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Phrma SPECIAL 301 SUBMISSION 2008 OVERVIEW PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) SPECIAL 301 SUBMISSION 2008 PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) SPECIAL 301 SUBMISSION 2008 1 PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) SPECIAL 301 SUBMISSION 2008 TABLE OF CONTENTS PhRMA SPECIAL 301 SUBMISSION 2008 OVERVIEW.....................................4 PRIORITY FOREIGN COUNTRIES ...................................................................26 Philippines .........................................................................................................28 Thailand .............................................................................................................32 SECTION 306 MONITORING ............................................................................42 Paraguay ...........................................................................................................44 The People’s Republic of China .........................................................................48 PRIORITY WATCH LIST COUNTRIES .............................................................56 ASIA-PACIFIC....................................................................................................58 Australia .............................................................................................................60 India (with OCR) ................................................................................................64 Indonesia ...........................................................................................................72 Korea .................................................................................................................76 New Zealand ......................................................................................................82 EUROPE ............................................................................................................88 European Union .................................................................................................90 Czech Republic ..................................................................................................92 Germany ............................................................................................................98 Hungary ...........................................................................................................104 Italy ..................................................................................................................108 Poland ..............................................................................................................112 Russia .............................................................................................................116 Turkey ..............................................................................................................120 LATIN AMERICA .............................................................................................126 Argentina .........................................................................................................128 Brazil ................................................................................................................132 Chile .................................................................................................................138 Costa Rica .......................................................................................................144 Venezuela ........................................................................................................148 MIDDLE EAST/ AFRICA/ SOUTH ASIA .........................................................154 Israel ................................................................................................................156 Lebanon ...........................................................................................................164 Pakistan ...........................................................................................................168 Saudi Arabia ....................................................................................................170 2 PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) SPECIAL 301 SUBMISSION 2008 WATCH LIST COUNTRIES .............................................................................174 ASIA-PACIFIC .................................................................................................176 Malaysia ...........................................................................................................178 Taiwan .............................................................................................................182 Vietnam ............................................................................................................190 CANADA .........................................................................................................198 Canada ............................................................................................................200 EUROPE ..........................................................................................................206 Austria ..............................................................................................................208 France ..............................................................................................................210 Norway .............................................................................................................216 Romania ..........................................................................................................218 Slovak Republic ...............................................................................................220 Slovenia ...........................................................................................................222 Spain ................................................................................................................226 Ukraine ............................................................................................................230 LATIN AMERICA .............................................................................................232 Colombia ..........................................................................................................234 Dominican Republic .........................................................................................240 Ecuador ...........................................................................................................242 El Salvador ......................................................................................................246 Guatemala .......................................................................................................248 Honduras .........................................................................................................250 Mexico .............................................................................................................252 Nicaragua ........................................................................................................256 Peru .................................................................................................................258 MIDDLE EAST/ AFRICA/SOUTH ASIA ..........................................................262 Algeria ..............................................................................................................264 Undesignated Countries ...............................................................................268 Egypt ................................................................................................................270 3 PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) SPECIAL 301 SUBMISSION 2008 PhRMA SPECIAL 301 SUBMISSION 2008 OVERVIEW 4 PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) SPECIAL 301 SUBMISSION 2008 5 PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) SPECIAL 301 SUBMISSION 2008 PhRMA SPECIAL 301 SUBMISSION 2008 OVERVIEW I. Importance of Special 301 and Effective Intellectual Property Protection During the Uruguay Round negotiations that produced the World Trade Organization (WTO), the United States made significant progress toward more consistent and effective intellectual property protection globally. The result of this effort was the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The TRIPS Agreement requires all WTO members to establish functional intellectual property systems. Its obligations extend to rights such as patents, undisclosed information, trademarks and copyrights. It also requires efficient registration procedures and effective enforcement regimes. Under the TRIPS Agreement, intellectual property owners must be given rights promptly, must gain certain minimum assurances of the characteristics of the rights, and must have recourse to effective means for enforcing those rights. All of these obligations must be implemented in practice as well as through laws and regulations. The TRIPS Agreement was a major achievement in strengthening the worldwide protection and enforcement of intellectual property rights by creating an international minimum standard, rather than an optimal level of protection for intellectual property rights. The Agreement was premised on the view that its obligations, if faithfully implemented by the diverse WTO Membership, would create the policy and legal framework necessary for
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