E-DRUG: US 2006 Special 301 Report: Data Exclusivity and Linkage
----------------------------------------------
This year's Special 301 Report placed 48 countries on the Priority Watch
List (PWL), Watch List (WL) or the Section 306 monitoring list. Fully 25
of those countries were criticized for pharmaceutical related policies,
primarily data exclusivity, patent-registration linkage, and lack of
criminal enforcement measures.
In addition to China and Russia, eleven countries are placed on the PWL
this year. The USTR mention the failure to adequately protect
pharmaceutical data both with respect to China and Russia and as follows
with respect to the other eleven PWL countries: Argentina (DE & linkage),
Belize (no mention), Brazil (DE), Egypt (DE and linkage), India (DE),
Indonesia (no mention), Israel (DE), Lebanon (DE and linkage), Turkey (DE
and linkage), Ukraine (none), and Venezuela (DE and linkage).
Thirty-four trading partners are placed on the lower level Watch List. In
the Watch List countries the pharmaceutical-related data exclusivity and
linkage criticisms were as follows: the Bahamas (none), Belarus (none),
Bolivia (none), Bulgaria (DE), Canada (DE), Chile (DE), Colombia (none),
Costa Rica (DE), Croatia (linkage), Dominican Republic (DE), Ecuador (DE &
linkage), European Union (none), Guatemala (DE), Hungary (linkage), Italy
(none), Jamaica (none), Kuwait (DE), Latvia (none), Lithuania (none),
Malaysia (none), Mexico (none), Pakistan (DE), Peru (linkage), the
Philippines (none), Poland (DE), the Republic of Korea (linkage), Romania
(none), Saudi Arabia (none), Taiwan (none), Tajikistan (none), Thailand
(DE), Turkmenistan (none), Uzbekistan (none), and Vietnam (none).
The Report gave special praise to this year to Ukraine, Croatia, Peru, the
Slovak Republic, Taiwan, and Vietnam for having adopted U.S. style data
exclusivity.
For the third year in a row, the US continues to prioritize
registration-related monopoly protections. Although this year’s Report
devotes more copy to enforcement issues, counterfeit drugs, and pricing
issues in Europe and although it pats itself on the back with respect to
the U.S. role in the Dec. 2005 Paragraph 6 TRIPS/health solution, the
Report is still being used as a cudgel to extract TRIPS-plus data
protection and linkage provisions from developing countries. These
provisions will ensure slower access to life-saving medicines for poor
people worldwide.
Brook K. Baker
Health GAP, USA
B.Baker@neu.edu