INDIA: Troubles with Pharmaceuticals and IPRs

Eric Linge, Pitt Law '09, files from Mumbai:

The cruel irony is that the most pressing diseases are the ones that don't make money. Multinational pharmaceutical corporations from the United States and Europe can rake in the profits selling drugs that treat rich world diseases like diabetes, hypertension, and, if it can actually be called a disease, erectile dysfunction. Even middle class Indians are now buying drugs for these diseases.

The drafters of independent India's patent laws have always had the poor in mind when drafting, yet even after sea changes in India's patent laws, getting drugs to the poor remains a challenge. Nearly every day a Mumbai lawyer confronts on his way to and from work someone crippled by what I usually guess was polio. The most painful to behold would probably be the men pushing themselves by their knuckles on ground-hugging carts along the pavement, their lifeless and skinny legs twisted over their shoulders. Luckier beggars can at least stand with the help of crutches.

Until the early 1990s India was famously protectionist, and an industry she jealously guarded was her generic drug industry. While pharmaceutical product patents had previously not been forbidden, the India Patents Act, 1970, made it so that the patenting of "substances intended for use, or capable of being used, as food or as medicine or drug" would receive no patent protection. Among the results of this patent law was the success of India's generic pharmaceutical industry — where Indian companies copy drugs invented in the West — and the lowering of drug prices in India.

It was expected that this generics industry would facilitate much-needed drugs reaching the poor Indian masses. An unintended result was that the brightest Indians did not stay in India to develop new drugs. They emigrated to the U.S. and Europe where their inventions were protected by enforceable patent laws. Indian pharmaceutical manufacturers ended up earning profits by selling their generic drugs to nations with lax IP enforcement like Yemen and Sudan. They also sold (and continue to sell today) their generics in Western nations, taking their chances with these legal systems, a high risk, high reward game. Another cruel irony is that the poor Indian masses were just apparently not profitable enough markets.

But fact was, as long as the drugs were consumed in India, sold to countries that did not recognize foreign pharmaceutical patents, or banned from importation into Western countries by their courts, India was not a pirate nation. She was living legally, and her scientists — those whose brains hadn't drained west — were becoming experts in reverse engineering and not in inventing original drug molecules.

The playing field for India's pharmaceutical industry is much altered today. India joined the WTO on January 1, 1995, and was thus obliged to amend her IPR laws to be in accordance with the TRIPS agreement by the end of a ten-year transition period. This meant pharmaceutical products would need to be patentable subject matter, and India amended the Patents Act accordingly in 2005.

There does not appear to be evidence that drug prices have skyrocketed or even risen since the patent law amendments. India's government has promised price controls so that prices of certain essential drugs do not rise too high anyway. It also doesn't appear that a wave of life saving drugs is sweeping the Indian countryside. It does appear that Western multinational drug companies are now more comfortable collaborating with Indian drug firms and more comfortable performing research and development in India. Furthermore, India's generic drug industry continues to function, manufacturing generics of drugs whose patents have expired, or by manufacturing generics and taking chances in foreign legal environments.

And amongst all the talk about new patent laws, India's poor have not been entirely forgotten. In hopeful sounding developments, non-profit groups underwritten by the Bill and Melinda Gates Foundation, Doctors Without Borders, and others, are working to develop drugs to fight the neglected diseases of the poor world. One of these groups, the Institute for OneWorld Health, has actually developed to fruition a drug called paromomycin that has proven to be an effective cure for black fever, the world's second largest parasitic killer after malaria. Paromomycin has been approved in India and could potentially eradicate the disease.

 

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