Death Sentence

HANOI, VIETNAM -- As Dr. Mary Kamb reads the lab tests of the delirious patient lying before her this past summer at Bach Mai hospital -- the Vietnamese national hospital -- she does her best to hide a look of concern. The patient's CD4+T-cell count is down to eight -- a normal count is at least 500 -- meaning she has little immune response left. In addition, she is suffering from a rare fungal infection called penicilliosis that preys upon people with compromised immune systems.

"You just don't see this stuff in the U.S. anymore," says Dr. Kamb, an epidemiologist from the Centers for Disease Control and Prevention who's stationed in Vietnam.

Like virtually all AIDS patients in Vietnam and the rest of the developing world, this one will die an agonizing and premature death because she cannot afford the several-thousand-dollar-per-year price for a regimen of antiretroviral medications -- drugs that have changed HIV in the developed world from a certain death sentence to a chronic but treatable illness.

But it is those very same live-saving drugs that the United States and Europe are currently blocking many Third World residents from receiving.

Since the early 1990s, when effective antiretrovirals first became available, AIDS activists have been lobbying to get them produced and distributed in a generic form for developing nations so that patients can afford them, or so that donor countries might subsidize their purchase. Generic competition has dramatically reduced -- from about $10,000 per year to about $200 per year -- the cost of antiretroviral drugs in a few countries that can legally produce or lawfully import generics. It has also forced major pharmaceutical companies such as GlaxoSmithKline, Merck and Bristol-Myers Squibb to discount their prices to a small number of patients in some developing countries by as much as 85 percent to 90 percent through the industry's "Accelerating Access Initiative."

But trade representatives from the wealthiest nations, particularly the United States, have been doing their best to limit the availability of these generic medications, increasing intellectual-property protections -- and profit margins -- for the Western pharmaceutical companies that developed the drugs, often after discovery and subsidization by the public sector. This has limited the availability of less-expensive generic medications in many parts of the developing world -- and pending changes in the international intellectual-property regime, effective in 2005, it will reduce access even more dramatically.

During the past couple of years -- as the death toll from AIDS has soared into the millions and it has become clear that HIV will kill more people than any other pandemic in world history -- the international community has been increasing pressure on the United States and other developed countries to relax patent protections. In response, the United States grudgingly signed the historic Doha Declaration in Doha, Qatar, on Nov. 14, 2001, promising to ease patent restrictions in order to promote access to vital drugs throughout the world. Specifically, the United States promised to find a solution to the so-called export ban -- a clause in the World Trade Organization's agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that prevents generic pharmaceutical makers from exporting their products to other countries -- by the end of 2002. Because of the export ban, any country without the industrial capacity or market size to efficiently produce its own medications (or most of the developing world, including Vietnam) will have no legal way of getting these drugs after 2005. But as the Dec. 31 deadline approaches, U.S. negotiators have backed away from many of their promises. No solution to the export ban is in sight.

Until 1994, there was tremendous variability in patent regulations among countries. In fact, 50 countries, including both developing and developed nations, offered no patent protection for pharmaceutical products whatsoever, and in these countries production of generic medications patented in other nations was legal. As these generic-drug markets increased in size, the pharmaceutical lobbies from Europe and the United States intensified their efforts to establish a global standard for patent laws.

So in 1994, members of the newly established WTO passed TRIPS. Under the agreement, patented products and processes, including pharmaceutical patents, are protected for a minimum of 20 years from the date of patent filing. In the interest of public health, a temporary exception was granted to some developing countries without patent protections for medicines; this allows these countries to produce generic forms of medications patented elsewhere until 2005. But because of tenacious lobbying from the pharmaceutical industry, TRIPS included the export-ban clause that prevented those same countries, and indeed all others, from producing generic versions of patented drugs in the future (except pursuant to a government-sanctioned compulsory license). It also further restricted exportation of any such generic medications to other countries.

Smaller, less-developed countries such as Vietnam have been especially hard-hit by the export ban. Vietnam has had to watch its neighbor Thailand institute a relatively effective program to provide domestically produced generic AIDS medications to some of its citizens, but has been unable to follow suit. That's because Vietnamese generic-drug manufacturers are not yet able to cheaply produce high-quality AIDS medications, and because the government cannot afford to import expensive brand-name products from the West.

The government recently began a program to provide AIDS drugs to 20 "particularly worthy" patients at Bach Mai, a miniscule fraction of those afflicted there. Among those selected was a mother of three who was infected by her intravenous-drug-using husband -- but the doctors had to turn down dozens of equally compelling patients. And because supplies are already running low, many of the patients at Bach Mai have been switched from the traditional triple drug therapy to a much less effective double therapy that typically leads to drug-resistance.

The United States government, as well as European governments and the pharmaceutical industry, have used stringent interpretations of TRIPS provisions to derail attempts by developing countries to access cheaper drugs for their desperate citizens. In 1998, the United States placed South Africa on a special trade-sanction list, and a coalition of U.S. and European drug companies filed a lawsuit against the South African government, because it had passed legislation permitting it to purchase generic drugs from other countries (and to substitute generics for prescription medicines which were no longer under patent). Then in 2000, GlaxoSmithKline, one of the world's largest and most profitable pharmaceutical companies, threatened a lawsuit against the Indian AIDS-drug manufacturer Cipla for lawfully supplying its generics to Ghana. As recently as 2001, the U.S. government filed a complaint with the WTO against Brazil -- which has developed a remarkable program through which the government provides free AIDS drugs to its citizens -- for threatening to produce generic AIDS drugs locally and export limited quantities to Africa. Fearing a similar response from Western nations, Vietnam decided not to try to import generic drugs from the prolific manufacturers in nearby Thailand and India.

Since Doha, the United States has done little to turn its promises into reality. The pharmaceutical industry is once again putting enormous pressure on the U.S. Trade Representative and on Congress -- spending $78.1 million and employing 623 lobbyists in 2001 -- to insist on a very narrow interpretation of the Doha Declaration. And the United States has been pursuing TRIPS-plus provisions, which provide even greater protections for pharmaceutical products, in regional negotiations to create a Free Trade Area of the Americas, a Central American Free Trade Area and even a free-trade area with the Southern Africa Trade Union. The United States has done likewise in bilateral trade negotiations such as the one just completed with Chile.

In the ongoing TRIPS council negotiations, the United States stubbornly continues to pursue conditions that would:

• Reduce eligible diseases to HIV/AIDS, tuberculosis, malaria and similar "severe" epidemics;

• Limit importing countries' eligibility to least-developed and low-income developing nations, excluding many middle-income developing countries with significant unmet public-health needs;

• Limit covered products to medicines only (and perhaps diagnostic kits), inexplicably excluding vaccines;

• And impose strict product-diversion rules that would severely tax the impoverished enforcement regimes of poor countries and prevent pooled procurement by regional groups of countries.

In addition, the United States is seeking to enforce a procedural solution that is both needlessly burdensome (requiring numerous compulsory licenses, issued product-by-product and country-by-country, in both exporting and importing countries) and temporary (favoring a short-term moratorium or waiver instead of a long-term, permanent solution).

Because of these unreasonable demands, the African delegation to the TRIPS council, led by Kenya, rejected the latest U.S. proposal. Though a compromise text was recently proposed by the chairman of the TRIPS council, as of yesterday, the United States was still holding out for even more stringent terms, particularly on the definition of covered diseases.

Meanwhile, 8,000 people die from AIDS every day, most of whom could have been saved by antiretrovirals. According to the World Health Organization, of the estimated 6 million people in the developing world who should be on antiretrovirals, a mere 300,000 currently receive therapy -- and more than one-third of those are in the model Brazilian program. The populations of the hardest-hit nations in Africa have already been decimated; as a result, millions of orphaned children roam the streets. Sadly, the situation in other countries throughout Africa and Southeast Asia is likely to soon follow suit.

Instead of fulfilling its promises at Doha and recognizing public-health and human-rights imperatives, the United States has tried to maximize the drug industry's objectives and prevent widespread access to high-quality, low-cost generic alternatives. As the negotiations of the TRIPS council continue, developing nations are becoming increasingly impatient -- and desperate -- for access to generic AIDS drugs. But by means of trade threats, new regional negotiations and behind-the-scenes attempts to narrow the Doha accord, the United States is pursuing drug-company profits at the cost of millions of lives.

As the United States stalls, Third World AIDS patients are becoming increasingly aware that good AIDS medications exist. "HIV-infected people are beginning to speak out," says Dr. Kamb. "They're starting to knock on doors, saying, 'Come on, government, when will these drugs become available?' " It's a good question. The United States owes them an answer -- and soon.

Brook K. Baker is a professor at the Northeastern University School of Law and a member of the Health Global Access Project. Michael Hochman is a second-year student at Harvard Medical School. He spent last summer in Vietnam.