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[NEW DELHI] Controversial legislation approved by the lower house of India's parliament yesterday (22 March) could drastically increase the cost of cheap HIV drugs and other medicines the country produces, according to international humanitarian organisations.

The law threatens to affect the provision of healthcare to hundreds of thousands of patients, many of them in Africa, for whom low-cost Indian drugs are the only affordable means of treating AIDS.

However, large pharmaceutical companies are welcoming the law, as it will protect products they have spent millions of dollars on during research and development.

The new patents bill is intended to bring India's patent regime into line with the World Trade Organization's (WTO) agreement on Trade Related Aspects of Intellectual Property Rights (known as TRIPS), one of the conditions of India's membership of the WTO.

The previous Indian Patents Act (1970) recognised patents on pharmaceutical processes but not on pharmaceutical products, allowing domestic pharmaceutical companies to produce cheap copies of patented drugs made by foreign companies using alternative production methods.

But as India emerged as one of the world's leading suppliers of these 'generic' medicines, multinational companies complained that the trade in generic drugs was losing them an estimated US$500 million every year.

To comply with TRIPS, the new law being proposed by the government recognises patents not only on processes but also on products such as drugs, agricultural chemicals, food and biotechnology products, and software. Compliance with TRIPS also requires patent protection to last for 20 years.

The Indian government says the changes are necessary to encourage the Indian drug industry to increase its research and development, and to attract foreign partners.

But critics argue that the government has adopted a regime that is more restrictive than required by TRIPS. For instance, while TRIPS does not require India to grant patents on new formulations or combinations of known drugs, the new bill does.

The changes "will drastically restrict, perhaps even prevent, the production and supply" of anti-HIV drugs by Indian pharmaceutical companies to other developing countries, said Rowan Gillies, president of the international medical aid organisation Médecins Sans Frontières (MSF) in a letter to India's president and prime minister.

Half of the world's 700,000 people using anti-HIV drugs depend on cheaper generic medicines from Indian pharmaceutical manufacturers, says Ellen't Hoen of MSF's Access to Essential Medicines Campaign.

MSF, for example, uses the anti-HIV drugs to treat 25,000 people in 27 countries, and 70 per cent of its patients use medicines made in India. Among the medicines used are those combining three HIV drugs in a single pill.

Any drugs patented outside India since 1 January 2005 would also be protected inside India under the new law.

Indian companies will have to wait for three years before they can apply for special permission to make generic versions of such drugs, in the event of a national health emergency.

Critics say this could increase prices of HIV drugs at a crucial stage of the epidemic, when the World Health Organization plans to make such drugs accessible to three million patients by 2005.

In an unprecedented joint appeal, Nafis Sadik and Stephen Lewis, the UN Special Envoys for HIV/AIDS in Asia and the Pacific, and in Africa, respectively, have appealed to the Indian government to ensure the primacy of public health over intellectual property.

"The lives of HIV-positive people throughout the developing world are now being sustained by quality generic drugs. … We are deeply concerned that, following the 1 January 2005 full implementation deadline for the TRIPS agreement, those lives are now in jeopardy," Sadik and Lewis said.

When India became a member of the WTO in 1995, it was given until 1 January 2005 to bring its patent laws into line with the TRIPS agreement.

The bill passed yesterday will be sent to the upper house of parliament, which is expected to ratify it, and then to the president for his signature before it becomes a law.

Dozens of organisations from Australia, Brazil, Colombia, Costa Rica, France, India, Malaysia, Namibia, Nepal, Nigeria, South Africa, Sri Lanka, Switzerland, Thailand, Uganda, United Kingdom, Venezuela and Zimbabwe met in Mumbai on 19-20 March to discuss the future of affordable medicines and the changes in the Indian patents act.

A statement released by the group said India has "a moral duty to all those around the world who have benefited from affordable Indian medicines to continue providing such access, so that people do not prematurely die without them".

Since joining the WTO, India has amended its patents act twice — in 1999 (with retrospective effect from 1995) and again in 2002 (with effect from 1999) to meet some of the obligations of TRIPS.

Read more about intellectual property in SciDev.Net's intellectual property dossier.