Press Release

PhRMA Statement on 2015 Special 301 Report

PhRMA April 30, 2015

WASHINGTON, D.C. (April 30, 2015) – Pharmaceutical Research and Manufacturers of America (PhRMA) Vice President Jay Taylor issued the following statement today:

America’s innovative biopharmaceutical manufacturers and the more than 810,000 women and men they employ 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.

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 support and promote compliance with global 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.

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. Despite renewed engagement on these concerns, recent negative decisions further highlight the unpredictability of intellectual property protection and enforcement in India. 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. We are disappointed USTR chose not to plan an out-of-cycle review (OCR) of India later this year. Such a review would have provided an important opportunity to take stock of progress and results. We do appreciate that USTR will continue to monitor India’s progress to see if an OCR will be warranted. We will continue to work closely with USTR and other federal agencies to promote and track substantive progress and to support and inform solutions on our outstanding concerns.

Innovative biopharmaceutical firms and their employees also face significant challenges in Canada, where courts have invalidated patents on 17 medicines and upended a practical and proven process used to bring new medicines to market in countries around the world. PhRMA members appreciate the prominent mention of these concerns in the Special 301 Report. We look forward to working with both the U.S. and Canadian governments to resolve these concerns and to strengthen Canada’s innovation climate. 

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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