When Agua Buena's Richard Stern writes, below, about a recent trip to the AIDS hospitals and advocacy groups of Lima, Perú, he could just as easily been describing the situation in Santo Domingo, Tegucigalpa, Guatemala City, or any number of Latin American capital cities. Easily, of course, is a poorly chosen word. He watches as a Catholic priest performs the last rites to three Gen X women—women with HIV who died of a simple OI which a couple doses of fluconazole would have cleared up. Women for whom the price of an antifungal medicine we might now take for granted made the difference between living to see their children come of age and dying an excruciating death.

It is the gentle simplicity of Richard's reporting that renders its bite all the more arresting. Working from the smallish San José apartment that doubles as his office, he might be the Sister Mary Elizabeth of Central America: quietly transforming the region's response to HIV one village at a time. A man on a mission determined to arm the masses with those most powerful of weapons: knowledge, solidarity and hope. "Sometimes I have the impression that the situation in Latin America is simply too insignificant to receive the prioritization it deserves," he observes in what would appear to be a rare disconsolate moment. He has been an enormous help in preparing this special TAGline dedicated to the plight of people with HIV in Latin America and the Caribbean. His take on Panamá and Honduras appears on page 3 of this issue. More of his work and writing can be found at the foundation's web site, www.aguabuena.org.

The situation regarding AIDS in Latin America reflects the reality of the public health system in general. Only a few miles from this beautiful neighborhood called Miraflores is a public hospital for women called Loaiza. I visited that hospital last September accompanied by Father Jose Fedora, a priest here in Lima who provides support to people living with HIV/AIDS. Father Fedora went to the hospital, as he does several times a week, to counsel patients with AIDS who are there.

The day I accompanied him he was also administering the last rites of the Roman Catholic church to three women (none of them over 35) who were dying of severe opportunistic infections. There were no medications provided in the hospital for these infections, so the women were dying from an infection that could have been cured with a ten day supply of fluconazole. But the medication was too expensive for these women.

In the public hospitals in Perú, there is no guarantee that you will receive treatment—even for medications that cost as little as $1 or less per day—unless your family can buy your medications for you. To see the rows and rows of beds filled with sick women who apparently receive only minimal medical attention was a sobering experience, especially when I considered the contrast to the obvious affluence of the neighborhood I had just come from. Of course, I have also visited public hospitals such as these in Guatemala, Honduras, Belize, and El Salvador.

This is typical of the panorama around the region. There is a divided health care system here in Perú—as well as in Ecuador, El Salvador, Guatemala, and Panamá—where those who have access to the "Seguro Social" will, most often, receive relatively good medical care, including antiretrovirals. Those who are not included in this system receive abysmal care. [NB: The Latin American version of Social Security is different from that of the United States and is more of a middle and upper-middle class entitlement.]

Of course the non-included individuals are the nation's poor—the informal labor force who cannot affiliate with the Seguro Sociales. So the whole societal value system with respect to not just AIDS, but other diseases as well, is that the poor are expendable. The role of Latin America governments (with some exceptions such as Brazil) seems to be to protect the wealth of the rich, because of a fear that there would not be enough money available if the poor were to be treated decently by the government.

AIDS then, as a disease that requires economic resources from the state, is a threat to these governments. It is also a fundamental reason why people with AIDS do not receive adequate care and attention. AIDS activists focus a lot on discrimination—specifically against people living with HIV/AIDS. And, a priori, discrimination is a critical factor related to the poor medical attention that people with AIDS receive. But the fact of being poor automatically makes a person vulnerable to discrimination in these societies—whether they have AIDS or not.

Sometimes I have the impression that the situation in Latin America is simply too insignificant to receive the worldwide prioritization it deserves. The figures presented in the accompanying table are dwarfed by the constant media reports about the millions of people in Sub-Saharan Africa who are dying of AIDS. In this updated table, you can see that in our target countries we estimate that there are 95,000 people who need medications.

These are 95,000 lives, and each one is worth saving. But the pressure on these government to provide treatment, I think, has ironically been lessened by all the attention focused on Africa—and Brazil. If there is a country in Latin America that receives a majority of the world's attention in the media, it is Brazil: again, ironically and deservedly, for its progressive politics of local generic production and universal medicines access for 110,000 people. But you rarely, if ever, see anything in the media about the situation of those living with HIV/AIDS in, for example, Bolivia or Ecuador or Guatemala. ¤

Richard Stern is Executive Director of the Agua Buena Human Rights Foundation in San José, Costa Rica.

At this point I would like to present some examples of a few "best case" scenarios of access to antiretroviral access in the region. This is by no means a complete list. Agua Buena participated in the actions described in Costa Rica, Panamá and Honduras, but not in the situation described regarding Brazil.

The first case in point is Costa Rica. In 1995 and 1996 I was working in an out-patient mental health clinic in San José. People would come to the clinic for psychological attention in a relatively advanced stage of AIDS. Most of them didn't live very long. In those days, the Costa Rican government was not even providing AZT. After finding out about the existence of antiretroviral drugs late in 1996, after the Vancouver World AIDS Conference, People with AIDS in Costa Rica formed an official coalition and began meeting with officials from the "Caja de Seguro Social," which provides universal health care in Costa Rica.

But after more than six months passed, it was apparent that negotiations were going nowhere, and the PWA group made the decision to file a lawsuit in the country's Constitutional Court. The lawsuit, filed by four people living with AIDS, was decided in their favor on September 27th, 1997. And the Court ordered the Seguro Social to immediately begin providing antiretroviral medications. In 1997, there were about 300 people who needed the medications, and the Seguro Social complied very rapidly with the Court's ruling. Now, in 2003, there are about 1,450 people receiving antiretroviral therapy. Thus it was advocacy resulting in legal actions by people living with HIV/AIDS which led to the provision of triple therapy in Costa Rica.

In Panamá, the process was similar but there were important differences. I visited Panamá early in 1998 after Norma and Orlando Quintero there asked me to come and explain what had happened in Costa Rica. Later in 1998, activists in Panamá did file a lawsuit, but the Supreme Court there threw out the case on technical grounds. This outraged the plaintiffs and, led by the Quinteros but with perhaps 20 additional people participating, there was a demonstration early in 1999 which closed one of the main streets in Panamá City. There was massive coverage of this demonstration by the media. A few days after the demonstration the "Seguro Social" in Panamá gave in, and agreed to begin provided antiretroviral medications. There are now 1,200 people who receive them there.

In this case, the methodology involved an impulsive community-based action, which involved some risks but paid off in a quick decision by the Seguro Social in Panamá. So I think that the Quinteros were aware that the Social Security system had the economic resources available to cover what at that time was a relatively small number of PLWHAs, and that if they pushed the right buttons, that they had a chance to win.

Panamá, however, like most of the other countries in the region, has a divided health care system. Wealthier people who work for large companies are able to become part of the "Seguro Social" through their employers. But poorer people, such as laborers, agricultural workers, domestic workers and street vendors, cannot affiliate with the Seguro Social and they only receive emergency health care through the Ministry of Health. The Ministry of Health, however, has recently begun to provide antiretroviral therapy, but perhaps to only about 100 people at the moment.

I have visited Honduras seven times in the past four years. The struggle there has been a difficult one, and is far from over. But there was a key moment and it involved a courageous woman living with HIV/AIDS named Rosa Gonzales who was willing to go public. During a demonstration held outside of the Honduran Congress in September of 2001, Rosa was introduced to a sympathetic Congressman named Marco Antonio Sosa, who was himself a physician. At that time no one in Honduras was receiving antiretroviral medications.

Dr. Sosa agreed that he would support a motion to allow Rosa to address the Congress for 15 minutes, a few days later, and she agreed to do it. She gave an impassioned and dramatic speech about her life as a mother living with HIV/AIDS, and within a few days the Honduran Congress voted a special budget (from monies that were available) of $190,000 for an emergency purchase of antiretrovirals. Since the Accelerated Access negotiations (UNAIDS pilot rx project—of mixed success—in a handful of countries, of which Honduras is one) had been carried out just a few months earlier in Honduras, the price of treatment has dropped dramatically for some cocktails. Thus the $190,000 would cover treatment for about 150 people for one year.

Unfortunately, due to the usual bureaucratic and political maneuvers, it would take another 8 months before PWAs would begin receiving any treatment from this "emergency" fund. Part of the problem was that elections occurred late in 2001, and a whole new Congress and Health Ministry was installed.

At the moment, a total of about 700 Hondurans are receiving antiretroviral medications, but this is out of a total of 4,800 who are estimated to need treatment. So Rosa's action created a precedent and has motivated people to become more active, but progress is still extremely slow. (Ironically, even after the approval of a $42 million Global Fund grant to Honduras.) -RS ¤

Talk about your nail biter. After token concessions to agricultural subsidies and tariffs, trade ministers from around the world spent the six days leading up to Labor Day weekend at the Geneva HQ of the World Trade Organization, ironing out a deal on new rules for the importation of generic medicines. With the 5th WTO Ministerial scheduled to kick off in Cancún the 10th of September, the pressure was on to cough up at least some preliminary concessions worthy of the trade talks' optimistic appellation: the Doha "development round."

Last they met (December 2002), even the protectionist steeped EU and pharma rich Switzerland had agreed to life-saving patent concessions for generic imports. But in a one-country-one-veto consensus based system, a simple nay say from steel eyed Uncle Sam (served its marching orders by the omnipotent U.S. pharma industry) was all it took to put the kibosh on the drug access proposal. (Yes, that would be the same pharmaceutical cabal that recently announced it was withholding drug stocks to any Canadian pharmacy caught doling out meds to cash strapped U.S. seniors as they disembark cross-border buses in a desperate attempt to fill their prescriptions while keeping food on the table.)

Back on Lac Léman, teaser news releases from closed door hearings throughout the week had it that India, Brazil, Kenya and South Africa banded together in order to hold the Yankee imperialists' feet to the fire. U.S. trade rep Robert Zoellick again found himself in the precarious position of advocating for the South.

As the week progressed, an agreed upon resolution seemed increasingly inevitable. If southern generic producers promised not to interpret the TRIPS loosening as carte blanche to flood the international market with cheap drug copies, WTO rules would be amended to allow poor countries facing (infectious) health emergencies (e.g., TB, malaria, AIDS) to import copy-cat meds from countries with the technological know-how.

By the end of the week, a resolution seemed so certain that more than a few jittery dailies jumped the gun and declared victory in their Friday (8/29) print editions. But in the wee hours (1 a.m.) Friday morning, trade reps from the Philippines, Argentina and Venezuela staged an attention seeking petulant fit over their being side-lined during the final negotiations. Of course, by Saturday a deal (of sorts) had been signed, and there was a general sense that the risks of another PR catastrophe might be averted when they re-assembled at Mexico's Gulf coast—Oxfam's and others' accusations of window dressing notwithstanding.

The end result approached a situation that ace investigative reportrix, Anne Christine d'Adesky, (among others) had seen coming some months ago: that Brazil at last would thumb its nose at U.S. threats and begin exporting its high quality generics to neighbors in need. As we used to chant from the streets of Bethesda, Rockville and other exotic locales: the whole world is watching.

Until very recently, the United States government has been strongly allied with big pharma in a tooth-and-nail fight with Brazilian officials to prevent generic competition in the AIDS drug arena. After failing to negotiate drug discounts from multinational patent holders, Brazil, Thailand and Cuba opted to manufacture generics.

What was at stake for big pharma wasn't really the tiny AIDS market in Africa—which represents only 1% of the billion-dollar AIDS market—but the larger patent system. Makers of new products or processes are customarily guaranteed a 20-year market monopoly under a WTO agreement on Trade Related Aspects of Intellectual Property and Public Health, or "TRIPs." U.S. trade officials feared that softening TRIPs' rules for lifesaving HIV medicines in a pandemic would usher in generic competition for other products.

Undeterred, Brazil fought back, arguing that Article 68 of Brazil's 1997 patent law allowed it to make generics to address its national emergency. These drugs—made only for its national AIDS program, not for export—do not break patents. In 1990 Brazil, at 170M the second-most populous country in the Western Hemisphere, had an exploding AIDS epidemic: average survival time was less than six months after a clinical diagnosis. Most citizens lacked access to HIV tests and drugs. In 1993, the private Brazilian company Microbiologics began making generic AZT, and in 1994, the state did the same, providing AZT free through its public health system. AZT prices fell dramatically. By 1997, the government was making ddC and d4T and within two years, other nucleosides were available. In 2000, indinavir was added, then nevirapine.

Brazil's estimated savings on these last two drugs was $80 million, or 30% of total drug costs for the year. By the time of the U.S. WTO challenge in 2001, AIDS drug prices had fallen domestically by 70%—and so had AIDS deaths. The health system had saved $677 million, and freed up hospital beds. Armed with such positive, cost-effective results, Brazil was cast as a fiery David against the Goliath of greedy big pharma.

Four months after filing the complaint, the U.S. dropped it. And Brazil continued to up the ante, threatening compulsory licensing to negotiate sharp 40% and 65% discounts on patented antiretrovirals from Switzerland's Roche and U.S.-based Merck. Then in November, Brazil helped broker a victory for developing countries at the 146-nation WTO Ministerial Conference in Doha, Qatar. A new ruling guaranteed poorer nations facing national emergencies the right to practice parallel importing or issue compulsory licenses to import or make generic drugs.

But the Doha agreement was only a partial victory, due to a clause banning exports and requiring countries to develop the capacity to manufacture their own generics—something they all lack. In 2002, WTO members again failed to resolve this hurdle. [Thwarted by the unilateral opposition of the United States.]

Consequently, while a full 31 countries have implemented Brazil's treatment and prevention guidelines, only Guyana has adopted its generics model. The Doha clause has effectively prevented the world from following Brazil's lead on generics.

"Why has no country adopted this? We need the agreement of countries," said Paolo Teixeira, the outspoken, outgoing head of the Brazilian Ministry of Health's AIDS program. "We can only say that some countries have tried to consider this and stopped with fear of pressure from the United States." For very poor countries, threatening to withhold foreign aid is an effective weapon.

The Pressure to Export
And yet, U.S. opposition isn't the only reason for the global reluctance to produce generics. In reality, making quality antiretrovirals is neither cheap nor easy, even for richer countries. It requires a substantial investment, an industrial manufacturing base and technical manpower. Aside from Brazil, Thailand and Cuba's state programs, only a half-dozen private companies in India and China meet that criteria for making pills. [NB: Many people receiving Cuban generics—in Venezuela. Peru, and Ecuador, for example—are understandably concerned about quality assurance issues.]

Globally, not many can even produce the necessary raw materials. Analysts predict a few developing countries will be able to make generic antiretrovirals based on their current industrial capacity and experience. Generics are also a tough business, especially when the local market for AIDS drugs is not well established. Even when companies succeed, generic drug prices may not necessarily be cheaper than imported drugs.

In the face of these realities, there has been a growing international demand that Brazil export not just its technical know-how, but also its high quality drugs. But even with possible approval from the WTO, that won't be easy. Brazil still imports 80% of its raw materials from India, which is costly. "Many drugs could be produced in Brazil and a large number are not under patents," said Dr. Norberto Rech, head of the government technology division. But current domestic antiretroviral production, he said, "is insufficient to meet national needs."

Six of 17 public laboratories produce 15 AIDS drugs, and Brazil hopes to add four more by 2005, including two new "fixed-dose" combinations and soon, new fixed-dose drugs for tuberculosis and malaria. But it must buy 13 other antiretrovirals from private companies, nine of which are imported. A single imported brand-name drug—Viracept (nelfinavir)—eats up 27% of the current AIDS drug budget.

Brazil's own regulatory drug agency has approved the quality of its state-produced antiretrovirals. But the WHO has not conducted any quality-control inspections of the state factories or laboratories, a critical step for a drug to be included on its list of approved drugs. A WHO inspection is planned for later this year at Far Manguinhos, the state-run generics plant.

"We will not break patents," insisted Teixeira. "We are focusing on the transfer of technology. Our question now is concentrated on how to solve the Doha resolution for developing countries without capacity or production. We are trying to get the WTO to adopt one resolution, for example, where Paraguay can adopt compulsory licensing and ask Brazil to produce, as a way of overcoming these barriers."

With Bush pushing his new international AIDS agenda, Teixeira said, there are hints of the U.S. accepting such a ruling. But critics say even that revision won't do the trick, since countries would still lack political muscle to issue compulsory licenses for generic imports. In September the WTO meets again in Cancún, where a showdown is expected—along with some resolution.

While awaiting the WTO's decision, Brazil has invested $1 million to set up 10 pilot national antiretroviral production plants, five in Latin America and the Caribbean and five in Africa. It is working closely with the WHO to develop these proof-of-concept projects. Teixeira, a tough negotiator, has also been tapped to assist the WHO's new director, Dr. Jong-Wook Lee, in the agency's goal of treating 3 million people by 2005.

Teixeira began developing a global scale-up plan for AIDS prevention and care based on Brazil's model in May. In July, Lee appointed him as AIDS Program Director at WHO to implement this plan. By then Brazil was starting to transfer technology and send teams from Far Manguinhos to train technicians in places like Guyana and Mozambique. Although Teixeira dismisses talk of pill exports, to an outsider it looks like Brazil is getting read, should the global call come. ¤

Afterword: Ditching the Doha clause?
Even as final pre-Cancún trade deals were being brokered between the drug giants and advocates for the poor, Brazil's new health minister Humberto Costa, honoring the hard-nosed bargaining stance of his illustrious predecessor, issued a fresh ultimatum to Abbott, Merck and Roche, calling for an immediate 50% price cut for Kaletra, Sustiva and Viracept. Government representatives explained that these three drugs—lopinavir, efavirenz, and nelfinavir—eat up 63% of Brazil's $172 million budget for antiretrovial AIDS drugs."If the price remains high, we'll start producing or importing the drugs," representatives from the Brazilian Health Ministry's AIDS division said.

In the post-Teixeira era, Brazil appears to be upping the ante yet again. The government reportedly set a 72-hour deadline for a decision.

Marcia Lage, spokeswoman for the Brazilian Health Ministry's AIDS division, said that a team of health officials would be traveling to India to determine if the drugs could be bought cheaper there than they can be made in Brazil. According to an AP report in the 8/28 Wall Street Journal, Brazil would need to pass new legislation to allow importation of the drugs. And that very bill was being drawn up by Mr. Costa's office.

For pharma's part, Abbott has offered to reduce the price of lopinavir by a whopping 1.3%—to $1.48 per dose, but Ms. Lage said the drug could be produced at a government-owned laboratory for a mere 25 cents. Roche has already reduced the price of nelfinavir (which is produced by Agouron and marketed outside the United States by the Swiss concern) by 40%—to 53 cents per dose, but it could be manufactured for about half that—27 cents a dose—in Brazil.

Merck's efavirenz fetches a cool $2.10 a dose in Brazil, and could be produced for 87 cents according to Brazilian officials. --MB

The complete text of Anne's report is available at amfAR's web site: www.amfar.org.