India, a major source of inexpensive AIDS drugs, passed a new patent law on Wednesday that groups providing drugs to the worlds poorest patients fear will choke off their supply of new treatments.
The new law, amending Indias 1970 Patent Act, affects everything from electronics to software to medicines, and has been expected for years as a condition for India to join the World Trade Organization.
But because millions of poor people in India and elsewhere – including by some estimates half the AIDS patients in the Third World – rely on Indias generic drug industry, lobbyists for multinational drug companies as well as activists fighting for cheap drugs had descended on New Delhi to try to influence the outcome.
The law, which passed by a voice vote in Parliaments upper house Wednesday after days of wrangling over amendments in the lower house, was in the end not as restrictive as the drug activists had feared.
– It is very disappointing, but it could have been worse, said Daniel Berman, a coordinator of the global access campaign for the medical charity Doctors Without Borders. – All generics could have been removed from the market, he added.
Instead, all the generic drugs already approved in India can still be sold, though sellers must now pay licensing fees. There are also provisions allowing companies that make generics to copy drugs in the future.
But there are relatively tough criteria for such copying, and activists predicted that prices for newly invented drugs will be much higher, because drug makers will have the same 20-year patent monopolies as they have in the West. As AIDS patients develop resistance to old drugs, new treatments will become less affordable, they said.
In addition, it is unclear whether makers of generic drugs in other countries, like Brazil, China and Thailand, will fill any increasing demand for cheaper medicines.
But Indias governing Congress Party, which sponsored the bill, disputed the contention that prices would soar. – The government will have enormous powers to deal with any unusual price rise, said Commerce Minister Kamal Nath.
All Western countries grant “product patents” on new inventions. Since 1970, India has granted “process patents,” which allow another inventor to patent the same product as long as it was created by a novel process.
In pharmaceuticals, that has meant that a tiny tweak in the synthesis of a molecule yields a new patent. Several companies can produce the same drug, creating competition that drives down prices.
Before 1970, Indias patent laws came from its colonial days, and it had some of the worlds highest drug prices. Process patents on drugs, fertilizers and pesticides have extended life expectancy and ended regular famines.
In Africa, exports by Indian companies, especially Cipla and Ranbaxy Laboratories, helped drive the annual price of antiretroviral treatment down from 15.000 US dollar per patient a decade ago to about 200 dollar now. They also simplified therapy by putting three AIDS drugs in one pill. Dr. Yusuf Hamied, Ciplas chairman, called the new law “a very sad day for India.”
But some other Indian drug makers, along with multinational companies, praised it. The International Federation of Pharmaceutical Manufacturers and Associations, a Geneva-based lobbying group, called the law “a significant step” that would let India “take a leading role in global pharmaceutical research and development.”
S. Ramakrishna, chief lobbyist for Pfizer India, a subsidiary of the worlds largest drug maker, said the bills passage abandoned “the utopian concept that every invention should be as free as air or water,” according to The International Herald Tribune.
In the United States, Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, the lobbying organization for the American drug industry, said the new law would be “good for India and good for Indian patients,” but cautioned that his group was “still measuring the impact on the overall bill of several last-minute amendments.”
Some multinationals had refused to invest in India without stronger patent protection, and Indian companies that do original research were also eager for it.
But Mr. Berman said a “mailbox” created by the government two years ago in which drug makers could deposit patents they hoped to file when the law was amended had 1.500 proposals from Indian companies – and 7.000 from foreign ones, suggesting the new law would benefit foreign companies more.
Under the new law, a maker of generics can apply to copy a patented drug, but only after it has been marketed for three years. In addition, the patent owner can object.
Also, the generics maker must pay a “reasonable” royalty, although the law does not define reasonable. Two years ago, Mr. Berman noted, the London-based company GlaxoSmithKline demanded 40 percent of the sales proceeds of an AIDS drug it licensed to a South African company. Under pressure from South African regulators and activists, it later licensed it to three rival companies for only 5 percent.
In 2003, the Swiss drug maker Novartis forced Indian competitors to stop making generic versions of its leukemia drug Glivec, which the Indian companies sold for 2.700 US dollar a year. Novartis then priced its version at 27.000 dollar a year, while giving free treatment to a few poor patients.
If a drug is desperately needed, the new law allows the government to declare an emergency and cancel its patent. But Mr. Berman said India had never declared such an emergency, and for years resisted admitting that it had an AIDS problem.
Kilde: The Push Journal
