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Generic drugs and the fate of the global AIDS response

Ramnath Subbaraman

The potential of antiretroviral therapy to transform the lives of the HIV-infected in developing countries inspires hope. However, new roadblocks are emerging that may compromise access to essential medicines.

ONLY SIX years ago, a coalition of 39 U.S. and European pharmaceutical companies (including Novartis) brought a lawsuit against the South African government for passing a law that would facilitate access to cheaper, generic medications. This lawsuit was happening against the backdrop of an unfathomable HIV epidemic, which had already affected more than 10 per cent of the country's population. The lives of millions of South Africans hinged on the possibility of accessing new medications called antiretrovirals, which had already drastically diminished the death rate from HIV in the United States. Western drug companies were charging more than $10,000 a year for even the cheapest of these HIV drug regimens — a cost which effectively placed this life-saving therapy out of reach of the 95 per cent of HIV-infected people who live in developing countries.

In the midst of this seemingly hopeless situation, the Indian pharmaceutical company Cipla announced that it could offer generic versions of these HIV medications for a mere $350 per year. Overnight, the prospect of treating the more than 30 million HIV patients in developing countries became imaginable. Had the western pharmaceutical companies won the lawsuit, they would have prevented millions of South Africans from accessing these cheaper generic medications for AIDS. While they eventually dropped the case after media coverage provoked international outrage, many of us have not forgotten this shameful behaviour of these companies in the face of an unprecedented humanitarian crisis.

As a young Indian-American college student studying abroad in South Africa at that time, witnessing those events left a profound impression on me. I entered medical school in the U.S. the next year inspired to become an HIV doctor. Prior to finishing medical school, I was given the chance to spend one year in Chennai on a research fellowship with a large non-governmental provider of HIV care. There I witnessed the remarkable benefits of antiretroviral therapy first hand.

At the Chennai centre, access to generic antiretroviral medications had decreased mortality almost five-fold in just six years. As impressive as these statistics are, they can never fully communicate the way antiretroviral medications can transform people's lives. Patients would often arrive with their bodies ravaged by tuberculosis, pneumonia, meningitis, and diarrhoea — infections that prey on a compromised immune system. A few months later, after taking antiretroviral medications, which allow the regeneration of the immune system, these same individuals would be revived to a normal state of health.

The potential of antiretroviral therapy to transform the lives of the tens of millions infected with HIV in developing countries inspires hope for the future. The distribution of generic HIV medications by Indian pharmaceutical companies has expanded HIV care to thousands of Indian patients and millions of others across the globe, especially in sub-Saharan Africa. Currently, more than half of all HIV medications used in developing countries come from India.

However, new roadblocks are emerging that may compromise access to essential medicines in developing countries. In 2005, to comply with World Trade Organisation (WTO) regulations, the Indian Government passed a law allowing pharmaceutical products to be patented in India. This effectively shuts down generic production of newly discovered drugs. This means that a plethora of new, emerging HIV medications are unlikely to become widely accessible through generic production in developing countries for at least another 20 years — the legal life of a drug patent.

I dream of one day being able to travel between hospitals in the United States and India and being able to write prescriptions for the same medications (and deliver the same standard of medical care) without thinking twice. But today's grim reality is one of double standards, in which the lives of Indians and Africans are worth less than those of people in western countries. In the current international calculus of human health, life and death are primarily a function of patents and profits. The struggle for access to essential medicines is a stand to reject this fundamental assumption of our times, to make health care a human right, and to ensure that people in developing countries can lead their lives in dignity.

(The writer is a final year student at the Yale University School of Medicine. ramnath.subbaraman@yale.edu.)

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