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India: Will Pharma, Trade Agreements Shut Down the Pharmacy of the Developing World?

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Not a week seems to go by without the West -- governments, pharmaceutical giants and the business press -- crying foul over India's handling of intellectual property. India is accused of being unfriendly to business interests because of its patent laws. In line with international trade agreements, these laws contain provisions that safeguard against unnecessary patenting of medicines and allow for competition from generic drug companies. As a doctor, speaking from a medical humanitarian perspective, the case for a defense of India is clear: competition between multiple manufacturers allows for lower prices and greater access to lifesaving medicines. But the ability of Indian manufacturers to continue to produce quality generic medicines that reach patients in the developing world is under threat.

Pharmaceutical companies are chipping away at India's legal safeguards in the courts. Bayer is attempting to clamp down on and delay the approval process required for generics to be marketed as soon as a patent is licensed, revoked or expires. Novartis, having lost a legal marathon challenging the very constitutionality of the most significant parts of Indian patent law, is now before the Indian Supreme Court to water down the use of these crucial provisions. And the outcome of ongoing trade negotiations between India, the European Union and Japan may prove to be the death knell of India's generics industry.

What's at stake? HIV treatment for patients in Africa and parts of Asia was revolutionized in 2001, when one of the Indian generic companies produced a three-in-one HIV/AIDS treatment for a dollar a day, at a time when brand-name pharmaceutical companies were charging $12,000 a year. This competition was the catalyst for a fall in the price of treatment of over 99 percent, as prices have lowered ever since. Without this and other price-busting moves, treatment providers, governments and aid agencies such as Doctors Without Borders/Médecins Sans Frontières (MSF) could not have expanded treatment to the levels seen today.

In short, India has become "the pharmacy of the developing world." MSF buys 80 percent of its AIDS medicines from Indian generic companies. Ninety percent of AIDS drugs provided to 13 countries by PEPFAR, the U.S. global AIDS program are generics -- the overwhelming majority from India. Without affordable Indian generics, millions of lives saved over the past decade would otherwise have been lost.

When India amended its patent law in 2005, it heightened intellectual property rules to comply with international trade laws, a requirement for countries joining the World Trade Organization (WTO). As a WTO member, India was now obliged to grant 20-year patents on medicines and treat lifesaving medicines in much the same way as any other invention. The impact of this on access to affordable medicines is already being felt, as newer HIV medicines have been patented and the future for patients across the globe needing newer medicines is looking bleak.

But India struck a unique balance to prevent the worst. Key amendments to the Indian patent law contained safeguards against unnecessary patents. These included creating a system for public interest groups to challenge unjustified patents. This mechanism has allowed the Delhi Network of Positive People (DNP+), a small organization working with people living with HIV, to take on the might of the U.S. multinational Gilead Sciences and challenge the validity of the company's patent applications on tenofovir, a drug that is the backbone of AIDS treatment regimens. This is possible thanks to key amendments prohibiting the pharmaceutical industry's practice of extending patents and price monopolies on certain drugs by patenting slight modifications to existing medicines. This is the customary way in which pharmaceutical companies in the U.S. and Europe hold on to a patent almost indefinitely.

This compromise is now in serious danger of collapsing. New trade agreements threaten to impose a much stricter patent system, effectively straight-jacketing the generics industry and preventing India from providing essential drugs to developing countries. The U.S. is also getting in on the action, placing India on its "Priority Watch List" for "weak intellectual property rights protection and enforcement," despite India's compliance with international law. Leaked text of discussions by governments secretly negotiating an anti-counterfeiting treaty indicates that certain generics would be erroneously classified as "fake," a confusion that has already led to legitimate generic medicines being detained by European customs authorities in 2008. This would pose a huge barrier against countries wanting to import generics from India, because who could argue against clamping down on fraudulent medicines?

Except that quality, legally-produced generic medicines are far from fake. They are the lifeblood of treatment programs across the world. MSF depends on them to run effective programs. Massive global health programs supported by the United States and other countries rely on them to ensure they reach the greatest number in need. Most of all, patients depend on generics for their survival.

As India's courts examine the various cases before them in the coming months, and trade negotiators haggle over the terms of various agreements -- I ask them: what will happen if you close the pharmacy of the developing world? The answer is all too clear.