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• W2133693288 abstract "Vociferous debate has surrounded India's new patent legislation, which finally passed last month after several concessions to campaigners. But are these compromises enough to appease opponents who say the law will limit access to medicines? Patralekha Chatterjee reports. India's new law for patents and patients has averted the worst-case scenario for people living with life-threatening diseases—but only in the short-term. Despite several last-minute amendments, the new law will make it far more difficult for poor people across the developing world to access vital drugs, especially new ones, at affordable prices. For more than three decades, Indian law recognised only process patents, not product patents. This allowed India's pharmaceutical companies to make inexpensive copycat versions of patented drugs. India became one of the world's biggest producers of generic drugs. But following the Patent (Amendment) Act, passed by Parliament last month, India has to implement laws in compliance with the World Trade Organisation Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The severe knock-on effect will be felt not only in India but also in many developing countries that depend on its imported generic drugs. The law is passed, but a bitter feud continues. Supporters argue that it will stimulate research investment in India; but critics maintain that India went beyond what was required by the World Trade Organisation and that patients will be hit hard by the changes. For those affected by the AIDS epidemic, rising drug prices are a serious concern. “First-line triple therapy is now available for as little as US$140 per patient per year … But when patients need to switch to second-line treatment, they could face treatment costs as high as US$5000 per patient per year”, argues Ellen T'Hoen of Médecins Sans Frontiéres (MSF). T'Hoen's concerns resonate across HIV-positive networks in South Africa and India, the two countries with the highest number of HIV positive individuals. “New drugs will be available, but poor people living with HIV will die prematurely because the law now makes it legally difficult for India's generic manufacturers like Cipla to produce affordable medicines”, says Denis Matwa, an activist with South African pressure group Treatment Action Campaign. “The scarcity of affordable drugs will cause the death of poor people living with HIV and AIDS in much larger numbers.” Loon Gangte, a member of the Delhi Network of HIV positive people and the International Treatment Preparedness Coalition, is equally candid. “We have the second highest population of HIV positive people after South Africa. But access to treatment, already a hard struggle, will become harder. The government has a programme of providing free antiretrovirals but currently less than 10% of those who need [these drugs] can access them … After a few years, when some of us graduate to the second-line of treatment, the new drugs will be beyond the reach of most Indians living with HIV and AIDS.” Gangte is among many who believe that India did not use all the available flexibilities under TRIPS. Some clauses are ambiguous and open to interpretation, raising fears of endless litigation and delays, he argues. “A key safeguard to assure availability of affordable medicines is the procedure of compulsory licences”, according to a recent statement from India's Affordable Medicines and Treatment Campaign, MSF, Lawyers Collective HIV/AIDS Unit, and Alternative Law Forum. “The government grants patents but allows generic companies to make their versions of the patented medicines against payment of royalty to the patent holder. However, in the new law, procedures are still extremely complex and there is no control on levels of royalties to be paid, which will lead to endless litigation and delays.” A spokesperson for the Positive Women Network of India agrees:“The compulsory licence provision remains impractical for accommodating the needs of people who rely on low-cost medicines on an urgent basis.” The safeguards in the current law take care of the present and the amendments before the law was passed were an important signal that the Indian Government can be receptive to changes. But as T'Hoen and her MSF colleague Daniel Berman emphasise, “India should look at the future threats … What is required is automatic licensing and reasonable royalties at fixed rates for new drugs.”" @default.
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• W2133693288 date "2005-04-01" @default.
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• W2133693288 title "India's new patent laws may still hurt generic drug supplies" @default.
• W2133693288 doi "https://doi.org/10.1016/s0140-6736(05)66356-8" @default.
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