Press Release

PhRMA Statement on 2016 Special 301 Report

PhRMA April 27, 2016

WASHINGTON, D.C. (April 27, 2016) – Pharmaceutical Research and Manufacturers of America (PhRMA) Vice President Jay Taylor issued the following statement today:

“PhRMA members appreciate the continuing work of the Office of the U.S. Trade Representative (USTR), the Departments of State and Commerce, U.S. overseas missions and others to establish and ensure full compliance with strong rules protecting patents and other intellectual property rights abroad. Special 301 is an essential tool to bring high-level attention to intellectual property and market access challenges in overseas markets that are harming American innovators, patients, and workers.

“America’s innovative biopharmaceutical manufacturers and the more than 810,000 women and men they employ across the United States are devoted to inventing, manufacturing, and distributing valuable medicines that enable people to live longer, healthier, and more productive lives. Biopharmaceutical innovators depend on strong intellectual property protection and enforcement to bring new medicines to patients who need them. Today, more than 7,000 medicines are in development across the country and around the world.

“Innovative biopharmaceutical firms and their employees continue to face significant challenges in Canada. PhRMA and its member companies operating in Canada are extremely concerned about Canada’s intellectual property environment, which continues to be characterized by significant uncertainty. The Canadian judiciary has invalidated patents on 25 medicines and upended a practical and proven process used to bring new medicines to market in countries around the world. While PhRMA members appreciate the prominent mention of these and other concerns in the Special 301 Report we believe that the seriousness of the IP violations in Canada demand particular focus by the U.S. Government to address this critical issue. We look forward to working with both the U.S. and Canadian governments to resolve these concerns and to strengthen Canada’s innovation climate.

“PhRMA members also face serious and growing intellectual property challenges in Colombia. This important regional trading partner has consistently failed to fully implement its intellectual property commitments under the U.S.-Colombia Free Trade Agreement (FTA). A new National Development Plan is undermining the ability of innovators to introduce new medicines by delaying the review of biopharmaceutical patents. PhRMA members welcome USTR’s decision to conduct a meaningful out-of-cycle review of Colombia at regular intervals over the next year. We look forward to working with USTR and other federal agencies to secure progress toward full implementation of Colombia’s FTA obligations and to address other critical concerns.

“India’s barriers to U.S. trade and investment, including its failure to respect intellectual property rights, continue to harm biopharmaceutical innovators and many other industries across the United States and around the world. While biopharmaceutical innovators saw potentially positive signs from the Indian Government in 2015, translating these positive statements into concrete progress has remained a challenge. PhRMA members welcome USTR’s decision to maintain India on the Priority Watch List and the emphasis the Special 301 Report places on achieving substantive and measurable results. Sustained engagement is essential to promote meaningful reform of India’s patent laws and policies.

“Discriminatory market access barriers, including non-transparent government pricing and reimbursement policies, undermine the value of intellectual property and weaken incentives to invest in the development of new medicines. PhRMA members welcome USTR’s recognition of market access barriers faced by innovative U.S. biopharmaceutical companies. Intellectual property rights that spur drug development and efforts to ensure that patients have access to those new drugs go hand in hand in improving health care and patient outcomes.

“PhRMA members look forward to working with USTR and other U.S. government agencies to address these and other unfair and discriminatory trade practices around the world.”


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 $51.2 billion in 2014 alone.


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