[Ip-health] US 2006 Special 301 Report: Data Exclusivity and Linkage

B.Baker@neu.edu B.Baker@neu.edu
Mon May 1 17:24:02 2006


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This year's Special 301 Report placed 48 countries on the Priority Watch=0D
List (PWL), Watch List (WL) or the Section 306 monitoring list.  Fully 25=
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of those countries were criticized for pharmaceutical related policies,=0D
primarily data exclusivity, patent-registration linkage, and lack of=0D
criminal enforcement measures.=0D
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In addition to China and Russia, eleven countries are placed on the PWL=0D
this year.  The USTR mention the failure to adequately protect=0D
pharmaceutical data both with respect to China and Russia and as follows=0D
with respect to the other eleven PWL countries:  Argentina (DE & linkage),=
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Belize (no mention), Brazil (DE), Egypt (DE and linkage), India (DE),=0D
Indonesia (no mention), Israel (DE), Lebanon (DE and linkage), Turkey (DE=
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and linkage), Ukraine (none), and Venezuela (DE and linkage).=0D
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Thirty-four trading partners are placed on the lower level Watch List. In=
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the Watch List countries the pharmaceutical-related data exclusivity and=0D
linkage criticisms were as follows:  the Bahamas (none), Belarus (none),=0D
Bolivia (none), Bulgaria (DE), Canada (DE), Chile (DE), Colombia (none),=0D
Costa Rica (DE), Croatia (linkage), Dominican Republic (DE), Ecuador (DE &=
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linkage), European Union (none), Guatemala (DE), Hungary (linkage), Italy=
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(none), Jamaica (none), Kuwait (DE), Latvia (none), Lithuania (none),=0D
Malaysia (none), Mexico (none), Pakistan (DE), Peru (linkage), the=0D
Philippines (none), Poland (DE), the Republic of Korea (linkage), Romania=
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(none), Saudi Arabia (none), Taiwan (none), Tajikistan (none), Thailand=0D
(DE), Turkmenistan (none), Uzbekistan (none), and Vietnam (none).=0D
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The Report gave special praise to this year to Ukraine, Croatia, Peru, the=
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Slovak Republic, Taiwan, and Vietnam for having adopted U.S. style data=0D
exclusivity.=0D
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For the third year in a row, the US continues to prioritize=0D
registration-related monopoly protections.  Although this year=E2=80=99s Re=
port=0D
devotes more copy to enforcement issues, counterfeit drugs, and pricing=0D
issues in Europe and although it pats itself on the back with respect to=0D
the U.S. role in the Dec. 2005 Paragraph 6 TRIPS/health solution, the=0D
Report is still being used as a cudgel to extract TRIPS-plus data=0D
protection and linkage provisions from developing countries.  These=0D
provisions will ensure slower access to life-saving medicines for poor=0D
people worldwide.=0D
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Brook K. Baker=0D
Health GAP, USA