The Changing Outlook for Worldwide HIV Treatment

The fight for affordable AIDS medications for the millions of poor people living with HIV/AIDS across the globe is far from over, yet one year ago, few would have predicted how far the struggle has come since the International AIDS Conference in Durban last summer.

A revolution is happening in Africa. Largely due to the efforts of the Treatment Action Campaign (TAC), a group of South African people affected by HIV/AIDS, chances are improving that some of the poorest people in the world may one day obtain the expensive anti-AIDS medicines that have saved so many lives in the U.S. and Europe. Founded in December of 1998, South Africa's TAC is arguing for access to drugs that directly attack the virus that causes AIDS, that treat the deadly opportunistic infections that kill people with HIV/AIDS, and that block mother-to-child transmission of HIV. Before the issue garnered headlines around the world, TAC was laying the foundation for a radical revision of how the rich, industrialized countries of North America and Europe should think about public health in the developing nations of Africa, Asia and South America.

For most of the two decades of the AIDS epidemic, even after therapies became available that clearly extended the health and lives of those who took them, not many people gave serious thought to treating the millions of people infected with HIV in developing countries. Most of these millions are too poor and the drugs too expensive. Instead, the world health community rallied around the hope for an AIDS vaccine to prevent new infections, essentially writing off the deaths of millions as a sad reality. But as the HIV-positive South African High Court Judge Edwin Cameron has said:

"We don't accept 'sad realities' in South Africa. If we accepted what others told us were sad realities, we would still have had a racist oligarchy oppressing our people. We would have had indescribable chaos and bloodshed. We have shown through our history that we will confront those 'sad realities,' and we will change them."

And change them, they have. Led by TAC (and a few other organizations, including the Nobel Prize-winning Doctors without Borders), there is now a global call to drastically reduce the prices of these expensive drugs and to allow the manufacture and importation of cheaper generic copies of patented medications. Many argue that the violation of pharmaceutical patent protections by poorer nations is permitted by international trade agreements allowing compulsory licensing and parallel importing in cases of national emergency, such as the AIDS epidemic.

The pharmaceutical companies have fought back. The South African Pharmaceutical Manufacturers Association and forty multinational drug companies (including GlaxoSmithKline, Merck, Bristol-Myers Squibb, Boehringer-Ingelheim and Roche) are challenging that country's Medicines and Related Substances Control Amendment Act. The Medicines Act, passed by the South African Parliament and signed into law by Nelson Mandela in 1997, contains several provisions intended to make essential medicines more accessible and affordable to its citizens. GlaxoSmithKline (GSK) has also warned generic manufacturers against supplying Ghana and Uganda with cheaper versions of its drugs lamivudine (3TC) and zidovudine (AZT). In a November, 2000, letter to Cipla Limited, the Indian generic drug maker, GSK barked:

"Importation, sale or offering for sale of products containing lamivudine and zidovudine in Uganda by Cipla or any of its affiliates represents an infringement of our Company's exclusive patent rights. I look forward to your assurance that you will cease all infringing activity in Uganda and respect the above mentioned patent rights."

Activists here in the U.S., led by the HealthGAP Coalition, the AIDS Coalition to Unleash Power/Philadelphia and the Consumer Project on Technology, have been successful in getting the federal government to moderate its unqualified support for industry on this issue. In December, 1999, President Clinton issued an Executive Order that allows countries in sub-Saharan Africa to pursue the manufacture, importation, and use of generic anti-AIDS drugs without the threat of U.S. government intervention to block their actions. To the surprise of many, the new Bush administration has announced that it will maintain the Clinton order.

However, the U.S. has asked the World Trade Organization to initiate a dispute resolution procedure against Brazil over one of its patent law provisions that allows compulsory licensing for products that are not produced locally. While the U.S. Trade Representative's office has assured activists that there are other provisions in Brazilian law that allow compulsory licensing of pharmaceuticals -- specifically in the case of national emergency -- many are worried that the U.S. actions will have a chilling effect on Brazil's successful AIDS program. The Brazilian approach has used locally produced generic versions of antiretroviral medications to treat approximately 100,000 people living with HIV/AIDS, sparing them from unnecessary suffering and death. In addition, the U.S. government is now pushing for stringent intellectual property provisions in the Free Trade Agreement of the Americas, which are more restrictive to compulsory licensing than current international agreements. These provisions, if enacted, could hinder the implementation of effective AIDS treatment programs like Brazil's in over thirty nations in North, Central and South America and the Caribbean.

Lately, the pharmaceutical industry has been feeling the heat. In February 2001, Cipla offered to supply HIV triple-combination therapy (i.e., stavudine, lamivudine and nevirapine) for $350 per patient per year to Doctors without Borders, and to sell the therapy for $600 per patient per year to poor governments. After the Cipla offer, and amid growing concern in the industry over a tarnished public image, several big AIDS drug makers have significantly dropped the prices of their patented antiretroviral medications in the developing world. While these price cuts are welcome (and belie the notion that industry cannot afford to sell these drugs in the developing world at reduced prices), many of the offers come with restrictions in the fine print that limit the reductions to only certain countries or regions. This patchwork-pricing plan leaves the drugs still out of reach for many nations and still more expensive than generic versions offered by Cipla and others. For instance, Merck said they would not offer Brazil the yearly per person price of $600 for Crixivan and $500 for Stocrin (efavirenz) that South Africa had been offered. Merck claimed that Brazil is not as needy as other countries, yet some activists wonder if Brazil has been targeted for its willingness to make its own generic antiretroviral drugs. Indeed, Brazil has threatened to start producing a generic version of Stocrin this summer if prices don't come down. In retaliation, Merck threatened to take legal action against a Brazilian laboratory when they imported a generic form of Stocrin from India as the first step towards copying the drug. As we went to press, Merck had struck a deal with the Brazilian government to lower the prices of its two antiviral drugs, proving once again that generic competition (or the prospect thereof) can drive prices down. Whether the deal holds needs to be watched carefully.

Last summer, many of us who went to the International AIDS Conference in Durban listened glumly as South African President Thabo Mbeki questioned whether HIV was the cause of AIDS. In a protest march to the conference center through the streets of Durban, the women and men of TAC were asking a different, altogether more important question: Why should some people have the privilege of purchasing their life and health when 34 million people in the resource-poor world are falling ill, feeling sick to death, and are dying? Justice Cameron posed this very question in a speech that same week. For Justice Cameron this "seems a moral inequity of such fundamental proportions that no one can look at it and fail to be spurred to thought and action about it." The world is beginning to rise to his challenge.

While prices from industry are not yet at the level that make them affordable to many countries, many people are now pondering how to deploy antiretroviral therapy in these regions. How do you procure these drugs in bulk? How do you distribute them? How do you build up the health care infrastructure in those places that need additional resources in order to deliver these drugs to patients? How do you train doctors and other healthcare providers in the painstaking details of treating HIV/AIDS? How do you medically manage antiretroviral therapy in resource-poor settings? Few dared to move beyond a theoretical consideration of these questions a year ago.

The pharmaceutical industry has made some public concessions but as yet they've shipped no drugs. Lately, they've been flexing their formidable public relations muscle to try to lower expectations -- recently a flurry of articles and op-ed pieces have appeared questioning the feasibility of ever solving the infrastructure problems of Africa. We've made considerable progress during the past year but the challenges posed by Justice Cameron will not be met until the tide of suffering and death is stemmed.

Back to the GMHC Treatment Issues April 2001 contents page.