India’s Upper House of Parliament Passes Bill That Would Prohibit Production of Generic Versions of Patented Drugs
India's upper house of parliament on Wednesday passed a bill that would change the country's patent laws to prohibit the domestic production of low-cost, generic versions of patented medicines, including antiretroviral drugs, the AP/Boston Globe reports (Mahapatra, AP/Boston Globe, 3/24). India's generic drug industry has made less-expensive medications available in India and abroad for more than 30 years, making it possible for many people in developing countries to receive treatment for various diseases (Kaiser Daily HIV/AIDS Report, 3/23). India since 1970 has granted "process patents" rather than the usual "product patents" that all Western countries grant, according to the New York Times. This allowed drug companies in India to produce generic versions of medications patented in other countries as long as they used a different manufacturing process. As a result, several companies often produced the same drug using different processes, creating a competitive market that kept drug prices low (McNeil, New York Times, 3/24). The bill would change India's laws to bring the country in line with a World Trade Organization agreement on intellectual property that it signed in 1994. The Indian government says that recognizing patents is a necessary precondition for the nation's drug industry to pursue additional drug research and development and attract foreign investors (Kaiser Daily HIV/AIDS Report, 3/23). The measure now goes to Indian President Abdul Kalam, who is expected to approve the changes, according to the Washington Post.
The measure will not eliminate the supply of existing generic drugs, but it will require generic drug makers that want to continue production to pay royalties to the manufacturers of drugs currently under patent, the Post reports (Lancaster, Washington Post, 3/24). The amount of the royalties and the potential price increases for consumers are not yet known, the New York Times reports (Rai, New York Times, 3/24). The "biggest concern" is the production of generic forms of new drugs, the Post reports. The measure will require generic drug makers to wait three years before they can apply to produce a generic form of a new drug, according to an analysis by Medecins Sans Frontieres, the Post reports. However, that waiting period could be overcome with a compulsory license issued by the government in the case of a national emergency (Washington Post, 3/24).
Some analysts say that, under the measure, prices for patented "breakthrough" drugs could increase to the same levels as in the United States, according to the Times. However, the Indian government said that it would have the power to intervene if prices on new drugs increase too much, according to the Times. "Prices are a concern for all of us," Indian Trade Minister Kamal Nath said, adding, "This patent bill does not make anything happen tomorrow. No patent will come into being for the next couple of years" (Rai, New York Times, 3/24). Nath said that only 10 out of the 195 drugs currently being sold in India would be covered by the new law and that because of "procedural complications," it will take at least three years for companies to be granted patents on those 10 drugs, according to AFP/Yahoo! News (AFP/Yahoo! News, 3/23). However, some generic drug makers might be priced out of the market, according to analysts, the Times reports. Yusuf Hamied, chair of the Indian generic drug maker Cipla, which produces low-cost antiretrovirals for export to Africa, cited the example of Italy, which instituted drug patents in 1984, according to the Times. "What is the position of indigenous Italian industry today?" Hamied asked, saying, "Zilch. They've all been taken over. And from being a net exporter, they've become a net importer of drugs" (Rai, New York Times, 3/24).
Although some AIDS advocates said that the measure will "choke off" the flow of new, low-cost antiretrovirals to developing countries, the final version of the bill was less-restrictive than some advocates had "feared," according to the Times. "It's very disappointing, but it could have been worse," Daniel Berman, a coordinator of the MSF Campaign for Access to Essential Medicines, said, adding, "All generics could have been removed from the market" (McNeil, New York Times, 3/24). The International Federation of Pharmaceutical Manufacturers and Associations called the measure a "significant step" that will allow India to "take a leading role in global pharmaceutical research and development," according to the Times. Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the measure will be "good for India and good for Indian patients" but added that his organization is "still measuring the impact on the overall bill of several last-minute amendments" (McNeil, New York Times, 3/24). However, Samar Verma, regional policy adviser for Oxfam, said, "Because India is one of the world's biggest producers of generic drugs, this law will have a severe knock-on effect on many developing countries which depend on imported generic drugs from India," adding, "Oxfam fears that the prices of drugs will be out of reach for millions living with HIV/AIDS in Africa and elsewhere" (AFP/Yahoo! News, 3/23). Michael Weinstein, president of the AIDS Healthcare Foundation, said the measure will "profoundly diminish the availability of, and access to, high-quality, inexpensive generic AIDS drugs, particularly in Africa and the rest of the developing world" (AHF release, 3/23).
"The World" -- a production of BBC World Service, PRI and WGBH Boston -- on Wednesday reported on the legislation. The segment includes comments from MSF spokesperson Nathan Ford and Njogu Morgan, international coordinator for the South African HIV/AIDS advocacy group Treatment Action Campaign (Costello, "The World," PRI, 3/23). The complete segment is available online in Windows Media.