"The TPP [Trans-Pacific Partnership] will…go down in history as the worst trade agreement for access to medicines in developing countries," said Doctors without Borders/Médecins Sans Frontières (MSF) in a statement following the signing of the TPP trade deal.
The controversial agreement is the largest trade deal in a generation, bringing together 12 countries around the world including the United States to govern 40 percent of the world's economy.
Negotiations on the TPP deal, initiated in 2008, finally came to a conclusion on Oct. 5 in the southern US city of Atlanta. It includes a range of economic policies including lowered tariffs as well as standards for labor law, environmental regulation, and international investments.
"This partnership levels the playing field for our farmers, ranchers, and manufacturers by eliminating more than 18,000 taxes that various countries put on our products," said US President Barack Obama in a statement following the end of negotiations. He also noted that the deal has the "strongest" commitments on labor and the environment of any trade agreement in history.
Though the deal has yet to be formally adopted by the signatories' legislative bodies, it has already received criticism from numerous civil society members, including MSF, whose main concern arises from the deal's provisions on data protection for biologic drugs.
Biologic drugs include any therapy from a biological source including vaccines, anti-toxins and monoclonal antibodies for diseases including cancer and HIV/AIDS.
According to the Brookings Institution, a US-based think tank, biologics are larger and structurally more complex than other drugs, making them more difficult and costly to develop. On average, biologics cost 22 times more than nonbiologics.
Due to these high costs, companies utilize data from the original drug creator to develop "biosimilars," cheaper, generic versions of biologics. MSF has stated that this competition is the "best way to reduce drug prices and improve access to treatment."
For instance, MSF treats almost 300,000 people with HIV/AIDS in 21 countries with generic drugs. These drugs have reduced the organization's cost of treatment from US$10,000 per patient per year to US$140 per patient per year.
However, in the US, biologics creators have 12 years of data exclusivity. During this period, the US Food and Drug Administration (FDA) cannot approve a biosimilar that utilizes original biologic data.
Data protection rules vary in other countries, while Peru, Chile and Mexico do not have any biologics data rules at all.
As part of the TPP negotiations, the U.S. sought to include the 12-year protection rule. Trade ministers went back and forth on the rule, finally settling on a mandatory minimum of five to eight years of data protection.
As a result, biosimilars will not be able to enter the market in countries that previously had no restrictions. According to MSF, this will lead to high, sustained drug prices by pharmaceutical companies, preventing individuals and health providers from acquiring affordable and essential medicines.
MSF predicts that at least half a billion people will be unable to access medicines once the TPP takes effect.
"The big losers in the TPP are patients and treatment providers in developing countries," MSF said in its statement.
The organization urged governments and its legislatures to consider the consequences.
"The negative impact of the TPP on public health will be enormous, be felt for years to come, and will not be limited to the current 12 TPP countries, as it is a dangerous blueprint for future agreements," MSF warned.