -- the revocation or revision of an=
y intellectual property or pharmaceutical market regulation of any developi=
ng country that

(1) promotes access to affordable pharmaceuticals or medical technologies; =
and

(2) provides adequate and effective intellectual property protection consis=
tent with the Agreement on Trade-Related Aspects of Intellectual Property R=
ights (TRIPS Agreement) referred to in section 101(d)(15) of the Uruguay Ro=
und Agreements Act (19 U.S.C.  511(d)(15)), the Doha Declaration on the TRI=
PS Agreement and Public Health, and the August 30 Decision system promoting=
 access to generics for countries with inadequate local capacity to manufac=
ture medicines and the WHO Global Strategy and Plan of Action on Public Hea=
lth, Innovation and Intellectual Property.

The Administration should undertake an urgent review of legislative and pol=
icy changes necessary to bring Special 301 into compliance with the WTO's b=
an on unilateral adjudication of trade disputes. Under Special 301, USTR de=
cides for itself what policies violate the TRIPS Agreement. And it has freq=
uently done so under frivolous legal interpretations, such as that Article =
39.3 requires data exclusivity when such a proposal was specifically amende=
d out of the Article during TRIPS negotiations.

The U.S. government could use the Special 301 process to pursue pro-innovat=
ion policies. For example, it could encourage our trading partners to inves=
t more in public sector  R&D, including open source projects, and could hig=
hlight best practices to promote access to knowledge, such as the  NIH poli=
cies 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 p=
rovide the full and fair adjudicative process needed to ascertain relevant =
facts and fairly interpret and implement the statutory requirements. Full a=
dministrative justice norms should be afforded during the adjudicative proc=
ess, including adequate notice and a right of reply, a neutral arbitrator a=
nd right of appeal, objective and transparent standards and interpretations=
 of law, and a public interest representation program.