Changes to India's patent law may deny cheap drugs to millions
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《英国医生杂志》
New Delhi
India's proposed changes to its 35 year old patent laws will deny inexpensive generic drugs to millions of people in India and other developing countries, international humanitarian agencies and health activists have warned.
This week the Indian parliament has been debating amendments to patent laws that will introduce product patents on drugs, as part of India's obligations under an international agreement on intellectual property rights and trade.
India's patent act of 1970 granted patents on chemical processes but did not permit patents on drugs. This allowed Indian drug companies to reverse engineer molecules to produce generic versions of patented drugs.
Health activists say the amendments would make it easier for companies to acquire patents on new uses of old drugs and on new combinations of old drugs. Under the new legislation, compulsory licensing that allows local companies to produce generic products would become difficult.
"Millions of people in the developing world will lose their lifeline of generic drugs from India if the amendments are passed," said Rhona MacDonald, head of Oxdocs, an Oxfam initiative that tries to get doctors involved in combating global poverty.
Médecins Sans Frontières has said that the amendments would drastically restrict the production of generic drugs in India and their supply to developing countries. Without competition from generic drugs the prices of new patented drugs will go up.
"A two tier system may emerge: new patented medicines for the rich and old generic products for the poor," said Ellen T'Hoen, director of policy advocacy and research for Médecins Sans Frontières's campaign for access to essential medicines.
Médecins Sans Frontières said that half the 700 000 people who receive antiretroviral drugs in developing countries rely on Indian generic products. The agency itself provides antiretroviral drugs to 25 000 people in 27 countries, 70% of whom use drugs from India.
Ms T'Hoen said the impact of India's generic manufacturers is most visible in HIV treatment. Five years ago the average cost of antiretroviral treatment was $10 000 (￡5200; 7500) a year. With competition from Indian generic drugs the price has fallen to $250 a year.
Under the international treaty, the new patent laws should have come into effect on 1 January this year. The government passed an ordinance in December 2004 and introduced a bill in parliament for debate last Friday.
Health activists say the amendments would also virtually eliminate opportunities to oppose patents before they are granted. Since 1995 more than 8000 patent applications have accumulated with the Indian government.
"The amendments are skewed in favour of Western multinational companies," said Anand Grover, director of Lawyers Collective, a legal organisation in Mumbai campaigning for public health issues.
India's drug industry is divided on the bill. Most small and medium sized firms favour the present situation, but some big firms look forward to the new law and have begun efforts to develop new drugs. "How long should Indian companies be dubbed as reverse engineers and copycats?" asked Harinder Sikka, a top officer with Nicholas Piramal, a leading drug company.(Ganapati Mudur)
India's proposed changes to its 35 year old patent laws will deny inexpensive generic drugs to millions of people in India and other developing countries, international humanitarian agencies and health activists have warned.
This week the Indian parliament has been debating amendments to patent laws that will introduce product patents on drugs, as part of India's obligations under an international agreement on intellectual property rights and trade.
India's patent act of 1970 granted patents on chemical processes but did not permit patents on drugs. This allowed Indian drug companies to reverse engineer molecules to produce generic versions of patented drugs.
Health activists say the amendments would make it easier for companies to acquire patents on new uses of old drugs and on new combinations of old drugs. Under the new legislation, compulsory licensing that allows local companies to produce generic products would become difficult.
"Millions of people in the developing world will lose their lifeline of generic drugs from India if the amendments are passed," said Rhona MacDonald, head of Oxdocs, an Oxfam initiative that tries to get doctors involved in combating global poverty.
Médecins Sans Frontières has said that the amendments would drastically restrict the production of generic drugs in India and their supply to developing countries. Without competition from generic drugs the prices of new patented drugs will go up.
"A two tier system may emerge: new patented medicines for the rich and old generic products for the poor," said Ellen T'Hoen, director of policy advocacy and research for Médecins Sans Frontières's campaign for access to essential medicines.
Médecins Sans Frontières said that half the 700 000 people who receive antiretroviral drugs in developing countries rely on Indian generic products. The agency itself provides antiretroviral drugs to 25 000 people in 27 countries, 70% of whom use drugs from India.
Ms T'Hoen said the impact of India's generic manufacturers is most visible in HIV treatment. Five years ago the average cost of antiretroviral treatment was $10 000 (￡5200; 7500) a year. With competition from Indian generic drugs the price has fallen to $250 a year.
Under the international treaty, the new patent laws should have come into effect on 1 January this year. The government passed an ordinance in December 2004 and introduced a bill in parliament for debate last Friday.
Health activists say the amendments would also virtually eliminate opportunities to oppose patents before they are granted. Since 1995 more than 8000 patent applications have accumulated with the Indian government.
"The amendments are skewed in favour of Western multinational companies," said Anand Grover, director of Lawyers Collective, a legal organisation in Mumbai campaigning for public health issues.
India's drug industry is divided on the bill. Most small and medium sized firms favour the present situation, but some big firms look forward to the new law and have begun efforts to develop new drugs. "How long should Indian companies be dubbed as reverse engineers and copycats?" asked Harinder Sikka, a top officer with Nicholas Piramal, a leading drug company.(Ganapati Mudur)