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SPECIAL 301 SUBMISSION 2021 PHARMACEUTICAL RESEARCH and MANUFACTURERS of AMERICA (Phrma) SPECIAL 301 SUBMISSION 2021

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SPECIAL 301 SUBMISSION 2021 PHARMACEUTICAL RESEARCH and MANUFACTURERS of AMERICA (Phrma) SPECIAL 301 SUBMISSION 2021 PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) SPECIAL 301 SUBMISSION 2021 PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) SPECIAL 301 SUBMISSION 2021 PAGE INTENTIONALLY LEFT BLANK PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) SPECIAL 301 SUBMISSION 2021 Table of Contents PhRMA 2021 SPECIAL 301 OVERVIEW ......................................................................................................... 1 PRIORITY FOREIGN COUNTRY .................................................................................................................... 42 CANADA ...................................................................................................................................................... 43 JAPAN .......................................................................................................................................................... 57 KOREA ......................................................................................................................................................... 69 SECTION 306 MONITORING .......................................................................................................................... 75 THE PEOPLE’S REPUBLIC OF CHINA ....................................................................................................... 76 PRIORITY WATCH LIST ................................................................................................................................. 99 ASIA – PACIFIC............................................................................................................................................ 100 INDIA .......................................................................................................................................................... 101 MALAYSIA ................................................................................................................................................. 117 THAILAND .................................................................................................................................................. 124 EUROPE ....................................................................................................................................................... 130 RUSSIA ...................................................................................................................................................... 131 TURKEY ..................................................................................................................................................... 144 UKRAINE ................................................................................................................................................... 153 LATIN AMERICA .......................................................................................................................................... 156 ARGENTINA............................................................................................................................................... 157 BRAZIL ....................................................................................................................................................... 163 CHILE ......................................................................................................................................................... 169 COLOMBIA ................................................................................................................................................ 174 MEXICO ..................................................................................................................................................... 182 MIDDLE EAST / AFRICA .............................................................................................................................. 191 ALGERIA .................................................................................................................................................... 192 SAUDI ARABIA .......................................................................................................................................... 199 WATCH LIST ................................................................................................................................................ 206 ASIA – PACIFIC............................................................................................................................................ 207 AUSTRALIA................................................................................................................................................ 208 INDONESIA ................................................................................................................................................ 218 THE PHILIPPINES ..................................................................................................................................... 225 SINGAPORE .............................................................................................................................................. 231 TAIWAN ..................................................................................................................................................... 235 PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) SPECIAL 301 SUBMISSION 2021 EUROPE ....................................................................................................................................................... 240 EUROPEAN UNION ................................................................................................................................... 241 UNITED KINGDOM .................................................................................................................................... 257 MIDDLE EAST / AFRICA .............................................................................................................................. 262 EGYPT ....................................................................................................................................................... 263 OUT-OF-CYCLE REVIEW ............................................................................................................................ 266 UNITED ARAB EMIRATES ........................................................................................................................ 267 PhRMA 2021 SPECIAL 301 OVERVIEW PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) SPECIAL 301 SUBMISSION 2021 PhRMA 2020 SPECIAL 301 OVERVIEW The Pharmaceutical Research and Manufacturers of America (PhRMA) appreciates the opportunity to provide this submission for the 2021 Special 301 Report. America leads the world in the research and development of valuable new medicines and vaccines. Established by the Trade Act of 1974, the Special 301 review gives the Administration a critical opportunity to confirm its strong commitment to defend these and other American inventions in overseas markets and a critical tool to address damaging market access and intellectual property barriers abroad that harm America’s innovative and creative industries and the more than 45 million jobs they support across the country.1 The COVID-19 pandemic has rattled health systems globally, but the biopharmaceutical industry is working around the clock to find ways to diagnose, treat and prevent infections from the virus and other conditions. In addition, the biopharmaceutical industry is providing financial support and in-kind donations to organizations and collaborating with U.S. and global health authorities to combat the pandemic. Durable intellectual property and market access policies have made possible the tremendous R&D effort required to deliver COVID-19 diagnostics, treatments and vaccines to patients that need them. More than half of PhRMA members have R&D for potential treatments and vaccines under way or are providing donations of medicines and critical medical supplies as well as providing financial donations to support patients and first responders in addressing this evolving crisis. As a result of the unprecedented collaboration and partnerships between the private sector, researchers, academia, governments and other organizations, PhRMA members have and are working to deliver numerous COVID-19 treatments and vaccines in record time. Urgent action is required to address serious market access and intellectual property barriers in the overseas markets named in this submission. As explained further below, biopharmaceutical innovators in the United States face a wide array of damaging government pricing policies abroad that undervalue American innovation, threaten billions of dollars in lost sales and put American competitiveness, jobs and exports at risk. Medicines discovered and manufactured by PhRMA member companies are the constant target of compulsory licensing and other harmful practices that deny the most basic intellectual property protections necessary to drive discovery and bring new treatments and cures to patients around the world. The Office of the U.S. Trade Representative and other federal agencies should prioritize action to address compulsory licensing threats, including in Indonesia, Malaysia and Russia, and to end egregious and discriminatory pricing policies in several markets, including Canada, Japan and Korea. Government price controls imposed in 1 U.S. Department of Commerce, Intellectual Property and the U.S.
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