DRUGS • Global trade protections threaten access to cheaper generics.
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Washington • If drug companies get their way in protecting brand-name drugs in a new international trade deal, critics fear that millions of people with AIDS in poor countries will go untreated, losing access to cheaper generics that could keep them alive.
The 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 from 10 to 15 years to win approval from the U.S. government for a single new medicine, according to the Pharmaceutical Research and Manufacturers of America, the lobbying arm of many drug companies.
Opponents counter that more generic drugs are needed for the global fight against AIDS. And they say that fattening the profits of the large drug companies only undermines that effort.
The debate has emerged as a key issue as negotiators from the U.S. and 10 other countries meet privately to wrap up details of 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 it, the finances of brand-name drug companies.
"We are basically facing a treatment time bomb - and what the U.S. 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. It's an international humanitarian organization that won the 1999 Nobel Peace Prize and now provides health care in nearly 70 countries.
Currently, 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. And she said the cost of treating an AIDS patient for one year has declined from an average of $10,000 in 2000, when doctors relied mainly on brand-name drugs, to $150 in 2012, after more generics drove down the price.
On the opposite side, Sam Taylor, president of the North Carolina Biosciences Organization, a trade association for the state's life-science industry and its 150 member companies, said U.S. businesses bank on selling their brand-name drugs in foreign markets to remain viable.
"It comes back to how highly do we value innovation, and are we willing to stand by that value in our international trade agreements?" Taylor said. And without the protections, he said, "We would certainly have less jobs at the end of the day. . And in this economy, every job counts."
One of the largest employers in North Carolina, drug maker GlaxoSmithKline, which has its U.S. headquarters, 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 Obama administration is taking "a careful look" at how to balance intellectual property rights with the need to ensure access to life-saving medicines around the world.
"It is a difficult balance to strike," said Kirk. He said his office will take months to study the issue and wants to hear more feedback from the public before the administration decides how to proceed.
The proposed deal, a top priority for 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. But 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 in current U.S. law. That would allow them to sell without competition from generic drug manufacturers while they attempt to recoup their investment.
Rius Sanjuan of Doctors Without Borders said that the drug companies want a monopoly and that they need more competition. She 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, or PhRMA, said access to drugs is limited more by a lack of doctors, roads, refrigeration and a basic health infrastructure. And he said that U.S. drug companies have spent more than $9.2 billion in the past decade in getting medicine to needy patients around the world. He called the proposed trade pact "the latest, greatest iteration of where U.S. trade policy is headed," and he said the 12 years of data protection will be important to get the confidence of investors.
As the administration decides its next move, the fight has moved to Capitol Hill and statehouses around the country.
PhRMA has lined up backing from a long list of members of Congress and 11 governors, including Democrats Bev Purdue of North Carolina and Chris Gregoire of Washington, and Republicans Chris Christie of New Jersey and Terry Branstad of Iowa. In a letter to Obama, the governors said strong protections are needed for the companies, noting that they have 901 biotechnology medicines and vaccines in the pipeline to target more than 100 life-threatening diseases.
In Washington state, the industry supported 91,000 jobs last year, Democratic Sens. Maria Cantwell and Patty Murray said in a letter to the president. In Texas, Republican Sens. John Cornyn and Kay Bailey Hutchison said in a letter to Kirk that 175,000 jobs are on the line in their state. And in a letter spearheaded by Cantwell and Republican Sen. Orrin Hatch of Utah, the two veteran members of the Senate Finance Committee said that "a robust knowledge economy" has given the U.S. one of its biggest competitive advantages. "Put bluntly, intellectual property equals jobs," they said in the letter, which was signed by 28 senators.
For critics, the issue goes far beyond jobs.
Arthur Stamoulis, executive director of the Citizens Trade Campaign, a coalition of environmental, farm and consumer groups, said that drug companies are out to increase their profits at a time when 2 million people are dying from AIDS every year. Giving the drug companies special protections, he said, would be "a virtual death sentence" for AIDS victims around the world and a big mistake for the Obama administration.
"There's all this excitement about ending AIDS within a generation, but if you can't get the medicine into the hands of the poor people who need it, it's pretty cut and dry," Stamoulis said.
And 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.