The Trans-Pacific Partnership, a trade deal reached Monday between the United States and 11 Pacific Rim nations, will regulate 40 percent of the world's economy. The way it will affect one industry, pharmaceuticals, is getting particular scrutiny, as some warn that the deal could cause a spike in generic drug prices and threaten access to life-saving treatments.
Doctors Without Borders, also known by its French acronym MSF, and other health rights advocacy groups say that millions of people with HIV, hepatitis C, Ebola and other diseases will be affected by provisions in the deal that the groups say will make it harder for companies to develop drugs based on previously available research, and will lengthen patent protections. MSF issued a statement calling the deal the “worst trade agreement for access to medicines in developing countries” in history.
The Trans-Pacific Partnership (TPP) deal is the result of months of secret negotiations. Pharmaceutical companies were deadlocked over a provision on the length of “data exclusivity windows” for biologics, a new class of drugs to fight cancer and other life-threatening diseases. The data exclusivity windows make it possible for a drug company to block its competitors for at least five years — with another three years of "regulatory review," officials told Reuters —from getting access to data that could be used to develop competing drugs.
Large drug companies wanted an even longer window — 12 years — which they say will encourage innovation. “We are disappointed that the Ministers failed to secure 12 years of data protection for biologic medicines, which represent the next wave of innovation in our industry," the Pharmaceutical Research and Manufacturers of America, a U.S. lobbying group involved in the deal, said in a statement.
The Generic Pharmaceutical Association (GPhA) told Al Jazeera it welcomed the outcome of the negotiations. “We are optimistic that the agreement announced today on the Trans-Pacific Partnership (TPP) brings us closer to achieving that goal by embracing competition from safe, effective biosimilar therapies,” a statement from the group said.
Public health advocates say that these data exclusivity windows and other provisions of the TPP effectively delay access to drugs for patients in need of urgent treatment. For example, countries may be forced to adjust their intellectual property laws to include clauses for data exclusivity, and may have to lengthen the worldwide 20-year patent term already in place by another five years, according to Tim Horn, HIV project director at Treatment Action Group, an AIDS research and policy think tank.
The deal also lowers patent requirement standards and permits brand-name manufacturers to maintain "evergreen" patents through simple formulation tweaks, Horn told Al Jazeera in an email. “These are already barriers to access to affordable generic drugs in the U.S. and abroad. TPP makes things considerably worse,” he said.
Horn said he is particularly concerned about countries where the majority of HIV-positive people are not yet on drug therapy. “Data exclusivity provisions in TPP are also a significant threat, particularly in low-income countries, given that vaccine and medication research and development data are required by generic manufacturers to cheaply and effectively get affordable options approved,” he said.
MSF warned that the TPP could set a dangerous precedent for future trade agreements. “The objective is to really create new monopolies for pharmaceutical companies and to strengthen and lengthen the monopolies they already have,” Judit Rius Sanjuan, legal policy advisor at MSF, told Al Jazeera. “At the end of the day, the big losers here are nations, ministers of health, and humanitarian treatment providers like MSF that work in developing countries.”