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Trade Deals For Cheap Drugs In Developing Nations Stalled By U.S.

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WASHINGTON -- A change of heart from the Obama administration may pave the way to a groundbreaking global deal to provide lifesaving medications to developing nations. But hardline American opposition to a related treaty has delayed talks to lower the price of AIDS drugs and other critical medications in poor countries.

For most of last week, global medical experts balked at the American position in both negotiations. In talks at the United Nations' World Intellectual Property Organization, 34 nonprofits including Oxfam and Doctors Without Borders wrote a letter criticizing American resistance to new standards that would lower the cost of medications in developing nations, calling the U.S. position "shameful."

Many of the same the groups were alarmed by another set of negotiations occuring simultaneously at the World Health Organization, where the Obama administration attempted to prevent the creation of a new global fund to finance research for new drugs combating diseases that are rampant in poor countries. At the World Intellectual Property Organization, "the U.S. government was opposing access to existing medicines, while at WHO they were opposing access to future medicines by blocking a process to develop innovative drugs," said Judit Rius, U.S. manager of Doctors Without Borders Access Campaign.

After several days of difficult deliberations, however, American negotiators eased resistance to the new drug research fund. Under a compromise reached on Friday, regional WHO committees will study the effectiveness of the new fund and present findings to a panel later this year. Global health experts said they were optimistic that the WHO will agree to establish a global fund next year, emphasizing that the eased U.S. position should lead to a deal that will help poor countries.

An April report by World Health Organization experts recommended the establishment of a research and development fund that all governments would be required to pay into based on their country's total economy. Any drugs created by the fund's research would then be made available with generic competition, rather than under far more expensive patent system, which grants corporate drugmakers long-term monopolies on their medications.

The U.S. currently bears the heaviest burden for medical research and development benefiting developing nations, through work funded by the National Institutes of Health. The new fund would effectively lower American costs by increasing input from other nations. But American pharmaceutical companies profit heavily from the existing intellectual property and drug financing system, and are reluctant to support a new international pact that does not include long-term monopolies for companies. Such a deal could establish a new global precedent, encouraging developing countries to deny such monopolies in other situations.

Although the U.S. softened its opposition to the new drug financing fund, it remained steadfast in rejecting proposals aimed at lowering the prices of existing medicines in poor countries. Countries involved in the talks at the U.N.'s WIPO meeting last week were unable to reach a deal of any kind in the face of the Obama administration's opposition -- a rare result in the annual negotiations.

At the WIPO meeting, developing nations and public health advocates had hoped to make progress on a proposal that would allow poor countries to provide inexpensive generic versions of lifesaving medications, rather than rely a single version of the same drugs under expensive patent monopolies. The U.S. flatly rejected the move toward generics. "Weakening patent protection for innovative medicines is not a productive approach to improving availability of health care," the U.S. said in its official statement.

"We are ... very concerned with the proposal submitted by the United States government as we consider it is a step backward in the very promising discussions at WIPO on patents and health," Doctors Without Borders said in its official comments on the proposal. "The U.S. government proposal seems to be based on several assumptions on the relationship between patents and global health, which does not reflect our experience providing medical care in many developing countries."

The U.S. Patent and Trademark Office elaborated on the American position at the meeting, explicitly invoking access to AIDS and HIV medications, which have become dramatically cheaper abroad as generic versions have replaced patented brand-name drugs.

"Some of the public health issues facing developing and least developed countries include neglected diseases, the spread of TB, malaria and HIV/AIDS, and availability of medicines to treat these and other ailments," the Patent and Trademark Office said. "There is no easy solution to these problems. Reducing patent protection is not likely to solve these thorny issues."

That statement prompted outrage from AIDS experts.

"Are you trying to say that reducing patent protection for AIDS drugs in developing countries did not enhance access to medicines? If so, where have you been the past 15 years?" wrote an incredulous Knowledge Ecology international director Jamie Love in an open letter last week, noting comments from former Office of Management and Budget director Mitch Daniels that the existing American global AIDS relief project would have been impossible without the availability of cheap generics from India. Daniels is now the Republican governor of Indiana.

Patent-inflated drug prices are particularly acute on AIDS medications, which require decades of constant use to be effective. One such drug, Atripla, costs roughly $25,000 a year for a single patient in the U.S., where it is marketed jointly by Gilead Sciences and Bristol-Myers Squibb. In countries that allow generic drugs to compete with Atripla, treatment costs about $200 a year.

In an open letter criticizing the American position, 33 public health organizations joined Doctors Without Borders, writing, "It is clear that the U.S. has deliberately chosen to ignore concrete evidence available today on the positive impact of the use of public health-relevant [patent] flexibilities on access to medicines."

The Obama administration declined to comment for this article.

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