In a perverse manifestation of corporate greed, pharmaceutical companies and their allies in government have once again placed profits ahead of public health. Under pressure from domestic as well as international drug manufacturers, the Indian Parliament is poised to approve a government order that would effectively ban the production of all generic medications, including those that treat HIV/AIDS.

Suhael Momin

Classified as “antiretrovirals,” these anti-HIV drugs have dramatically improved the life expectancy, as well as quality of life, for individuals afflicted with the HIV virus. In the past, cocktails of ARV drugs were prohibitively expensive; a yearlong course of treatment would run upward of $12,000. However, the advent of generic knockoffs, many coming from India, reduced the cost to under $400 per year. In many poor African nations, this dramatic fall in price enabled government health agencies to administer the life-extending drugs at a very low cost. In 2003, in an effort to address the exploding AIDS crisis in southern Africa, the Clinton Foundation brokered a deal between the Republic of South Africa and a handful of generic drug manufacturers to provide ARV treatment at $140 per patient per year.

As reported by The New York Times, generic pharmaceuticals in India have become tremendously successful because national patent laws protect the production pathway used to synthesize the drugs, not the actual drugs. However, as The Times reports, efforts to bring India in line with the World Trade Organization’s agreement on intellectual property have led the government to order statutory changes. Generic drug companies would have to receive specific permission to make a generic drug, while name-brand manufacturers would be able to “evergreen” — extend their patents by simply changing the form, such as from capsule to syrup, of their medication. These changes would cripple the generic drug industry, but India’s Parliament, which must approve the order before it goes into effect, does not seem likely to protest.

ARV treatments, while not cures, can extend the lifespan of HIV-positive individuals by decades when properly administered. The assault on Indian generic drug manufacturers may protect sizeable profits for name-brand pharmaceuticals, but at what social cost?

The magnitude of the public health crisis posed by HIV/AIDS in sub-Saharan Africa defies comprehension. In South Africa, where the government has been notoriously ineffective at combating the spread of HIV, about 25 percent of the adult population has tested positive for the virus. The implications are dire. Considering that the HIV/AIDS life expectancy without ARV treatment is less than a decade, South Africa is facing the imminent loss of a huge portion of its workforce and a massive economic contraction. More disturbingly, if ARV treatment is not expanded dramatically, almost one out of every 10 citizens in South Africa will be orphaned within the next decade. The South African social service system is prepared neither financially nor logistically to accommodate such a huge influx of parentless children.

The pharmaceutical industry is by far one of the most profitable of all the major industries. This is in no small part due to government patent protections. Rapid advancements in drug technology ensure that pharmaceuticals are almost always obsolete before their patent protections expire; thus, drug companies virtually always charge monopoly prices for their products. Of course, arguing that drugs should have no patent protections is absurd. The short-term right to charge monopoly prices ensures that pharmaceutical companies have incentives to innovate and further the frontiers of medicine. An equitable balance between protecting intellectual property and the future of pharmaceutical research while securing care and treatment to individuals afflicted by a spreading pandemic must be established.

Canada appears ready to implement a responsible generic drug policy that protects pharmaceutical companies and simultaneously addresses the HIV/AIDS crisis in the developing world. In May 2004, the Canadian Senate approved a bill amending the country’s patent laws to allow the government to bypass patent protections and allow pharmaceutical manufacturers to produce and export generic drugs for use in developing nations. This protects profits in richer nations where patients can afford name-brand ARV drugs while enabling generics to be distributed to the vast majority of HIV/AIDS sufferers who cannot. Assuming Canada follows through on its legislation, it will set a fine example for the developed — and in India’s case, developing — world.


Momin can be reached at smomin@umich.edu.

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