Download The New Trade Policy for America

The New Trade Policy
for America – How Will
It Affect Korea?
Mike Palmedo
Research Coordinator
Program on Information Justice and Intellectual Property
Washington College of Law, American University
June 4, 2006 - Seoul, Republic of Korea
May 10, 2007: New Trade
Policy Announced
“Today we have seized an historic opportunity to
restore the bipartisan consensus on trade with a
clear and reasonable path forward for
congressional consideration of Free Trade
Agreements with Peru, Colombia, Panama and
Korea.
- USTR Susan Schwab
Labor Chapter of the New
Trade Policy for America
 An enforceable commitment that FTA countries
will adopt the in their laws and practice the five
basic international labor standards, as stated in
the 1998 International Labor Organization
Declaration.
 Binding commitment prohibiting FTA countries
from lowering labor standards.
 Same dispute settlement mechanisms and
penalties as other FTA obligations.
Environmental Chapter of the
New Trade Policy for America
 A fully enforceable commitment that FTA
countries adopt, implement and enforce in their
laws and practice obligations under seven
common major multilateral environmental
agreements.
 A binding commitment prohibiting FTA
countries from lowering environmental
standards.
 Same dispute settlement mechanisms and
penalties as other FTA obligations.
 A "conflict of laws" provision, where
environmental treaty obligations trump FTA
obligations when the two conflict.
IPR Chapter of the New
Trade Policy for America
 Though portrayed in the media as a
compromise, language on access to
medicines still TRIPS-Plus.
 The intellectual property section is meant
to increase access to medicines in
“developing countries.” It is meant for the
FTAs with Peru, Panama, and Colombia.
Korus FTA & New Trade Policy
for America’s IP Guidelines
“Most of the IP provisions do not apply to the
Korus FTA. The one provision that would
apply is point 3(d).”
- Ways and Means Staff
May 29, 2007
Data Exclusivity
New Trade Policy
Korus FTA
 Five year period of data
exclusivity for New
Chemical Entities.
 Concurrent periods of
exclusivity if approval in
one nation is based on
approval in another
 Five year period of data
exclusivity for New
Chemical Entities.
 Three year period of data
exclusivity for drugs that
are not NCEs, but
required clinical testing
for approval.
 Non-concurrent periods
of exclusivity if approval
in one nation is based on
approval in another
“Linkage”
New Trade Policy
Korus FTA
 “No requirement that
the drug regulatory
agency withhold
approval of a generic
until it can certify that
no patent would be
violated if the generic
were marketed.”
 Parties must
“implement measures
in its marketing
approval process to
prevent… other
persons from
marketing a product
without the consent or
acquiescence of the
patent owner during
the term of a patent.”
Patent Extensions
New Trade Policy
Korus FTA
 Parties “may” include  Parties “shall”
patent extensions to
include patent
make up for delays in
extensions to make
the granting of either
up for delays in the
a patent or marketing
granting of either a
approval.
patent or marketing
approval.
Second Use Patents
New Trade Policy
Korus FTA
 Second use patents
not covered.
 Second use patents
mandatory.
Pharmaceuticals Chapter
Favors Brand Name Firms
 When determining reimbursement, authorities
must "appropriately recognize the value of
patented pharmaceutical products and medical
devices."
 Pharmaceutical firms may appeal any decision
not to include their products on the positive list
for reimbursement.
 Korus FTA mandates a burdensome process for
the negotiation of the reimbursement rate for
each drug.
Three Things to Remember
 The New Trade Policy for America does not
apply to the intellectual property chapter of the
Korus FTA.
 The Korus FTA intellectual property chapter will
delay generic competition.
 The Pharmaceuticals and Medical Devices
Chapter will encourage the Korean National
Health Insurance to favor expensive, brandname drugs.
wcl.american.edu/pijip