International aid groups on Wednesday slammed the Indian Parliament's decision to approve patent legislation that ends the decades-old practice of allowing domestic drug companies to make low-cost copies of expensive Western medicines, saying hundreds of thousands of poor people will be affected.
The changes, expected to become law later this week, stem from India's membership in the World Trade Organization, which enhances the country's participation in global trade but requires it to enforce stricter patent rules for its US$5 billion (euro3.8 billion) pharmaceutical industry.
But international aid groups said Wednesday the legislation will curb the supply of cheap generic drugs to impoverished nations in Africa, Asia and Latin America, threatening the survival of hundreds of thousands of AIDS and cancer patients.
"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," said Samar Verma, regional policy adviser at Oxfam International.
The Paris-based Doctors Without Borders on Wednesday described the Indian move as "the beginning of the end of affordable generics."
The powerful lower house of Parliament approved the bill Tuesday after the government agreed to last-minute changes demanded by leftist allies to placate fears that multinational companies could extend the duration of their patents indefinitely and gain dominance of India's market.
The bill is widely expected to become law later this week when it is expected to be passed by Parliament's upper house, where the governing coalition and its Communist allies have a majority.
The amendments sought to tighten the definition of "new inventions" to prevent drug companies from winning new patents by making minor changes to existing drugs. The proposed law would also permit patents to be challenged even before they are granted -- a move opposed by multinationals but long demanded by the domestic industry.
Ellen 't Hoen of Doctors Without Borders, who led representatives from more than two dozen aid groups, said the bill was still vague in many key areas and allowed for abuses by multinational companies.
"We are deeply disturbed and concerned that you are failing to listen to the voices of your people who have entrusted you with their welfare, not to mention the poor in the developing world who rely on affordable medicine from India," the aid groups said in a letter to Sonia Gandhi, the leader of the governing Congress party.
A key concern relates to a provision allowing the government to override patents on medicines that a large number of people need, but can't afford to buy. The bill says the government must wait at least three years before this is allowed, except in a national emergency.
Even though India has some 5.1 million HIV-infected people -- the second largest number after South Africa -- the disease is not seen as a national emergency, and Indian companies will therefore no longer be allowed to copy new inventions in AIDS treatment, Hoen said.
Another concern relates to royalties to be paid by generic producers to the companies holding patents for drugs. The new law doesn't set any cap on royalty rates, thus giving a big leverage to multinational companies, said Fatima Hassan of the South Africa-based Treatment Action Campaign.
Although international norms for royalties are in the range of 3 percent to 4 percent, Hassan said GlaxoSmithKline once tried to charge a 40 percent royalty for a lifesaving drug in South Africa until activists and the courts intervened.
By RAJESH MAHAPATRA Associated Press Writer MAR. 23 4:07 A.M. ET
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