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Indian patents may hamper access to antiretrovirals globally
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Libyan officials stand trial for torture of health professionals See Lancet Infect Dis 2004; 4: 130 and 316
AP Photo/Francois Mori
Rights were not granted to include this image in electronic media. Please refer to the printed journal.
A group of Libyan officials accused of torturing five Bulgarian nurses and a Palestinian doctor into making false confessions faces a trial at a Libyan court. In May last year, the health workers were sentenced to death by the Benghazi Criminal Court after they were convicted of deliberately infecting around 400 children with HIV while working in the al-Fateh Children’s Hospital in Benghazi in 1998. Many of the HIV-infected children have since died. The health-care workers have claimed their innocence, and some of them have complained of being tortured by the investigators. The ten accused of torture, including a doctor, have been ordered to appear for the next hearing on March 22. Several human-right groups, including the Washington, DC-based
Physicians for Human Rights (PHR) have welcomed the new trial. “It is important that those who order or participate in torture be held accountable for their acts. It is a serious violation of medical ethics for health professionals to participate in torture”, Eileen Campbell of PHR told TLID. PHR also called on the Libyan government to immediately release the health workers and collaborate with HIV/AIDS experts to identify and address the shortcomings in Libya’s health system that may contribute to the spread of HIV/AIDS, such as unsafe injection practices and insufficient sterilisation. “Scapegoating foreign health workers is a travesty and will not solve these problems”, Campbell said. Just 2 weeks before the new trial started, the Libyan parliament issued a statement that called for the
execution of the convicted health workers and compensation for the affected families. But two leading HIV researchers—Vittorio Colizzi (Tor Vegatta University, Rome) and Luc Montagnier (Institut Pasteur, Paris), co-discoverer of HIV—commissioned by the Libyan government to investigate the outbreak, have ruled out the possibility of a deliberate spread of HIV by the health-care workers. The Benghazi Criminal Court disregarded the findings of the investigation, complained over 30 leading HIV/AIDS researchers in a letter addressed to Libyan leader Colonel Muammar al-Qadhafi last year. According to Qadhafi, the “deliberate outbreak” was part of a plot by the secret agencies of the USA and Israel to destabilise his country.
Khabir Ahmad
Indian patents may hamper access to antiretrovirals globally International AIDS action groups fear that the supply of cheap antiretroviral drugs from India to poor countries will be hit by the new product patent regime the country has adopted from Jan 1, 2005, and have urged the government to withdraw the new law. Before the new law, India recognised only process patents, and not product patents, helping local companies to make copies of patented drugs and sell them in India as well as other developing countries. This forced multinational companies to reduce prices of antiretrovirals, thereby enhancing access to treatment in many poor countries. Although production of some offpatent generic antiretrovirals will continue, grant of product patents will block generic production of secondline antiretrovirals needed by patients not responding to current treatment regimens. “This will increase prices of new drugs, as well as some AIDS medicines that are already produced and 136
exported in generic form”, said Rolake Nwagwu (Positive Action for Treatment, Nigeria) after a meeting of action groups (Mumbai, India; Jan 13). “Rising treatment costs will spell disaster for people with HIV in India and around the world.” The WHO requested India not to adopt “unnecessary restrictions that are not required under the TRIPS agreement and that would impede access to medicines” while bringing in the new law. However, India chose to go beyond the trade-related aspects of intellectual property rights (TRIPS)— under the new law, patents can be granted not only to new chemicals but also to formulations, polymorphs, combinations, new drug delivery systems, and new use. TRIPS does not require additional patents for new uses or new dosage forms of known medicines. “This clause will block combinations of old drugs also from reaching the generic market. Zidovudine and
lamivudine are pre-1995 drugs and not eligible for product patents in India but their combination— Combivir—is already in the [patent] mailbox. If a patent is granted, manufacture and supply of Combivir by generic manufacturers will have to be stopped”, said Gopa Kumar (Affordable Medicine and Treatment Campaign, Mumbai). “Tenofovir, a commonly used second-line antiretroviral drug, is also in the mailbox, and so Indian generic manufacturers are reluctant to start its production.” The new law prevents export of compulsorily licensed medicines from India without the importing country also having a compulsory license. “This is absurd because there is no obligation to provide product patents until 2016 in less developed countries. How can such a country issue a compulsory license to a product in the absence of patent itself?”, asked Kumar.
Dinesh C Sharma http://infection.thelancet.com Vol 5 March 2005
Libyan officials stand trial for torture of health professionals See Lancet Infect Dis 2004; 4: 130 and 316
AP Photo/Francois Mori
Rights were not granted to include this image in electronic media. Please refer to the printed journal.
A group of Libyan officials accused of torturing five Bulgarian nurses and a Palestinian doctor into making false confessions faces a trial at a Libyan court. In May last year, the health workers were sentenced to death by the Benghazi Criminal Court after they were convicted of deliberately infecting around 400 children with HIV while working in the al-Fateh Children’s Hospital in Benghazi in 1998. Many of the HIV-infected children have since died. The health-care workers have claimed their innocence, and some of them have complained of being tortured by the investigators. The ten accused of torture, including a doctor, have been ordered to appear for the next hearing on March 22. Several human-right groups, including the Washington, DC-based
Physicians for Human Rights (PHR) have welcomed the new trial. “It is important that those who order or participate in torture be held accountable for their acts. It is a serious violation of medical ethics for health professionals to participate in torture”, Eileen Campbell of PHR told TLID. PHR also called on the Libyan government to immediately release the health workers and collaborate with HIV/AIDS experts to identify and address the shortcomings in Libya’s health system that may contribute to the spread of HIV/AIDS, such as unsafe injection practices and insufficient sterilisation. “Scapegoating foreign health workers is a travesty and will not solve these problems”, Campbell said. Just 2 weeks before the new trial started, the Libyan parliament issued a statement that called for the
execution of the convicted health workers and compensation for the affected families. But two leading HIV researchers—Vittorio Colizzi (Tor Vegatta University, Rome) and Luc Montagnier (Institut Pasteur, Paris), co-discoverer of HIV—commissioned by the Libyan government to investigate the outbreak, have ruled out the possibility of a deliberate spread of HIV by the health-care workers. The Benghazi Criminal Court disregarded the findings of the investigation, complained over 30 leading HIV/AIDS researchers in a letter addressed to Libyan leader Colonel Muammar al-Qadhafi last year. According to Qadhafi, the “deliberate outbreak” was part of a plot by the secret agencies of the USA and Israel to destabilise his country.
Khabir Ahmad
Indian patents may hamper access to antiretrovirals globally International AIDS action groups fear that the supply of cheap antiretroviral drugs from India to poor countries will be hit by the new product patent regime the country has adopted from Jan 1, 2005, and have urged the government to withdraw the new law. Before the new law, India recognised only process patents, and not product patents, helping local companies to make copies of patented drugs and sell them in India as well as other developing countries. This forced multinational companies to reduce prices of antiretrovirals, thereby enhancing access to treatment in many poor countries. Although production of some offpatent generic antiretrovirals will continue, grant of product patents will block generic production of secondline antiretrovirals needed by patients not responding to current treatment regimens. “This will increase prices of new drugs, as well as some AIDS medicines that are already produced and 136
exported in generic form”, said Rolake Nwagwu (Positive Action for Treatment, Nigeria) after a meeting of action groups (Mumbai, India; Jan 13). “Rising treatment costs will spell disaster for people with HIV in India and around the world.” The WHO requested India not to adopt “unnecessary restrictions that are not required under the TRIPS agreement and that would impede access to medicines” while bringing in the new law. However, India chose to go beyond the trade-related aspects of intellectual property rights (TRIPS)— under the new law, patents can be granted not only to new chemicals but also to formulations, polymorphs, combinations, new drug delivery systems, and new use. TRIPS does not require additional patents for new uses or new dosage forms of known medicines. “This clause will block combinations of old drugs also from reaching the generic market. Zidovudine and
lamivudine are pre-1995 drugs and not eligible for product patents in India but their combination— Combivir—is already in the [patent] mailbox. If a patent is granted, manufacture and supply of Combivir by generic manufacturers will have to be stopped”, said Gopa Kumar (Affordable Medicine and Treatment Campaign, Mumbai). “Tenofovir, a commonly used second-line antiretroviral drug, is also in the mailbox, and so Indian generic manufacturers are reluctant to start its production.” The new law prevents export of compulsorily licensed medicines from India without the importing country also having a compulsory license. “This is absurd because there is no obligation to provide product patents until 2016 in less developed countries. How can such a country issue a compulsory license to a product in the absence of patent itself?”, asked Kumar.
Dinesh C Sharma http://infection.thelancet.com Vol 5 March 2005