WASHINGTON If drug companies get their way in protecting brand-name drugs in a new international trade deal, critics say, millions of AIDS patients in poor countries will go untreated, losing access to cheaper generic drugs that could keep them alive.
Drug makers say they need to protect their industry, which supports 4 million U.S. jobs, and their investment in research. It costs an average of $1.2 billion and takes 10 to 15 years to win U.S. approval for a single new medicine, according to the lobbying group Pharmaceutical Research and Manufacturers of America.
Opponents say more generic drugs are needed for the global fight against AIDS. Fattening the profits of large drug companies undermines that effort, they say.
The debate has become a key issue as negotiators from the United States and 10 other countries meet privately to wrap up the Trans-Pacific Partnership, poised to become the largest trade deal in U.S. history.
The talks, which concluded their 14th round in Leesburg, Va., last month, involve a tussle over how far to go to protect intellectual property rights and, with them, the finances of brand-name drug companies.
“We are basically facing a treatment time bomb, and what the United States is demanding here will make the situation much worse,” said Judit Rius Sanjuan, a lawyer from Spain who is the U.S. manager for the access campaign of Doctors Without Borders. The international humanitarian organization won the 1999 Nobel Peace Prize, and now provides health care in nearly 70 countries.
Rius Sanjuan said generic drugs – most of them from India – are being used to treat more than 80 percent of the 8 million people who are receiving AIDS treatment in developing countries.
The cost of treating one AIDS patient for one year, she said, has declined from an average of $10,000 in 2000, when doctors relied mainly on brand-name drugs, to $150 in 2012, now that generics have driven prices down.
On the opposite side, Sam Taylor, president of the N.C. Biosciences Organization – a trade association for North Carolina’s life-science industry and its 150 member companies – said U.S. drugmakers bank on selling their brand-name drugs in foreign markets to remain viable.
Without the protections, he said, “We would certainly have less jobs at the end of the day.”
One of the largest employers in the state, drug maker GlaxoSmithKline, with U.S. headquarters in Research Triangle Park, is “closely following the TPP negotiations,” said Sarah Alspach, the company’s director of external communications.
The Obama administration finds itself caught in the middle.
In July, U.S. Trade Representative Ron Kirk said the administration was taking “a careful look” at how to balance intellectual property rights with the need to ensure access to life-saving medicines worldwide.
The proposed deal, a top priority for President Obama, is an attempt to get the United States to cash in on a region that now accounts for more than 40 percent of all international trade.
The latest round of negotiations included nine countries: the United States, Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore and Vietnam. Mexico and Canada have already been approved to join, and others could follow, including Japan.
Drug companies want U.S. negotiators to grant them 12 years of “data exclusivity,” the same standard as in U.S. law. That would allow them to sell without competition from generics so they can try to recoup their research investment.
Rius Sanjuan of Doctors Without Borders said her organization decided to challenge the pact after leaked documents showed that the U.S. demands “were the worst we’ve ever seen in a trade agreement” including developing countries.
“In the world of health care in developing countries, if you don’t have competition, you don’t have access to medicines,” she said.
Jay Taylor, vice president of international affairs for Pharmaceutical Research and Manufacturers of America, said access to drugs is limited more by a lack of doctors, roads, refrigeration and basic health infrastructure. U.S. drug companies have spent more than $9.2 billion in the past decade getting medicine to needy patients around the world, he said.
Taylor said the 12 years of data protection will be important to get the confidence of investors.
PhRMA has lined up backing from a long list of members of Congress and 11 governors, including Democrats Bev Perdue of North Carolina and Chris Gregoire of Washington, and Republicans Chris Christie of New Jersey and Terry Branstad of Iowa.
In a letter to President Obama, the governors said the companies need strong protections, noting that they have 901 biotechnology medicines and vaccines in the pipeline to target more than 100 life-threatening diseases.
Edward Low, director of the Positive Malaysian Treatment Access and Advocacy Group, called it “a matter of life and death” for AIDS patients. His group wants a halt to the trade pact negotiations “because, without affordable and accessible medicines, more of us will die,” he said.