India’s government proposed on Friday to change the country’s patent laws to make it illegal to copy patented drugs, a practice that has made cheaper medicines available in India and abroad. The bill proposed to parliament, which also covers other products such as chemicals, mobile phones and computers, would fulfil India’s commitment to the World Trade Organization to recognize patents from Jan. 1, 2005.
But the legislation faces huge resistance from the ruling coalition’s communist allies and opposition parties who are concerned about the availability of affordable drugs in India. Domestic pharmaceutical companies and aid organizations working in developing countries have also expressed concerns. The existing patent law has allowed drug makers to copy patented drugs as long as they use a different process. It has fostered a strong drug manufacturing industry in India for more than three decades. The government argues, however, that patent recognition is an essential pre-condition for India’s drug industry to further its own drug research and development or attract foreign partners. The country is already the world’s fourth-largest producer of medicines by volume but ranks only 13th by value, reflecting the very low prices of products in the local market. India issued a presidential decree at the end of December but the change needs to be ratified by parliament within six months. CONCERNS AT HOME AND OVERSEAS Y K Hamied, chairman of drug maker Cipla Ltd., argued in a recent article published by the Indian Drug Manufacturers Association, that the amended law should make provision to grant compulsory licenses to Indian manufacturers to prevent monopolies, with the inventor given a suitable royalty. He said the government should also have the freedom to grant automatic licenses to Indian companies for national health programs such as drugs for cancer, tuberculosis, malaria, asthma, hepatitis and HIV/AIDS. Another local industry concern is that multinationals will be granted patents even when they make minor changes to drugs so that their patent lives get extended, thereby delaying the introduction of generic medicines.Relief agency Medecins Sans Frontieres, or Doctors Without Borders, has said it is concerned about the availability of cheap medicines to patients in developing countries. “We believe they (the amendments) will drastically restrict, perhaps even prevent, the production and supply of vital therapies by Indian pharmaceutical companies to other developing countries,” Ellen ‘t Hoen, director of policy advocacy and research at MSF, said in a statement earlier this week. MSF said about half of the 700,000 people receiving antiretroviral treatment for HIV/AIDS in developing countries relied on drugs from Indian generic drug makers. Indian companies have also developed combination pills from drugs patented by different companies, which have become popular in HIV/AIDS treatment in developing countries. This was possible only because Indian law hitherto had no product patent constraints.(Source: Reuters Health, March 2005)