WASHINGTON, D.C. (April 25, 2019) – The Pharmaceutical Research and Manufacturers of America (PhRMA) welcomed the 2019 Special 301 Report released today by U.S. Trade Representative (USTR) Robert Lighthizer. The report highlights serious market access and intellectual property (IP) barriers American innovators face in countries around the world, including in Canada, Chile, Colombia, India, Indonesia, Malaysia, Saudi Arabia and other markets. 

“Biopharmaceutical innovators rely on predictable, transparent and fair intellectual property and market access systems around the world to continue developing new medicines and get those treatments to patients,” said Brian Toohey, senior vice president for International Advocacy, PhRMA. “We are pleased the Administration is shining a light on damaging practices abroad that undermine American innovation and limit local patient access to new medicines.”

PhRMA’s 2019 Special 301 submission called on USTR to address serious concerns in Canada, Japan, Korea and Malaysia as well as other markets. The report released today outlined efforts the Administration is undertaking regarding those markets and extends an ongoing out-of-cycle review of Malaysia’s IP protection and enforcement practices. As trading partners continue to undervalue innovative medicines, Special 301 should be a valuable tool in leveling the playing field for American innovators and patients, who shoulder the burden of global innovation.  

USTR highlighted the potentially devastating impact of measures under consideration in several markets that would break patents on innovative medicines – a drastic action known as “compulsory licensing”. For example, legislation currently being considered in Chile’s Congress could harm health care innovation and delay access to new treatments and cures. USTR’s attention to this market can help spur meaningful engagement from stakeholders in government and the private sector.     

“We will continue working with the Administration and Congress to break down barriers for American innovators abroad, including through the successful ratification of the United States-Mexico-Canada Agreement,” added Toohey. “Strong trade agreements like the USMCA can drive innovation and spur economic growth and job creation, including for the biopharmaceutical industry.”

IP protections are vital to biopharmaceutical innovators who invest $90 billion annually in research and development to find tomorrow’s cures for diseases like cancer and Alzheimer’s. Today there are about 7,000 medicines in development globally that could benefit U.S. patients. Fair, predictable and transparent markets and robust protections for new inventions make it possible for scientists to seek breakthroughs that can save and improve patients’ lives.

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.

View PhRMA’s complete 2019 Special 301 Submission here and the press release here. To read USTR’s Special 301 Report, 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 $900 billion in the search for new treatments and cures, including an estimated $79.6 billion in 2018 alone.

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