Maui, 28 July 2015 — At the secret Trans-Pacific Partnership (TPP) negotiations taking place this week in Maui, Hawaii, trade ministers from the U.S. and 11 Pacific-Rim countries are reportedly on the verge of agreeing to include new and additional periods of monopoly exclusivity for biologic health products, which would block access to the latest medical advances for millions around the world.
Biologics refers to a class of medical products which include everything from vaccines to cancer and multiple sclerosis drugs. If a data exclusivity obligation is included in the TPP, it would prevent national regulatory authorities from using clinical trial data needed to approve price-lowering generic biologic products, even after patents have expired. At the behest of the U.S. pharmaceutical industry, the U.S. government had originally demanded 12 years of data exclusivity for biologics. The latest reports from the negotiations indicate that the United States is now offering a fake compromise of eight years.
Eight years is nothing new; the White House has been asking U.S. Congress to change U.S. law from 12 years of market exclusivity to seven years to reduce health care spending. Eight years is not only not required by international law, there is well-documented evidence that eight years of exclusivity is not necessary to promote innovation in biologics.
Statement by Judit Rius Sanjuan, U.S. manager and legal policy advisor for MSF’s Access Campaign from Hawaii:
"Eight years of data exclusivity is still an exceedingly long and unnecessary time to block access to price-lowering competition for this important class of lifesaving medicines and vaccines.
"Pharmaceutical companies already enjoy some of the longest monopoly protections of any industry, and granting them extended and additional exclusivity terms is just another way to delay competition and keep medicines out of reach of MSF medical operations and millions of people. Government representatives meeting this week in Hawaii have an obligation to protect access to affordable medicines."