Administration’s Special 301 Report highlights deteriorating global environment for biopharmaceutical innovation

In the latest publication of its annual Special 301 Report, the Office of the U.S. Trade Representative (USTR) brings renewed attention to intellectual property (IP) and market access challenges in overseas markets that are harming American innovators, patients, and workers. PhRMA is encouraged by the Administration’s emphasis on the importance of enforcing obligations in existing trade agreements and bilateral discussions. We view the report as a potential basis for engaging trading partners to more effectively address negative practices and regain a level-playing field for American companies – particularly those that rely heavily on IP protections like companies in the innovative biopharmaceutical industry. 

Of primary concern to PhRMA and its member companies is the continued deterioration of IP rights around the world. For example:

• Canada’s judiciary has invalidated patents on 25 medicines and upended a practical and proven process used to bring new medicines to market.
• Indonesia recently adopted a new patent system that severely limits patenting of biopharmaceutical inventions and expands the use of compulsory licensing.

These countries, and others such as Australia, Colombia and India, have disregarded the incentives needed to promote innovation in medicines and have taken specific actions to weaken biopharmaceutical patents.

In addition to the weakening of IP rights, discriminatory market access barriers, including non-transparent government pricing and reimbursement policies, are further devaluing biopharmaceutical patents and weakening incentives to invest in the development of new medicines. Collectively, these efforts hinder research and development that can improve outcomes for patients. PhRMA members are encouraged by USTR’s recognition of market access barriers faced by innovative U.S. biopharmaceutical companies.

With more than 7,000 medicines in development around the world, biopharmaceutical companies depend on strong IP protections and enforcement to bring these new treatments and cures to patients who need them. PhRMA member companies look forward to working with both U.S. and foreign governments to resolve these concerns and to strengthen the global climate for medical innovation.