As the AIDS pandemic affects hundreds of thousands, even millions, of victims throughout the world, it is crucial to make the most advanced medications available to as many sufferers as possible. Tremendous antagonism is developing between privately financed American and British developers of effective pharmaceutical products and groups like Médecins sans Frontières (MSF) who wish to make these treatments available at low-cost to every AIDS patient throughout the world (Kumar, 2001). This position paper will provide valid arguments for allowing low-cost production of generic versions of these drugs to be distributed to the many Third World nations most in need of them. Indeed, distribution of low cost generic HIV/AIDS medications in the Third World is both legal and justified on public health, socio-economic, and humanitarian grounds.

Casting a retrospective glance back into the 1980s when AIDS first surfaced in Africa, then France, Canada, California, and on to Asia, no known cure was available. The immune systems of HIV and AIDS victims simply collapsed under the unrelenting assault of this retrovirus, transmitted in the early days of the disease, in the Western World, through intimate homosexual contact. Later, in the 1990s, it became obvious that AIDS could be transmitted heterosexually and through contaminated syringes, among other means. No cure was available for HIV/AIDS regardless of means of transmission. As physicians became aware of the dangers that were inherent in this invariably lethal syndrome, they encouraged massive infusion of research funds into finding a cure. British, French and American pharmaceutical firms joined the battle, using their own funds with some government subsidization.

Ultimately, in the late 1990s, progress was made in delaying the lethal effects of AIDS through administration of a combination of medications costing between 10 and 30 thousand dollars annually per patient. Sometimes referred to as the "cocktail", these medications are technically known as Studuvine, Lamivudine, and Nevirapine. They are used in the West in rotation for six-month periods of time, prolonging life. Pharmaceutical companies, such as Glaxo-Smith-Kline, Beecham, and Bristol-Myers-Squibb, among other firms, expended billions of dollars to research and develop these medications (Kumar, 2001). Now, they are furious that MSF and many major humanitarian groups, notably OXFAM, have gone beyond the stage of merely suggesting that prices be lowered for Third World countries. MSF, known in English as Doctor without Borders, has actively contacted foreign drug manufacturers who would be able to essentially ‘steal’ Glaxo’s and Bristol-Meyers’ patented formulas and produce a generic variety of these three medications at extremely low cost. In fact, the cost of administering ‘pirated’ generic versions of these medications would be about $350 per year or less than one dollar per day per patient. The best offer that Glaxo, according to The Lancet (Kumar, 2001), would submit brought their price down to three times that of the generic brand, and, even then, this price would be effective only in narrowly selected Third World markets.

In encapsulated form, the controversy revolves around the offering of these newly developed medications, in generic form, to AIDS patients in locations such as Botswana and Zimbabwe – but also throughout the entire world. These medications, mostly manufactured currently in India by CIPLA, would be initially distributed by MSF. Other agencies would ultimately receive similar supplies from CIPLA or from other sources in Brazil, Cuba or South Africa where drug manufacturers have agreed to mass-produce the generic brand at rock-bottom prices.

The United States has filed a protest action with the World Trade Organization to attempt to protect the intellectual property rights of the pharmaceutical firms, based on US soil, which developed the AIDS ‘cure’. But this legal maneuver is not likely to offset the huge demand for the generic medications. Massive street protests have already erupted in South Africa to dramatize the plight of Third World AIDS sufferers who are dying a painful and miserable death in increasingly alarming numbers. While this demonstration was organized to protest the South African Government’s policy of blocking importation of generic medication, as opposed to a broader appeal for elimination of worldwide price structures for these types of life-saving medications, it was an effective indication of the emotions being aroused by this issue. Currently, partly because of the protests, there is talk in South African governmental circles of parallel importation of drugs, whereby a patent royalty would be paid to the original inventing-firm whenever the government had to ask a local producers to manufacture the drug at low cost for local consumption (Copman, 2001). However, this is not an entirely adequate response and there are many obstacles to its implementation.

With this scenario as a backdrop, it is appropriate to examine the reasons for favoring the distribution of life-saving drugs at low or no cost to AIDS and HIV patients. There are at least five key points that need to be elucidated:

• Humanitarian Rationale
• Legal Justification
• Dramatic Life-Sustaining Results
• Community Health and Welfare

Although the British and American pharmaceutical firms, and their irate stockholders who invested heavily in this research, are understandably angered by what amounts essentially to the purloining of their life-prolonging medication, they should have realized long ago that their proprietary rights would be under tremendous pressure from the world community. Even the low-cost manufacturers in India are not interested solely from a humanitarian viewpoint, because they stand to profit handsomely as well, although at lower levels of revenue multiplied times tens of millions of third world patients.

Nonetheless, let us examine the purely humanitarian position taken by MSF, OXFAM, SAVE THE CHILDREN, and dozens of Church-Affiliated Charitable Organizations involved worldwide in enforcing basic human rights, entitlements, and the dignity of the individual.

One of the primary reasons for energetically confronting Western pharmaceutical firms rather sternly is because, not only are mature, sexually active adults at risk of AIDS, but mothers, faithful to their spouses, and newborn infants are also falling victim to this lethal viral infection. Overall there have been 17 million Africans who have died of AIDS, including 2.4 million who perished in the year 2000 (Copson, 2001). A high percentage of these have been women and children, who are less able to defend themselves socially, medically or financially against this disease than men who are sometimes more socially interactive and have a better chance of locating the required medication.. Fortunately, Nivirapine has been found effective in blocking transmission of AIDS from mother to child (O’Connor, 1999). Clearly, the ratio of women and children who are victims of AIDS or HIV in Africa is much higher than in the developed nations of the Northern Hemisphere. Millions of children in Africa and Asia have been orphaned by AIDS, and many of them are carriers of the disease. These are just some of the pressing humanitarian issues justifying the distribution of at least the three basic medications mentioned earlier to Third World populations stricken heavily by AIDS/HIV. Naturally, the low-cost medications would only serve as part of a broad-based humanitarian AIDS-Awareness campaign that would, hopefully, influence the incidence of AIDS in countries such as Uganda, Botswana and Congo where rates have not been declining.

The World Trade Organization has been petitioned by the United States to block the manufacture and export of non-patented AIDS medications under existing intellectual property and fair trade legislation. Intellectual Property Rights laws, known as TRIPS legislation, allows manufacture of life-saving medications without royalty payments, but the powerful Western drug companies have adamantly opposed use of these WTO clauses (Copson, 2001). However, groups like MSF, OXFAM and Catholic Charities (known internationally as CARITAS) have their own legal teams working on establishing a legal and juridical mechanism for overriding the initiatives of Western Drug companies. There are provisions of the World Health Organization’s empowering legislation, through the United Nations, that may begin to provide the international legal justification for free or low-cost distribution of the life-prolonging "cocktail" (Murray, 2000).

Coupled with what we have called the Humanitarian Rationale are impressive AIDS suppression results obtained in nations, like Brazil, that have already been using the low-cost medications, technically without authorization from the big drug firms. Not only are abstract concerns about the importance of human life part of this issue, therefore, but something concrete-- such as a 50% decrease in the AIDS death rate --is actually occurring in Brazil (Yamey, 2001). The unfortunate part of this on-going battle is that trade sanctions may be imposed upon Brazil for having dared to produce these drugs, on legal footing, but without actual permission from, or payment to, the coalition of 40 major drugs companies now attacking the South African government and soon to attack the Brazilian Government. Since the drug companies’ combined wealth exceeds that of most Third World nations, individually and even collectively, the initial stages of the legal and trade battles soon to erupt may be won by the drug companies. There is no reason to believe that Brazilian life saving AIDS statistics, produced by administering these drugs, would not be replicated in Africa as well.

As the World Health Organization realizes very well, if men, women and children are all at risk of AIDS over tremendous stretches of the Third World, the entire planet could be at risk, and, indeed, already is. In light of this recognition, the significance of winning the battle against the drug companies takes on gargantuan proportions. As whole sectors of Third World countries succumb to unacceptable death rates, their economic structure disintegrates, GNP decreases and even the raw materials necessary to fuel Western nations become more difficult to obtain. With HIV infection rates of 35.8% in Botswana, which has a population of only a million to begin with, for example, the magnitude of the economic devastation can be glimpsed (Copson, 2001). These justifications alone, that is to say the community health aspect and socio-economic disintegration, serve as compelling grounds for ensuring that MSF and the charities prevail in their noble efforts to obtain low cost or cost-free medications for Third World Victims of this ravaging disease. Combined with the humanitarian thrust, now underway, so necessary to ensure the dignity of humankind, and legal initiatives to offset the influence of powerful drug lobbies in Washington and London, the economic devastation and the global health risks associated with the proliferation of AIDS are truly determining factors in ensuring victory for pro-distribution groups laboring hard to achieve their justifiable goals.

Although there seems to be cautious movement in the direction of providing financing for the export of some medications at Western prices so that a modest percentage of Third World AIDS victims may benefit, there is still an enormous gap between the needs and the available supplies of these medications. The only viable plan of attack against the onslaught of AIDS and HIV, worldwide, is the approach adopted first by MSF and then promoted by humanitarian agencies and charitable groups. Without their efforts to distribute low-cost medications, manufactured by CIPLA and other well-intentioned firms, it is obvious that entire continents will be depopulated in a matter of a few decades. Already, AIDS has risen to become the first cause of death in Africa, over malaria, and is soon to assume that unhappy ranking in South America and Asia. Effective medication is available and must be distributed without artificial and political barriers being interposed by the few wealthy nations of the world.

Copson, R. "IB10050: AIDS in Africa", National Council for Science and the Environment, The Congressional Research Service, Washington, DC, January 11, 2001. http://www.cnie.org/nle/inter-34.html

Kumar, S. "Indian company offers low cost AIDS drugs", The Lancet, London, February 24, 2000, 616.

Murray, M and Lagnado, L. "Drug Companies Face Assault on Prices – Pressure Rises for Price Controls, but Pharmaceutical Firms aren’t ready to Dial 911 Yet", The Wall Street Journal, New York, N.Y., May 11, 2000, B1.

O’Connor, E. Affordable Drug Reduces Mother to Child HIV Transmission, Study Says", CNN-News, Washington, DC, July 14, 1999, http://www.cnn.com/HEALTH/AIDS/9907/14/preventing.baby.hiv/

Yamey, G. "U.S. trade action threatens Brazilian AIDS program", British Medical Journal, London, Feb 17, 2001, 383.