Blogged by: Ruth Gidley
What has an Indian high court case about a cancer drug got to do with 25 million HIV-positive Africans?If AIDS activists are right, it could decide if those Africans live or die.
Hearings started this week. And if the High Court in Chennai sides with pharmaceutical giant Novartis and agrees to grant a patent for its drug Glivec, it would set a precedent for other new drugs to be patented too, including AIDS drugs. And that would make it harder for the world's poorest to get hold of cheap generic medicines. That's what the campaigners are saying.
Novartis itself doesn't make HIV medicines, but Indian-produced generics are central to international programmes to get affordable antiretroviral drugs to people with AIDS in the developing world.
Eighty percent of the drugs international relief agency Medecins Sans Frontieres (MSF) uses in its AIDS projects come from India, and MSF is campaigning for Novartis to drop the case. They've even got a podcast about it.
ARVs - which tranform AIDS from a death sentence into a manageable condition - are taken for granted in high-income countries, but used to be out of reach of the vast majority of the world's population.
Since generic drugs arrived on the scene, the price of treatment has dropped from about $12,000 a year per person to as low as $70 per patient annually. As a result, the number of people on ARVs jumped from next to nothing up to more than 1.6 million as of June 2006.
Even so, the United Nations estimates only 24 percent of people who need drugs get them, and AIDS activists say any threat to Indian generics would hit hardest in sub-Saharan Africa, where two-thirds of the world's 40 million HIV-positive people live.
India has been an important source of affordable generic medicines for quite a while, since it didn't grant pharmaceutical patents until 2005, when it was forced to comply with World Trade Organisation rules on intellectual property.
AIDS activists say Indian companies are likely to find it harder to produce copies of newer, often more effective drugs.
This is particularly important when it comes to AIDS medication because patients tend to become resistant to ARVs over time, and need to move on to so-called second-line treatments which are more expensive.
For example, MSF says second-line drugs already cost $1,400 per patient per year in Kenya, while in Guatemala they're a prohibitive $6,500 annually.
India originally turned down Novartis' patent application for Glivec because it is a new form of a substance that was already known. MSF argues that patents for "new" drugs that aren't significantly different - like a drug becoming a capsule rather than a pill and no longer requiring refrigeration - are threatening lives in the developing world by cutting off access to generics.
Brazil and Thailand are the other big generic drug producers.
Thailand seems to be standing up to the international pharmaceutic companies. This week it confirmed it approved a cheap, copycat version of a blockbuster heart disease medication - the first time a developing country has torn up the international patent for treatments like this - and a generic version of an AIDS drug.
Copycat drugs would initially be imported from India and then produced by Thailand's state-owned drug maker, according to the Health Ministry.
"We have to do this because we don't have enough money to buy safe and necessary drugs for the people under the government's universal health scheme," the health minister explains.
Thai authorities say it will save the country $24 million a year, but it's worrying foreign investors. They say the government - which took power after a September coup - is acting unilaterally and doesn't seem to care about international opinion.
The drug companies argue that you need to protect intellectual property rights in order to stimulate innovation.
But for Monique Wanjala, a Kenyan woman who has lived with HIV for 13 years, this week's court hearing in India is a matter of life and death. "If Novartis gets through with its case our lives are at risk," she told journalists.
It's all pretty complicated, but AlertNet's got a crisis briefing on the AIDS pandemic which gives a clear and thorough explanation of what you really need to know.
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