India's parliament passed a new law Wednesday, the Patent (Amendment) Bill, prohibiting the copying of patented drugs, despite strong criticism that the legislation would prohibit the manufacture of low-cost generic drugs.
The bill was passed by the 250 member upper house of parliament the day after it was approved by 545 member lower house on Tuesday. The opposition staged a walkout in both the houses.
The approval paves the way for the bill, which prohibits domestic firms from copying low-cost generic versions of patented drugs, to become law.
Health activists said the law would affect the provision of cheaper generic drugs to millions of HIV-AIDS and cancer sufferers in poorer countries, a claim disputed by drugs firms.
The bill is an attempt to ensure India falls in line with World Trade Organisation rules and replaces legislation which allows drug makers to copy patented products using a different manufacturing process.
Commerce Minister Kamal Nath told parliament that concerns over the rise of medicine prices were baseless as only 10 out of the 195 drugs currently being sold in the domestic market would be covered by the new patent law, which affects only drugs patented after 1995, and procedural complications means it will take at least three years to secure patents for those 10 drugs.
Oxfam and the World Health Organisation (WHO) were among those to voice concern that the law would have international ramifications, especially for those living with HIV-AIDS and cancer in poorer countries.Oxfam's regional policy advisor Samar Verma says because India is one of the world's biggest producers of generic drugs, the law will have a severe knock-on effect on many developing countries which depend on imported generic drugs from India, and they fear that the prices of drugs will be out of reach for millions living with HIV-AIDS in Africa and elsewhere.
The WHO's deputy director for the department of essential medicines, German Velasquez, says they are very concerned and are following the debate very closely. The Geneva-based UN health body had recalled in a letter to Indian Prime Minister Manmohan Singh "the importance of the manufacture in India of generic medicines affects many developing countries".
"People who rely on low-cost medicines will have to wait three years before a generic company can even make an application for a right to produce the drug," said a statement by a group of activists including France-based Medecins Sans Frontieres (MSF) and the Affordable Medicines and Treatment Campaign (India).Poor people will have to wait years until new medicines are proved safe and effective.