New law will hinder ARV supply
Jul 25, 2006
SCARING news for the poor living with HIV/AIDS has popped up once again. <i>Reuters</i> reported last week that India is planning to change its drug approval system in a way that would put the price of Anti Retroviral drugs (ARVs) out of reach of millions of poor people.
By Esther Alalo
SCARING news for the poor living with HIV/AIDS has popped up once again. Reuters reported last week that India is planning to change its drug approval system in a way that would put the price of Anti Retroviral drugs (ARVs) out of reach of millions of poor people.
New Delhi, under pressure from the United States and global drug giants, is considering a law that could grant a monopoly to the developer of a new drug for several years even without a patent. Leena Menghaney of Swiss-based Medecins Sans Frontieres, which campaigns for better access to healthcare, says this will seriously affect accessibility to essential drugs for poor people, especially in developing countries.
Particularly threatened are people with HIV who had developed immunity to first-line anti-retroviral drugs and were waiting for second-line drugs to become affordable, Menghaney said.
According to a Reuters report, making generic ARVs has been easy in India. Once a new drug is approved for sale, other drug companies only need to prove that the one they are copying is identical to the original. But innovating drug companies say this is unfair. That they invest millions of dollars collecting the necessary data they need for marketing approval through clinical trials yet the system makes it difficult for them to recover their investment capital.
They argue that this reduces the incentive to research and develop new drugs.
India, as a member of the World Health Organisation (WHO), is being hard pressed to concede to the demands of the US and the giant companies by giving them exclusive rights to reap the benefit of their investment for several years under the Trade-related aspects of Intellectual Property Rights (TRIPs) treaty.
However, other campaigners including WHO argue that facts go beyond what TRIPS require and should not be introduced at the expense of public health.
At least 90,000 Ugandans urgently need ARVs and India remains the main manufacturer of these lifesavers.
But Dr Elizabeth Madra, the Head of the Aids Control Programme at the Ministry of Health, says Uganda is on the verge of manufacturing ARVs. Quality Chemicals Limited, a local agent of CIPLA Ltd, the worlds leading manufacturer of generic pharmaceutical drugs, is constructing the plant in Luzira Industrial Park.
Emmanuel Katongore, the managing director of Quality Chemicals, said the $50m project is expected to start test runs this month and the project is expected to be commissioned in October.
Dr Philip Okumu from Bugolobi Nursing Home said generic drugs have been a blessing to the poor who cannot afford brand names. The cost of one brand name ARV dose can purchase three doses of generic drugs. Okumu said if India yields to the US pressure, over 25 million people in sub-Saharan Africa would be affected. “Very few people can afford branded ARVs. This would mean that over 80% of the people in poor countries would be affected,†he said.
SCARING news for the poor living with HIV/AIDS has popped up once again. Reuters reported last week that India is planning to change its drug approval system in a way that would put the price of Anti Retroviral drugs (ARVs) out of reach of millions of poor people.
New Delhi, under pressure from the United States and global drug giants, is considering a law that could grant a monopoly to the developer of a new drug for several years even without a patent. Leena Menghaney of Swiss-based Medecins Sans Frontieres, which campaigns for better access to healthcare, says this will seriously affect accessibility to essential drugs for poor people, especially in developing countries.
Particularly threatened are people with HIV who had developed immunity to first-line anti-retroviral drugs and were waiting for second-line drugs to become affordable, Menghaney said.
According to a Reuters report, making generic ARVs has been easy in India. Once a new drug is approved for sale, other drug companies only need to prove that the one they are copying is identical to the original. But innovating drug companies say this is unfair. That they invest millions of dollars collecting the necessary data they need for marketing approval through clinical trials yet the system makes it difficult for them to recover their investment capital.
They argue that this reduces the incentive to research and develop new drugs.
India, as a member of the World Health Organisation (WHO), is being hard pressed to concede to the demands of the US and the giant companies by giving them exclusive rights to reap the benefit of their investment for several years under the Trade-related aspects of Intellectual Property Rights (TRIPs) treaty.
However, other campaigners including WHO argue that facts go beyond what TRIPS require and should not be introduced at the expense of public health.
At least 90,000 Ugandans urgently need ARVs and India remains the main manufacturer of these lifesavers.
But Dr Elizabeth Madra, the Head of the Aids Control Programme at the Ministry of Health, says Uganda is on the verge of manufacturing ARVs. Quality Chemicals Limited, a local agent of CIPLA Ltd, the worlds leading manufacturer of generic pharmaceutical drugs, is constructing the plant in Luzira Industrial Park.
Emmanuel Katongore, the managing director of Quality Chemicals, said the $50m project is expected to start test runs this month and the project is expected to be commissioned in October.
Dr Philip Okumu from Bugolobi Nursing Home said generic drugs have been a blessing to the poor who cannot afford brand names. The cost of one brand name ARV dose can purchase three doses of generic drugs. Okumu said if India yields to the US pressure, over 25 million people in sub-Saharan Africa would be affected. “Very few people can afford branded ARVs. This would mean that over 80% of the people in poor countries would be affected,†he said.