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 Developing nations are in search of affordable AIDS medications, while some industrialized countries, although seeking to maintain a humanitarian face on the AIDS issue, want to protect the patent rights of their pharmaceutical companies. The General Assembly gathering will discuss a plan to combat the disease in poor countries, spending up to $10 billion a year by 2005.

The conference comes at a pivotal time in the battle against acquired immune deficiency syndrome (AIDS). More money from foundations and some governments is becoming available; pharmaceutical companies are beginning to respond to pressure to lower prices for their life-saving drugs, and U.N. Secretary-General Kofi Annan has made the issue a personal priority. 

The matter came into focus at a World Health Organization meeting on May 17, when the group rejected radical proposals pushed by Brazil for wider international access to cheap HIV/AIDS drugs. 

Those proposals called for protection of the right to produce cheap generic drugs in national emergencies, a plan criticized by the large pharmaceutical companies with patents on those drugs. The United States and some European countries objected on the grounds that the health organization didn't have the authority or resources to take on such a role, and that trade and patent issues were best handled by the World Trade Organization, which sets global trade rules. 

In a resolution adopted after two days of heated debate at the U.N. health body's annual assembly, the organization instead urged greater efforts toward tackling the epidemic. 

Health activists said the resolution doesn't go far enough and accused officials of putting commercial interests before people's lives. 

The May meeting set the stage for the upcoming U.N. AIDS session, June 25-27. 

The debate continues to heat up. Kenyan lawmakers yesterday passed a bill that will allow the country to bypass international patent laws - even though abiding by WTO rules - and purchase cheaper generic AIDS drugs. 

The pharmaceutical industry had lobbied against the bill, defending its patents as necessary to finance research on new medicines.

According to analysts, the drug companies fear the bill will set in motion a domino effect throughout Africa. Kenya is the second African nation after South Africa to take such action. 

The backdrop 

Worldwide, 36 million people are living with HIV - the virus that causes AIDS - but most of them are dying. Africa is home to nearly 70 percent of adults and 80 percent of children infected with the virus. It has buried three-quarters of the more than 20 million who have died of AIDS since the epidemic began. There were an estimated 3.8 million new infections on the continent last year, raising the total to 25.3 million, according to the Joint United Nations Program on HIV/AIDS (UNAIDS). 

The catastrophe is not measured only by the loss of life. Studies have estimated that in South Africa, for instance, the gross domestic product is expected to be 17 percent lower for 2010 than it would have been without AIDS. 

In Thailand, one-third of rural families affected by AIDS see their agricultural output cut in half, leading to starvation. Children are taken out of school to work, and more than half of the elderly are left to fend for themselves. AIDS has robbed schools of their teachers and health programs of their doctors and nurses. 

Until a year ago, the drug cocktail used to manage AIDS cost $10,000 to $15,000 a year per patient, well out of reach of the poor. The 32.9 million AIDS/HIV patients in underdeveloped nations had little chance of survival, and the countries were left with just prevention programs - such as condom distribution and sex education - to stop the epidemic. 

But the situation changed dramatically this year. 

Cipla Laboratories, a pharmaceutical company in India, offered to sell a generic anti-AIDS drug cocktail to Doctors without Borders, an international charity, for $350 per patient per year, as long as patients received the drug free. 

U.S. pharmaceutical giant Pfizer announced last week that it will expand its free distribution of Diflucan, a drug that treats some of AIDS' effects, in 50 of the world's least-developed countries. 

At the same time, Brazil's AIDS program has come into focus. Along with a strong prevention campaign, Brazil has begun providing free AIDS treatment for everyone infected, using generic anti-AIDS drugs manufactured in state-owned laboratories. AIDS deaths have been reduced to 24.8 percent of the estimated half-million people infected in 1999, from 73.7 percent of those infected in 1990. Infection rates are being kept at 0.6 percent of its population of 170 million. By early last year, 85,000 Brazilians living with HIV/AIDS were receiving free treatment. 

But the pharmaceutical industry has argued that production of generic AIDS drugs violates their patents. Patents protect a company's right to a product for a set time, allowing it to recoup its development costs and make a profit.

This year, overall, the industry is expected to spend $30 billion in general research and development, and without the protection of patents, companies would have no incentive to research new medicines, it says. 

The Pharmaceutical Research and Manufacturers of America - an organization representing the leading pharmaceutical and biotechnology companies in the U.S. - says it can cost up to $500 million to develop new medicines, and of every 5,000 medicines tested, only five reach clinical trials and only one is approved. 

Meanwhile the U.S. government has threatened any developing country that considered using cheaply made generics with trade retaliations. 

Brazil hasn't budged from its position. Actually, in its latest arm-wrestling with the giant pharmaceutical Merck, Brazil negotiated a 59 percent price cut on Efavirenz, one of the four anti-AIDS drugs that Brazil does not produce locally. Since Brazil started making generic AIDS drugs, their costs have plummeted 80 percent. 

Brazil's example is a nightmare for the pharmaceutical industry because it exposes a loophole in WTO rules that allows any nation to use generics, without violating international patents, in case of national emergency. In case of an epidemic, such as AIDS, governments can get a compulsory license and manufacture or import generic drugs, paying the patent holder a reasonable royalty. 

In 1997, South Africa amended its laws to allow compulsory licensing of essential medicines, including AIDS drugs. The pharmaceutical companies sued to prevent the law from taking effect and got themselves into a public-relations nightmare. On April 19, they settled the case. Kenya yesterday followed South Africa's example. 

On April 27, at the African AIDS conference in Nigeria, Kofi Annan renewed a proposal to create an international fund to fight AIDS in developing nations. The idea received the ringing endorsement of most industrialized nations, and the support of both AIDS activists and the pharmaceutical firms. 

Four days after Annan's pronouncement, Italy proposed that the world's 1,000 largest corporations donate at least $500,000 each to the fund, to be matched by the industrialized nations to reach a starting target of $1 billion. The U.N. hopes to be raising as much as $10 billion a year by 2005. The Italian proposal will be presented at the next G-7 meeting in Genoa, on July 20-22. The G-7 group comprises the seven largest industrialized nations: the United States, Canada, France, Britain, Germany, Italy and Japan.

Meantime, Brazil brought forward a nonbinding resolution to the U.N. Human Rights Commission asking that international agreements be "supportive of public-health policies" that promote affordable drugs and medical technologies. On April 23, 52 countries on the 53-member commission approved the proposal. The U.S. abstained. 

A rock and a hard place

Although the idea of a war chest to combat AIDS was received with lukewarm enthusiasm by the U.S., the Bush administration pledged $200 million to the effort on May 11, making it the first government to commit resources to the fund. The $200 million was not part of Bush's 2002 budget proposal, leading officials to speculate about the source of the funds. 

AIDS activists and nongovernmental groups have criticized the amount as too small. 

The Bush administration also has to contend with the U.S. pharmaceutical industry. On April 30, the U.S. trade representative, Robert Zoellick, released a report charging Brazil with patent violations and protectionism, under the guise of health concerns. The matter is under arbitration by the WTO, which should report its findings by September. 

Brazil reformulated its patent laws when it joined the WTO in 1997. All drugs commercialized after that date are protected by Brazilian laws.That leaves eight of the 12 antiretroviral drugs used to combat AIDS free to be copied by state-owned laboratories. A typical treatment in Brazil now costs about $4,400 per person a year compared with up to $15,000 in United States. 

The U.S. government and drug companies say they do not object to Brazil's AIDS program but to its patent laws. 

Brazil has not backed down. President Fernando Henrique Cardoso declared that he would not be shy to issue a compulsory license if the pharmaceutical industry didn't meet Brazil's needs.

Action at home 

On the home front, activists are pushing the U.S. government to use the laws already available to guarantee AIDS treatment to any patient. 

James Love, a Seattle native and head of the Consumer Project on Technology - an advocacy group founded by Ralph Nader - is pushing for the creation of a nonprofit company to license the rights to make and sell a low-cost version of d4T, a widely used AIDS drug sold by Bristol-Meyers, for $10 a day in the U.S. Known as Zerit, it was discovered by government-sponsored research at Yale, which has a deal with the company. 

Love argues that a provision of the 1980 Bayh-Dole Act, which regulates a private company's use of federally funded research, requires the federal government to issue a compulsory license when a company's profits are deemed excessive in the face of people's needs, provided tax money was used in the research.

"Our immediate goal is to take inventions the public paid for and stop them from getting ripped off," Love said. 

The Pharmaceutical Research and Manufacturers of America disagrees. According to its Web site, 91 percent of the AIDS and AIDS-related drugs were discovered and developed by drug companies.