PhRMA 2018 Special 301 Submission Calls for Urgent Action to Address Serious Access and IP Barriers

WASHINGTON, D.C. (February 8, 2018) — Today, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed its 2018 Special 301 submission, which urges the Office of the United States Trade Representative (USTR) to take immediate action to address serious market access and intellectual property barriers in 19 overseas markets. The submission calls on USTR to designate Canada, Korea and Malaysia as “Priority Foreign Countries” and to include Japan and 11 other countries on the “Priority Watch List.”

Required by the Trade Act of 1974, the annual Special 301 Report identifies foreign countries that deny adequate and effective intellectual property protection or fair and equitable market access for U.S. products.

“Discriminatory pricing policies in Canada, Korea and Japan and compulsory licensing in Malaysia are threatening American jobs and exports,” said PhRMA Senior Vice President for International Advocacy Brian Toohey. “Countries that blatantly disregard trade rules to benefit their own domestic industries are undermining investment in new treatments and cures for patients around the world.”

“Special 301 gives the Administration a critical tool to combat these damaging practices and to level the playing field for America’s innovative and creative industries that collectively support more than 45 million jobs across the country,” Toohey added. “Ending discriminatory foreign government pricing policies alone could add billions of dollars to research and development for new medicines and lower overall health care costs worldwide.”

PhRMA is urging USTR to name Canada, Korea and Malaysia as Priority Foreign Countries, a designation reserved for countries with the most onerous and egregious intellectual property or market access practices that have the greatest impact on U.S. products. USTR and other federal agencies should use all available tools to remedy the following serious concerns in these countries:

  • Canada: Canada’s intellectual property and pricing environment has created significant instability for U.S. innovative biopharmaceutical companies. Of particular concern are proposed pricing changes for patented products, which would undermine Canada’s trade-related intellectual property commitments and create uncertainty for Canadian patients.
  • Korea: Korea’s pricing policies severely devalue U.S. intellectual property and favor Korea’s own pharmaceutical industry at the expense of U.S. companies. These pricing practices are inconsistent with its commitments under the U.S.-Korea Free Trade Agreement (KORUS).
  • Malaysia: Late last year, the Malaysian government announced a compulsory license for the patent that protected an innovative U.S. medicine, a move that significantly degrades the protection of intellectual property in the country. This unjustified and unwarranted action has sent a clear signal to America’s biopharmaceutical innovators that their patents are not safe in Malaysia.

Additionally, PhRMA recommends that Japan and eleven other countries be included on the Priority Watch List. The detailed information presented in PhRMA’s submission demonstrates that the practices of these countries are denying adequate and effective intellectual property protection or fair and equitable market access. They are harming biopharmaceutical innovators in the United States and the more than 4.7 million jobs they support across the country.

To view PhRMA’s complete 2018 Special 301 Submission, please visit

To view an infographic on the 2018 Special 301 Submission, please click here.

About PhRMA
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Since 2000, PhRMA member companies have invested more than $600 billion in the search for new treatments and cures, including an estimated $65.5 billion in 2016 alone.

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