Healthy Skepticism Library item: 760

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Publication type: news

Editorial .
India's Choice
The New York Times 2005 Jan 18

Full text:

For an AIDS patient in a poor country lucky enough to get antiretroviral treatment, chances are that the pills that stave off death come from India. Generic knockoffs of AIDS drugs made by Indian manufacturers – now treating patients in 200 countries – have brought the price of antiretroviral therapy down to $140 a year from $12,000.

That luck may soon run out. India has become the world’s supplier of cheap AIDS drugs because it has the necessary raw materials and a thriving and sophisticated copycat drug industry made possible by laws that grant patents to the process of making medicines, rather than to the drugs themselves. But when India signed the World Trade Organization’s agreement on intellectual property in 1994, it was required to institute patents on products by Jan. 1, 2005. These rules have little to do with free trade and more to do with the lobbying power of the American and European pharmaceutical industries.

India’s government has issued rules that will effectively end the copycat industry for newer drugs. For the world’s poor, this will be a double hit – cutting off the supply of affordable medicines and removing the generic competition that drives down the cost of brand-name drugs.

But there is still a chance to fix the flaws in these rules, because they are contained in a decree that must be approved by Parliament. Heavily influenced by multinational and Indian drug makers eager to sell patented medicines to India’s huge middle class, the decree is so tilted toward the pharmaceutical industry that it does not even take advantage of rights countries enjoy under the W.T.O. to protect public health.

In November 2001, members of the World Trade Organization agreed that countries can issue compulsory licenses to permit generic production of patented drugs without the patent holder’s agreement in order to protect public health, at home or abroad. But under the Indian decree, getting a compulsory license would be slow and difficult; each application would face a fight from multinational drug firms and the governments that do their bidding. India should adopt laws that expedite compulsory licenses, including allowing challenges to proceed after production begins instead of holding it up. In addition, India must close an important loophole affecting the sick overseas: under the current rules, Malawi, for example, could not import from India an inexpensive version of a medicine that is not under patent in Malawi. This needs to be changed.

Industry lobbyists managed to insert two noxious provisions in the decree that go well beyond the W.T.O. rules. The decree would limit efforts to challenge patents before they take effect. Also, it is uncomfortably vague about whether companies could engage in “evergreening” – extending their patents by switching from a capsule to tablet, for example, or finding a new use for the product. This practice, a problem in America and elsewhere, extends monopolies and discourages innovation.

While some drugs – those that existed before 1995 – will always be off patent in India, some widely used drugs are at risk. So are new generations of much more expensive AIDS drugs that will soon be needed worldwide as resistance builds to current medicines. If the decree is not changed before Parliament approves it, it will be very difficult for India to supply them. India’s parliamentarians must keep in mind that this arcane dispute is actually a crucial battleground for the health of hundreds of millions of people in India and worldwide.