GPhA Issues Statement Regarding Proposed IP Provisions of Trans-Pacific Partnership Agreement

McDonnell Boehnen Hulbert & Berghoff LLP

Generic  Pharmaceutical Association (GPhA)The Generic Pharmaceutical Association (GPhA) issued a statement today regarding ongoing talks between major Pacific Rim countries (including the U.S.) related to the proposed Trans-Pacific Partnership Agreement.  This trade agreement, whose terms have not been disclosed but have been the subject of leaks by WikiLeaks and others, has been controversial for containing terms believed by some to increase intellectual property protection across a wide spectrum but particularly relating to patented drugs.

The GPhA's statement is as follows:

The generic drug industry is a true American success story.  Over the past 30 years, generic utilization in the United States increased from just 20% in the mid-1980s to 86% today.  According to the IMS Institute for Healthcare Informatics, in the past decade generic drugs have saved the U.S. health care system more than $1.46 trillion dollars.

Many countries have publicly declared policy objectives to increase utilization of generics.  Unfortunately, the recently published version of the Trans-Pacific Partnership (TPP) intellectual property negotiating text would put those objectives in jeopardy.

The information disclosed last week confirms our concerns that the treaty would take an unbalanced approach to intellectual property protection that will impede access to safe and affordable medicines for hundreds of millions of the world's citizens.  This would have grave consequences for patients, health systems and budgets worldwide.

Trade agreements should promote competition and allow U.S. generics companies to enter markets where there is great potential for growth.  GPhA members manufacture the vast majority of all generic pharmaceuticals dispensed in the United States and fill nearly three billion prescriptions a year, while employing more than 50,000 people in 31 states.  Using intellectual property protections to create new barriers to entry for generic medicines would threaten the growth of U.S. exports and jobs.

According to the press release, "GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry.  Generic pharmaceuticals fill 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending.  Additional information is available at"


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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